What changed in Semler Scientific, Inc.'s 2023 10-K compared to 2022?

Across the narrative sections we track, Semler Scientific, Inc. (SMLR) added 249 paragraphs, removed 259, and edited 205 between the 2022 and 2023 10-K filings. The biggest movers are Item 1A. Risk Factors (+112/−107), Item 1. Business (+78/−95), Item 7. Management's Discussion & Analysis (+53/−52).

Did Semler Scientific, Inc. add new Risk Factors in the 2023 10-K?

Yes — Item 1A Risk Factors shows 112 new/edited paragraphs and 107 removed paragraphs versus the 2022 10-K.

What changed in Semler Scientific, Inc.'s MD&A (Item 7) in 2023?

Item 7 Management's Discussion & Analysis shows 53 new/edited paragraphs and 52 removed paragraphs year-over-year. Read the side-by-side diff to see exactly which revenue, margin, and outlook commentary was rewritten.

Did Semler Scientific, Inc.'s Legal Proceedings (Item 3) change in 2023?

Item 3 shows 1 added/edited paragraphs and 1 removed paragraphs — usually indicating new litigation disclosed or settled cases removed.

Where does this SMLR 10-K diff come from?

The source filings are Semler Scientific, Inc.'s official 2022 and 2023 Form 10-K annual reports from SEC EDGAR. 10q10k.net parses each filing, aligns paragraphs by section (Item 1, 1A, 1C, 2, 3, 7, 7A), and highlights every added, removed and edited sentence side-by-side.

Semler Scientific, Inc.SMLREarnings & Financial Report

Nasdaq · Health Care · Electromedical & Electrotherapeutic Apparatus

Deep Analysis

Semler Scientific, Inc. develops, manufactures and distributes non-invasive medical diagnostic devices for chronic disease screening. Its flagship QuantaFlo system delivers fast, accurate peripheral arterial disease testing, serving hospitals, clinics, primary care practices and other healthcare providers primarily in the United States.

What changed in Semler Scientific, Inc.'s 10-K — 2022 vs 2023

Top changes in Semler Scientific, Inc.'s 2023 10-K

249 paragraphs added · 259 removed · 205 edited across 6 sections

Item 1A. Risk Factors+112 / −107 · 93 edited
Item 1. Business+78 / −95 · 72 edited
Item 7. Management's Discussion & Analysis+53 / −52 · 35 edited
Item 5. Market for Registrant's Common Equity+3 / −3 · 3 edited
Item 2. Properties+2 / −1 · 1 edited

Item 1. Business

Business — how the company describes what it does

72 edited+6 added−23 removed133 unchanged

2022 filing

2023 filing

Our intention is to provide a tool to internists and non-cardiovascular experts, for whom it was previously impractical to conduct a blood flow measurement unless in a specialized vascular laboratory.

Among other limitations of the study, the study had a small sample size, was conducted at specialty practices not primary care practices, had a retrospective design with incomplete collection of demographic information and clinical characteristics of the population, was not peer reviewed and was not peer reviewed.

This may have led to an underestimation of the true risk as targeted PAD risk management and behavior modification strategies may have been initiated at the discretion of the provider and patient. A September 2022 a peer-reviewed study under real-world conditions, illustrating the benefits of PAD in-home screening was published.

This may have led to an underestimation of the true risk as targeted PAD risk management and behavior modification strategies may have been initiated at the discretion of the provider and patient. A September 2022 peer-reviewed study under real-world conditions, illustrating the benefits of PAD in-home screening was published.

The FDA can also impose restrictions on the sale, distribution or use of devices at the time of their clearance or approval or authorization, or subsequent to marketing. 510(k) Clearance Pathway To obtain 510(k) clearance, a medical device manufacturer must submit a pre-market notification demonstrating that the proposed device is substantially equivalent to a previously cleared 510(k) device or a device that was in commercial distribution before May 28, 1976 for which the FDA has not yet called for the submission of a PMA application or a device that has been reclassified from class III to class II or class I.

The FDA can also impose restrictions on the sale, distribution or use of devices at the time of their clearance or approval or authorization, or subsequent to marketing. 510(k) Clearance Pathway To obtain 510(k) clearance, a medical device manufacturer must submit a premarket notification demonstrating that the proposed device is substantially equivalent to a previously cleared 510(k) device or a device that was in commercial distribution before May 28, 1976 for which the FDA has not yet called for the submission of a PMA application or a device that has been reclassified from class III to class II or class I.

One-year all-cause mortality, 1- and 2-year major adverse cardiovascular events (MACE), and major adverse limb events (MALE) in the PAD positive patients were all significantly increased versus those patients who screened negative for PAD (p A February 2023 a peer-reviewed study was published assessing the accuracy our vascular testing product using cardiac echocardiography (Echo) as a gold standard of heart failure.

One-year all-cause mortality, 1- and 2-year major adverse cardiovascular events (MACE), and major adverse limb events (MALE) in the PAD positive patients were all significantly increased versus those patients who screened negative for PAD (p 11 Table of Contents A February 2023 peer-reviewed study was published assessing the accuracy of our vascular testing product using cardiac echocardiography (Echo) as a gold standard of heart failure.

Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts and Vermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration to physicians.

Additionally, the commercial compliance environment is continually evolving in the healthcare industry, and some states, including California, Massachusetts and Vermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration to physicians and other healthcare providers.

Also, there are millions of diabetic patients seen routinely by endocrinologists. Many podiatrists who see patients with these problems and orthopedic surgeons may see value in screening patients for circulation issues prior to leg 7 Table of Contents procedures. Neurologists may need a tool to differentiate leg pain from vascular versus neurologic etiology.

Also, there are millions of diabetic patients seen routinely by endocrinologists. Many podiatrists who see patients with these problems and orthopedic surgeons may see value in screening patients for circulation issues prior to leg procedures. Neurologists may need a tool to differentiate leg pain from vascular versus neurologic etiology.

Women may lack early detection programs and have inadequate preventive disease management. A study was compiled and published in a peer reviewed journal in 2019 that presented a retrospective analysis of 68,402 female 11 Table of Contents patients tested with our product at primary care medical practices in the United States.

Women may lack early detection programs and have inadequate preventive disease management. A study was compiled and published in a peer reviewed journal in 2019 that presented a retrospective analysis of 68,402 female patients tested with our product at primary care medical practices in the United States.

The FDA’s 510(k) clearance pathway usually takes from three to 12 months from the date the notification is submitted, but it can take significantly longer, and clearance is never assured. Although many 510(k) pre-market notifications are cleared without clinical data, in some cases, the FDA requires significant clinical data to support substantial equivalence.

The FDA’s 510(k) clearance pathway usually takes from three to 12 months from the date the notification is submitted, but it can take significantly longer, and clearance is never assured. Although many 510(k) premarket notifications are cleared without clinical data, in some cases, the FDA requires significant clinical data to support substantial equivalence.

Further analysis of a subset of 26,459 patients for whom clinical characteristics were recorded showed that 95% were asymptomatic. The authors concluded that earlier recognition of PAD may lead to earlier secondary preventive measures and improved outcomes for a population with a high-risk of cardiovascular mortality and morbidity.

Further analysis of a subset of 26,459 patients for whom clinical characteristics were recorded showed that 95% were 10 Table of Contents asymptomatic. The authors concluded that earlier recognition of PAD may lead to earlier secondary preventive measures and improved outcomes for a population with a high-risk of cardiovascular mortality and morbidity.

Devices deemed to pose lower risk are placed in either class I or II, which requires the manufacturer to submit to the FDA a pre-market notification requesting permission for commercial distribution. This process is known as 510(k) clearance. Some low risk devices are exempt from this requirement.

Devices deemed to pose lower risk are placed in either class I or II, which requires the manufacturer to submit to the FDA a premarket notification requesting permission for commercial distribution. This process is known as 510(k) clearance. Some low risk devices are exempt from this requirement.

Failure to comply with the conditions of approval can result in materially adverse enforcement action, including the loss or withdrawal of the approval. New PMA applications or PMA application supplements are required for significant modifications to the manufacturing process, labeling and design of a device that is approved through the PMA process.

Failure to comply with the conditions of approval can result in materially adverse enforcement action, including the loss or withdrawal of the approval. New PMA applications or PMA application supplements are required for significant modifications to the 13 Table of Contents manufacturing process, labeling and design of a device that is approved through the PMA process.

Accordingly, under CMS guidelines, risk factor adjustments per patient will provide payment that is higher for sicker patients who have conditions that are codified. 6 Table of Contents The current coding system used by CMS for the Medicare Advantage program is a hierarchical condition category, or HCC, diagnostic classification system that began by classifying over 14,000 diagnosis codes into approximately 1,500 diagnostic groups, or DXGs.

Accordingly, under CMS guidelines, risk factor adjustments per patient will provide payment that is higher for sicker patients who have conditions that are codified. The current coding system used by CMS for the Medicare Advantage program is a hierarchical condition category, or HCC, diagnostic classification system that began by classifying over 14,000 diagnosis codes into approximately 1,500 diagnostic groups, or DXGs.

Class I devices are those for which safety and effectiveness can be reasonably assured by adherence to FDA’s “general controls”, which include compliance with the applicable portions of the FDA’s Quality System Regulation, or QSR, facility registration and product listing, reporting of adverse medical events and malfunctions through the submission of Medical Device Reports, or MDRs, and appropriate, truthful and non-misleading labeling, advertising and promotional materials.

Class I devices are those for which safety and effectiveness can be reasonably assured by adherence to FDA’s “general controls”, which include compliance with the applicable portions of the FDA’s Quality System 12 Table of Contents Regulation, or QSR, facility registration and product listing, reporting of adverse medical events and malfunctions through the submission of medical device reports, and appropriate, truthful and non-misleading labeling, advertising and promotional materials.

FDA’s Pre-market Clearance and Approval Requirements To commercially distribute QuantaFlo or any future medical device we develop requires or will require either prior 510(k) clearance or prior approval of a pre-market approval, or PMA, application or de novo classification from the FDA. The FDA classifies medical devices into one of three classes.

FDA’s Premarket Clearance and Approval Requirements To commercially distribute QuantaFlo or any future medical device we develop requires or will require either prior 510(k) clearance or prior approval of a premarket approval, or PMA, application or de novo classification from the FDA. The FDA classifies medical devices into one of three classes.

ITEM 1. BUSINESS General We are a company providing technology solutions to improve the clinical effectiveness and efficiency of healthcare providers. Our mission is to develop, manufacture and market innovative products and services that assist our customers in evaluating and treating chronic diseases. Our patented and U.S.

Published studies have shown that there are over one million hospitalizations per year in the United States from heart failure and the annual cost of care exceeds $30 billion. According to a study published in AHA Journals by S.L.

Published studies have shown that there are over one million hospitalizations per year in the United States from heart failure and the annual cost of care exceeds $30 billion. 6 Table of Contents According to a study published in AHA Journals by S.L.

If an IDE application is approved by the FDA and one or more IRBs, human clinical trials may begin a specific number of investigational sites with a specific number of patients, as approved by the FDA. If the device is considered a “non-significant risk,” an IDE application to the FDA is not required.

If an IDE application is approved by the FDA and one or more IRBs, human clinical trials may begin a specific number of investigational sites with a specific number of patients, as approved by the FDA. 14 Table of Contents If the device is considered a “non-significant risk,” an IDE application to the FDA is not required.

Additionally, if a healthcare company settles an investigation with the DOJ or other law 18 Table of Contents enforcement agencies, the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.

Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies, the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.

Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions: ● untitled letters or warning letters; ● fines, injunctions and civil penalties; ● recall or seizure of our products; ● operating restrictions, partial suspension or total shutdown of production; ● refusing our request for 510(k) clearance or pre-market approval or de novo classification of new products; ● withdrawing pre-market approvals that are already granted or reclassifying the devices; and ● criminal prosecution.

Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions: ● untitled letters or warning letters; ● fines, injunctions and civil penalties; ● recall or seizure of our products; ● operating restrictions, partial suspension or total shutdown of production; 15 Table of Contents ● refusing our request for 510(k) clearance or premarket approval or de novo classification of new products; ● withdrawing premarket approvals that are already granted or reclassifying the devices; and ● criminal prosecution.

Among other limitations of the study, the publication 10 Table of Contents mentioned the study’s retrospective design, no direct comparison to other vascular tests and passive data collection such that 8% of patients had one or more missing data fields.

Among other limitations of the study, the publication mentioned the study’s retrospective design, no direct comparison to other vascular tests and passive data collection such that 8% of patients had one or more missing data fields.

For example, several executive orders were issued along with other directives designed to delay the implementation of certain provisions of the Health Care Reform Law or otherwise circumvent some of the requirements for health insurance mandated by the Health Care Reform Law.

Further, it is possible that additional governmental action is taken in response to the ongoing COVID-19 pandemic or other global pandemics. Human Capital Management As of December 31, 2022, we had 127 employees, all of which were full-time. None of our employees are represented by a labor union, and we consider our relationship with our employees to be positive.

Further, it is possible that additional governmental action is taken in response to the COVID-19 pandemic or other global pandemics. Human Capital Management As of December 31, 2023, we had 92 employees, all of which were full-time. None of our employees are represented by a labor union, and we consider our relationship with our employees to be positive.

Specifically, we believe there are more than 400,000 physicians and other potential customers in the United States alone, many of whom care for patients will be more than 50 years old and at increased risk of developing cardiac and vascular diseases. Based on U.S.

Reimbursement is contingent on established coding for a given procedure, coverage of the codes by the third-party payors and adequate payment for the resources used. 16 Table of Contents Physician coding for procedures is established by the American Medical Association.

Reimbursement is contingent on established coding for a given procedure, coverage of the codes by the third-party payors and adequate payment for the resources used. Physician coding for procedures is established by the American Medical Association.

Class II devices are subject to FDA’s general controls and any other “special controls” deemed necessary by FDA to ensure the safety and effectiveness of the device, such as performance standards, product-specific guidance documents, special labeling requirements, patient registries or post-market surveillance.

Class II devices are subject to FDA’s general controls and any other “special controls” deemed necessary by FDA to ensure the safety and effectiveness of the device, such as performance standards, special labeling requirements, patient registries or post-market surveillance.

Pre-market Approval Pathway A PMA application must be submitted if the device cannot be cleared through the 510(k) clearance process and requires proof of the safety and effectiveness of the device to the FDA’s satisfaction.

Premarket Approval Pathway A PMA application must be submitted if the device cannot be cleared through the 510(k) clearance process and requires proof of the safety and effectiveness of the device to the FDA’s satisfaction.

While our current independent contract manufacturers source some supplies from China, we believe QuantaFlo is relatively easy to manufacture, and should we encounter issues due to supply chain disruptions as a result of the ongoing COVID-19 pandemic or other global supply chain constraints, we believe alternative sources should be available.

While our current independent contract manufacturers source some supplies from China, we believe QuantaFlo is relatively easy to manufacture, and should we encounter issues due to supply chain disruptions as a result of a global health emergency, such as the COVID-19 pandemic or any other global supply chain constraints, we believe alternative sources should be available.

Such information is now made publicly available in a searchable format, and device manufacturers are now required to report and disclose any investment interests held by physicians and their family members during the preceding calendar year.

Such information is now made publicly available in a searchable format, and device manufacturers are now required to report 17 Table of Contents and disclose any investment interests held by physicians and their family members during the preceding calendar year.

To market low to moderate risk devices that are automatically placed into class III, a manufacturer may request a de novo classification from FDA. Both pre-market clearance, PMA applications and de novo classification requests are subject to the payment of user fees, paid at the time of submission for FDA review.

To market low to moderate risk devices that are automatically placed into class III, a manufacturer may request a de novo classification from FDA. Premarket notifications, PMA applications and de novo classification requests are subject to the payment of user fees, paid at the time of submission for FDA review.

Census data, the evaluable patient population for QuantaFlo is estimated to be more than 80 million patients in the United States annually. 8 Table of Contents ● Expanding the tools available to internists and non-peripheral vascular experts.

Census data, the evaluable patient population for QuantaFlo is estimated to be more than 80 million patients in the United States annually. ● Expanding the tools available to internists and non-peripheral vascular experts.

Our two largest customers are U.S. diversified healthcare companies and affiliated plans, and in the year ended December 31, 2022, they accounted for 40.4% and 29.0% of our revenues, respectively, compared to 40.8% and 28.6%, respectively, in the prior year. 5 Table of Contents Other Blood Flow Testing Methods Blood flow is the amount of blood delivered to a given region per unit time, whereas blood pressure is the force exerted by circulating blood on the walls of arteries.

Our two largest customers are U.S. diversified healthcare companies and affiliated plans, and in the year ended December 31, 2023, they accounted for 36.0% and 34.9% of our revenues, respectively, compared to 40.4% and 29.0%, respectively, in the prior year. 5 Table of Contents Other Blood Flow Testing Methods Blood flow is the amount of blood delivered to a given region per unit time, whereas blood pressure is the force exerted by circulating blood on the walls of arteries.

FDA regulations govern, among other things, the following activities that we or our partners perform and will continue to perform: ● product design and development; ● product testing; ● product manufacturing; ● product safety; 12 Table of Contents ● post-market adverse event reporting; ● post-market surveillance; ● product labeling; ● product storage; ● record keeping; ● pre-market clearance or approval; ● post-market approval studies; ● advertising and promotion; and ● product sales and distribution.

FDA regulations govern, among other things, the following activities that we or our partners perform and will continue to perform: ● product design and development; ● product testing; ● product manufacturing; ● product safety; ● post-market adverse event reporting; ● post-market surveillance; ● product labeling; ● product storage; ● record keeping; ● premarket clearance or approval; ● post-market approval studies; ● advertising and promotion; and ● product sales and distribution.

After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, will require a new 510(k) clearance or could require a PMA application.

We intend to do this by: ● Targeting customers with patients at risk of developing cardiac and vascular diseases. Healthcare providers use blood flow measurements as part of their assessment of a patient’s cardiac and vascular condition.

We intend to do this by: ● Targeting customers with patients at risk of developing PAD and other cardiovascular diseases (subject to FDA clearance). Healthcare providers use blood flow measurements as part of their assessment of a patient’s cardiac and vascular condition.

If the FDA disagrees with a manufacturer’s determination regarding whether a new pre-market submission is required for the modification of an existing device, the FDA can require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or approval of a PMA application is obtained.

If the FDA disagrees with a manufacturer’s determination regarding whether a new premarket submission is required for the modification of an existing device, the FDA can require the manufacturer to cease marketing and/or recall the modified device until clearance or approval is obtained.

To date, we roughly estimate that routine office usage of the QuantaFlo has ranged from a few tests per week up to 10 tests per day. We also offer contracts in which we invoice on a per test basis for use of QuantaFlo.

QuantaFlo has an expected average lifetime of at least three years. To date, we roughly estimate that routine office usage of the QuantaFlo has ranged from a few tests per week up to 10 tests per day. We also offer contracts in which we invoice on a per test basis for use of QuantaFlo.

Because QuantaFlo is relatively easy to use, training can generally be accomplished in less than one day. Customers who have licensed our QuantaFlo product may pay by credit card or check generally on the 15th of each month as an advance for usage during the next 30 days. In some cases, customers prefer an annual license paid in advance.

Because QuantaFlo is relatively easy to use, training can generally be accomplished in less than one day. 8 Table of Contents Customers who have licensed our QuantaFlo product may pay by credit card or check generally on the 15 th of each month as an advance for usage during the next 30 days.

For cardiovascular specialists, QuantaFlo does not require the use of blood pressure cuffs (which should not be used on some breast cancer patients), and measures without blood pressure in obese patients and patients with non-compressible, hard, calcified arteries. Currently, these patients often are unable to be measured with traditional devices.

Even if a clinical trial is completed, there can be no assurance that the data generated during a clinical study will meet the safety and effectiveness endpoints or otherwise produce results that will lead the FDA to grant marketing clearance or approval.

In addition to the license model with a fixed monthly fee, we also have contracts that charge a variable monthly fee, in which we invoice based on the number of tests performed with QuantaFlo. In addition to licensing the QuantaFlo software, we have sold QuantaFlo equipment and accessories.

We upgrade QuantaFlo operating systems as appropriate by direct shipments or electronically. In addition to the license model with a fixed monthly fee, we also have contracts that charge a variable monthly fee, in which we invoice based on the number of tests performed with QuantaFlo. In addition to licensing the QuantaFlo software, we have sold QuantaFlo equipment and accessories.

We believe our company culture has been a critical component of our success in attracting and retaining personnel. Diversity and Inclusion - We aim to create an inclusive working environment where all employees are respected and treated equally.

Our director of human resources and her team are also actively involved in implementing these decisions. We believe our company culture has been a critical component of our success in attracting and retaining personnel. Diversity and Inclusion - We aim to create an inclusive working environment where all employees are respected and treated equally.

In the year ended December 31, 2022, we had total revenues of $56.7 million and net income of $14.3 million compared to total revenues of $53.0 million and net income of $17.2 million in 2021.

In the year ended December 31, 2023, we had total revenues of $68.2 million and net income of $20.6 million compared to total revenues of $56.7 million and net income of $14.3 million in 2022.

For example, through the process created by the Budget Control Act of 2011 and subsequent legislation, there are automatic reductions of Medicare payments to providers of generally 2% per fiscal year; these reductions went into effect in April 19 Table of Contents 2013 and except for a period of temporary relief that was afforded in response to the COVID-19 public health emergency will remain in effect through fiscal year 2031 unless additional Congressional action is taken.

For example, through the process created by the Budget Control Act of 2011 and subsequent legislation, there are automatic reductions of Medicare payments to providers of generally 2% per fiscal year; these reductions went into effect in April 2013 and will remain in effect through fiscal year 2031 unless additional Congressional action is taken.

Most of our employees work remotely, with the exception of a few employees who work in the office. These employees are generally in fulfillment and sales support roles. Our human resources department coordinates on-line training programs with the help of outside consultants. We believe that this model of training better fits our business operations and needs.

Most of our employees work remotely, with the exception of a few employees who work in the office. These employees are generally in fulfillment and sales support roles. Our human resources department coordinates on- 19 Table of Contents line training programs with the help of outside consultants.

In March 2015, we received FDA 510(k) clearance of our product, QuantaFlo, reflecting several updates and modifications to the original model that were developed in conjunction with our consultant engineering groups. In January 2024, we announced that we are seeking a new 510(k) clearance for the expanded use of QuantaFlo following correspondence with the FDA.

It is unclear how additional litigation or executive orders will impact the Health Care Reform Law and our business. Other legislative changes have been proposed and adopted in the United States since Health Care Reform Law.

As a result, the Supreme Court did not rule on the constitutionality of the Health Care Reform Law. It is unclear how additional litigation or executive orders will impact the Health Care Reform Law and our business. Other legislative changes have been proposed and adopted in the United States since the passage of the Health Care Reform Law.

In reviewing pre-market notification, the FDA may request additional information, including 13 Table of Contents clinical data, which may significantly prolong the review process.

In reviewing premarket notification, the FDA may request additional information, including clinical data, which may significantly prolong the review process.

Competitors are beginning to market competing digital devices seeking to provide fast results that may be used outside of a specialized vascular laboratory. Given the potential size of the market, we expect competitors to continue to enter the space.

Currently, these patients often are unable to be measured with traditional devices. 9 Table of Contents Competitors are marketing competing digital devices seeking to provide fast results that may be used outside of a specialized vascular laboratory. Given the potential size of the market, we expect competitors to continue to enter the space.

When FDA grants a de novo request for classification, the device is granted marketing authorization and further can serve as a predicate for future devices of that type through a 510(k) premarket notification. 14 Table of Contents Clinical Trials Clinical trials are typically required to support a PMA and often for a de novo classification request, and are sometimes required to support a 510(k) submission.

