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.
Edwards Lifesciences Corp. set analysts a-spin ahead of its investor day activities with the revelation it plans to launch its critical care unit as a stand-alone public company next year. Edwards expects that dividing the business will allow it to focus on cardiovascular and surgical markets.
One-year results from the CLASP IID trial and registry showed outstanding results in patients with significant symptomatic degenerative mitral regurgitation (DMR) for Pascal, Edwards Lifesciences Corp.’s transcatheter-edge-to-edge repair (TEER) system, in a presentation at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) meeting in San Francisco hosted by the Cardiovascular Research Foundation.
The U.S. Securities and Exchange Commission (SEC) has issued the final order concluding an action against Baxter International Inc. over the company’s use of accounting mechanisms to produce gains by manipulating foreign exchange transactions. While these activities are said to have been undertaken entirely at the behest of only two employees, the agreement will cost Baxter $18 million and serves as a cautionary tale about a lack of supervision of employees charged with managing company funds.
The $31.4 million investment Capstan Medical Inc. recently received in its Series B funding round will allow the company to make headway in its efforts to use a catheter-based, robotic delivery platform to treat patients with mitral and tricuspid valve disease. With heart disease a leading cause of death globally and cardiac procedures remaining highly invasive and filled with complications, Capstan is working to provide patients with safer, less invasive alternative.
Among the many companies presenting data at the EuroPCR conference in Paris, several late breaking trials from heavy hitters Medtronic plc, Royal Phillips NV and Edwards Lifesciences Corp. stood out.
Device durability for transcatheter aortic valve replacement (TAVR) devices remains topical for patients, payers and regulators, but the standard measure of 10-year data were difficult to obtain for the first decade after the FDA first approved a TAVR device in 2011.
The patent wars over the design of transcatheter aortic valve replacement (TAVR) devices seemed to disappear roughly nine years ago, but there is at least one more episode for Dublin-based Medtronic plc before the company could lay the issue to rest. A jury declared that Medtronic is liable for more than $100 million in damages over alleged infringement of a patent held by Broomfield, Colo.-based Colibri Heart Valve LLC, but the contested patent has expired, and Medtronic said it intends to pursue the matter further.
Truleaf Medical Ltd., a subsidiary of Israel-based Allmed Solutions, is ready to begin human trials of its Rosedoc platform to replace the heart’s leaky mitral valve using cardiac catheterization.
Structural heart startup Nyra Medical Inc. scooped up $20 million in a series A round co-led by Vensana Capital and a large, unnamed global medical device company. The funds will be used to advance Nyra’s transcatheter heart valve repair technology through early feasibility clinical studies.
