Vapotherm Inc., a Stevensville-based maker of respiratory devices that struggled for more than a year without revenue after voluntarily recalling the machines, announced yesterday that the Food and Drug Administration has approved an upgraded version of the machine.
About 800 hospitals in the U.S. and more than 20 countries now use Vapotherm devices in neonatal, pediatric and adult units to treat chronic lung and acute breathing disorders, company officials said.
The machines heat and moisten air to help patients breathe.
FDA approval of the new Precision Flow will allow the company to fill what it sees as growing demand by hospitals for noninvasive oxygen therapy and clears the way for mass production, said Kevin Thibodeau, executive vice president of sales and marketing.
He said the machines have helped hospitals reduce the number of patients needing mechanical ventilators, which require the insertion of a tube into the throat.
"Our goals are certainly to sell a couple thousand units this year alone," said Thibodeau, who based that estimate on the 5,000 total sales of the less sophisticated Vapotherm machine.
The company has been making a comeback since December 2005, when it voluntarily recalled its original Vapotherm machines - then the company's only product - after some machines became contaminated with a bacterium called Ralstonia.
After more than a year with no revenue, the 11-year-old company returned the redesigned Vapotherm machines to hospitals. It has managed to rebuild its annual sales to about $12 million, the level prior to the recall, Thibodeau said.
The new machine comes with additional safety features and blends humidification technology with breathing gases in one device.
Saint Barnabas Medical Center in Livingston, N.J., now uses about 21 Vapotherm machines throughout the 601-bed hospital, said Bob Tero, the hospital's senior respiratory care manager. It hopes to be one of the first to bring in the new Precision Flow machines, he said.
"This is a device that we had purchased a few years ago to deliver noninvasive respiratory support to our patients, more particularly the premature babies, although we've used it in all types of populations," Tero said.
"It has reduced our need for invasive respiratory support, resulting in less complications and lower chronic lung disease rates."
Vapotherm, which employs 51 people, is poised to grow "substantially" during the next six to 12 months and to launch new products by the end of the year, Thibodeau said.
He said production of the approved device will be outsourced to companies in the U.S. and offshore.
Final assembly will be performed at the company's headquarters.