Mercator Announces Enrollment of First Patient in DEXTERITY-AFP Clinical Trial Treating Inflammation in Deep Vein Thrombosis
EMERYVILLE, Calif., November 3, 2021 – Mercator MedSystems, Inc. (“Mercator”), a medical technology company specializing in localized drug therapy, today announced enrollment of the first patient in the DEXTERITY (DEXamethasone Therapy Examining Reduction of Inflammation after Thrombus Removal to Yield Benefit in DVT) Phase 2 clinical trials. Mercator’s proprietary Bullfrog® Micro-Infusion Device is a delivery solution designed to address local inflammation associated with the causes, the treatment, and the outcomes of deep vein thrombosis (DVT). In July 2021, Mercator received an investigational new drug (IND) approval for the two DVT studies from the U.S. Food and Drug Administration (FDA).
Deep vein thrombosis (DVT) occurs in up to 600,000 Americans annually when a blood clot (thrombus) forms in one or more of the deep veins in the body, usually in the legs, and can cause pain, swelling, redness, and skin ulceration. DVT spans a broad range of demographics including the elderly, pregnant women, travelers (long distance and confined seating), and those with a sedentary lifestyle. Inflammation causing re-thrombosis and contributing to the failure of venous valves is one of the key drivers leading to post thrombotic syndrome (PTS), which occurs in 20-50% of patients with DVT in their upper leg or pelvis. Mercator’s Bullfrog device can potentially improve outcomes in peripheral vascular intervention for DVT by delivering an anti-inflammatory therapeutic agent directly around the affected vein, where it is needed most.
The DEXTERITY studies are intended to enroll a group of patients with acute femoropopliteal DVT (the DEXTERITY-AFP study) and another group with subacute or chronic iliofemoral DVT (the DEXTERITY-SCI study). Principal Investigator David Dexter, MD, of Sentara Vascular Specialists, treated and enrolled the first patient in the DEXTERITY-AFP study on October 29, 2021, at Sentara Norfolk General Hospital in Virginia. “We have long recognized the need for successful and long-lasting outcomes for DVT patients. We are delighted to have initiated this important clinical trial for bringing local anti-inflammatory drug delivery to DVT interventions. The goal of this study is to show that local steroid treatment for DVT can address the inherent inflammation associated with DVT and improve the outcomes and durability after mechanical thrombus removal,” stated Dr. Dexter.
“Local drug therapy with thrombolytics has been used for years to remove thrombus from the legs, but the DEXTERITY studies represent the first locally targeted drug therapy designed to treat DVT inflammation. While it has long been an incredibly difficult problem in the treatment of DVT, it has been unaddressed until now,” said Trent Reutiman, Chief Executive Officer of Mercator. “We are excited to be at the forefront of treatment for the devastating, chronic outcomes of DVT, showcasing the capabilities that come with efficient drug delivery using our portfolio of Micro-Infusion devices.”
About the Bullfrog® Micro-Infusion Device The Bullfrog Micro-Infusion Device is FDA cleared and CE marked. The device includes a balloon that hydraulically deploys a micro-needle through the vessel wall into perivascular tissues, where the needle can then efficiently infuse drugs or biologics around an artery or vein. Drug delivery through the Bullfrog is tracked with X-ray contrast agents, allowing precision therapy to local tissues with visual feedback to the physician using the device.
About Mercator MedSystems, Inc. Mercator MedSystems, Inc. (“Mercator”), is a medical technology company focused on the clinical and commercial development of proprietary, FDA-cleared and CE marked catheter-based micro-infusion technologies, including the Bullfrog® Micro-Infusion Device for the local delivery of therapeutics in blood vessels and the Blowfish® Transbronchial Micro-Infusion Catheter for delivery in airways. Mercator is developing clinical applications in peripheral vascular disease, cancer, hypertension and cardiac regeneration. For further information, please visit www.mercatormed.com.
Corporate Contact: Trent Reutiman Chief Executive Officer Mercator MedSystems, Inc. 1900 Powell Street, Suite 800 Emeryville, CA 94608 Phone: +1.510.564.7757 E-mail: firstname.lastname@example.org
Investor Contact: Jennifer K. Zimmons, Ph.D., MBA Investor Relations Zimmons International Communications, Inc. Phone: +1.917.214.3514 E-mail: email@example.com ###