10q10k10q10k.net

What changed in FEMASYS INC's 10-K — 2024 vs 2025

vs

Paragraph-level year-over-year comparison of FEMASYS INC's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+462 added−408 removedSource: 10-K (2026-03-31) vs 10-K (2025-03-27)

Top changes in FEMASYS INC's 2025 10-K

462 paragraphs added · 408 removed · 341 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

143 edited+54 added−32 removed196 unchanged
Biggest changeProducts Our Artificial Insemination Solution. 510(k) Clearance for FemaSeed Intratubal Insemination Device FemaSeed, our FDA-cleared innovative advancement in artificial insemination, is designed to enhance fertilization by precisely delivering sperm into the fallopian tube, the natural site of conception. It offers a safe, accessible and cost-effective first-line therapeutic option for infertile women, men and couples seeking pregnancy through insemination.
Biggest changeThis PMS study is a key component of Femasys’ long-term commitment to monitor the safety and performance of its products in real‑world settings while complying with the rigorous post-market requirements introduced under the MDR framework (Annex XIV Part B). 13 Table of Contents Products Our Artificial Insemination Solution. 510(k) Clearance for FemaSeed Intratubal Insemination Device FemaSeed, our FDA-cleared innovative advancement in artificial insemination, is designed to enhance fertilization by precisely delivering sperm into the fallopian tube, the natural site of conception.
Our Intellectual Property and Production Capabilities We have designed and developed the proprietary methods utilized in our women’s health solutions so that they are protected by patents, know-how, and trade secrets. Each product and product candidate in our portfolio is covered by both design and utility patents in the U.S. and significant ex-U.S. markets.
Our Intellectual Property and Production Capabilities We have designed and developed the proprietary methods utilized in our women’s health solutions so that they are protected by patents, know-how, and trade secrets. Each product and U.S. product candidate in our portfolio is covered by both design and utility patents in the U.S. and significant ex-U.S. markets.
This is significantly lower than the performance goal of 6% based on the historical control, surgical sterilization (one-sided p-value=0.0426). Safety reports were consistent with those typically observed for intrauterine transcervical procedures, with no on-going safety concerns through five years. There were no reports of serious adverse events (n=0/229).
This is significantly lower than the performance goal of 6% based on the historical control, surgical sterilization (one-sided p-value=0.0426). Safety reports were consistent with those typically observed for intrauterine transcervical procedures, with no on-going safety concerns through five years. There were no reports of serious adverse events (n=0/229).
The trial met its primary endpoint with a pregnancy rate per subject of 26.3% (95%CI: 13.4‒43.1%; n=10/38) and 17.5% per cycle (95%LCB: 7.6%, 95%CI: 5.7‒29.4%; n=10/57), which was significantly higher than the performance goal of 7% based on the historical control (one-sided P =0.041). Safety reports were consistent with IUI.
The trial met its primary endpoint with a pregnancy rate per subject of 26.3% (95%CI: 13.4‒43.1%; n=10/38) and 17.5% per cycle (95%LCB: 7.6%, 95%CI: 5.7‒29.4%; n=10/57), which was significantly higher than the performance goal of 7% based on the historical control (one-sided P =0.041). Safety reports were consistent with IUI.
The publication entitled, “FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes” includes positive data from three initial clinical trials (Clinicaltrials.gov NCT03067272, NCT03433911, and NCT04273594). The pregnancy rate for FemBloc subjects, who met trial eligibility and were determined bilaterally occluded after a confirmation test three months post-FemBloc was 0% (95%UCB: 0.057; n=0/51).
The publication entitled, “FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes” includes positive data from three initial clinical trials (Clinicaltrials.gov NCT03067272, NCT03433911, and NCT04273594). The pregnancy rate for FemBloc subjects, who met trial eligibility and were determined bilaterally occluded after a confirmation test three months post-FemBloc was 0% (95%UCB: 0.057; n=0/51).
This is significantly lower than the performance goal of 6% based on the historical control, surgical sterilization (one-sided p-value=0.0426). Safety reports were consistent with those typically observed for intrauterine transcervical procedures, with no on-going safety concerns through five years. There were no reports of serious adverse events (n=0/229).
This is significantly lower than the performance goal of 6% based on the historical control, surgical sterilization (one-sided p-value=0.0426). Safety reports were consistent with those typically observed for intrauterine transcervical procedures, with no on-going safety concerns through five years. There were no reports of serious adverse events (n=0/229).
In addition, the study is designed as a roll-in beginning with enrollment of 50 women for a clinical readout primarily of preliminary safety data prior to enrolling the remaining subjects. An interim analysis of clinical data endpoints is planned once 300 women have used FemBloc for permanent birth control for one year. Follow-up will continue annually for five years post-market.
In addition, the study is designed as a roll-in beginning with enrollment of 50 women for a clinical readout primarily of preliminary safety data prior to enrolling the remaining subjects. An interim analysis of clinical data endpoints is planned once 300 women have used FemBloc for permanent birth control for one year. Follow-up will continue annually for five years post-market.
The trial met its primary endpoint with a pregnancy rate per subject of 26.3% (95%CI: 13.4‒43.1%; n=10/38) and 17.5% per cycle (95%LCB: 7.6%, 95%CI: 5.7‒29.4%; n=10/57), which was significantly higher than the performance goal of 7% based on the historical control (one-sided P =0.041). Safety reports were consistent with IUI.
The trial met its primary endpoint with a pregnancy rate per subject of 26.3% (95%CI: 13.4‒43.1%; n=10/38) and 17.5% per cycle (95%LCB: 7.6%, 95%CI: 5.7‒29.4%; n=10/57), which was significantly higher than the performance goal of 7% based on the historical control (one-sided P =0.041). Safety reports were consistent with IUI.
Delivery of washed spermatozoa directly into the utero-tubal ostium and fallopian tube without catheterization likely increases sperm-oocyte interaction, suggestive of improved efficiency over conventional intrauterine insemination particularly for male-factor infertility. In March 2024, we announced the first commercial use of FemaSeed. In September 2024, we announced the strategic distribution partnerships for FemaSeed and FemVue in Spain.
Delivery of washed spermatozoa directly into the utero-tubal ostium and fallopian tube without catheterization likely increases sperm-oocyte interaction, suggestive of improved efficiency over conventional intrauterine insemination particularly for male-factor infertility. In March 2024, we announced the first commercial use of FemaSeed. In September 2024, we announced strategic distribution partnerships for FemaSeed and FemVue in Spain.
Beginning in 2022, applicable manufacturers also are required to report information regarding payments and transfers of value provided to advanced practice providers, including physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists and certified nurse-midwives.
Beginning in 2022, applicable manufacturers are also required to report information regarding payments and transfers of value provided to advanced practice providers, including physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists and certified nurse-midwives.
These include: • establishment registration and device listing; • the Quality System Regulation, or QSR, which requires manufacturers, including third-party contract manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process; • labeling regulations and the FDA prohibitions against the promotion of products for uncleared or unapproved uses (“off-label” uses) and other requirements related to promotional activities, including the advertising of restricted devices; • medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury, or if their device malfunctioned and the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; • corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections or removals if undertaken to reduce a risk to health posed by a device or to remedy a violation of the FDCA that may present a risk to health; and • post market surveillance regulations, which apply to certain Class II or III devices when necessary to protect the public health or to provide additional safety and efficacy data for the device.
These include: • establishment registration and device listing; • the Quality System Regulation, or QSR, which requires manufacturers, including third-party contract manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process; • labeling regulations and the FDA prohibitions against the promotion of products for uncleared or unapproved uses (“off-label” uses) and other requirements related to promotional activities, including the advertising of restricted devices; • medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury, or if their device malfunctioned and the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; 23 Table of Contents • corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections or removals if undertaken to reduce a risk to health posed by a device or to remedy a violation of the FDCA that may present a risk to health; and • post market surveillance regulations, which apply to certain Class II or III devices when necessary to protect the public health or to provide additional safety and efficacy data for the device.
Blocked fallopian tubes are necessary for successful permanent birth control, and FemChec offers significant advantages over other existing approaches, including use of existing ultrasound. In June 2023 we received an IDE approval from the FDA to allow us to initiate the pivotal trial for the FemBloc system followed by a confirmation test with FemChec (Clinicaltrials.gov NCT05977751).
Blocked fallopian tubes are necessary for successful permanent birth control, and FemChec offers significant advantages over other existing approaches, including use of existing ultrasound. In June 2023 we received an IDE approval from the FDA to allow us to initiate the first phase of the pivotal trial for the FemBloc system followed by a confirmation test with FemChec (Clinicaltrials.gov NCT05977751).
Our non-surgical permanent birth control solution, FemBloc, is complimented by our diagnostic companion product, FemChec, an FDA-cleared product that creates natural saline and air contrast that is delivered in a controlled manner for a safe, reliable, real-time evaluation of the fallopian tubes using ultrasound for confirmation of procedure success often by the same healthcare practitioner.
Our non-surgical permanent birth control solution, FemBloc, is complemented by our diagnostic companion product, FemChec, an FDA-cleared product that creates natural saline and air contrast that is delivered in a controlled manner for a safe, reliable, real-time evaluation of the fallopian tubes using ultrasound for confirmation of procedure success often by the same healthcare practitioner.
Failure by us or by our suppliers to comply with applicable regulatory requirements can result in enforcement action by the FDA or state authorities, which may include any of the following sanctions: • warning or untitled letters, fines, injunctions, consent decrees and civil penalties; customer notifications, voluntary or mandatory recall or seizure of our products; • operating restrictions, partial suspension or total shutdown of production; • delay in processing submissions or applications for new products or modifications to existing products; 23 Table of Contents • withdrawing PMA approvals that have already been granted; and • criminal prosecution.
Failure by us or by our suppliers to comply with applicable regulatory requirements can result in enforcement action by the FDA or state authorities, which may include any of the following sanctions: • warning or untitled letters, fines, injunctions, consent decrees and civil penalties; customer notifications, voluntary or mandatory recall or seizure of our products; • operating restrictions, partial suspension or total shutdown of production; • delay in processing submissions or applications for new products or modifications to existing products; • withdrawing PMA approvals that have already been granted; and • criminal prosecution.
The FDA can also impose sales, marketing or other restrictions on devices in order to ensure that they are used in a safe and effective manner. 510(k) Clearance Pathway When a 510(k) clearance is required, we must submit a pre-market notification to the FDA demonstrating that our proposed device is substantially equivalent to a predicate device, which may be a previously cleared and legally marketed 510(k) device or a device that was in commercial distribution before May 28, 1976, or a device that that was de novo classified under section 513(f)(2) of the FDCA.
The FDA can also impose sales, marketing or other restrictions on devices in order to ensure that they are used in a safe and effective manner. 20 Table of Contents 510(k) Clearance Pathway When a 510(k) clearance is required, we must submit a pre-market notification to the FDA demonstrating that our proposed device is substantially equivalent to a predicate device, which may be a previously cleared and legally marketed 510(k) device or a device that was in commercial distribution before May 28, 1976, or a device that that was de novo classified under section 513(f)(2) of the FDCA.
Our experienced leadership team with concentrated development and execution expertise has an unwavering commitment to advancing women’s health. We have raised over $130 million since inception from both institutional and strategic investors, including Medtronic and executives from leading life science companies and our initial public offering, or IPO, in June 2021.
Our experienced leadership team with concentrated development and execution expertise has an unwavering commitment to advancing women’s health. We have raised over $170 million since inception from both institutional and strategic investors, including Medtronic and executives from leading life science companies and our initial public offering, or IPO, in June 2021.
In March 2024, topline data was announced, followed by the data published in the Journal of Gynecology & Reproductive Medicine (JGRM) in November 2024. The publication titled, “FemaSeed directional intratubal artificial insemination for couples with male-factor or unexplained infertility associated with low male sperm count,” includes positive data from the pivotal trial ( Clinicaltrials.gov NCT04968847 ).
In March 2024, topline data were announced, followed by the data published in the Journal of Gynecology & Reproductive Medicine (JGRM) in November 2024. The publication titled, “FemaSeed directional intratubal artificial insemination for couples with male-factor or unexplained infertility associated with low male sperm count,” includes positive data from the pivotal trial ( Clinicaltrials.gov NCT04968847 ).
We perform our own final quality control testing of each product and product candidate, and we have complete control over all aspects of the manufacturing process and are compliant with QSR good manufacturing practice regulations applicable to our products. Our suppliers are managed through our supplier management program that is focused on reducing supply chain risk.
We perform our own final quality control testing of each product and U.S. product candidate, and we have complete control over all aspects of the manufacturing process and are compliant with QSR good manufacturing practice regulations applicable to our products. Our suppliers are managed through our supplier management program that is focused on reducing supply chain risk.
Although we believe that there are several potential alternative suppliers who could provide these components, we may incur added costs and delays in identifying and qualifying any such replacement. Finally, for our products and product candidate, we utilize third-party sterilizers to ensure these single-use products are packaged and shipped sterile for use.
Although we believe that there are several potential alternative suppliers who could provide these components, we may incur added costs and delays in identifying and qualifying any such replacement. Finally, for our products and U.S. product candidate, we utilize third-party sterilizers to ensure these single-use products are packaged and shipped sterile for use.
These issued patents, and any patents granted from such applications, are expected to expire between 2025 and 2046, without taking potential patent term extensions or adjustments into account. We believe that the patents expiring in 2025 are not material to our business. In the United States, our FemBloc patent portfolio includes two patent families.
These issued patents, and any patents granted from such applications, are expected to expire between 2025 and 2046, without taking potential patent term extensions or adjustments into account. We believe that the patents expiring in 2025 are not material to our business. In the United States, our controlled delivery FemBloc patent portfolio includes two patent families.
Genetic testing of the eggs or embryo, also known as preimplantation genetic testing (PGT), are often optional costs up to $10,000 or more if disorders are tested. IVF/ICSI is also physically and emotionally demanding for the patient, with an increased risk of ectopic pregnancy and miscarriage.
Genetic testing of the eggs or embryo, also known as preimplantation genetic testing (PGT), is an often optional cost up to $10,000 or more if disorders are tested. IVF/ICSI is also physically and emotionally demanding for the patient, with an increased risk of ectopic pregnancy and miscarriage.
The Company is a woman-founded and led company with an expansive, internally created intellectual property portfolio with approximately 200 issued patents globally, in-house chemistry, manufacturing, and controls (CMC) and device manufacturing capabilities and proven ability to develop products with commercialization efforts underway.
The Company is a woman-founded and led company with an expansive, internally created intellectual property portfolio with approximately 228 issued patents globally, in-house chemistry, manufacturing, and controls (CMC) and device manufacturing capabilities and proven ability to develop products with commercialization efforts underway.
As a manufacturer, our facilities, records and manufacturing processes are subject to periodic scheduled or unscheduled inspections by the FDA and the CDHS. Our failure to maintain compliance with the QSR could result in the shutdown of, or restrictions on, our manufacturing operations and the recall or seizure of our products.
As a manufacturer, our facilities, records and manufacturing processes are subject to periodically scheduled or unscheduled inspections by the FDA and the CDHS. Our failure to maintain compliance with the QSR could result in the shutdown of, or restrictions on, our manufacturing operations and the recall or seizure of our products.
Information related to the device, patient population, phase of investigation, study sites and investigators and other aspects of the clinical trial is made public as part of the registration. 22 Table of Contents Ongoing Regulation by the FDA Even after a device receives clearance, grant of a de novo classification request or approval and is placed on the market, numerous regulatory requirements apply.
Information related to the device, patient population, phase of investigation, study sites and investigators and other aspects of the clinical trial is made public as part of the registration. Ongoing Regulation by the FDA Even after a device receives clearance, grant of a de novo classification request or approval and is placed on the market, numerous regulatory requirements apply.
Also, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory clearance or approval of our products under development. We are also subject to other federal, state and local laws and regulations relating to safe working conditions, laboratory and manufacturing practices.
Also, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory clearance or approval of our products under development. 24 Table of Contents We are also subject to other federal, state and local laws and regulations relating to safe working conditions, laboratory and manufacturing practices.
Many women, who spend an average of three years seeking to become pregnant and thirty years avoiding pregnancy, are not satisfied with the current methods for preventing unwanted pregnancies and achieving pregnancy (Gutttmacher Institute, 2019).
Many women, who spend an average of three years seeking to become pregnant and thirty years avoiding pregnancy, are not satisfied with the current methods for preventing unwanted pregnancies and achieving pregnancy (Guttmacher Institute, 2019).
In February 2025, we announced a peer-reviewed publication of positive data from its initial clinical trials of FemBloc permanent birth control in the Journal of Gynecology & Reproductive Medicine (JGRM), a leading journal covering gynecology and reproductive medicine.
In February 2025, we announced a peer-reviewed publication of positive data from our initial clinical trials of FemBloc permanent birth control in the Journal of Gynecology & Reproductive Medicine (JGRM), a leading journal covering gynecology and reproductive medicine.
While we plan to continue manufacturing our product and product candidate, if approved or granted marketing authorization, we will consider outsourcing arrangements for certain sub-assemblies as needed as we scale our commercial production.
While we plan to continue manufacturing our product and U.S. product candidate, if approved or granted marketing authorization, we will consider outsourcing arrangements for certain sub-assemblies as needed as we scale our commercial production.
Since FemBloc requires both fallopian tubes are blocked for use as permanent birth control, FemChec is an essential companion diagnostic. FemChec is U.S. FDA-cleared with approvals in Europe and Canada. FemChec can be used with our FDA-cleared and marketed FemCath device, which allows for selective evaluation of each fallopian tube.
Since FemBloc required that both fallopian tubes are blocked for use as permanent birth control, FemChec is an essential companion diagnostic. FemChec is U.S. FDA-cleared with approvals in Europe and Canada. FemChec can be used with our FDA-cleared and marketed FemCath device, which allows for selective evaluation of each fallopian tube.
Enforcement agencies also continue to pursue novel theories of liability under these laws, such as indirect remuneration, off-label promotion, HIPAA noncompliance and violations of the Sunshine Act. 26 Table of Contents Enforcement and Penalties for Noncompliance with Fraud and Abuse Laws and Regulations Compliance with these federal and state laws and regulations requires substantial resources.
Enforcement agencies also continue to pursue novel theories of liability under these laws, such as indirect remuneration, off-label promotion, HIPAA noncompliance and violations of the Sunshine Act. Enforcement and Penalties for Noncompliance with Fraud and Abuse Laws and Regulations Compliance with these federal and state laws and regulations requires substantial resources.
Our suite of products and product candidate addresses what we believe are multi-billion dollar global market segments in which there has been little advancement for many years, helping women avoid pharmaceutical solutions, implants and surgery that can be expensive and expose women to harm. 5 Table of Contents The following table summarizes our current products and product candidate pipeline: FemaSeed – Our Artificial Insemination Therapeutic Solution and FemVue – Our Companion Diagnostic for Tubal Evaluation .
Our suite of products and U.S. product candidate addresses what we believe are multi-billion dollar global market segments in which there has been little advancement for many years, helping women avoid pharmaceutical solutions, implants and surgery that can be expensive and expose women to harm. 5 Table of Contents The following table summarizes our current products and product candidate pipeline: FemaSeed – Our Artificial Insemination Therapeutic Solution, FemVue – Our Companion Diagnostic for Tubal Evaluation and FemSperm – Our Sperm Handling Solution .
Other publications have stated that FemVue is an accurate test for diagnosing tubal occlusion, performs similarly to a fluoroscopic HSG and could potentially replace fluoroscopic HSG. Our Endocervical Tissue Sampler. Post-Market Information FemCerv, a next generation endocervical tissue sampler for cervical cancer diagnosis, is U.S. FDA-cleared with approvals in Europe, UK, Canada and Israel.
Other publications have stated that FemVue is an accurate test for diagnosing tubal occlusion, performs similarly to a fluoroscopic HSG and could potentially replace fluoroscopic HSG. 14 Table of Contents Our Endocervical Tissue Sampler. Post-Market Information FemCerv, a next generation endocervical tissue sampler for cervical cancer diagnosis, is U.S. FDA-cleared with approvals in Europe, UK, Canada and Israel.
Over time, the blended polymer fully degrades and produces nonfunctional scar tissue to permanently block the fallopian tubes in the safest most natural approach. This is in stark contrast to centuries-old surgical sterilization with reported risks that include infection, minor or major bleeding, injury to nearby organs, anesthesia-related events, and even death.
Over time, the blended polymer fully degrades and produces nonfunctional scar tissue to permanently block the fallopian tubes in a safe and natural approach. This is in stark contrast to centuries-old surgical sterilization with reported risks that include infection, minor or major bleeding, injury to nearby organs, anesthesia-related events, and even death.
The increased flexibility has ultimately allowed states to offer marketplace plans with variations in coverage, compared to the original mandates of the ACA. In addition, other legislative changes have been proposed and adopted since the passage of the ACA.
The increased flexibility has ultimately allowed states to offer marketplace plans with variations in coverage, compared to the original mandates of the ACA. 28 Table of Contents In addition, other legislative changes have been proposed and adopted since the passage of the ACA.
Devices that are classified into class I or class II in response to a de novo classification request may be marketed and used as predicates for future premarket notification 510(k) submissions.
Devices that are classified into class I or class II in response to a de novo classification request may be marketed and used as predicates for future pre-market notification 510(k) submissions.
Along with the various surgical risks, some patients may not qualify as good surgical candidates due to obesity or medical comorbidities. The FemBloc non-surgical approach has the potential to offer a safer, more accessible in-office alternative with fewer risks, contraindications, and substantially lower cost.
Along with the various surgical risks, some patients may not qualify as good surgical candidates due to obesity or medical comorbidities. The FemBloc non-surgical approach has the potential to offer a safe and effective, more accessible in-office alternative with fewer risks, contraindications, and substantially lower cost than the surgical alternative.
Peer-reviewed publication of positive data from its initial clinical trials of FemBloc have demonstrated compelling effectiveness and five-year safety with high satisfaction from both patients and practitioners.
A peer-reviewed publication of positive data from its initial clinical trials of FemBloc has demonstrated compelling effectiveness and five-year safety with high satisfaction from both patients and practitioners.
The two patent families include granted utility and design patents providing protection until at least 2027, 2032, and 2033. The utility patent family includes a pending patent application, which if granted, could result in a patent expiring in 2033. Our controlled delivery device patent portfolio includes one patent family.
