Israeli company Cardiovalve, the spin-off of the cardiology company Valtech Cardio, is already standing on its own, and developing a device for minimally-invasive valve replacement. Valtech was acquired in 2017 by the American company Edwards Lifesciences, but its founders retained a new activity for further development. This activity turned into Cardiovalve, whose CEO is Amir Gross, one of the founders of Valtech.
One valve fits all
The heart has four valves, which can be damaged due to infectious disease, heart attack, aging, arteriosclerosis, and more. If left untreated, this can lead to heart failure and even death. Valve repair and/or replacement is one of the hottest fields in cardiology, and - because heart surgery is dangerous - the goal is to perform, as much as possible, minimally invasive procedures that do not require general anesthesia or large incisions.
Both Valtech and Cardiovalve have developed products for the treatment of the mitral valve: Valtech for valve repair and Cardiovalve for valve replacement. According to Gross, Cardiovalve 's product has a range of benefits. "We insert a catheter via a small incision in the groin, and if all goes as planned, it’s a half-hour to 45-minute procedure. Unlike the competition, our product comes in different sizes, suitable for about 95% of the population, and using the same delivery system, which saves the hospital on costs. The delivery system is similar to another system that most doctors are already used to using, the product has a short profile for minimal protrusion and the anchoring mechanism is robust, despite its small size."
According to Gross, the procedure does not require stopping the heart, and there is no need for a heart-lung machine. "We’ve learned that tools must be super-simple, and you should keep as many of the existing body structures as possible."
How did it happen that Edwards acquired Valtech but not the next generation product?
"From their point of view, it was in early development, and they preferred not to acquire it until further improvements and trials were made. However, they’ve invested in the company, along with all previous Valtech investors.
"I’m not here to compete with Edwards, who are really number one in valves, and also have innovative mitral products. But specifically, what we have now, they don’t have."
To date, about $40 million has been invested in the company. Most Cardiovalve investors were also Valtech investors: Peregrine Ventures, GlenRock, Pertec Management, OXO Capital Valve Ventures, NGN Capital and Edwards, as well as Gross himself, through the VVV fund which he controls.
The total market for minimally invasive mitral valve replacement is estimated by major medical device companies at about $3-3.5 billion.
Another product on the way
Since its inception, the company has treated 12 patients, of which two have reached the two-year mark required for follow-up. The results look promising. "One underwent major surgery due to another illness - after our product was implanted in him - and had no complications. The other patient, a wood-cutter, is now back to work. He was very weak when he came to us."
The company estimates that it will be able to begin trails for obtaining marketing approval in Europe later this year, and enter the market in about four years.
What additional investment is needed to bring the product to market?
"Several tens of millions of dollars to complete development and get the approvals. The intention is to sell the company before the sales stage, but if we have to go into sales, we’ll do it the way we did at Valtech."
In addition to the mitral valve replacement product, the company has developed another product, addressing a valve that currently has almost no replacement solution, the tricuspid valve. "The technological concept is very similar," Gross says. Patients have already been recruited for clinical trials, but due to the Covid-19 crisis, implantations have not yet been performed.
Cardiovalve
- Founded in 2017 by Valtech's founders, including Amir Gross, who serves as CEO
- The company develops cardiovascular replacement devices for minimally invasive surgery To date, about $40 million has been invested in the company
- The company operates from Or Yehuda and employs 40 people
Published by Globes, Israel business news - en.globes.co.il - on August 25, 2020 © Copyright of Globes Publisher Itonut (1983) Ltd. 2020