iTraumaCare Receives Expanded Indication from FDA For iTClamp System

Early-stage device firm iTraumaCare has achieved its fifth regulatory milestone with an expanded indication for use from the U.S. Food and Drug Administration (FDA) for its first product. The agency has expanded indications for the company’s iTClamp Hemorrhage Control System, to include the temporary control of severe bleeding of the neck. Previously, the product’s indications for use in the United States included the extremities (arms and legs), axilla (arm pit), inguinal (groin) areas and the scalp.

The iTClamp is designed to control severe bleeding – a leading cause of death in traumatic injury – in seconds. The iTClamp seals the edges of a wound closed to create a temporary pool of blood under pressure that mitigates further blood loss until the wound can be surgically repaired.

“Addressing difficult to control hemorrhage in the neck has been a consistent problem with few solutions. This expanded indication for the iTClamp will allow first responders, medical professionals and tactical and battlefield medics to use the device in even more meaningful ways to improve patient care,” iTraumaCare Founder/Chief Medical Officer Dennis Filips, M.D., said.

The iTClamp system received FDA 510(k) clearance and CE Marking in the spring of 2013. It was used for the first time in the United States in September 2013 to close a 7-inch-long, 1-inch-deep chainsaw wound on a Tennessee man. Within minutes of applying two iTClamps to the wound, the bleeding stopped, the patient stabilized, and surgeons stitched him up. Eight hours later, the 64-year-old patient was released from the hospital.

In the wake of the FDA’s expanded indication for the iTClamp, the company named Joseph P. Brennan as president/CEO. Board Executive Chairman Philip W. Faris will continue to consult with the company on management and growth strategies.

Brennan has more than two decades of experience, previously serving in management positions with Genzyme Corporation and Kinetic Concepts Inc. (KCI). He also founded sales consulting firm Redzone Leadership. While at Genzyme, he grew the biosurgical division’s commercial sales from $10 million to more than $100 million and supervised multiple diverse teams through his 17-year tenure. In his position with KCI, he achieved year-to-year commercial growth for product lines in the skin substitute and wound care space.

Brennan is a graduate of the U.S. Naval Academy and served in Operation Desert Storm as a division officer on the USS Frederick; he also worked with the Chief of Naval Operations in the Foreign Liaison Office. He has an M.B.A. from the Goizueta Business School at Emory University in Atlanta, Ga.

“iTraumaCare has made inroads into the marketplace and has significant growth potential. The iTClamp is the first significant improvement to address mechanical hemorrhage control in years, and I look forward to leading market growth and aggressive sales strategies for this product to make it a standard of care,” Brennan said.

Incorporated in 2010 and based in Edmonton, Canada, with its global commercialization headquarters in San Antonio, Texas, iTraumaCare develops, manufactures, and commercializes traumatic injury treatments.