Manny Villafaña could have retired decades ago, but after pioneering the lithium-ion battery-powered pacemaker and reinventing the heart valve, the 81-year-old said his latest endeavor, Medical 21 Inc., is his most important yet.
The Plymouth-based company is engineering a mesh that encourages the body to build new blood vessels used in coronary artery bypass grafting (or CABG) surgery. In a CABG surgery, a blocked artery in the heart is bypassed by a vein or veins, which are usually taken from the patient's legs.
Late last month, Medical 21 opened a $40 million financing round through a Reg A+ offering. The Reg A+ was created through the JOBS Act in 2015 and allows companies to raise money from private investors without the tangle of regulations required for an initial public offering.
“This method allows a small company to have access to both accredited and nonaccredited investors,” Villafaña said. “So Joe the bartender can take part in what we have.”
Villafaña’s first seven companies, including St. Jude Medical Inc., Kips Bay Medical Inc. and Cardiac Pacemakers Inc., raised funds through an IPO. However, he said the challenge of going that route is that it requires a company to have positive revenue. That caveat can be difficult for medical-device startups that require years of research and clinical testing before becoming commercially viable.
Villafaña said he’s avoiding pitching the company to venture capital firms, which have deep enough pockets to fund multimillion-dollar rounds.
"In a typical venture capital route, you're going to have to change who's going to run the company and who's going to finance the company," he said. "If I could do it the way I've been doing it, I'm going to try that."
Medical 21 is the third time Villafaña has started a company attempting to improve CABG surgery. The current iteration is different, he said, because this implant, which acts as a scaffold, disappears and leaves behind cells grown by the patient.
CABG surgery is the most common form of heart surgery, with over 300,000 operations performed each year. Villafaña said Medical 21's technology will save hospitals and patients tens of thousands of dollars since patients won't require a lengthy rehabilitation.
Medical 21 has demonstrated this cellulose technology, licensed from the University of Iowa, in numerous animal trials. The company now plans to begin human trials later this year through a partnership with Rochester-based Mayo Clinic, Houston-based Texas Heart Institute and other sites.
In anticipation of the clinical trial, Medical 21 is preparing to open a second office and production facilityin Plymouth, which will increase its manufacturing capabilities by 400%.
