Medical 21 Inc., the medical device startup founded by St. Jude Medical founder Manny Villafaña, is nearing its goal of raising $10 million, Villafaña said Tuesday. The firm hopes to use the cash to start human trials of its product, an artificial blood vessel, within the year, he said.
Medical 21 has raised about $8 million since it was founded in 2016, Villafaña said, including a recent infusion of about $3 million. All of the company's investment has come from private individuals thus far.
RELATED: Read Medical 21's Form D here.
The firm is currently testing its product in animals and aims to start human trials in the fourth quarter of 2021 or the first quarter of 2022. Around that time, it will also start exploring an initial public offering, Villafaña said. That IPO would be worth between $50 million and $100 million, he said.
Villafaña has experience taking medical device firms public. He's the founder of St. Jude Medical, Kips Bay Medical Inc. and Cardiac Pacemakers Inc., among others.
Medical 21's vessel is for 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. Medical 21's artificial blood vessel would remove the need for that part of the procedure entirely, Villafaña said. The vessel is made with cellulose technology licensed from the University of Iowa.
And the potential market is large. There are an estimated 2- to 3-million grafts a year, he said.
Medical 21 has seven employees and manufactures its vessels in Plymouth.
Villafaña has been trying to revolutionize CABG surgery for decades. His CABG Medical Inc., which also created artificial heart grafts, closed in 2006 after opening in 1999. And Kips Bay Medical Inc., which created a mesh device for use during CABG surgeries, closed in 2015.
