Theradaptive has announced that the first patient has been treated in its Phase I/II OASIS Trial, a cutting-edge study evaluating the safety and effectiveness of OsteoAdapt SP in spinal fusion procedures
FREDERICK, Md., Sept. 11, 2024 /PRNewswire/ -- Theradaptive, Inc., a market leader in targeted regenerative therapeutics, today announced that the first patient has been treated in its Phase I/II OASIS Trial. The patient was treated by Dr. David Schwartz, MD, MBA, Spine Surgeon at OrthoIndy Hospital in Indianapolis, Indiana.
“OrthoIndy has a proud history of clinical research, including the original recombinant BMP spinal fusion studies more than 25 years ago,” said Dr. David Schwartz, MD, MBA. “Theradaptive’s technology represents a significant advancement in the application of these potent bone forming proteins, and I’m excited to be a part of this important clinical study to evaluate safety and effectiveness in a relevant patient population.”
The OASIS Trial is a prospective, blinded, controlled, dose-randomized, multicenter, investigational study evaluating the safety and effectiveness of OsteoAdapt SP in single-level Transforaminal Lumbar Interbody Fusion (TLIF) procedures for the treatment of symptomatic degenerative diseases of the lumbosacral spine. The primary focus of the clinical study is to evaluate the dosing, safety and efficacy of OsteoAdapt SP as an alternative for autologous bone graft, the current standard of care in spinal fusion surgery.
The demand for spinal fusion surgery continues to increase in line with an aging population, with 40% of adults over 40 and 80% of adults over 80 experiencing at least one degenerated disc. While autologous bone graft – which involves harvesting bone from the patient’s own body – remains the standard treatment approach, there are challenges due to limited availability of bone graft and donor-site morbidity, amongst other complications. Alternative procedures, such as artificial implants and donor bone, also present notable issues, including a failure rate of up to 35%. OsteoAdapt SP aims to combat these issues by offering a more powerful, precise, and persistent solution, while addressing the limitations of existing options.
“It is an incredible moment to reach the stage where we can bring a much-needed advance in spinal fusion surgery to patients for the first time,” stated Dr. Luis Alvarez, Founder and CEO of Theradaptive. “This milestone validates not only our approach to spinal fusion but highlights our broader strategy to unlock the power of therapeutics and anatomically precise bone regeneration for patients through our unique protein engineering technology.”
About OsteoAdapt SP
OsteoAdapt SP is an investigational therapeutic for patients with degenerative disc disease, a condition characterized by the deterioration of spinal joints, which leads to pain and dysfunction. OsteoAdapt SP contains a next-generation protein called AMP2, which retains the powerful bone formation properties of recombinant human bone morphogenetic protein-2 (rhBMP-2) but without its off-target effects. Preclinical studies suggest that OsteoAdapt SP may offer improved safety and effectiveness compared to spinal fusion grafts. OsteoAdapt is also being developed for dental, orthopedic, sports medicine and veterinary applications.CAUTION – OsteoAdapt SP is an investigational device. Limited by Federal law to investigational use or clinical trial use.
About Theradaptive
Theradaptive is a venture-backed biopharmaceutical and medical device company based in Frederick, Maryland. The company aims to leverage its therapeutic delivery platform to deliver biologics to targeted areas in the body with high levels of precision and persistence, addressing 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. For more information on Theradaptive and its clinical development program, visit www.theradaptive.com and follow the company on LinkedIn.The work was supported by the Assistant Secretary of Defense for Health Affairs in the Department of Defense, 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: Serena Lertora, serena.lertora@theradaptive.com
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SOURCE Theradaptive
