Minnow Medical Aims to Commercialize Improved Device for Treating Peripheral Artery Disease

9/9/09Follow @bvbigelow

Tom Steinke says he founded San Diego’s Minnow Medical out of an abiding conviction of the limitations of the medical stent, a mesh tube inserted in arteries to help prop open clogged blood vessels.

Steinke came to this view after spending 20 years developing medical devices in the cardiovascular industry. His previous startup was San Diego-based Reva Medical, which he founded in 1998 around a novel slide-and-lock design for a metal stent that does not deform as it expands. Before that, he was a product group director for Medtronic, director of engineering for Sonotek, and a development engineer at Advanced Cardiovascular Systems, which became Guidant, the maker of heart pacemakers and defibrillators.

“I know the industry,” Steinke says. With a metal stent, he says, “you’re going to have an ongoing inflammation to a foreign body… Even a [stent with a] drug coating doesn’t last forever; eventually the coating dissolves.” As Denise has reported, drug-coated stents represented a major innovation for the industry, and one that caught Reva off-guard. As the industry shifted to drug-coated stents, Steinke helped Reva reinvent itself in 2003 by developing a bio-absorbable stent that fully dissolves over time.

By the end of 2003, though, Steinke had moved on.

Tom Steinke

Tom Steinke

He founded Minnow Medical that year, and tells me the company sprang from his “altruistic desire to improve health care for the masses.” Now, after six years of development, Steinke is working to commercialize the technology that sprang from his convictions.

Steinke tells me that during his first couple of years at Minnow, he searched for alternatives to vascular stents. The founder and CEO says he self-funded Minnow until he had identified a way to improve the medical device used in balloon angioplasty to treat arteries that have narrowed and hardened due to atherosclerotic disease, the build-up of waxy plaque along the inside walls of an artery. In the process, Steinke also focused on peripheral artery disease, or PAD, partial blockages of blood vessels that can cause intense leg pain and circulatory problems. The standard treatment in many cases is amputation, according to Steinke.

A number of other biomedical companies have been modifying stents developed for coronary care for use in the legs, but Steinke regards the knee in particular as a “no stent zone.” He views atherectomies as even more problematic; the surgical procedure uses a laser catheter or a rotating shaver to blast or shave away the waxy buildup inside arterial walls, and Steinke worries that debris generated from an atherectomy just causes more downstream complications.

Balloon Catheter

Balloon Catheter

Steinke says his design represents an improvement in existing technology by adding electrodes to the outside of the balloon catheter, which is threaded inside a blood vessel to the site where an artery is constricted. The electrodes use radiofrequency energy to heat the targeted plaque to temperatures that range from 122 degrees to 176 degrees Fahrenheit. That’s not enough to make your blood boil, but Minnow says the energy “denatures” the plaque, breaking molecular bonds so that much of the hardened fatty buildup seems to dissolve with very little effort.  As a result, Steinke says it takes about one-third less atmospheric pressure to inflate the balloon (which is basically designed to squish the plaque against the inside of the artery wall) so the angioplasty procedure works with far better effect. “The artery takes the shape of the balloon angioplasty catheter and remains that way for several weeks,” Steinke says. So far, Minnow has secured one patent covering its technology and has 11 patent applications pending.

Steinke says Minnow’s device is intended eventually for heart patients with atherosclerotic disease, a multibillion-dollar market. But first Minnow has targeted non-coronary patients with peripheral artery disease, a worldwide market the company estimates at about 27 million people—with 10 to 12 million in the United States. Minnow’s device so far has been used to successfully treat 78 patients outside the United States who faced possible amputation because arteries in their knees were so badly constricted.

Eric Dippel, a cardiologist and biomedical consultant in Davenport, IA, who has reviewed Minnow’s technology but is not involved with the company, says he’s excited by the concept, and he notes that medical technology for treating peripheral artery disease is about 10 years behind advances in coronary disease. “It’s been a neglected area,” says Dippel. He also notes, “In general, the U.S. market is probably three years or more behind the European market” in developing new technology for peripheral artery disease. So while there are a lot of randomized trials and clinical data that support the use of stents in heart patients, Dippel says Minnow’s approach seems better-suited for fixing arteries in the knee. “Arteries in the legs are subjected to a lot of forces, such as bending and twisting, that arteries in the heart are not subjected to,” Dippel says.

The Davenport cardiologist calls Minnow’s technology “potentially exciting.” But Eric J. Topol, a cardiologist who is the chief academic officer and chief of genomic medicine and translational science for Scripps Health in San Diego, says he’s doubtful about Minnow’s technology.

“It’s possible, but it’s quite speculative,” Topol tells me. “Outside of drug-coated stents, there’s really nothing that addresses this problem of re-narrowing of the arteries” following angioplasty. “I’d love for the technology to succeed,” Topol adds. “But this technology, there hasn’t been a lot done in this area to indicate that it will work.”

Steinke says he intends to prove to the satisfaction of federal regulators that Minnow’s technology works. That takes money, so Steinke also has embarked on an effort to raise additional investment capital in the San Diego startup, which now has 28 employees. Minnow has raised $22 million so far, primarily from Fjord Ventures, a firm that former Domain Associates partner Olav Bergheim founded in Laguna Hills, CA, and NeoMed Management, an international life sciences VC firm with offices in Boston, Oslo, Norway, and Geneva, Switzerland.

As Steinke puts it, Minnow also is in “commercialization mode.” After winning a CE mark of European certification for Minnow’s first-generation clinical system, Steinke says the company has been working to meet different health insurance reimbursement standards in various European countries. Minnow also has been laying the groundwork to eventually seek regulatory approval in the United States, and Steinke says he has been seeking additional capital from prospective investors, including potential corporate partners.

In other words, stand by for more developments.

Bruce V. Bigelow is the editor of Xconomy San Diego. You can e-mail him at bbigelow@xconomy.com or call (619) 669-8788 Follow @bvbigelow

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