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ELUT on Nasdaq

ELUTIA INC.

American biological products company based in Silver Spring1

In its 2026 annual report the company says: “We develop proprietary drug-eluting biomatrix products for use in surgical reconstruction and related applications. Our focus is on addressing unmet medical needs and reducing complications associated with surgery, including infection, migration, erosion, implant rejection, and fibrosis. We have applied these capabilities to develop and commercialize products for specific surgical applications.”5

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Last updated Oct 21, 2026.

Overview

$12.3MRevenue, fiscal 20252
$53.4MNet income, fiscal 20252

Compare with Revolution Medicines (United States), Caribou Biosciences, Inc. or Lineage Cell Therapeutics, or pick any stock.

  • TickerELUT on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersSilver Spring, Maryland1
  • Incorporated inDE3
  • Business address12510 Prosperity Drive, Suite 370, Silver Spring, Md 209043
  • Filer category, Emerging growth company3
  • Legal formCorporation

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At Elutia, our mission is to humanize medicine so that patients can thrive without compromise. We develop proprietary drug-eluting biomatrix products for use in surgical reconstruction and related applications. These products are designed to improve the interaction between implanted medical devices and patients. Our focus is on addressing unmet medical needs and reducing complications associated with surgery, including infection, migration, erosion, implant rejection, and fibrosis. Our operations span research and development through the commercial distribution of biologic matrix products used in plastic and reconstructive surgery.5 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

53.7%Gross margin2
-218.9%Operating margin2
434.2%Net margin2
-15.0%Revenue growth, 20252
192.9%Return on equity2
-$46.7MFree cash flow2

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Business segments

Women's Health brought in 74% of the revenue ELUTIA INC. broke down this way in fiscal 2025.

  1. Women's Health$9.1M274%down 21% from 2024
  2. Cardiovascular$3.2M226%up 8% from 2024
Business segments by year
Business segments20242025
Women's Health$11.6M$9.1M
Cardiovascular$2.9M$3.2M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue9¢$5.7M
  • Research and development7¢$4.2M
  • Income tax0¢$13.0K
  • Profit84¢$53.4M

Out of $12.3M in revenue.2

Financial statements

Revenue6789102$12.3M in 2025−71% since 2019
0$20.0M$40.0M$60.0M2019: $42.9M$42.9M20192020: $42.7M$42.7M2020−1%2021: $47.4M$47.4M2021+11%2022: $23.8M$23.8M2022−50%2023: $24.7M$24.7M2023+4%2024: $14.5M$14.5M2024−42%2025: $12.3M$12.3M2025−15%
Gross profit6789102$6.6M in 2025−67% since 2019
0$10.0M$20.0M$30.0M2019: $19.8M$19.8M20192020: $20.6M$20.6M2020+4%2021: $19.0M$19.0M2021−7%2022: $11.6M$11.6M2022−39%2023: $11.1M$11.1M2023−5%2024: $6.7M$6.7M2024−39%2025: $6.6M$6.6M2025−2%
Operating income6789102-$26.9M in 2025+220% since 2019
-$40.0M-$30.0M-$20.0M-$10.0M02019: -$8.4M-$8.4M20192020: -$13.6M-$13.6M2020+62%2021: -$23.0M-$23.0M2021+69%2022: -$35.2M-$35.2M2022+53%2023: -$30.5M-$30.5M2023−13%2024: -$30.7M-$30.7M2024+1%2025: -$26.9M-$26.9M2025−12%
Net income6789102$53.4M in 2025
-$100.0M-$50.0M0$50.0M$100.0M2019: -$11.9M-$11.9M20192020: -$21.8M-$21.8M2020+83%2021: -$24.8M-$24.8M2021+14%2022: -$32.9M-$32.9M2022+32%2023: -$37.7M-$37.7M2023+14%2024: -$53.9M-$53.9M2024+43%2025: $53.4M$53.4M2025

Every line of the income statement as filed: the last 2 fiscal years, latest first.2

