OBIO on Nasdaq

Orchestra BioMed Holdings, Inc.

American surgical and medical instruments and apparatus company1

In its 2026 annual report the company says: “We are a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. We are led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development.”4 It is headquartered in New Hope, Pennsylvania.1 Its shares trade on Nasdaq under the symbol OBIO.1

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Last updated Oct 21, 2026.

Overview

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  • TickerOBIO on Nasdaq1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersNew Hope, Pennsylvania1
  • Incorporated inDE2
  • Business address150 Union Square Drive, New Hope, Pa 189382
  • Filer categoryNon-accelerated filer, Smaller reporting company2

Our vision is to accelerate medical innovation to patients through risk-reward-sharing partnerships with leading medical device companies.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

-154.7%Operating margin5
-157.4%Net margin5
1169.2%Revenue growth, 20255
-98.4%Return on equity5
0.28×Debt to equity5
-$49.5MFree cash flow5

What sells

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

Products and services

Partnership Revenue brought in 98% of the revenue Orchestra BioMed Holdings, Inc. broke down this way in fiscal 2025.

  1. Partnership Revenue$32.9M598%up 1539% from 2024
  2. Product$611.0K52%down 3% from 2024
Products and services by year
Products and services20242025
Partnership Revenue$2.0M$32.9M
Product$633.0K$611.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue0¢$190.0K
  • Research and development68¢$58.2M
  • Selling, general and admin32¢$26.9M

Out of $33.5M in revenue.5 The company lost money this year.

Financial statements

Revenue675$33.5M in 2025+848% since 2022
0$10.0M$20.0M$30.0M$40.0M2022: $3.5M$3.5M20222023: $2.8M$2.8M2023−22%2024: $2.6M$2.6M2024−4%2025: $33.5M$33.5M2025+1169%
Operating income8675-$51.8M in 2025+13024% since 2021
-$80.0M-$60.0M-$40.0M-$20.0M02021: -$394.8K-$394.8K20212022: -$32.7M-$32.7M2022+8173%2023: -$51.5M-$51.5M2023+58%2024: -$64.3M-$64.3M2024+25%2025: -$51.8M-$51.8M2025−19%
Net income8675-$52.7M in 2025+13814% since 2021
-$80.0M-$60.0M-$40.0M-$20.0M02021: -$378.8K-$378.8K20212022: -$33.6M-$33.6M2022+8773%2023: -$49.1M-$49.1M2023+46%2024: -$61.0M-$61.0M2024+24%2025: -$52.7M-$52.7M2025−14%

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Total revenue$33.5M$2.6M
Cost of product revenues$190.0K$204.0K
Research and development$58.2M$42.8M
Selling, general and administrative$26.9M$23.9M
Total expenses$85.3M$66.9M
Loss from operations-$51.8M-$64.3M
Interest (expense) income, net-$1.1M$3.4M
Change in the fair value of derivative liability$254.0K
Loss on fair value of strategic investments-$68.0K
Other expense-$11.0K
Total other (expense) income-$894.0K$3.3M
Adjustment to carrying value of Series A Preferred Stock-$254.0K
Net loss attributable to common stockholders-$53.0M-$61.0M
Basic (in dollars per share)-$1.11-$1.66
Diluted (in dollars per share)-$1.11-$1.66
Weighted-average shares used in computing net loss attributable to common stockholders per share, basic (in shares)47.7M shares36.8M shares
Weighted-average shares used in computing net loss attributable to common stockholders per share, diluted (in shares)47.7M shares36.8M shares
Net loss-$52.7M-$61.0M
Unrealized gain on marketable securities$8.0K$62.0K
Comprehensive loss-$52.7M-$61.0M

Compare Orchestra BioMed Holdings, Inc. with another company

Corporate structure

Orchestra BioMed Holdings, Inc. sits at the top of its group. 9 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Orchestra BioMed Holdings, Inc.

