SI on NYSE
SHOULDER INNOVATIONS, INC.
In its 2026 annual report the company says: “We are a commercial-stage medical technology company exclusively focused on transforming the shoulder surgical care market. We currently offer advanced implant systems for shoulder arthroplasty. Our ecosystem is also comprised of enabling technologies, efficient instrument systems, specialized support and surgeon-to-surgeon collaboration.”4 It is headquartered in Wilmington, United States.2
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Last updated Oct 20, 2026.
Overview
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- TickerSI on NYSE2
- IndustrySurgical & Medical Instruments & Apparatus2
- HeadquartersWilmington, United States2
- Incorporated inDE3
- Business address1535 Steele Avenue Sw, Suite B, Grand Rapids, Mi 495073
- Filer category, Emerging growth company3
- Legal formCorporation2
- LEI529900LTH37ALD2K74372
- StatusActive2
- LEI statusIssued and current2
- Registered addressc/o THE CORPORATION TRUST COMPANY, CORPORATION TRUST CENTER 1209 ORANGE ST, 19801 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 47052072
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We are a commercial-stage medical technology company exclusively focused on transforming the shoulder surgical care market. We currently offer advanced implant systems for shoulder arthroplasty. These systems are a core element of our ecosystem, which we designed to improve core components of shoulder surgical care – preoperative planning, implant design and procedural efficiency – to benefit each stakeholder in the care chain. Our ecosystem is also comprised of enabling technologies, efficient instrument systems, specialized support and surgeon-to-surgeon collaboration. Together, these elements seek to address the long-standing clinical and operational challenges in the shoulder surgical care market by delivering predictable outcomes, procedural simplicity, and efficiency across all sites of care. We believe our exclusive focus on shoulder surgical care, combined with a highly specializ…4 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2025
Where the money goes
Where each dollar of revenue went, fiscal 2025
- Cost of revenue15¢$11.1M
- Research and development11¢$7.7M
- Selling, general and admin74¢$54.8M
Out of $47.3M in revenue.5 The company lost money this year.
Financial statements
| Fiscal year | 2023 | 2024 | 2025 |
|---|---|---|---|
| Revenue | $31.6M5 | $47.3M5 | |
| Cost of revenue | $7.3M5 | $11.1M5 | |
| Gross profit | $24.3M5 | $36.2M5 | |
| Research and development | $4.5M5 | $7.7M5 | |
| Selling, general and admin | $34.5M5 | $54.8M5 | |
| Operating income | -$14.7M5 | -$26.3M5 | |
| Income before tax | -$15.6M5 | -$40.4M5 | |
| Income tax | $05 | $05 | |
| Net income | -$15.6M5 | -$40.4M5 | |
| Earnings per share | -$242.045 | -$4.655 | |
| Earnings per share (diluted) | -$242.045 | -$4.655 | |
| Shares (weighted, basic) | 64.5K shares5 | 8.7M shares5 | |
| Shares (weighted, diluted) | 64.5K shares5 | 8.7M shares5 |
| Fiscal year | 2023 | 2024 | 2025 |
|---|---|---|---|
| Cash | $6.2M5 | $6.1M5 | $26.9M5 |
| Receivables | $5.1M5 | $8.3M5 | |
| Inventory | $14.0M5 | $21.6M5 | |
| Current assets | $35.1M5 | $157.2M5 | |
| Property, plant and equipment | $7.5M5 | $12.5M5 | |
| Intangible assets | $400.0K5 | $100.0K5 | |
| Total assets | $43.1M5 | $169.9M5 | |
| Accounts payable | $4.9M5 | $8.9M5 | |
| Current liabilities | $7.6M5 | $14.2M5 | |
| Long-term debt | $14.7M5 | $14.9M5 | |
| Long-term liabilities | $15.7M5 | $15.0M5 | |
| Total liabilities | $23.3M5 | $29.2M5 | |
| Retained earnings | -$57.0M5 | -$97.4M5 | |
| Shareholders’ equity | -$39.7M5 | -$54.7M5 | $140.8M5 |
| Shares outstanding | 83.9K shares5 | 20.6M shares5 |
Corporate structure
SHOULDER INNOVATIONS, INC. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of SHOULDER INNOVATIONS, INC.
