Summary: ZetaGen, an early stage regenerative medicine company, is developing products that grow bone by activating a novel molecular pathway in mesenchymal stem cells. Discovered serendipitously, ZetaGen is commercializing a small molecule-based osteoinductive platform technology that addresses a large unmet need for several medical applications for which bone growth leads to optimal outcomes. As opposed to other products on the market that contain biologic growth factors, which have declined in use precipitously due to high cancer risk and other side effects, ZetaGen’s solution is more effective at growing bone, has a unique safety profile, and is significantly more cost effective to manufacture. ZetaGen’s first product, ZetaFuse™, is a drug-device combination product that has been designated as a device by FDA and utilizes components with well-established clinical safety profiles.
Need: There are approximately 7 million fractures, 1 million joint replacements, 600,000 cases of bone tumor and 500,000 spine fusions annually in the US. While these conditions and treatments are disparate in presentation and cause, the outcomes for each rely on successful bone growth. Each can be compromised by slow, incomplete, or weak bone formation, leading to significant patient complications. Treatment for these compromised cases is even more difficult and expensive than the initial procedure. Our goal is to provide a solution for these challenging cases.
Value: ZetaFuse™ has a unique set of benefits driven by the activation of a novel molecular pathway. By leveraging this unique mechanism, ZetaFuse grows bone by directly turning stem cells into osteoblasts (osteoinductive), prevents bone resorption (anti-osteolytic), and stops tumor cell division (anti-tumorigenic). Importantly, ZetaFuse is a drug-device combination product built on a novel, small molecule-based osteogenic platform technology. As opposed to other products on the market that contain biologic growth factors, which have seen a precipitous decline in use due to high cancer risk and significant side effects, ZetaFuse will also be significantly more cost effective to manufacture and leverage components with well-established clinical safety profiles.