The two patent families include granted utility and design patents providing protection until at least 2027, 2032, and 2033. The utility patent family includes a pending patent application, which if granted, could result in a patent expiring in 2033. Our FemEMB patent portfolio includes one patent family. The patent family includes granted utility patents providing protection until at least 2033.
The market for assisted reproduction is large and growing, and we believe the market in the United States alone could exceed $2 billion with a safe and effective novel first-line approach as women move to seek care for the treatment of infertility. Clinical Development Overview of Clinical Programs .
The market for assisted reproduction is large and growing, and we believe the market in the United States alone could exceed $1 billion with a safe and effective novel first-line approach as women move to seek care for the treatment of infertility. 12 Table of Contents Clinical Development Overview of Clinical Programs .
Any resulting changes in regulation may result in unexpected delays, increased costs, or other negative impacts that are difficult to predict but could have a material adverse effect on our business and financial condition. Employees and Human Capital Resources As of December 31, 2024, we employed 69 full-time employees and two part-time employees.
Any resulting changes in regulation may result in unexpected delays, increased costs, or other negative impacts that are difficult to predict but could have a material adverse effect on our business and financial condition. Employees and Human Capital Resources As of December 31, 2025, we employed 51 full-time employees and 3 part-time employees.
We believe our FemaSeed product has the potential to offer a first-line approach with local delivery of sperm directly to the fallopian tube where conception occurs. We estimate the immediately addressable U.S. market for FemaSeed and FemVue, a companion diagnostic product, may be over $1 billion.
We believe our FemaSeed product has the potential to offer a first-line approach with local delivery of sperm directly to the fallopian tube where conception occurs. We estimate the immediately addressable U.S. market for FemaSeed, FemVue, a companion diagnostic product, and FemSperm, for in-office handling of sperm by the gynecologist, may be over $1 billion.
Many infertile women and couples are unwilling to undergo treatment mostly due to financial reasons. IVF is extremely expensive, costing as much as $15,000 to $30,000 per IVF cycle according to Forbes Health, 2021 (with cycle effectiveness usually only around 25%), and often not covered by insurance.
Many infertile women and couples are unwilling to undergo treatment mostly due to financial reasons as services are provided by referral to an infertility center. IVF is extremely expensive, costing as much as $15,000 to $30,000 per IVF cycle according to Forbes Health, 2021 (with cycle effectiveness usually only around 25%), and often not covered by insurance.
We have passed numerous manufacturing audits, including those by the FDA and international notified bodies. 8 Table of Contents Our Strategy Our goal is to become a global leader in women’s health providing safe and effective solutions that have the potential to disrupt and grow the market segments for which they address.
We have passed numerous manufacturing audits, including those by the FDA and international notified bodies. Our Strategy Our goal is to become a global leader in women’s health providing safe and effective solutions that have the potential to disrupt and grow the market segments that they address.
Only a little over half of these women proceed with some form of intervention, and only a very small proportion undergo more advanced assisted reproductive technologies such as IVF.
Only a little over half of these women proceed with some form of intervention, and only a very small proportion undergo more advanced assisted reproductive technologies such as IVF at a referral infertility center.
With the 510(k) clearance from the FDA and regulatory approval from Europe, UK, Canada and Israel for FemaSeed, we have recruited a direct sales force comprising approximately 10 sales representatives with strong sales backgrounds and experience in medical device sales, and with possible existing relationships with reproductive endocrinologists and gynecologists for commercialization in the U.S.
With the 510(k) clearance from the FDA and regulatory approval from Europe, UK, Canada and Israel for FemaSeed, we have recruited a direct sales force comprising approximately 10 sales representatives with strong sales backgrounds and experience in medical device sales to gynecologists for commercialization in the U.S.
For additional information regarding obligations under federal healthcare statutes and regulations, please see the section titled “Risk Factors—If we fail to comply with U.S. federal and state fraud and abuse laws and regulations, including those relating to kickbacks and false claims for reimbursement, we could face substantial penalties and our business operations and financial condition could be adversely affected.” United States Healthcare Reform There have been and continue to be proposals by the federal government, state governments, regulators and third-party payors to control or manage the increased costs of healthcare and, more generally, to reform the U.S. healthcare system.
Corporate Integrity Agreements typically impose substantial costs on companies to ensure compliance. 27 Table of Contents For additional information regarding obligations under federal healthcare statutes and regulations, please see the section titled “Risk Factors—If we fail to comply with U.S. federal and state fraud and abuse laws and regulations, including those relating to kickbacks and false claims for reimbursement, we could face substantial penalties and our business operations and financial condition could be adversely affected.” United States Healthcare Reform There have been and continue to be proposals by the federal government, state governments, regulators and third-party payors to control or manage the increased costs of healthcare and, more generally, to reform the U.S. healthcare system.
The vast majority of subjects stated they would probably or definitely recommend FemBloc, and investigator satisfaction was similarly high. 7 Table of Contents In March 2025, we announced CE mark certification under EU MDR as the first regulatory approval in the world for the FemBloc delivery system for non-surgical female permanent birth control.
The vast majority of subjects stated they would probably or definitely recommend FemBloc, and investigator satisfaction was similarly high. 7 Table of Contents In March 2025, we announced CE mark certification under EU MDR as the first regulatory approval in the world for the FemBloc delivery system for non-surgical female permanent birth control and in June 2025, we announced CE mark certification under EU MDR for the class III blended polymer component, achieving approval for the entire FemBloc system in the EU.
To commercialize medical devices in the EU, we must have a CE marking that demonstrates compliance with the MDR. 24 Table of Contents Other Regions Most major markets have different levels of regulatory requirements for medical devices. Modifications to the cleared or approved products may require a new regulatory submission in all major markets.
To commercialize medical devices in the EU, we must obtain and maintain a CE marking demonstrating compliance with the MDR. 25 Table of Contents Other Regions Most major markets have different levels of regulatory requirements for medical devices. Modifications to the cleared or approved products may require a new regulatory submission in all major markets.
We believe our FemBloc system has the potential to offer the first non-surgical, non-implant option performed exclusively in the providers’ office without the use of anesthesia, which would potentially allow a doctor to perform multiple procedures in the same room.
We believe our FemBloc system has the potential to offer the first non-surgical, non-implant option performed exclusively in the provider’s office without the risk of general anesthesia and incisions, which would potentially allow a doctor to perform multiple procedures in the same room.
In addition, new competition and products may arise due to consolidation within the industry and other companies may develop products that could compete with our products or product candidate, and there may be product candidates in early stages of development of which we are not aware. Sales & Marketing FemaSeed – Our Artificial Intratubal Insemination Solution.
In addition, new competition and products may arise due to consolidation within the industry and other companies may develop products that could compete with our products or U.S. product candidate, and there may be product candidates in early stages of development of which we are not aware.
In March 2025, we announced strategic distribution partnerships for FemBloc in Spain. FemBloc has the potential to offer significant advantages over the only existing option, surgical sterilization (i.e., tubal ligation or “having her tubes tied”), including a significant cost savings at likely half the overall cost and a confirmation test to ensure procedure success.
FemBloc has the potential to offer significant advantages over the only existing option, surgical sterilization (i.e., tubal ligation or “having her tubes tied”), including a significant cost savings at likely half the overall cost and a confirmation test to ensure procedure success.
In September 2024, we announced the strategic distribution partnerships for FemaSeed and FemVue in Spain. In October and December 2024 and March 2025, we announced partnerships with prominent infertility center conglomerates, Boston IVF, HRC Fertility, and CNY Fertility, respectively. Continuously innovate to introduce additional product offerings for women .
In September 2024, we announced the strategic distribution partnerships for FemaSeed and FemVue in Spain. In October and December 2024 and March 2025, we announced partnerships with prominent infertility center conglomerates, Boston IVF, HRC Fertility, and CNY Fertility, respectively.
We expect to begin building our sales organization prior to potential FDA approval of the product candidate in the U.S. We plan to engage in awareness raising activities, highlighting the benefits of our FemBloc system in jurisdictions where we are approved to market.
We expect to begin building our sales organization in advance of potential FDA approval of the product candidate in the U.S. We plan to conduct awareness education initiatives, highlighting the benefits of our FemBloc system in jurisdictions where we are approved to market.
We do not have long-term supply agreements and we purchase certain components for our products on a purchase order basis. We do not currently have arrangements in place for redundant supply of certain components of our products. If our current third-party suppliers cannot perform as agreed, we may be required to replace those suppliers.
We do not currently have arrangements in place for redundant supply of certain components of our products. If our current third-party suppliers cannot perform as agreed, we may be required to replace those suppliers.
In November 2024, we announced a peer-review publication of positive data from its pivotal trial in the Journal of Gynecology & Reproductive Medicine (JGRM), a leading journal covering gynecology and reproductive medicine.
Topline results of the clinical trial were announced in March 2024. In November 2024, we announced a peer-reviewed publication of positive data from its pivotal trial in the Journal of Gynecology & Reproductive Medicine (JGRM), a leading journal covering gynecology and reproductive medicine.
Additional sonographic training will be required for the healthcare practitioners or sonographers who will support the ultrasound confirmation test. Based on our clinical experience to date, we believe the healthcare practitioners and sonographers will require minimal training and it can be accomplished largely online. Those with FemVue experience will require minimal training for the confirmation test.
Based on our clinical experience to date, we believe the healthcare practitioners and sonographers will require minimal training and it can be accomplished largely through online training program. Those with FemVue experience will require minimal training for the confirmation test.
In March 2025, we announced Conformité Européene (CE) mark certification under European Union Medical Device Regulation (EU MDR) as the first regulatory approval in the world for the FemBloc delivery system for non-surgical female permanent birth control.
In March 2025, we announced Conformité Européene (CE) mark certification under European Union (“EU”) Medical Device Regulation (“MDR”) as the first regulatory approval in the world for the FemBloc delivery system for non-surgical female permanent birth control and in June 2025, we announced CE mark certification under EU MDR for the class III blended polymer component, achieving approval for the entire FemBloc system in the EU.
The two patent families include granted design patents providing protection until at least 2034 and 2049. The utility patent family include a pending patent application, which if it provides the priority for a granted patent, could result in patents expiring in 2044, plus any eligible patent term adjustments and extensions. Our FemChec patent portfolio includes five patent families.
The utility patent family includes two pending patent applications, which if it provides the priority for a granted patent, could result in patents expiring at least in 2045, plus any eligible patent term adjustments and extensions. Our FemChec patent portfolio includes five patent families.
Approximately 1.2 million women undergo surgical tubal ligation each year in the United States alone (Martinez, 2024), with an average cost of approximately $6,000 per procedure (Planned Parenthood, 2019).
Approximately 1.2 million women undergo surgical tubal ligation each year in the United States alone (Martinez, 2024), with an average cost of approximately $6,000 per procedure (Planned Parenthood, 2019). The total cost is estimated to be higher with the increase in surgical operating room costs.
In addition, we plan to continue to expand our in-house manufacturing capabilities as we scale to meet the demand and introduce new products while evaluating potential suppliers to assess the viability of outsourcing portions of our manufacturing and assembly processes to ensure significant growth, profitability and operating leverage. 10 Table of Contents Expand gynecologists’ practice capabilities by diversifying products and services to include artificial insemination with FemaSeed.
In addition, we plan to continue to expand our in-house manufacturing capabilities as we scale to meet the demand and introduce new products while evaluating potential suppliers to assess the viability of outsourcing portions of our manufacturing and assembly processes to ensure significant growth, profitability and operating leverage.
Department of Health and Human Services Office of Inspector General in order to avoid exclusion from participation (i.e., loss of coverage for their products) in federal healthcare programs such as Medicare and Medicaid. Corporate Integrity Agreements typically impose substantial costs on companies to ensure compliance.
Department of Health and Human Services Office of Inspector General in order to avoid exclusion from participation (i.e., loss of coverage for their products) in federal healthcare programs such as Medicare and Medicaid.
While we have confidence in the measures we take to protect and preserve our trade secrets and proprietary information, such measures can be breached, and we may not have adequate remedies for any such breach. In addition, our trade secrets and proprietary information may otherwise become known or be independently discovered by competitors.
However, trade secrets and proprietary information can be difficult to protect. While we have confidence in the measures we take to protect and preserve our trade secrets and proprietary information, such measures can be breached, and we may not have adequate remedies for any such breach.
In March 2025, we announced strategic distribution partnerships for FemBloc in Spain. In June 2023 we received FDA approval of our IDE to evaluate the safety and efficacy of FemBloc, our non-surgical, non-implant, in-office solution for permanent birth control in a pivotal clinical trial.
Our Permanent Birth Control Solution – FemBloc and ultrasound confirmation with FemChec Clinical Trials In June 2023 we received FDA approval of our IDE to evaluate the safety and efficacy of FemBloc, our non-surgical, non-implant, in-office solution for permanent birth control in a pivotal clinical trial.
We rely on a combination of patent, trademark, trade secret, copyright and other intellectual property rights and measures to protect the intellectual property rights that we consider important to our business. We also rely on know-how and continuing technological innovation to develop and maintain our competitive position.
We rely on a combination of patent, trademark, trade secret, copyright and other intellectual property rights and measures to protect the intellectual property rights that we consider important to our business.
FemBloc – Our Permanent Birth Control Solution. In March 2025, we announced CE mark certification under EU MDR as the first regulatory approval in the world for the FemBloc delivery system for non-surgical female permanent birth control.
In March 2025, we announced CE mark certification under EU MDR as the first regulatory approval in the world for the FemBloc delivery system for non-surgical female permanent birth control and in June 2025, we announced CE mark certification under EU MDR for the class III blended polymer component, achieving approval for the entire FemBloc system in the EU.
The first subject was enrolled in July 2021. In October 2022, we announced an updated study design for the pivotal trial to focus on couples experiencing male factor infertility, an underserved patient segment. In April 2023 we received approval to sell FemaSeed in Canada. In September 2023 we announced 510(k) clearance from the FDA for FemaSeed for ITI.
In April 2021 we received an IDE approval from the FDA that allowed us to initiate a pivotal trial for the FemaSeed device. The first subject was enrolled in July 2021. In October 2022, we announced an updated study design for the pivotal trial to focus on couples experiencing male factor infertility, an underserved patient segment.
Our FemaSeed patent portfolio includes three patent families. Two patent families include granted utility and design patents providing protection until at least 2025 and 2044. We believe that the patents expiring in 2025 are not material to our business.
Our FemVue patent portfolio includes five patent families, including granted utility and design patents providing protection until at least 2026 and 2028. We believe that the patents expiring in 2026 are not material to our business.
In August 2023, we announced the initiation of enrollment in the FINALE [Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control] pivotal trial. This prospective, multi-center, open-label, single-arm study design includes pregnancy rate as the primary endpoint, which will be analyzed once 401 women have used FemBloc for one year for permanent birth control.
This prospective, multi-center, open-label, single-arm study design includes pregnancy rate as the primary endpoint, which will be analyzed once 401 women have used FemBloc for one year for permanent birth control.
In August 2023, we announced the initiation of enrollment in the FINALE [Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control] pivotal trial. This prospective, multi-center, open-label, single-arm study design includes pregnancy rate as the primary endpoint, which will be analyzed once 401 women have used FemBloc for one year for permanent birth control.
This prospective, multi-center, open-label, single-arm study design includes pregnancy rate as the primary endpoint, which will be analyzed once 401 women have used FemBloc for one year for permanent birth control.
In most countries, including the United States, the patent term is 20 years from the earliest claimed filing date of a nonprovisional patent application in the applicable country.
The term of individual patents depends upon the legal term for patents in the countries in which they are granted. In most countries, including the United States, the patent term is 20 years from the earliest claimed filing date of a nonprovisional patent application in the applicable country.
The five patent families include granted utility and design patents providing protection until at least 2026, 2028, 2029 2032, and 2046. The utility patent family includes a pending patent application, which if granted, could result in a patent expiring in 2028, plus any eligible patent term adjustments and extensions. Our FemCerv patent portfolio includes two patent families.
The two utility patent families include pending patent applications, which if granted, could result in patents expiring in 2028, plus any eligible patent term adjustments and extensions. Our FemVue Mini patent portfolio includes two patent families. The two patent families include granted design patents providing protection until at least 2034 and 2049.
We value innovation, passion, data-driven decision making, persistence and honesty, and are building a diverse environment where our employees can thrive and be inspired to make exceptional contributions to bring novel and proprietary diagnostic and device solutions to disrupt the approaches to women’s health worldwide. 28 Table of Contents Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, motivating and integrating our existing and future employees.
We value innovation, passion, data-driven decision making, persistence and honesty, and are building a diverse environment where our employees can thrive and be inspired to make exceptional contributions to bring novel and proprietary diagnostic and device solutions to disrupt the approaches to women’s health worldwide.
We believe there are also significant advantages over other temporary or reversible methods that women may be using in lieu of the surgical tubal ligation option, as FemBloc does not use hormones or leave a long-term implant behind. Additional Women’s Health Solutions . Our FemCerv product, an endocervical tissue sampler for cervical cancer diagnosis, is U.S.
We believe there are also significant advantages over other temporary or reversible methods that women may be using in lieu of the surgical tubal ligation option, as FemBloc does not use hormones or leave a long-term implant behind.
We also intend to promote broader awareness of the FemBloc system as the first non-surgical, non-implant option for permanent birth control among patients and healthcare practitioners. Reimbursement In the United States, we anticipate deriving the majority of our revenue from the sale of products in our infertility portfolio, including the FemaSeed and FemVue products, to fertility practices.
These activities are intended to increase familiarity among healthcare practitioners and patients with FemBloc as the first non-surgical, non-implant option for permanent birth control. Reimbursement In the United States, we anticipate deriving the majority of our revenue from the sale of products in our infertility portfolio, including the FemaSeed, FemVue, and FemSperm products, to gynecologists and infertility specialists.
FDA-cleared and approved in Europe, UK, Canada and Israel. Our product candidate, FemBloc® permanent birth control, is a revolutionary first-of-its-kind non-surgical approach, that involves minimally-invasive placement of a patented delivery system for precise delivery of our proprietary synthetic tissue adhesive (blended polymer) into both fallopian tubes simultaneously.
FemCerv ® , an endocervical tissue sampler for cervical cancer diagnosis, is U.S. FDA-cleared and approved in Europe, UK, Canada, Israel and New Zealand. FemBloc ® permanent birth control is a revolutionary first-in-class non-surgical solution, which involves minimally-invasive placement of a patented delivery system for precise delivery of our proprietary synthetic tissue adhesive (blended polymer) into both fallopian tubes simultaneously.
If the FDA issues a PMA approval, the approval may contain post approval conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale and distribution, and collection of long-term follow-up data from patients in the clinical trial that supported a PMA or requirements to conduct additional clinical trials post-approval.
If the FDA issues a PMA approval, the approval may contain post approval conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale and distribution, and collection of long-term follow-up data from patients in the clinical trial that supported a PMA or requirements to conduct additional clinical trials post-approval. 22 Table of Contents Certain changes to an approved device, such as changes in manufacturing facilities, methods, or quality control procedures, or changes in the design performance specifications, which affect the safety or effectiveness of the device, require submission and approval of a PMA supplement.
We sponsored a post-market study of FemCerv where subjects found the procedure to be relatively pain-free and the sample obtained was complete for analysis, which we believe may aid in reliable diagnosis. Our FemCerv product was made available to the United States market in September 2022, however, the focus of the commercial efforts remains the infertility line of products.
We sponsored a post-market study of FemCerv where subjects found the procedure to be relatively pain-free and the sample obtained was complete for analysis, which we believe may aid in reliable diagnosis.
Issued patents have a limited term for enforcement, and the termination dates differ for utility and design patents, and from country to country. Expirations of our earlier-filed patents in the US or overseas are anticipated by several strategies. Some earlier-filed design patents were directed to devices that are no longer used or marketed.
Our patent portfolio includes both utility and design patents and patent applications, both in the U.S. and overseas. Issued patents have a limited term for enforcement, and the termination dates differ for utility and design patents, and from country to country. Expirations of our earlier-filed patents in the US or overseas are anticipated by several strategies.
For example, the BBA amended the ACA to close the coverage gap, commonly known as the “donut hole,” in most Medicare prescription drug plans. 27 Table of Contents In December 2018, CMS published a final rule permitting the continued collections of, and payments to, certain ACA qualified health plan and health insurance issuers under the ACA risk adjustment program – addressing issues raised previously in federal district court litigation over CMS’ method for calculating risk adjustment payments.
In December 2018, CMS published a final rule permitting the continued collections of, and payments to, certain ACA qualified health plan and health insurance issuers under the ACA risk adjustment program – addressing issues raised previously in federal district court litigation over CMS’ method for calculating risk adjustment payments.
We began limited market release in the U.S. in September 2022, however, the commercial efforts are currently focused on the infertility portfolio. 14 Table of Contents Manufacturing We have developed and implemented the infrastructure required to manufacture and distribute finished medical devices, including a robust medical device quality management system, which meets the requirements of the FDA Quality System Regulation, and is certified to Medical Device Single Audit Program (MDSAP) and International Organization for Standardization (ISO) 13485:2016.
Manufacturing We have developed and implemented the infrastructure required to manufacture and distribute finished medical devices, including a robust medical device quality management system, which meets the requirements of the FDA Quality System Regulation, and is certified to Medical Device Single Audit Program (MDSAP) and International Organization for Standardization (ISO) 13485:2016.

