Theradaptive announced that the first patient has been treated in its Phase I/II OASIS Trial.
OASIS 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) 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.
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.
“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.”
Theradaptive announced that the first patient has been treated in its Phase I/II OASIS Trial.
OASIS 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) for the treatment of symptomatic...
Theradaptive announced that the first patient has been treated in its Phase I/II OASIS Trial.
OASIS 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) 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.
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.
“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.”
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