InnovHeart may not have grown three sizes in one day, but it’s gotten quite a boost from the recent close of its series C funding round.
The Milan-based company makes transcatheter mitral valve replacement (TMVR) systems designed to treat mitral regurgitation, a common heart condition in which the mitral valve between the left ventricle and the left atrium doesn’t close tightly, allowing blood to flow backward into the heart.
The new $55 million financing will help InnovHeart bring the transseptal version of its flagship Saturn TMVR system into clinical trials. In a transseptal approach, the device is placed in the heart using a catheter inserted into the femoral vein, in contrast to the transapical method, which sends the catheter through an incision in the chest.
The funding was led by China’s Grand Pharmaceutical Group, with additional participation from existing investors Indaco Venture Partners, Panakes Partners and Genextra. The last of these led InnovHeart’s previous funding a round, a €20 million ($22.3 million) series B that closed in August 2020 and that was meant to wrap up clinical trials of the transapical Saturn system and complete development of the transseptal version.
In leading the series C, Grand Pharma also signed an exclusive licensing agreement with InnovHeart. Under the terms of the agreement, the Hong Kong-based company will have the sole rights to developing, manufacturing and commercializing the Saturn TMVR system throughout China.
In total, the new financing brings in upward of $55 million for InnovHeart, comprising equity financing, upfront licensing fees, milestone payments and, once Grand Pharma begins selling the devices, royalties.
“Interventional treatment for mitral regurgitation is considered to be one of the most challenging areas in the field of structural heart disease, yet also represents huge market potential, estimated to reach $17.4 billion globally in future years,” said Keith Dawkins, M.D., chairman of the company’s board.
“This strategic agreement will provide InnovHeart with resources that will accelerate the development of the transseptal version of the Saturn system into first-in-human clinical trials, as well as access to the dynamic Chinese structural heart market,” Dawkins said.
Since the last funding round closed, InnovHeart has proven the transapical Saturn system’s success in treating mitral regurgitation, with “excellent results” in patients one year after being implanted with the device, according to Paolo Denti, M.D., a cardiac surgeon who has helped conduct the trials.
In study results shared in 2020, the first patient implanted with the transapical TMVR device demonstrated a similarly successful reaction to the system. One month after the procedure, the 72-year-old’s mitral valve showed no signs of regurgitation and no outflow tract obstruction. Additionally, the patient showed improvements in a six-minute walk test, dropped to a lower classification of heart failure and reported higher quality of life symptoms after the implant.