|Bob White, CEO of Tyrx|
Based: Monmouth Junction, NJ
The Scoop: Tyrx's Aigis antibacterial envelope is designed to reduce the risk of infections during pacemaker or ICD implant surgeries. A pacemaker or ICD is inserted in an Aigis envelope (resembling an orange baby sock), and both are implanted together into the patient. Over the next week to 10 days, the envelope releases an antibiotic.
What Makes It Fierce: Aigis is a remarkably basic solution to a serious problem--the risk of infections during medical device implant surgeries. Four years after gaining initial FDA clearance and three years after hitting the market, Tyrx has already sold more than 30,000 units. And the company is waiting for FDA clearance of a fully bioresorbable version of Aigis that dissolves within 90 days (version one is partially dissolvable). Progress comes after the company almost completely switched gears in 2007, pulling out of a partnership with Boston Scientific ($BSX) to develop a next-generation paclitaxel-loaded stent.
Tyrx, meanwhile, sees both iterations of its Aigis envelope as performing a crucial task.
"The problem we are trying to solve--today you have a 2% to 3% infection rate for pacemakers and ICDs," Tyrx President and CEO Bob White explains. "When it happens, the hardware has to be removed and the pacemaker comes out and the leads. The patient has to be in the hospital for, on average, two more weeks for long-term antibiotic therapies. Many are sick with heart failure."
White says the expenses per patient in this situation average about $75,000, and patients in this situation face a high mortality rate. Tyrx's technology is between 70% and 100% effective in reducing infections, he says.
The 50-employee enterprise has attracted two rounds of financing: a $25 million round in 2008 and $23 million in 2010, White notes, adding that the second round still supports the company's activities. The money comes from a number of investors including Clarus Ventures, Pappas Ventures and HLM Venture Partners. Aigis' technology comes from numerous sources. Rutgers University licensed the polymer technology that enables the drug release; Baylor University and The University of Texas MD Anderson Cancer Center contributed the antibiotic element; the third element comes from Tyrx itself, which combined the components into the Aigis envelope.
"It is a very basic concept," he said. "It does seem like someone should have come up with this 20 to 30 years ago, but nobody did."
What To Look For: Tyrx hopes to obtain FDA clearance for its next-generation Aigis product by October and launch it next year. A new venture funding round will likely help support this, and also be used to fuel other related products in the pipeline being developed for tissue and other types of implants. Tyrx is also aiming to become cash-flow positive and will generate between $10 million and $12 million in revenue for 2012. That's a big jump from $7 million in sales last year, and much smaller sales levels in the previous three years before fully ramping up marketing operations. Tyrx also expects to gain from a CMS decision to no longer reimburse for preventable hospital infections relating to pacemakers and ICDs. Overseas, Tyrx expects it will gain a CE mark for both generations of its Aigis cardiac envelope by year-end.
Tyrx's future likely involves its eventual acquisition, White says. But he added that it is hard to predict when, and the company is in no rush to do so.
"We have the ability to go on our own for some time," he says. "But we are sitting in a unique [space] and lots of companies are interested out there in infection control."
-- Mark Hollmer (Twitter | email)