Medical startup seeks FDA approval for lung-disease product

Published: Tuesday, Jul. 29, 2014 - 10:41 am

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 FDA’s “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 Bee’s Dale Kasler, (916) 321-1066. Follow him on Twitter @dakasler.

Read more articles by Dale Kasler

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