For Medicare Advantage patients CMS pays a fee per patient, also known as capitation. CMS uses risk adjustment to adjust capitation payments to health plans, either higher or lower, to account for the differences in expected health costs of individuals.

CMS uses risk adjustment to adjust capitation payments to health plans, either higher or lower, to account for the differences in expected health costs of individuals.

Our Products and Services We currently market a patented and FDA-cleared, cardiac and vascular testing product, QuantaFlo, to our customers, who include insurance plans, physician groups, risk assessment groups, hospitals and retailers.

Our Products and Services We currently market a patented and FDA-cleared, vascular testing product, QuantaFlo, to our customers, who include insurance plans, physician groups, risk assessment groups, hospitals and retailers. 4 Table of Contents QuantaFlo QuantaFlo is a four-minute in-office blood flow test.

Many managed care programs are paying their providers on a capitated basis, which puts the providers at financial risk for the services provided to their patients by paying them a predetermined amount per member per month. The percentage of individuals covered by managed care programs is expected to grow in the United States over the next decade.

Many managed care programs are paying their providers on a capitated basis, which puts the providers at financial risk for the services provided to their patients by 16 Table of Contents paying them a predetermined amount per member per month.

We continue to develop additional complementary proprietary products in-house (such as our recently released QuantaFlo extension as an aid to measure hemodynamics related to heart dysfunction), and seek out other arrangements for additional products and services that we believe will bring value to our customers and to our company.

We continue to develop additional complementary proprietary products in-house and seek out other arrangements for additional products and services that we believe will bring value to our customers and to our company.

We provide technical support daily, coupled directly to the manufacturing operation so that replacement products, if needed, can be shipped overnight directly to the customer. The majority of the support is over the telephone and focuses on software and connectivity issues, rather than hardware. We upgrade QuantaFlo operating systems as appropriate by direct shipments or electronically.

In some cases, customers prefer an annual or quarterly license paid in advance. We provide technical support daily, coupled directly to the manufacturing operation so that replacement products, if needed, can be shipped overnight directly to the customer. The majority of the support is over the telephone and focuses on software and connectivity issues, rather than hardware.

We use different incentive plans such as annual cash bonuses, no-cost healthcare for employees and their families, paid vacation and generous referral bonuses to attract, retain and motivate our employees.

Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and additional employees. We use different incentive plans such as annual cash bonuses, no-cost healthcare for employees and their families, paid vacation for employees ranked below director and generous referral bonuses to attract, retain and motivate our employees.

Sales and Marketing We provide our QuantaFlo product to our customers through our salespersons, who have experience selling products and services to our anticipated market. We deliver our QuantaFlo testing product directly to our customers, and in-service training to the customers is provided either on-line or in person.

We deliver our QuantaFlo testing product directly to our customers, and in-service training to the customers is provided either on-line or in person.

Information about certain device clinical trials must be posted on clinicaltrials.gov. 15 Table of Contents Pervasive and Continuing FDA Regulation After a device is placed on the market, regardless of its classification or pre-market pathway, numerous regulatory requirements apply.

Pervasive and Continuing FDA Regulation After a device is placed on the market, regardless of its classification or premarket pathway, numerous regulatory requirements apply.

The following diagram illustrates the use of QuantaFlo: QuantaFlo features a sensor clamp that is placed on the toe or finger. Infrared light emitted from the clamp on the dorsal surface of the digit is scattered and reflected by the red blood cells coursing through the area of illumination. Returning light is ‘sensed’ by the sensor.

Infrared light emitted from the clamp on the dorsal surface of the digit is scattered and reflected by the red blood cells coursing through the area of illumination. Returning light is ‘sensed’ by the sensor. A blood flow waveform is instantaneously constructed by our proprietary software algorithm.

We have an agreement with Mellitus Health, Inc, or Mellitus, a private company to exclusively market and distribute Insulin Insights, an FDA-cleared software product that recommends optimal insulin dosing for diabetic outpatients in the United States, including Puerto Rico, except for selected accounts.

We do not track directly how physicians code for and receive payment for such procedures. Other Products and Services In addition to our internal research and development efforts, in April 2021, we entered into an agreement with Mellitus Health, Inc, or Mellitus to exclusively market and distribute Insulin Insights, a FDA-cleared software product that recommends optimal insulin dosing for diabetic outpatients in the United States, including Puerto Rico, except for selected accounts.

We also regularly engage consultants and subcontractors on an as-needed basis. We increased our head count in the fiscal year 2022 from 124 to 127, which represents a 2% increase from the prior year.

We also regularly engage consultants and subcontractors on an as-needed basis. As a part of the strategic plan to streamline operations implemented in the third quarter of 2023, we decreased our head count in the fiscal year 2023 from 127 to 92, which represents a 28% decrease from the prior year.

Our contracts provide for subassemblies, product final assembly, test, serialization, finished goods, 9 Table of Contents inventory and shipping operations. Our current contracts will remain in force until terminated by us upon three months written notice, or until terminated by either party for cause.

Our current contracts will remain in force until terminated by us upon three months written notice, or until terminated by either party for cause.

For example, the government has enforced the federal Anti-Kickback Law to reach large 17 Table of Contents settlements with healthcare companies based on, among other things, inappropriate consultant arrangements with physicians or questionable joint venture arrangements.

For example, the government has enforced the federal Anti-Kickback Law to reach large settlements with healthcare companies based on, among other things, inappropriate consultant arrangements with physicians or questionable joint venture arrangements. The majority of states also have anti-kickback laws, which establish similar prohibitions that may apply to items or services reimbursed by any third-party payor, including commercial insurers.

In health care, it gives an incentive for physicians to provide more treatments because payment is dependent on the quantity of care, rather than quality of care.

Market Opportunity QuantaFlo Fee-for-service is a payment model where services are unbundled and paid for separately. In health care, it gives an incentive for physicians to provide more treatments because payment is dependent on the quantity of care, rather than quality of care. For Medicare Advantage patients CMS pays a fee per patient, also known as capitation.

This license model eliminates the need to make a capital equipment sale. Consequently, we generally require no down payment or long-term commitment from our customers. QuantaFlo has an expected average lifetime of at least three years.

Both index fingers and both large toes are interrogated, which takes about 30 seconds for each. We have primarily developed a license model rather than an outright sales model for QuantaFlo. This license model eliminates the need to make a capital equipment sale. Consequently, we generally require no down payment or long-term commitment from our customers.

Governance and Culture - Our board of directors, including committees thereof, and executive management team are actively involved in overseeing our employee-related strategies and practices as well as our company culture. Our director of human resources and her team are also actively involved in implementing these decisions.

Beginning February 1, 2023, due to a change in policy, we no longer accrue vacation for employee ranked director or higher, which included all of our executive officers. Governance and Culture - Our board of directors, including committees thereof, and executive management team are actively involved in overseeing our employee-related strategies and practices as well as our company culture.

In addition to our in-house research and development efforts, we are also seeking out opportunities to expand our product and service offerings through marketing, distribution and licensing arrangements, such as our agreement to exclusively market and distribute Insulin Insights line in the United States, including Puerto Rico.

In addition to our in-house research and development efforts, we are also seeking out opportunities to expand our product and service offerings through marketing, distribution and licensing arrangements. Such arrangements will allow us to sell products related to chronic disease management through our network of physicians and other customers.

We recently began marketing QuantaFlo as an aid to measure hemodynamics related to heart dysfunction and continue to explore potential new product and service offerings through our research and development programs.

The new 510(k) is intended to enable expanded labeling for QuantaFlo as an aid in the diagnosis of other cardiovascular diseases in addition to PAD. Further, we continue to explore potential new product and service offerings through our research and development programs.

Such arrangements will allow us to sell products related to chronic disease management through our network of physicians and other customers. We may also consider opportunistically acquiring additional products if we believe they fit within our strategy.

We may also consider opportunistically acquiring additional products if we believe they fit within our strategy. Sales and Marketing We provide our QuantaFlo product to our customers through our salespersons, who have experience selling products and services to our anticipated market.

We believe this product will be attractive to our existing customers as well as help expand our customer base. 4 Table of Contents QuantaFlo QuantaFlo is a four-minute in-office blood flow test. Healthcare providers can use blood flow measurements as part of their examinations of a patient’s vascular condition, including assessments of patients who have vascular disease.

Healthcare providers can use blood flow measurements as part of their examinations of a patient’s vascular condition, including assessments of patients who have vascular disease. The following diagram illustrates the use of QuantaFlo: QuantaFlo features a sensor clamp that is placed on the toe or finger.

Physicians who seek reimbursement for testing procedures are likely to use codes that describe non-invasive physiologic testing. We do not track directly how physicians code for and receive payment for such procedures. Insulin Insights Of the growing diabetic population in the United States, over a quarter use insulin according to the Center for Disease Control and Prevention.

Physicians who seek reimbursement for testing procedures are likely to use codes that describe non-invasive physiologic testing.

We signed several customers to a license for this product in late 2022. As of December 31, 2022, we had not generated any material revenues from this product. Manufacturing We manufacture our product, QuantaFlo, in the United States through independent contractors whom we pay for finished goods.

We will continue our marketing and selling efforts of the product. Manufacturing We manufacture our product, QuantaFlo, in the United States through independent contractors whom we pay for finished goods. Our contracts provide for subassemblies, product final assembly, test, serialization, finished goods, inventory and shipping operations.

Removed

Food and Drug Administration, or FDA, cleared product, QuantaFlo, measures arterial blood flow in the extremities to aid in the diagnosis of peripheral arterial disease, or PAD, and serves as an aid to measure hemodynamics related to heart dysfunction.

Added

Our patented and FDA cleared product, QuantaFlo, measures arterial blood flow in the extremities to aid in the diagnosis of PAD. We are currently seeking a new 510(k) clearance from the FDA for the expanded use of QuantaFlo, which is intended to enable expanded labeling as an aid in the diagnosis of other cardiovascular diseases in addition to PAD.

Removed

We have also made cash investments in Mellitus, in Monarch Medical Technology, LLC, or Monarch, a privately-held digital health company whose proprietary product, EndoTool Glucose Management System, or EndoTool, offers a technology-enabled approach to inpatient glycemic management, and in NeuroDiagnostics Inc., a privately-held company that is doing business as SYNAPS Dx, or SYNAPS, whose product , Discern, is a test for early Alzheimer’s disease.

Added

We have also made cash investments in Mellitus. Due to slow uptake of the product despite our marketing efforts, we wrote off our prepaid licenses and a portion of our investment. 7 Table of Contents In October 2020, we invested in SYNAPS , whose product, Discern, is a test for early Alzheimer’s disease.

Removed

We also have an exclusive distribution arrangement for the United States, including Puerto Rico, to distribute Insulin Insights, an FDA-cleared, software solution designed to provide insulin dosing recommendations to clinicians for the adjustment and maintenance of blood glucose levels in insulin-dependent patients with Type 2 diabetes.

Added

In spite of strong marketing, we were not able to generate significant revenue from Insulin Insights to date. We assessed the recoverability of the prepayment and determined it was not recoverable within the contract period. Consequently, we wrote off the entire balance of $2.5 million as of December 31, 2023.

Removed

A blood flow waveform is instantaneously constructed by our proprietary software algorithm. Both index fingers and both large toes are interrogated, which takes about 30 seconds for each. The product may be used with provocative maneuvers. We have primarily developed a license model rather than an outright sales model for QuantaFlo.

Added

Clinical Trials Clinical trials are typically required to support a PMA and often for a de novo classification request, and are sometimes required to support a 510(k) submission.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

93 edited+19 added−14 removed144 unchanged

2022 filing

2023 filing

We are a “smaller reporting company,” as defined in the Securities Exchange Act of 1934, as amended, or the Exchange Act, and will remain a smaller reporting company for so long as either our annual revenues are less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter, or our annual revenues are greater than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter.

