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Global study will assess the safety and efficacy of the company's lead spinal fusion product, OsteoAdapt SP FREDERICK, Md., Feb. 1, 2024 /PRNewswire/ -- Theradaptive, the market leader in targeted regenerative therapeutics, has gained approval from the U.S. Food and Drug Administration (FDA) for their Investigational Device Exemption (IDE) submission to begin enrolling patients into OASIS, their global Phase I/II Feasibility study in spine fusion. With an aging population, more people will suffer from debilitating spinal conditions. Around 40% of adults over the age of 40 and 80% of adults over the age of 80 have at least one degenerated vertebral disc. Currently, more than 1 in 6 Americans are over the age of 65 and this proportion is increasing. However, current spinal fusion treatments can leave patients with sub-optimal outcomes, and often suffering from excruciating pain. Theradaptive's spinal fusion product, OsteoAdapt SP, aims to provide safer and more effective treatments for transforaminal lumbar interbody fusion (TLIF) procedures, whereby vertebrae in the lower back are fused in a minimally invasive posterior procedure. It is used for a range of conditions including degenerative disc disease, lumbar spondylolisthesis, and spinal stenosis. Theradaptive's therapeutic platform aims to improve efficacy and safety by creating material-binding variants of recombinant proteins that bind to medical devices, implants and injectable carriers to achieve anatomically-precise and locally-sustained therapeutic delivery. IDE approval from the FDA serves as a key milestone for this platform and will generate its first human clinical data, thus opening a new chapter in Theradaptive's growth into a clinical-stage company. Starting in April, this study of 80 patients will assess the safety and efficacy of OsteoAdapt SP. The feasibility study will also identify the required OsteoAdapt SP dose that will be investigated in a future pivotal study. The study will produce early interim data to permit interim assessments of safety and efficacy. More details can be found at ClinicalTrials.gov identifier NCT06154005. Theradaptive's path to FDA IDE approval has been aided by their unprecedented three Breakthrough Medical Device Designations which provide them with priority review and interactive communication regarding device development and clinical trial protocols. John Greenbaum, SVP of Regulatory & Clinical Affairs at Theradaptive, said: "The FDA created Breakthrough Device Designations to accelerate the clinical trials and approval processes for devices that promise to improve on current treatments for life-threatening and debilitating conditions. The fact that OsteoAdapt has been awarded three Breakthrough Device Designations is an indicator of the ground-breaking nature of the technology. The FDA has extensive experience with rh-BMP2, which was used to design the AMP2 biologic within OsteoAdapt. Based on the safety profile of OsteoAdapt, we will be allowed to combine Phase I and II trials. We can now apply these insights to our other programs in dental, orthopedics, and sports medicine." Dr. Brett Freedman, Chair, Spine Surgery Division, Mayo Clinic said: "The FDA's approval to combine Phase I and II into one feasibility trial, along with three Breakthrough Designations is a strong signal that OsteoAdapt SP shows promise to significantly improve our current therapeutic offerings in the area of bone graft, and more importantly that OsteoAdapt SP represents a valid solution to long unmet needs in spinal fusion. OsteoAdapt has beaten the standard of care in every preclinical study to date and we're excited by the prospect of proving the same in humans and overcoming limitations with the current standard of care". Theradaptive's clinical work is supported in part by a Department of Defense Clinical Trial Award under the Peer Reviewed Medical Research Program and the Maryland Stem Cell Research Fund. In addition to spine, Theradaptive has active development programs in trauma, orthopedic, dental, craniomaxillofacial repair, and bone-tendon and bone-ligament repair for sports medicine indications, all based on the OsteoAdapt product. The company is actively collaborating with physicians to advance each of those indications into the clinic on the back of its IDE approval in spine. Theradaptive CEO and founder Luis Alvarez, PhD, commented on synergies with these other programs: "Advancing OsteoAdapt into the clinic under this IDE will also enable acceleration of partnered programs that use OsteoAdapt as a component. One key example is our partnership with 3D Systems where we are developing products that incorporate OsteoAdapt in 3D printed implants using our OrthoTex 3D printable graft containment system. This accelerates the development of truly regenerative 3D printed implants for applications in cranial repair and sports medicine." About Theradaptive Founded in 2016 and headquartered in Maryland, U.S., Theradaptive is a venture-backed biopharmaceutical and medical device company with the goal of leveraging its therapeutic delivery platform to deliver biologics where they are needed in the body with high local precision and high persistence to address unmet medical needs. Theradaptive's innovative platform is enabling the development of new therapeutics in spine, orthopedics, and soft tissue repair as well as targeted immuno-oncology. The work was supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $7,408,939, through the Peer Reviewed Medical Research Program under Award No. HT9425-23-1-0693. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense. Contact: Marcus McCabe [email protected] SOURCE Theradaptive

The Korean bio-regenerative medicine developer has developed the second-generation material using recombinant human bone morphogenetic protein 2 for spine implantation CGBio has secured FDA breakthrough status for Novosis Putty. (Credit: Kenny Eliason on Unsplash) CGBio has received Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA) for its advanced bone substitute material, Novosis Putty. The Korean bio-regenerative medicine developer has developed this second-generation material using recombinant human bone morphogenetic protein 2 (rhBMP-2). Novosis Putty is said to be the first such implantable medical device in Korea for spine implantation. It incorporates a ceramic-based synthetic scaffold with advanced moldability and osteoconductive properties. In addition, the material features advanced sustained-release formulation technology (SLOREL) from its predecessor, Novosis Ortho. Novosis Putty’s key ingredient is rhBMP-2, which is a mass-produced by South Korean pharma firm Daewoong Pharmaceutical. According to CGBio, the protein supports bone regeneration and helps transform stem cells into bone cells in cases of bone defect. It is globally known as Nebotermin and recognised by organisations, including the World Health Organization (WHO). CGBio CEO Hyun Seung Yu said: “The breakthrough device designation for Novosis Putty is further proof of CGBio’s technological prowess, innovation, and potential. “With the designation’s emphasis on quickly bringing beneficial products to market, we are committed to helping more patients overcome diseases and return to healthy lives through Novosis Putty.” The breakthrough status for the bone substitute material is expected to result in prioritised FDA support during the approval process. During this support, the American health regulator maintains continuous communication, assigns a specialised review team, and prioritises the review of clinical trial design to approval. This in turn will accelerate the FDA approval and allow rapid entry into the US market compared to other devices. CGBio has finished a preclinical trial for Novosis Putty and is conducting clinical trials to identify the optimal dosage. The bio-regenerative medicine firm has plans to apply for US confirmatory clinical trials in the first half of 2024.