Tenon Medical, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Tenon Medical, Inc. has filed its 2023 10-K annual report, detailing its corporate structure and Nasdaq-listed securities.</b>

AI Summary

Tenon Medical, Inc. (TNONW) filed a Annual Report (10-K) with the SEC on March 29, 2024. Tenon Medical, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The company is incorporated in Delaware and its principal executive offices are located at 104 Cooper Court, Los Gatos, CA 95032. Tenon Medical's common stock trades on The Nasdaq Stock Market LLC under the symbol TNON, and its warrants trade under TNONW. The company is classified as a non-accelerated filer and a smaller reporting company. The filing confirms that Tenon Medical has submitted all required reports for the preceding 12 months and has been subject to these filing requirements for the past 90 days.

Why It Matters

For investors and stakeholders tracking Tenon Medical, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Tenon Medical's financial and operational status for the fiscal year 2023, which is crucial for investors to assess the company's performance and outlook. The classification as a non-accelerated filer and smaller reporting company indicates the company's size and reporting obligations, influencing how investors interpret its disclosures.

Risk Assessment

Risk Level: low — Tenon Medical, Inc. shows low risk based on this filing. The risk is low as this is a standard annual filing (10-K) that confirms routine compliance with SEC reporting requirements, with no immediate red flags identified in the provided header information.

Analyst Insight

Investors should review the full 10-K filing for detailed financial statements, risk factors, and management's discussion and analysis to form an investment thesis.

Key Numbers

• 20231231 — Fiscal Year End (Conformed period of report)
• 20240329 — Filing Date (Date the report was filed)
• 001-41364 — Commission File Number (SEC file number for the registrant)
• 45-5574718 — IRS Number (Registrant's IRS Employer Identification No.)

Key Players & Entities

• Tenon Medical, Inc. (company) — Filer name and subject of the report
• TNON (company) — Trading symbol for common stock
• TNONW (company) — Trading symbol for warrants
• The Nasdaq Stock Market LLC (company) — Exchange where securities are registered
• Delaware (company) — State of incorporation
• Los Gatos, CA (company) — Location of principal executive offices

FAQ

Industry Context

Tenon Medical, Inc. operates in the surgical and medical instruments & apparatus industry (SIC code 3841). This sector involves the development and manufacturing of devices used in medical procedures.

Regulatory Implications

The company is subject to the reporting requirements of the Securities Exchange Act of 1934, including the filing of annual reports (Form 10-K) to provide transparency to investors.

What Investors Should Do

1. Review the full 10-K for detailed financial statements and operational disclosures.
2. Analyze the 'Risk Factors' section for potential business challenges.
3. Compare key financial metrics to previous periods and industry peers.

Key Dates

• 2023-12-31: Fiscal Year End — Defines the reporting period for the 10-K
• 2024-03-29: Filing Date — Date the 10-K was officially submitted to the SEC

Year-Over-Year Comparison

This filing is the 2023 annual report, following previous filings which would include quarterly reports (10-Q) and potentially other current reports (8-K) throughout the year.

Key Financial Figures

• $0.001 — ich Registered Common stock, par value $0.001 per share TNON The Nasdaq Stock Market
• $2.75 — s based on a closing price per share of $2.75 on such date. As of March 29, 2024, t
• $2.0 billion — otential annual market of approximately $2.0 billion. These estimates are driven by coding d