Period ending2025-12-312024-12-31
Net sales$12.3M$14.5M
Cost of goods sold$5.7M$7.8M
Gross profit$6.6M$6.7M
Sales and marketing$5.8M$5.0M
General and administrative$15.1M$18.1M
Research and development$4.2M$3.0M
Litigation costs, net$8.5M$11.4M
Total operating expenses$33.5M$37.4M
Loss from continuing operations-$26.9M-$30.7M
Interest (income) expense, net$387.0K-$934.0K
(Gain) loss on revaluation of warrant liability-$13.4M$14.9M
Other expense (income), net$2.8M-$1.2M
Loss from continuing operations before provision for income taxes-$15.9M-$45.3M
Income tax expense$13.0K$7.0K
Net loss from continuing operations-$15.9M-$45.3M
(Income) loss from discontinued operations$69.3M-$8.6M
Net income (loss)$53.4M-$53.9M
Less: dilutive gain on revaluation of warrant liability-$13.4M
Net income (loss) for dilutive earnings per share$40.0M-$53.9M
Net loss from continuing operations per share - basic (in dollars per share)-$0-$2
Net loss from continuing operations per share - diluted (in dollars per share)-$1-$2
Net income (loss) from discontinued operations per share - basic (in dollars per share)$2-$0
Net income (loss) from discontinued operations per share - diluted (In dollars per share)$2-$0
Net income (loss) per share - basic (in dollar per share)$1.29-$1.86
Net income (loss) per share - diluted (in dollar per share)$0.87-$1.86
Weighted average common shares outstanding - basic (in shares)41.4M shares29.1M shares
Weighted average common shares outstanding - diluted (in shares)45.9M shares29.1M shares

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Corporate structure

ELUTIA INC. sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of ELUTIA INC.

  • ELUTIA INC. Silver Spring, Maryland
    • Elutia Med LLC Subsidiary · Delaware, United States

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What ELUTIA 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

ItemLatestA year beforeChange
Property and equipment, before depreciation$2.8M2 Dec 31, 2025$892.0K2 Dec 31, 2024+213.2%
Accumulated depreciation$283.0K2 Dec 31, 2025$221.0K2 Dec 31, 2024+28.1%
Property and equipment, net$2.5M2 Dec 31, 2025$671.0K2 Dec 31, 2024+274.2%
Operating-lease assets (leased space)$2.4M2 Dec 31, 2025$154.0K2 Dec 31, 2024+1475.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$36.4M2 Dec 31, 2025$13.2M2 Dec 31, 2024+174.6%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$1.5M2 Dec 31, 2025$2.6M2 Dec 31, 2024−41.2%
Finite-lived intangibles, gross$10.8M2 Dec 31, 2025$10.8M2 Dec 31, 20240%
Accumulated amortization$9.2M2 Dec 31, 2025$8.2M2 Dec 31, 2024+13.1%
Finite-lived intangibles, net$1.5M2 Dec 31, 2025$2.6M2 Dec 31, 2024−41.2%

Inventory

ItemLatestA year beforeChange
Inventory, total$2.6M2 Dec 31, 2025$1.9M2 Dec 31, 2024+35.5%
Raw materials$239.0K2 Dec 31, 2025$68.0K2 Dec 31, 2024+251.5%
Work in process$740.0K10 Dec 31, 2024$286.0K10 Dec 31, 2023+158.7%
Finished goods$2.4M2 Dec 31, 2025$1.9M2 Dec 31, 2024+27.6%

Properties, in its own words

Our principal executive office at December 31, 2025 is in Gaithersburg, Maryland, where we lease 26,598 square feet of office, manufacturing and laboratory space under a lease that expires in January 2036 with early termination dates in 2029 and 2033. We also lease 2,391 square feet for administrative space in San Diego, California that expires in June 2028. We believe that our facilities are sufficient to meet our current and future business needs.

Item 2 of the 10-K filed Mar 13, 2026.5

Leadership

Who has led ELUTIA INC., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Ronald K. Lloyd2020–2022

President

  1. Ronald K. Lloyd2020–2022

Chief financial officer

  1. Matthew Ferguson2020–now
2025
Board members and other officers (11)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • President, Chief Executive OfficerC. Randal Mills named Oct 3, 202326
  • Senior Vice President - Finance, Treasurer and SecretaryJeffrey Randal Hamet named Oct 3, 202326
  • Executive OfficerJeffrey Hamet named Dec 22, 202127
  • DirectorC. Randal Mills. Ph.D. named Dec 22, 202127

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Elutia Med LLC Delaware4

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • AZIYO BIOLOGICS, INC.Jun 9, 2017 to Aug 14, 20233

