Tyrx gains FDA clearance for dissolvable antibacterial envelope

Bob White, President and CEO of Tyrx

Tyrx gained a vital FDA clearance for its next-generation antibacterial envelope, and now the New Jersey company is eyeing a 2013 third-quarter rollout for the product in the U.S.

The 2012 FierceMedicalDevices Fierce 15 winner disclosed the news on July 9. Company President and CEO Bob White told FMD via email that clearance for the fully bioresorbable device should help the private company reach profitability within the next 6-12 months of its commercial release.

"The AigisRx R represents the most important advance in the company's history, providing all of the advantages of the original AigisRx but with the added benefit of being fully bioresorbable," White told us. "This FDA clearance cements our leadership in the effort to reduce surgical site infections following" implantation of cardiac electronic devices.

Both Aigis models work the same way: A pacemaker or ICD is placed inside the envelopes before they are implanted in the patient. Aigis subsequently releases antibiotics over 7 to 10 days to reduce the risk of postsurgical infections. But unlike the original model, the new version dissolves in about three months and is absorbed back into the body. Both are billed as helping to reduce infections and death, actions that can also lead to lower medical costs. The company cites data suggesting its initial antibacterial envelope helped reduce infections between 70% and 100%.

The new Aigis device follows a similar approval in Canada back in January. Tyrx submitted its FDA clearance application more than 18 months ago.

- read the release

Special Report: Tyrx – 2012 Fierce 15