NEW PATENT PROTECTS ADDITIONAL PIPELINE OPPORTUNITY FOR MERCATOR MEDSYSTEMS' MICRO-INFUSION DRUG DELIVERY DEVICES
-Company Secures U.S. Rights in Multi-Billion Dollar Renal Denervation Market Opportunity to Treat Hypertension;
-Reports Successful Outcomes on Lidocaine Use as Pre-treatment for Energy-Based Approaches;
-Advances its "Outside-In" Drug Delivery Approach for Other Cardiovascular & Pulmonary Diseases
SAN LEANDRO, CA – (July 29, 2013) Further expanding the treatment portfolio of its Micro-Infusion drug delivery platform, Mercator MedSystems, Inc., announced today the issuance of U.S. Patent 8,465,752, which protects and secures the company's sole U.S. rights to deliver drugs or other nerve modifying agents to tissue surrounding arteries for renal denervation (RDN) or carotid body modulation (CBM) procedures. These procedures, used to modulate or deaden hyperactive nerves, are designed to decrease uncontrolled hypertension, or high blood pressure, and are believed to be effective alternative therapies for the 12+ million patients worldwide whose blood pressure remains uncontrolled – even with the use of three or more anti-hypertensive medications. This emerging market is generally estimated to be a multi-billion dollar global opportunity by stock analysts.
"This patent issuance positions Mercator MedSystems as an important next-generation competitor for the treatment of hypertension," said Mercator President and Chief Science and Technology Officer, Kirk Seward, Ph.D., "and represents an additional pipeline opportunity for our proprietary Bullfrog® Micro-Infusion devices. Our unique outside-in approach to delivering biologics and drugs – spanning the spectrum of stem cells to generic anti-inflammatory steroids – empowers the physician to select site-specific, customized solutions to intractable problems associated with some of the world's most significant diseases," he added. Mercator's Micro-Infusion devices are currently used for treating peripheral artery disease (PAD), other cardiovascular diseases, pulmonary disease, and for the delivery of stem cells.
As part of their work in the renal denervation market, Mercator recently completed a clinical feasibility study at St. Catherine's Hospital in Frankfurt, Germany to determine the effectiveness of lidocaine delivery, prior to energy-based renal denervation, as a means of alleviating or minimizing pain experienced with these procedures. Ablating or cauterizing the nerves lining the renal arteries with radio-frequency or ultrasound-equipped catheters often produces intense pain that is difficult to control – even with the use of systemic painkillers and morphine. Four patients were pre-treated with promising results.
After the procedures, one of St. Catherine's treating physicians, Professor Horst Sievert commented, "I am impressed with the ease of delivery and the interactive visualization offered by Mercator's Bullfrog Micro-Infusion device. While there is more work to be done, this appears to be a promising approach as a pre-treatment – and longer term, with a neuro-modulating drug, as an alternative approach to RDN."
Other interventional cardiologists have concurred. Gary Ansel, M.D., Clinical Director of Peripheral-Vascular Interventionists at Riverside Methodist Hospital in Columbus, Ohio, and Founding Board Member of the VIVA Conference – an annual global meeting of educational courses for vascular medicine and intervention, said, "The Mercator approach is intriguing and I hope to see it borne out in clinical practice, as it may produce the same or potentially even better blood pressure-lowering effects while avoiding the side effect of procedural pain associated with advanced energy sources or cooling techniques during renal denervation."
Mercator's Bullfrog® and Cricket Micro-Infusion devices are cleared for commercialization in Europe, the United States and Australia. The Micro-Infusion approach was created in the labs of The University of California, Berkeley in 2000.