Timeline

  1. Aug 21, 20268-K Completed an acquisition or sale; Regulation FD disclosure28
  2. Aug 13, 20268-K Results of operations29
  3. Aug 7, 20268-K Listing notice or transfer30
  4. Jul 20, 20268-K Entered a material agreement; Regulation FD disclosure31
  5. Jun 16, 20268-K Executive or director change; Shareholder vote32
  6. May 14, 20268-K Results of operations33
  7. Mar 11, 20268-K Results of operations34
  8. Mar 9, 20268-K Executive or director change35
  9. Mar 4, 20268-K Other events36
  10. Jan 12, 20268-K Results of operations37
  11. Jan 2, 20268-K Listing notice or transfer38
  12. Nov 12, 20258-K Listing notice or transfer39
  13. Oct 7, 2020New chief executive Ronald K. Lloyd becomes CEO15

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/202640

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results29
  2. May 14, 2026Reported quarterly or annual results33
  3. Mar 11, 2026Reported quarterly or annual results34
  4. Jan 12, 2026Reported quarterly or annual results37
  5. Nov 6, 2025Reported quarterly or annual results41
  6. Aug 14, 2025Reported quarterly or annual results42
  7. May 8, 2025Reported quarterly or annual results43
  8. Mar 6, 2025Reported quarterly or annual results44

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

297 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 75 major events, 129 insider forms, 30 large holders, 2 private raises, 41 other. The latest 20:

  1. Sep 14, 20264 EDGAR
  2. Sep 14, 20264 EDGAR
  3. Sep 14, 20264 EDGAR
  4. Aug 21, 20268-K EDGAR
  5. Aug 14, 2026S-8 EDGAR
  6. Aug 14, 202610-Q EDGAR
  7. Aug 14, 2026SCHEDULE 13G/A EDGAR
  8. Aug 13, 20268-K EDGAR
  9. Aug 11, 2026SCHEDULE 13G EDGAR
  10. Aug 7, 20268-K EDGAR
  11. Jul 20, 20268-K EDGAR
  12. Jun 22, 20264 EDGAR
  13. Jun 16, 20268-K EDGAR
  14. Jun 15, 20264 EDGAR
  15. Jun 15, 20264 EDGAR
  16. Jun 15, 20264 EDGAR
  17. Jun 15, 20264 EDGAR
  18. Jun 12, 20264 EDGAR
  19. Jun 12, 20264 EDGAR
  20. Jun 12, 20264 EDGAR

The 297 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

35 open-market trades by officers, directors and large owners since October 2021: 33 buys and 2 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jan 30, 2026NEELS GUIDO JDirectorBuy20,000$1.04$20.8KForm 4
Jan 30, 2026RAKIN KEVINDirectorBuy70,000$1.06$74.2KForm 4
Jan 29, 2026NEELS GUIDO JDirectorBuy15,000$1.06$15.9KForm 4
Jan 28, 2026NEELS GUIDO JDirectorBuy15,000$1.06$15.9KForm 4
Dec 17, 2025Colpman DavidDirectorBuy12,500$0.51$6.4KForm 4
Dec 17, 2025Makes BrigidDirectorBuy25,000$0.52$13.0KForm 4
Dec 17, 2025Mills C RandalPRESIDENT AND CEOBuy3,000$0.51$1.5KForm 4
Dec 17, 2025Ferguson MatthewCHIEF FINANCIAL OFFICERBuy60,000$0.53$31.8KForm 4
Dec 17, 2025HighCape Partners GP II, LLC10% ownerBuy50,000$0.52$26.0KForm 4
Dec 2, 2025Ferguson MatthewCHIEF FINANCIAL OFFICERBuy5,500$0.67$3.7KForm 4
Dec 1, 2025Ferguson MatthewCHIEF FINANCIAL OFFICERBuy4,500$0.65$2.9KForm 4
Nov 24, 2025Mills C RandalPRESIDENT AND CEOBuy5,000$0.60$3.0KForm 4
Nov 17, 2025Colpman DavidDirectorBuy15,500$0.74$11.5KForm 4
Nov 13, 2025Mills C RandalPRESIDENT AND CEOBuy13,500$0.75$10.1KForm 4
Feb 3, 2025HighCape Capital, L.P.DirectorBuy420,000$2.50$1.1MForm 4
Feb 3, 2025HIGHCAPE PARTNERS, L.P.10% ownerBuy420,000$2.50$1.1MForm 4
Mar 27, 2023Birchview Fund LLCBuy10,000$1.59$15.9KForm 4
Mar 27, 2023Birchview Capital, LPBuy10,000$1.59$15.9KForm 4
Mar 24, 2023Birchview Fund LLCBuy20,000$1.35$27.0KForm 4
Mar 24, 2023Birchview Capital, LPBuy20,000$1.35$27.0KForm 4

All 35 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.

