Funds will support clinical development and regulatory approval of fully absorbable percutaneous closure devices for large-bore vessels
Vivasure Medical ("Vivasure" or the "Company"), a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the closing of the first tranche of €22 million ($23M) as part of its Series D financing round that could reach up to €52 million ($54M) in total. Led by a multi-national strategic corporation, the financing includes an option to buy the Company upon certain milestones. Other participants in this Series D financing round include a second strategic corporate investor as well as existing investors, Fountain Healthcare Partners, Orchestra BioMed, LSP Health Economics Fund managed by the EQT Life Sciences team, Panakès Partners and Evonik Venture Capital.
The financing will support the U.S. and European clinical development and regulatory approval of the Company's portfolio of fully absorbable, patch-based large-bore percutaneous vessel closure devices for transcatheter endovascular and cardiovascular procedures, including PerQseal and PerQseal+ for arterial closure and PerQseal Blue for venous closure. Vivasure's innovative PerQseal technology consists of a proprietary bioabsorbable intravascular patch that seals the vessel from the inside, returning the artery or vein to its natural state without leaving behind the remains of any materials such as collagen, metal implants or sutures commonly used in other closure technologies.
Vivasure Medical's PerQseal device is the first sutureless and fully absorbable synthetic implant for large-bore arterial vessel punctures and is available to physicians in Europe for use in transcatheter endovascular procedures, including transcatheter aortic valve replacement (TAVR), thoracic endovascular aneurysm repair (TEVAR) and endovascular abdominal aneurysm repair (EVAR). The Company's next-generation PerQseal+ device has an enhanced bioabsorbable patch designed to address more complex patient anatomies and is currently under clinical evaluation in Europe and the U.S. Vivasure is also developing PerQseal Blue, designed exclusively for sutureless and fully absorbable large-bore venous vessel closure following percutaneous cardiovascular procedures, such as transcatheter mitral valve repair or replacement (TMVR), transcatheter tricuspid valve repair or replacement (TTVR) and leadless pacemaker implants. Currently, there are no sutureless options available for vessel closure following large-bore venous procedures.
"As minimally invasive approaches have become the standard of care for cardiovascular procedures, conventional vessel closure techniques have proven to prolong recovery and lead to bleeding complications for patients. This funding represents an important milestone for our company that will help to further advance our portfolio of novel PerQseal sutureless and fully absorbable vessel closure devices in the U.S. and Europe," said Andrew Glass, chief executive officer of Vivasure Medical. "We are encouraged by early clinical progress from leading heart centers participating in studies currently underway for PerQseal+ and PerQseal Blue, and we look forward to initiating a U.S. pivotal study for PerQseal+ later this year that will support our submission to the FDA."
"While tremendous progress has been made for minimally invasive structural heart procedures, vascular issues related to the closure of the procedure remain the most common complication of these interventions," said Azeem Latib, M.D., section head and director of interventional cardiology and director of structural heart interventions at Montefiore Health System. "The novel PerQseal technology is designed to address these shortcomings and has tremendous potential to improve patient outcomes and enhance procedure efficiency."
About Vivasure Medical
Based in Galway, Ireland, Vivasure is a medical device company developing 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 and is backed by leading international medtech investors. For more information, please visit www.vivasuremedical.com.
PerQseal, PerQseal+ and PerQseal Blue are not available for sale in the United States.
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