  • RTW INVESTMENTS, LP Filed SCHEDULE 13D/A on Orchestra BioMed Holdings, Inc., latest Apr 29, 2026 (8 filings since Oct 12, 2022)
  • Medtronic plc Filed SCHEDULE 13G/A on Orchestra BioMed Holdings, Inc., latest Feb 27, 2026 (4 filings since Feb 6, 2023)
  • Tasso Partners, LLC Filed SCHEDULE 13G on Orchestra BioMed Holdings, Inc., latest Nov 19, 2025
  • PERCEPTIVE ADVISORS LLC Filed SCHEDULE 13G/A on Orchestra BioMed Holdings, Inc., latest Nov 14, 2025 (4 filings since Sep 13, 2023)
  • BlackRock Filed SCHEDULE 13G/A on Orchestra BioMed Holdings, Inc., latest Apr 29, 2025 (3 filings since Oct 23, 2024)
  • HSAC 2 Holdings, LLC Filed SC 13D/A on Orchestra BioMed Holdings, Inc., latest Aug 7, 2024 (3 filings since Oct 12, 2022)
  • PRICE T ROWE ASSOCIATES INC /MD/ Filed SC 13G on Orchestra BioMed Holdings, Inc., latest Feb 14, 2024 (2 filings since Feb 14, 2023)
  • RA CAPITAL MANAGEMENT, L.P. Filed SC 13G on Orchestra BioMed Holdings, Inc., latest Feb 14, 2023
  • Geoffrey Wade Smith Filed SC 13D on Orchestra BioMed Holdings, Inc., latest Feb 7, 2023
  • Orchestra BioMed Holdings, Inc. New Hope, Pennsylvania
    • Motus GI Holdings, Inc. Stake · New Hope, Pennsylvania, United States
    • Accelerated Technologies, LLC Subsidiary · Delaware, United States
    • BackBeat Medical, LLC Subsidiary · Delaware, United States
    • Caliber Therapeutics, LLC Subsidiary · Delaware, United States
    • FreeHold Surgical, LLC Subsidiary · Delaware, United States
    • Motus GI Medical Technologies, Ltd. Subsidiary · Israel
    • Motus GI, LLC Subsidiary · Delaware, United States
    • Orchestra BioMed, Inc. 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; stakes of 5% or more it reported on Schedules 13D and 13G (1 companies). Each entity in the chart links to its source.

What it owns

What Orchestra BioMed Holdings, 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$3.3M5 Dec 31, 2025$2.7M5 Dec 31, 2024+24.5%
Accumulated depreciation$1.6M5 Dec 31, 2025$1.3M5 Dec 31, 2024+25.2%
Property and equipment, net$1.7M5 Dec 31, 2025$1.4M5 Dec 31, 2024+23.9%
Operating-lease assets (leased space)$1.5M5 Dec 31, 2025$2.1M5 Dec 31, 2024−28.9%

Real estate and locations

ItemLatestA year beforeChange
Area of real estate6,496 sq ft5 Sep 30, 20247,800 sq ft5 Nov 30, 2022−16.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$34.7M5 Dec 31, 2025$22.3M5 Dec 31, 2024+55.8%
Marketable securities, current$71.8M5 Dec 31, 2025$44.6M5 Dec 31, 2024+61.2%
Marketable securities, non-current$4.9M5 Dec 31, 2025$3.3M7 Dec 31, 2024+48.5%
Debt securities available for sale$71.8M5 Dec 31, 2025$44.6M5 Dec 31, 2024+61.2%

Inventory

ItemLatestA year beforeChange
Inventory, total$310.0K5 Dec 31, 2025$173.0K5 Dec 31, 2024+79.2%

Properties, in its own words

Our headquarters are located at 150 Union Square Drive New Hope, Pennsylvania 18938, where we lease 8,052 rentable square feet of office and laboratory space under a lease that terminates on September 30, 2027. We believe that our existing facilities are adequate to meet our current needs, and that suitable additional alternative spaces will be available in the future on commercially reasonable terms.