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.

YearExecutiveAgeSalaryTotal pay
2025C. Randal MillsPh.D.$600.0K$1.3M55
2025Matthew Ferguson$385.0K$747.0K55
2025Michelle WilliamsPh.D.$355.0K$688.7K55
2024President and ChiefExecutive Officer$600.0K$4.5M55
2024Chief Financial Officer$385.0K$1.8M55
2024Chief Scientific Officer$355.0K$1.6M55

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Sep 21, 2023Raised $10.5 million in a private offering of equity Form D: 12 investors so far Form D
  2. Dec 5, 2021Raised $14 million in a private offering of equity Form D: 15 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 38. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Nantahala Capital Management, LLC6,369,894$6.2M0.2%+3,184,947
AIGH Capital Management LLC2,695,644$2.6M0.2%−899,606
Knollwood Investment Advisory, LLC2,556,724$2.5M0.2%No change
Silverarc Capital Management, LLC2,192,980$2.1M0.2%−305,040
Vanguard Capital Management LLC1,142,575$1.1M0.0%+118,876
Perkins Capital Management Inc694,094$379.9K0.3%−62,800
Geode Capital Management, LLC285,229$279.4K0.0%−8,167
Corient Private Wealth LP253,500$248.3K0.0%+4,468
Renaissance Technologies LLC201,816$197.7K0.0%+119,100
Vanguard Fiduciary Trust Co172,446$169.0K0.0%+53,101
BlackRock, Inc.167,857$164.4K0.0%+45,784
Birchview Capital, LP165,094$161.7K0.1%No change
Citadel Advisors LLC123,505$121.0K0.0%+11,400
Rossmore Private Capital120,000$117.6K0.0%No change
XTX Topco Ltd52,606$51.5K0.0%+14,456
Jane Street Group, LLC44,697$43.8K0.0%−19,380
Northern Trust Corp44,670$43.8K0.0%+17,008
Atom Investors LP44,231$43.3K0.0%New
LRI Investments, LLC25,224$24.7K0.0%New
Brown Advisory Inc20,135$19.7K0.0%No change
Verdence Capital Advisors LLC19,410$19.0K0.0%No change
Qube Research & Technologies Ltd17,175$16.8K0.0%+99
Indie Asset Partners, LLC12,612$12.4K0.0%No change
Fund Evaluation Group, LLC12,612$12.3K0.0%No change
State Street Corp11,969$11.7K0.0%No change

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How ELUTIA INC. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARELUTIA INC.1
  • CIK0001708527
  • Employer ID (EIN)47-47903345
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address12510 Prosperity Drive, Suite 370, Silver Spring, MD 209041
  • Phone240-247-11431
  • Shares outstanding42,784,848 Common Class A shares as of Mar 4, 20265
  • Public float$65.1M as of Jun 30, 20255
  • AuditorPricewaterhouseCoopers LLP, Philadelphia, Pennsylvania PCAOB ID 2385
  • On EDGAR sinceJun 9, 20171
  • Filings369 in all: 4 (141), 8-K (85), 10-Q (18), 3 (18), SC 13G/A (9), SCHEDULE 13G/A (8), CORRESP (7), 10-K (6)1
    All 35 form types

    424B5 (6), D (6), DEF 14A (6), DEFA14A (6), SC 13G (6), UPLOAD (6), EFFECT (5), S-3 (4), S-8 (4), 4/A (3), 424B3 (3), SC 13D/A (3), SCHEDULE 13G (3), ARS (2), SCHEDULE 13D/A (2), 144 (1), 3/A (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), DRS (1), DRS/A (1), DRSLTR (1), S-1 (1), S-1/A (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Mar 13, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) Apr 22, 2026
    Latest 8-K (8-K) Aug 21, 2026

