A Sacramento medical-device startup and its partners are about to seek U.S. Food and Drug Administration approval for its first product, a home-purification system aimed at fighting lung infections in cystic fibrosis patients.
The Asthma & Allergy Prevention Co. is developing the product with two partners, heating-cooling contractor Beutler Corp. and design firm HTA Science & Engineering. Asthma & Allergy said the group will submit the product to the FDA for a license.
The product is called Syntopical System I and is a device for purifying the air, water and surfaces in the home.
Ashthma & Allergy and its partners are seeking FDA approval for a humanitarian device exemption, which would expedite approval.
Such exemptions are designed for diseases that are so rare, a developer might not be able to make a profit if it had to go through the typical approval process, according to the FDA.
The Syntopical product already has received the FDAs humanitarian use designation, a first step in the expedited process.
Beutler will manufacture the products; its main office at McClellan Park also serves as the incubator for Asthma & Allergy.
Call The Bees Dale Kasler, (916) 321-1066. Follow him on Twitter @dakasler.