Orchestra BioMed to Receive Up to $21 Million in Proceeds from Acquisition of Vivasure by Haemonetics

Orchestra BioMed (NASDAQ: OBIO) expects to receive up to $21 million in cash proceeds from the sale of its strategic holding Vivasure to Haemonetics, which closed on January 9, 2026.

Rhea-AI Summary

Orchestra BioMed (NASDAQ: OBIO) expects to receive up to $21 million in cash proceeds from the sale of its strategic holding Vivasure to Haemonetics, which closed on January 9, 2026. Orchestra expects $11 million in 2026 (approximately $5 million upfront and ~$6 million milestone) with the remainder payable via future revenue earnouts tied to milestones. Vivasure’s PerQseal Elite is CE marked for arterial and venous indications, has a PMA filed with the FDA in 2025, and reported 0% major complications at 30 days in the ELITE arterial study.

Positive

• Proceeds up to $21M from Vivasure acquisition
• $11M expected to be received in 2026
• PerQseal Elite holds CE Mark for arterial and venous use
• PMA application for PerQseal Elite submitted to FDA in 2025
• ELITE study: 0% major complications at 30 days

Negative

• Remainder of proceeds contingent on future revenue earnouts
• Only ~$5M upfront received at close, limiting immediate cash
• FDA PMA outcome and timing remain unresolved and material

Argus Jan 12 session

-2.92% close to close Open Argus

Details

News Market Reaction – OBIO

On Jan 12, the day this news came out, OBIO closed 2.92% below the previous close.

Data tracked by StockTitan Argus for the Jan 12 session.

Key Figures

Total expected proceeds: $21 million Proceeds in 2026: $11 million Upfront payment: $5 million +5 more

Total expected proceeds

$21 million

Maximum cash proceeds from Vivasure acquisition by Haemonetics

Proceeds in 2026

$11 million

Cash expected in 2026 from upfront and first milestone

Upfront payment

$5 million

Approximate upfront component of 2026 proceeds

First milestone payment

$6 million

Approximate first milestone payment in 2026

Sheath size

up to 26 F

PerQseal Elite indicated for large-bore arteriotomies and venotomies

Major complications

0%

ELITE arterial study at 30-day follow-up

Follow-up period

30-day

Major complication assessment window in ELITE arterial study

PMA and CE Mark timing

2025

PMA submission and CE Mark approvals for PerQseal Elite

Historical Context

5 past events · Latest: Dec 08

5 events

1. Dec 08

   Scientific presentations

   24h Move

   -0.2%

   ICI meeting presentations on AVIM Therapy and Virtue SAB programs.

2. Nov 26

   Inducement grants

   24h Move

   +1.5%

   Stock option grants to 12 new employees under inducement plan.

3. Nov 11

   Investor conferences

   24h Move

   +8.5%

   Participation in late-2025 healthcare investor conferences and meetings.

4. Nov 10

   Earnings & funding

   24h Move

   -0.8%

   Q3 2025 results and capital raises extending cash runway into Q4 2027.

5. Nov 03

   Business update call

   24h Move

   +1.3%

   Planned call on clinical, strategic and financing developments.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

percutaneous, arteriotomies, venotomies, bioabsorbable, +3 more

7 terms

percutaneous medical

"pioneering next-generation technology for percutaneous vessel closure, by Haemonetics"

Percutaneous describes medical procedures or delivery methods that reach internal organs or tissues by passing through the skin — for example with needles, catheters or small tubes — instead of opening the body with large incisions. For investors it matters because percutaneous approaches are generally less invasive, often mean lower hospital time, quicker recovery and smaller device footprints, which can broaden market adoption and affect regulatory and reimbursement outlooks.

arteriotomies medical

"to seal large-bore (up to 26 F) arteriotomies and venotomies from inside the vessel"

