Vapotherm Inc. is waging a comeback after revenue at the Stevensville respiratory device maker disappeared two years ago.
The company's only product, an innovative machine that heats and moistens air to help patients breathe better, was still gaining market share during the summer of 2005 when disaster struck.
Its device was in more than 900 hospitals and the eight-year-old company was about to reach the break-even point.
That's when Kevin Thibodeau, executive vice president and chief marketing officer, was calling on a hospital in California and a message from a Vapotherm distributor flashed on his BlackBerry: One Pennsylvania hospital had reported that a Vapotherm machine had become contaminated with a bacterium called Ralstonia. The Centers for Disease Control and Prevention (CDC) was investigating.
"CDC - those are three letters I never wanted to see associated with our company," Thibodeau recounted.
After more than a year off the market, Vapotherm returned its machines to hospitals in January 2007 with some tweaks in design and instructions.
Now, use of the devices is nearly what it was before the recall, quelling fears that hospitals forced to use other machines wouldn't return as Vapotherm customers.
But as he read that e-mail back in 2005, Thibodeau wasn't feeling so confident.
Vapotherm first set out to verify the reports, then tried new disinfectant procedures. A test by the CDC found that the new cleaning procedure worked for a few days, but after a week, Ralstonia returned.
For the remainder of that year, 29 hospitals in 16 states found Ralstonia in Vapotherm machines, and the germ was found in 40 pediatric patients at those hospitals, according to the CDC publication Morbidity and Mortality Weekly Report.
In eight of those cases, CDC reported, the patient had an infection. In the rest, Ralstonia was present, but it did not appear to have made the patient sicker.
Vapotherm voluntarily recalled the machines in December 2005 after its attempts at a quick fix failed. That meant the company was taking its only product off the market.
"We definitely had our egg in one basket," Thibodeau said. For a company that had about $12 million in revenue in 2005, "sales went essentially to zero in 2006," he said.
About 5,000 returned machines were laid out in Vapotherm's warehouse, in an industrial park just at the eastern end of the Chesapeake Bay Bridge.