Item 2 of the 10-K filed Mar 12, 2026.4

Leadership

Who has led Orchestra BioMed Holdings, Inc., and when. Pick a name to see everywhere that person has worked.

2025
Board members and other officers (24)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Accelerated Technologies, LLC Delaware3
  • BackBeat Medical, LLC Delaware3
  • Caliber Therapeutics, LLC Delaware3
  • FreeHold Surgical, LLC Delaware3
  • Motus GI Medical Technologies, Ltd. Israel3
  • Motus GI, LLC Delaware3
  • Orchestra BioMed, Inc. Delaware3

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

Former names

  • Health Sciences Acquisitions Corp 2Jun 22, 2020 to Jan 26, 20232

Timeline

  1. Oct 1, 20268-K Regulation FD disclosure; Other events34
  2. Sep 8, 20268-K Regulation FD disclosure35
  3. Jun 23, 20268-K Shareholder vote36
  4. Feb 13, 20268-K Executive or director change37
  5. Jan 12, 20268-K Other events38
  6. Nov 13, 20258-K Regulation FD disclosure39
  7. Oct 30, 20258-K Regulation FD disclosure40
  8. Oct 28, 20258-K Entered a material agreement; Ended a material agreement; Unregistered sale of shares41
  9. Aug 4, 20258-K Entered a material agreement; Regulation FD disclosure; Other events42
  10. Jul 31, 20258-K Entered a material agreement; New debt or obligation; Unregistered sale of shares43
  11. Jun 24, 20258-K Shareholder vote44
  12. Apr 29, 20258-K Regulation FD disclosure; Other events45
  13. Aug 3, 2020New chief executive Roderick Wong becomes CEO12

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.40) a share, on Nov 10, 2025.46

When it reported results

  1. Mar 24, 2023Reported quarterly or annual results47

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

Filings

373 filings to the SEC since October 2021: 6 annual reports, 16 quarterly reports, 43 major events, 194 insider forms, 27 large holders, 87 other. The latest 20:

  1. Oct 2, 20264 OWNERSHIP DOCUMENT EDGAR
  2. Oct 1, 2026144 EDGAR
  3. Oct 1, 20268-K EDGAR
  4. Sep 11, 20264 OWNERSHIP DOCUMENT EDGAR
  5. Sep 8, 20268-K EDGAR
  6. Sep 8, 20264 OWNERSHIP DOCUMENT EDGAR
  7. Sep 2, 20264 OWNERSHIP DOCUMENT EDGAR
  8. Sep 1, 2026144 EDGAR
  9. Aug 28, 20264 OWNERSHIP DOCUMENT EDGAR
  10. Aug 28, 20264 OWNERSHIP DOCUMENT EDGAR
  11. Aug 28, 20264 OWNERSHIP DOCUMENT EDGAR
  12. Aug 14, 20264 OWNERSHIP DOCUMENT EDGAR
  13. Aug 14, 20264 OWNERSHIP DOCUMENT EDGAR
  14. Aug 14, 20264 OWNERSHIP DOCUMENT EDGAR
  15. Aug 14, 20264 OWNERSHIP DOCUMENT EDGAR
  16. Aug 10, 202610-Q EDGAR
  17. Aug 4, 20264 OWNERSHIP DOCUMENT EDGAR
  18. Aug 3, 2026144 EDGAR
  19. Jul 2, 20264 OWNERSHIP DOCUMENT EDGAR
  20. Jul 1, 2026144 EDGAR