… 149 more changes not shown on this page.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

140 edited+47 added−19 removed505 unchanged
Biggest changeDespite the implementation of security measures, our internal computer systems and those of our current and any future CROs, other contractors, consultants, potential future collaborators and other third-party service providers are vulnerable to damage from various methods, including cybersecurity attacks, breaches, intentional or accidental mistakes or errors, attacks using artificial intelligence, or other technological failures, which can include, among other things, computer viruses, unauthorized access attempts, including third parties gaining access to systems using stolen or inferred credentials, denial-of-service attacks, phishing attempts, service disruptions, natural disasters, fire, terrorism, war and telecommunication and electrical failures.
Biggest changeOur internal computer systems, or those of any of our Contract Research Organizations (“CROs”), manufacturers, other contractors, consultants, existing or future collaborators, may fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of or destruction of our proprietary and confidential data, employee data or personal data, which could result in additional costs, significant liabilities, harm to our reputation and material disruption of our operations. 74 Table of Contents Despite the implementation of security measures, our internal computer systems and those of our current and any future CROs, other contractors, consultants, potential future collaborators and other third-party service providers are vulnerable to damage from various methods, including cybersecurity attacks, breaches, intentional or accidental mistakes or errors, attacks using artificial intelligence, or other technological failures, which can include, among other things, computer viruses, unauthorized access attempts, including third parties gaining access to systems using stolen or inferred credentials, denial-of-service attacks, phishing attempts, service disruptions, natural disasters, fire, terrorism, war and telecommunication and electrical failures.
As a general rule, demonstration of conformity of medical devices and their manufacturers with the essential requirements must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use.
As a general rule, demonstration of conformity of medical devices and their manufacturers with the essential requirements must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use.
Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence.
Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence.
We may experience a number of events during the conduct of our clinical trials that could adversely affect the costs, timing or successful completion, including: • We are required to submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials, and the FDA may reject our IDE application and notify us that we may not begin investigational trials; • Regulators and other comparable foreign regulatory authorities may disagree as to the design or implementation of our clinical trials; • Regulators and/or IRBs or other reviewing bodies may not authorize us or our investigators to commence a clinical trial, or to conduct or continue a clinical trial at a prospective or specific trial site; • We may not reach agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • Clinical trials may produce negative or inconclusive results, or we may not agree with regulatory authorities on the interpretation of our clinical trial results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs; • The number of subjects or patients required for clinical trials may be larger than we anticipate, enrollment in these clinical trials may be insufficient or slower than we anticipate, and the number of clinical trials being conducted at any given time may be high and result in fewer available patients for any given clinical trial, or patients may drop out of these clinical trials at a higher rate than we anticipate; 35 Table of Contents • Our third-party contractors, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; • We might have to suspend or terminate clinical trials for various reasons, including a finding that the subjects are being exposed to unacceptable health risks; • We may have to amend clinical trial protocols or conduct additional studies to reflect changes in regulatory requirements or guidance, which we may be required to submit to an IRB and/or regulatory authorities for reexamination; • Regulators, IRBs, or other parties may require or recommend that we or our investigators suspend or terminate clinical research for various reasons, including safety signals or noncompliance with regulatory requirements; • The cost of clinical trials may be greater than we anticipate; • Clinical sites may not adhere to the clinical protocol or may drop out of a clinical trial; • We may be unable to recruit a sufficient number of clinical trial sites or trial subjects; • Regulators, IRBs, or other reviewing bodies may fail to approve or subsequently find fault with our manufacturing processes for clinical and commercial supplies, the supply of devices or other materials necessary to conduct clinical trials may be insufficient, inadequate or not available at an acceptable cost, or we may experience interruptions in supply; • Approval policies or regulations of FDA or applicable foreign regulatory authorities may change in a manner rendering our clinical data insufficient for approval; and • Our current or future products may have undesirable side effects or other unexpected characteristics.
We may experience a number of events during the conduct of our clinical trials that could adversely affect the costs, timing or successful completion, including: • We are required to submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials, and the FDA may reject our IDE application and notify us that we may not begin investigational trials; • Regulators and other comparable foreign regulatory authorities may disagree as to the design or implementation of our clinical trials; • Regulators and/or IRBs or other reviewing bodies may not authorize us or our investigators to commence a clinical trial, or to conduct or continue a clinical trial at a prospective or specific trial site; • We may not reach agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • Clinical trials may produce negative or inconclusive results, or we may not agree with regulatory authorities on the interpretation of our clinical trial results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs; • The number of subjects or patients required for clinical trials may be larger than we anticipate, enrollment in these clinical trials may be insufficient or slower than we anticipate, and the number of clinical trials being conducted at any given time may be high and result in fewer available patients for any given clinical trial, or patients may drop out of these clinical trials at a higher rate than we anticipate; 38 Table of Contents • Our third-party contractors, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; • We might have to suspend or terminate clinical trials for various reasons, including a finding that the subjects are being exposed to unacceptable health risks; • We may have to amend clinical trial protocols or conduct additional studies to reflect changes in regulatory requirements or guidance, which we may be required to submit to an IRB and/or regulatory authorities for reexamination; • Regulators, IRBs, or other parties may require or recommend that we or our investigators suspend or terminate clinical research for various reasons, including safety signals or noncompliance with regulatory requirements; • The cost of clinical trials may be greater than we anticipate; • Clinical sites may not adhere to the clinical protocol or may drop out of a clinical trial; • We may be unable to recruit a sufficient number of clinical trial sites or trial subjects; • Regulators, IRBs, or other reviewing bodies may fail to approve or subsequently find fault with our manufacturing processes for clinical and commercial supplies, the supply of devices or other materials necessary to conduct clinical trials may be insufficient, inadequate or not available at an acceptable cost, or we may experience interruptions in supply; • Approval policies or regulations of FDA or applicable foreign regulatory authorities may change in a manner rendering our clinical data insufficient for approval; and • Our current or future products may have undesirable side effects or other unexpected characteristics.
State attorneys general can also bring a civil action to enjoin a HIPAA violation or to obtain statutory damages on behalf of residents of his or her state; • analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers or patients; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm customers, foreign and state laws, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; privacy and data protection laws, including the EU General Data Protection Regulation, governing the privacy and security of personal data, including health information; federal government price reporting laws, which may require calculations and reporting of complex pricing metrics in an accurate and timely manner to government programs; and state laws related to insurance fraud in the case of claims involving private insurers; and 56 Table of Contents • In addition, certain states have adopted new or modified privacy and security laws and regulations that may apply to our business.
State attorneys general can also bring a civil action to enjoin a HIPAA violation or to obtain statutory damages on behalf of residents of his or her state; 59 Table of Contents • • analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers or patients; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm customers, foreign and state laws, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; privacy and data protection laws, including the EU General Data Protection Regulation, governing the privacy and security of personal data, including health information; federal government price reporting laws, which may require calculations and reporting of complex pricing metrics in an accurate and timely manner to government programs; and state laws related to insurance fraud in the case of claims involving private insurers; and • In addition, certain states have adopted new or modified privacy and security laws and regulations that may apply to our business.
The market price of our common stock has been highly volatile and may fluctuate substantially due to many factors, some of which are beyond our control, including: • announcements of U.S. regulatory approval or disapproval of our FemBloc system or the FDA’s decision to grant or decline any future approvals or clearances for enhancements to our products; • announcements of international regulatory approval or disapproval of our FemBloc system or the foreign regulatory body or notified body’s decision to grant or decline any future approvals for enhancements to our products; • adverse results from or delays in clinical pivotal trial of our FemBloc system; • unanticipated safety concerns related to the use of our FemBloc system; • unanticipated safety concerns related to the use of our FemaSeed product or other products; • FDA or other U.S. or foreign regulatory or legal actions or changes affecting us or our industry; • our ability to develop, obtain regulatory clearance or approval for, and market new and enhanced medical products on a timely basis; • any voluntary or mandated product recalls; • adverse developments concerning our suppliers or any future strategic partnerships; • the volume and timing of sales of our products; • the introduction of new products or product enhancements by us or others in our industry; • disputes or other developments with respect to our or others’ intellectual property rights; • product liability claims or other litigation; • quarterly variations in our results of operations or those of others in our industry; • media exposure of our products or of those of others in our industry; • changes in governmental regulations or in reimbursement; • changes in earnings estimates or recommendations by securities analysts; • changes in financial estimates or guidance, including our ability to meet our future revenue and operating profit or loss estimates or guidance; • the public’s reaction to our earnings releases, other public announcements and filings with the SEC; • sales of substantial amounts of our stock by directors, officers or significant stockholders, or the expectation that such sales might occur; • operating and stock performance of other companies that investors deem comparable to us and overall performance of the equity markets; • additions or departures of key personnel; • changes in our capital structure, such as future issuances of securities and the incurrence of debt; • general market conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors; and • other factors described in this “Risk Factors” section.
The market price of our common stock has been highly volatile and may fluctuate substantially due to many factors, some of which are beyond our control, including: • announcements of U.S. regulatory approval or disapproval of our FemBloc system or the FDA’s decision to grant or decline any future approvals or clearances for enhancements to our products; • announcements of international regulatory approval or disapproval of our FemBloc system or the foreign regulatory body or notified body’s decision to grant or decline any future approvals for enhancements to our products; • adverse results from or delays in clinical pivotal trial of our FemBloc system; • unanticipated safety concerns related to the use of our FemBloc system; • unanticipated safety concerns related to the use of our FemaSeed product or other products; • FDA or other U.S. or foreign regulatory or legal actions or changes affecting us or our industry; • our ability to develop, obtain regulatory clearance or approval for, and market new and enhanced medical products on a timely basis; • any voluntary or mandated product recalls; • adverse developments concerning our suppliers or any future strategic partnerships; 76 Table of Contents • the volume and timing of sales of our products; • the introduction of new products or product enhancements by us or others in our industry; • disputes or other developments with respect to our or others’ intellectual property rights; • product liability claims or other litigation; • quarterly variations in our results of operations or those of others in our industry; • media exposure of our products or of those of others in our industry; • changes in governmental regulations or in reimbursement; • changes in earnings estimates or recommendations by securities analysts; • changes in financial estimates or guidance, including our ability to meet our future revenue and operating profit or loss estimates or guidance; • the public’s reaction to our earnings releases, other public announcements and filings with the SEC; • sales of substantial amounts of our stock by directors, officers or significant stockholders, or the expectation that such sales might occur; • operating and stock performance of other companies that investors deem comparable to us and overall performance of the equity markets; • additions or departures of key personnel; • changes in our capital structure, such as future issuances of securities and the incurrence of debt; • general market conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors; and • other factors described in this “Risk Factors” section.
In addition, if other companies are successful in developing devices that are approved for a broader range of indications than our permanent birth control system, we will be at a further competitive disadvantage, which could also affect our business, financial condition and results of operations. 39 Table of Contents Many of the companies against which we may compete may have competitive advantages with respect to primary competitive factors in the women’s healthcare market, including: • greater company, product and brand recognition; • superior product safety, reliability and durability; • better quality and larger volume of clinical data; • more effective marketing to and education of patients and healthcare practitioners; • more sales force experience and greater market access; • better product support and service; • more advanced technological innovation, product enhancements and speed of innovation; • more effective pricing and revenue strategies; • lower procedure costs to patients; • more effective reimbursement teams and strategies; • dedicated practice development; and • more effective clinical training teams.
In addition, if other companies are successful in developing devices that are approved for a broader range of indications than our permanent birth control system, we will be at a further competitive disadvantage, which could also affect our business, financial condition and results of operations. 42 Table of Contents Many of the companies against which we may compete may have competitive advantages with respect to primary competitive factors in the women’s healthcare market, including: • greater company, product and brand recognition; • superior product safety, reliability and durability; • better quality and larger volume of clinical data; • more effective marketing to and education of patients and healthcare practitioners; • more sales force experience and greater market access; • better product support and service; • more advanced technological innovation, product enhancements and speed of innovation; • more effective pricing and revenue strategies; • lower procedure costs to patients; • more effective reimbursement teams and strategies; • dedicated practice development; and • more effective clinical training teams.
International sales are subject to a number of risks, including: • difficulties in securing distribution partnerships and managing our international relationships; • increased competition as a result of more products and procedures receiving regulatory approval or otherwise free to market in international markets; • longer accounts receivable payment cycles and difficulties in collecting accounts receivable; 43 Table of Contents • reduced or varied protection for intellectual property rights in some countries; • impact of tariffs; • export restrictions, trade regulations, and foreign tax laws; • fluctuations in currency exchange rates; • foreign certification and regulatory clearance or approval requirements; • customs clearance and shipping delays; • political, social, and economic instability abroad, terrorist attacks, and security concerns in general; • preference for locally produced products; • potentially adverse tax consequences, including the complexities of foreign value-added tax systems; • the burdens of complying with a wide variety of foreign laws and different legal standards; and • increased financial accounting and reporting burdens and complexities.
International sales are subject to a number of risks, including: • difficulties in securing distribution partnerships and managing our international relationships; • increased competition as a result of more products and procedures receiving regulatory approval or otherwise free to market in international markets; 46 Table of Contents • longer accounts receivable payment cycles and difficulties in collecting accounts receivable; • reduced or varied protection for intellectual property rights in some countries; • impact of tariffs; • export restrictions, trade regulations, and foreign tax laws; • fluctuations in currency exchange rates; • foreign certification and regulatory clearance or approval requirements; • customs clearance and shipping delays; • political, social, and economic instability abroad, terrorist attacks, and security concerns in general; • preference for locally produced products; • potentially adverse tax consequences, including the complexities of foreign value-added tax systems; • the burdens of complying with a wide variety of foreign laws and different legal standards; and • increased financial accounting and reporting burdens and complexities.
If the FDA requires us to go through a lengthier, more rigorous process for future products or modifications to existing products than we had expected, product introductions or modifications could be delayed or canceled, which could adversely affect our ability to grow our business. FemaSeed, FemVue, FemCath, FemChec, FemCerv and FemVue Mini have each received 510(k) clearance.
If the FDA requires us to go through a lengthier, more rigorous process for future products or modifications to existing products than we had expected, product introductions or modifications could be delayed or canceled, which could adversely affect our ability to grow our business. FemaSeed, FemVue, FemCath, FemChec, FemCerv and FemVue Controlled and Mini have each received 510(k) clearance.
If we fail to remain in compliance with applicable European laws and directives, we would be unable to continue to affix the CE mark to our products, which would prevent us from selling them within the EEA. FemaSeed, FemVue, FemCath, FemChec, FemCerv and FemVue Mini have each received the CE mark demonstrating compliance with the EU Medical Device Regulation.
If we fail to remain in compliance with applicable European laws and directives, we would be unable to continue to affix the CE mark to our products, which would prevent us from selling them within the EEA. FemBloc, FemaSeed, FemVue, FemCath, FemChec, FemCerv and FemVue Mini have each received the CE mark demonstrating compliance with the EU Medical Device Regulation.
Third-party coverage and reimbursement for procedures using our products or any of our products in development for which we may receive regulatory approval may not be available or adequate in either the United States or international markets, which could have an adverse effect on our business, financial condition and results of operations and impair our ability to grow our business. 38 Table of Contents Third-party payors and healthcare practitioners who do not cover or use our permanent birth control solution or other women’s healthcare devices may require additional clinical data prior to adopting or maintaining coverage of our products.
Third-party coverage and reimbursement for procedures using our products or any of our products in development for which we may receive regulatory approval may not be available or adequate in either the United States or international markets, which could have an adverse effect on our business, financial condition and results of operations and impair our ability to grow our business. 41 Table of Contents Third-party payors and healthcare practitioners who do not cover or use our permanent birth control solution or other women’s healthcare devices may require additional clinical data prior to adopting or maintaining coverage of our products.
The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that: • any of our patents, or any of our pending patent applications, if issued, will include claims having a scope sufficient to protect our FemBloc system and FemaSeed product; • any of our pending patent applications will issue as patents; • we will be able to successfully commercialize our products on a substantial scale, if approved, before our relevant patents we may have expire; • we were the first to make the inventions covered by each of our patents and pending patent applications; • we were the first to file patent applications for these inventions; • others will not develop similar or alternative technologies that do not infringe our patents; any of our patents will be found to ultimately be valid and enforceable; • any patents issued to us will provide a basis for an exclusive market for our commercially viable products, will provide us with any competitive advantages or will not be challenged by third parties; 62 Table of Contents • we will develop additional proprietary technologies or products that are separately patentable; or • our commercial activities or products will not infringe upon the patents of others.
The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that: • any of our patents, or any of our pending patent applications, if issued, will include claims having a scope sufficient to protect our FemBloc system and FemaSeed product; • any of our pending patent applications will issue as patents; • we will be able to successfully commercialize our products on a substantial scale, if approved, before our relevant patents we may have expire; • we were the first to make the inventions covered by each of our patents and pending patent applications; • we were the first to file patent applications for these inventions; • others will not develop similar or alternative technologies that do not infringe our patents; any of our patents will be found to ultimately be valid and enforceable; • any patents issued to us will provide a basis for an exclusive market for our commercially viable products, will provide us with any competitive advantages or will not be challenged by third parties; • we will develop additional proprietary technologies or products that are separately patentable; or • our commercial activities or products will not infringe upon the patents of others.
We cannot guarantee that we will be able to establish alternative relationships on similar terms, without delay or at all. 41 Table of Contents While we believe replacement suppliers exist for all materials, components and services necessary to manufacture our products, establishing additional or replacement suppliers for any of these materials, components or services, if required, could be time-consuming and expensive, may result in interruptions in our operations and product delivery, may affect the performance specifications of our products or could require that we modify their design.
We cannot guarantee that we will be able to establish alternative relationships on similar terms, without delay or at all. 44 Table of Contents While we believe replacement suppliers exist for all materials, components and services necessary to manufacture our products, establishing additional or replacement suppliers for any of these materials, components or services, if required, could be time-consuming and expensive, may result in interruptions in our operations and product delivery, may affect the performance specifications of our products or could require that we modify their design.
By way of further example, the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) enacted on April 16, 2015, repealed the formula by which Medicare made annual payment adjustments to physicians and replaced the formula with fixed annual payment updates and a new incentive payment system based on performance measures and participation in alternative payment models; the MACRA began in 2019 and continues to this day. of incentive payments scheduled to begin in 2019 that are based on various performance measures and healthcare practitioner’s participation in alternative payment models such as accountable care organizations.
By way of further example, the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) enacted on April 16, 2015, repealed the formula by which Medicare made annual payment adjustments to physicians and replaced the formula with fixed annual payment updates and a new incentive payment system based on performance measures and participation in alternative payment models; the MACRA began in 2019 and continues to this day. of incentive payments scheduled to begin in 2019 that are based on various performance measures and healthcare practitioners’ participation in alternative payment models such as accountable care organizations.
