![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Zetagen’s ZetaMet for Bone Cancer Designated FDA Breakthrough Device
Zetagen’s ZetaMet for Bone Cancer Designated FDA Breakthrough Device
Syracuse, N.Y.-based Zetagen Therapeutics has received the FDA’s Breakthrough Device designation for ZetaMet, a combination drug-device technology for treating bone lesions.
ZetaMet delivers a precise dose of a synthetic, small-molecule drug that targets metastatic bone lesions while inhibiting future tumor growth and regenerating bone. The treatment activates stem cells to grow healthy bone and inhibits cells associated with bone degradation.
“Our researchers have discovered an entirely new pathway for an established molecule which, if proven successful in human clinical trials, could create a new treatment paradigm,” said Zetagen CEO Joe Loy. The company expects to launch a clinical trial early next year.
Upcoming Events
-
21Oct