VentureMed Technology Breaks Through in First-In-Man Trials

Written by Kevin Volz.

Peripheral artery disease (PAD) affects one in 20 Americans over the age of 50, leaving patients with tired, heavy legs due to blockages in their arteries. While some cases can be treated with medication and lifestyle changes, more advanced PAD requires artery-clearing surgery that is very expensive due to the high cost of the medical devices used. Toledo, Ohio-based VentureMed Group (VMG) is hoping to help reduce these costs by the end of 2015 with its groundbreaking FLEX Scoring Catheter.

Searching for a more cost effective way to treat artery blockages in the leg, VMG formed in 2012. Their mission was to develop a tool with the same patient benefits at a much lower cost to physicians. They accomplished that with the FLEX Scoring Catheter, completing tests on humans for the first time, or first-in-man trials, in October 2014.

Critical funding to get VMG prepped and through this first-in-man trial came from Ohio Third Frontier, specifically from the Global Cardiovascular Innovation Center (GCIC) in Cleveland, Ohio. Additional funding and administrative business services for VMG came from Rocket Ventures in Toledo, Ohio.

A total of 12 patients were treated in the first-in-man trial, and the device worked well in all of them with no adverse effects. These types of results are huge for a medtech company like VMG. It shows that the medical device is safe and effective, which is extremely attractive to potential investors and clinical users.

“The success of our first-in-man trial essentially breaks open the gate for us to proceed to EU and US regulatory approvals,” said Gary Smith, CEO of VMG. “Our size enables us to run our trials faster and cheaper than any big company could do. We are a capital-efficient machine.”

VMG knows that much of its success has to do with its location in northwest Ohio, the strong venture capital community in the state and the support of Ohio Third Frontier.

“From northwest Ohio, we are within geographic reach of some of the most populous medical cities in the country,” said John Bigott, MD, founder and CSO of VMG. “Toledo is an excellent place to launch a tech company and establish traction in the marketplace, and investors are really starting to notice.”

So what’s next for VMG? The company’s main goal is to be in the marketplace by the end of 2015. They will spend the next 6-9 months going through product and process validation so they can file with the FDA and get clearance. They will also be validating their quality system with the EU. The hope is to get the product to market as soon as possible, so patients around the world can start benefitting from this technology.