We are a “smaller reporting company,” as defined in the Securities Exchange Act of 1934, as amended, or the Exchange Act, and will remain a smaller reporting company for so long as either our annual revenues are less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter, or our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter.

Additionally, investments in privately held companies are inherently risky, in some instances because the markets for the technologies or products these companies have under development may never materialize or achieve expectations. If these companies do not succeed, we may be forced to record impairment charges and could lose some or all of our investment in these companies.

Additionally, investments in privately held companies are inherently risky, in some instances because the markets for the technologies or products these companies have under development may never materialize or achieve expectations. If these companies do not succeed, we may be forced to record additional impairment charges and could lose some or all of our investment in these companies.

Our cardiac and vascular testing product and any future medical devices that we may develop or services that we may offer are subject to extensive regulation in the United States by the federal government, including by the FDA.

Our vascular testing product and any future medical devices that we may develop or services that we may offer are subject to extensive regulation in the United States by the federal government, including by the FDA.

Failure to hire or retain qualified direct sales and marketing personnel or independent distributors would prevent us from expanding our business and generating revenues, which would have a material adverse effect on our ability to achieve or maintain profitability. 24 Table of Contents To adequately commercialize our products and any new products we add, we may need to increase our sales and marketing network, which will require us to hire, train, retain and supervise employees and other independent contractors.

Failure to hire or retain qualified direct sales and marketing personnel or independent distributors would prevent us from expanding our business and generating revenues, which would have a material adverse effect on our ability to achieve or maintain profitability. 23 Table of Contents To adequately commercialize our products and any new products we add, we may need to increase our sales and marketing network, which will require us to hire, train, retain and supervise employees and other independent contractors.

If we operate our business without insurance, we could be responsible for paying claims or judgments against us that would have otherwise been covered by insurance, which could adversely affect our results of operations or financial condition. 36 Table of Contents We operate in an intensely competitive and rapidly changing business environment, and there is a substantial risk our products or service offerings could become obsolete or uncompetitive.

If we operate our business without insurance, we could be responsible for paying claims or judgments against us that would have otherwise been covered by insurance, which could adversely affect our results of operations or financial condition. 35 Table of Contents We operate in an intensely competitive and rapidly changing business environment, and there is a substantial risk our products or service offerings could become obsolete or uncompetitive.

Our amended and restated bylaws provide that a state or federal court located within the State of Delaware is the sole and exclusive forum for: ● any derivative action or proceeding brought on our behalf; ● any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee or stockholder of our company to us or our stockholders; ● any action asserting a claim arising pursuant to any provision of the General Corporation Law of the State of Delaware, our charter or our bylaws, as to which the General Corporation Law of the State of Delaware confers jurisdiction on the Court of Chancery of the State of Delaware; and ● any action asserting a claim governed by the internal affairs doctrine.

Our amended and restated bylaws provide that a state or federal court located within the State of Delaware is the sole and exclusive forum for: ● any derivative action or proceeding brought on our behalf; ● any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee or stockholder of our company to us or our stockholders; 32 Table of Contents ● any action asserting a claim arising pursuant to any provision of the General Corporation Law of the State of Delaware, our charter or our bylaws, as to which the General Corporation Law of the State of Delaware confers jurisdiction on the Court of Chancery of the State of Delaware; and ● any action asserting a claim governed by the internal affairs doctrine.

It is possible that our development efforts will not be successful and that we will not be able to develop new products or service offerings, either alone or in partnership 26 Table of Contents with others, or if developed that we will obtain the necessary regulatory approvals for commercialization.

It is possible that our development efforts will not be 25 Table of Contents successful and that we will not be able to develop new products or service offerings, either alone or in partnership with others, or if developed that we will obtain the necessary regulatory approvals for commercialization.

For example, in September and October 2020, we made investments in Mellitus and SYNAPS Dx, two private companies working in other product areas, Discern and Insulin Insights (for which we have an exclusive distribution agreement) and in December 2022, we extended a loan to Monarch, maker of EndoTool.

For example, in September and October 2020, we made investments in Mellitus and SYNAPS Dx, two private companies working in other product areas, Insulin Insights (for which we have an exclusive distribution agreement) and Discern, and in December 2022, we extended a loan to Monarch, maker of the software product EndoTool.

Although we have remedied our prior material weaknesses, if we identify additional material weaknesses in the future, or if our former material weaknesses recur, it could have an adverse effect on our company. In prior years, we have identified certain material weaknesses in connection with management’s evaluation of our internal control over financial reporting that we have remedied.

Although we have remediated our prior material weaknesses, if we identify additional material weaknesses in the future, or if our former material weaknesses recur, it could have an adverse effect on our company. In prior years, we have identified certain material weaknesses in connection with management’s evaluation of our internal control over financial reporting that we have remediated.

Our attempts to alter aspects of our business strategy, such as our recent entry into an exclusive marketing and distribution agreement and our investments in private companies, may not yield positive effects on our business, results of operations and financial condition.

Our attempts to alter aspects of our business strategy, such as our prior entry into an exclusive marketing and distribution agreement and our investments in private companies, may not yield positive effects on our business, results of operations and financial condition.

We believe that physicians and other customers will not widely adopt our vascular testing product or our other products in development or products we distribute unless they determine, based on experience, long-term clinical data and published peer reviewed journal articles, that the use of such product provides a safe and effective alternative to other existing ABI devices.

We believe that physicians and other customers will not widely adopt our vascular testing product or our other products in development or products we distribute unless they determine, based on experience, long-term clinical data 21 Table of Contents and published peer reviewed journal articles, that the use of such product provides a safe and effective alternative to other existing ABI devices.

Moreover, if our customers do not believe they can benefit from increased capitated payments by identifying sicker patients in their patient pools, they may not see the benefit in screening patients for PAD or heart dysfunction using our products, which would have material and adverse effect on our business, financial condition and results of operations.

Moreover, if our customers do not believe they can benefit from increased capitated payments by identifying sicker patients in their patient pools, they may not see the benefit in screening patients for PAD using our products, which would have material and adverse effect on our business, financial condition and results of operations.

We may decide to alter or discontinue aspects of our business strategy and may adopt different strategies due to business or competitive factors not currently foreseen, such as new medical technologies that would make our products obsolete or changes in the regulatory landscape that may undermine the economic rationale for QuantaFlo.

We may decide to alter or discontinue aspects of our business strategy and may adopt 20 Table of Contents different strategies due to business or competitive factors not currently foreseen, such as new medical technologies that would make our products obsolete or changes in the regulatory landscape that may undermine the economic rationale for QuantaFlo.

Although we have remedied our prior material weaknesses, we cannot assure you that we have identified all material weaknesses or that we will not in the future have additional, or recurrence of our prior, material weaknesses in our internal control over financial reporting.

Although we have remediated our prior material weaknesses, we cannot assure you that we have identified all material weaknesses or that we will not in the future have additional, or recurrence of our prior, material weaknesses in our internal control over financial reporting.

ITEM 1A. RISK FACTORS Any investment in our securities involves a high degree of risk. Investors should carefully consider the risks described below and all of the information contained in this annual report on Form 10-K before deciding whether to 20 Table of Contents purchase our common stock.

If some investors find our 37 Table of Contents common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

If some investors find our 36 Table of Contents common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

The stock market in general and the market for smaller medical device companies in particular have experienced extreme volatility that has often been unrelated to the 33 Table of Contents operating performance of particular companies. As a result of this volatility, you may not be able to sell your common stock.

The stock market in general and the market for smaller medical device companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, you may not be able to sell your common stock.

Changes to or repeal of the Health Care Reform Law could adversely affect our financial results and business. The applicable healthcare fraud and abuse laws and regulations, along with the increased enforcement environment, may lead to an enforcement action targeting us, which could adversely affect our business.

Changes to or repeal of the Health Care Reform Law could adversely affect our financial results and business. 28 Table of Contents The applicable healthcare fraud and abuse laws and regulations, along with the increased enforcement environment, may lead to an enforcement action targeting us, which could adversely affect our business.

For a discussion of healthcare reform activity, see “Business—Government Regulation—Healthcare Reform.” We believe that the Health Care Reform Law measures are mainly positive for our business given the ability of our cardiac and vascular testing product to measure blood flow in an in-office setting, which can assist doctors and other providers to suspect PAD and other vascular diseases.

For a discussion of healthcare reform activity, see “Business—Government Regulation—Healthcare Reform.” We believe that the Health Care Reform Law measures are mainly positive for our business given the ability of QuantaFlo to measure blood flow in an in-office setting, which can assist doctors and other providers to suspect PAD and other vascular diseases.

More specifically, if FDA concludes that we are not in compliance with applicable laws or regulations, or that our vascular testing product or any future medical device we develop is ineffective or poses an unreasonable health risk, the FDA could: ● require us to notify health professionals and others that our devices present unreasonable risk of substantial harm to public health; ● order us to recall, repair, replace or refund the cost of any medical device that we manufactured or distributed; ● detain, seize or ban adulterated or misbranded medical devices; ● refuse to provide us with documents necessary to export our product; ● refuse requests for 510(k) clearance or pre-market approval of new products or new intended uses; ● withdraw 510(k) clearances that are already granted or reclassify our device; ● impose operating restrictions, including requiring a partial or total shutdown of production; ● enjoin or restrain conduct resulting in violations of applicable law pertaining to medical devices; and/or ● assess criminal or civil penalties against our officers, employees or us.

More specifically, if FDA concludes that we are not in compliance with applicable laws or regulations, or that our vascular testing product or any future medical device we develop is ineffective or poses an unreasonable health risk, the FDA could: ● require us to notify health professionals and others that our devices present unreasonable risk of substantial harm to public health; ● order us to recall, repair, replace or refund the cost of any medical device that we manufactured or distributed; ● detain, seize or ban adulterated or misbranded medical devices; ● refuse to provide us with documents necessary to export our product; ● refuse requests for 510(k) clearance or premarket approval of new products or new intended uses; ● withdraw 510(k) premarket approvals we may receive or reclassify our device; ● impose operating restrictions, including requiring a partial or total shutdown of production; ● enjoin or restrain conduct resulting in violations of applicable law pertaining to medical devices; and/or ● assess criminal or civil penalties against our officers, employees or us.

In addition, because our board of directors is responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by 32 Table of Contents making it more difficult for stockholders to replace members of our board of directors.

In addition, because our board of directors is responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors.

Our future financial performance will depend in part on our ability to influence, anticipate, identify and respond to changing user preferences and needs and the technologies relating to the care and treatment of vascular problems. We can provide no assurances that our cardiac and vascular testing product will achieve significant commercial success and that it will gain meaningful market share.

Our future financial performance will depend in part on our ability to influence, anticipate, identify and respond to changing user preferences and needs and the technologies relating to the care and treatment of vascular problems. We can provide no assurances that QuantaFlo will achieve significant commercial success and that it will gain meaningful market share.

If we are found to have promoted such 28 Table of Contents “off-label” uses, we may become subject to significant government fines and other related liability. The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion.

If we are found to have promoted such “off-label” uses, we may become subject to significant government fines and other related liability. The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion.

We had 81 sales and marketing employees as of December 31, 2022. If any of our sales or marketing force were to resign, our sales could be adversely affected. We may need to seek out alternatives, such as increasing our direct sales and marketing force or contracting with external independent sales representatives or enter another distributor relationship.

We had 56 sales and marketing employees as of December 31, 2023. If any of our sales or marketing force were to resign, our sales could be adversely affected. We may need to seek out alternatives, such as increasing our direct sales and marketing force or contracting with external independent sales representatives or enter another distributor relationship.

This concentration of revenues and accounts receivable among a limited number of customers represents a significant risk. We rely on a small number of independent suppliers and facilities for the manufacturing of our cardiac and vascular testing product. Any delay or disruption in the supply of the product or facility may negatively impact our operations.

