Vivasure Medical has announced the closing of the first tranche of €22 million (US$23 million) as part of its Series D financing round that could reach up to €52 million (US$54 million) in total.
The company states that the financing, led by a multinational strategic corporation, includes an option to buy Vivasure 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 US 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, a press release details. These devices include PerQseal and PerQseal+ for arterial closure and PerQseal Blue for venous closure.
Vivasure’s 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.
According to Vivasure, the 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 aortic repair (TEVAR) and endovascular aneurysm repair (EVAR).
The company communicates that its 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 USA.
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. The company claims that, currently, there are no sutureless options available for vessel closure following large-bore venous procedures.
“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, section head and director of interventional cardiology and director of structural heart interventions at Montefiore Health System (New York, USA). “The novel PerQseal technology is designed to address these shortcomings and has tremendous potential to improve patient outcomes and enhance procedure efficiency.”
