Spinol Medical™ Advances OctaSeal™ Into FDA Review — A Minimally Invasive, Intradiscal Annular Closure Technology Backed by Five-Year Clinical Data

CHICAGO--(BUSINESS WIRE)--Spinol Medical™ today announced the advancement of its OctaSeal™ Annular Closure System into U.S. FDA review. OctaSeal represents a novel, tubular-based, intradiscal technology designed to close annular defects following lumbar discectomy. Delivered through a 5mm minimally invasive working channel, the implant expands within the disc space to create a stable, tissue-preserving, motion preserving repair.

The U.S. market for annular repair represents a multi-billion-dollar opportunity, driven by an estimated 3 million lumbar disc herniation cases annually, with ~18% of operated patients experiencing recurrent herniation, the leading cause of repeat spine surgery. Despite the scale of this clinical burden, there is only one annular closure device currently on the U.S. market, leaving significant whitespace and unmet need for novel technologies that preserve anatomy, reduce re-herniation, and avoid escalation to more invasive procedures.

A Novel, Minimally Invasive Approach to Annular Repair

OctaSeal offers a unique combination of intradiscal, anatomic placement and tubular-based insertion, avoiding the need for bone removal, defect widening, or additional nerve retraction. The implant self-deploys within the disc space and engages the endplates through eight low-profile anchoring surfaces.

Key Technology Attributes

• Micro-invasive, 5mm tube-based insertion
• Intradiscal, anatomical placement
• Self-deploying architecture; Single-Step, Single Instrument
• Preserves native tissue and surgical corridor, Outpatient & ASC Friendly
• Compatible with any microdiscectomy and endoscopic workflows
• Single use, pre-sterile kit

By preserving anatomy and simplifying technique, OctaSeal is designed to help prevent re-herniation and reduce progression to more invasive surgical interventions.

Leadership Commentary

Michael S. Butler, Executive Chairman, Spinol Medical

“Advancing OctaSeal into FDA review represents a significant inflection point, not just for Spinol, but for a market that has been underserved for decades. With only one competitor in a multi-billion-dollar category, the opportunity to deliver a novel, minimally invasive solution supported by five-year data is extraordinary. OctaSeal’s intradiscal, tissue-preserving approach is designed to reduce unnecessary anatomical disruption, which may help keep patients from progressing to larger, more invasive surgeries. We believe this is the type of elegant design that can shift a standard of care.”

Roey Shafrir, Founder & CEO, Spinol Medical

“Few spine technologies enter FDA review with validated, multi-year clinical durability. OctaSeal does, and it pairs that durability with a straightforward tubular insertion technique that preserves native anatomy. By maintaining tissue integrity and stabilizing the disc early, OctaSeal is designed to help reduce the cycle of re-herniation that often drives patients toward fusion or other complex procedures. In a category with limited competition and massive unmet need, we see OctaSeal as a foundational technology with the potential to meaningfully change outcomes for millions of patients worldwide.”

About OctaSeal™

OctaSeal is a novel, minimally invasive annular closure system intended to reduce re-herniation following lumbar discectomy. The implant expands within the disc space and anchors via a self-deploying, tissue-sparing fixation mechanism. OctaSeal is not available for sale in the U.S.

About Spinol Medical™

www.spinolmed.com

Spinol develops novel, minimally invasive medical technologies. The company’s leadership brings decades of experience in product development, regulatory strategy, and commercialization across global medical device markets.