This concentration of revenues and accounts receivable among a limited number of customers represents a significant risk. We rely on a small number of independent suppliers and facilities for the manufacturing of QuantaFlo. Any delay or disruption in the supply of the product or facility may negatively impact our operations.

Moreover, even if insurance plans, home health care providers and physicians understand the benefits of cardiovascular and other risk assessment testing, they still may elect not to use our products for a variety of reasons, such as familiarity with other devices and approaches, or the impact of the recent CMS Advance Notice, which may change the regulatory landscape for HCC codes and could impact the perceived profitability of using QuantaFlo to aid diagnosis of cardiovascular diseases.

Moreover, even if insurance plans, home health care providers and physicians understand the benefits of cardiovascular and other risk assessment testing, they still may elect not to use our products for a variety of reasons, such as familiarity with other devices and approaches, or the impact of CMS regulatory revisions, which revised the regulatory landscape for HCC codes and could impact the perceived profitability of using QuantaFlo to aid diagnosis of cardiovascular diseases.

For example, these persons, if they choose to act together, can impact the election of directors and approval of any merger, consolidation or sale of all or substantially all of our assets.

For example, these persons, if they choose to act together, can impact the election of directors 31 Table of Contents and approval of any merger, consolidation or sale of all or substantially all of our assets.

There can be no assurance that we will have sufficient resources to successfully commercialize our cardiac and vascular testing product or any other future products, if and when they are approved for sale or license, or service offerings that we may develop. Our future success will depend largely upon our ability to anticipate and keep pace with developments and advances.

There can be no assurance that we will have sufficient resources to successfully commercialize QuantaFlo or any other future products, if and when they are approved for sale or license, or service offerings that we may develop. Our future success will depend largely upon our ability to anticipate and keep pace with developments and advances.

Our inability to provide a product that meets delivery schedules could have a material adverse effect on our reputation in the industry, which could have a material adverse effect on our financial condition and results of operations. Further, our cardiac and vascular testing product is manufactured in the United States in a limited number of facilities.

Our inability to provide a product that meets delivery schedules could have a material adverse effect on our reputation in the industry, which could have a material adverse effect on our financial condition and results of operations. Further, QuantaFlo is manufactured in the United States in a limited number of facilities.

We manufacture our cardiac and vascular testing product through a small number of independent contractors based in the United States. We also purchase inventory under our exclusive marketing and distribution agreement with Mellitus. The loss or disruption of our relationships with outside vendors and suppliers could subject us to substantial delays in the delivery to customers.

We manufacture QuantaFlo through a small number of independent contractors based in the United States. We also purchase inventory under our exclusive marketing and distribution agreement with Mellitus. The loss or disruption of our relationships with outside vendors and suppliers could subject us to substantial delays in the delivery to customers.

A recall of our cardiac and vascular testing product or one of our future products, or a similar product manufactured by another manufacturer, could impair sales of the products we market as a result of confusion concerning the scope of the recall or as a result of the damage to our reputation for quality and safety.

A recall of QuantaFlo or one of our future products, or a similar product manufactured by another manufacturer, could impair sales of the products we market as a result of confusion concerning the scope of the recall or as a result of the damage to our reputation for quality and safety.

Therefore, we cannot be certain that the procedures or patient care performed with our product will be reimbursed at a cost-effective level. 23 Table of Contents Our cardiac and vascular testing product is generally but not specifically approved for reimbursement under any third-party payor codes; if third-party payors refuse to reimburse our customers for their use of our product, it could have a material adverse effect on our business.

Therefore, we cannot be certain that the procedures or patient care performed with our product will be reimbursed at a cost-effective level. 22 Table of Contents QuantaFlo is generally but not specifically approved for reimbursement under any third-party payor codes; if third-party payors refuse to reimburse our customers for their use of our product, it could have a material adverse effect on our business.

Service costs relating to our product may be greater than anticipated, rentals may be returned prior to the end of the license term, and we may be required to devote significant resources to address any quality issues associated with our cardiac and vascular testing product.

In addition, we are seeking to increase our sales and, in order to do so, might need to continue to expand our direct and distributor sales forces in existing and new territories, all of which could result in our becoming subject to additional or different regulatory requirements, with which we may not be able to comply.

In addition, we are seeking to increase our sales and, in order to do so, might need to continue to expand our direct and distributor sales forces in existing and new territories, which could subject us to additional or different regulatory requirements with which we may not be able to comply.

Accordingly, at this time, and given the way we intend our cardiac and vascular testing product to be used, we do not intend to pursue formal approval for our cardiac and vascular testing product for any particular code. Moreover, we are unable to predict what changes will be made to the reimbursement methodologies used by third-party payors.

Accordingly, at this time, and given the way we intend our QuantaFlo to be used, we do not intend to pursue formal approval for QuantaFlo for any particular code. Moreover, we are unable to predict what changes will be made to the reimbursement methodologies used by third-party payors.

If our sales grow more slowly than we anticipate or if our operating expenses exceed our expectations, our financial performance will likely be adversely affected. Our future financial performance will depend in part on the successful improvements and software updates to our cardiac and vascular testing product on a cost-effective basis.

There can be no assurance that the businesses we invest in will become profitable or remain so or that we will realize any financial benefit from our investments, including whether or not we will distribute Discern and EndoTool or realize any benefits from our efforts to distribute Insulin Insights, or that we will be repaid upon maturity of our loans.

We continually assess these threats and make investments to increase internal protection, detection, and response capabilities, as well as ensure our third-party providers have required capabilities and controls, to address this risk.

We continually assess these threats and make investments 34 Table of Contents to increase internal protection, detection, and response capabilities, as well as ensure our third-party providers have required capabilities and controls, to address this risk.

Our executive officers, directors and significant stockholders beneficially own in the aggregate shares representing approximately 47.0% of our common stock as of March 16, 2023. If these stockholders choose to act together, they are able to substantially influence the outcome of all matters submitted to our stockholders for approval, as well as our management and affairs.

Our executive officers, directors and significant stockholders beneficially own in the aggregate shares representing approximately 32.0% of our common stock as of March 1, 2024. If these stockholders choose to act together, they are able to substantially influence the outcome of all matters submitted to our stockholders for approval, as well as our management and affairs.

If we are unable to expand our sales and marketing capabilities, we may not be able to effectively commercialize our cardiac and vascular testing product or our other products and service offerings in development, which would adversely affect our business, results of operations and financial condition.

If we are unable to expand our sales and marketing capabilities, we may not be able to effectively commercialize QuantaFlo or our other products and service offerings in development, which would adversely affect our business, results of operations and financial condition.

If an event occurred that resulted in material damage to these manufacturing facilities or our manufacturing contractors lacked sufficient labor to fully operate their facilities, we may be unable to transfer the manufacture of our cardiac and vascular testing product to another facility or location in a cost-effective or timely manner, if at all.

If an event occurred that resulted in material damage to these manufacturing facilities or our manufacturing contractors lacked sufficient labor to fully operate their facilities, we may be unable to transfer the manufacture of QuantaFlo to another facility or location in a cost-effective or timely manner, if at all.

Healthcare providers that use medical devices such as our cardiac and vascular testing product to test their patients generally rely on third-party payors to pay for all or part of the costs and fees associated with the procedures performed with these devices, or to compensate them for their patient care services.

Healthcare providers that use medical devices such as QuantaFlo to test their patients generally rely on third-party payors to pay for all or part of the costs and fees associated with the procedures performed with these devices, or to compensate them for their patient care services.

The price per share at which we sell or issue additional shares of our common stock or other securities convertible into or exchangeable for our common stock in future transactions may be higher or lower than the price at which you purchased your shares. ITEM 1B. UNRESOLVED STAFF COMMENTS None.

Although we are not a borrower or party to any such instruments with SVB, Signature or any other financial institution currently in receivership, if any of our lenders or counterparties to any financial instruments (such as letters of credit) were to be placed into receivership, we may be unable to access such funds.

Although we took steps to diversify our banking relationships and are not a borrower or party to any such instruments with SVB, Signature or any other financial institution currently in receivership, if any of our lenders or counterparties to any financial instruments (such as letters of credit) were to be placed into receivership, we may be unable to access such funds.

For some governmental programs, such as Medicaid, coverage and reimbursement differ from state to state, and some state Medicaid programs may not pay an adequate amount for the procedures or patient care performed with our cardiac and vascular testing product if any payment is made at all.

Our current contractor manufacturers source some supplies from China and should these outside vendors encounter issues due to supply chain disruptions as a result of the ongoing COVID-19 pandemic or 25 Table of Contents otherwise, we believe alternative suppliers should be available.

Our current contractor manufacturers source some supplies from China and should these outside vendors encounter 24 Table of Contents issues due to supply chain disruptions as a result of the global health emergency such as COVID-19 pandemic or otherwise, we believe alternative suppliers should be available.

We also have a minority investment in, NeuroDiagnostics Inc., doing business as SYNAPS Dx, which is developing an additional potentially complementary product offering, Discern, although such product is in early stages and may not ultimately fit with our strategy and customer base.

We will continue our marketing and selling efforts of the product. We also have a minority investment in NeuroDiagnostics Inc., doing business as SYNAPS Dx, which is developing an additional potentially complementary product offering, Discern, although such product is in early stages and may not ultimately fit with our strategy and customer base.

We may not correctly anticipate or identify trends in user preferences or needs or may identify them later than competitors do. In addition, difficulties in manufacturing or in obtaining regulatory approvals may delay or prohibit improvements to our cardiac and vascular testing product or our other products in development.

The FDA may change its policies, adopt additional regulations, or revise existing regulations, in particular relating to the 510(k) clearance process. The FDA may change its policies, adopt additional regulations, or revise existing regulations, each of which could prevent or delay pre-market approval or 510(k) clearance of a device, or could impact our ability to market our currently cleared device.

The FDA may change its policies, adopt additional regulations, or revise existing regulations, each of which could prevent or delay premarket approval or 510(k) clearance of a device, or could impact our ability to market our currently cleared device.

Securities litigation could result in substantial costs and divert management’s attention and resources from our business. Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain. We have never declared or paid cash dividends on our capital stock.

Securities litigation could result in substantial costs and divert management’s attention and resources from our business. 33 Table of Contents Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.

Further, we may not be able to develop improvements and software updates to our cardiac and vascular testing product at a cost that allows us to meet our goals for profitability.

Further, we may not be able to develop improvements and software updates to QuantaFlo at a cost that allows us to meet our goals for profitability.

In December 2022, we committed to loan up to $5.0 million through the purchase of a senior convertible promissory note to Monarch, a digital health company whose proprietary product, EndoTool, offers a technology-enabled approach to inpatient glycemic management.

We do not have any distribution agreement for Discern. In December 2022, we committed to loan up to $5.0 million through the purchase of a senior convertible promissory note to Monarch, a digital health company whose proprietary product, EndoTool, offers a technology-enabled approach to inpatient glycemic management.

We may rely on third parties to support certain aspects of our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory clearance or approval or commercialize our products, and our business could be substantially harmed.

If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory clearance or approval or commercialize our products, and our business could be substantially harmed.

It is possible that a review of our business practices or those of our customers by courts or government authorities could result in a determination with an adverse effect on our business.

It is possible that a review of our business practices or those of our customers by courts or government authorities could result in a determination with an adverse effect on our business. We cannot predict the effect of possible future enforcement actions on our business.

We are currently exploring other sales models to generate revenues from our products in addition to the leasing model, such as our fee per test model. We also have exclusive distribution rights to a new product area and may in the future acquire rights to other complementary products.

We are currently exploring other sales models to generate revenues from our products in addition to the leasing model, such as our fee per test model. We also may in the future acquire rights to other complementary products.

Future reforms could require us to file new 510(k) clearances and could increase the total number of 510(k) clearances to be filed. We cannot predict what effect these reforms will have on our ability to obtain 510(k) clearances in a timely manner.

Further, future reforms could require us to file new 510(k)s and could increase the total number of 510(k)s to be filed. We cannot predict what effect these reforms will have on our ability to obtain 510(k) clearances in a timely manner. We also cannot predict the nature of other regulatory reforms and their resulting effects on our business.

