Affluent Medical plans to engage with the US Food and Drug Administration (FDA) regarding the clearance of its mitral valve repair device, Kalios.
The French company will base its application on the positive one-year data from the OPTIMISE II trial (NCT03908983). The trial enrolled 13 primary (degenerative) and seven secondary (functional) mitral regurgitation patients.
At the one-year mark, none of the patients showed severe mitral regurgitation (Grade III or IV). Additionally, there were no reported deaths, myocardial infarction, valve thrombosis or endocarditis during this period.
Affluent has paused its European trial of the Kalios device to direct its resources to penetrate the US market as the latter offers more commercial benefits. GlobalData’s market model forecasts that more than 39,000 patients in the US will require mitral valve repairs in 2030 and the average price for these devices would be $29,000 during that period.
This is a significant market that is currently dominated by Abbott, with the company occupying 99% of the market share in the transcatheter mitral valve repair (TMVR) market. Even with Abbott having a monopoly in the market, GlobalData forecasts the new market entrants to prosper due to high patient demand in the sector.
Affluent pipeline updates
The company has received clearance to proceed with a trial for its biomimetic mitral heart valve, Epygon, from the Data Safety and Monitoring Board (DSMB). The clearance was granted following the successful implantation of the Epygon valve in a patient with a severe mitral valve insufficiency profile combined with several comorbidity factors, as part of the pilot study.
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It has added another trial site in Seville, Spain, and expects to implant up to ten valves in the pilot phase. Affluent has also developed two new valve sizes (sizes 40 and 42) for Epygon valves.
Affluent plans to start trials for its remote-controlled artificial sphincter, Artus, for treating moderate to severe urinary incontinence by the end of 2023. The company plans to recruit 70 patients for the pilot and pivotal phases of the trial across multiple centres in Europe.
Affluent expects its cash runway to last until February 2024. The company raised €13.7m ($14.5m) through the issuance of shares with redeemable share subscription warrants (BSAR) in March.