Polares Medical SA raised $50 million in a series C financing round for Mrace, its posterior leaflet replacement system designed to treat mitral regurgitation.

Highlife SAS secured CE mark for its transcatheter mitral valve replacement (TMVR) system, bringing a much needed treatment option for patients with limited alternatives. The Highlife TMVR system is indicated for individuals with symptomatic moderate-severe or severe mitral valve regurgitation who are unsuitable for surgical repair or replacement and transcatheter edge-to-edge repair.

Although there is a clear clinical need for transcatheter mitral valve replacement technologies, a number of challenges must be overcome before they can safely be used to treat patients with mitral regurgitation. Nevertheless, two new devices could enter the European market next year, Edwards Lifesciences Corp.’s Sapien M3 and Highlife Medical SAS’s Highlife TMVR device.

Cardiomech AS raised $13 million in fresh capital via a convertible loan agreement that will go towards developing its transcatheter mitral valve chordal repair technology. The round was heavily oversubscribed, indicating investors' expectations that the company’s technology may be a first-line therapy for patients suffering from degenerative mitral regurgitation.

Affluent Medical SA reported initial success from the first minimally invasive transcatheter implantation of its biomimetic Epygon heart valve. This was placed in a 62-year-old female suffering from a severe form of mitral regurgitation, considered untreatable via traditional heart surgery due to multiple risk factors. This first-in-human trial was performed at the Molinette Hospital, part of the City of Turin University Hospitals of Health and Science.

Affluent Medical SA reported the imminent raising of nearly $14 million to fund development throughout 2023 of its implantable medical devices for treating urinary incontinence and heart valve pathology. Affluent, quoted on the Paris Euronext stock exchange since 2021, issued new shares accompanied by redeemable share warrants with shareholder preferential subscription rights being preserved.

One of the biggest stories coming out of Transcatheter Cardiovascular Therapeutics’ annual meeting in Boston this weekend focuses on the success of Edwards Lifesciences Corp.’s freshly FDA-approved Pascal Precision transcatheter valve repair system in the CLASP IID trial, which compared it to Abbott Laboratories’ Mitraclip device in patients with degenerative mitral regurgitation (DMR) who were determined to be at prohibitive surgical risk.

Venus Medtech (Hangzhou) Inc. reported it has acquired 100% equity interest and corresponding equity in Cardiovalve Ltd. for $300 million. Or Yehuda, Israel-based Cardiovalve produces the Cardiovalve system, a transcatheter interventional replacement product for mitral or tricuspid regurgitation.

NATIONAL HARBOR, Md. – Cardiovalve Ltd., of Or Yehuda, Israel, scored a double hit with the U.S. FDA, winning a breakthrough device designation for its transcatheter tricuspid valve replacement system, as well as approval to conduct an early feasibility study in tricuspid regurgitation (TR).