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Lutonix Enrolls First Patient In Three Separate Clinical Trials

Lutonix Inc. announced that patient enrollment is underway for its three simultaneous first-in-human clinical trials. The three studies are designed to test whether the proprietary Lutonix Drug Coated Balloon (DCB) Catheter is safe and effective in the treatment of vascular narrowing.

The PERVIDEO I Registry is investigating the Lutonix Drug Coated Balloon Catheter for the treatment of coronary bare metal stent in-stent restenosis (ISR). The study will assess various safety and clinical endpoints over a two year period. Dr. Laura Mauri, Associate Physician and Director of Biometrics at Brigham & Women’s Hospital in Boston, MA is serving as the Principal Investigator for the study along with Co-Principal Investigator Prof. Detlef Mathey of the Medical Center in Hamburg, Germany. The first patient was enrolled by Prof. Mathey. “It is very exciting to have the PERVIDEO I study underway,” said Dr. Mauri. “The scientific evidence

collected from this investigation will support the initiation of large global trials in the near future” she added. Prof. Mathey states, “I have been involved in DCB research for several years now and I believe this technology, if formulated correctly, shows great promise for treating many types of coronary diseases, including bare metal ISR.”

The LEVANT I Trial is a randomized study designed to test the safety and efficacy of the Lutonix Drug Coated Balloon Catheter in preventing restenosis in the femoropopliteal arteries. Scheduled clinical and safety visits will assess endpoints out to two years.

Study Principal Investigator Prof. Dierk Scheinert, Director of Angiology at the Park-Krankenhaus in Leipzig, Germany states, “The initiation of the LEVANT I study is a major milestone and I am honored to lead such an outstanding group of physician investigators.” Prof. Scheinert adds, “The optimal intervention treatment strategy for this population has yet to be discovered, and the DCB technology may mark the next major advancement in peripheral interventions.” The first patient was enrolled by Prof. Stephan Duda of the Jewish Hospital in Berlin, Germany.

The Lutonix De Novo study will assess the interaction between bare metal stents and the Lutonix Drug Coated Balloon Catheter. Safety and clinical outcome data will be collected over two years. Prof. Patrick Serruys, Chief of Cardiology at Erasmus Medical Center in Rotterdam, the Netherlands is serving as study Principal Investigator. The first patient was enrolled by Dr. Jacques Koolen at Catharina Hospital in Eindhoven, the Netherlands. President & CEO Dr. Dennis Wahr added, “Lutonix is committed to the principle of clinical excellence and dedicated to substantially improving long term patient outcomes. Through close collaboration with global thought leaders and experienced CROs, we have been able initiate a clinical program designed to provide objective evidence that our DCB formulation is clinically effective.”