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When Partnership Drives Progress: Reflections on the Vivasure Journey

Written by Orchestra BioMed | Mar 2, 2026 3:27:08 PM

When Partnership Drives Progress: Reflections on the Vivasure Journey

The recent acquisition of Vivasure Medical by Haemonetics follows over a decade of collaboration between Vivasure and Orchestra BioMed. Over that time, Orchestra worked alongside the Vivasure team through early-stage fundraising, clinical development and next-generation advancement of the PerQseal® technology, including during the formation and evolution of Vivasure’s strategic relationship with Haemonetics.

In connection with the transaction, Orchestra BioMed expects to receive up to $21 million in cash proceeds, including approximately $11 million anticipated in 2026 comprised of a $4.7 million upfront payment, which was received on January 9, 2026, and approximately $6.0 million in an expected first milestone payment, with the remainder expected through future revenue-based earnouts tied to defined milestones.

OBIO CEO David Hochman sat down with former Vivasure CEO Andy Glass to discuss the deal, Vivasure’s PerQseal technology and Orchestra’s partnership and guidance along the development journey. 

Watch key highlights from their conversation here:

 

 

Clinical Development

PerQseal was developed to address large-bore vascular closure in structural heart and other interventional procedures. Unlike traditional suture-based systems deployed at the beginning of a case, PerQseal utilizes a fully bioresorbable patch delivered at the end of the procedure, designed to support vessel closure while allowing the vessel to return to its natural state over time. The next-generation PerQseal Elite platform further streamlined deployment and expanded use across both arterial and venous access.

Under Andy Glass’s leadership, Vivasure advanced PerQseal through two U.S. early feasibility studies, a U.S. pivotal IDE trial, and multiple European studies evaluating arterial and venous applications. Throughout development, Orchestra BioMed executives worked alongside the Vivasure team, contributing to clinical strategy, regulatory engagement, and next-generation product planning.

The U.S. pivotal study met both primary safety and efficacy endpoints, with time to hemostasis below historical benchmarks and very low complication rates in the 1–2% range. European studies demonstrated similarly low complication rates and improved procedural efficiency, supporting advancement toward commercialization.

 

 

Early and Ongoing Involvement of Orchestra BioMed

Orchestra BioMed’s leadership team was involved in Vivasure’s formation and early financing rounds, supporting early development by connecting the company with U.S.-based key opinion leaders, investors and clinical advisors, and contributing to early strategic, product and clinical decisions.

As the program advanced, Orchestra continued to provide input across clinical strategy, regulatory engagement, next-generation development, and structured transaction discussions. This included support navigating CMS processes and providing perspective during pivotal trial execution.

Andy described the collaboration as having “a coach in our corner” during the development process.
“You need people in your corner. You’re not going to get there alone.”

David Hochman reflected on the scope of execution required to advance the program:
“The outcome is a result of a lot of hard work, overcoming a lot of obstacles, across an array of different moving targets.”

Developing Class III implantable technologies involves clinical, regulatory, technical, and financial considerations that evolve over time. Glass emphasized the importance of sustained effort and adaptability throughout the process.

“It’s a marathon, not a sprint.”

 

Structured Strategic Alignment

In 2021, Vivasure entered into a structured strategic relationship with Haemonetics. The objective was to support execution of the U.S. pivotal trial and advance next-generation development.

The structured agreement included milestone-based components aligned with regulatory and commercialization objectives. Negotiating such arrangements requires anticipating future development and market milestones years in advance, as well as managing valuation and uncertainty over time.

Haemonetics had previously expanded into vascular closure through its acquisition of Cardiva and its VASCADE platform. PerQseal extends capability into larger sheath sizes, complementing its existing portfolio. Throughout the process, Orchestra BioMed leadership counseled the Vivasure team in navigating complex financial dynamics, risk-sharing structures, and long-term considerations. 

 

Transition to Commercialization

Following the acquisition announcement, work continues across several areas. Regulatory engagement with the FDA remains ongoing. Manufacturing scale-up efforts are underway to support anticipated demand. Integration activities across operational and commercial functions are in progress.

The earnout structure aligns stakeholders around defined, achievable milestones as the product advances toward broader commercialization.

Reflecting on the potential impact of this technology, Hochman added:
“The end result is not just financial. This is a product that is going to help physicians do complex procedures easier and faster.”

 

Looking Ahead

Glass described the path to market as nonlinear and requiring adaptation at multiple stages.

“It’s extremely naive to think you’re going to come up with a concept and the next thing you know it’s in the market.”

The acquisition by Haemonetics represents the next phase in the progression of PerQseal to market, transitioning the technology toward commercialization within an established vascular portfolio.
In announcing the acquisition, Haemonetics Senior Vice President of Strategy and Corporate Development, Rajeev Varma highlighted both Orchestra’s role as a long-term strategic partner and the clinical differentiation of PerQseal:

“We recognize and appreciate the meaningful role Orchestra BioMed played as a long-term strategic partner in the development of Vivasure. Vivasure has built a clinically differentiated closure device technology with PerQseal Elite, representing a compelling opportunity to strengthen our impact in the large-bore closure market and structural heart and endovascular procedures.”

For Orchestra BioMed, the Vivasure journey reflects the role we seek to play in advancing innovative medical technologies. Our business model centers on identifying differentiated core technologies to advance through clinical and regulatory inflection points and designing strategic collaborations for long-term value creation.

While each program is distinct, the underlying approach remains consistent: strong partnerships, sustained engagement, and aligned execution through key development milestones. Vivasure represents one example of that model in action.

- Team OBIO

Published March 2026

Forward-Looking Statements

Certain statements included in the content distributed by Orchestra BioMed Holdings, Inc. (the “Company”) to which this disclaimer relates (including, but not limited to, visual, auditory, or written statements accessible through the link included in the Company’s digital communication) (the “Content”) 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 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 the Content, 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 Form 10-K for the year ended December 31, 2024, and under the heading “Item 1A. Risk Factors” in our quarterly report on Form 10-Q for the quarter ended March 31, 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 the Content. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made in the Content, except as required by law.