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Monday, May 23, 2022

Heart Shunt Channels $98 Million Investment

 Private medical device company V-Wave Ltd., based in Agoura Hills and Israel, managed to make a big impression with investors despite the pandemic that curtailed venture capital funding not related to COVID.V-Wave secured up to $98 million in financing for its Series C round announced Sept. 23, a pot of money that should take the company all the way to U.S. Food and Drug Administration clearance for its flagship product — the Ventura Interatrial Shunt.The heart shunt is set to appear in two market segments within a matter of years, according to Dr. Neal Eigler, chief executive of V-Wave. In an October interview with the Business Journal, Eigler said the shunt will help patients with heart failure and pulmonary arterial hypertension.There are no interatrial shunts approved in the U.S., Eigler said, making V-Wave’s product a completely new form of therapy for patients who 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 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.Financing was led by Deerfield Management. Other investors included Aperture Venture Partners; BRM Group; Endeavour Vision; Johnson & Johnson Innovation – JJDC Inc.; Pontifax; Pura Vida Investments; GHS Fund, or Quark Venture LP; Triventures and the Israel Secondary Fund.In total, the company has raised $172 million between its three rounds of funding.“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.Flexibility and a sizable sum came because of the firm’s talent pool, promising clinical data and demand in the market, Eigler said.Positioned for acquisitionEigler 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.Litvack indicated market demand for an improved shunt in a statement from September: “There is a huge unmet clinical and economic need for simple, cost effective new therapies. Advanced heart failure has a prognosis worse than many cancers and is one of the leading drivers of hospital expenditures both domestically and abroad.”According to Ahmed Enany, chief executive of the Southern California Biomedical Council, there have been “a lot of disappointments” when it comes to cardiovascular disease treatments.“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,” Enany said in an October interview.Litvack said that there are more than 26 million patients suffering from congestive heart failure in the world — more than 6 million in the U.S.The company’s interatrial shunt received the FDA’s “breakthrough designation” for both market segments last year. This program helps speed up development, assessment and review of a device, according to the FDA’s website.“Breakthrough status will facilitate a timely regulatory review and solve a major issue with medical device investments, namely that reimbursement will effectively be secured immediately upon approval,” Dr. Andrew ElBardissi, partner on the medical devices team at Deerfield Management, said in a statement. ElBardissi is also on V-Wave’s board of directors.The Ventura Interatrial Shunt is currently under evaluation on an international level, thanks to a randomized trial called RELIEVE-HF, which started taking patients in October 2018. Clinical research involves 500 patients across 75 different heart hospitals, reports said.Enany expects V-Wave to be bought by a giant in the medtech industry, a company like Medtronic, which has a presence in Northridge.

“Based on what we know about this market segment, they are positioning the company for acquisition,” added Enany. “That is kind of the playbook for a lot of the smaller companies, particularly for those coming from somewhere else.”V-Wave was founded in Israel, and established its roots in Agoura Hills more than five years ago.

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