The 373 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

45 open-market trades by officers, directors and large owners since October 2021: 31 buys and 14 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 3, 2026Hochman David PSee RemarksBuy10,000$4.79$47.9KForm 4
Sep 1, 2026Sherman DarrenSee RemarksSale15,000$4.94$74.1KForm 4
Aug 26, 2026Sherman DarrenSee RemarksBuy2,000$5.33$10.7KForm 4
Aug 3, 2026Sherman DarrenSee RemarksSale15,000$4.09$61.4KForm 4
Jul 1, 2026Sherman DarrenSee RemarksSale15,000$4.27$64.0KForm 4
Jun 1, 2026Hochman David PSee RemarksBuy5,000$3.83$19.1KForm 4
Jun 1, 2026Sherman DarrenSee RemarksSale15,000$3.87$58.0KForm 4
May 18, 2026Aryeh JasonDirectorBuy665$3.75$2.5KForm 4
May 15, 2026Aryeh JasonDirectorBuy8,971$3.90$35.0KForm 4
May 15, 2026Hochman David PSee RemarksBuy5,000$3.77$18.9KForm 4
May 14, 2026Fain Eric SDirectorBuy20,000$4.13$82.6KForm 4
Apr 27, 2026RTW INVESTMENTS, LP10% ownerSale32$4.13$132Form 4
Mar 13, 2026Hochman David PSee RemarksBuy10,000$4.29$42.9KForm 4
Nov 14, 2025Hochman David PSee RemarksBuy5,000$4.07$20.4KForm 4
Sep 19, 2025Aryeh JasonDirectorBuy1,000$2.45$2.5KForm 4
Aug 25, 2025Fain Eric SDirectorBuy5,760$2.61$15.0KForm 4
Aug 25, 2025Sherman DarrenSee RemarksBuy3,000$2.62$7.9KForm 4
Aug 25, 2025Taylor Andrew LawrenceChief Financial OfficerBuy2,000$2.55$5.1KForm 4
Aug 21, 2025Hochman David PSee RemarksBuy6,000$2.49$14.9KForm 4
Aug 4, 2025Hochman David PSee RemarksBuy20,000$2.75$55.0KForm 4

All 45 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.

Stakes it holds

Orchestra BioMed Holdings, Inc. has told the SEC it owns more than 5% of 1 company, latest first (Schedules 13D and 13G).

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
2025David P. Hochman50$595.0K$2.3M58
2025Darren R. Sherman54$495.0K$1.8M58
2025Andrew L. Taylor55$409.6K$1.2M58
2024Chief Executive Officer & Chairman$595.0K$1.9M58
2024President & Chief Operating Officer$495.0K$1.8M58
2024Chief Financial Officer$395.0K$1.1M58

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 77. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Rtw Investments, LP9,556,063$41.2M0.4%+1,250,000
Perceptive Advisors LLC5,037,906$21.7M0.3%No change
BlackRock, Inc.2,510,387$10.8M0.0%+1,874,673
Vanguard Capital Management LLC2,022,916$8.7M0.0%−181,403
Geode Capital Management, LLC1,007,908$4.4M0.0%+522,416
Alyeska Investment Group, L.P.1,000,000$4.3M0.0%No change
Propel Bio Management, LLC896,701$3.9M2.0%No change
UBS AM, a distinct business unit of UBS ASSET MANAGEMENT AMERICAS LLC642,154$2.8M0.0%New
State Street Corp516,050$2.2M0.0%+346,640
Rice Hall James & Associates, LLC424,000$1.8M0.1%+404,999
Charles Schwab Investment Management Inc349,544$1.5M0.0%+84,045
Northern Trust Corp343,640$1.5M0.0%+225,366
UBS Group AG325,773$1.4M0.0%+275,463
Vanguard Fiduciary Trust Co292,253$1.3M0.0%+57,039
Vanguard Portfolio Management LLC274,973$1.2M0.0%New
Knott David M Jr253,651$1.1M0.6%No change
Flat Footed LLC251,372$1.1M0.2%New
Simplify Asset Management Inc.219,387$946.7K0.0%No change
Goldman Sachs Group Inc179,606$775.0K0.0%+24,364
DAFNA Capital Management LLC126,841$547.3K0.1%No change
Renaissance Technologies LLC90,000$388.4K0.0%+19,100
IFP Advisors, Inc89,608$386.7K0.0%−9,279
Daytona Street Capital LLC96,398$379.3K0.3%+43,798
Bank of New York Mellon Corp86,103$371.5K0.0%New
Bridgeway Capital Management, LLC80,600$347.8K0.0%+10,000

