Dive Brief:

• Two French cardiovascular disease medtech companies have separately disclosed progress in their efforts to get devices to market. 

• Carmat revealed it is gearing up to start selling its artificial heart in the second quarter. The device, branded Aeson, is aimed at the more than 2,000 people waiting for heart transplants in major European countries.

• Separately, CorWave disclosed a $40 million financing round. The money will equip CorWave to take its left ventricular assist device (LVAD) into clinical trials.

Dive Insight:

The two French companies are targeting different populations of the heart failure market.

CorWave is developing a twist on the LVADs sold by companies including Abbott and Medtronic. The experimental device features a membrane designed to generate a pulse that mimics the blood flow and pressure characteristics of the patient’s own heart. 

CorWave has incorporated the membrane into its design to prevent complications associated with existing LVADs, which include bleeding, thrombosis and strokes. In the two years after implantation, 80% of patients suffer one or more adverse events. 

Venture capital firms Bpifrance, Novo Holdings, Seventure, Sofinnova Partners and Ysios Capital joined with a $4.4 billion fund set up by the European Commission to give CorWave the money to take its idea forward. CorWave will use the $40 million to finalize the design of its device, put it through nonclinical regulatory testing and start its first study in humans. 

For its part, Carmat is striving to sell a new option for patients who are ineligible for the implantable heart pumps. Carmat’s Aeson is a total artificial heart system designed for use in patients waiting for a heart transplant and not amenable to maximal medical therapy or the implantation of an LVAD.

Carmat received a CE mark for Aeson late last year, positioning it to start selling the device in Germany in the second quarter of 2021. The French medtech is addressing its home market through a clinical trial that will treat 52 patients to generate some of the data it expects to need to obtain reimbursement in France. 

The initial commercialization efforts will focus on establishing Aeson as a temporary solution for patients awaiting heart transplants but ultimately Carmat wants to serve the destination therapy market. Carmat has enough money to reach the third quarter of 2021, by when it expects to have begun the French trial and started selling Aeson in Germany, and “is considering different options to finance” its work beyond that point. 

While the two French medtech companies are developing devices with distinct designs, CorWave CEO Louis de Lillers sees similarities between the organizations beyond their shared home country.  

“Heart surgeons today will tell you that the devices need to imitate the natural functioning of the heart,” the CEO told the Financial Times. “That is what both CorWave and Carmat are trying to achieve in different ways by replicating the physiology of the heart.” 

As Carmat and, in particular, CorWave advance those efforts, they will encounter competition from major medical device companies. Abbott and Medtronic compete for the LVAD market and SynCardia sells an artificial heart.