Participated · Series D · Mar 2023

Vivasure Medical develops advanced polymer implants and delivery systems for minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Its lead product, PerQseal, is designed to be the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures, with a low-profile patch that can be placed from inside the vessel. Clinical studies to date have shown a low complication rate and high technical success. The company operates a fully integrated R&D and ISO 13485 certified manufacturing facility. Vivasure intends to use clinical study results to support an FDA pre-market approval submission and a multinational commercial launch of the PerQseal system. The company is led by CEO Andrew Glass and is backed by a syndicate of international medtech investors and public supporters. Vivasure Medical develops fully absorbable, patch-based large-bore percutaneous vessel closure devices for transcatheter endovascular and cardiovascular procedures. Its PerQseal technology is a proprietary bioabsorbable intravascular patch that seals the vessel from the inside and restores the artery or vein without leaving collagen, metal implants, or sutures. PerQseal is the first sutureless, fully absorbable synthetic implant for large-bore arterial punctures and is available in Europe for TAVR, TEVAR and EVAR. The next-generation PerQseal+ is under clinical evaluation in Europe and the U.S. to address more complex anatomies. Vivasure is also developing PerQseal Blue for large-bore venous closure, where no sutureless options currently exist. The company operates an integrated R&D and ISO 13485 certified manufacturing facility in Galway, Ireland and is backed by international medtech investors. Vivasure has closed the first tranche of €22 million (~$23M) of a Series D that could reach €52 million (~$54M); the financing will support U.S. and European clinical development, regulatory approvals and a planned U.S. pivotal study for PerQseal+. Vivasure Medical has developed the PerQseal platform and its first product, the Vivasure Closure Device, a fully bioabsorbable, sutureless and entirely synthetic implant and delivery system to close large‑bore arteriotomies. The device is CE marked (received January 2016) and has been evaluated in clinical studies across four European countries, demonstrating 97% device technical success with no major device‑related complications and follow‑up to 12 months. It is intended for use after percutaneous transcatheter procedures including TAVR and EVAR and offers a percutaneous alternative to surgical cut‑down. The company is based in Galway, Ireland. Vivasure plans to use the new financing to support commercialization in the European Union and to execute an FDA regulatory study to pursue United States approval. The global market for large arteriotomy closure devices is projected to exceed $500 million by 2021.