Filing Documents

• ea0201083-10k_tenonmed.htm (10-K) — 1574KB
• ea020108301ex4-5_tenonmed.htm (EX-4.5) — 40KB
• ea020108301ex10-7_tenonmed.htm (EX-10.7) — 45KB
• ea020108301ex10-8_tenonmed.htm (EX-10.8) — 37KB
• ea020108301ex10-10_tenonmed.htm (EX-10.10) — 54KB
• ea020108301ex10-11_tenonmed.htm (EX-10.11) — 55KB
• ea020108301ex19-1_tenonmed.htm (EX-19.1) — 89KB
• ea020108301ex23-1_tenonmed.htm (EX-23.1) — 2KB
• ea020108301ex23-2_tenonmed.htm (EX-23.2) — 2KB
• ea020108301ex31-1_tenonmed.htm (EX-31.1) — 10KB
• ea020108301ex31-2_tenonmed.htm (EX-31.2) — 10KB
• ea020108301ex32-1_tenonmed.htm (EX-32.1) — 3KB
• ea020108301ex32-2_tenonmed.htm (EX-32.2) — 3KB
• ea020108301ex97-1_tenonmed.htm (EX-97.1) — 54KB
• image_001.jpg (GRAPHIC) — 46KB
• image_002.jpg (GRAPHIC) — 13KB
• image_003.jpg (GRAPHIC) — 38KB
• image_004.jpg (GRAPHIC) — 112KB
• image_005.jpg (GRAPHIC) — 38KB
• image_006.jpg (GRAPHIC) — 26KB
• image_007.jpg (GRAPHIC) — 23KB
• image_008.jpg (GRAPHIC) — 44KB
• image_009.jpg (GRAPHIC) — 19KB
• image_010.jpg (GRAPHIC) — 28KB
• ex10-11_001.jpg (GRAPHIC) — 4KB
• ex10-11_002.jpg (GRAPHIC) — 2KB
• ex10-11_003.jpg (GRAPHIC) — 2KB
• 0001213900-24-028010.txt (&nbsp;) — 8394KB
• tnon-20231231.xsd (EX-101.SCH) — 58KB
• tnon-20231231_cal.xml (EX-101.CAL) — 48KB
• tnon-20231231_def.xml (EX-101.DEF) — 312KB
• tnon-20231231_lab.xml (EX-101.LAB) — 577KB
• tnon-20231231_pre.xml (EX-101.PRE) — 306KB
• ea0201083-10k_tenonmed_htm.xml (XML) — 668KB

Business

Business 1 Item 1A

Risk Factors

Risk Factors 17 Item 1B Unresolved Staff Comments 46

Cybersecurity

Item 1C Cybersecurity 46 Item 2

Properties

Properties 46 Item 3

Legal Proceedings

Legal Proceedings 46 Item 4 Mine Safety Disclosures 46 PART II 47 Item 5 Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities 47

[Reserved]

Item 6 [Reserved] 49

Management's

Item 7 Management's Discussion and Analysis of Financial Condition and Results of Operations 50

Quantitative and

Item 7A. Quantitative and Qualitative Disclosures about Market Risk 58

Financial Statements

Item 8 Financial Statements and Supplementary Data F-1

Changes in and Disagreements

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 59

Controls and Procedures

Item 9A Controls and Procedures 59

Other Information

Item 9B Other Information 60

Disclosure Regarding

Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 60 PART III 61

Directors, Executive

Item 10 Directors, Executive Officers and Corporate Governance 61

Executive Compensation

Item 11 Executive Compensation 67

Security ownership

Item 12 Security ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 70

Certain Relationships

Item 13 Certain Relationships and Related party Transactions, and Director Independence 72

Principal Accounting

Item 14 Principal Accounting Fees and Services 72 PART IV 73

Exhibit and Financial

Item 15 Exhibit and Financial 73 i CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING This Annual Report on Form 10-K contains "forward-looking as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends impacting the financial condition of our business. Forward-looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time those statements are made and/or management's good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements.

