The level of investment in Europe’s med-tech sector in 2025 did not materialize as many had hoped at the beginning of the year. Reciprocal tariffs introduced by the U.S. government created an uncertain macroeconomic environment, curtailing dealmaking and slowing financing activity. Nevertheless, amid uncertainty, there were some bright spots as medical devices remain essential, and investors know how to navigate market cycles.
Like waves crashing on the beach, med-tech IPOs keep on coming. Heartflow Inc. set terms for its IPO on Aug. 1, offering 12.5 million shares at a price range of $15 to $17 per share. At the top of the range, the company could raise a sunny $212.5 million. It plans to list on the Nasdaq with the symbol “HTFL.”
Bioprosthetic heart maker Carmat SA shares collapsed on June 23, reaching €0.28 on the Paris Stock Exchange after the company announced it would run out of cash by the end of the month without immediate financial support.
The U.S. FDA’s decision to grant breakthrough device designation for Bivacor Inc.’s titanium total artificial heart (TAH) sent real hearts aflutter at the Huntington, Calif.-based company’s headquarters. While the designation supports use of the TAH as a bridge to transplant for adults with biventricular or univentricular heart failure for whom current options are insufficient or unsuitable, Bivacor hopes its device will eventually serve as a long-term heart replacement.
Carmat SA recently reported a software update for its bioprosthetic total artificial heart Aeson device that will significantly improve its safety profile. In the past, the company had to suspend implantations of its device following issues around quality. With the enhancements, the Aeson software will be able to detect signals of malfunctions in real time and adapt the control of the prosthesis so that its performance is not affected.
“The FDA approval to begin the Bivacor Total Artificial Heart EFS is a critical milestone for Bivacor and is another validation of the remarkable work and accomplishments of the entire Bivacor team. This device will provide a unique approach to help patients currently with limited clinical options,” said William Cohn, heart surgeon at the Texas Heart Institute and Bivacor chief medical officer.
Carmat SA just completed a flash fundraising of $33 million to increase production of its Aeson total artificial heart and support sales growth in Europe. The operation featured two distinct but concurrent actions: a reserved offer and a public offer. The reserved offer, intended for specialist investors, raised $28.9 million.
Carmat SA just completed a funding exercise, raising nearly $44 million to resume production and implantation of its Aeson total artificial heart, designed for patients suffering from end-stage bi-ventricular heart failure. The capital raise was achieved by issuing 4.05 million new shares on the Paris Euronext exchange, at a fixed price of $10.81 a share.
PARIS – Carmat SA has just completed a capital increase of $66.4 million to boost development of its total artificial heart. The Aeson system was awarded CE marking four months ago, as a total bridge to transplantation for patients suffering with end-stage biventricular heart failure who are not eligible for maximal medical therapy or a left ventricular assist device (LVAD), and who are likely to undergo a heart transplant within 180 days of the implantation.
Carmat SA said its total artificial heart received the CE mark, and the company plans to ramp up production to enable the launch of the device in the second quarter of 2021. The artificial heart offers a bridge to transplant in patients with end-stage biventricular heart failure. It provides an alternative for individuals for whom maximal medical therapy and left ventricular assist device are insufficient or contraindicated.
