French startup Affluent Medical SA has launched a European pilot study in humans of its native-like transcatheter mitral valve technology. The Epygon valve is designed to restore the normal blood flow vortex in the left side of the heart and treat left ventricle disease, particularly in so-called functional patients.

Coinciding with the launch of the pilot, the company announced 10.3 million (US$11.6 million) in new financing and the addition of three new members on its board of directors.

According to the Aix-en-Provence company, the Epygon valves asymmetric, D-shaped and one-leaflet design allows it to restore the natural vortex, a rotational blood flow that is thought to be more efficient that a straight, steady flow. To our knowledge, no other mitral valve in development is a one-leaflet allowing the restore the physiological vortex, CEO Michel Finance told BioWorld.

The unique design is expected to result in high procedural success, restore left ventricular blood flow and avoid thrombus formation and left ventricular outflow tract (LVOT) obstruction, while also reducing left ventricular effort.

Finance called the pilot study a major milestone for the company.

Epygon is a world premiere and a potential best-in-class valve in a market where physiology has been overlooked for decades, he said. This pilot study aims to confirm the improved clinical outcomes already demonstrated in preclinical testing. It should open up a new era both for surgeons and patients, with physiology as a key factor in cardiac surgery.

CE mark pivotal study targeted for 2022

Affluent Medical estimates that as many as 4 million people in the U.S., Europe and Asia suffer from mitral valve regurgitation, due to the lack of optimal therapies. The global market is expected to reach $3.5 billion to $5 billion by the end of 2022, growing at an annual rate of 35%.

The prospective, nonrandomized, single-arm, multicenter MINERVA (Mitral valve INsufficiency with the Epygon TRanscatheter mitral VAlve system) study will enroll up to 20 patients in three centers in Austria, Italy and Spain. Affluent Medical plans to complete enrollment by the first quarter of 2021 and report the results after one year of follow-up.

We are anticipating our first human implant in the next weeks, Finance said.

If the pilot study is successful, the company plans to launch a pivotal trial to support CE marking of the Epygon valve in early 2022.

Finance said the company will be pursuing a similar approach for U.S. FDA approval, starting most probably in the next six to 12 months.

Capital injection

The 10.3 million private placement financing was led by Truffle Capital via the Truffle Biomedtech FCPI Fund and Truffle Innov FRR France. Other participants included Head Leader Ltd., Affluent Medicals partner for two ventures in Shanghai, Ginko Invest, Fate and Simone Merkle. The company has earmarked the funds to advance its cardiology clinical programs, particularly the MINERVA study, completion of its OPTIMISE II pivotal trial of Kalios, an adjustable mitral ring, as well as the start of a pilot/pivotal study of its Artus implantable urinary sphincter for urinary incontinence.

The OPTIMISE II trial got underway in December and is slated to complete enrollment of about 62 patients in four European countries this quarter. The goal is to demonstrate Kalios safety and effectiveness as a treatment for post-operative residual valve insufficiency. Primary outcomes from the trial are after 12-month follow-up early next year, with commercialization possibly in about two years, Finance said.

Additionally, Affluent Medical announced 5.5 million (US$6.2 million) in financing from two government-backed loans: 2.2 million from the banks Socit Gnrale and BNP Paribas to mitigate COVID-19s economic impact; 1 million by Bpifrance to support cardiology R&D; and 2.3 million in grants from Bifrance for the MINERVA study.

The new funding brings Affluent Medicals total capital raised to about 38 million since 2012.

In conjunction with the financing, the company named Jean-Franois Le Bigot, CEO of Oncovita and chairman of Ginko Invest, and Benot Adelus, president of Fate, as board members. Rounding out the board appointments was Finance, who was elected as chairman.

We are very pleased to welcome Jean-Franois Le Bigot and Benot Adelus to our board of directors, Finance said. Their expertise along with the 15.8 million in refinancing should allow Affluent Medical to make rapid progress on its clinical programs and its commitment to bring new-generation, minimally invasive medical devices to the market for the treatment of large unmet medical needs.

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Affluent Medical kicks off first-in-human trial of Epygon valve - BioWorld Online