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Theradaptive Treats First Patient in OASIS Trial for Spinal Fusion with OsteoAdapt SP

• Theradaptive has initiated its Phase I/II OASIS trial, evaluating OsteoAdapt SP for spinal fusion, with the first patient successfully treated. • The OASIS trial is a multicenter, blinded, controlled study assessing the safety and efficacy of OsteoAdapt SP as an alternative to autologous bone graft in TLIF procedures. • OsteoAdapt SP contains AMP2, a next-generation protein designed to enhance bone formation without the off-target effects associated with rhBMP-2. • The trial addresses the increasing demand for spinal fusion and the limitations of current treatments like autologous bone grafts and artificial implants.

Theradaptive has announced the treatment of the first patient in its Phase I/II OASIS (OsteoAdapt SP in Spinal Fusion) clinical trial. The trial is designed to evaluate the safety and effectiveness of OsteoAdapt SP in patients undergoing single-level Transforaminal Lumbar Interbody Fusion (TLIF) for symptomatic degenerative diseases of the lumbosacral spine.
The first patient was treated by Dr. David Schwartz at OrthoIndy Hospital in Indianapolis, Indiana. The OASIS trial is a prospective, blinded, controlled, dose-randomized, multicenter study. Its primary objective is to assess the dosing, safety, and efficacy of OsteoAdapt SP as a substitute for autologous bone graft, which is the current standard of care in spinal fusion surgery.

Addressing Limitations of Current Spinal Fusion Techniques

The demand for spinal fusion surgery is growing due to 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 remains a common treatment, it presents challenges such as limited availability and donor-site morbidity. Alternative procedures, including artificial implants and donor bone, have failure rates of up to 35%. OsteoAdapt SP aims to overcome these limitations by providing a more effective and precise solution.

OsteoAdapt SP: A Novel Approach to Bone Regeneration

OsteoAdapt SP is an investigational therapeutic containing AMP2, a next-generation protein that retains the bone-forming properties of recombinant human bone morphogenetic protein-2 (rhBMP-2) but is designed to mitigate its off-target effects. Preclinical studies suggest that OsteoAdapt SP may offer improved safety and effectiveness compared to traditional spinal fusion grafts. OsteoAdapt is also under development for dental, orthopedic, sports medicine, and veterinary applications.

Theradaptive's Vision for Targeted Therapeutics

"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," said 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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Reference News

[1]
THERADAPTIVE ANNOUNCES FIRST PATIENT TREATED IN OASIS CLINICAL TRIAL OF ...
prnewswire.com · Sep 11, 2024

Theradaptive's Phase I/II OASIS Trial treats first patient with OsteoAdapt SP in spinal fusion, aiming to improve safety...

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