- Gilde Healthcare Holding B.V. Filed SCHEDULE 13D/A on SHOULDER INNOVATIONS, INC., latest Aug 7, 2026 (2 filings since Aug 5, 2025)
- FMR LLC Filed SCHEDULE 13G/A on SHOULDER INNOVATIONS, INC., latest Aug 6, 2026 (2 filings since Sep 8, 2025)
- cultivate(MD) Holdings, LLC Filed SCHEDULE 13G/A on SHOULDER INNOVATIONS, INC., latest May 7, 2026 (2 filings since Nov 12, 2025)
- LSV Associates II, LLC Filed SCHEDULE 13G on SHOULDER INNOVATIONS, INC., latest Nov 14, 2025
- Presidio Management Group XII, L.L.C. Filed SCHEDULE 13G on SHOULDER INNOVATIONS, INC., latest Nov 14, 2025
- Arboretum Ventures VI, L.P. Filed SCHEDULE 13G on SHOULDER INNOVATIONS, INC., latest Aug 8, 2025
- SHOULDER INNOVATIONS, INC. Wilmington, Delaware, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What SHOULDER INNOVATIONS, INC. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $19.4M5 Dec 31, 2025 | $11.7M5 Dec 31, 2024 | +65.5% |
| Accumulated depreciation | $6.9M5 Dec 31, 2025 | $4.2M5 Dec 31, 2024 | +62.2% |
| Property and equipment, net | $12.5M5 Dec 31, 2025 | $7.5M5 Dec 31, 2024 | +67.4% |
| Operating-lease assets (leased space) | $110.0K5 Dec 31, 2025 | $68.0K5 Dec 31, 2024 | +61.8% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $26.9M5 Dec 31, 2025 | $6.1M5 Dec 31, 2024 | +338.9% |
| Marketable securities, current | $97.4M5 Dec 31, 2025 | $8.9M5 Dec 31, 2024 | +992.2% |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Intangible assets, net (excluding goodwill) | $100.0K5 Dec 31, 2025 | $400.0K5 Dec 31, 2024 | −75.0% |
| Finite-lived intangibles, net | $100.0K5 Dec 31, 2025 |
Inventory
| Item | Latest | A year before | Change |
|---|---|---|---|
| Inventory, total | $21.6M5 Dec 31, 2025 | $14.0M5 Dec 31, 2024 | +54.7% |
| Finished goods | $22.4M5 Dec 31, 2025 | $14.2M5 Dec 31, 2024 | +57.5% |
Properties, in its own words
Our corporate headquarters is located in Grand Rapids, Michigan where we lease a 7,000 square foot facility pursuant to a lease agreement that expires in June 2026. This facility includes warehouse, distribution and office space. We also lease a third-party approximately 3,000 square foot distribution facility in Modesto, California that distributes our implant systems in the western United States. We believe that this facility is sufficient to meet our current and anticipated needs in the near term and that suitable additional space is available as needed to accommodate expansion of our operations and distribution activities.
Item 2 of the 10-K filed Mar 10, 2026.4
Leadership
Who has led SHOULDER INNOVATIONS, INC., and when. Pick a name to see everywhere that person has worked.
Chief financial officer
Chief operating officer
- Chief financial officerJeffrey S. Points Jul 30, 2025 to now8
- Chief operating officerMatthew Fraser Ahearn Jul 30, 2025 to now9
Board members and other officers (7)
- OfficerDavid Lawrence Blue Jul 30, 2025 to now10
- Board memberAndrew Hykes Mar 4, 2026 to now11
- Board memberCasey M. Tansey Jul 30, 2025 to now12
- Board memberMatthew Fraser Ahearn Jul 30, 2025 to now9
- Board memberMichael A. Carusi Jul 30, 2025 to now13
- Board memberPaul Buckman Jul 30, 2025 to now14
- Board memberRichard Buchholz Jul 30, 2025 to now15
Named in SEC Form D filings
People the company listed in its private-offering notices.
