Osteo-Pharma and Emultech Announce Joint Venture to Develop First-in-Class Disease-Modifying Treatment for Osteoarthritis

Emultech and Osteo-Pharma today announced a joint venture, Bone-Tech, to develop what could be the first disease-modifying treatment for osteoarthritis of the knee. Bone-Tech brings together Osteo-Pharma's novel combination drug therapy for the local treatment of osteoarthritis with Emultech's world-leading microfluidics' microspheres technology. Bone-Tech's patented OsteoActivator^TM microspheres treatment promises to be the first and only extended-release treatment targeting subchondral bone remodelling for patients suffering from osteoarthritis-related pain and disability.

Osteoarthritis (OA), the most common form of arthritis, is a chronic, degenerative disease affecting over 1.5 billion people globally. OA causes life-long pain and is a leading cause of disability in the US and worldwide, accounting for >$185 billion in annual costs in the US alone in 2016. In OA patients, subchondral bone is characterized by impaired bone remodelling and the presence of bone marrow lesions (BML). BML's are a hallmark in OA diagnosis and are strongly associated with pain, are a prognostic marker for cartilage loss and are predictive for the need for knee replacement surgery.

"Intraosseous injection of OsteoActivator^TM microspheres directly into subchondral bone locally targets osteoblast and osteoclast cells to restore bone remodelling, improves bone quality and relieves pain. There are currently no disease modifying treatments in the OA therapies market, and as such, OsteoActivator^TM microspheres will be the first of its kind", said Jan Gossen, CEO of Osteo-Pharma.

"With its extended-release microsphere formulation, we believe the Bone-Tech product holds the potential to disrupt the current treatment paradigm, and we are dedicated to bringing this important new therapy to market for the millions of patients confronting this relentless disease", said Rene Hansen, CEO of Emultech.

Bone-Tech's novel approach has demonstrated proof-of-concept in in-vitro and animal studies and is under development in preparation for IND filing and first-in-man studies. The Bone-Tech product employs proprietary microsphere technology for the extended-release of a combination of two well-known therapeutic agents delivered via intraosseous injection. Bone-Tech plans to pursue a rapid and low-risk 505(b)(2) strategy to progress the product through clinical trials.