An arteriotomy is a surgical cut made into an artery to gain access for procedures like placing catheters, stents, or performing repairs. For investors, the prevalence and safety of arteriotomies affect demand for closure devices, surgical tools and consumables because these cuts carry bleeding and infection risks and require reliable ways to seal the artery—like making a doorway in a water pipe that must be securely closed afterward.

venotomies medical

"to seal large-bore (up to 26 F) arteriotomies and venotomies from inside the vessel"

A venotomy is a medical procedure that involves making a small cut into a vein to gain direct access for treatment, such as inserting a catheter, removing a clot, or taking a tissue sample. It matters to investors because the need for venotomies drives demand for surgical tools, catheters and clot-removal devices and can affect hospital procedure volumes, device company revenues, and regulatory scrutiny tied to patient safety and outcomes—similar to how a repair opening enables a mechanic to fix a car and shapes sales of shop tools.

bioabsorbable medical

"uses a proprietary bioabsorbable patch to seal large-bore (up to 26 F)"

A bioabsorbable material is engineered to gradually dissolve and be absorbed or cleared by the body after it has fulfilled its medical role—like a temporary scaffold that disappears once tissue heals. Investors care because bioabsorbable products can cut the need for follow-up surgeries and long-term complications, affect regulatory approval and reimbursement prospects, and provide a competitive edge that can influence future sales and company valuation.

premarket approval regulatory

"Vivasure submitted a Premarket Approval application to the U.S. Food and Drug"

Premarket approval is the formal regulatory clearance required before certain medical devices can be sold, based on detailed evidence that the product is safe and effective. For investors, it’s a major milestone because receiving approval typically clears the way for commercial sales and reduces regulatory uncertainty, while failure or delays can block revenue and raise the risk profile; think of it like a safety certificate needed before a new car model can be sold.

ce mark regulatory

"and received CE Mark approval in Europe for both arterial and venous"

A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.

structural heart medical

"solution for structural heart and endovascular procedures."

Structural heart describes medical devices and treatments that fix or replace the heart’s valves, walls, chambers and other physical parts — essentially the mechanical “plumbing and doors” of the heart rather than electrical or artery-focused care. It matters to investors because advances, regulatory approvals, and shifts from open surgery to less invasive procedures can quickly change sales, profit margins and adoption rates for companies that make these devices, much like a new, more efficient tool reshaping a repair market.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• $11 million in proceeds expected to be received during 2026, with remainder of expected proceeds to be received in future revenue earnouts
• Vivasure Medical Limited (“Vivasure”) has been a strategic holding of Orchestra BioMed since the Company’s formation

NEW HOPE, Pa., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that it expects to receive up to $21 million in cash proceeds in connection with the acquisition of Vivasure, an Ireland-based company pioneering next-generation technology for percutaneous vessel closure, by Haemonetics Corporation (NYSE: HAE, “Haemonetics”), which closed on January 9, 2026.

Vivasure was a strategic holding of Orchestra BioMed prior to the transaction. In connection with the closing of the transaction, Orchestra BioMed expects to receive $11 million of proceeds in 2026 made up of approximately $5 million upfront and approximately $6 million in a first milestone payment. The remainder of the proceeds are expected to be received in future revenue earnouts based on the achievement of certain milestones.

Vivasure’s PerQseal^® Elite system uses a proprietary bioabsorbable patch to seal large-bore (up to 26 F) arteriotomies and venotomies from inside the vessel, offering a sutureless, fully absorbable solution for structural heart and endovascular procedures. In 2025, Vivasure submitted a Premarket Approval application to the U.S. Food and Drug Administration for the PerQseal Elite arterial closure system and received CE Mark approval in Europe for both arterial and venous indications. Results from the prospective, single-arm, multi-center ELITE arterial study demonstrated ease of use with no need for pre-close, with 0% major complications at 30-day follow-up, and immediate median time to hemostasis.^1,2

David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed, who also served as an active board observer of Vivasure stated, “Vivasure has been a strategic holding since the formation of Orchestra BioMed, and we have been active and intentional in supporting the company for many years. We are very proud of the outstanding clinical results from the PerQseal product platform which we believe clearly positions it as a best-in-class solution for large diameter percutaneous vessel closure. This transaction represents a clear realization of our preferred approach to device development, powered by long-term, strategically aligned partnerships. We wish Haemonetics every success as it takes PerQseal forward commercially.”

