When Tom Steinke started Minnow Medical (San Diego, California) five years ago he didn't know if his new company's technology would provide a cost-effective solution or if it would even work. As it turns out, according to Steinke, the company's arterial catheter technology is a cost effective alternative to treating peripheral artery disease (PAD) without the use of stents. That's the good news.

But Steinke is a forward-thinking entrepreneur and he told Medical Device Daily he is concerned about the direction he sees healthcare going in the U.S., particularly with a cost effectiveness-based healthcare plan. In the near term, Steinke says such a system will benefit Minnow because its approach to treating PAD is cost effective.

"It's a dream solution. It's faster, it's better and that makes it cheaper," Steinke said. But he fears that healthcare reform, if not managed carefully, will impact future medical innovation in the U.S.

"Innovation is very, very fragile," Steinke said. "The slightest change could make something not be invented."

If the U.S. moves towards a healthcare system that more closely mirrors that of Canada or the UK, Steinke believes that venture capital and private equity funding for emerging medical technology companies will "completely dry up."

According to Minnow, its solution to the problem of treating arterial disease is a system which incorporates a catheter and energy based technology which delivers precisely-controlled, non-ablative, low-powered radio frequency energy, which triggers biologic responses in diseased peripheral arteries that open stenoses and reduce plaque volume, potentially resulting in a permanently reshaped artery. Minnow says its peripheral vascular system, through a combination of radio frequency and mechanical energy, accomplishes this stenosis dilation and plaque reduction in peripheral arteries via hyperthermia and mild pressure, respectively.

"When Minnow was in its early stages of development, we didn't know that our technology would yield a cost effective solution to treating PAD. That and other factors only came to light after we secured funding and were able to break through the R&D phase and finally saw what we really have," Steinke said. "Bottom line, if there is no means to drive a profit; investors will quickly turn to sectors where innovation can pay dividends, and if that happens, future medical advances will be dramatically damaged."

Steinke told MDD that the impact for healthcare reform won't be obvious in the next year or two – it will take about 20 years. That's when, according to him, people will start to realize that "my best healthcare isn't here in the U.S. anymore."

Steinke says his entire career has been devoted exclusively to developing cardiac device technology and he has worked for larger companies such as Medtronic (Minneapolis). Over time, he became concerned about the use of metal implants to treat artery disease. He said he was asked to run a stent program at Medtronic but declined the offer because of his concerns. Instead, he started Minnow with the goal of finding a better way to treat PAD.

"We looked at every possible solution of treating artery disease that didn't involve an implant," Steinke said.

The technology actually turned out better than the team thought it would, Steinke said. With the Minnow treatment, it actually looks like a stent is there, even though there isn't a stent or any other type of implant, he said. "A stent is a scaffolding that literally props the artery open and it works incredibly well for a short time," Steinke said. But, he added, having a foreign body in the artery causes an inflammatory response and as long as there is a foreign body in the artery it continues to scar. That's where the development of drug-eluting stents comes in. The drug inhibits the scar formation, making DES a popular treatment choice, he acknowledged. But, eventually the drug will run out and the scar is formed, Steinke said.

"These stents all eventually break," Steinke told MDD, calling himself the "anti-stent guy."

According to Steinke, Minnow's approach is attractive because not only does it work, but it works fast. Also, he added, the treatment preserves the option of using a stent or another type of implant at the same time or later on if the physician wants to.

"It appears to be a greatly improved treatment without any downside and that's very attractive," Steinke said, adding that he has a strong family history of the disease and therefore fully expects that someday "I will be using these products."

Although he could not provide specific data, Steinke said that in preliminary clinical studies outside the U.S. the technology has been "incredibly successful as being the standalone treatment in treating peripheral artery disease. In no instance was a stent or any adjunctive technology needed or used. The doctors using our product were completely satisfied."