Patient shares early success story as OrthoIndy seeks additional patients with degenerative disc disease to take part in the study
INDIANAPOLIS—OrthoIndy, a leader in advanced orthopedic care, is proud to be the first orthopedic practice worldwide to treat patients in a new clinical trial evaluating an innovative spinal fusion implant for degenerative spine conditions. The Phase I/II OASIS trial is assessing the safety and effectiveness of OsteoAdapt SP, an investigational device developed by Theradaptive, Inc., to address challenges associated with traditional bone grafts and artificial implants in spinal fusion, a procedure that stabilizes and connects bones in the spine.
Unlike traditional bone grafts, the OsteoAdapt SP implant is made from synthetic material and contains a specially engineered protein designed to encourage bone growth. The implant eliminates the risk of disease transmission that can be associated with donor bone grafts. It may also reduce or even prevent chronic pain some patients experience with bone grafts recovered from their own bodies.
Dr. David Schwartz, a spine surgeon at OrthoIndy Hospital, performed the first procedure in the trial, followed by fellow OrthoIndy spine surgeon Dr. M. Craig McMains, who recently performed the second procedure.
“OrthoIndy has a proud history of clinical research, including early work in recombinant BMP spinal fusion studies over 25 years ago,” said Dr. Schwartz. “Theradaptive’s technology represents a significant advancement in the application of these potent bone-forming proteins, and I’m honored to be a part of this important clinical study to help evaluate the potential to improve spinal fusion outcomes for my patients and others worldwide.”
Early Success Story
The OASIS trial is randomized, with every two out of three patients receiving a spinal fusion with OsteoAdapt SP. Despite not knowing which option he received, the study’s first patient, Jay Wilkerson, says participating in the clinical trial gave him new hope as he experienced a significant decrease in pain following surgery. Before the procedure, Wilkerson lived with debilitating pain radiating from his back to his ankle.
“I’m thrilled to say my leg pain was gone right after surgery,” said Wilkerson. “The team at OrthoIndy provided compassionate, thorough care and kept me informed every step of the way. The trial has been seamless. I return for check-ups more often, but that just means I get to see my progress in real time. My X-rays look great, my blood tests are on track, and I feel as though I’m part of a significant turning point in spinal care.”
Completing the first procedure in the trial marked a milestone for both OrthoIndy and Theradaptive, whose founder and CEO, Dr. Luis Alvarez, commented on the impact of the achievement.
“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. Alvarez. “This milestone validates our approach to spinal fusion and highlights our broader strategy to unlock the power of therapeutics and anatomically precise bone regeneration for patients through our unique protein engineering technology.”
Seeking Additional Participants
As proud leaders of the Phase I/II OASIS trial, Drs. Schwartz and McMains are actively seeking additional patients with degenerative disc disease to join the study and aim to reassure all prospective participants.
“It’s natural to have some hesitation about joining a clinical trial, but we want to assure patients that we’re dedicated to ensuring their safety at every step,” said Dr. McMains. “The foundational science behind the product is promising. This study involves thorough monitoring and advanced imaging so we can track progress and address any concerns right away. We’re thrilled to bring patients new options that could provide long-term relief from pain and allow for a quicker, more stable recovery.”
OrthoIndy welcomes Central Indiana patients who suffer from degenerative spinal conditions to learn more about participating. For more information and to explore this potential alternative to traditional spinal fusion, contact OrthoIndy at 317.802.2000 to schedule an assessment with Drs. Schwartz or McMains.
Media Contact: Brandon Smith, Chief Development Officer at OrthoIndy, P: 317.802.2439, E: brasmith@orthoindy.com
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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 SP 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.
About OrthoIndy
OrthoIndy is one of the most highly respected orthopedic practices in the country. With over 90 physicians providing care to Indiana residents, OrthoIndy provides leading-edge bone, joint, spine and muscle care. Recognized with numerous national and statewide honors from Healthgrades, OrthoIndy has been ranked number one in Indiana for joint replacement for the third year in a row. OrthoIndy is the official orthopedic provider for the Indiana Pacers, Indiana Fever and Andretti Autosport, and serves as the preferred orthopedic provider for employees of both the State of Indiana and Indianapolis Public Schools. For more information on OrthoIndy, please call 317.802.2000 or visit us at OrthoIndy.com.