Securities registered for trading

ClassSymbolExchange
Class A Common Stock, par value $0.001 per shareELUTNasdaq

From the cover page of the 10-K filed Mar 13, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks ELUTIA INC. names in Item 1A of its 10-K filed Mar 13, 2026: 64 risks under these headings, as written.5

  • Risks Related to Our Business
  • Our future results largely depend upon our ability to successfully develop, commercialize, market and sell breast reconstruction biologic products.
  • We have incurred operating losses and may continue to do so in the near-term, and we cannot assure that we will be able to generate sufficient revenue to achieve or sustain profitability.
  • We face significant litigation related to our FiberCel and Viable Bone Matrix recalls and have no more insurance coverage on the FiberCel recall.
  • We face the risk of product liability claims and may not be able to obtain or maintain adequate product liability insurance.
  • Our future capital needs are uncertain, and we may need to raise funds in the future, and such funds may not be available on acceptable terms or at all.
  • Adverse changes in general domestic and global economic conditions and instability and disruption of credit markets could adversely affect our business, financial condition, results of operations and liquidity.
  • Our long-term growth depends on our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings.
  • We may not realize all of the potential consideration associated with the sale of our Orthobiologics Business.
  • Because we depend upon a limited number of third-party suppliers and manufacturers and, in certain cases, exclusive suppliers for products essential to our business, we may incur significant product development costs and experience material delivery delays if we lose any significant supplier, which could materially and adversely affect our business, financial condition and results of operations.
  • Our net sales are generated through independent sales agents, which subjects us to various risks.
  • Our future growth depends on physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products.
The other 53 risks
  • Our success depends on the continued and future acceptance of our products by the medical community.
  • Unfavorable results from any of our pre-clinical or clinical studies, comparative effectiveness, economic or other studies, or from similar studies conducted by others, may negatively affect the use or adoption of our products by physicians, hospitals and payors, which could have a negative impact on the market acceptance of our products and their profitability.
  • We may need to continue to expand our organization and managing growth may be more difficult than we expect.
  • We face significant and continuing competition from other companies, some of which have longer operating histories, more established products and/or greater resources than we do, which could adversely affect our business, financial condition and results of operations.
  • Pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability.
  • Performance issues, service interruptions or price increases by our shipping carriers could adversely affect our business, harm our reputation and impair our ability to provide our products on a timely basis or at all.
  • If our research and development facility is damaged or becomes inoperable, we will be unable to continue to research and develop our product candidates and delays in our product development could result in an adverse effect on our business.
  • Increased prices for raw materials or supplies used in our products could adversely affect our business, financial condition and results of operations.
  • If we are not able to accurately forecast demand for our products and manage our inventory, our margins could decrease and we could lose sales, either of which could have a material adverse effect on our business, financial condition and results of operations.
  • If hospitals and other healthcare providers are unable to obtain coverage or adequate reimbursement for procedures performed with our products, it is unlikely our products will be widely used.
  • We bear the risk of warranty claims on our products.
  • Our operating results may fluctuate significantly from quarter to quarter and year to year due to the seasonality of our business, as well as a variety of other factors, many of which are outside of our control.
  • Security breaches, loss of or damage to data, information technology system failures and other disruptions could compromise sensitive information related to our business or our customers’ patients, or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
  • Our success depends on our ability to retain and motivate key management personnel and other employees and consultants, to attract, retain and motivate additional qualified personnel and to effectively navigate changes in our senior management team.
  • Our officers, employees, independent contractors, principal investigators, consultants and independent sales agents may engage in misconduct or activities that are improper under other laws and regulations, which would create liability for us.
  • Our estimates of market opportunity and forecasts of market and sales growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business could fail to grow at similar rates, if at all.
  • Our ability to use certain tax attributes to offset future income tax liabilities may be subject to limitations.
  • Changes in tax laws, unfavorable resolution of tax contingencies or exposure to additional income tax liabilities could have a material impact on our results of operations or financial condition.
  • New lines of business and new products and services may subject us to additional risks.
  • We may from time to time evaluate opportunities to make acquisitions of, investments in, and licenses or other commercial arrangements involving, other companies or technologies, and to enter into other strategic transactions. These transactions entail significant risks.
  • Risks Related to Government Regulation
