Conducting FDA nonclinical studies for bone fusion product. This includes the 10993 Tox and IDE definitive efficacy study which the FDA has endorsed us to complete.
OssiFi is a private Medtech/Pharma hybrid company developing market disruptive anti-sclerostin small molecules for acceleration of bone fusion, fracture healing and for increasing bone quality in systemic bone disease. Please visit www.ossifi.com for more detailed information or contact me at [email protected].
The company is focused on bringing to market new small molecules that target the human sclerostin protein. Sclerostin has been dubbed the most sought after bone building target of our century. Evenity (Amgen) was FDA approved in 2019 to reduce fractures in osteoporotic women (grossing $1.4B in revenues in 2024) and Setrusumab (Ultragenyx), which is in clinical trials for the orphan disease, Osteogenesis Imperfecta, both are injectable antibodies targeting sclerostin.
OssiFi is developing the first orally available pill for systemic bone disease (market of $12B) and a next generation synthetic bone graft (non-cadaver; market $7B) containing our anti-sclerostin small molecule.
OssiFi's team consists of very talented scientists including the scientist who discovered the sclerostin protein mechanisms of action and in Evenity's development, and the lead scientist for Medtronic's Infuse Bone graft, which after two decades is still the leading bone graft on the market.
OssiFi is differentiated from both of these excellent products by:
Its ability to be administered orally and not by injection
Low cost to manufacture
Safety profile
Different mechanism than BMP and thus no heterotopic bone
Long shelf life stability without the need of refrigeration
…and many more.
We have been invited to present our findings at leading global clinical conferences this year and are getting tremendous traction with clinicians. Surgeons across the US are excited and anxious to see these products ready for human use.
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