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

SEC filer profile

How Orchestra BioMed Holdings, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGAROrchestra BioMed Holdings, Inc.1
  • CIK0001814114
  • Employer ID (EIN)92-20387554
  • Filer statusNon-accelerated filer not 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 address150 Union Square Drive, New Hope, PA 189381
  • Phone646-343-92981
  • Shares outstanding60,105,049 as of Aug 6, 202610
  • Public float$63.4M as of Jun 30, 20254
  • AuditorErnst & Young LLP, Philadelphia, Pennsylvania PCAOB ID 42; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceJun 22, 20201
  • Filings409 in all: 4 (159), 8-K (43), 3 (29), 10-Q (18), 4/A (18), 144 (14), CORRESP (13), UPLOAD (10)1
    All 43 form types

    425 (9), SC 13G (9), 10-K (6), DEFA14A (6), S-8 (6), SC 13D/A (5), 3/A (4), 424B3 (4), DEF 14A (4), EFFECT (4), S-4/A (4), SCHEDULE 13D/A (4), SCHEDULE 13G/A (4), 424B5 (3), ARS (3), SC 13D (3), SC 13G/A (3), 8-K/A (2), S-1 (2), S-1/A (2), S-3 (2), S-3/A (2), SEC STAFF LETTER (2), 10-K/A (1), 10-Q/A (1), 424B4 (1), 5 (1), 8-A12B (1), CERT (1), DRS (1), PRE 14A (1), PRER14A (1), S-1MEF (1), S-4 (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 12, 2026
    Quarterly report (10-Q) Aug 10, 2026
    Proxy statement (DEF 14A) Apr 29, 2026
    Latest 8-K (8-K) Oct 1, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, par value $0.0001 per shareOBIONasdaq

From the cover page of the 10-K filed Mar 12, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Orchestra BioMed Holdings, Inc. names in Item 1A of its 10-K filed Mar 12, 2026: 75 risks under these headings, as written.4