For example, on March 10, 2023, Silicon Valley Bank, or SVB, was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation, or FDIC, as receiver. Similarly, on March 12, 2023, Signature Bank and Silvergate Capital Corp. were each swept into receivership. At December 31, 2022, we held approximately $30.1 million of U.S.

We may also fail to generate meaningful revenues from our Insulin Insights distribution arrangement, which includes prepaid licenses, or benefit from our recent investments in other companies developing complementary products.

If our cardiac and vascular testing product, QuantaFlo, our diabetes software, Insulin Insights, or other products we may offer are not viewed as an attractive alternative to other products, procedures and techniques, we will not achieve significant market penetration or be able to generate significant revenues.

If QuantaFlo or other products we may offer are not viewed as an attractive alternative to other products, procedures and techniques, we will not achieve significant market penetration or be able to generate significant revenues.

Therefore, our ability to successfully commercialize our cardiac and vascular testing product could depend on the coverage and adequacy of reimbursement from these third-party payors. Currently, our cardiac and vascular testing product is generally but not specifically approved for any particular reimbursement code.

We cannot control whether or not providers who use QuantaFlo will seek reimbursement. Therefore, our ability to successfully commercialize our vascular testing product could depend on the coverage and adequacy of reimbursement from these third-party payors. Currently, our QuantaFlo is generally but not specifically approved for any particular reimbursement code.

In addition to patents, we rely on trade secrets and proprietary know-how, which we seek to protect, in part, through confidentiality and proprietary information agreements. The other parties to these agreements may breach these provisions, and we may not have adequate remedies for any breach.

In addition to seeking patents for some of our technology and product, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed. In addition to seeking patents for some of our technology and product, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position.

We also cannot predict the nature of other regulatory reforms and their resulting effects on our business. 27 Table of Contents Our business is subject to unannounced inspections by FDA to determine our compliance with FDA requirements. FDA inspections can result in inspectional observations on FDA’s Form-483, warning letters, untitled letters or other forms of more significant enforcement action.

Our business is subject to unannounced inspections by FDA to determine our compliance with FDA requirements. FDA inspections can result in inspectional observations on FDA’s Form-483, warning letters, untitled letters or other forms of more significant enforcement action.

This impact could result in reputational, competitive, operational or other business harm as well as financial costs and regulatory action. 35 Table of Contents Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and our financial condition and results of operations.

Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and our financial condition and results of operations.

Our cardiac and vascular testing product is licensed by healthcare providers. They may bill various third-party payors, including governmental healthcare programs, such as Medicare and Medicaid, private insurance plans and managed care programs for procedures in which our testing product is used.

QuantaFlo is licensed by healthcare providers. They may bill various third-party payors, including governmental healthcare programs, such as Medicare and Medicaid, private insurance plans and managed care programs for procedures in which our testing product is used. Reimbursement is a significant factor considered by healthcare providers in determining whether to license medical devices or systems such as QuantaFlo.

As a result, we have had and will have less control over the conduct of the clinical trials, the timing and completion of the trials, the required reporting of adverse events, and the management of data developed through the trials than would be the case if we were relying entirely on our own staff.

These third-party contract research organizations and consultants may carry out portions of our clinical and preclinical research studies and regulatory filing assistance and as a result, if retained, we will have less control over the conduct of the clinical trials, the timing and completion of the trials, the required reporting of adverse events, and the management of data developed through the trials than would be the case if we were relying entirely on our own staff.

As a result, only appreciation of the price of our common stock will provide a return to stockholders. 34 Table of Contents General Risk Factors Because we operate in an industry with significant product liability risk, and we may not be sufficiently insured against this risk, we may be subject to substantial claims against our product or services that we may provide.

General Risk Factors Because we operate in an industry with significant product liability risk, and we may not be sufficiently insured against this risk, we may be subject to substantial claims against our product or services that we may provide.

Our and their assignment agreements may not be self-executing or may be breached, and we may be forced to bring claims against third parties, or defend claims they may bring against us, to determine the ownership of what we regard as our intellectual property. 31 Table of Contents If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.

If the FDA concludes that we failed to comply with any regulatory requirement during an inspection, it could have a material adverse effect on our business and financial condition. We could incur substantial expense and harm to our reputation, and our ability to introduce new or enhanced products in a timely manner could be adversely affected.

If the FDA concludes that we failed to comply with any regulatory requirement during an inspection or otherwise, it could have a material adverse effect on our business and financial condition.

We may continue to choose to invest some of our cash resources in other entities that may have complementary technologies or product offerings and may not realize the benefit of such investments. For example, in November 2021 we mutually terminated a distribution agreement for a product line and wrote down $1.2 million of inventory.

We may continue to choose to invest some of our cash resources in other entities that may have complementary technologies or product offerings and may not realize the benefit of such investments.

During the past several years, third-party payors have undertaken cost-containment initiatives including different payment methods, monitoring healthcare expenditures, and anti-fraud initiatives. We may not be able to achieve or maintain profitability if third-party payors deny coverage or reduce their current levels of payment, or if our costs of production increase faster than increases in reimbursement levels.

We may not be able to achieve or maintain profitability if third-party payors deny coverage or reduce their current levels of payment, or if our costs of production increase faster than increases in reimbursement levels.

For a discussion of the relevant regulatory regime, see “Business—Government Regulation.” We cannot assure that any new medical devices or new uses or modifications for our cardiac and vascular testing product that we develop will be cleared or approved in a timely or cost-effective manner, if cleared or approved at all.

For a discussion of the relevant regulatory regime, see “Business—Government Regulation.” We cannot assure that any new medical devices or new uses or modifications for QuantaFlo that we develop, including our planned 510(k) for the use of QuantaFlo to enable expanded labeling as an aid in the diagnosis of other cardiovascular diseases in addition to PAD, will be cleared or approved in a timely or cost-effective manner, if cleared or approved at all.

Recently CMS issued an Advance Notice, which proposes to revise the HCC codes for vascular disease, created uncertainty in the future whether identifying patients with PAD or heart dysfunction will qualify for an increased capitated payment.

For example, CMS revised the HCC codes for vascular disease and created uncertainty in the future whether identifying patients with PAD will qualify for an increased capitated payment.

We may implement a product recall or voluntary market withdrawal or stop shipment of our product due to product defects or product enhancements and modifications, which would significantly increase our costs. The manufacturing and marketing of QuantaFlo and any future products that we may develop involves an inherent risk that our products may prove to be defective.

We do not have any distribution agreement for Discern or EndoTool and we may never generate meaningful revenues from distribution of our prepaid licenses for Insulin Insights. Moreover, there is a risk that we may never receive repayment of our loans to Mellitus or Monarch, nor receive any benefit from our equity investment in SYNAPS Dx.

As of December 31, 2023, we loaned $4.5 million out of the $5.0 million loan committed. We do not have any distribution agreement for EndoTool. Moreover, there is a risk that we may never receive repayment of our loans to Mellitus or Monarch, nor receive any benefit from our equity investment in SYNAPS Dx.

To the extent that any products we offer are not commercially successful or are withdrawn from the market for any reason, our revenues will be adversely impacted, and our business, operating results and financial condition will be harmed. 22 Table of Contents Physicians and other customers may not widely adopt our products unless they determine, based on experience, long-term clinical data and published peer reviewed journal articles, that the use of our products provides a safe and effective alternative to other existing ABI devices.

Physicians and other customers may not widely adopt our products unless they determine, based on experience, long-term clinical data and published peer reviewed journal articles, that the use of our products provides a safe and effective alternative to other existing ABI devices.

Further, many private payors use coverage decisions and payment amounts determined by CMS, which administers the Medicare program, as guidelines in setting their coverage and reimbursement policies.

Further, many private payors use coverage decisions and payment amounts determined by CMS, which administers the Medicare program, as guidelines in setting their coverage and reimbursement policies. Those private payors that do not follow the Medicare guidelines may adopt different coverage and reimbursement policies for procedures or patient care performed with our vascular testing product.

Our cardiac and vascular testing product, including our recent extension of QuantaFlo to aid in diagnosis of heart dysfunction, and any other products we may be offering in the future, may not gain broad market acceptance unless we continue to educate physicians and plans of their benefits.

Accordingly, we expect that revenues from our vascular testing product will account for the vast majority of our revenues for at least the next several years. QuantaFlo, and any other products we may be offering in the future, may not gain broad market acceptance unless we continue to educate physicians and plans of their benefits.

For the year ended December 31, 2022, two customers accounted for 40.4%, and 29.0% of our revenues, and as of December 31, 2022, three customers accounted for 26.8%, 25.9% and 16.8% of our accounts receivable.

For the year ended December 31, 2023, two customers accounted for 36.0%, and 34.9% of our revenues, and as of December 31, 2023, three customers accounted for 27.5%, 27.5% and 23.6% of our accounts receivable.

A license to such intellectual property may not be available or may not be available on commercially reasonable terms, which could have a material adverse effect on our business and financial condition. 30 Table of Contents We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.

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Item 2. Properties

Properties — owned and leased real estate

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ITEM 2. PROPERTIES Because we outsource our manufacturing to “turn-key” manufacturers and have a geographically dispersed sales force and distributor arrangement, we have minimal needs for office space to conduct our day-to-day business operations. Our headquarters are located in Santa Clara, CA, where we lease an operations fulfillment space that also serves as our corporate headquarters address.

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Our headquarters are located in Santa Clara, CA, where we lease an operations fulfillment space that also serves as our corporate headquarters address. 38 Table of Contents

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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We are not currently a party to any litigation the outcome of which, if determined adversely to us, would individually or in the aggregate be reasonably expected to have a material adverse effect on our business, operating results, cash flows or financial condition. ITEM 4. MINE SAFETY DISCLOSURES Not applicable. 38 Table of Contents PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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On that date, our shares of common stock were held by approximately 33 stockholders of record. The number of record holders was determined from the records of our transfer agent and does not include beneficial owners of our common stock whose shares are held in the names of various security brokers, dealers, and registered clearing agencies.

On that date, our shares of common stock were held by approximately 30 stockholders of record. The number of record holders was determined from the records of our transfer agent and does not include beneficial owners of our common stock whose shares are held in the names of various security brokers, dealers, and registered clearing agencies.

Securities Authorized for Issuance Under Equity Compensation Plans Information about our equity compensation plans is incorporated herein by reference to Part III, Item 12 of this annual report on Form 10-K. Recent Sales of Unregistered Securities Not applicable. Issuer Purchases of Equity Securities Not applicable. ITEM 6. Reserved Not applicable.

MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock has been trading on the Nasdaq Stock Market LLC under the symbol “SMLR” since September 27, 2021. Holders On March 16, 2023, the closing sale price of a share of our common stock was $19.73 per share and there were 6,844,512 shares of our common stock outstanding.

MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock has been trading on the Nasdaq Stock Market LLC under the symbol “SMLR” since September 27, 2021. Holders On March 1, 2024, the closing sale price of a share of our common stock was $47.49 per share and there were 7,031,083 shares of our common stock outstanding.

Item 7. Management's Discussion & Analysis

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

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We believe that the following discussion addresses the Company’s most critical accounting policies, which are those that are most important to the portrayal of our financial condition and results of operations and require management’s most difficult, subjective and complex judgments.

We believe that the following discussion addresses our most critical accounting policies, which are those that are most important to the portrayal of our financial condition and results of operations and require management’s most difficult, subjective and complex judgments.

Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those set forth under “Risk Factors” and elsewhere in this annual report on Form 10-K. 39 Table of Contents Overview We are a company providing technology solutions to improve the clinical effectiveness and efficiency of healthcare providers.

Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those set forth under “Risk Factors” and elsewhere in this annual report on Form 10-K. Overview We are a company providing technology solutions to improve the clinical effectiveness and efficiency of healthcare providers.