Timeline
- Oct 8, 20268-K Regulation FD disclosure17
- Aug 10, 20268-K Regulation FD disclosure18
- Aug 6, 20268-K Results of operations19
- Jun 29, 20268-K Entered a material agreement; Ended a material agreement; New debt or obligation20
- Jun 26, 20268-K Shareholder vote21
- May 13, 20268-K Results of operations22
- Apr 27, 20268-K Regulation FD disclosure23
- Apr 14, 20268-K Entered a material agreement24
- Mar 10, 20268-K Results of operations; Executive or director change25
- Mar 2, 20268-K Executive or director change; Regulation FD disclosure26
- Dec 3, 20258-K Regulation FD disclosure27
- Nov 12, 20258-K Results of operations28
- Jul 1, 2009Founded SHOULDER INNOVATIONS, INC. is founded2
Calendar
Coming up
- Nov 5, 2026 · After the closeReports results for the quarter ending Sep/2026 A year earlier it reported ($0.48) a share, on Nov 11, 2025.29
When it reported results
- Aug 6, 2026Reported quarterly or annual results19
- May 13, 2026Reported quarterly or annual results22
- Mar 10, 2026Reported quarterly or annual results25
- Nov 12, 2025Reported quarterly or annual results28
- Sep 9, 2025Reported quarterly or annual results30
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
129 filings to the SEC since October 2021: 1 annual reports, 4 quarterly reports, 14 major events, 64 insider forms, 9 large holders, 3 private raises, 34 other. The latest 20:
- Oct 8, 20268-K EDGAR
- Oct 6, 20264 EDGAR
- Oct 6, 20264 EDGAR
- Oct 6, 20264 EDGAR
- Oct 6, 20264 EDGAR
- Sep 14, 20264 EDGAR
- Sep 14, 2026144 EDGAR
- Aug 28, 20264 EDGAR
- Aug 24, 20264 EDGAR
- Aug 18, 20264 EDGAR
- Aug 17, 2026144 EDGAR
- Aug 13, 2026EFFECT EDGAR
- Aug 10, 20263 EDGAR
- Aug 10, 20268-K EDGAR
- Aug 7, 2026S-3 EDGAR
- Aug 7, 2026SCHEDULE 13D/A EDGAR
- Aug 7, 20264 EDGAR
- Aug 6, 202610-Q EDGAR
- Aug 6, 20268-K EDGAR
- Aug 6, 2026SCHEDULE 13G/A EDGAR
The 129 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
32 open-market trades by officers, directors and large owners since October 2021: 17 buys and 15 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Sep 14, 2026 | Ball Robert JosephCEO & Executive Chairman | Sale | 10,175 | $18.45 | $187.7K | Form 4 |
| Aug 26, 2026 | Gilde Healthcare Holding B.V.10% owner | Sale | 1,196 | $22.60 | $27.0K | Form 4 |
| Aug 24, 2026 | Gilde Healthcare Holding B.V.10% owner | Sale | 681 | $22.62 | $15.4K | Form 4 |
| Aug 21, 2026 | Gilde Healthcare Holding B.V.10% owner | Sale | 20,516 | $22.61 | $463.9K | Form 4 |
| Aug 20, 2026 | Gilde Healthcare Holding B.V.10% owner | Sale | 3,900 | $22.60 | $88.1K | Form 4 |
| Aug 18, 2026 | Ahearn Matthew FraserChief Operating Officer | Sale | 14,186 | $20.99 | $297.8K | Form 4 |
| Aug 17, 2026 | Ahearn Matthew FraserChief Operating Officer | Sale | 8,314 | $20.10 | $167.1K | Form 4 |
| Aug 6, 2026 | Gilde Healthcare Holding B.V.10% owner | Sale | 2,095 | $22.60 | $47.3K | Form 4 |
| Aug 5, 2026 | Gilde Healthcare Holding B.V.10% owner | Sale | 7,338 | $22.64 | $166.1K | Form 4 |
| Aug 4, 2026 | Gilde Healthcare Holding B.V.10% owner | Sale | 99,812 | $22.77 | $2.3M | Form 4 |
| Aug 3, 2026 | Gilde Healthcare Holding B.V.10% owner | Sale | 10,751 | $22.71 | $244.2K | Form 4 |
| Jul 31, 2026 | Gilde Healthcare Holding B.V.10% owner | Sale | 20,034 | $22.73 | $455.4K | Form 4 |
| Jul 30, 2026 | Gilde Healthcare Holding B.V.10% owner | Sale | 28,245 | $23.36 | $659.8K | Form 4 |
| Jun 15, 2026 | Ahearn Matthew FraserChief Operating Officer | Sale | 4,144 | $18.84 | $78.1K | Form 4 |
| Jun 12, 2026 | Ahearn Matthew FraserChief Operating Officer | Sale | 15,856 | $18.68 | $296.2K | Form 4 |
| Mar 13, 2026 | Ball Robert JosephCEO & Executive Chairman | Buy | 2,200 | $15.18 | $33.4K | Form 4 |
