Irvine-based medical device maker Hancock Jaffe Laboratories Inc., which went public in 2018, has a new name and a new ticker, a rebranding that the company’s CEO says will closer tie it to its work treating venous disease.
The clinical stage company, which last week counted a market valuation approaching $105 million, is now known as enVVeno Medical Corp. and its new ticker symbol is NVNO.
Its shares trade on the Nasdaq Stock Market.
The company was known as Hancock Jaffe since its incorporation in 1987. The device maker, whose founders count ties to OC’s largest public company, Edwards Lifesciences (NYSE: EW), develops bioprosthetics, or products made from pig (porcine) tissue, to treat severe venous disease in the legs.
Edward’s primary heart-valve products are also porcine-based.
The lead product of enVVeno, the VenoValve, is an implant being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI), a condition that occurs when valves inside of the leg become damaged, resulting in the backwards flow of blood and blood pooling in the leg.
The condition affects approximately 2.4 million people in the U.S., all of whom could be candidates for the VenoValve, company officials say.
“People don’t understand that there are valves in the legs that carry blood up to the heart,” Chief Executive Robert Berman told the Business Journal. “The challenge we face is the lay public isn’t familiar with the condition, although everybody knows a family member whose leg swells up and turns funny colors.”
Restarts, Edwards Ties
Berman joined the company in 2018, for the purpose of bringing it public.
Prior to that, “it was really a small company run by scientists and so I pretty much remade the company over the past three years from top to bottom; new directors, new employees and changed the culture of the company,” he said. “I tend to call these restarts,” Berman said of the organizational changes.
Directors at the company include Dr. Francis Duhay, the former chief medical officer at Edwards, and Dr. Sanjay Shrivastava, previously the principal research and development engineer for transcatheter heart valves at Edwards.
In terms of the new name and rebranding, “this is the third restart I’ve been involved with.”
The latest restart means that the company is going “all in on the VenoValve and the treatment of venous disease,” Berman said at the time of the rebranding.
That refocus means that the company is shelving a bovine-based product called the CoreoGraft that was in its pipeline.
The company said it “has elected to not pursue further development of the CoreoGraft device as a treatment for patients undergoing cardiac bypass surgery, as it falls outside of the Company’s new strategic focus.”
Focusing on devices treating issues pertaining to the veins has served another Irvine-based firm well.
Inari Medical Inc. (Nasdaq: NARI), which makes products that treat blood clots in veins, went public last year at a price of $19 a share. Its stock is now trading around $86, giving it a market valuation topping $4 billion.
Hancock Jaffe’s 2018 IPO was a modest one, raising less than $10 million; it has raised more in subsequent offerings.
The company’s shares were priced around $5 in the IPO and now trade close to $10.
The VenoValve
The VenoValve is currently being evaluated in the Surgical Anti-Reflux Venous Valve Enroprosthesis (SAVVE) pivotal study; 75 CVI patients are enrolled across 20 sites throughout the U.S., with the closest site to Orange County being Cedars-Sinai Hospital in Los Angeles.
In December 2020, enVVeno completed its first in-human feasibility study, during which the VenoValve was implanted into 11 “highly disabled” CVI patients.
It went “extremely well,” according to Berman, adding 10 of the 11 patients went from having severe CVI to having a more mild case of the disease, or no disease at all.
“Doctors have been trying to treat this disease for up to 60 years,” he added. “I think we’ve come up with the right combination of elements that show enough promise – certainly enough promise to facilitate a pivotal trial in the US.”
In August, the VenoValve was also granted Breakthrough Device Designation by the FDA.
The company cannot take the VenoValve to market until the SAVVE study data comes back in late 2022, Bergman said.
Development of a second enVVeno device for the treatment of venous disease is underway, according to the company. Dubbed enVVe, it is expected to be unveiled in mid-2022.
An Overlooked Market
According to Berman, arterial disease has been in focus over the last 30 years, while venous diseases “always took a back seat,” a comment often echoed by execs at Irvine’s Inari.
“We believe that venous disease has as much potential as arterial diseases did decades ago, to become a huge growth market,” he said, adding that enVVeno’s abandoned the development of all other products to focus squarely on the VenoValve.
“We’re so enthusiastic about the VenoValve and the possibility of helping so many patients who currently have no other effective treatments, that we are focusing 100% of our resources on this device.”
Currently, the current standard of care for CVI patients is elevating the leg or tightly binding it with compression stockings.
“It doesn’t happen that often where a company has the chance to change the paradigm of how a disease is treated,” Bergman said. “We’re talking a disease that affects 2.4 million people—it’s a truly unique opportunity.”
