Primary Focus

Spine fusion is a prevalent procedure performed by orthopedic surgeons and neurosurgeons in order to address spinal deformities and provide stability. Over 400,000 spine fusion surgeries are performed annually in the US. This number is expected to increase significantly over the coming years. Annually, the aggregate hospital cost associated with spine fusion surgeries surpasses $13 billion, the highest of any surgical procedure. Of course, poor clinical outcomes, such as ‘failed fusions’, not only add to this high cost but also cause immense setbacks in patients who often must suffer through repeated surgeries. For example, failed fusions can occur in up to 40% of spine fusion surgeries using autologous bone grafts, even when grafting the patient’s own iliac crest bone, the so called “gold-standard” for these procedures.

That is why the use of osteoinductive growth factors in bone graft materials, such as recombinant human bone morphogenetic protein 2 (rhBMP2), has become popular, particularly for spine fusion procedures. However, rhBMP2 is produced using expensive recombinant DNA technology and carry their own set of risks, such as uncontrolled or ectopic bone formation, among others. For that reason, we are developing Oxy133, a semi-synthetic osteogenic compound with excellent osteoinductive properties that stimulates bone formation through a different and effective bone forming mechanism than rhBMP2. Oxy133 is an oxysterol-based small molecule, inexpensive and readily produced (compared to recombinant human proteins), shelf stable and easy to use during orthopedic procedures. Oxy133 stimulates bone formation by selectively targeting mesenchymal stem cells as well as other osteoprogenitor cells in the body through allosteric activation of the osteoinductive Hedgehog signaling pathway. Under the right conditions, these cells can transform themselves and help form and repair certain tissues, such as bone, muscle, fat and cartilage. Oxy133 can induce mesenchymal stem cells to differentiate exclusively into bone forming cells (osteoblasts), and prevents them from converting into fat cells (unlike rhBMP2 that stimulates the formation of both bone and fat cells). In humans, the formation of new fat cells in bone often occurs at the expense of bone forming osteoblasts, especially as we age. We believe that Oxy133 could enter the market as a viable alternative to rhBMP2 (Infuse®), a leading product on the market for spine fusion despite its less than favorable safety profile and high cost, and other bone graft materials and lead to improved patient safety and outcomes. We have demonstrated robust bone formation by Oxy133 in animal models of spine fusion, such as in rat and rabbit models as well as the healing of cranial and maxillofacial bone defects. This program is currently about 12 months from entering human clinical trials and the Company has engaged Bruder Consulting and Venture Group (BCVG) that is putting together its pre-IDE and IDE activities toward human clinical trials.

Spine fusion is a prevalent procedure performed by orthopedic surgeons and neurosurgeons in order to address spinal deformities and provide stability. Over 400,000 spine fusion surgeries are performed annually in the US. This number is expected to increase significantly over the coming years. Annually, the aggregate hospital cost associated with spine fusion surgeries surpasses $13 billion, the highest of any surgical procedure. Of course, poor clinical outcomes, such as ‘failed fusions’, not only add to this high cost but also cause immense setbacks in patients who often must suffer through repeated surgeries. For example, failed fusions can occur in up to 40% of spine fusion surgeries using autologous bone grafts, even when grafting the patient’s own iliac crest bone, the so called “gold-standard” for these procedures.

That is why the use of osteoinductive growth factors in bone graft materials, such as recombinant human bone morphogenetic protein 2 (rhBMP2), has become popular, particularly for spine fusion procedures. However, rhBMP2 is produced using expensive recombinant DNA technology and carry their own set of risks, such as uncontrolled or ectopic bone formation, among others. For that reason, we are developing Oxy133, a semi-synthetic osteogenic compound with excellent osteoinductive properties that stimulates bone formation through a different and effective bone forming mechanism than rhBMP2. Oxy133 is an oxysterol-based small molecule, inexpensive and readily produced (compared to recombinant human proteins), shelf stable and easy to use during orthopedic procedures. Oxy133 stimulates bone formation by selectively targeting mesenchymal stem cells as well as other osteoprogenitor cells in the body through allosteric activation of the osteoinductive Hedgehog signaling pathway. Under the right conditions, these cells can transform themselves and help form and repair certain tissues, such as bone, muscle, fat and cartilage. Oxy133 can induce mesenchymal stem cells to differentiate exclusively into bone forming cells (osteoblasts), and prevents them from converting into fat cells (unlike rhBMP2 that stimulates the formation of both bone and fat cells). In humans, the formation of new fat cells in bone often occurs at the expense of bone forming osteoblasts, especially as we age. We believe that Oxy133 could enter the market as a viable alternative to rhBMP2 (Infuse®), a leading product on the market for spine fusion despite its less than favorable safety profile and high cost, and other bone graft materials and lead to improved patient safety and outcomes. We have demonstrated robust bone formation by Oxy133 in animal models of spine fusion, such as in rat and rabbit models as well as the healing of cranial and maxillofacial bone defects. This program is currently about 12 months from entering human clinical trials and the Company has engaged Bruder Consulting and Venture Group (BCVG) that is putting together its pre-IDE and IDE activities toward human clinical trials.