Andrew Glass, Chief Executive Officer of Vivasure Medical Limited commented, “Orchestra BioMed has been a deeply engaged partner since the earliest days of Vivasure. Their co-founders helped to lead our initial financing and supported the development of our PerQseal technology from concept stage. With Orchestra BioMed CEO, David Hochman, serving as an active board observer since 2019, and COO, Darren Sherman as an original board member through 2016, their strategic insight and guidance contributed meaningfully to the development of our product and its evolution to this next chapter.”

“We recognize and appreciate the meaningful role Orchestra BioMed played as a long-term strategic partner in the development of Vivasure,” said Rajeev Varma, Senior Vice President, Strategy and Corporate Development of Haemonetics. “Vivasure has built a clinically differentiated closure device technology with PerQseal Elite, supported by strong clinical performance and safety data, representing a compelling opportunity to strengthen our impact in the large-bore closure market and structural heart and endovascular procedures.”

About Orchestra BioMed
Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates - Atrioventricular Interval Modulation (AVIM) Therapy and Virtue^® Sirolimus AngioInfusion™ Balloon (Virtue SAB) - are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind non-coated drug delivery angioplasty balloon system designed to deliver a large liquid dose of proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn.

About Haemonetics
Haemonetics is a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care. Haemonetics innovative solutions addressing critical medical needs include a suite of hospital technologies designed to advance standards of care and help enhance outcomes for patients; end-to-end plasma collection technologies to optimize operations for plasma centers; and products to enable blood centers to collect in-demand blood components. To learn more about Haemonetics, visit www.haemonetics.com.

About Vivasure Medical Limited
Based in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility.

PerQseal and PerQseal Elite are not available for sale in the United States. For more information, please visit www.vivasuremedical.com.

Forward-Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the results of the acquisition of Vivasure by Haemonetics including the proceeds expected to be received by the Company pursuant to the achievement of certain milestones. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading “Item 1A. Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025.

The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law.

Investor Contact:
Silas Newcomb
Orchestra BioMed
Snewcomb@orchestrabiomed.com

Media Contact:
Kelsey Kirk-Ellis
Orchestra BioMed
kkirkellis@orchestrabiomed.com

References

1. Miegham, First in man use of the Vivasure PerQseal^® Elite for large hole arterial closure, PCR London Valves Meeting 2024.
2. Miegham, First in Man (FIM) Experience of the Vivasure PerQseal^® ELITE System for Large Hole Closure: The ELITE and ELITE Venous Studies, Transcatheter Cardiovascular Therapeutics Meeting 2024.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How much will Orchestra BioMed (OBIO) receive from Vivasure's acquisition by Haemonetics?

Orchestra expects up to $21 million in total proceeds, with $11 million expected in 2026 and the balance via future earnouts.

What cash does OBIO expect to get in 2026 from the Vivasure sale?

Approximately $11 million in 2026, comprising about $5 million upfront and ~$6 million as a first milestone payment.

What regulatory milestones does Vivasure's PerQseal Elite have after the acquisition?

PerQseal Elite has received a CE Mark for arterial and venous indications and a PMA application was submitted to the FDA in 2025.

How did Vivasure's PerQseal Elite perform clinically in the ELITE arterial study?

The ELITE arterial study reported 0% major complications at 30-day follow-up and immediate median time to hemostasis.

What portion of OBIO's proceeds are tied to future performance after the Vivasure deal?

The remainder of the $21 million purchase price is contingent on future revenue-based earnouts linked to milestone achievements.