Preliminary Results Demonstrate That the Novel Delivery of Dexamethasone via Mercator's Platform Micro-Infusion Catheter Inhibits Restenosis for at Least 9 Months in 10 Patients Treated for Peripheral Vascular Disease (PAD)
Dexamethasone, an anti-inflammatory medication approved by the FDA, was uniquely infused into the inflamed tissue around lesions via the proprietary Mercator 'Bullfrog®' catheter designed to enhance clinical efficacy after femoropopliteal revascularization
'DANCE' trial is now fully enrolled and will continue to follow patients at the University of California, San Francisco (UCSF)
"Ours is a disruptive technology that is designed to transform therapeutic delivery." Thomas Loarie, Executive Chairman, Mercator MedSystems
SAN LEANDRO, Calif., July 16, 2012 — Mercator MedSystems, a medical technology company whose platform Micro-Infusion Catheter technology—catheter-guided, microfluid injection systems for site-specific, non-systemic delivery of therapeutic agents directly across any peripheral or coronary blood vessel to treat peripheral vascular diseases, cancer, heart attacks, and other life-threatening diseases and disorders—announced today preliminary results of its 'DANCE' clinical trial that continues to follow patients at the University of California, San Francisco (UCSF) and San Francisco VA Medical Center.
The Sponsor and Principal investigator of the 'DANCE' clinical trial is Christopher D. Owens, M.D., an associate professor and vascular surgeon at the Center for Limb Preservation, part of the UCSF Heart and Vascular Center. Results on 10 patients to date, at nine-month follow-up after an angioplasty or atherectomy, showed that those patients who also were infused with dexamethasone to the adventitia of the targeted blood vessel made possible by Mercator MedSystems' patented and FDA-cleared Bullfrog® Micro-Infusion Catheter have now passed nine months without restenosis of the index lesion. The Mercator platform is the first and only vascular-access system designed to inject drugs, genes and cells safely through vessel walls into deep tissues without major surgery.
"Our technology platform of Micro-Infusion Catheters is designed to enable the safe and accurate delivery of therapies anywhere within the body, ranging from drugs for diseased blood vessels to stem cells that regenerate ailing tissues and organs. Consequently, we believe our disruptive technology will allow the expansion of medical therapy and stimulate profound intellectual exploration into new treatments for disease," said Mercator's Executive Chairman Thomas M. Loarie, who has brought nearly two dozen medical devices to market worldwide during his 40-year medtech industry career. He also has served as Assistant Professor of Surgery, Creighton University Medical School; and has served as Chairman, Board Member, and Executive Committee member of AdvaMed (the Advanced Medical Technology Association).
"Our Micro-Infusion Catheters are the first catheter-guided systems designed to inject—directly and non-systemically—therapeutic and diagnostic agents safely through blood vessel walls into deep tissues. With this enabling technology, novel therapies can be developed and delivered site-specifically nearly anywhere in the body. These therapies may include treatments for plaque stabilization or reduction of angioplasty-induced inflammation in diseased vessels, drugs to disrupt the hyperactive renal nerves in hypertensive patients, anti-tumor drugs, growth factors to stimulate cell division, stem cell transplantation and gene therapies," added Kirk Seward, Ph.D., Co-Founder, Director, President and Chief Technology Officer. Dr. Seward is the inventor of the Mercator Micro-Infusion Catheter and has led its development from prototype through FDA 510(k) marketing clearance. Prior to co-founding Mercator MedSystems Dr. Seward was a staff principal investigator at Lawrence Livermore National Laboratory. He completed his doctoral studies in mechanical engineering at the University of California at Berkeley, and his master's and bachelor's in mechanical engineering at MIT. He has authored more than 50 patent applications.
Delivering drugs through the blood vessel wall into the perivascular space and adventitia allows for direct, highly controllable and concentrated treatment, not only minimizing the toxicity of systemic administration but also avoiding the "washing away" of drug into the bloodstream. This can reduce drug side effects, increase therapeutic effectiveness, decrease the cost of medical treatment and improve patient quality of life.
Mercator MedSystems, Inc., based in San Leandro, Calif., is a privately held medical technology company focused on commercializing catheter-guided, microfluid infusion systems for site-specific delivery of therapeutic agents for applications in hypertension, cardiovascular disease, pulmonary, oncology and regenerative medicine.