| Mar 13, 2026 | Buchholz RichardDirector | Buy | 1,000 | $14.84 | $14.8K | Form 4 |
| Mar 13, 2026 | Points Jeffrey S.Chief Financial Officer | Buy | 2,000 | $15.00 | $30.0K | Form 4 |
| Dec 12, 2025 | Points Jeffrey S.Chief Financial Officer | Buy | 1,005 | $14.98 | $15.1K | Form 4 |
| Dec 12, 2025 | Ball Robert JosephCEO & Executive Chairman | Buy | 3,900 | $14.89 | $58.1K | Form 4 |
All 32 trades can be filtered by person here when JavaScript is on.
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- Gilde Healthcare Holding B.V.SCHEDULE 13D/A, 2 filings Aug 5, 2025 to Aug 7, 202631
- FMR LLCSCHEDULE 13G/A, 2 filings Sep 8, 2025 to Aug 6, 202632
- cultivate(MD) Holdings, LLCSCHEDULE 13G/A, 2 filings Nov 12, 2025 to May 7, 202633
- LSV Associates II, LLCSCHEDULE 13G, 1 filing Nov 14, 202534
- Presidio Management Group XII, L.L.C.SCHEDULE 13G, 1 filing Nov 14, 202535
- Arboretum Ventures VI, L.P.SCHEDULE 13G, 1 filing Aug 8, 202536
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2025 | Robert BallChief Executive Officer | 53 | $467.9K | $1.2M37 |
| 2025 | David L. BlueChief Customer Experience Officer | 65 | $364.5K | $778.8K37 |
| 2025 | Jeffrey PointsChief Financial Officer | 49 | $378.1K | $719.8K37 |
| 2024 | Robert BallChief Executive Officer | 53 | $449.6K | $628.1K37 |
| 2024 | Jeffrey PointsChief Financial Officer | 49 | $363.4K | $507.8K37 |
| 2024 | David L. BlueChief Customer Experience Officer | 65 | $349.9K | $497.3K37 |
Money raised
Private offerings the company reported to the SEC on Form D.
- Mar 6, 2025Raised $20.1 million in a private offering of equity Form D: $40.1 million offered in all Form D
- Feb 10, 2023Raised $32.2 million in a private offering of equity Form D: $39.8 million offered in all Form D
- Sep 29, 2022Raised $3.5 million in a private offering of debt Form D: $7 million offered in all Form D
SEC filer profile
How SHOULDER INNOVATIONS, INC. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARSHOULDER INNOVATIONS, INC.1
- CIK0001699350
- Employer ID (EIN)27-05387644
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 311
- Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus1
- SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
- Business address1535 Steele Avenue Sw, Suite B, Grand Rapids, MI 495071
- Phone616-294-10261
- Shares outstanding20,818,957 as of Jul 30, 20267
- Public float$0 as of Jun 30, 20255
- AuditorDeloitte & Touche LLP, Grand Rapids, Michigan PCAOB ID 34; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceMar 1, 20171
- Filings133 in all: 4 (50), 3 (14), 8-K (14), D (6), CORRESP (5), SCHEDULE 13G (5), 10-Q (4), 144 (4)1
All 29 form types
UPLOAD (4), S-1/A (3), DRS/A (2), DRSLTR (2), EFFECT (2), S-8 (2), SCHEDULE 13G/A (2), 10-K (1), 424B4 (1), 8-A12B (1), ARS (1), CERT (1), D/A (1), DEF 14A (1), DEFA14A (1), DRS (1), FWP (1), S-1 (1), S-3 (1), SCHEDULE 13D (1), SCHEDULE 13D/A (1)
- Latest filingsAnnual report (10-K) Mar 10, 2026
Quarterly report (10-Q) Aug 6, 2026
Proxy statement (DEF 14A) Apr 29, 2026
Latest 8-K (8-K) Oct 8, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.001 per share | SI | The New York Stock Exchange |
From the cover page of the 10-K filed Mar 10, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks SHOULDER INNOVATIONS, INC. names in Item 1A of its 10-K filed Mar 10, 2026: 73 risks under these headings, as written.4
- Risks Related to Our Financial Condition and Capital Requirements
- We are an early-stage company with a history of significant net losses, we expect to incur operating losses in the future and we may not be able to achieve or sustain profitability.