Healthcare practitioners may choose not to adopt our products for women’s healthcare for a number of reasons, including: • lack of availability of adequate third-party payor coverage or reimbursement; • lack of experience with our products and more familiarity with other widely adopted products, procedures or treatments as alternatives; • our inability to convince key opinion leaders to provide recommendations regarding our products, or to convince healthcare practitioners, patients and healthcare payors that our products are an attractive alternative to currently accepted alternatives; • perceived inadequacy of evidence supporting clinical benefits, safety or cost-effectiveness of our products existing alternatives; • liability risks generally associated with the use of new products and procedures; and • the training required to use new products. 37 Table of Contents With respect to FemBloc, we intend to focus our sales, marketing and training efforts primarily on obstetrical and gynecological physicians.
Healthcare practitioners may choose not to adopt our products for women’s healthcare for a number of reasons, including: • lack of availability of adequate third-party payor coverage or reimbursement; • lack of experience with our products and more familiarity with other widely adopted products, procedures or treatments as alternatives; • our inability to convince key opinion leaders to provide recommendations regarding our products, or to convince healthcare practitioners, patients and healthcare payors that our products are an attractive alternative to currently accepted alternatives; • perceived inadequacy of evidence supporting clinical benefits, safety or cost-effectiveness of our products’ existing alternatives; • liability risks generally associated with the use of new products and procedures; and • the training required to use new products. 40 Table of Contents With respect to FemBloc, we intend to focus our sales, marketing and training efforts primarily on obstetrical and gynecological physicians.
If we are not successful in expanding our indications and developing and commercializing new products and product enhancements, our ability to increase our revenue may be impaired, which could have a material adverse effect on our business, financial condition and results of operations. 40 Table of Contents Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our artificial insemination solution, permanent birth control solution, and women-specific medical products and manage our inventory.
If we are not successful in expanding our indications and developing and commercializing new products and product enhancements, our ability to increase our revenue may be impaired, which could have a material adverse effect on our business, financial condition and results of operations. 43 Table of Contents Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our artificial insemination solution, permanent birth control solution, and women-specific medical products and manage our inventory.
Any potential intellectual property litigation also could force us to do one or more of the following: • stop making, selling or using products or technologies that allegedly infringe the asserted intellectual property; • lose the opportunity to license our technology to others or to collect royalty payments based upon successful protection and assertion of our intellectual property rights against others; incur significant legal expenses; • pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing; • pay the attorney’s fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; • redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive and infeasible; and • attempt to obtain a license to the relevant intellectual property from third parties, which may not be available on reasonable terms or at all, or from third parties who may attempt to license rights that they do not have.
Any potential intellectual property litigation also could force us to do one or more of the following: • stop making, selling or using products or technologies that allegedly infringe the asserted intellectual property; • lose the opportunity to license our technology to others or to collect royalty payments based upon successful protection and assertion of our intellectual property rights against others; incur significant legal expenses; • pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing; 67 Table of Contents • pay the attorney’s fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; • redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive and infeasible; and • attempt to obtain a license to the relevant intellectual property from third parties, which may not be available on reasonable terms or at all, or from third parties who may attempt to license rights that they do not have.
Similarly, strikes, severe weather, natural disasters or other service interruptions affecting delivery services we use would adversely affect our ability to process orders for our products on a timely basis. 42 Table of Contents Consolidation in the healthcare industry or group purchasing organizations could lead to demands for price concessions, which may affect our ability to sell our products at prices necessary to support our current business strategies.
Similarly, strikes, severe weather, natural disasters or other service interruptions affecting delivery services we use would adversely affect our ability to process orders for our products on a timely basis. 45 Table of Contents Consolidation in the healthcare industry or group purchasing organizations could lead to demands for price concessions, which may affect our ability to sell our products at prices necessary to support our current business strategies.
If such disclosures occur, there is a risk that trial enrollment may be adversely impacted, that we may fail to monitor and comply with applicable adverse event reporting obligations or that we may not be able to defend our business or the public’s legitimate interests in the face of the political and market pressures generated by social media due to restrictions on what we may say about our product candidate.
If such disclosures occur, there is a risk that trial enrollment may be adversely impacted, that we may fail to monitor and comply with applicable adverse event reporting obligations or that we may not be able to defend our business or the public’s legitimate interests in the face of the political and market pressures generated by social media due to restrictions on what we may say about our U.S. product candidate.
We continue to evaluate these regulatory nuances in an attempt to maintain compliance with these evolving enforcement trends; 55 Table of Contents • the federal civil and criminal false claims laws and civil monetary penalties laws, including the federal civil False Claims Act, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other federal healthcare programs that are false or fraudulent.
We continue to evaluate these regulatory nuances in an attempt to maintain compliance with these evolving enforcement trends; 58 Table of Contents • the federal civil and criminal false claims laws and civil monetary penalties laws, including the federal civil False Claims Act, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other federal healthcare programs that are false or fraudulent.
These provisions include: • being permitted to present only two years of audited financial statements and only two years of related management’s discussion and analysis of financial condition and results of operations; • not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act; • an exemption from compliance with any new requirements adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotations; • reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and • exemptions from the requirement to hold a nonbinding advisory vote on executive compensation and to obtain stockholder approval of any golden parachute payments not previously approved.
These provisions include: • being permitted to present only two years of audited financial statements and only two years of related management’s discussion and analysis of financial condition and results of operations; • not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act; • an exemption from compliance with any new requirements adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotations; • reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and 70 Table of Contents • exemptions from the requirement to hold a nonbinding advisory vote on executive compensation and to obtain stockholder approval of any golden parachute payments not previously approved.
In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable. 57 Table of Contents Disruptions at the FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.
In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable. 60 Table of Contents Disruptions at the FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.
Future growth would impose significant added responsibilities on members of management, including: • identifying, recruiting, integrating, maintaining and motivating additional employees; • managing our internal development efforts effectively, including the clinical and FDA application preparation for our product candidate, while complying with our contractual obligations to contractors and other third parties; and • improving our operational, financial and management controls, reporting systems and procedures.
Future growth would impose significant added responsibilities on members of management, including: • identifying, recruiting, integrating, maintaining and motivating additional employees; • managing our internal development efforts effectively, including the clinical and FDA application preparation for our U.S. product candidate, while complying with our contractual obligations to contractors and other third parties; and • improving our operational, financial and management controls, reporting systems and procedures.
If we fail to remain in compliance with applicable European laws, we would be unable to continue to affix the CE mark to our products, which would prevent us from selling them within the EEA. 49 Table of Contents All medical devices must be registered with the Medicines & Healthcare products Regulatory Agency (MHRA) before being placed on the Great Britain, or GB, market.
If we fail to remain in compliance with applicable European laws, we would be unable to continue to affix the CE mark to our products, which would prevent us from selling them within the EEA. 52 Table of Contents All medical devices must be registered with the Medicines & Healthcare products Regulatory Agency (MHRA) before being placed on the Great Britain, or GB, market.
If such an event were to occur and cause interruptions in our operations or result in the unauthorized acquisition of or access to personally identifiable information or individually identifiable health information (violating certain privacy laws such as HIPAA, or HITECH Act, the CCPA and GDPR), it could result in a material disruption of our product candidate development programs and our business operations, and we could incur significant liabilities.
If such an event were to occur and cause interruptions in our operations or result in the unauthorized acquisition of or access to personally identifiable information or individually identifiable health information (violating certain privacy laws such as HIPAA, or HITECH Act, the CCPA and GDPR), it could result in a material disruption of our U.S. product candidate development programs and our business operations, and we could incur significant liabilities.
We are currently seeking PMA approval for our permanent birth control solution. In order to obtain PMA approval for the FemBloc system, we must conduct a well-controlled clinical trial designed to assess the safety and effectiveness of the product candidate. Conducting clinical trials is a complex and expensive process, can take many years, and outcomes are inherently uncertain.
We are currently seeking PMA approval for our permanent birth control solution. In order to obtain PMA approval for the FemBloc system, we must conduct a well-controlled clinical trial designed to assess the safety and effectiveness of the U.S. product candidate. Conducting clinical trials is a complex and expensive process, can take many years, and outcomes are inherently uncertain.
If any of these events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability, face regulatory actions or incur other harm to our business. 47 Table of Contents Risks Related to Government Regulation Our products and operations are subject to extensive government regulation and oversight both in the United States and abroad, and our failure to comply with applicable requirements could harm our business.
If any of these events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability, face regulatory actions or incur other harm to our business. 50 Table of Contents Risks Related to Government Regulation Our products and operations are subject to extensive government regulation and oversight both in the United States and abroad, and our failure to comply with applicable requirements could harm our business.
We need substantial additional funding and may be unable to raise capital when needed, which could force us to delay or reduce our commercialization efforts or product development programs. Based on our current operating plan, our current cash, cash equivalents and revenue are expected to be sufficient to fund our ongoing operations into the third quarter of 2025.
We need substantial additional funding and may be unable to raise capital when needed, which could force us to delay or reduce our commercialization efforts or product development programs. Based on our current operating plan, our current cash, cash equivalents and revenue are expected to be sufficient to fund our ongoing operations into the third quarter of 2026.
Although we possess insurance for damage to our property and the disruption of our business, this insurance may not be sufficient to cover all of our potential losses and this insurance may not continue to be available to us on acceptable terms, or at all. 46 Table of Contents Our ability to maintain our competitive position depends on our ability to attract and retain senior management and other highly qualified personnel.
Although we possess insurance for damage to our property and the disruption of our business, this insurance may not be sufficient to cover all of our potential losses and this insurance may not continue to be available to us on acceptable terms, or at all. 49 Table of Contents Our ability to maintain our competitive position depends on our ability to attract and retain senior management and other highly qualified personnel.
Any future funding requirements will depend on many factors, including: • The initiation, scope, rate of enrollment, progress, success, and cost of our current or future clinical trials; • The cost of our research and development activities; • Patient, healthcare practitioner and market acceptance of our intrauterine artificial insemination product and permanent birth control system women-specific medical product solutions; • The cost of filing and prosecuting patent applications and defending and enforcing our patent or other intellectual property rights; • The cost of defending, in litigation or otherwise, any claims that we infringe third-party patents or other intellectual property rights; • The cost and timing of additional regulatory clearances, de novo grants or approvals; • The cost and timing of establishing additional sales and marketing capabilities; • Costs associated with any product recall that may occur; 30 Table of Contents • The effect of competing technological and market developments; • The extent to which we acquire or invest in products, technologies and businesses, although we currently have no commitments or agreements relating to any of these types of transactions; and • The costs of operating as a public company.
Any future funding requirements will depend on many factors, including: • The initiation, scope, rate of enrollment, progress, success, and cost of our current or future clinical trials; • The cost of our research and development activities; • Patient, healthcare practitioner and market acceptance of our intratubal insemination product and permanent birth control system women-specific medical product solutions; • The cost of filing and prosecuting patent applications and defending and enforcing our patent or other intellectual property rights; • The cost of defending, in litigation or otherwise, any claims that we infringe third-party patents or other intellectual property rights; • The cost and timing of additional regulatory clearances, de novo grants or approvals; • The cost and timing of establishing additional sales and marketing capabilities; • Costs associated with any product recall that may occur; • The effect of competing technological and market developments; • The extent to which we acquire or invest in products, technologies and businesses, although we currently have no commitments or agreements relating to any of these types of transactions; and 31 Table of Contents • The costs of operating as a public company.
Our product candidate may fail in development or suffer delays that adversely affect its commercial viability. If we fail to obtain or maintain FDA approval to market and sell our FemBloc our business will be materially harmed. The process of seeking regulatory approval to market a medical device is expensive and time consuming.
Our U.S. product candidate may fail in development or suffer delays that adversely affect its commercial viability. If we fail to obtain or maintain FDA approval to market and sell our FemBloc our business will be materially harmed. The process of seeking regulatory approval to market a medical device is expensive and time consuming.
In addition, any amortization or charges resulting from the costs of acquisitions could increase our expenses. 45 Table of Contents Risks Related to Managing Growth and Employee Matters We face risks related to health epidemics and outbreaks, which could significantly disrupt our commercialization activities and clinical trials, and could have an adverse impact on our business.
In addition, any amortization or charges resulting from the costs of acquisitions could increase our expenses. 48 Table of Contents Risks Related to Managing Growth and Employee Matters We face risks related to health epidemics and outbreaks, which could significantly disrupt our commercialization activities and clinical trials, and could have an adverse impact on our business.
In addition, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services provided by consultants is compromised for any reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval of our product candidate or otherwise advance our business.
In addition, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services provided by consultants is compromised for any reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval of our U.S. product candidate or otherwise advance our business.
We must be able to effectively manage our development efforts, recruit and train sales and marketing personnel, effectively manage our participation in the clinical studies in which our product candidate and any future product candidates are involved and improve our managerial, development, operational and finance systems, all of which may impose a strain on our administrative and operational infrastructure.
We must be able to effectively manage our development efforts, recruit and train sales and marketing personnel, effectively manage our participation in the clinical studies in which our U.S. product candidate and any future product candidates are involved and improve our managerial, development, operational and finance systems, all of which may impose a strain on our administrative and operational infrastructure.
We, IRBs, the FDA, or another regulatory authority may suspend or terminate the clinical trial at any time to avoid exposing trial participants to unacceptable health risks. 34 Table of Contents Successful results of preclinical studies are not necessarily indicative of future clinical trial results, and predecessor clinical trials results may not be replicated in subsequent clinical trials.
We, IRBs, the FDA, or another regulatory authority may suspend or terminate the clinical trial at any time to avoid exposing trial participants to unacceptable health risks. 37 Table of Contents Successful results of preclinical studies are not necessarily indicative of future clinical trial results, and predecessor clinical trials results may not be replicated in subsequent clinical trials.
If one or more of these analysts cease coverage of us or fail to publish reports covering us regularly, we could lose visibility in the market, which in turn could cause our stock price or trading volume to decline and result in the loss of all or a part of your investment in us. 73 Table of Contents
If one or more of these analysts cease coverage of us or fail to publish reports covering us regularly, we could lose visibility in the market, which in turn could cause our stock price or trading volume to decline and result in the loss of all or a part of your investment in us. 77 Table of Contents
If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the tasks necessary to further develop and commercialize our products and potentially commercialize our product candidate and, accordingly, may not achieve our research, development and commercialization goals.
If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the tasks necessary to further develop and commercialize our products and potentially commercialize our U.S. product candidate and, accordingly, may not achieve our research, development and commercialization goals.
These provisions include: • a prohibition on actions by our stockholders by written consent; • advance notice requirements for election to our board of directors and for proposing matters that can be acted upon at stockholder meetings; • a requirement that directors may only be removed “for cause”; 67 Table of Contents • a requirement that only the board of directors may change the number of directors and fill vacancies on the board; • division of our board of directors into three classes, serving staggered terms of three years each; and • the authority of the board of directors to issue preferred stock with such terms as the board of directors may determine.
These provisions include: • a prohibition on actions by our stockholders by written consent; • advance notice requirements for election to our board of directors and for proposing matters that can be acted upon at stockholder meetings; • a requirement that directors may only be removed “for cause”; • a requirement that only the board of directors may change the number of directors and fill vacancies on the board; • division of our board of directors into three classes, serving staggered terms of three years each; and • the authority of the board of directors to issue preferred stock with such terms as the board of directors may determine.
In addition, we rely on clinical trial sites to ensure timely conduct of our clinical trials and, while we have entered into agreements governing their services, we are limited in our ability to compel their actual performance. Our current product candidate, FemBloc is in late-stage of development.
In addition, we rely on clinical trial sites to ensure timely conduct of our clinical trials and, while we have entered into agreements governing their services, we are limited in our ability to compel their actual performance. Our current U.S. product candidate, FemBloc is in late-stage of development.
The FDA can delay, limit or deny approval of a device for many reasons, including: • We may not be able to demonstrate to the FDA’s satisfaction that our product is safe and effective for its intended use; • The FDA may disagree that our clinical data supports the label and use that we are seeking; • The FDA may disagree that the data from our preclinical studies and clinical trials is sufficient to support marketing authorization; and • The manufacturing process and facilities we use may not meet applicable requirements.
The FDA can delay, limit or deny approval of a device for many reasons, including: 35 Table of Contents • We may not be able to demonstrate to the FDA’s satisfaction that our product is safe and effective for its intended use; • The FDA may disagree that our clinical data supports the label and use that we are seeking; • The FDA may disagree that the data from our preclinical studies and clinical trials is sufficient to support marketing authorization; and • The manufacturing process and facilities we use may not meet applicable requirements.
Other factors that may cause fluctuations in our quarterly and annual results include: • Patient and healthcare practitioner adoption of our FemBloc system, if approved to market; • Patient and healthcare practitioner adoption of our FemaSeed product; • Changes in coverage policies by third-party payors that affect the reimbursement of procedures using our products; • Unanticipated pricing pressure; • The hiring, retention and continued productivity of sales representatives; • Our ability to expand the geographic reach of our sales and marketing efforts; • Our ability to obtain regulatory clearance or approval for any products in development or for our current products for additional indications or in additional countries outside the United States; • Results of clinical research and trials on our existing products and products in development; • Delays in receipt of anticipated purchase orders; • Delays in, or failure of, component and raw material deliveries by our suppliers; and • Positive or negative coverage in the media or clinical publications of our products or products of our competitors or our industry.
Other factors that may cause fluctuations in our quarterly and annual results include: • Patient and healthcare practitioner adoption of our FemBloc system, if approved to market in the U.S.; • Patient and healthcare practitioner adoption of our FemaSeed product in the U.S.; • Changes in coverage policies by third-party payors that affect the U.S. reimbursement of procedures using our products; • Unanticipated pricing pressure; • The hiring, retention and continued productivity of sales representatives for domestic commercial team; • Our ability to expand the geographic reach of our sales and marketing efforts; • Our ability to obtain regulatory clearance or approval for any products in development or for our current products for additional indications or in additional countries outside the United States; • Results of clinical research and trials on our existing products and products in development; • Delays in receipt of anticipated purchase orders; • Delays in, or failure of, component and raw material deliveries by our suppliers; and • Positive or negative coverage in the media or clinical publications of our products or products of our competitors or our industry.
