Medical device maker CVRx will announce Tuesday that it has raised $93 million in venture capital, the largest Minnesota haul this year.
The investment was led by Johnson & Johnson Innovation, which also invested in a 2008 round. The fresh funds should enable CVRx to complete its final clinical tests of its Barostim Neo implant for U.S. regulators and proceed to U.S.-market commercialization. The product already is sold in Europe.
"It's been quite a ride," said CEO Nadim Yared, who joined the Brooklyn Park company of nearly 80 employees a decade ago from Medtronic, where he was a surgical-products executive.
"We've been on an upswing since 2011," Yared said. "Before that, it was about the technology development and proving to ourselves, regulators and physicians that it is safe and sustainable. Since then, we produced the second-generation embodiment of our device. It's simple and less invasive."
The CVRx Barostim Neo uses the company's patented technology to trigger the body's own natural blood flow regulation system to treat patients suffering from chronic heart failure by activating the body's natural mechanism to regulate cardiovascular function. Millions of Americans take pills to control high blood pressure and heart maladies. Medical device companies are vying to bring an electronic, drug-free alternative.
The American Heart Association estimates that more than 5 million adults in the United States and more than 23 million globally experience heart failure annually, which includes shortness of breath, fluid retention and an inability to exercise, and may lead to death.
Yared, 48, said the company already is enrolling patients who suffer from heart failure in this third and last U.S. study. The study is known as a "pivotal trial" that was designed with the U.S. Food and Drug Administration (FDA). Yared said CVRx is benefiting from a quicker approval process in cooperation with the FDA, under new guidelines that resulted from FDA listening to industry concerns about the length and expense of U.S. trials for new products and therapies.
Yared also is chairman-elect of Advanced Medical Technology Association — it's a rarity for a small-company CEO to run the influential industry group.
All told, CVRx, which is owned mostly by venture capitalists, raised $113 million in its most recent round of capital raising, including $20 million in debt. In 2008, the company raised $84 million, including funds from J & J, which is the single-largest albeit a minority shareholder in CVRx.
Venture capital raising appears headed for another strong year both nationally and in Minnesota.
Venture capitalists during the first six months of 2016 invested $172.7 million in seven Minnesota companies, according to the MoneyTree Report from PricewaterhouseCoopers and the National Venture Capital Association, based on data provided by Thomson Reuters.