On December 9, 2021 Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company that works out of Upstate Medical University’s Central New York Biotech Accelerator (CNYBAC), reported that it has received Breakthrough Device designation from the Centers for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) for its ZetaMet technology (Press release, SUNY Upstate, DEC 9, 2021, View Source [SID1234596803]).

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Previously known as ZetaFuse, ZetaMet is a synthetic, small-molecule, inductive biologic technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone.

ZetaMet works through a mechanism of action (MOA) which is a novel and patented molecular pathway. The small molecule, precisely-dosed, delivered to the affected area through a proprietary drug-eluting carrier, stimulates stem cells, activating cells to grow healthy bone known as "osteoblasts", and inhibits cells associated with bone degradation called "osteoclasts". The combination technology has, thus far, in preclinical studies, demonstrated its ability to resolve existing metastatic bone lesions, inhibit pain and stimulate targeted bone regeneration.

"We are pleased to receive this important designation from the Agency and look forward to partnering with them," said Joe C. Loy, CEO of Zetagen Therapeutics. "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."

Loy credits the CNYBAC with Zetagen’s success. "The Biotech Accelerator has been instrumental in helping Zetagen access the necessary resources needed to continue to grow and enhance our business," Loy said. "Whether it be educational, business or even physical space capacity, the continued support from the program has been invaluable. During these pandemic times, when so many early-stage companies have found it difficult to survive, the SUNY Bioaccelerator has helped us thrive."

Loy continued, "At Zetagen, we have been grateful to have the Biotech Accelerator as a venue to support and grow our innovative therapeutics."

In addition to laboratory space, startups in the CNYBAC can also gain expert assistance through access to SUNY Upstate faculty, and to specialists in areas such as FDA submissions and intellectual property concerns.

Zetagen started in a collaborative, shared wet lab space within the Biotech Accelerator and then expanded into its own, full lab of more than 900 square feet as its technology and funding has progressed.

Kathi Durdon, executive director of the CNYBAC applauded Zetagen for its success. "Zetagen is a perfect example of how the CNYBAC is fertile ground for the biomedical sciences and biotechnology ventures."

The CNYBAC currently has 22 clients.