- If we fail to manage our growth effectively, our business could be materially and adversely affected.
- We have a significant amount of debt, which may affect our ability to operate our business and secure additional financing in the future.
- We may acquire other complementary companies, products or technologies, through the licensing of products or technologies from third parties or other strategic alliances, and the failure to manage acquisitions, investments, licenses or other strategic alliances, or the failure to integrate them with our existing business could fail to result in a
- commercial product or net sales, divert our management’s attention, result in additional dilution to our stockholders, cause us to incur significant expense and otherwise disrupt our business.
- We may require substantial additional funding, which may not be available to us on acceptable terms, or at all, and, if not available, may require us to delay, scale back, or cease our innovation efforts or operations.
- Risks Related to Our Business and Industry
- We operate in a very competitive business environment, and if we are unable to compete successfully against our existing or potential competitors, our business, financial condition and results of operations may be adversely affected.
- If we fail to develop and retain an effective commercial organization, or if we are unable to successfully expand our organization, it could negatively impact our sales, and we may not generate sufficient net revenue to sustain profitability.
- We rely in part on independent distributors to sell our products to our customers, and if we are unable to maintain and expand our network of independent distributors, we may be unable to generate anticipated sales.
- Our business plan relies on certain assumptions about the market for our implant systems, however, the size and expected growth of our addressable market has not been established with precision and may be smaller than we estimate, and even if the addressable market is as large as we have estimated, we may not be able to capture additional market share.
The other 63 risks
- Our business is dependent upon the adoption of our implant systems by hospitals, ASCs, surgeons and patients.
- The seasonality of our business creates variance in our quarterly revenue, which makes it difficult to compare or forecast our financial results.
- Our long-term growth depends on our ability to enhance our implant systems, expand our indications and develop and commercialize additional products in a timely manner. If we cannot innovate, we may not be able to develop or exploit new products in time to remain competitive.
- We may expend our limited resources to pursue particular improvements or enhancements or new products and fail to capitalize on development opportunities that may be more profitable or for which there is a greater likelihood of success.
- We face the risk of product liability claims that could be expensive, divert management’s attention and harm our reputation and business. We may not be able to maintain adequate product liability insurance.
- Industry trends have resulted in increased downward pricing pressure on medical services and products, which may affect our ability to sell our products at prices necessary to support our current business strategy.
- Our employees and independent contractors, including independent distributors and any other consultants, any future service providers and other vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
- If rising prices or unavailability of raw materials continue to persist, our business and results of operations may be adversely affected.
- Risks Related to Administrative, Organizational and Commercial Operations and Growth
- If hospitals, ASCs, and other health care facilities do not approve the use of our implant systems, our sales may not increase.
- Performance issues, service interruptions or price increases by shipping carriers could adversely affect our business and harm our reputation and ability to provide our systems on a timely basis.
- If coverage or adequate levels of reimbursement from third-party payors for procedures using our implant systems, or any future products we may seek to commercialize, are not obtained or maintained, shoulder specialists and patients may be reluctant to use our systems and our business will suffer.
