FDA OKs Home Oxygen Liquefaction System

Denver

An in-home system that converts gaseous oxygen to liquid form received FDA clearance in late April.

In-X Corp.’s Home-Away system “will enable patients on [long-term oxygen therapy] to remain mobile and maintain their quality of life,” said company President Doug Powell. “Additionally, it is exciting news for home health care providers because it eliminates costly and time-consuming deliveries … .”

Powell explained that the system takes “feed flow from an oxygen concentrator and sends a portion of it through a cryogenic cooling device that chills to the temperature at which oxygen condenses [into liquid form].” The liquid oxygen is stored until it’s ready to be transfilled into a portable, 4.2-pound unit that can give a typical patient six to eight hours worth of oxygen.

“This basically gives the patient an unlimited supply of liquid O2,” Powell said, adding that the new technology is in line with a push to lower costs through fewer home deliveries.

“As cost goes up to deliver and the reimbursement goes down, [providers] are going to look at that radius [of the coverage area] they’re servicing and tighten up. So what will happen to the folks in those outer areas?”

The company expects to have the system ready for sale during the last quarter this year with delivery to begin in early 2006.

The FDA clearance has been a long time coming, Powell said. A prototype unit was introduced about five years ago, and “we’ve gone through a number of iterations based on that early concept,” he explained. “Every time you make a change, you have to re-apply [with the FDA].”

The company had hoped to gain FDA approval for the product in time for Medtrade Spring in early April.

With the product finally on its way to the market, observers say they are waiting to see if it meets the kind of success other home oxygen filling systems have experienced during the last year. Elyria, Ohio-based Invacare Corp. attributed growth in its North American respiratory sales — 43 percent over all of 2004 and 16 percent during first quarter 2005 — to its HomeFill product line, along with strong concentrator sales. Meanwhile, Chatsworth Calif.-based Chad Therapeutics said shipments of its Total O(2) Delivery System for the third quarter, which ended Dec. 31, had tripled over prior-year results.

He added that the new technology is in line with the industry’s push to lower costs through fewer in-home deliveries.