UM Growth Capital News: Nervive Inc. Taps Midwest Resources to Advance Its VitalFlow Stimulator to Clinical Trials

Dr. Mark Borsody, the chief medical officer at Nervive Inc. in Akron, Ohio, is reaching back to his Midwestern roots to advance his company’s development of the VitalFlow stimulator, a safe noninvasive medical device he invented for the emergency treatment of stroke.

“The Midwest has a number of advantages,” says Borsody, who grew up in Middleburg Heights, Ohio, southwest of Cleveland and earned his medical degree at Ohio State University College of Medicine. “The cost of doing business is much lower than on the coasts, and it’s a place where people know how to make things, and make them well. We have found an ideal product design and development firm for the VitalFlow, and some of our management team is based in the region. The Midwest also has a number of hospitals with great experience in the treatment of stroke. It is a good center for distribution, as well. The only thing lacking is larger venture investors, but I hope those will develop in time.”

From 1999 to 2006, Borsody conducted neurosurgery research at the University of Chicago, completed his neurology residency at Northwestern Memorial Hospital and pursued a clinical fellowship in stroke neurology at the Detroit Medical Center/Wayne State University. He also served as medical director for major pharmaceutical stroke programs at AstraZeneca, Lundbeck and Genentech. In 2010, he launched his current company, originally called Lake Biosciences LLC, and funded it with $2.8 million in grants and founder’s investment.

Borsody presented at the 2013 Michigan Growth Capital Symposium in an effort to raise additional investment capital to augment an initial bridge investment of $250,000 from Akron BioInvestments Fund. “Regional investors who attended our MGCS presentation liked what they heard,” he reports. “We are now in talks with several Midwest venture-investment firms that have expressed initial interest in participating in Series A funding.” An additional tranche of venture-backed funding would allow Nervive to advance its work on the development of a clinical prototype of the VitalFlow stimulator, which increases blood flow to the brain by stimulating the facial nerve with electromagnetic pulses. This early treatment can improve a stroke patient’s odds of a good clinical outcome significantly and even reverse the debilitating effects of a stroke.

Since the symposium, Borsody has incorporated the company, changed its name to Nervive, restructured the management team and hired a new CEO, Jerry Gibson, to lead the ramp-up to full-scale production. “We expect to begin clinical testing in 2015 and anticipate entering the U.S. market two or three years later,” Borsody says. “We may complete a European market entry earlier, however, because the regulatory climate is more favorable for medical devices in Europe.”

Although it’s still too early to make revenue projections, Borsody estimates there is a $7.5 billion total available market for the VitalFlow stimulator. “Stroke is the largest health-care burden in the world, affecting 16 million people and killing 5 million every year,” he says. “In the United States, nearly 800,000 cases of stroke occur annually, costing some $69 billion in health-care expenditures and lost productivity.”

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