RiverVest’s Founding Role Launches Device Company

Lutonix_BoxLutonix, Inc.
Founded by RiverVest® in July 2007
Acquired by C.R. Bard, Inc. in December 2011
Minneapolis, MN

“Lixiao Wang is one of the great inventors and IP writers in the medical device industry. After a thorough evaluation, we determined the best course of action was for me to step in to run this company. It’s been a tremendous founding opportunity for RiverVest. We are making rapid progress, with clinical trials expected to begin in 2009.”

—Dennis Wahr, M.D., president and CEO of Lutonix, Inc. and RiverVest Venture Partner

When medical device inventor Lixiao Wang, Ph.D., called on Dennis Wahr, M.D., Managing Director at RiverVest, to help develop a drug-coated balloon catheter based on his patent-pending technology, he was looking for leadership in addition to funding.

Dr. Wang is the inventor of several revolutionary interventional cardiology products for SciMed and Boston Scientific that generate billions of dollars in revenue and continue to dominate the market today.

Together, Drs. Wahr and Wang, along with RiverVest Managing Director Jay Schmelter, founded Lutonix with a mission to rapidly develop and commercialize the safest and most effective drug-coated balloon catheters for treatment of vascular disease. Dr. Wahr is now president and CEO of Lutonix, Dr. Wang is chief technology officer, and Mr. Schmelter represents RiverVest, which led a $5 million Series A financing in 2007, on the board.  This financing was syndicated with U.S. Venture Partners.

As founder, president, and CEO of Velocimed, LLC, as well as former chief of cardiology at the Michigan Heart and Vascular Institute Group, Dr. Wahr is intimately familiar with the cardiovascular device market.  Velocimed was a cardiology device company in which RiverVest Venture Fund I had invested that was sold in 2005 for $82.5 million.

Drug-eluting stents are multibillion-dollar products, yet numerous vascular indications are poorly served by these devices. Small vessel disease, bifurcated lesions, in-stent restenosis, and peripheral vascular disease, for example, represent a $1.9 billion market. In addition, because of bleeding risk, cost, or compliance, many patients cannot tolerate the long-term anti-platelet therapy that is required to prevent late thrombosis, a severe complication of drug-eluting stents, which opens the door to markets otherwise well-treated by drug-eluting stents.

Compelling Proof of Concept
Exciting clinical data from European scientists Ulrich Speck, Ph.D. and Bruno Scheller, M.D., using first-generation technology, demonstrated in 2006 that drug-coated balloons have the potential to significantly improve clinical outcomes. This promise has since held true in four prospective, randomized clinical trials. In all four trials, patients treated with Speck and Scheller’s non-commercial, drug-coated balloon fared significantly better than patients treated with a control—which, in one case, was the multibillion-dollar drug-eluting stent Taxus™. Dr. Wang’s improved drug-coating formulation, along with his and Dr. Wahr’s proven track record in medical device development and successful navigation of clinical and regulatory landscapes, as well as, RiverVest’s medical device investment experience, position Lutonix to be first to market in the U.S. with a drug-coated balloon.

Next Steps
Dr. Wahr has assembled a proven, proactive board of directors and R&D team to rapidly develop the company’s patent-pending drug-coated balloon catheter. Board members include USVP Managing Director Jonathan Root, M.D.; former Boston Scientific/SciMed President Michael Berman; and RiverVest Managing Director Jay Schmelter. Chris Barry, former program director for Abbott Vascular’s Drug-Eluting Stents programs, was recruited to head research and development.

RiverVest Entrepreneur-in-Residence Scott Naisbitt, M.D., Ph.D., a founding board member, has recently transitioned to an operating role at Lutonix. Dr. Wang commented, “Scott is very good and has great depth in technology and intellectual property.” Dr. Naisbitt is expanding his focus from preclinical and IP development to clinical and regulatory in preparation for Lutonix’ soon-to-be-initiated human clinical trials.

Lutonix began Series B fundraising in July 2008 to finance these clinical trials.

Lutonix, Inc. has the vision to improve the quality of life for patients with vascular disease through innovative solutions. The company’s mission is to rapidly develop and commercialize the safest and most efficacious drug-coated balloon catheters for treatment of vascular disease.