VentureMed Group Prepares to Enter the $3.3 Billion U.S. PAD Device Market

Peripheral artery disease, or PAD, is on the rise in the U.S., increasing 6% to 7% annually. An estimated 12 million people, according to the American Heart Association, will be diagnosed this year with the debilitating and often deadly condition, which is characterized by the build-up of plaque inside peripheral arteries, particularly in the legs. Smoking, obesity and lack of exercise among Americans are some of the key factors fueling the disease.

VentureMed Group, which was founded by vascular surgeon John Pigott, M.D., has been working since 2012 to develop a new medical device for the treatment of PAD. Its innovative FLEX Scoring Catheter is designed to provide interventional surgeons with a more effective, cost-saving vessel preparation tool for opening up diseased arteries.

“Our core product is a plaque modification and scoring platform,” explains Gary Smith, the CEO of the Sylvania, Ohio-based start-up. “It creates a cleavage plane in the plaque in the artery and enables surgeons to more effectively insert a drug-coated balloon or drug-eluding stent device into the blood vessel.” The FLEX Scoring Catheter utilizes three very sharp scoring elements that can treat any length lesion in any size artery. This one-size-fits-all design allows hospitals to treat lesions and vessels of many different sizes and diameters with a single device.

The U.S. PAD device market currently stands at an estimated $3.3 billion, and is poised for continued growth, according to Smith. This provides enormous upside potential for VentureMed Group’s FLEX technology platform of PAD products. To date, the company has completed its seed and Series A rounds of equity funding, raising a total of $3.3 million. Smith expects to start raising $5 million in Series B funding in the second quarter of this year. Capital from this new round will enable the company to introduce its products in the U.S. and the E.U.

“We completed First in Man clinical trials on 12 patients in Poland during the fourth quarter of 2014,” Smith explains. “Now we are working to get a CE Mark that will enable us to sell our products in the European Economic Area. We also plan to complete the U.S. FDA’s 510(k) requirements for medical devices. Once we receive FDA clearance, we will launch sales in strategic markets in the U.S. in early 2016.”

Although Smith has attended the Michigan Growth Capital Symposium in the past, last year’s event was the first time he made a fundraising pitch to angel and venture capital investors. “I thought the networking opportunities and the prospective investors attending the MGCS were excellent,” he says. “I hope some of those investors will come into our Series B round.”

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