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

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.

Bob White, CEO of Tyrx

“It’s possible we might do an additional raise if we think we need more sales people, but at this point we haven’t made that determination,” White says.

Tyrx has about 14 people in its sales force currently but is hoping to take that to 22 or so by the end of the year, he says.

The company was founded out of technology licensed from Rutgers University in New Brunswick, NJ, in 1998, based on the notion of delivering drugs into the body by combining them with polymers that are bioresorbable, meaning the body can break them down on its own. Tyrx used that idea to target a seemingly simple, yet unmet problem: how to prevent infections that occur after medical devices are implanted into patients. Tyrx’s first tangible product is designed to protect people when they get a pacemaker or defibrillator.

By combating these potentially fatal infections—including superbugs such as methicillin-resistant S. aureus, or MRSA—Tyrx can help keep patients from long, costly hospital stays.

Patients who contract infections following implantation procedures spend … Next Page »

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