- We depend on third-party contract manufacturers and suppliers, some of which are single source, to produce and package all elements comprising our shoulder implant systems, and if these suppliers and manufacturers fail to supply us, our products or their components or subcomponents in sufficient quantities or at all, or in accordance with applicable regulatory requirements and our specifications, it will have a material adverse effect on our business, financial condition, and results of operations.
- Our results of operations will be materially harmed if we are unable to accurately forecast demand for our implant systems and manage our inventory.
- We may enter into collaborations, in-licensing arrangements, joint ventures, strategic alliances or partnerships with third parties that may not result in the development of commercially viable products, product improvements or the generation of significant future revenues.
- AI presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information and personal data.
- We may not be able to establish or strengthen our brand.
- Our inability to maintain contractual relationships with health care professionals could have a negative impact on our research and development and medical education programs.
- We may be unable to continue to successfully demonstrate to shoulder specialists or key opinion leaders the merits of our implant systems and technologies compared to those of our competitors, which may make it difficult to achieve market acceptance.
- If surgeons fail to safely and appropriately use our implant systems, or if we are unable to train surgeons on the safe and appropriate use of our systems, we may be unable to achieve our expected sales, growth or profitability.
- The loss of any member of our executive management team or our inability to attract and retain highly skilled members of our dedicated commercial leadership and marketing teams as well as certain third-party engineers could have a material adverse effect on our business, financial condition and results of operations.
- Certain of our officers and directors also serve as directors of, and are affiliates of, Genesis Innovation, Genesis Software and cultivate(MD), which may give rise to a perceived or actual conflict of interest which may adversely impact your interests.
- Any future international expansion will subject us to additional costs and risks that may have a material adverse effect on our business, financial condition and results of operations.
- Risks Related to Our Intellectual Property
- If we are unable to obtain and maintain significant patent or other intellectual property protection for our products, or if the scope of our patents and other intellectual property rights do not adequately protect our products, our competitors could develop and commercialize products similar or identical to ours and we may be unable to gain significant market share and be unable to operate our business profitably.
- Obtaining and maintaining intellectual property protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental agencies, and our intellectual property protection could be reduced or eliminated for non-compliance with these requirements.
- We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products.
- We are presently party to lawsuits involving patents and other intellectual property and the possibility exists that we may in the future be party to other lawsuits or administrative proceedings involving patents or other intellectual property. If we were to lose any intellectual property lawsuits, a court could require us to pay significant damages and/or prevent us from selling our products.
- If we fail to execute invention assignment agreements with our employees and contractors involved in the development of intellectual property or are unable to protect the confidentiality of our trade secrets, the value of our products and our business and competitive position could be harmed.
- If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our competitive position may be harmed.
- Patent terms may not be sufficient to effectively protect our systems and business for an adequate period of time.
- Changes in U.S. or foreign patent laws or their interpretation may limit our ability to obtain, maintain, defend and/or enforce our patents.
- We have foreign intellectual property rights and may be unable to enforce our intellectual property rights throughout the world.
- We may in the future be subject to claims that we or our employees have misappropriated the intellectual property of a third party, including trade secrets or know-how, or are in breach of non-competition or non-solicitation agreements with our competitors and third parties may claim an ownership interest in intellectual property we regard as our own.
- If our third-party manufacturing partners do not respect our intellectual property and trade secrets and produce competitive products using our designs or intellectual property, our business, financial condition and results of operations would be harmed.
- Our use of open source software could impose limitations on our ability to commercialize our product.
- Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
- Risks Related to Regulatory Matters
- Our devices and operations are subject to extensive government regulation and oversight in the United States, and our failure to comply with applicable requirements could harm our business.
- Our relationships with customers, physicians and third-party payors are subject to federal and state health care fraud and abuse laws, false claims laws, physician payment transparency laws and other health care laws and regulations. If we or our employees, independent contractors, consultants, commercial partners, or vendors violate these laws we could face substantial penalties.
- Failure to maintain marketing authorizations for our systems, or to timely obtain necessary marketing authorizations for our future products, may have a material adverse effect on our business, financial condition, results of operations, and prospects.
