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AgNovos Healthcare and Asahi Kasei Pharma Enter Into an Exclusive Option Agreement for Japan

AgNovos Healthcare, LLC (“AgNovos”) and Asahi Kasei Pharma Corporation (“Asahi Kasei Pharma”) announced today that the companies have entered into an exclusive option agreement for the commercialization of AgNovos’ AGN1 LOEP Hip Kit in Japan. The kit is used to perform a minimally invasive procedure to treat osteoporotic bone loss in the hip.

AgNovos will receive up to $19.5 million of non-dilutive funding. If the AGN1 LOEP Hip Kit is successfully developed and commercialized, AgNovos will be eligible to receive up to $103 million in additional payments and will also receive double-digit royalties on product sales in Japan, that AgNovos estimates could be worth more than $400 million during the term. AgNovos and Asahi Kasei Pharma have agreed to collaborate on all aspects of Japanese market entry and launch.

Tanner Howe, CEO of AgNovos, commented: “We are excited to enter into this agreement with Asahi Kasei Pharma, a proven leader and innovator in the commercialization of osteoporosis treatments in Japan. This partnership validates the promise that our technology can help to address the persistent unmet needs in osteoporosis care in Japan. Asahi Kasei Pharma’s team is experienced, and their network is expansive, making them an ideal partner for us in Japan.”

Yoshikazu Aoki, President of Asahi Kasei Pharma, commented: “We envision the option agreement with AgNovos to be an important step into the medical device business and believe that the AGN1 LOEP Hip Kit may contribute to a better life and living for people who suffer from osteoporosis. We look forward to collaborating with AgNovos for the Japanese market.”

About Osteoporosis and Hip Fragility Fractures

Osteoporosis is characterized by bone loss and reduced bone strength, increasing the risk of fragility fractures. These fractures result from low-energy trauma such as a fall from standing height. The risk of falls resulting in fractures is influenced by the severity of bone loss. The most debilitating type of fragility fractures occur at the hip. These fractures are associated with significant morbidity and mortality, and often create significant burden for affected individuals, families, and healthcare systems. More than two million hip fragility fractures occur globally annually and 200,000 take place in Japan.

About AGN1 LOEP Hip Kit

The AGN1 LOEP Hip Kit contains the instruments and materials to perform a minimally invasive procedure to implant AGN1, a proprietary, calcium-based, osteoconductive, and tri-phasic implant material. AGN1 is uniquely formulated with a cell-friendly surface architecture and a resorption profile that enables the rapid formation of new bone. Preclinical and clinical research has shown that AGN1 LOEP treatment delivers immediate, substantial and durable increase in the strength of osteoporotic femurs. The kit is available in select markets under the brand name OSSURE® LOEP kit.

About AgNovos Healthcare

AgNovos Healthcare is a developer of new therapies that leverage proprietary, bone-building technology and regenerative medicine to address unmet needs in the treatment of bone disease. AgNovos Healthcare is privately held and has its corporate headquarters in New York City with manufacturing, research & development, and corporate support services located in Rockville, MD. www.agnovos.com

About Asahi Kasei Pharma

In accordance with the Asahi Kasei Pharma Mission "To sincerely care for each individual life and solve their unmet medical needs with a wealth of ideas and solid science," Asahi Kasei Pharma operates pharmaceutical and diagnostic businesses in the Health Care Business Unit of the Asahi Kasei Group. For more information, please visit https://www.asahikasei-pharma.co.jp/en/ .

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