A Sacramento medical-device startup said Monday it’s teaming up with two other area companies, including one of the region’s leading heating-cooling contractors, to manufacture its first product, a home purification system designed to prevent lung infections in children with cystic fibrosis.
The Asthma & Allergy Prevention Co. of Sacramento said it has signed a letter of intent with heating-cooling contractor Beutler Corp. to build and install the purification product, known as Syntopical System I. The company also signed a letter of intent with a Sacramento engineering design firm, HTA Science & Engineering, to work on the system.
Frank Hagie, co-founder and president of Asthma & Allergy, said the letters of intent are a significant milestone in the 3-year-old company’s quest to bring the product to market.
At the same time, the company is pursuing fast-track approvals from the U.S. Food and Drug Administration, which must clear the system before it can be marketed.
Hagie said Asthma & Allergy will soon ask the FDA for a “humanitarian device exemption.” If approved, the exemption would streamline the approval process. Humanitarian exemptions are reserved for products that would only serve a tiny segment of the population.
Hagie said the FDA has already granted the product “humanitarian use device” status, a first step in the streamlining process.
The product is a kind of whole-house environmental control system designed to purify the air, water supply and even surfaces within the home, “like a medical clean room,” Hagie said.
“We’re trying to focus on disease prevention,” he said.
Beutler would become the contract manufacturer and would install the devices in customers’ homes. The company is a natural choice; it already serves as Asthma & Allergy’s “incubator,” providing work space and access to technology, Hagie said.