Modifications to products that are approved through a PMA application generally require FDA approval. 48 Table of Contents Similarly, certain modifications made to products cleared through a 510(k) or granted a de novo classification may require a new 510(k) clearance, or could require a new de novo classification request or even a PMA.
Modifications to products that are approved through a PMA application generally require FDA approval. 51 Table of Contents Similarly, certain modifications made to products cleared through a 510(k) or granted a de novo classification may require a new 510(k) clearance, or could require a new de novo classification request or even a PMA.
A violation of these laws or regulations would negatively affect our business, financial condition and results of operations. We have implemented policies and procedures that are designed to ensure compliance by us and our directors, officers, employees, representatives, consultants and agents with the FCPA, OFAC restrictions, the Bribery Act and other export control, anti-corruption, anti-money-laundering and anti-terrorism laws and regulations.
A violation of these laws or regulations would negatively affect our business, financial condition and results of operations. 64 Table of Contents We have implemented policies and procedures that are designed to ensure compliance by us and our directors, officers, employees, representatives, consultants and agents with the FCPA, OFAC restrictions, the Bribery Act and other export control, anti-corruption, anti-money-laundering and anti-terrorism laws and regulations.
In addition, regardless of merit or eventual outcome, product liability claims may result in: • costs of litigation; • distraction of management’s attention from our primary business; • the inability to commercialize our current and future products; • decreased demand for our current and future products; • damage to our business reputation; • product recalls or withdrawals from the market; • withdrawal of clinical trial participants; • substantial monetary awards to patients or other claimants; or • loss of sales.
In addition, regardless of merit or eventual outcome, product liability claims may result in: 47 Table of Contents • costs of litigation; • distraction of management’s attention from our primary business; • the inability to commercialize our current and future products; • decreased demand for our current and future products; • damage to our business reputation; • product recalls or withdrawals from the market; • withdrawal of clinical trial participants; • substantial monetary awards to patients or other claimants; or • loss of sales.
The increasing use of social media platforms presents new risks and challenges. Social media is increasingly being used in connection with our commercialization efforts for our products, our clinical development program and following approval of our product candidate, if any.
The increasing use of social media platforms presents new risks and challenges. Social media is increasingly being used in connection with our commercialization efforts for our products, our clinical development program and following approval of our U.S. product candidate, if any.
The availability of the PTAB as a lower-cost, faster and potentially more potent tribunal for challenging patents could increase the likelihood that our own patents will be challenged, thereby increasing the uncertainties and costs of maintaining and enforcing them. Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.
The availability of the PTAB as a lower-cost, faster and potentially more potent tribunal for challenging patents could increase the likelihood that our own patents will be challenged, thereby increasing the uncertainties and costs of maintaining and enforcing them. 69 Table of Contents Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.
As we begin commercializing our products and if we obtain FDA approval of our product candidate in the United States, our potential exposure under such laws will increase significantly, and our costs associated with compliance with such laws will also increase.
As we begin commercializing our products and if we obtain FDA approval of our U.S. product candidate in the United States, our potential exposure under such laws will increase significantly, and our costs associated with compliance with such laws will also increase.
We believe that any disclosure controls and procedures, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. 68 Table of Contents These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake.
We believe that any disclosure controls and procedures, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake.
Any of these actions could significantly and negatively affect supply of our products. If any of these events occurs, our reputation could be harmed, we could be exposed to product liability claims and we could lose customers and experience reduced sales and increased costs.
Any of these actions could significantly and negatively affect supply of our products. If any of these events occur, our reputation could be harmed, we could be exposed to product liability claims and we could lose customers and experience reduced sales and increased costs.
If any party infringes on any of the trademarks on which we rely, enforcing those trademarks may be difficult, costly, time-consuming and ultimately unsuccessful. 66 Table of Contents Risks Related to Our Common Stock We are a “smaller reporting company” and an “emerging growth company” and the reduced disclosure requirements applicable to “smaller reporting companies” may make our common stock less attractive to investors.
If any party infringes on any of the trademarks on which we rely, enforcing those trademarks may be difficult, costly, time-consuming and ultimately unsuccessful. Risks Related to Our Common Stock We are a “smaller reporting company” and an “emerging growth company” and the reduced disclosure requirements applicable to “smaller reporting companies” may make our common stock less attractive to investors.
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position could be harmed. 64 Table of Contents In addition to patent protection, we also rely upon copyright and trade secret protection, as well as non-disclosure agreements and invention assignment agreements with our employees, consultants and third parties, to protect our confidential and proprietary information.
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position could be harmed. In addition to patent protection, we also rely upon copyright and trade secret protection, as well as non-disclosure agreements and invention assignment agreements with our employees, consultants and third parties, to protect our confidential and proprietary information.
If we are unable to achieve and maintain adequate levels of coverage or reimbursement for our permanent birth control solution or any other products we seek to commercialize, our commercial success may be severely hindered. The primary customers for our products are reproductive endocrinologists for our infertility products and gynecological physicians, related healthcare professionals, and women’s healthcare provider organizations.
If we are unable to achieve and maintain adequate levels of coverage or reimbursement for our permanent birth control solution or any other products we seek to commercialize, our commercial success may be severely hindered. The primary customers for our products are gynecological physicians, related healthcare professionals, and women’s healthcare provider organizations.
Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. 65 Table of Contents U.S. patent laws could diminish the value of patents in general and may limit our ability to obtain, defend and/or enforce our patents.
Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. U.S. patent laws could diminish the value of patents in general and may limit our ability to obtain, defend and/or enforce our patents.
In the event of an accident, state or federal or other applicable authorities may curtail our use of these materials and interrupt our business operations, which could adversely affect our business. 60 Table of Contents We are subject to anti-bribery, anti-corruption, and anti-money laundering laws, including the U.S.
In the event of an accident, state or federal or other applicable authorities may curtail our use of these materials and interrupt our business operations, which could adversely affect our business. We are subject to anti-bribery, anti-corruption, and anti-money laundering laws, including the U.S.
We have, and we may in the future, receive letters or other threats or claims from third parties inviting us to take licenses under, or alleging that we infringe, their patents. 63 Table of Contents Moreover, we may become party to future adversarial proceedings regarding our patent portfolio or the patents of third parties.
We have, and we may in the future, receive letters or other threats or claims from third parties inviting us to take licenses under, or alleging that we infringe, their patents. Moreover, we may become party to future adversarial proceedings regarding our patent portfolio or the patents of third parties.
To the extent that any disruption or security breach were to result in a loss of, or damage to, our data, or inappropriate disclosure of confidential or proprietary information, we could be exposed to litigation and governmental investigations, the further development and commercialization of our product candidates could be delayed, and we could be subject to significant fines or penalties for any noncompliance with certain state, federal or international privacy and security laws.
To the extent that any disruption or security breach were to result in a loss of, or damage to, our data, or inappropriate disclosure of confidential or proprietary information, we could be exposed to litigation and governmental investigations, the further development and commercialization of our U.S. product candidate could be delayed, and we could be subject to significant fines or penalties for any noncompliance with certain state, federal or international privacy and security laws.
A de novo classification is a risk-based classification process through which devices are classified into class I or class II. Devices classified in response to a de novo classification request may be marketed and used as predicates for future premarket notification 510(k) submissions.
A de novo classification is a risk-based classification process through which devices are classified into class I or class II. Devices classified in response to a de novo classification request may be marketed and used as predicates for future pre-market notification 510(k) submissions.
For de novo classified or 510(k) cleared devices we will need to submit a new 510(k) premarket notification for any change or modification in the device that could significantly affect the safety or effectiveness of the device, or for a major change or modification in the intended use of the device.
For de novo classified or 510(k) cleared devices we will need to submit a new 510(k) pre-market notification for any change or modification in the device that could significantly affect the safety or effectiveness of the device, or for a major change or modification in the intended use of the device.
We currently have limited experience as a company in our infrastructure for sales, marketing and distribution, and our operations have historically been limited primarily to clinical development activities. 33 Table of Contents We have established a direct sales organization with technical expertise in supporting commercial capabilities to market FemaSeed in the U.S. This is expensive and time-consuming.
We currently have limited experience as a company in our infrastructure for sales, marketing and distribution, and our operations have historically been limited primarily to clinical development activities. We have established a direct sales organization with technical expertise in supporting commercial capabilities to market FemaSeed in the U.S. This is expensive and time-consuming.
In addition, we may not be able to hire a sales force that is sufficient in size or has adequate expertise in the medical markets that we target. Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely affect the commercialization of FemaSeed and other products and product candidates.
In addition, we may not be able to hire a sales force that is sufficient in size or has adequate expertise in the medical markets that we target. Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely affect the commercialization of FemaSeed and other products and our U.S. product candidate.
Even if we are able to replace any raw materials or other materials with an alternative, such alternatives may cost more, result in lower yields or not be as suitable for our purposes. In addition, some of the materials that we use to manufacture our product candidates are complex materials, which may be more difficult to substitute.
Even if we are able to replace any raw materials or other materials with an alternative, such alternatives may cost more, result in lower yields or not be as suitable for our purposes. In addition, some of the materials that we use to manufacture our U.S. product candidate are complex materials, which may be more difficult to substitute.
With respect to FemaSeed, we intend to focus our sales, marketing and training efforts initially on reproductive endocrinologist physicians with possible expansion to gynecologists who are often the initial point of contact for patients with infertility needs.
With respect to FemaSeed, we intend to focus our sales, marketing and training efforts initially on reproductive endocrinologist physicians with expansion to gynecologists who are often the initial point of contact for patients with infertility needs with the availability of FemSperm.
As a result, we do not have long-term committed arrangements with respect to certain of the materials for our products and product candidates and other materials. If we obtain marketing approval, grant or clearance for our product candidates, we will need to establish an agreement for the commercial manufacture of certain key materials with a third party.
As a result, we do not have long-term committed arrangements with respect to certain of the materials for our products and U.S. product candidate and other materials. If we obtain marketing approval, grant or clearance for our U.S. product candidate, we will need to establish an agreement for the commercial manufacture of certain key materials with a third party.
Clinical trials are necessary to support PMA applications, certain de novo classification requests, and certain 510(k) premarket notifications and may be necessary to support PMA supplements or subsequent 510(k) submissions for modified versions of our marketed devices.
Clinical trials are necessary to support PMA applications, certain de novo classification requests, and certain 510(k) pre-market notifications and may be necessary to support PMA supplements or subsequent 510(k) submissions for modified versions of our marketed devices.
We manufacture and assemble components for our products and product candidates, and a loss or degradation in the performance of our manufacturing capabilities could have a material adverse effect on our business, financial condition and results of operations. We manufacture and assemble components used in our artificial insemination product, permanent birth control system, and women-specific medical products.
We manufacture and assemble components for our products and U.S. product candidate, and a loss or degradation in the performance of our manufacturing capabilities could have a material adverse effect on our business, financial condition and results of operations. We manufacture and assemble components used in our artificial insemination product, permanent birth control system, and women-specific medical products.
FemaSeed, FemVue and FemCerv have received approval from the MHRA.
FemBloc, FemaSeed, FemVue and FemCerv have received approval from the MHRA.
If we fail to satisfy the continued listing standards, we could be de-listed, which would have a negative effect on the price of our common stock. 72 Table of Contents We expect that the price of our common stock will fluctuate substantially.
If we fail to satisfy the continued listing standards, we could be de-listed, which would have a negative effect on the price of our common stock. We expect that the price of our common stock will fluctuate substantially.
Contract sterilizers are inspected by the FDA and may be inspected by foreign regulatory authorities. Additionally, the closures and potential closures of facilities that use ethylene oxide to sterilize medical devices prior to their use may create delays or interruptions in the supply chain for our products and product candidates.
Contract sterilizers are inspected by the FDA and may be inspected by foreign regulatory authorities. Additionally, the closures and potential closures of facilities that use ethylene oxide to sterilize medical devices prior to their use may create delays or interruptions in the supply chain for our products and U.S. product candidate.
Any compliance failures at any contract sterilizers we may contract with for sterilization of our products and product candidates also could create supply chain delays and interruptions and may require that we identify and contract with alternative contract sterilizers which we may not be able to do timely or on terms favorable to us.
Any compliance failures at any contract sterilizers we may contract with for sterilization of our products and U.S. product candidate also could create supply chain delays and interruptions and may require that we identify and contract with alternative contract sterilizers which we may not be able to do timely or on terms favorable to us.
Moreover, we rely on third-party sterilizers to effectively sterilize our products and product candidates and failure of any third-party sterilizer could result in safety risks associated with our products and product candidates and could result in patient or study subject injuries which could expose our company to product liability claims and actions.
Moreover, we rely on third-party sterilizers to effectively sterilize our products and U.S. product candidate and failure of any third-party sterilizer could result in safety risks associated with our products and U.S. product candidate and could result in patient or study subject injuries which could expose our company to product liability claims and actions.
Any actual or perceived failure by us or the third parties with whom we work to comply with privacy or security laws, policies, legal obligations or industry standards, or any security incident that results in an effect on personal information, may result in governmental enforcement actions and investigations including by European Data Protection Authorities and U.S. federal and state regulatory authorities, fines and penalties, litigation and/or adverse publicity, including by consumer advocacy groups, and could cause our customers, their patients and other healthcare professionals to lose trust in us, which could harm our reputation and have a material adverse effect on our business, financial condition and results of operations. 58 Table of Contents Healthcare policy changes, including recently enacted legislation reforming the U.S. healthcare system, could harm our business, financial condition and results of operations.
Any actual or perceived failure by us or the third parties with whom we work to comply with privacy or security laws, policies, legal obligations or industry standards, or any security incident that results in an effect on personal information, may result in governmental enforcement actions and investigations including by European Data Protection Authorities and U.S. federal and state regulatory authorities, fines and penalties, litigation and/or adverse publicity, including by consumer advocacy groups, and could cause our customers, their patients and other healthcare professionals to lose trust in us, which could harm our reputation and have a material adverse effect on our business, financial condition and results of operations.
For example, the loss of clinical trial data from completed, ongoing or future clinical trials involving our product candidates could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the lost data.
For example, the loss of clinical trial data from completed, ongoing or future clinical trials involving our U.S. product candidate could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the lost data.
We have limited experience marketing and selling our women-specific medical product solutions, and if we are unable to expand, manage and maintain our direct sales and marketing organization we may not be able to generate revenue growth. We have limited experience marketing and selling our women-specific medical products.
We have limited experience marketing and selling our women-specific medical product solutions, and if we are unable to expand, manage and maintain our direct sales and marketing organization we may not be able to generate revenue growth. We have limited experience marketing and selling our women-specific medical products. We currently sell primarily our FemaSeed.
If we are unable to obtain authorization from the FDA to market and sell this system in the United States and then to achieve significant market acceptance in the United States, our results of operations will be adversely affected as the United States is expected to be a principal market for this product.
If we are unable to obtain authorization from the FDA to market and sell this system in the United States, or if the product fails to achieve significant market acceptance in the United States, our results of operations could be adversely affected as the United States is expected to represent a principal market for this product.
A government-mandated or voluntary recall by us could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing defects, labeling or design deficiencies, packaging defects or other deficiencies or failures to comply with applicable regulations. Product defects or other errors may occur in the future.
A government-mandated or voluntary recall by us could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing defects, labeling or design deficiencies, packaging defects or other deficiencies or failures to comply with applicable regulations.
We have other commercial products, but their revenue is currently minimal, thus, if we are unsuccessful in commercializing the FemBloc system or are unable to market the FemBloc system as a result of a quality problem, failure to maintain or obtain regulatory marketing authorizations, unexpected or serious complications or other unforeseen negative effects related to this system or the other factors discussed in these risk factors, we would lose an additional source of revenue, and our business will be materially adversely affected.
Accordingly, if we are unsuccessful in commercializing the FemBloc system or are unable to market the FemBloc system as a result of a quality problem, failure to maintain or obtain regulatory marketing authorizations, unexpected or serious complications or other unforeseen negative effects related to this system or the other factors discussed in these risk factors, we would lose an additional source of revenue, and our business will be materially adversely affected.
Companies are required to maintain certain records of recalls and corrections, even if they are not reportable to the FDA. We may initiate voluntary withdrawals or corrections for our products in the future that we determine do not require notification of the FDA.
Certain voluntary field actions are required to be reported to the FDA and other regulatory authorities. Companies are required to maintain certain records of recalls and corrections, even if they are not reportable to the FDA. We may initiate voluntary withdrawals or corrections for our products in the future that we determine do not require notification of the FDA.
We own numerous issued patents and pending patent applications that relate to our intrauterine artificial insemination product, permanent birth control system and women-specific medical product solutions. As of December 31, 2024, we owned 53 issued U.S. patents and 169 issued foreign patents, 18 pending U.S. patent applications and 41 pending foreign patent applications.
We own numerous issued patents and pending patent applications that relate to our intrauterine artificial insemination product, permanent birth control system and women-specific medical product solutions. As of December 31, 2025, we owned 41 issued U.S. patents and 187 issued foreign patents, 15 pending U.S. patent applications and 41 pending foreign patent applications.
Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA, state or foreign regulatory authorities, which may include any of the following sanctions: • untitled letters or warning letters; • fines, injunctions, consent decrees and civil penalties; • recalls, termination of distribution, administrative detention, or seizure of our products; • customer notifications or repair, replacement or refunds; • operating restrictions or partial suspension or total shutdown of production; • delays in or refusal to grant our requests for future PMA approvals or foreign regulatory approvals of new products, new intended uses, or modifications to existing products; • withdrawals or suspensions of our current PMA or foreign regulatory approvals, resulting in prohibitions on sales of our products; • FDA refusal to issue certificates to foreign governments needed to export products for sale in other countries; and • criminal prosecution. 51 Table of Contents Any of these sanctions could result in higher than anticipated costs or lower than anticipated sales and have a material adverse effect on our reputation, business, financial condition and results of operations.
Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA, state or foreign regulatory authorities, which may include any of the following sanctions: • untitled letters or warning letters; • fines, injunctions, consent decrees and civil penalties; • recalls, termination of distribution, administrative detention, or seizure of our products; • customer notifications or repair, replacement or refunds; • operating restrictions or partial suspension or total shutdown of production; 54 Table of Contents • delays in or refusal to grant our requests for future PMA approvals or foreign regulatory approvals of new products, new intended uses, or modifications to existing products; • withdrawals or suspensions of our current PMA or foreign regulatory approvals, resulting in prohibitions on sales of our products; • FDA refusal to issue certificates to foreign governments needed to export products for sale in other countries; and • criminal prosecution.
Where state laws are more protective, we must comply with the stricter provisions. In addition to fines and penalties that may be imposed for failure to comply with state law, some states also provide for private rights of action to individuals for misuse of personal information. Other jurisdictions have also adopted similar laws, regulations, guidelines and rules.
In addition to fines and penalties that may be imposed for failure to comply with state law, some states also provide for private rights of action to individuals for misuse of personal information. Other jurisdictions have also adopted similar laws, regulations, guidelines and rules.