  • Risks Related to Our Business and Products
  • We have a history of net losses, and we expect to continue to incur losses for the foreseeable future. If we ever achieve profitability, we may not be able to sustain it.
  • We may need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
  • We currently have a limited operating history and limited sources of revenue and may never become profitable.
  • If we do not achieve our projected development and commercialization goals, our business may be harmed.
  • The clinical study process required to obtain regulatory approvals or certifications carries substantial risks and is lengthy and expensive with uncertain outcomes. If our clinical studies are unsuccessful or significantly delayed, or if we do not complete our clinical studies, our business may be harmed.
  • Failures or perceived failures in our clinical studies will delay and may prevent our product candidate development and regulatory approval or certification process, damage our business prospects and negatively affect our reputation and competitive position.
  • The FDA and comparable foreign regulatory authorities may not accept data from any preclinical or clinical trials we may conduct in foreign countries.
  • Up to 50% of our BACKBEAT study data is expected to come from sites or patients outside of the United States. While we remain in compliance with the parameters the FDA has set for us regarding clinical data received from abroad in the BACKBEAT study, the FDA’s acceptance of data generated for patients recruited outside the United States from clinical trials conducted in whole or in part outside the United States may be subject to certain conditions.
  • Even if we obtain all necessary FDA approvals, our product candidates may not achieve or maintain market acceptance and may be subject to additional regulatory requirements post-approval.
  • We may be unable to compete successfully with larger companies in our highly competitive industry.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
The other 64 risks
  • The sizes of the markets for product candidates have not been established with precision and may be smaller than we estimate.
  • The long-term macroeconomic effects of the COVID-19 pandemic and any future pandemic or epidemic could adversely impact our business, including our clinical studies and financial condition.
  • Interim, “topline” and preliminary data from our clinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Our product candidates have in the past and may in the future be associated with serious adverse events, undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval or certification, limit their commercial potential or result in significant negative consequences.
  • We depend on attracting, retaining and developing key management, clinical, scientific, regulatory, quality, marketing and other expert personnel, and losing these personnel could impair the development and sales of our products or product candidates.
  • If we make acquisitions, we could incur significant costs and encounter difficulties that harm our business.
  • If we do not manage our growth or control costs related to growth, our results of operations will suffer.
  • Litigation and other legal proceedings may adversely affect our business.
  • Product liability and other claims against us may reduce demand for our products or result in substantial damages.
  • The misuse or promotion of off-label uses of our products may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies, any of which could be costly to our business.
  • Our information technology systems, or those of any of our CROs, manufacturers, other contractors, consultants, collaborators or potential future collaborators, may fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data, or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand and material disruption of our operations.
  • We must successfully maintain and upgrade our information technology systems, and our failure to do so could have a material adverse effect on our business, financial condition and results of operations.
  • Economic conditions may adversely affect our business, financial condition and share price.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • Disruptions at the FDA, other government agencies and notified bodies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved, certified or commercialized in a timely manner or at all, or otherwise prevent those agencies and bodies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • We, in conjunction with our partners, intend to sell our products internationally in the future, but we and our partners may experience difficulties in obtaining regulatory approval or certification or in successfully marketing and distributing our products internationally even if approved or certified. A variety of risks associated with marketing and distributing our products internationally could materially adversely affect our business.
  • We may in the future bring certain cGMP product release testing, stability testing and cGMP pharmaceutical manufacturing capabilities in-house, and we may not be able to do so successfully or in compliance with FDA regulations.
  • We may expend our limited resources to pursue a particular product or indication and fail to capitalize on products or indications that may be more profitable or for which there is a greater likelihood of success.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  • Changes in tax laws could adversely affect the taxes we pay and, as a result, adversely affect our financial condition and results of operations.
  • Risks Related to Our Reliance on Third Parties
  • We are, and expect to continue to be, highly dependent on partners to drive the successful marketing and sale of our initial product candidates. There is no assurance that we will be able to form and properly manage partnerships. There is no assurance that partnerships will be successful.
  • We expect to be highly dependent on partners and third-party vendors to manufacture and provide important materials and components for our products and product candidates. There is no assurance that we will be able properly manage our supply chain. Further, we currently do not have redundancy built into our supply chain.
  • We and our partners may be unable to sustain revenue growth.
  • The failure of our manufacturing partners and component suppliers to meet regulatory quality standards applicable to their manufacturing processes could have an adverse effect on our business, financial condition and results of operations.
  • From time to time, we engage outside parties to perform services related to certain of our clinical studies and trials, and any failure of those parties to fulfill their obligations could cause costs and delays.
  • The continuing development of many of our products and product candidates depends upon our maintaining strong working relationships with physicians.
  • We have limited pharmaceutical manufacturing experience and our CMOs may experience development or manufacturing problems or delays in producing our product candidates and planned or future products that could limit or prevent the potential growth of our revenue or increase our losses.
