Last month V-Wave Ltd., a private medtech company based in Agoura Hills and Israel, secured up to $98 million in financing to take the startup all the way to U.S. Food and Drug Administration clearance for its heart shunt device expected in several years.In total, the company has raised $172 million between three rounds of financing, according to Dr. Neal Eigler, chief executive of V-Wave, for the development, data collection and FDA clearance of its primary product, the Ventura Interatrial Shunt.
“The financing is flexible, depending on our needs over the next several years. It has a lot to do with funding a company in an uncertain time, due to uncertainties related to COVID,” said Eigler, referring to clinical trial delays, securing space at hospitals, and persuading patients to go into said hospitals for data collection, as well as the negative effects of the virus on cardiovascular morbidity and mortality.He added that the shunt will appeal to two market segments.“One is for patients that have heart failure, sometimes called congestive heart failure. … The other indication is a much less common problem called pulmonary arterial hypertension. This tends occurs in a younger population, with a female predominance of about two or three to one over males. It’s a uniformly fatal disorder,” Eigler said.There are no interatrial shunts approved in the U.S., Eigler continued, making V-Wave’s product a completely new form of therapy for patients that that have either condition.The term “interatrial” refers to a flow between the right and left atria of the heart. Heart failure patients build up pressure in the left atria when this chamber of the heart doesn’t contract or fill properly; the condition “drives fluid into their lungs and then they can’t breathe,” said Eigler.Pulmonary arterial hypertension is just the opposite, Eigler added, with a malfunction in the right atria.“The technology they’re working on is very exciting, it’s a big market and there have been a lot of disappointments there,” said Ahmed Enany, chief executive of the Southern California Biomedical Council. “It costs the health care system a lot of money to deal with chronic heart failure, hypertension and all the problems that result from it.”“That’s what the investors are so excited about, with the positive results coming out of the trials,” continued Enany.V-Wave’s shunt is for the patients who aren’t doing well on existing drugs and devices, who still have symptoms and are in and out of the hospital with acute episodes of worsening heart failure, Eigler noted.Room to growConceptualization and development for the Ventura shunt started in Israel, with a team of engineers and medical scientists.V-Wave chose the 101 corridor in the Conejo Valley as a headquarters for its deep talent pool in the biotech space, with medical device companies including Medtronic, with its diabetes division in Northridge; St. Jude Medical Center in Fullerton; Valencia’s Boston Scientific Corp.; and Edwards Lifesciences in Irvine having a presence here, Eigler said.“We really had the wonderful opportunity to pull people into this company that had worked in small and large medtech firms that have been successful,” he added. “Our core senior management people have been around the block, been in this business for decades and have networked, built good reputations. People are willing to join a startup venture when they think it has a good chance of being successful.”The same logic goes for investors, who look at an early-stage biotech startup in terms of its people and their track records.Eigler, for one, was an interventional cardiologist at Cedars-Sinai for more than two decades. He ran the cardiac catheterization lab there and published multiple academic works, teaching interventional cardiologist techniques in other countries and meeting “the best and the brightest.”Fellow interventional cardiologist and entrepreneur Dr. Frank Litvack, board chairman for V-Wave, co-founded half a dozen medical device startups in the state over the last several decades, including Savacor, a left atrial pressure monitoring company acquired by St. Jude’s in 2005, and Conor MedSystems, a drug-eluting stent technology bought by Johnson & Johnson in 2004.Currently, R&D and manufacturing for V-Wave are carried out in Israel, while the majority of clinical operations, regulatory and general business operations are conducted in Agoura Hills.Eigler, who actually grew up in the Valley and was living in Malibu when brought on as V-Wave’s chief executive more than five years ago, expects senior management will reside in the U.S. moving forward.He also anticipates the company needing another manufacturing facility outside of Israel, but declined to mention a possible location.As for V-Wave’s exit strategy, Eigler said, “an IPO, an M&A or other structures are possible.”“Based on what we know about this market segment, they are positioning the company for acquisition,” added Enany. “You bring the company up to a certain level of development and then sell it to a company like Boston Scientific or St. Jude, Medtronic.”This is especially true for a smaller company that got its start in another country, Enany said. Foreign companies end up establishing a presence in the U.S. to do clinical trials here and become more visible to the biotech industry, raise more capital and become a potential acquisition candidate.“That is kind of the playbook for a lot of the smaller companies,” explained Enany.Officially, Eigler said the company is more focused on trials and further development at the moment: “First, let’s build it and make it successful, and let’s see down the road what is the best type of exit.”
Cardiac Shunt Valued at $98M