  • The regulatory approval, certification and clearance processes of the FDA and comparable foreign authorities and notified bodies are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval or other marketing authorizations or certifications for our products and product candidates, our business will be substantially harmed.
  • Modifications to our medical device products may require new 510(k) clearances or other marketing authorizations or certifications, and if we make modifications to such products without obtaining requisite marketing authorization, we may be required to cease marketing or recall the modified products until clearances or other marketing authorizations or certifications are obtained.
  • Our HCT/P product is subject to extensive government regulation, and our failure to comply with these requirements could cause our business to suffer.
  • The clinical study process is lengthy and expensive with uncertain outcomes. We have limited data and experience regarding the safety and efficacy of our products. Results of earlier studies may not be predictive of future clinical study results, or the safety or efficacy profile for such products.
  • We are bound by federal, state, and foreign fraud and abuse laws, violations of which could result in significant penalties. Challenges or investigations into our practices under these laws may lead to adverse publicity, incurring substantial response costs and potential harm to our business.
  • Healthcare policy changes, including recently enacted legislation reforming the U.S. healthcare system, could harm our cash flows, financial condition and results of operations.
  • Actual or perceived failure to comply with data protection laws and regulations could lead to government enforcement actions, private litigation and/or adverse publicity and could negatively affect our business.
  • Risks Related to Intellectual Property
  • If we are unable to obtain, maintain and adequately protect our intellectual property rights, our competitive position could be harmed or we could be required to incur significant expenses to enforce or defend our rights.
  • We may not enter into invention assignment and confidentiality agreements with all of our employees and contractors and such agreements could be ineffective or breached.
  • The patent protection we obtain for our products may not be sufficient enough to provide us with any competitive advantage or our patents may be challenged.
  • Litigation or other proceedings or third-party claims of intellectual property infringement, misappropriation or other violations could require us to spend significant time and money, prevent us from selling our products and adversely affect our stock price.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position could be harmed.
  • Third parties may assert ownership or commercial rights to inventions we develop.
  • Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
  • Recent changes in U.S. patent laws may limit our ability to obtain, defend and/or enforce our patents.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • If we do not obtain patent term extension in the United States under the Hatch-Waxman Amendments, thereby potentially extending the term of marketing exclusivity for our product candidates, our business may be materially harmed.
  • We depend on certain technologies that are licensed to us. We do not control the intellectual property rights covering these technologies, and any loss of our rights to these technologies or the rights licensed to us could prevent us from selling our products and adversely impact our business.
  • We may not be able to protect and enforce our trademarks and trade names, or build name recognition in our markets of interest, thereby harming our competitive position.
  • Risks Related to Our Common Stock
  • We may not be able to maintain a listing of our Class A common stock on the Nasdaq Capital Market.
  • We expect that the price of our Class A common stock will fluctuate substantially. You may not be able to sell the shares you purchase at or above the price you paid for such shares, and our common stock could be subject to delisting if its price falls too low.
  • You may be diluted by the future issuance of additional common stock in connection with any future public or private offerings of our securities, our incentive plans, acquisitions or otherwise.
  • We are a “smaller reporting company,” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
  • We will continue to incur increased costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives and corporate governance practices. Failure to comply may result in delisting of our common stock, government penalties or other materially adverse consequences.
  • Provisions in our certificate of incorporation and bylaws and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • Our certificate of incorporation designates specific courts as the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, would be your sole source of gain.
  • We could be subject to securities class action litigation.
  • General Risk Factors
  • Changes in accounting standards and subjective assumptions, estimates and judgments by management related to complex accounting matters could significantly affect our business, financial condition and results of operations.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
  • Failure to comply with requirements to design, implement and maintain effective internal control over financial reporting could have a material adverse effect on our business and stock price.
  • If our operating and financial performance in any given period does not meet the guidance we provide to the public, the market price of our Class A common stock may decline.
  • If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our Class A common stock, our stock price and trading volume would likely decline.

Legal proceedings

From time to time, we may be involved in claims and proceedings arising in the course of our business. The outcome of any such claims or proceedings, regardless of the merits, is inherently uncertain. For information about legal proceedings in which we are involved, see Note 17 to the consolidated financial statements included elsewhere in this Annual Report.

The opening of Item 3, Legal Proceedings.5

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