Significant changes to these estimates may result in an increase or decrease in our tax provision in the current period or subsequent periods. Factors Affecting Future Results We have not identified any other factors that have a recurring effect that are necessary to understand period to period comparisons as appropriate, nor any one-time events that have an effect on the financials.

Significant changes to these estimates may result in an increase or decrease in our tax provision in the current period or subsequent periods. 42 Table of Contents Factors Affecting Future Results We have not identified any other factors that have a recurring effect that are necessary to understand period to period comparisons as appropriate, nor any one-time events that have an effect on the financials.

Engineering and product development expense Our engineering and product development expense consists of costs associated with the design, development, testing and enhancement of our cardiac and vascular testing product and other products in development. We also include salaries and related employee benefits, research-related overhead expenses and fees paid to external service providers in our engineering and product development expense.

Engineering and product development expense Our engineering and product development expense consists of costs associated with the design, development, testing and enhancement of QuantaFlo and other products in development. We also include salaries and related employee benefits, research-related overhead expenses and fees paid to external service providers in our engineering and product development expense.

Each vascular testing product unit has a depreciation schedule based on the cost of the unit. The cost of each unit is depreciated on a straight-line basis over 36 months. Each unit has its own cost of production, which varies from time to time.

Each vascular testing product 41 Table of Contents unit has a depreciation schedule based on the cost of the unit. The cost of each unit is depreciated on a straight-line basis over 36 months. Each unit has its own cost of production, which varies from time to time.

The remainder was from other equipment/supply sales of accessories, which were $1.4 million in 2022 as compared to $1.0 million in 2021. Revenues from fees for products are recognized monthly, usually billed as a fixed monthly fee or as a variable monthly fee dependent on usage.

The remainder was from other equipment/supply sales of accessories, which were $1.9 million in 2023 as compared to $1.4 million in 2022. Revenues from fees for products are recognized monthly, usually billed as a fixed monthly fee or as a variable monthly fee dependent on usage.

Sales and marketing expense Our sales and marketing expense consists primarily of sales commissions and support costs, salaries and related employee benefits, travel, education, trade show and marketing costs. 41 Table of Contents General and administrative expense Our general and administrative expense consists primarily of salaries and related employee benefits, professional service fees, associated travel costs and depreciation and amortization expense.

Sales and marketing expense Our sales and marketing expense consists primarily of sales commissions and support costs, salaries and related employee benefits, travel, education, trade show and marketing costs. General and administrative expense Our general and administrative expense consists primarily of salaries and related employee benefits, professional service fees, associated travel costs and depreciation and amortization expense.

Results of Operations Year Ended December 31, 2022 Compared to Year Ended December 31, 2021 Revenues We had revenues of $56.7 million for the year ended December 31, 2022, compared to $53.0 million in 2021. Our revenues are primarily from fees charged to customers for use of our products and from sale of accessories used with these products.

Results of Operations Year Ended December 31, 2023 Compared to Year Ended December 31, 2022 Revenues We had revenues of $68.2 million for the year ended December 31, 2023, compared to $56.7 million in 2022. Our revenues are primarily from fees charged to customers for use of our products and from sale of accessories used with these products.

Total other income and expense Our total other income and expense primarily reflects other taxes and fees as well as interest income. Critical Accounting Policies and Estimates Our accounting policies are more fully described in Note 2 of the Financial Statements.

Total other income and expense Our total other income and expense primarily reflects other taxes and fees, interest and dividend income, as well as changes in value and impairments of our investments. Critical Accounting Policies and Estimates Our accounting policies are more fully described in Note 2 of the financial statements.

Our pre-tax net income was $17.7 million in 2022 compared to $19.5 million in 2021. Recent Developments On March 14, 2022, our Board of Directors authorized a share repurchase program under which we may repurchase up to $20.0 million of our outstanding common stock.

Our pre-tax net income was $24.1 million in 2023 compared to $17.7 million in 2022. Recent Developments Common Stock Repurchase Program and Repurchase of Common Stock Warrants On March 14, 2022, our board of directors authorized a share repurchase program under which we may repurchase up to $20.0 million of our outstanding common stock.

Our mission is to develop, manufacture and market innovative proprietary products and services that assist our customers in evaluating and treating chronic diseases. Our patented and FDA cleared product, QuantaFlo, which measures arterial blood flow in the extremities to aid in the diagnosis of PAD, and as an aid to measure hemodynamics related to heart dysfunction.

Our mission is to develop, manufacture and market innovative proprietary products and services that assist our customers in evaluating and treating chronic diseases. Our patented and FDA cleared product, QuantaFlo measures arterial blood flow in the extremities to aid in the diagnosis of PAD.

Our arrangements with customers for our vascular testing product are normally on a month-to-month basis with fees billed at the rates established in our customer agreements, which are either fixed fees, or variable fees based on usage.

As of December 31, 2022, we had working capital of approximately $42.1 million. We believe that our current sources of funds will provide us with adequate liquidity during the 12-month period following December 31, 2022, as well as in the long-term. Our cash is held in a variety of non-interest bearing bank accounts and three-month treasury bills.

As of December 31, 2023, we had working capital of approximately $59.7 million. We believe that our current sources of funds will provide us with adequate liquidity during the 12-month period following December 31, 2023. Our cash is held in a variety of non-interest bearing bank accounts, interest bearing money market accounts and treasury bills.

We recognize revenues from the licensing of our vascular testing product pursuant to agreements that normally automatically renew each month with revenues recognized on a daily convention basis.

Sources of Revenues and Expenses Revenues We generate revenues primarily from the rental or license of our vascular testing product. We recognize revenues from the licensing of our vascular testing product pursuant to agreements that normally automatically renew each month with revenues recognized on a daily convention basis.

We recognized revenues of $55.3 million from fees for our products in 2022, consisting of $34.0 million from fixed-fee licenses and $21.3 million from variable-fee licenses, compared to $52.0 million in 2021, consisting of $30.5 million from fixed-fee licenses and $21.5 million from variable-fee licenses.

We recognized revenues of $66.3 million from fees for our products in 2023, consisting of $37.3 million from fixed-fee licenses and $29.0 million from variable-fee licenses, compared to $55.3 million in 2022, consisting of $34.0 million from fixed-fee licenses and $21.3 million from variable-fee licenses.

In the year ended December 31, 2022, we had total revenues of $56.7 million and net income of $14.3 million compared to total revenues of $53.0 million and net income of $17.2 million in 2021. We had an income tax expense of $3.4 million in 2022, compared to $2.2 million in 2021.

In the year ended December 31, 2023, we had total revenues of $68.2 million and net income of $20.6 million compared to total revenues of $56.7 million and net income of $14.3 million in 2022. We had an income tax expense of $3.5 million in 2023, compared to $3.4 million in 2022.

Investing Activities We used $26.8 million of net cash in investing activities for the year ended December 31, 2022, compared to $0.8 million of net cash in investing activities for the year ended December 31, 2021.

Investing Activities We generated $18.4 million of net cash from investing activities for the year ended December 31, 2023, compared to $26.8 million of net cash used in investing activities for the year ended December 31, 2022.

The primary reason for the increase in revenues was growth in the number of installed units from both new customers and established customers, which we believe is the result of our sales and marketing efforts. 42 Table of Contents Operating Expenses We had total operating expenses of $39.5 million for the year ended December 31, 2022, compared to $33.6 million in 2021.

The primary reason for the increase in revenues was growth in the usage of our product from both new customers and established customers, which we believe is the result of our sales and marketing efforts. Operating Expenses We had total operating expenses of $45.9 million for the year ended December 31, 2023, compared to $39.5 million in 2022.

The changes in the various components of our operating expenses are described below. Cost of Revenues We had cost of revenues of $4.3 million for the year ended December 31, 2022, compared to $6.1 million for 2021.

As a percentage of revenues, operating expenses, including cost of revenues, decreased to 67% in 2023, as compared to 70% in 2022. The changes in the various components of our operating expenses are described below. Cost of Revenues We had cost of revenues of $7.0 million for the year ended December 31, 2023, compared to $4.3 million for 2022.

The repurchase program has no expiration date, does not require the purchase of any minimum number of shares and may be suspended, modified or discontinued at any time without prior notice. We purchased 148,500 shares of our common stock for approximately $5.0 million during the twelve months ended December 31, 2022.

The repurchase program has no expiration date, does not require the purchase of any minimum number of shares and may be suspended, modified or discontinued at any time without prior notice. We did not purchase any shares of our common stock under this repurchase program in 2023.

The increase was primarily attributable to purchase of short-term treasury bills of $20 million, notes held for investments of $4.7 million, an increase in purchase of assets for lease and an increase of property, plant and equipment.

The increase was primarily attributable to maturities of short-term treasury bills of $20.2 million, partially offset by purchase of notes held for investment of $1.0 million, purchase of assets for lease of $0.5 million and property, plant and equipment of $0.3 million.

Net Income For the foregoing reasons, we had a net income of $14.3 million for the year ended December 31, 2022, compared to a net income of $17.2 million for the year ended December 31, 2021. 43 Table of Contents Liquidity and Capital Resources We had cash and cash equivalents and short-term investments of $43.1 million at December 31, 2022, compared to $37.3 million at December 31, 2021, and total current liabilities of $6.9 million at December 31, 2022, compared to $4.9 million at December 31, 2021.

Liquidity and Capital Resources We had cash, cash equivalents, restricted cash and short-term investments of $57.3 million at December 31, 2023, compared to $43.1 million at December 31, 2022, and total current liabilities of $6.2 million at December 31, 2023, compared to $6.9 million at December 31, 2022.

The increase was primarily due to personnel, consulting fees and other costs associated with our product development and customization efforts, which were partially offset by lower clinical studies. As a percentage of revenues, engineering and product development expense was 9% in 2022 compared to 7% in 2021.

Engineering and Product Development Expense We had engineering and product development expense of $5.8 million for the year ended December 31, 2023, compared to $4.8 million in 2022. The increase was primarily due to personnel costs, consulting fees and other costs associated with our product development and customization efforts, which were partially offset by lower dues and subscriptions.

As a percentage of revenues, cost of revenues decreased to 8% in 2022, as compared to 12% in 2021. Engineering and Product Development Expense We had engineering and product development expense of $4.8 million for the year ended December 31, 2022, compared to $3.8 million in 2021.

As a percentage of revenues, sales and marketing expense decreased to 27% in 2023 compared to 31% in 2022. 43 Table of Contents General and Administrative Expense We had general and administrative expense of $14.3 million for the year ended December 31, 2023, compared to $12.7 million in 2022.

Financing Activities We used $4.9 million of net cash in financing activities during the year ended December 31, 2022, compared to generating $13 thousand during the year ended December 31, 2021, primarily due to the treasury stock acquisition of $5.0 million, under our recently announced share purchase program, and taxes paid related to equity awards of $0.1 million, partially offset by the exercise of stock options of $0.2 million. ITEM 7A.

Financing Activities We used $5.4 million of net cash in financing activities during the year ended December 31, 2023, compared to $4.9 during the year ended December 31, 2022, primarily due to taxes paid related to equity awards of $3.5 million, and warrant repurchase for $1.9 million. ITEM 7A.

Our investment guidelines allow for holdings in U.S. government and agency securities, corporate securities, taxable municipal bonds, commercial paper, money market accounts and treasury bills. In addition, we have, and may in the future, choose to invest some of our cash resources in other entities that may have complementary technologies or product offerings.

In addition, we have, and may in the future, choose to invest some of our cash resources in other entities that may have complementary technologies or product offerings .

We have an agreement with Mellitus, a private company to exclusively market and distribute Insulin Insights, an FDA-cleared software product that recommends optimal insulin dosing for diabetic outpatients in the United States, including Puerto Rico, except for select accounts.

Impairment of Mellitus and Insulin Insights Prepaid Licenses We have an agreement with Mellitus to exclusively market and distribute Insulin Insights, a software product line in the United States, including Puerto Rico, for which we prepaid an aggregate of $2.5 million of software licenses.

