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Tyrx's dissolvable antibacterial envelope wins Canadian approval

FDA officials continue to evaluate the device, which is designed to reduce implant infections
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Bob White, CEO of Tyrx

Tyrx won Canadian regulatory approval for its next-generation antibacterial envelope. The new iteration is also designed to reduce the risk of infections after pacemaker or ICD implant surgeries, but this one dissolves into the body after 90 days.

The New Jersey outfit and 2012 FierceMedicalDevices Fierce 15 company plans to start marketing the AigisRx fully resorbable antibacterial envelope in March, once it can ramp up production. Original Aigis has FDA clearance in the U.S. But a U.S. regulatory signoff for the resorbable version remains pending following Tyrx's clearance submission more than a year ago. Tyrx President and CEO Bob White told FierceMedicalDevices that Canada's approval should help the process in the U.S.

Canada "is a small market, but the number one thing for us is it gives us a chance to put it in humans," White told us. "Procedures will begin in Canada in March, and we will build clinical evidence based on that. It is important to have that type of information on hand. Hopefully with Canadian clearance it will allow us to move a little more quickly in the U.S."

In the U.S., White said Tyrx has been working with the FDA for some time now on the next-generation envelope and is "optimistic in the near future that we will receive clearance."

Health Canada also approved the original Aigis antibacterial envelope--a small orange "sock" in which antimicrobial agents are placed--in October. A pacemaker or ICD goes inside and both are implanted in the patient, and Aigis releases antibiotics over 7 to 10 days in order to reduce the risk of postsurgical infections--but the envelope stays in the body. The new version is completely resorbed back into the body over time, dissolving in about three months.

Meanwhile, Tyrx is working on obtaining a CE marking for both Aigis versions. Earlier this week, Tyrx nailed down an $8.5 million senior secured credit facility to help support, in part, commercialization plans in the U.S, Canada and globally.

- read the release

Special Report: Tyrx – 2012 Fierce 15

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