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.
Premarket Approval (PMA)regulatory
Premarket Approval (PMA) is the strict regulatory review process used by the U.S. authority for high-risk medical devices to prove they are safe and effective before they can be sold. For investors, a granted PMA is like receiving a key to a locked market: it can open exclusive sales opportunities, reduce near-term competition, and justify higher valuations, while also signaling that the company has cleared a costly, time-consuming hurdle.
FDAregulatory
The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.
CE markregulatory
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.
bioresorbablemedical
Bioresorbable describes medical implants or materials designed to break down safely inside the body and be absorbed or expelled over time, removing the need for a later surgical removal. For investors, bioresorbable products can change revenue patterns, lower some long‑term risks for patients, and demand stronger clinical proof and regulatory scrutiny—think of them as devices that act like a biodegradable product that may drive repeat sales or faster adoption if proven reliable.
GALWAY, Ireland--(BUSINESS WIRE)--
Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced that the company has been acquired by Haemonetics Corporation (NYSE: HAE) in a transaction valued up to €185M (~$215M) on completion of certain milestones.
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. In 2022, Vivasure Medical received a strategic investment from Haemonetics, which included an option to acquire Vivasure Medical.
Earlier this year, Vivasure Medical announced the submission of a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its PerQseal® Elite vascular closure system for arterial procedures, building upon the successful results of the PATCH study as well as positive clinical use in Europe. The company previously received European CE mark approval for an expanded indication for PerQseal Elite, covering large-bore venous closure following its first CE mark approval for arterial procedures, positioning PerQseal Elite as the first fully bioresorbable, sutureless solution in Europe for both arterial and venous access closure.
“We’re extremely proud of the progress made in advancing closure technology, and grateful to the clinicians who supported Vivasure’s mission,” said Andrew Glass, CEO of Vivasure Medical. "Joining Haemonetics provides the global scale and resources to accelerate the availability of PerQseal Elite and bring its clinical benefits to more physicians and patients worldwide.”
Besides Haemonetics, Vivasure was also backed by Fountain Healthcare Partners, Orchestra BioMed Holdings Inc. (Nasdaq: OBIO), LSP Health Economics Fund managed by the EQT Life Sciences team, Panakès Partners, and Evonik Venture Capital. In addition, Vivasure Medical received support from Enterprise Ireland, Western Development Commission, and European Investment Bank.
“We want to thank the Vivasure employees and founders for their dedication and commitment. We also want to recognize the board, investors, and government bodies for their phenomenal support over the years,” said Ger Brett, Chief Operations Officer and Co-founder of Vivasure Medical. “We’re proud to make PerQseal in Ireland and distribute it around the world.”
The PerQseal® and PerQseal® Elite are not available for sale in the United States.