Forward-looking statements include all statements

Forward-looking statements include all statements that are not historical facts. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "could," "would," "expect," "intend," "seek," "plan," "anticipate," "believe," "estimate," "project," "predict," "potential," "might," "forecast," "continue," or the negative of those terms, and similar expressions and comparable terminology intended to reference future periods. Forward-looking statements include, but are not limited to, statements about: Our ability to effectively operate our business segments; Our ability to manage our research, development, expansion, growth and operating expenses; Our ability to evaluate and measure our business, prospects and performance metrics; Our ability and our national distributor's ability to compete, directly and indirectly, and succeed in the highly competitive medical devices industry; Our ability to respond and adapt to changes in technology and customer behavior; Our ability to protect our intellectual property and to develop, maintain and enhance a strong brand; and Other factors (including the risks contained in the section of this report entitled "Risk Factors") relating to our industry, our operations, and results of operations. Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance or achievements. Accordingly, the forward-looking statements in this Annual Report on Form 10-K should not be regarded as representations that the results or conditions described in such statements will occur or that our objectives and plans will be ac

, "Risk Factors" and should not be relied upon as an exhaustive summary of the material risks we face

Item 1A, "Risk Factors" and should not be relied upon as an exhaustive summary of the material risks we face. We have incurred losses in the past, our financial statements have been prepared on a going concern basis and we may be unable to achieve or sustain profitability in the future; Epidemic diseases including COVID 19, or the perception of their effects could have a material adverse effect on our business, financial condition, results of operations, or cash flows; If hospitals, clinicians, and other healthcare providers are unable to obtain and maintain coverage and reimbursement from third-party payors for procedures performed using our products, adoption of our products may be delayed, and it is unlikely that they will gain further acceptance; We may not be able to convince physicians that the Catamaran SI Joint Fusion System ("The Catamaran System") is an attractive alternative to our competitors' products and that our procedure is an attractive alternative to existing surgical and non-surgical treatments of the SI-Joint; Clinicians and payors may not find our clinical evidence to be compelling, which could limit our sales, and ongoing and future research may prove our products to be less safe and effective than initially anticipated; Pricing pressure from our competitors, changes in third-party coverage and reimbursement, healthcare provider consolidation, payor consolidation and the proliferation of "physician-owned distributorships" may impact our ability to sell our product at prices necessary to support our current business strategies; Practice trends or other factors, including the COVID-19 pandemic, may cause procedures to shift from the hospital environment to ambulatory surgical centers, or ASCs, where pressure on the prices of our products is generally more acute; We operate in a very competitive business environment and if we are unable to compete successfully against our existing or potential competitors, our sales and operating re

Business

Item 1. Business Introduction Tenon Medical, Inc. (the "Company"), was incorporated in the State of Delaware on June 19, 2012 and was headquartered in San Ramon, California until June 2021 when it relocated to Los Gatos, California. The Company is a medical device company that has developed The Catamaran SI Joint Fusion System ("the Catamaran System") that offers a novel, less invasive approach to the sacroiliac joint (the "SI Joint") using a single, robust, titanium implant for treatment of the most common types of SI Joint disorders that cause lower back pain. The Company received U.S. Food and Drug Administration ("FDA") clearance in 2018 for The Catamaran System and is currently focused on the US market. Since the national launch of the Catamaran System in October 2022, the Company is focused on three commercial opportunities: 1) Primary SI Joint procedures, 2) Revision procedures of failed SI Joint implants and 3) SI Joint fusion adjunct to a spine fusion construct. The Opportunity We estimate that over 30 million American adults have chronic lower back pain. Published clinical studies have shown that 15% to 30% of all chronic lower back pain is associated with the SI-Joint. For patients whose chronic lower back pain stems from the Sacroiliac Joint ("SI-Joint"), our experience in both clinical trials and commercial settings indicates the system to be introduced by Tenon could be beneficial for patients who are properly diagnosed and screened for surgery by trained healthcare providers. In 2019, approximately 475,000 patients in the United States were estimated to have received an aesthetic injection to temporarily alleviate pain emanating from the SI-Joint and/or to diagnose SI-Joint pain. Additionally, several non-surgical technologies have been introduced in the past 10 years to address patients who do not respond to conservative options, including systemic oral medications, opioids, physical therapy and injection therapy. To date, the penetration of

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View this 10-K filing on SEC EDGAR