… 126 more changes not shown on this page.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

6 edited+0 added−0 removed3 unchanged
Biggest changeOur Chief Financial Officer reports directly to the Board of Directors and the Audit Committee, which is the principal committee charged with the Board’s risk management oversight, including cybersecurity risks. The Chief Financial Officer or Chief Operating Officer briefs the Board and Audit Committee on the effectiveness of our cybersecurity program quarterly.
Biggest changeGovernance and Role of Management and the Board Our Chief Financial Officer leads our cybersecurity program and reports directly, with respect to cybersecurity incidents, to the Board of Directors and the Audit Committee, which is the principal committee charged with the Board’s risk management oversight, including cybersecurity risks.
We have established processes to assess, identify, and manage risks from cybersecurity threats as part of our broader enterprise-wide risk management system and processes and engaged third-party consultants to assess and gather threat intelligence and cyber risk trends and conduct assessments and testing of our cybersecurity procedures and protections, which is overseen by our Board of Directors through our Audit Committee, along with our executive management.
We have established processes to assess, identify, and manage risks from cybersecurity threats as part of our broader enterprise-wide risk management system and processes and engaged third-party consultants to assess and gather threat intelligence and cyber risk trends and conduct assessments and testing of our cybersecurity procedures and protections, which is reported to and overseen by our Board of Directors through our Audit Committee, along with our executive management.
The Chief Financial Officer is informed about and monitors the prevention, detection, mitigation, and remediation of cybersecurity incidents through the Financial Officer’s oversight of the Company’s information technology function and supervision of the Company’s IT administrator. We have not experienced any cybersecurity threats or incidents that have had a material impact on our business to date.
The Chief Financial Officer is informed about and monitors the prevention, detection, mitigation, and remediation of cybersecurity incidents through the Financial Officer’s oversight of the Company’s information technology function. We have not experienced any cybersecurity threats or incidents that have had a material impact on our business to date.
As of the date of this Annual Report, we have not encountered any risks from cybersecurity threats that have materially affected or are reasonably likely to materially affect the Company, including its business strategy, results of operations, or financial condition.
We also maintain cybersecurity insurance to cover us for costs and expenses we may incur due to a cybersecurity incident. As of the date of this Annual Report, we have not encountered any risks from cybersecurity threats that have materially affected or are reasonably likely to materially affect the Company, including its business strategy, results of operations, or financial condition.
The Chief Operating Officer oversees the operation of our cybersecurity program and has over 20 years of executive experience overseeing risk management and internal controls.
The Chief Financial Officer briefs the Board and Audit Committee on the effectiveness of our cybersecurity program quarterly. The Chief Financial Officer oversees the operation of our cybersecurity program and has over 30 years of executive experience overseeing risk management and internal controls.
For more information on our cybersecurity related risks, see “General Risks Factors” included elsewhere in this Annual Report on Form 10-K. Governance and Role of Management and the Board Our Chief Operating Officer leads our cybersecurity program and reports, with respect to cybersecurity incidents, to the Company’s Chief Financial Officer.
For more information on our cybersecurity related risks, see “General Risks Factors” included elsewhere in this Annual Report on Form 10-K.

Item 2. Properties

Properties — owned and leased real estate

2 edited+0 added−0 removed0 unchanged
Biggest changeOur lease expires in April 2029, and we have the option to extend the term for one consecutive term of five years, subject to certain terms and conditions.
Biggest changeOur lease expires in April 2029, and we have the option to extend the term for one consecutive term of five years, subject to certain terms and conditions. 78 Table of Contents
Item 2. Properties. We lease our facility in Suwanee, Georgia which, together with our research and development, controlled environment room and office space, currently totals approximately 41,000 square feet. As of December 31, 2024, our monthly rent payment was $50,590 and is subject to increases on an annual basis.
Item 2. Properties. We lease our facility in Suwanee, Georgia which, together with our research and development, controlled environment room and office space, currently totals approximately 41,000 square feet. As of December 31, 2025, our monthly rent payment was $52,614 and is subject to increases on an annual basis.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

2 edited+0 added−0 removed2 unchanged
Biggest changeItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. MARKET FOR COMMON EQUITY Market Information Our common stock is listed on the NASDAQ Capital Market under the ticker symbol FEMY. On March 20, 2025 there were 145 holders of record of our common stock.
Biggest changeItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. MARKET FOR COMMON EQUITY Market Information Our common stock is listed on the NASDAQ Capital Market under the ticker symbol FEMY. On March 20, 2026 there were 147 holders of record of our common stock.
Purchases of Equity Securities by the Issuer and Affiliated Purchasers None.
Purchases of Equity Securities by the Issuer and Affiliated Purchasers None. Other Information

