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Urine bag FDA approval could help prevent deaths from sepsis

12:49 pm by | 0 Comments

The specialty medical equipment company Future Path Medical has received regulatory clearance for its first product: a urine bag monitored with wireless technology.

The Columbus, Ohio-area company received 510(k) clearance from the U.S. Food and Drug Administration for its iBag System, an FDA spokeswoman said. Future Path’s urine bag system could help prevent deaths from sepsis, a severe and life-threatening infection in which the bloodstream is overwhelmed by bacteria.

The company says its disposable vinyl bag and wireless urology monitoring sensors reduces the likelihood of urine spills and provides an early warning if bladder temperature increases, which can signal the possibility of infection. Infection and eventual deaths from sepsis can occur when urine bags become filled and backed up.

The iBag System will be available with a doctor’s prescription via the company’s web page and through select distribution partners which Future Path is now building.

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The issue of combating hospital-acquired infections has taken on increased importance to the U.S. health system in recent years. A recent study in the Archives of Internal Medicine found that two of the most common types of hospital-acquired infections — sepsis and pneumonia — killed 48,000 people and increased health costs by $8.1 billion in 2006.

Urinary tract infections account for about 40 percent of all healthcare-associated infections, and the “overwhelming majority” of those are associated with catheters, Medscape News reported.

The company will initially target the home and rehabilitation hospital markets for patients who are quadriplegics or severely disabled. A second product that hasn’t received regulatory approval, UroSense, will be targeted toward the hospital intensive care unit market.

Like many healthcare startups, Future Path was born from personal tragedy suffered by the company’s founder. Christopher Bryant, the son of founder and chairman Ty Bryant, lived for about eight years as a quadriplegic after a diving accident. Christopher died in 2005 from  a case of sepsis that resulted from ulcers caused by a urine bag overflow in his hospital bed.

Bryant projects that the home market could support annual sales of about 40 million units, while the hospital market would support about 9 million units annually. Based on projected sales prices ($9 per bag), that would come out to a market opportunity of about $360 million annually for the iBag (home) and about $160 million for the UroSense (hospital).

Bryant wouldn’t provide specifics on when Future Path might file for regulatory approval of the hospital-targeted urine management system, saying it would happen “as soon as possible.”

The company is raising $400,000 to help fund manufacturing and distribution of its products, Bryant said. He declined to specify how much investment capital the company has pulled in since its inception.

Future Path recently hired a CEO, Brian Gilbert, who has experience in wireless technology from working with Cisco and various startups.

The company has filed for three patents around its technology and has thus far been issued one.

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Brandon Glenn

By Brandon Glenn MedCity News

Brandon Glenn is the Ohio bureau chief for MedCity News.
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