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July 12, 2017

FDA approves Z-Medica's severe-bleeding control device

Wallingford-based Z-Medica LLC, a developer and marketer of bleeding-control devices, has received Food and Drug Administration approval to market and sell a new product for controlling the most severe bleeding inside the body caused by trauma or major surgeries, such as organ transplants.

The FDA cleared use of QuikClot Control+ under the so-called de novo classification process, providing Z-Medica significant patent protection and making it very difficult to copy the product, said President and CEO Stephen J. Fanning. The approval follows more than three years of development and safety testing on the product, which was submitted for FDA approval in March 2016.

Z-Medica’s new product follows its QuikClot bleeding-control device for superficial bleeding already used worldwide by first responders, hospital and military personnel, presenting an expanded market for the company in hospitals to use the product inside the body, Fanning said.

“This is big for us,” he said.

The company plans to hire seven more sales staff for its U.S. hospital sales division, which now has 18 people. The company, which makes its products in Wallingford, has about 25 to 30 employees there and roughly 85 worldwide.

Z-Medica says the QuikClot Control+ is the first nonabsorbable hemostatic dressing cleared for internal organ space use in severely bleeding patients and is intended for temporary control of internal organ space bleeding. Being nonabsorbable, it can’t be left inside the body for more than 48 hours, but would be considered “kind of the first line of defense for very aggressive bleeding,” Fanning said, after which products the body absorbs can be used.

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