- We are subject to ongoing regulatory review and scrutiny. Failure to comply with post-marketing regulatory requirements could subject us to enforcement actions, including substantial penalties, and might require us to recall or withdraw a product from the market.
- Our products must be manufactured in accordance with applicable laws and regulations, and we could be forced to recall our devices or terminate production if we fail to comply with these regulations.
- Legislative or regulatory reforms may have a material adverse effect on us.
- The misuse or off-label use of our systems may result in injuries that harm patients and lead to product liability suits, harm our reputation in the marketplace, or result in costly investigations, fines, or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
- Our implant systems and other future products may cause or contribute to adverse medical events or be subject to failures or malfunctions which we may be required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition, results of operations, and prospects. In addition, the discovery of serious safety issues, or a voluntary or required recall, could have a negative impact on us.
- Disruptions at the FDA and other government agencies caused by funding shortages, staffing limitations, or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, and prevent new or modified products from being developed, reviewed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
- Risks Related to Ownership of Our Common Stock
- We are an “emerging growth company” and a “smaller reporting company,” and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies and smaller reporting companies will make our common stock less attractive to investors.
- We continue to incur increased costs and are subject to additional regulations and requirements as a public company, which could lower our profits or make it more difficult to run our business.
- If we are unable to design, implement, and maintain effective internal control over financial reporting in the future, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock may decline.
- We do not intend to pay dividends in the foreseeable future. As a result, your ability to achieve a return on your investment will depend on appreciation in the market price of our common stock.
- The market price of our common stock may be volatile, which could result in substantial losses for owners of our common stock.
- If our operating and financial performance in any given period does not meet any guidance that we provide to the public, the market price of our common stock may decline.
- Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
- Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
- Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
- Claims for indemnification by our directors, officers, and other employees or agents may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.
- Our current amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between us and our stockholders and that the federal
- district courts shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees or the underwriters or any offering giving rise to such claim.
- General Risk Factors
- If we engage in acquisitions or strategic partnerships, it may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
- Unfavorable global and regional economic, political and health conditions could adversely affect our business, financial condition or results of operations.
- We or the third parties we depend on may be adversely affected by natural disasters and other catastrophic events, and our business continuity and disaster recovery plans may not adequately protect us from a serious natural disaster or other catastrophic event. Any interruption in our operations or the operations of third parties who supply components or other materials for our products may have a material adverse effect on our business, financial condition, results of operations, and prospects.
- We are subject to risks from legal and arbitration proceedings that may prevent us from pursuing our business activities or require us to incur additional costs in defending against claims or paying damages.
- The requirements of being a public company may divert our management’s attention from our growth strategies and other business concerns.
- If securities or industry analysts issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.
- Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
Legal proceedings
From time to time, we may be party to legal proceedings that arise in the ordinary course of our business, some of which may be covered by insurance. Except for the description of legal proceedings disclosed in Note 13 to our audited financial statements, which is incorporated herein by reference, management believes that we do not have any pending legal proceedings that, separately or in the aggregate, would have a material adverse effect on our results of operations, financial condition or cash flows. No material legal proceedings were terminated, settled or otherwise resolved during the year ended December 31, 2025.
The opening of Item 3, Legal Proceedings.4
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 10SEC EDGARDavid Lawrence Blue, Officer
- 11SEC EDGARAndrew Hykes, Board member
- 12SEC EDGARCasey M. Tansey, Board member
- 13SEC EDGARMichael A. Carusi, Board member
- 14SEC EDGARPaul Buckman, Board member
- 15SEC EDGARRichard Buchholz, Board member
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- 17SEC EDGARRegulation FD disclosure
- 18SEC EDGARRegulation FD disclosure
- 19SEC EDGARResults of operations
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- 21SEC EDGARShareholder vote
- 22SEC EDGARResults of operations
- 23SEC EDGARRegulation FD disclosure
- 24SEC EDGAREntered a material agreement
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- 27SEC EDGARRegulation FD disclosure
- 28SEC EDGARResults of operations
- 29NasdaqNasdaq calendar
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