FDA Clears New Version of Tyrx’s Infection-Fighting Pacemaker Sleeve

From: Xconomy

Tyrx climbed its first big hurdle in 2008 when it began selling its first product to hospitals in the U.S. With a key green light today from the Food and Drug Administration, the Monmouth Junction, NJ-based company has a bigger goal within its grasp—becoming cash-flow positive.

The FDA today cleared the company to begin selling the second iteration of its AigisRx Antibacterial Envelope, a drug-device combination used to prevent infections in patients getting an implantable electronic cardiac device such as a pacemaker or defibrillator. The new device, which Tyrx will price at around $900 per unit, releases two antibiotics into the system over the course of seven to 10 days and dissolves completely over about 90 days, according to CEO Bob White.

Regulatory approval is the latest step 15-year-old Tyrx has taken towards generating returns for investors HLM Venture Partners, Clarus Ventures, Pappas Ventures, and the Memorial Care Innovation Fund (a strategic investment company owned by MemorialCare Health System), which have poured just over $50 million into the company. Tyrx is now tracking about $20 million in revenue annually, a more than 100 percent jump from last year, and with its new product in the fold, hopes to become cash flow positive by the end of the year. Since Tyrx has enough cash to take it to that point, the company is unsure if it will need more financing.

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