Operating Activities We generated $17.5 million of net cash from operating activities for the year ended December 31, 2022, compared to $16.1 million for the year ended December 31, 2021. The improvement was primarily due to changes in non-cash adjustments and operating assets and liabilities.

Operating Activities We generated $21.3 million of net cash from operating activities for the year ended December 31, 2023, compared to $17.5 million of net cash from operating activities for the same period of the prior year. The change was primarily due to the generation of additional net income from operating activities.

Non-cash adjustments to reconcile net income to net cash from operating activities were $1.5 million in the year ended December 31, 2022, compared to $3.4 million in the year ended December 31, 2021, primarily due to stock-based compensation expense, depreciation expense, and loss on disposal of leased assets, partially offset by an increase in deferred tax expense.

Non-cash adjustments to reconcile net income to net cash from operating activities provided net cash of $4.5 million and were primarily due to prepaid licenses write-off of $2.5 million, stock-based compensation expense of $0.9 million, depreciation of $0.6 million, loss on disposal of assets 44 Table of Contents for lease of $0.4 million, impairment of long-term investments of $0.3 million, change in fair value of notes of $0.3 million and allowance for credit losses of $0.3 million, partially offset by deferred tax income of $0.7 million and gain on treasury bills of $0.1 million.

Changes in operating assets and liabilities provided $1.7 million of net cash in the year ended December 31, 2022, compared to used $4.6 million of net cash in the year ended December 31, 2021, primarily due an increase of accrued expenses and trade payables due to timing of payments to the vendors, decrease of prepaid and other current assets, partially offset by increase in other non-current assets and trade receivable.

Changes in operating assets and liabilities used $3.7 million of net cash. These changes in operating assets and liabilities included an increase in trade receivable of $2.5 million, prepaid expenses and other assets of $0.6 million and a decrease in trade payables of $0.4 million and accrued expenses of $0.2 million .

The primary reasons for this change were that 2021 includes a $1.2 million inventory write-down due to cancellation of the distribution agreement, as well as lower consulting expenses in 2022, which were partially offset by increased personnel costs due to increased headcount and annual salary increases.

The primary reasons for this change were the $2.5 million write-off of prepayment for Insulin Insights licenses, as well as increased personnel costs due to annual salary increases and increased shipping costs. As a percentage of revenues, cost of revenues increased to 10% in 2023, as compared to 8% in 2022.

General and Administrative Expense We had general and administrative expense of $12.7 million for the year ended December 31, 2022, compared to $9.2 million in 2021. The increase was primarily due to employee compensation related expenses, higher insurance, patent and legal expenses and dues and subscriptions, partially offset by lower stock-based compensation and other miscellaneous expenses.

The increase was primarily due to higher dues and subscriptions, professional expenses and legal expenses, partially offset by lower insurance costs. As a percentage of revenues, general and administrative expense decreased to 21% in 2023, compared to 23% in 2022.

Sales and Marketing Expense We had sales and marketing expense of $17.7 million for the year ended December 31, 2022, compared to $14.4 million in 2021. The increase was primarily due to higher sales compensation and personnel expense, trade shows expenses, travel expenses and subscriptions expenses.

As a percentage of revenues, engineering and product development expense was unchanged at 9% in both 2023 and in 2022. Sales and Marketing Expense We had sales and marketing expense of $18.1 million for the year ended December 31, 2023, compared to $17.7 million in 2022.

At December 31, 2022, we held approximately $30.1 million of U.S. Treasury bills, and the remainder of our cash was held in non-interest bearing bank accounts. We have banking relationships with First Republic Bank and Edward Jones, and are taking steps to diversify further.

At December 31, 2023, we held approximately $10.5 million of U.S. Treasury bills and $41.4 million in government money market fund accounts and the remaining cash was held in non-interest bearing bank accounts. Our investment guidelines allow for holdings in U.S. government and agency securities, corporate securities, taxable municipal bonds, commercial paper, money market accounts and treasury bills.

Removed

We have also made cash investments in Mellitus, in Monarch, a privately-held a digital health company whose proprietary product, EndoTool, offers a technology-enabled approach to inpatient glycemic management, and in NeuroDiagnostics Inc., a privately-held company that is doing business as SYNAPS Dx, whose product , Discern is a test for early Alzheimer’s disease.

Added

We are currently seeking a new 510(k) clearance from the FDA for the expanded use of QuantaFlo, which is intended to enable expanded labeling as an aid in the diagnosis of other cardiovascular diseases in addition to PAD.

Removed

In May 2022, we acquired $179 thousand aggregate principal amount of outstanding convertible notes of Mellitus, which bear interest at a rate of 10% per annum, and as amended, mature July 2025, if not automatically converted into preferred stock prior thereto.

Added

In 2022, we acquired 148,500 shares of our common stock for approximately $5.0 million under the repurchase program. In May 2023, we repurchased outstanding warrants to acquire an aggregate 76,875 shares of our common stock for $1.9 million in cash from our chief executive officer.

Removed

We acquired these notes to facilitate their subordination in connection with our June 2022 purchase of an aggregate $1.0 million of senior secured notes, that bear interest at a rate of 5% per annum and mature in three years, unless accelerated due to an event of default as provided in the notes.

Added

The warrants were originally issued on June 7, 2012 (16,875 shares) with an exercise price of $4.00 per share and on July 31, 2013 (60,000 shares), with an exercise price of $4.50 per share, all of which were amended in September 2015 to set an expiration date of July 31, 2023.

Removed

Repayment of these notes is secured by a first priority interest in all of Mellitus’ assets. In December 2022, we amended our April 2021 distribution agreement with Mellitus to prepay for an additional $0.5 million of licenses (for an aggregate $2.5 million when including the $2.0 million of licenses prepaid in April 2021).

Added

The repurchase of the 40 Table of Contents warrants for $1.9 million cash reflects the difference between the aggregate exercise price of the warrants and the aggregate fair market value of the shares of common stock underlying the warrants based on the closing price of a share of our common stock on May 16, 2023, the date of the warrant repurchase agreement.

Removed

In December 2022, we announced a commitment to loan up to $5.0 million to Monarch, a Nevada limited liability company, through the purchase of a senior secured convertible promissory note that bears interest at a rate of 10% per annum. The note also contemplates payment of up to $100 thousand of transaction expenses.

Added

Following the warrant repurchase, the warrants were cancelled and we no longer have any warrants issued and outstanding. Strategic Operational Streamlining In July 2023, our board of directors approved a strategic plan to streamline operations and reduce employee headcount by approximately 30% by mid-September 2023.

Removed

Repayment of the note is secured by a first priority interest in all of Monarch’s assets. Monarch is a digital health company whose proprietary EndoTool offers a technology-enabled approach to inpatient glycemic management. The software-as-a-service solution is FDA 510(k) cleared, patent protected and installed at more than 100 health systems across the United States.

Added

This plan was meant to be proactive and sought to drive operational efficiency, while still providing high quality service to our customers.

Removed

We believe the investment in Monarch complements our offering of Insulin Insight, a glycemic management software application that healthcare providers can use to optimize outpatient insulin dosing for persons with diabetes. As of 40 Table of Contents December 31, 2022, Monarch had borrowed $3.5 million, out of the $5.0 million committed.

Added

As of December 31, 2023, we incurred severance cost of $0.7 million consisting of one-time termination benefits, which we have reported on the statement of income under “strategic streamlining”. CMS Rate Notice In late March 2023, CMS issued the final 2024 rate announcement with payment changes for the Medicare Advantage and Part D prescription drug programs.

Removed

In January 2023, Monarch borrowed an additional $0.5 million from the balance of the note. In February 2023, CMS issued an Advance Notice, which proposes to revise the HCC codes for vascular disease, created uncertainty in the future whether identifying patients with PAD or heart dysfunction will qualify for an increased capitated payment.

Added

Essentially, CMS is phasing in a new Medicare Advantage risk adjustment model (2024 model) from the previous model (2020 model) over a three-year period. The 2024 model does not include risk adjusted payments for PAD without complications, which payments many health insurers, including our customers, relied upon for their Medicare Advantage patients in the 2020 model.

Removed

Although the Advance Notice is not final and is open to public comment, there may be uncertainty regarding proper HCC codes and reimbursement, which could negatively impact our business. Sources of Revenues and Expenses Revenues We generate revenues primarily from the rental or license of our vascular testing product.

Added

The changes will be phased in as follows: in calendar year 2023, full payment under the 2020 model; in calendar year 2024, 67% of the 2020 model; in calendar year 2025, 33% of the 2020 model. It is premature to determine the potential impact to our future revenues of this CMS rate notice.

Removed

We also recognize revenue for hardware and supplies sales, as well as sales of product licenses under our exclusive marketing and distribution agreement, as of the date of shipment. We also generate other license revenue from distributing Insulin Insights software product.

Added

Due to slow uptake of the Insulin Insights product despite our marketing efforts, we wrote off the $2.5 million prepayment for the software licenses and took at $0.6 million impairment charge on our investments in Mellitus in the fourth quarter of 2023. Seeking New 510(k) Clearance from the U.S.

Removed

The primary reason for this change was overall growth in our business, increased compensation of the sales team and increased headcount of field sales and technical support personnel to service the expanding number of customers. As a percentage of revenues, operating expenses increased to 70% in 2022, as compared to 63% in 2021.

Added

Food and Drug Administration (FDA) In January 2024, we announced we are seeking a new 510(k) clearance from the FDA for the expanded use of QuantaFlo following correspondence with the FDA. The new 510(k) is intended to enable expanded labeling for QuantaFlo as an aid in the diagnosis of other cardiovascular diseases in addition to PAD.

Removed

In the prior year we could not travel, attend trade shows or contact the customers personally due to COVID. As a percentage of revenues, sales and marketing expense increased to 31% in 2022 compared to 27% in 2021.

Added

The primary reason for this change was overall growth in our business, which increased cost of revenues (in addition to the $2.5 million charge related to Insulin Insights), as well as payment of severance in connection with our strategic streamlining.

Removed

As a percentage of revenues, general and administrative expense was 23% in 2022, compared to 17% in 2021. Other Income and Expense We had other income of $0.5 million for 2022, compared to $10 thousand in 2021.

Added

The increase was primarily due to higher trade shows expenses, travel expenses and other expenses.

Removed

The increase was primarily due to interest income associated with higher rates on short term government debt and money market funds, as well as interest from notes receivable. Provision for Taxes In 2022, we recorded an income tax expense of $3.4 million, compared to $2.2 million in 2021.

Added

Strategic Operational Streamlining During the year ended December 31, 2023, we incurred severance cost of $0.7 million consisting of one-time termination benefits, which we have reported on the statement of income under “strategic streamlining”. We did not incur any strategic streamlining expenses during the year ended December 31, 2022.

Removed

The increase was primarily due to lower windfall gains resulting from the exercise of stock options compared to the prior year.

Added

Other Income and Expense We had other income of $1.8 million for 2023, compared to $0.5 million in 2022. The increase was primarily due to interest and dividend income associated with higher cash balances and interest rates, partially offset by our $0.6 million impairment of our investment in Mellitus.

Removed

Prior year adjustments of $3.4 million were due to a $1.2 million inventory write-off, an increase of stock-based compensation and depreciation, partially offset by a decrease in deferred tax expense .

Added

Provision for Taxes In 2023, we recorded income tax expense of $3.5 million, compared to $3.4 million in 2022. In 2023 income tax expenses were partially offset by tax benefits related to employee stock option exercises and the $2.5 million write-off of the Insulin Insights prepaid licenses.

Removed

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Not applicable.

Added

Net Income For the foregoing reasons, we had a net income of $20.6 million for the year ended December 31, 2023, compared to a net income of $14.3 million for the year ended December 31, 2022.

Added

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Not applicable. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA The financial statements and supplementary data required by this item are included in Part IV, Item 15 of this annual report on Form 10-K. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None.

Other SMLR 10-K year-over-year comparisons

SMLR 10-K 2023 vs 2024