Innoventric secures $28.5 million for unique catheter valve development

Innoventric, a startup based in the Science Park in Rehovot that develops a novel catheter tricuspid valve, has announced a Series B funding round of $28.5 million led by American venture capital firm RA Capital. Additional investors participating in this round include the European Investment Committee (EIC), BRM Group, JG Private Equity, and Mivtach Shamir. The raised capital will be invested in completing an Early Feasibility Study (EFS) currently underway in the U.S., obtaining approval for a pivotal trial in the U.S. and Europe, and initiating that trial.

Since its founding, Innoventric has raised a total of $41 million, with other investors in the company including Agate JT Healthcare Fund and Prof. Benad Goldwasser. Additionally, the company has received grants from the Innovation Authority and the Horizon Europe program.

Founded in 2017 by Amir Danino, a leading founder and the inventor of the technology, along with Rafi Benari, a co-founder and entrepreneur who has established several medical device companies, including Ventor Technologies (acquired by Medtronic in 2009), Endospan, and Revamp, and Dr. David Planer, a co-founder and head of the catheterization unit at Hadassah, the company employs 23 staff members, most of whom are based in Israel.

Innoventric aims to address a severe medical issue affecting 5 million patients in the U.S. and Europe: tricuspid valve regurgitation (the tricuspid valve is located between the right atrium and the right ventricle of the heart). This condition significantly reduces quality of life and leads to increased mortality among those affected.

Over the past 20 years, dozens of companies have attempted to develop a product for replacing a leaking tricuspid valve via catheterization. However, to date, only one valve has successfully passed clinical trials and received marketing approval in the U.S. and Europe, highlighting the primary challenge in developing catheter-based tricuspid valves: stabilizing the prosthetic valve in a way that ensures a seal in a beating heart.

Innoventric takes a unique approach: the valve it is developing is not placed on the natural tricuspid valve, which complicates catheterizations, but instead replaces the function of the natural valve with a valve installed in a different location. This method achieves the necessary total sealing that prevents leakage from the valve. As a result, a large patient population can receive swift and effective treatment without the need for general anesthesia.

The simple implantation procedure, as observed in dozens of patients who received the Innoventric valve (in Europe, Canada, the U.S., and Israel), takes only a few minutes and does not require general anesthesia. Furthermore, as it is not implanted on the natural tricuspid valve, Innoventric's product allows treatment for patients deemed unsuitable for any other treatment option due to large tricuspid anatomy or prior unsuccessful tricuspid treatments. Until now, these patients have had no options for treatment.

The catheter-based valve replacement market is estimated at approximately $10 billion annually and has demonstrated double-digit growth rates over the past decade. Currently, there are many companies operating in the field (the vast majority in development and clinical trial stages), including major medical device giants such as Medtronic, Edwards Lifesciences, Boston Scientific, Abbott Cardiovascular, and many startups.

Amir Danino, CEO of Innoventric, stated, "We are very pleased with the trust expressed by all the investors in this round, and we are excited to work with leading investment groups from Israel, Europe, and the U.S., whether they are from previous rounds who continue to demonstrate their faith in our technology and team or from the European Investment Committee or the leading venture capital firm RA Capital that led this current funding round."

Danino continued, "So far, we have successfully completed the first clinical trial in Europe, implanted the product in over 40 patients, received FDA approval for a feasibility trial in the U.S., and begun recruiting patients for this trial. As we advance and expand into additional territories, we see a growing market need for the solution we have developed. The funding raised will enable us to make significant progress toward marketing approvals in Europe and the U.S., and we look forward to collaborating with RA Capital and the European Union to shape the clinical and regulatory pathway that will lead us to penetrate these markets."

Anurag Kondapalli, a manager at RA Capital, which led the fundraising round, said, "We are excited to support Innoventric, which is changing the approach to TR treatments. The excellent results the company achieved in their first European trial in humans demonstrate the tremendous potential of the valve they have developed to treat a wide range of patients previously deemed unsuitable for repair or replacement of their valves. We were very impressed with Innoventric's technology and management, and we believe their solution has the potential to significantly improve and reshape the future of TR treatment."