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FDA OKs S.A. firm’s medical clamp
May 29, 2013

By Peggy O'Hare, San Antonio Express-News

A trauma-care medical device company with U.S. headquarters in San Antonio has received U.S. Food and Drug Administration approval to market a clamp designed to stop heavy bleeding.

Innovative Trauma Care Inc. expects its iTClamp Hemorrhage Control System - the company's first product - will be available for sale in the U.S. by July 1. The device has already been approved for sale in Canada and Europe.

The iTClamp controls severe bleeding in seconds by sealing the edges of a wound and forming a clot to stop further blood loss until the injured person reaches a hospital. The device can be used for injuries suffered in battle or in car wrecks, shootings or stabbings.

The FDA's approval "opens the largest market in the world to the company," said Philip Faris, executive chairman of Innovative Trauma Care's board.

The city invested $300,000 last year - for an equity stake - to help the Canadian-based company establish its U.S. operations in San Antonio at 3463 Magic Drive. Innovative Trauma Care now employs eight people at its San Antonio office and will begin hiring sales and support personnel to help launch the product. The company expects to have a workforce of 14 to 18 people in San Antonio when the current fiscal year ends in March 2014.

The company secured $3.7 million in initial funding last year. It is now raising a second round of financing to introduce the product in U.S., Canadian and European markets, securing $3 million in convertible debt financing so far and aiming to raise an additional $5.5 million by September or October, Faris said.

Sales of the iTClamp are already underway in 15 countries in Europe, including the United Kingdom, Ireland, Germany, France, the Netherlands, Sweden and Denmark, Faris said. Sales in Canada are expected to begin by mid-June.

The initial prototype of the iTClamp was developed in 2010. So far, the device has been shown to 1,500 to 2,000 health care professionals at trade shows in the United States, Canada and Europe, Faris said. A number of emergency medical services, military operations and hospital emergency departments have expressed interest in evaluating the clamp, he said.

The FDA granted 510(k) clearance for the device on May 14, meaning the company provided the required pre-market notification of its intent to introduce the iTClamp commercially in the U.S. within 90 days.

The company, based in Edmonton, Canada, develops, manufactures and sells devices to stop preventable deaths resulting from traumatic injuries.

The manufacturer's suggested retail price for the iTClamp in the U.S. is $79, Faris said.

 

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