  • Reduction or interruption in supply and an inability to develop alternative sources for supply may adversely affect our partners’ manufacturing operations and related product sales.
  • We source certain products from foreign suppliers, making us vulnerable to supply problems or price fluctuations caused by trade conflicts and other geopolitical events.
  • The imposition of new duties, tariffs, trade barriers and retaliatory countermeasures implemented by the U.S. and other governments and the resulting impact on the cost of imported materials and demand for our future products may have a material adverse effect on our business, financial condition and results of operations.
  • Risks Related to Government Regulation and Our Industry
  • Healthcare reform initiatives and other administrative and legislative proposals may adversely affect our business.
  • Regulatory compliance is expensive, complex and uncertain, and approvals or certifications can often be denied or significantly delayed. We may not obtain the necessary approvals or certifications and failure to obtain timely regulatory approval or certification, if at all, would adversely affect our business.
  • Our medical device products must be manufactured in accordance with federal, state and foreign regulations, and we or any of our suppliers or third-party manufacturers could be forced to recall our installed systems or terminate production if we fail to comply with these regulations.
  • Even if we obtain regulatory approval or certification for a product candidate, our products will remain subject to regulatory scrutiny and post-marketing requirements. 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.
  • Modifications to any approved or certified device products may require us to obtain new PMA approvals or approvals of a PMA supplement or foreign certification, and if we market modified products without obtaining necessary approvals or certifications, we may be required to cease marketing or recall the modified products until required approvals or certifications are obtained.
  • Our medical device products, if approved or certified, may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are required to report to the FDA or similar foreign regulatory authorities, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.
  • Virtue SAB is a drug/device combination, which may result in additional regulatory and other risks.
  • If the FDA does not conclude that SirolimusEFR as a standalone product candidate satisfies the requirements for the Section 505(b)(2) regulatory approval pathway, or if the requirements for SirolimusEFR under Section 505(b)(2) are not as we expect, the approval pathway for SirolimusEFR may take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • Our relationships with physicians, patients and payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, and other healthcare laws and regulations.
  • Healthcare cost-containment pressures and legislative or administrative reforms resulting in restrictive coverage and reimbursement practices of third-party payors could decrease the demand for our products, the prices that customers are willing to pay for those products and the number of procedures performed using our devices, which could have an adverse effect on our business.
  • Actual or perceived failures to comply with U.S. and foreign privacy and data protection laws, regulations and standards may adversely affect our business, operations and financial performance.
  • Environmental and health safety laws may result in liabilities, expenses and restrictions on our operations.
  • We are subject to economic sanctions, export control, anti-bribery, anti-corruption and anti-money laundering laws, including the U.S. Foreign Corrupt Practices Act, and violations of these laws could result in substantial penalties and prosecution.
  • Risks Related to Our Intellectual Property
  • We may not effectively be able to protect or enforce our intellectual property, which could have a material adverse effect on our business, financial condition, results of operations and prospects.
  • We may be unable to enforce our intellectual property rights throughout the world.
  • If we cannot protect and control unpatented trade secrets, know-how and other proprietary technology, we may suffer competitive harm.
  • Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
  • We may be involved in litigation or other proceedings relating to patent, trade secret and other intellectual property rights, which could cause substantial costs and liability.
  • Patents covering our technology or products could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We may be subject to claims challenging the ownership or inventorship of our patents and other intellectual property and, if unsuccessful in any of these proceedings, we may be required to obtain licenses from third parties, which may not be available on commercially reasonable terms, or at all, or to cease the development, manufacture and commercialization of one or more of our products.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • We may be unable to acquire patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation.
  • We may need to obtain intellectual property rights from third parties, and may not be successful in obtaining necessary rights to develop any future product through acquisitions and in-licenses.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Risks Related to Ownership of Our Common Stock
  • Stockholder litigation and regulatory inquiries and investigations are expensive and could harm our business, financial condition and operating results and could divert management attention.
  • Anti-takeover provisions contained in our Charter and our Bylaws and under Delaware law could impair a takeover attempt.
  • Our Charter provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States will be the exclusive forums for certain disputes between us and our stockholders, which could make our securities less attractive and impose legal costs on us if such limitations are challenged.
  • The price of our common stock has in the past been volatile and may continue to be volatile and subject to significant fluctuation.
  • Our ability to timely raise capital in the future may be limited, or may be unavailable on acceptable terms, if at all. The failure to raise capital when needed could harm our business, operating results and financial condition. Debt or equity issued to raise additional capital may reduce the value of our common stock.
  • The future sales, or the perception of future sales, of shares by existing stockholders and future exercise of registration rights may adversely affect the market price of our common stock.
  • Our warrants may not be exercised at all and we may not receive any cash proceeds from the exercise of the warrants.

Legal proceedings

From time to time, we may become involved in various claims and legal proceedings that arise in the ordinary course of our business. We are not currently a party to any material legal proceedings and are not aware of any pending or threatened legal proceeding against us that we believe would have a material adverse effect on our business, operating results or financial condition.

The opening of Item 3, Legal Proceedings.4

Sources

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