Innovalve

Innovalve is developing a safer, more effective solution to heart valve replacement surgery.

This solution has been praised as the “holy grail” of Interventional Cardiology, and has the potential to impact the lives of 4 million Americans.

In September 2018, Innovalve raised $7 million in a Series A round. Now it’s raising up to $8 million — OurCrowd is joining the round with up to $1.6 million — in a Series A-1.

(Please note: This particular startup is raising funds from “accredited” investors only. An accredited investor is someone with a net worth of at least $1 million, or annual income of at least $200,000, or $300,000 with their spouse.)

Innovalve’s solution targets patients suffering from what’s called mitral regurgitation, or “MR,” for short. MR is the leakage of blood backwards through the heart’s mitral valve. This leakage can increase blood volume and pressure in the area, which can result in congestion or fluid build-up in the lungs and lead to heart failure.

The two most common forms of treatment for MR are valve repair (which preserves the patient’s native valve) and valve replacement (which involves inserting a mechanical valve or one made from animal tissue).

Replacement is generally considered the better option for improved longer-term valve function. The problem is that the only means of replacing a mitral valve is highly-invasive open heart surgery.

More than 4 million people in the U.S. are potential candidates for treatment, but only 2% undergo surgery due to the risks involved.

These patients need a way to receive a replacement mitral valve via a minimally-invasive catheter. This is how cardiologists use stents to open clogged heart arteries.

Innovalve believes its solution will enable a simple, fast, safe catheter-based mitral valve replacement procedure.

Notably, replacement of the heart’s aortic valve via catheter has grown into a multi-billion-dollar market, projected to reach $13 billion by 2025.

Mitral valve replacement, in contrast, is a much larger market, but poses a greater technical challenge. According to Innovalve, there is currently no catheter-based mitral valve replacement device that’s received regulatory approval to be put on the market.

Also notably, a handful of startups that began developing transcatheter solutions were acquired for large sums, for example:

• In 2015, Medtronic (NYSE: MDT) acquired Twelve for $408 million.

• Edwards Lifesciences (NYSE: EW) acquired CardiAQ for $350 million.

• And Abbott (NYSE: ABT) acquired Tendyne for $225 million.

Despite these deals, none of these companies followed through with a solution. As a result, big medical companies like Abbott, Medtronic, and Boston Scientific are still searching for solutions.

If Innovalve is successful in its development and first-in-human clinical cases — slated for Q4 2020 — the company believes it could be seen as a viable acquisition target.

Innovalve’s solution differs from the competition in two ways:

First, rather than trying to “plug” its device into different mitral valves, which can have different shapes and sizes, Innovalve uses the valve’s native tissue to fuse to its prosthetic device.

Second, instead of an invasive procedure that requires open heart surgery — opening the chest, placing the patient on a heart bypass machine, and actually stopping the beating heart — Innovalve’s solution enables mitral valve replacement via a catheter placed onto a beating heart.

The system is comprised of two elements:

The Valve — This prosthetic device is implanted in the heart and serves as the new mitral valve for the patient.

The Transseptal Delivery System — This multi-catheter system allows the valve to reach the heart without opening the chest.

Innovalve’s underlying technology is patented in the U.S., China, Japan, and Australia. Patents are pending for this technology in Europe and Canada.

Sheba Medical Center, where company founders Ehud Raanani and Dr. Boris Orlov serve as senior cardiac surgeons, owns the original patents for Innovalve’s technology. This gives the company an exclusive license for those patent rights. The company has also developed additional IP and patent applications which it owns.

Innovalve is nearing completion of development of the prosthetic mitral valve that will be tested in human clinical studies. Meanwhile, the company is developing its proprietary catheter system that will deliver and implant the valve.

Once these pieces are completed, Innovalve will begin the testing required by regulatory authorities in order to receive approval to conduct human clinical studies. From there, the company will make further device improvements, complete additional human feasibility studies, and aim to bring its product to market.

With funds raised, Innovalve will have enough capital to conduct business through 2021, and use some of this money to begin its first-in-human clinical testing prior to the end of 2020.

Team Background

Robert Bash - CEO

Robert has extensive experience in strategic planning for medical device companies, focusing on taking them from product development to commercialization.

Prior to starting Innovalve, he spent 12 years as a strategic consultant in the medical device industry.

Before that, he was CEO of Nephera Ltd., an Israel-based company creating medical devices, specifically ones to treat patients with congestive heart failure. In addition, he was CEO of FlowSense Medical, another medical device company.

Robert began his career as a manager and partner with Infinity Venture Capital, a VC fund, where he was responsible for financial organization and portfolio management.

He earned a Bachelor’s degree from the University of Pennsylvania, and Law degrees from Georgetown University and NYU.

Ehud Raanani - Co-Founder

Ehud is a specialist in the field of cardiothoracic surgery.

He graduated from the Sackler School of Medicine at Tel Aviv University and completed a clinical fellowship in cardiac surgery at the University of Toronto. There he specialized in surgical repair of aneurysms and heart valves.

In addition to his role with Innovalve, Ehud is a professor of surgery at the Sackler Faculty of Medicine. He is also Director of the Department of Cardiac Surgery at Sheba Medical Center.

He has published more than 150 papers in peer-reviewed journals for cardiac surgery and cardiology, and is a member of the American Association for Thoracic Surgery and Society of Heart Valve Diseases.

Nadav Agian - Chief Operating Officer

Before joining the team at Innovalve, Nadav gained experience working for several biomedical companies.

He spent six years as Head of Product Development for Microtech, three years as Engineering and Product Development Manager for NanoPass, and a year as R&D Manager for NiliMedix.

He earned a Bachelor’s degree in Mechanical Engineering from Ben Gurion University and an MBA from Ruppin College.

Dr. Boris Orlov - Co-Founder

Like co-founder Ehud Raanani, Boris is a cardiac surgeon at Sheba Medical Center, where he also serves as Director of Mitral Valve Surgery Service.

Throughout his career, he has been awarded more than 40 patents for his inventions.

Co-Investors