FDA Grants Breakthrough Device Designation to ORTHOSON's Bio-Structural Gel

This designation assures enhanced FDA cooperation and priority regulatory review of the company's novel medical solution for back pain due to degenerative disc disease

OXFORD, England--(BUSINESS WIRE)--ORTHOSON, a medtech innovator developing a portfolio of novel treatments for back pain, today announced that its Bio-Structural Gel product has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This micro-invasive new treatment is designed to alleviate back pain due to degenerative disc disease.

ORTHOSON's Bio-Structural Gel follows the natural fissures of degeneration in the nucleus pulposus of the intervertebral disc, before gelling in-situ to form a highly-hydrated biology-supporting structure. The patented pNIPAM-DMAc co-polymer is designed to mimic the body's own natural tissue in the nucleus pulposus, while restoring mechanical function of the intervertebral disc.

ORTHOSON Bio-Structural Gel is being developed in close collaboration with the University of Oxford's Institute of Biomedical Engineering, the University of Sheffield and Sheffield Hallam University and is scheduled to be in clinic next year.

“Gaining Breakthrough Device Designation is a significant achievement that will prioritize our work with the FDA as we go through the regulatory process,” said Ken Reali, chair of ORTHOSON. “ORTHOSON's innovative Bio-Structural Gel is a significant innovation essential to changing the course of degenerative disc disease and positively impacting the multitudes of patients who have lower back pain. Helping to guide the development and marketability of this product is the reason I joined the ORTHOSON Board at this exciting stage in the company evolution. Congratulations to the ORTHOSON team!”

The FDA’s Breakthrough Devices Program is intended to speed up development, assessment, and review of innovative medical devices that the FDA believes may provide a more effective treatment of life-threatening or irreversibly debilitating conditions.

To achieve this status, ORTHOSON has leveraged its in-house regulatory leadership and best-in-class network of advisors.

"This recognition by the FDA is a result of the great work of ORTHOSON’s technical team of engineers, working closely with our academic collaborators and external advisors,” said Mey Saied, PhD RAC, head of regulatory and quality at ORTHOSON. “It shows we have the capability, vision, and plan to meet the challenge of developing a new class of treatment for back pain head-on.”

The FDA can use the Breakthrough Device Program to assign additional support to ORTHOSON via:

• Allowances for efficient and flexible clinical study design
• Priority review by the designated FDA Review team
• Engagement with senior FDA management
• Expedited review of manufacturing and quality systems compliance
• Consideration of premarket and postmarket data in reviews

This support assists ORTHOSON in providing the objective evidence required to illustrate its Bio-Structural Gel’s safety and effectiveness and make it available to patients as early as possible.

“This is another successful step towards our mission to ease the impact of back pain on so many lives,” said Rich Simmonds, chief executive officer of ORTHOSON. “We believe the Breakthrough Device Designation for our Bio-Structural Gel is a testament to our team's spirit of innovation and dedication. The market is also taking notice—I'm already seeing intensified interest in our Series B Fundraising round.”

To learn more about ORTHOSON and its Bio-Structural Gel, please visit orthoson.com.

About ORTHOSON Limited

ORTHOSON is innovating a new class of bio-structural solutions for back pain. Its technologies and products are designed to be micro-invasive, treating both pain and the causes of degeneration, making them more patient-friendly and cost-effective than current treatment options. ORTHOSON’s medical technologies are the result of multi-decade ongoing research with the University of Oxford's Institute of Biomedical Engineering, the University of Sheffield, and Sheffield Hallam University. Headquartered in Oxford, UK, the company has participating researchers and partners located across Europe and the United States.

Rich Simmonds
Chief Executive Officer
ORTHOSON Limited
+44 (0) 1865 784350
info@orthoson.com