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

47 edited+20 added−16 removed22 unchanged
Biggest changeWe have a full valuation allowance for deferred tax assets, including net operating loss carryforwards and tax credits related primarily to R&D. 78 Table of Contents Results of Operations Comparison of the Years Ended December 31, 2024 and 2023 The following table shows our results of operations for the years ended December 31, 2024 and 2023: Year Ended December 31, 2024 2023 Change % Change Sales $ 1,629,108 1,071,970 557,138 52.0 % Cost of sales (excluding depreciation expense) 544,903 380,069 164,834 43.4 % Operating expenses: Research and development 8,216,543 7,208,701 1,007,842 14.0 % Sales and marketing 4,030,150 650,126 3,380,024 519.9 % General and administrative 6,325,999 6,858,008 (532,009 ) -7.8 % Depreciation and amortization 297,318 483,481 (186,163 ) -38.5 % Total operating expenses 18,870,010 15,200,316 3,669,694 24.1 % Loss from operations (17,785,805 ) (14,508,415 ) (3,277,390 ) 22.6 % Other (expense) income: Interest income 582,354 431,019 151,335 35.1 % Interest expense (1,603,575 ) (165,390 ) (1,438,185 ) 869.6 % Total other (expense) income (1,021,221 ) 265,629 (1,286,850 ) -484.5 % Loss before income taxes $ (18,807,026 ) (14,242,786 ) (4,564,240 ) 32.0 % Income tax expense 9,602 4,338 5,264 121.3 % Net loss $ (18,816,628 ) (14,247,124 ) (4,569,504 ) 32.1 % Sales increased by $557,138 or 52.0%, to $1,629,108 in 2024 from $1,071,970 in 2023.
Biggest changeWe have a full valuation allowance for deferred tax assets, including net operating loss carryforwards and tax credits related primarily to R&D. 83 Table of Contents Results of Operations Comparison of the Years Ended December 31, 2025 and 2024 The following table shows our results of operations for the years ended December 31, 2025 and 2024: Year Ended December 31, 2025 2024 Change % Change Sales $ 2,293,313 1,629,108 664,205 40.8 % Cost of sales (excluding depreciation expense) 872,400 544,903 327,497 60.1 % Operating expenses: Research and development 7,577,704 8,216,543 (638,839 ) -7.8 % Sales and marketing 4,443,807 4,030,150 413,657 10.3 % General and administrative 6,646,037 6,325,999 320,038 5.1 % Depreciation and amortization 342,034 297,318 44,716 15.0 % Total operating expenses 19,009,582 18,870,010 139,572 0.7 % Loss from operations (17,588,669 ) (17,785,805 ) 197,136 -1.1 % Other (expense) income: Interest income 101,760 582,354 (480,594 ) -82.5 % Change in fair value of conversion option liability 503,000 — 731,000 100 % Change in fair value of warrants liabilities 731,000 — 503,000 100 % Interest expense (1,891,119 ) (1,603,575 ) (287,544 ) 17.9 % Other expense (482,562 ) — ( 482,562 ) -100 % Total other expense, net (1,037,921 ) (1,021,221 ) (16,700 ) 1.6 % Loss before income taxes (18,626,590 ) (18,807,026 ) 180,436 -1.0 % Income tax expense 1,297 9,602 (8,305 ) -86.5 % Net loss $ (18,627,887 ) (18,816,628 ) 188,741 -1.0 % Sales increased by $664,205 or 40.8%, to $2,293,313 in 2025 from $1,629,108 in 2024.
See the section titled “Risk Factors” for more information. Components of Our Comprehensive Loss Sales Sales are primarily from the sale of our FemaSeed and FemVue products. We sell our product to medical centers, including healthcare practitioner offices, primarily through our direct commercial team in the U.S., as well as through distribution partners in select international markets.
See the section titled “Risk Factors” for more information. Components of Our Comprehensive Loss Sales Sales are primarily from the sale of our FemaSeed, FemBloc and FemVue products. We sell our product to medical centers, including healthcare practitioner offices, primarily through our direct commercial team in the U.S., as well as through distribution partners in select international markets.
Our future capital requirements will depend on many factors, including: • the cost, timing and results of our clinical trial and regulatory reviews; • the cost and timing of establishing sales, marketing and distribution capabilities; • the timing, receipt and amount of sales from our current and potential products; • our ability to continue manufacturing our products and product candidate and to secure the components, services and supplies needed in their production; • the degree of success we experience in commercializing our products; • the emergence of competing or complementary technologies; • the cost of preparing, filing, prosecuting, maintaining, defending and enforcing any patent claims and other intellectual property rights; and • the extent to which we acquire or invest in businesses, products or technologies, although we currently have no commitments or agreements relating to any of these types of transactions.
Our future capital requirements will depend on many factors, including: • the cost, timing and results of our clinical trial and U.S. regulatory reviews; • the cost and timing of establishing sales, marketing and distribution capabilities; • the timing, receipt and amount of sales from our current and potential products; • our ability to continue manufacturing our products and U.S. product candidate and to secure the components, services and supplies needed in their production; • the degree of success we experience in commercializing our products; • the emergence of competing or complementary technologies; • the cost of preparing, filing, prosecuting, maintaining, defending and enforcing any patent claims and other intellectual property rights; and • the extent to which we acquire or invest in businesses, products or technologies, although we currently have no commitments or agreements relating to any of these types of transactions.
In the future, we expect R&D expenses to increase in absolute dollars as we continue to develop our product candidate FemBloc, expand our product candidate pipeline, enhance our existing products and technologies and perform activities related to obtaining additional regulatory approval. Sales and marketing Sales and marketing expenses consist of personnel-related expenses, including compensation, benefits, and stock-based compensation.
In the future, we expect R&D expenses to increase in absolute dollars as we continue to develop our U.S. product candidate FemBloc, expand our product candidate pipeline, enhance our existing products and technologies and perform activities related to obtaining additional regulatory approval. Sales and marketing Sales and marketing expenses consist of personnel-related expenses, including compensation, benefits, and stock-based compensation.
Our suite of products and product candidate address what we believe are multi-billion dollar global market segments in which there has been little advancement for many years, helping women avoid pharmaceutical solutions, implants and surgery that can be expensive and expose women to harm.
Our suite of products and U.S. product candidate address what we believe are multi-billion dollar global market segments in which there has been little advancement for many years, helping women avoid pharmaceutical solutions, implants and surgery that can be expensive and expose women to harm.
If we are unable to obtain additional financing when needed, we may need to terminate, significantly modify, or delay the development of our product candidate, or we may need to obtain funds through collaborations or otherwise on terms that may require us to relinquish rights to our technologies or product candidate that we might otherwise seek to develop or commercialize independently.
If we are unable to obtain additional financing when needed, we may need to terminate, significantly modify, or delay the development of our U.S. product candidate, or we may need to obtain funds through collaborations or otherwise on terms that may require us to relinquish rights to our technologies or U.S. product candidate that we might otherwise seek to develop or commercialize independently.
The change in our net operating assets and liabilities was primarily due to increases of $2,379,205 in inventory, $397,467 in accounts receivable, $139,136 in prepaid and other assets, a decrease of $406,636 in lease liabilities, partially offset by an increase of $207,481 in accounts payable.
The change in our net operating assets and liabilities was primarily due to increases of $2,379,205 in inventory, $389,467 in accounts receivable, $139,136 in prepaid and other assets, a decrease of $406,636 in lease liabilities, partially offset by an increase of $207,481 in accounts payable.
We expect to continue to make substantial investments in our ongoing pivotal trial that is designed to provide clinical evidence of the safety and effectiveness of our product candidate, FemBloc. We also expect to continue to make investments in research and development to develop future products, manufacturing, regulatory affairs and post-market clinical trials.
We expect to continue to make substantial investments in our ongoing pivotal trial that is designed to provide clinical evidence of the safety and effectiveness of our U.S. product candidate, FemBloc. We also expect to continue to make investments in research and development to develop future products, manufacturing, regulatory affairs and post-market clinical trials.
We are a woman-founded and led company with an expansive, internally created intellectual property portfolio with approximately 200 issued patents globally, in-house chemistry, manufacturing, and controls (CMC) and device manufacturing capabilities and proven ability to develop products with commercialization efforts underway.
We are a woman-founded and led company with an expansive, internally created intellectual property portfolio with approximately 228 issued patents globally, in-house chemistry, manufacturing, and controls (CMC) and device manufacturing capabilities and proven ability to develop products with commercialization efforts underway.
We will additionally need to make investments in our sales and marketing organization for FemaSeed, and if approved, FemBloc. Because of these and other factors, we expect to continue to incur substantial net losses and negative cash flows from operations for the foreseeable future.
We will additionally need to make investments in our sales and marketing organization for FemaSeed and FemBloc. Because of these and other factors, we expect to continue to incur substantial net losses and negative cash flows from operations for the foreseeable future.
As of December 31, 2024, we have not had a history of significant returns. Recent Accounting Pronouncements See Notes 2(aa) and 2(ab) to our financial statements in Part II, Item 8 for information related to recently issued accounting pronouncements.
As of December 31, 2025, we have not had a history of significant returns. Recent Accounting Pronouncements See Notes 2(aa) and 2(ab) to our financial statements in Part II, Item 8 for information related to recently issued accounting pronouncements.
We must successfully recruit and enroll clinical trial participants in our clinical trial for FemBloc, in order to have the requisite data for regulatory submissions to the FDA for marketing authorization. • Regulatory approval of our product candidate . We must successfully obtain timely approval for our product candidate.
We must successfully recruit and enroll clinical trial participants in our clinical trial for FemBloc, in order to have the requisite data for regulatory submissions to the FDA for marketing authorization. • Regulatory approval of our U.S. product candidate . We must successfully obtain timely approval for our U.S. product candidate.
The success of our business will ultimately depend on our ability to commercialize our approved products and gain broad market acceptance of our products, which will require an extensive education process for both healthcare practitioners and patients of the benefits of our products, development of a robust sales force infrastructure and increased manufacturing capacity. 76 Table of Contents • Competition .
The success of our business will ultimately depend on our ability to commercialize our approved products and gain broad market acceptance of our products, which will require an extensive education process for both healthcare practitioners and patients of the benefits of our products, development of a robust sales force infrastructure and increased manufacturing capacity. • Competition .
R&D expenses include: • cost of clinical trials to support our product candidate FemBloc and product enhancements, including expenses for activities conducted by third-party services providers, primarily clinical research organizations, or CROs, and site payments; • certain personnel-related expenses, including salaries, benefits and stock-based compensation; • materials and supplies used for internal R&D and clinical activities; • allocated overhead information technology expenses; and • cost of outside consultants, who assist with technology development, regulatory affairs, clinical affairs and quality assurance, and testing fees.
R&D expenses include: • cost of clinical trials to support our U.S. product candidate FemBloc and product enhancements, including expenses for activities conducted by third-party services providers, primarily clinical research organizations, or CROs, and site payments; 82 Table of Contents • certain personnel-related expenses, including salaries, benefits and stock-based compensation; • materials and supplies used for internal R&D and clinical activities; • allocated overhead information technology expenses; and • cost of outside consultants, who assist with technology development, regulatory affairs, clinical affairs and quality assurance, and testing fees.
Over time, the blended polymer fully degrades and produces nonfunctional scar tissue to permanently block the fallopian tubes in the safest most natural approach. This is in stark contrast to centuries-old surgical sterilization with reported risks that include infection, minor or major bleeding, injury to nearby organs, anesthesia-related events, and even death.
Over time, the blended polymer fully degrades and produces nonfunctional scar tissue to permanently block the fallopian tubes in a safe and natural approach. This is in stark contrast to centuries-old surgical sterilization with reported risks that include infection, minor or major bleeding, injury to nearby organs, anesthesia-related events, and even death.
Along with the various surgical risks, some patients may not qualify as good surgical candidates due to obesity or medical comorbidities. The FemBloc non-surgical approach has the potential to offer a safer, more accessible in-office alternative with fewer risks, contraindications, and substantially lower cost.
Along with the various surgical risks, some patients may not qualify as good surgical candidates due to obesity or medical comorbidities. The FemBloc non-surgical approach has the potential to offer a safe and effective, more accessible in-office alternative with fewer risks, contraindications, and substantially lower cost than the surgical alternative.
We expect cost of sales to increase in absolute terms as our revenue grows. 77 Table of Contents Research and development Research and development, or R&D, expenses consist of engineering, product development, clinical, quality assurance and regulatory expenses.
We expect cost of sales to increase in absolute terms as our revenue grows. Research and development Research and development, or R&D, expenses consist of engineering, product development, clinical, quality assurance and regulatory expenses.
Factors Affecting Our Business There are a number of factors that have impacted, and we believe will continue to impact, our results of operations and growth. These factors include: • Commencement and conduct of clinical trial for our product candidate .
Factors Affecting Our Business There are a number of factors that have impacted, and we believe will continue to impact, our results of operations and growth. These factors include: 81 Table of Contents • Commencement and conduct of clinical trial for our U.S. product candidate .
For our sales to grow, we will need to receive FDA approval for the FemBloc system for permanent birth control, and will need to obtain regulatory approval or marketing authorization of our product candidate in international markets. • Clinical results .
For our sales to grow, we will need to receive FDA approval for the FemBloc system for permanent birth control, and will need to obtain additional regulatory approvals or marketing authorizations of our U.S. product candidate in international markets. • Clinical results .
Investing activities In 2024, cash used in investing activities for the purchases of fixed assets and intangible assets was $761,706 and $86,058, respectively. In 2023, cash used in investing activities for the purchase of fixed assets was $143,917.
In 2024, cash used in investing activities for the purchases of fixed assets and intangible assets was $761,706 and $86,058, respectively.
Revenue is recognized upon shipment of the Company’s goods based upon contractually stated pricing at standard payment terms ranging from 30 to 60 days.
Revenue is recognized upon shipment of the Company’s goods based upon contractually stated pricing at standard payment terms typically ranging from 30 to 60 days. All revenue is recognized at a point in time.
Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate. 81 Table of Contents Our cash and cash equivalents as of December 31, 2024, revenues from product sales and approximately $5.4 million we raised subsequent to year end, will not be sufficient to sustain our operations, including funding our product candidate, FemBloc, through regulatory approval, and we will need to raise additional capital to complete the development and commercialization of our product candidate.
Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate. 86 Table of Contents Based on our current operating plan, our cash and cash equivalents as of December 31, 2025, anticipated revenues from product sales, proceeds from our 2025 financings, and approximately $0.4 million we raised subsequent to year end, will not be sufficient to sustain our operations, including funding our U.S. product candidate, FemBloc, through regulatory approval, and we will need to raise additional capital to complete the U.S. development and EU commercialization of our product candidate.
All revenue is recognized point in time. 83 Table of Contents The majority of products sold directly to U.S. customers are shipped via common carrier, and the customer pays for shipping and handling and assumes control Free on Board (FOB) shipping point.
The majority of products sold directly to U.S. customers are shipped via common carrier, and the customer pays for shipping and handling and assumes control Free on Board (FOB) shipping point.
The Company is a U.S. manufacturer that has received global regulatory approvals for its product portfolio worldwide, and they are currently being commercialized in the U.S. and key international markets. FemaSeed ® Intratubal Insemination, a groundbreaking infertility treatment delivering sperm directly to the site of conception, is U.S. FDA-cleared and approved in Europe, United Kingdom (UK), Canada and Israel.
The Company is a U.S. manufacturer that has received global regulatory approvals for its product portfolio, which is currently being commercialized in the U.S. and key international markets. FemaSeed ® Intratubal Insemination, a groundbreaking first-step infertility treatment delivering sperm directly to the site of conception, is U.S.
FDA-cleared and approved in Europe, UK, Canada and Israel. FemBloc® permanent birth control is a revolutionary first-of-its-kind non-surgical approach, that involves minimally-invasive placement of a patented delivery system for precise delivery of our proprietary synthetic tissue adhesive (blended polymer) into both fallopian tubes simultaneously.
FemCerv ® , an endocervical tissue sampler for cervical cancer diagnosis, is U.S. FDA-cleared and approved in Europe, UK, Canada, Israel and New Zealand. FemBloc ® permanent birth control is a revolutionary first-in-class non-surgical solution which involves minimally-invasive placement of a patented delivery system for precise delivery of our proprietary synthetic tissue adhesive (blended polymer) into both fallopian tubes simultaneously.
For so long as our public float is less than $75.0 million, we may not sell more than the equivalent of one-third of our public float during any 12 consecutive months pursuant to the baby shelf rules.
For so long as our public float is less than $75.0 million, we may not sell more than the equivalent of one-third of our public float during any 12 consecutive months pursuant to the baby shelf rules. In June 2025, we sold 3,600,000 shares of common stock in an underwritten public offering at $0.85 per share.
Other (expense) income Other (expense) income consists largely of interest earned on our cash equivalents and short-term investments, offset by interest expense and other expenses. Income tax expense Income tax expense consists of the minimum state income taxes we are required to pay.
Other expense, net Other expense, net consists of debt financing costs, interest expense and other expenses, partially offset by changes in fair value of derivatives and interest earned on our cash equivalents. Income tax expense Income tax expense consists of the minimum state income taxes we are required to pay.
While our significant accounting policies are more fully described in Note 2 to our financial statements appearing elsewhere in this Annual Report on Form 10-K, we believe the following discussion addresses our most critical accounting policy, which are those that are most important to our financial condition and results of operations and require our most difficult, subjective and complex judgments.
While our significant accounting policies are more fully described in Note 2 to our financial statements appearing elsewhere in this Annual Report on Form 10-K, we believe the following discussion addresses our most critical accounting policy, which are those that are most important to our financial condition and results of operations and require our most difficult, subjective and complex judgments. 88 Table of Contents Revenue recognition Our policy is to recognize revenue when a customer obtains control of the promised goods under Accounting Standards Codification 606— Revenue from Contracts with Customers (Topic 606) , which we adopted effective January 1, 2018.
As of December 31, 2024, we had $3,451,761 of cash and cash equivalents and an accumulated deficit of $127,198,257. In July 2022, we entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Piper Sandler & Co.
As of December 31, 2025, we had $9,266,353 of cash and cash equivalents and an accumulated deficit of $145,826,144. 85 Table of Contents In July 2022, we entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Piper Sandler & Co.
Research and development The following table summarizes our R&D expenses incurred during the periods presented: Year Ended December 31, 2024 2023 Compensation and related personnel costs $ 4,652,802 3,733,928 Clinical-related costs 1,665,736 1,702,985 Material and development costs 1,113,129 1,091,930 Professional and outside consultant costs 673,733 570,628 Other costs 111,143 109,230 Total research and development expenses $ 8,216,543 7,208,701 R&D expenses increased by $1,007,842 or 14.0%, to $8,216,543 in 2024 from $7,208,701 in 2023.
