Zetagen Therapeutics announced today that it received FDA breakthrough device designation for its ZetaMet cancer treatment technology.

Syracuse, New York-based Zetagen designed its ZetaMet (previously known as ZetaFuse) as a synthetic, small-molecule, inductive biologic technology for targeting and resolving metastatic bone lesions while inhibiting future tumor growth and regenerating bone.

According to a news release, ZetaMet works through a mechanism of action, a novel and patented molecular pathway in which the precisely dosed small molecule is delivered to the affected area through a proprietary drug-eluting carrier. The small molecule then stimulates stem cells, activating the cells to grow healthy bone known as osteoblasts while inhibiting cells associated with bone degradation called osteoclasts.

The company said it has successfully passed its preclinical trials and has plans for its first human clinical trial to commence in early 2022.

“We are pleased to receive this important designation from the Agency and look forward to partnering with them,” Zetagen Therapeutics CEO Joe C. Loy said in the release. “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 for the hundreds of thousands of patients living with cancers that involve metastatic bone lesions.”