Trial Studies Bullfrog Device in Vascular Disease Patients with Critical Limb Ischemia
EMERYVILLE, CA., October 30, 2017 - Mercator MedSystems, Inc., a medical technology company specializing in localized delivery of drug therapies for deep in the body, announced completion of enrollment today in the company's LIMBO-ATX (Lower-Limb Adventitial Infusion of Dexamethasone via Bullfrog to Reduce Occurrence of Restenosis after Atherectomy-Based Revascularization) clinical trial. The LIMBO-ATX trial was designed to use Mercator's proprietary Bullfrog® micro-infusion catheter to test a new treatment strategy to potentially improve blood flow and decrease repeat revascularization procedures in below-the-knee (BTK) critical limb ischemia (CLI), a debilitating vascular disease that may result in amputation and is estimated to affect 22-30 million persons worldwide. Current solutions for CLI are substandard and face many limitations, leaving a significant unmet need for these patients and physicians treating the disease.
"The investigators associated with LIMBO-ATX are very excited to have completed enrollment in this important study. Meaningful results utilizing Mercator's proprietary delivery technique could lead to a change in the standard of care treatment of CLI in the U.S.," said Dr. George Adams, National co-Principal Investigator for LIMBO-ATX and Director of Cardiovascular and Peripheral Vascular Research at the University of North Carolina, Chapel Hill.
LIMBO-ATX is a prospective, multi-center, randomized, controlled trial that enrolled over 100 patients with arterial obstructions in their BTK arteries. Lack of blood flow through these arteries to the foot causes complications such as resting pain, non-healing wounds or tissue loss. Positive results from the study can be used by the company to seek new indications for the use of Bullfrog to deliver the generic steroid dexamethasone for patients with CLI to improve the outcomes of revascularization alone.
"The completion of enrollment in LIMBO-ATX is an important step in validating Mercator's new therapeutic approach to treat CLI disease, and we look forward to seeing the primary 6-month endpoint data in the second quarter of 2018," said Trent Reutiman, CEO of Mercator. "We are encouraged by our investigators' ability to swiftly complete this study in an area where other technologies have consistently yielded little benefit or have been unable to reach the conclusion of the study."
Mercator previously sponsored the DANCE trial, which reached its primary endpoint in early 2017 and demonstrated positive patency outcomes from delivering dexamethasone in combination with angioplasty or atherectomy in above-the-knee (ATK) endovascular revascularization.
Approximately 2 million people in the U.S. are living with CLI. While revascularization is widely regarded as the cornerstone of treatment, restenosis – or the recurrence of the narrowing of the vessel – after treatment of long and complex arterial obstructions has been reported to occur up to 75% of the time within 3 months of the initial revascularization. If not resolved, CLI can lead to the need for amputations of the toes, foot or lower leg.
About the Bullfrog® Micro-Infusion Device:
The Mercator Bullfrog Micro-Infusion Device is a FDA 510(k)-cleared and CE-Marked system that infuses therapeutic and diagnostic agents directly, non-systemically, and safely through blood vessel walls into adventitial tissues. The closed balloon provides a protective covering for a tiny, perpendicular-oriented injection microneedle as it is guided safely through the vascular system to target vessels with diameters of 2 to 8 millimeters.
About the LIMBO-ATX Trial:
The Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Atherectomy (ATX)-Based Revascularization (LIMBO-ATX) trial is a perivascular drug delivery trial that pairs the Bullfrog® Micro-Infusion Device with the generic steroid dexamethasone to treat below-the-knee arteries after revascularization. LIMBO-ATX is being conducted in 11 centers in the U.S. Its national Principal Investigators are George Adams, MD, from the University of North Carolina, Rex Hospital in Raleigh, North Carolina and Donald Jacobs, MD from Saint Louis University in Missouri. The LIMBO-ATX study was approved by the U.S. Food and Drug Administration (FDA) under an Investigational New Drug (IND) application. More information about the LIMBO-ATX trial is available at https://clinicaltrials.gov/ct2/show/NCT02479620.
Mercator MedSystems, Inc. (www.mercatormed.com), based in Emeryville, CA, is a venture-backed, privately held medical technology company. The company develops proprietary catheter-guided micro-infusion systems for targeted delivery of drugs and biologics deep inside the body to treat the root cause of a growing portfolio of medical conditions, including peripheral disease, cardiovascular disease, cancer, hypertension and heart disease.
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