Research and development The following table summarizes our R&D expenses incurred during the periods presented: Year Ended December 31, 2025 2024 Compensation and related personnel costs $ 4,506,695 4,652,802 Clinical-related costs 1,023,995 1,665,736 Material and development costs 886,064 1,113,129 Professional and outside consultant costs 508,262 673,733 Other costs 652,688 111,143 Total research and development expenses $ 7,577,704 8,216,543 R&D expenses decreased by $638,839 or 7.8%, to $7,577,704 in 2025 from $8,216,543 in 2024.
Cost of sales Cost of sales consists primarily of costs of components for use in our products, the materials and labor that are used to produce our products, and the manufacturing overhead that directly supports production.
For products sold to distributors internationally, control is transferred upon shipment or delivery to the customer’s named location, based on the contractual shipping terms. Cost of sales Cost of sales consists primarily of costs of components for use in our products, the materials and labor that are used to produce our products, and the manufacturing overhead that directly supports production.
As of December 31, 2024, approximately 4.6 million shares of common stock have been sold to date for aggregate proceeds of $9.8 million under the Equity Distribution Agreement pursuant to the prospectus. Subsequent to December 31, 2024, we raised approximately $5.4 million under the Equity Distribution Agreement.
As of December 31, 2025, approximately 10.2 million shares of common stock have been sold to date for aggregate proceeds of $16.7 million under the Equity Distribution Agreement pursuant to the prospectus. In December 2025, we filed a new prospectus pursuant to which we may sell up to $9.8 million under the Equity Distribution Agreement.
Financing activities In 2024, cash provided by financing activities was $2,027,457, attributable to sales under the at-the-market facility of $2,025,104 and proceeds from common stock issued through the employee stock purchase plan of $63,106, less at-the-market facility issuance costs of $60,753.
The proceeds were partially offset by repayments of the 2023 Convertible Notes for $6,765,000 and note payable for $367,450. In 2024, cash provided by financing activities was $2,027,457, attributable to sales under the at-the-market facility of $1,964,351, net of issuance costs and proceeds from common stock issued through the employee stock purchase plan of $63,106.
Cash Flows Comparison of the Years Ended December 31, 2024 and 2023 The following table summarizes our cash flows for the years ended December 31: Year Ended December 31, 2024 2023 Net cash used in operating activities $ (19,444,009 ) (11,280,546 ) Net cash used in investing activities (847,764 ) (143,917 ) Net cash provided by financing activities 2,027,457 20,178,604 Net change in cash and cash equivalents $ (18,264,316 ) 8,754,141 Operating activities In 2024, cash used in operating activities was $19,444,009, attributable to a net loss of $18,816,628, a net change in our net operating assets and liabilities of $3,144,778, partially offset by non-cash charges of $2,517,397.
Cash Flows Comparison of the Years Ended December 31, 2025 and 2024 The following table summarizes our cash flows for the years ended December 31: Year Ended December 31, 2025 2024 Net cash used in operating activities $ (18,690,565 ) (19,444,009 ) Net cash used in investing activities (630,098 ) (847,764 ) Net cash provided by financing activities 25,135,255 2,027,457 Net change in cash and cash equivalents $ 5,814,592 (18,264,316 ) Operating activities In 2025, cash used in operating activities was $18,690,565, attributable to a net loss of $18,627,887 and a net change in our net operating assets and liabilities of $2,056,843, partially offset by non-cash charges of $1,994,165.
For the year ended December 31, 2024, Comercial Medico Quiruigca, SA and Durgalab, distributors in Spain, accounted for approximately 15% and 12%, respectively, of our total revenue. For the years ended December 31, 2024 and 2023, Bayer Yakuhin, Ltd. accounted for approximately 7% and 5%, respectively, of our total revenue.
Kebomed Europe AG, a distributor in France, accounted for approximately 21% of our revenue for the year ended December 31, 2025. Comercial Medico Quirugica, SA and Durgalab, distributors in Spain, accounted for approximately 8% and 8%, respectively, of our total revenue for the year ended December 31, 2025, and 15% and 12%, respectively, for the year ended December 31, 2024.
The increase relates primarily to compensation, marketing and travel costs as we recruited a commercial team to promote our available products. General and administrative General and administrative expenses decreased by $532,009, or 7.8%, to $6,325,999 in 2024 from $6,858,008 in 2023.
The increase relates primarily to compensation, marketing and travel costs as we began recruitment of a commercial team in 2024 to promote our available products, partially offset by reduced professional fees. General and administrative General and administrative expenses increased by $320,038, or 5.1%, to $6,646,037 in 2025 from $6,325,999 in 2024.
Peer-reviewed publication of positive data from its pivotal clinical trial of FemaSeed demonstrated effectiveness and safety with high satisfaction from both patients and practitioners. FemVue ® , a companion diagnostic for fallopian tube assessment via ultrasound, is U.S. FDA-cleared and approved in Europe, UK, Canada, Japan and Israel. FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis, is U.S.
FDA-cleared and approved in Europe, United Kingdom (UK), Canada, Israel, Australia and New Zealand. A peer-reviewed publication of positive data from its pivotal clinical trial of FemaSeed demonstrated effectiveness and safety with high satisfaction from both patients and practitioners.
Income tax expense Income tax expense increased by $5,264 or 121.3%, to $9,602 in 2024 from $4,338 in 2023 due to an increase in the state minimum taxes we are required to pay. 80 Table of Contents Liquidity and Capital Resources Sources of liquidity Since our inception through December 31, 2024, our operations have been financed primarily by net proceeds from the sale of our common stock and convertible indebtedness and, to a lesser extent, product revenue.
Liquidity and Capital Resources Sources of liquidity Since our inception through December 31, 2025, our operations have been financed primarily by net proceeds from the sale of our common stock and convertible indebtedness and, to a lesser extent, product revenue.
Funding requirements Based on our current operating plan, our current cash and cash equivalents, which include approximately $5.4 million we raised subsequent to year end 2024, and anticipated revenues from product sales are expected to be sufficient to fund our ongoing operations into the third quarter of 2025.
The financing resulted in aggregate gross proceeds of $12,000,000, with total potential funding of approximately $58 million, if all warrants are exercised for cash. Funding requirements Based on our current operating plan, our current cash and cash equivalents and anticipated revenues from product sales are expected to be sufficient to fund our ongoing operations into the third quarter of 2026.
The decrease relates primarily to decreased compensation expense and professional costs, partially offset by increased facility and other overhead costs. Depreciation and amortization Depreciation and amortization expenses decreased by $186,163, or 38.5%, to $297,318 in 2024 from $483,481 in 2023.
The increase relates primarily to increased compensation expense, partially offset by reduced facility and other overhead costs. Depreciation and amortization Depreciation and amortization expenses increased by $44,716, or 15.0%, to $342,034 in 2025 from $297,318 in 2024. The increase relates additional fixed assets and intangible assets in service.
In November 2023, we entered into a securities purchase agreement with certain accredited investors pursuant to which we sold (i) senior unsecured convertible notes in an aggregate principal amount of $6,850,000, convertible into shares of common stock at a conversion price of $1.18 per share, (ii) Series A Warrants to purchase up to an aggregate of 5,805,083 shares of common stock at an exercise price of $1.18 per share, and (iii) Series B Warrants to purchase up to an aggregate of 5,805,083 shares of common stock at an exercise price of $1.475 per share (collectively, the “November 2023 Financing”).
In November 2025, we entered into a definitive agreement for the issuance of (i) senior secured convertible notes in an aggregate principal amount of $12,000,000, convertible into shares of 16,378,563 common stock at a conversion price of $0.73 per share, (ii) Series A-1 Warrants to purchase up to an aggregate of 16,378,563 shares of common stock at an exercise price of $0.81 per share, subject to adjustments (iii) Series B-1 Warrants to purchase an aggregate of 16,378,563 shares of common stock at an exercise price of $0.92 per share, subject to adjustments, and (iv) Series C-1 Warrants to purchase an aggregate of 16,378,563 shares of common stock at an exercise price of $1.10 per share, subject to adjustments.
Peer-reviewed publication of positive data from its initial clinical trials of FemBloc have demonstrated compelling effectiveness and five-year safety with high satisfaction from both patients and practitioners. In March 2025, we announced CE mark certification under EU MDR as the first regulatory approval in the world for the FemBloc delivery system for non-surgical female permanent birth control.
A peer-reviewed publication of positive data from its initial clinical trials of FemBloc has demonstrated compelling effectiveness and five-year safety with high satisfaction from both patients and practitioners.
The increase is primarily due to increased compensation costs, material and development costs, and professional and outside consultant costs. 79 Table of Contents Sales and marketing Sales and marketing expenses increased by $3,380,024 or 519.9%, to $4,030,150 in 2024 from $650,126 in 2023.
The decrease is primarily due to reduced clinical costs, commercialization of development products into inventory, reduced professional fees, and reduced compensation and related personnel costs, partially offset by increased regulatory costs. 84 Table of Contents Sales and marketing Sales and marketing expenses increased by $413,657 or 10.3%, to $4,443,807 in 2025 from $4,030,150 in 2024.
In April 2023, we sold an aggregate of (i) 1,318,000 shares of common stock and (ii) pre-funded warrants to purchase up to 1,878,722 shares of common stock in a registered direct offering and, in a concurrent private placement, warrants to purchase up to 3,196,722 shares of common stock.
In August 2025, we sold an aggregate of (i) 10,434,586 shares of common stock in a public offering and to certain Company officers (ii) pre-funded warrants to purchase up to 11,750,000 shares of common stock and (iii) common warrants to purchase up to 22,184,586 shares of common stock.
In March 2025, we announced strategic distribution partnerships for FemBloc in Spain. The pivotal clinical trial (clinicaltrials.gov: NCT05977751) is now enrolling participants for U.S. approval. FemCath® and FemChec®, companion diagnostic products for FemBloc’s ultrasound-based confirmation test, are U.S. FDA-cleared and approved in Europe and Canada.
The Company received FDA approval in November 2025 of its investigational device exemption (“IDE”) supplement to move forward to the final phase of the pivotal clinical trial (clinicaltrials.gov: NCT05977751) for U.S. approval. In March 2026, we announced the initiation of enrollment in this final phase. FemChec, a companion diagnostic product for FemBloc’s ultrasound-based confirmation test, is U.S.
The Company intends to meet future operating cash requirements through increased sales of commercial products and fundraising, as discussed in Funding requirements. 82 Table of Contents In 2023, cash used in operating activities was $11,280,546, attributable to a net loss of $14,247,124, offset by non-cash charges of $1,739,186 and a net change in our net operating assets and liabilities of $1,227,392.
The Company intends to meet future operating cash requirements through increased sales of commercial products and fundraising, as discussed in Funding requirements. Investing activities In 2025, cash used in investing activities for the purchases of fixed assets and intangible assets was $525,007 and $105,091, respectively.
For products sold in the U.S. through direct customer service, control is transferred upon shipment to customers. For products sold to distributors internationally, control is transferred upon shipment or delivery to the customer’s named location, based on the contractual shipping terms.
For the years ended December 31, 2025 and 2024, Bayer Yakuhin, Ltd. accounted for approximately 3% and 7%, respectively, of our total revenue. For products sold in the U.S. through direct customer service, control is transferred upon shipment to customers.
Removed
For the FemBloc blended polymer, an integral part of the FemBloc permanent birth control, we have successfully completed an expedited G12 Special MDR Audit for Class III devices and the Notified Body has recommended for CE mark approval pending the final stages of EMA review, with potential approval expected mid-2025.
Added
FemSperm ® , which includes setup, preparation and analysis kits designed to expand our infertility portfolio and, for the first time, enables gynecologists to perform in-office sperm preparation and analysis for use with FemaSeed. FemVue ® , a companion diagnostic for fallopian tube assessment via ultrasound, is U.S.
Removed
The increase is attributable primarily to FemaSeed product sales of $509,650, which was commercialized in 2024. FemVue units sold increased by 6.9% in 2024 as compared to 2023, while maintaining a relatively flat average selling price. Cost of sales Cost of sales increased by $164,834, or 43.4%, to $544,903 in 2024 from $380,069 in 2023.
Added
FDA-cleared and approved in Europe, UK, Canada, Japan, Israel, Australia and New Zealand. FemVue Controlled is a US FDA-cleared diagnostic device and is the next-generation design integrating features of FemVue and FemChec ® technologies into a single platform, enabling multiple clinical uses within one solution, including confirmation of tubal patency prior to use with FemaSeed.
Removed
The increase in cost of sales is primarily attributed to increased sales, partially offset by certain manufacturing efficiencies.
Added
In March 2025, we announced Conformité Européenne (CE) mark certification under European Union (“EU”) Medical Device Regulation (“MDR”) as the first regulatory approval in the world for the FemBloc delivery system for non-surgical female permanent birth control and in June 2025, we announced CE mark certification under EU MDR for the class III blended polymer component, achieving approval for the entire FemBloc system in the EU.
Removed
The decrease relates to depreciation expense associated with the Company’s fixed assets and amortization expense associated with the Company’s intangible assets that have reached the end of their useful lives. Other (expense) income Total other (expense) income decreased by $1,286,850, or 484.5%, to $1,021,221 net expense in 2024 from $265,629 net income in 2023.
Added
In August and September 2025, we announced UK and New Zealand regulatory approvals, respectively, for FemBloc. In March and September 2025, we announced strategic distribution partnerships for FemBloc in Spain and France/Benelux region, respectively.
Removed
The decrease relates to increased interest expense and non-cash discount amortization related to the convertible notes payable which were outstanding for the full year, partially offset by increased interest income.
Added
FDA-cleared and approved in Europe, UK, Canada, Israel, Australia and New Zealand. FemCath ® for selective fallopian tube evaluation is U.S. FDA-cleared and approved in Europe, Canada and Israel for selective fallopian tube evaluation.
Removed
As of October 2023, the Sales Agent was authorized to sell shares of common stock for an aggregate offering price up to $16.7 million pursuant to the prospectus.
Added
The increase is attributable primarily to FemBloc product sales of $810,000, which were commercialized in 2025. Cost of sales Cost of sales increased by $327,497 or 60.1%, to $872,400 in 2025 from $544,903 in 2024. The increase in cost of sales is primarily attributed to increased sales and newly commercialized products.
Removed
During the year ended December 31, 2024, we sold approximately 1.3 million shares of common stock for aggregate proceeds of $2 million, and as of December 31, 2024, approximately $7.0 million remains available for sale pursuant to the prospectus.
Added
Other expense, net Total other expense, net increased by $16,700, or 1.6%, to $1,037,921 in 2025 from $1,021,221 in 2024.
Removed
Additionally, common warrants were issued to the placement agent in this transaction to purchase up to 191,803 shares of common stock as compensation for services, collectively the (“April 2023 Financing”). The purchase price per share for the common stock, prefunded warrants was $1.22 and $1.2199, respectively. The net proceeds from the April 2023 Financing at closing were approximately $3.4 million.
Added
Other expense, net, primarily consists of interest income earned on our cash and cash equivalents, interest expense for our 2025 and 2023 convertible notes, non-cash interest expense related to the amortization of debt issuance costs for our 2025 and 2023 convertible notes, and non-cash charges recognized for the change in fair value of our 2025 Conversion Option liability and Warrants liabilities, issuance costs related to the AMPA derivative liability, and deferred financing costs expensed in relation to an expired shelf.
Removed
The warrants in the April 2023 Financing were fully exercised for additional cash proceeds of $3.5 million during 2023. Placement agent warrants of 122,994 were exercised for additional cash proceeds of $0.2 million during 2023.
Added
Refer below for further details on the separate components of other expense, net.
Removed
Net proceeds from the November 2023 Financing were $6.3 million. The Series B Warrants expired in November 2024 unexercised. If exercised for cash, the Series A Warrants issued in the November 2023 Financing could result in proceeds of up to an additional $6.8 million. The Series A Warrants expire in November 2028.
Added
Year Ended December 31, 2025 2024 Interest income $ 101,760 582,354 Amortization of debt issuance costs and discount for 2025 and 2023 Notes (1,387,050 ) (1,192,574 ) Interest expense (504,069 ) (411,001 ) Debt issuance costs for AMPA (286,295 ) — Change in fair value of Conversion Option liability 503,000 — Change in fair value of Warrants liabilities 731,000 — Other expenses (196,267 ) — Total other expense, net $ (1,037,921 ) (1,021,221 ) Income tax expense Income tax expense decreased by $8,305 or 86.5%, to $1,297 as compared to $9,602 in 2024 due to a decrease in the state minimum taxes we were required to pay.
Removed
In February 2025, $85,000 of Series A Convertible Notes were converted into 72,033 shares of common stock.
Added
Subsequent to December 31, 2025, we raised approximately $0.4 million under the Equity Distribution Agreement.
Removed
In addition, we are limited under the terms of the convertible notes to sell securities at a price below $1.18 until May 2025.
Added
Separately and concurrently, we sold 1,686,275 shares of common stock in a private placement at a price of $0.85 per share to certain existing institutional stockholders and a price of $1.02 per share to certain directors and officers. Net proceeds from the transaction were $3,705,061.
Removed
Non-cash charges primarily consisted of $675,700 in stock-based compensation, $907,985 in depreciation and amortization and $107,963 in amortization of the discount on the convertible notes. The change in our net operating assets and liabilities was primarily due to an increase of $1,614,647 in accounts payable and accrued liabilities, partially offset by a decrease of $440,489 in lease liabilities.
Added
On June 30, 2025, we entered into an Any Market Purchase Agreement (“Purchase Agreement” or “AMPA” ) with Alumni Capital LP (“Alumni”) whereby we have the right, but not obligation, to sell to Alumni up to an aggregate of $10 million in shares of common stock in a series of purchases until December 31, 2026.
Removed
In 2023, cash provided by financing activities was $20,178,604, attributable primarily to cash provided by proceeds from the issuance of stock and subsequent warrant exercises of $7,587,977, sales under the at-the-market facility of $7,665,066, and the issuance of convertible notes for $6,850,000.
Added
We may elect that Alumni purchase up to $1 million in shares of common stock (or up to $5 million if mutually agreed) at either (i) the lowest traded price for 4 previous business days, multiplied by 90%, or (ii) up to the lesser of (a) $1 million in shares of common stock, or (b) 100% of the average daily trading volume of common stock for previous two business days at lowest daily dollar volume-weighted-average price, multiplied by 97%.
Removed
Cash used in financing activities included payments of offering costs of $1,072,908, repayments on notes payable of $610,340, issuance costs for the at-the-market facility of $229,953 and payments under lease obligations of $16,193.
Added
We are limited to issuances to Alumni or 19.99% of the shares of common stock outstanding immediately prior to the execution of the Purchase Agreement.
Removed
Revenue recognition Our policy is to recognize revenue when a customer obtains control of the promised goods under Accounting Standards Codification 606— Revenue from Contracts with Customers (Topic 606) , which we adopted effective January 1, 2018.
Added
Additionally, common warrants to purchase 443,692 shares of common stock were issued to the underwriter as compensation for services performed. The purchase price per share for the common stock was $0.36, except for shares sold to certain company officers, which was $0.5151 per share. The purchase price per share for the pre-funded warrants was $0.3599.
Added
The net proceeds from the August 2025 Financing at closing were approximately $7.1 million. As of December 31, 2025, 5,000,000 pre-funded warrants and 9,219,110 common warrants were exercised for approximately $3.3 million.

… 3 more changes not shown on this page.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

1 edited+0 added−0 removed1 unchanged
Biggest changeWe have elected not to take advantage of such extended transition period, which means that we will adopt a new standard when a standard is issued or revised. 84 Table of Contents
Biggest changeWe have elected not to take advantage of such extended transition period, which means that we will adopt a new standard when a standard is issued or revised. 89 Table of Contents

Other FEMY 10-K year-over-year comparisons