Theradaptive Receives 2024 Best Technology in Spine Award by Orthopedics This Week

Theradaptive, a clinical-stage biologics company focused on protein therapeutics for spine, orthopedics, and targeted immuno-oncology, announced that its investigational product OsteoAdapt™ SP has won the Gold Level Award for Best Technology in Spine 2024 from Orthopedics This Week. CEO and Founder Luis Alvarez, PhD, expressed pride in receiving this recognition, noting that the award highlights OsteoAdapt SP’s precision in delivering bone-forming proteins for complex spine surgeries, as well as Theradaptive’s dedication to improving patient outcomes in spine, orthopedic, and dental treatments. [1]

OsteoAdapt SP, designed for degenerative disc disease, utilizes Theradaptive’s engineered protein AMP2 combined with a fully resorbable bone graft, offering therapeutic benefits while minimizing BMP-2’s off-target effects. Preclinical studies have shown OsteoAdapt SP’s superior safety and effectiveness compared to standard spinal fusion grafts, and the company is enrolling patients in its OASIS Phase I/II clinical trial to further assess its efficacy in lumbosacral spine disease. The award, determined by a panel of esteemed spine and neurosurgeons, underscores the significance of innovations in spine surgery and the dedication of researchers and engineers driving these advances. [1]

Earlier…

On November 19, 2021, Theradaptive announced that its Osteo-Adapt SP Spinal Fusion implant received Breakthrough Medical Device designation from the FDA for treating degenerative disc disease, spondylolisthesis, and retrolisthesis in transforaminal lumbar interbody spinal fusion procedures. This designation under the FDA’s Breakthrough Devices Program enables priority review and guidance during the device’s development, accelerating its path to market. According to Dr. George Muschler of the Cleveland Clinic, Osteo-Adapt SP could offer safer, more consistent outcomes than current spinal fusion options, marking a significant advancement in regenerative implants.[2]

On February 1, 2024, Theradaptive has received FDA approval for an Investigational Device Exemption (IDE) to initiate its OASIS Phase I/II Feasibility study, assessing OsteoAdapt SP in transforaminal lumbar interbody fusion (TLIF) for degenerative spine conditions. This study, enrolling 80 patients, will evaluate OsteoAdapt SP’s safety, efficacy, and optimal dose for future pivotal trials. Designed with a next-generation AMP2 protein to improve spinal fusion outcomes, OsteoAdapt SP aims to meet the needs of an aging population suffering from spine-related pain and sub-optimal current treatments. With three FDA Breakthrough Device Designations, OsteoAdapt SP benefits from priority review and accelerated clinical timelines. Supported by partnerships like 3D Systems and funding from the Department of Defense and the Maryland Stem Cell Research Fund, Theradaptive is also advancing OsteoAdapt applications in orthopedics, dental, trauma, and sports medicine.[3]

On September 11, 2024, Theradaptive announced that it had initiated patient treatment in its Phase I/II OASIS Trial, a controlled, dose-randomized study assessing the safety and efficacy of OsteoAdapt SP in single-level Transforaminal Lumbar Interbody Fusion (TLIF) for degenerative lumbosacral spine diseases. The trial aims to determine if OsteoAdapt SP, which incorporates the next-generation AMP2 protein, could serve as a safer, effective alternative to autologous bone grafts in spinal fusion surgeries. Preclinical studies suggest OsteoAdapt SP’s potential to minimize off-target effects associated with rhBMP-2, showing promise not only for spinal fusion but also for dental, orthopedic, sports medicine, and veterinary uses.[4]

“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…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.”

Dr. Luis Alvarez, Founder and CEO of Theradaptive

Pre-Clinical Study

In vivo Assessment of AMP2, a Novel Ceramic-Binding BMP-2, in Ovine Lumbar Interbody Fusion | Summary [5]

Clinical Outcomes:

• Animals recovered well post-surgery.
• At three weeks, two high-dose OsteoAdapt SP animals showed mild symptoms (partial paresis), possibly due to mild cord compression; one animal was replaced.
• At week 4, two other animals (one low-dose OsteoAdapt SP, one ICBG) exhibited similar bone changes without symptoms.
• No differences in hematology, biochemistry, or systemic toxicity across groups.

Fusion Results (Manual Palpation):

• At 8 weeks: Two ICBG and one OsteoAdapt SP animals (low and high dose) showed incomplete fusion.
• At 16 weeks: All OsteoAdapt SP animals fused; one ICBG animal remained unfused.
• At 26 weeks: All animals showed complete fusion.

CT and mCT Assessments:

• CT scans showed higher fusion scores in low-dose OsteoAdapt SP at 8 weeks compared to ICBG.
• mCT revealed robust bone formation in OsteoAdapt groups, with increased fusion and bone grades at 8 weeks.

Range of Motion:

• Movement decreased with fusion over time in all groups.
• High-dose OsteoAdapt SP showed reduced lateral bending and axial rotation at 8 weeks compared to ICBG.

Spine Histology:

• Extensive new bone formation seen in both OsteoAdapt doses at 8 weeks, with bridging observed.
• By 26 weeks, both OsteoAdapt doses showed greater remodeling and integration with host bone than ICBG.

Bone Histomorphology:

• OsteoAdapt SP groups showed significantly increased bone formation within the available void at 8 weeks compared to ICBG, with less fibrous tissue.
• No significant differences in bone or marrow among groups by 26 weeks, with all groups showing bone increase over time.

Tissue Reactivity:

• Minimal to no tissue reaction to OsteoAdapt SP, confirming compatibility as per ISO 10993:6 standards.

References

[1] Theradaptive. (2024, October 23). Theradaptive Receives 2024 Best Technology in Spine Award by Orthopedics This Week. PR Newswire. https://www.prnewswire.com/news-releases/theradaptive-receives-2024-best-technology-in-spine-award-by-orthopedics-this-week-302283782.html

[2] FDA grants theradaptive Breakthrough Medical Device Designation – theradaptive. (2023, February 16). Theradaptive. https://www.theradaptive.com/in-the-media/fda-grants-theradaptive-breakthrough-medical-device-designation/

[3] Theradaptive. (2024a, February 1). U.S. FDA GRANTS THERADAPTIVE IDE APPROVAL FOR PHASE I/II CLINICAL TRIALS. PR Newswire. https://www.prnewswire.com/news-releases/us-fda-grants-theradaptive-ide-approval-for-phase-iii-clinical-trials-302050556.html

[4] Vetalice, J. A. (2024, September 11). Treatment Opens in Spinal Fusion Trial with Theradaptive OsteoAdapt SP. ORTHOWORLD. https://www.orthoworld.com/treatment-opens-in-spinal-fusion-trial-with-theradaptive-osteoadapt-sp/

[5] Christou, Chris BVSc, PhDa; Varcoe, Tamara PhDa; Williams, Georgia MMagRes Techa; Heil, Todd PhDb; Leifeld, Sarah BScb; Park, Hyeon PhDb; Peckham, Steve PhDc; Stewart, David PhDb; Greenbaum, John MBAb; Wang, Tian PhDd; Pelletier, Matthew PhDd; Walsh, William PhDd; Alvarez, Luis PhDb. In vivo Assessment of AMP2, a Novel Ceramic-Binding BMP-2, in Ovine Lumbar Interbody Fusion. Spine 49(19):p 1381-1390, October 1, 2024. | DOI: 10.1097/BRS.0000000000005091  https://pubmed.ncbi.nlm.nih.gov/38988089/

IMAGE — https://www.theradaptive.com/