Spinol Medical™ Advances OctaSeal™ Annular Closure System Into FDA Review, Introducing a Minimally Invasive Intradiscal Solution Supported by Five-Year Clinical Data
Spinol Medical™ today announced that its OctaSeal™ Annular Closure System has advanced into formal review by the U.S. Food and Drug Administration (FDA), marking a major milestone for the company and for the field of spine surgery. OctaSeal is a novel, minimally invasive, intradiscal annular closure technology designed to address one of the most persistent challenges following lumbar discectomy: recurrent disc herniation caused by unhealed annular defects. Backed by five-year clinical data, OctaSeal aims to preserve native anatomy, maintain motion, and reduce the need for repeat or more invasive spine surgeries.
Lumbar disc herniation is one of the most common spinal conditions worldwide and a leading cause of lower back pain and radiculopathy. In the United States alone, an estimated three million patients are diagnosed with lumbar disc herniation each year. While lumbar discectomy is widely considered an effective surgical intervention for relieving symptoms, it leaves behind an annular defect that can predispose patients to recurrent herniation. Approximately 18% of surgically treated patients experience re-herniation, which remains the leading cause of repeat spine surgery and a major contributor to escalating healthcare costs, patient morbidity, and long-term disability.
Despite the scale and clinical impact of this problem, there is currently only one FDA-approved annular closure device available on the U.S. market. This limited competitive landscape underscores a significant unmet need and substantial opportunity for innovative solutions that can effectively close annular defects while minimizing tissue disruption and preserving spinal biomechanics. Spinol Medical believes OctaSeal has the potential to fill this gap by offering a fundamentally different approach to annular repair—one that is intradiscal, micro-invasive, and designed to integrate seamlessly into existing surgical workflows.
A Novel Intradiscal Technology Designed for Tissue Preservation
OctaSeal represents a new class of annular closure systems, distinguished by its tubular-based, intradiscal design. Unlike traditional approaches that may require bone removal, annular defect widening, or additional nerve root manipulation, OctaSeal is delivered through a 5mm minimally invasive working channel commonly used in microdiscectomy and endoscopic spine procedures. Once inserted into the disc space, the implant self-expands to create a stable, anatomic seal of the annular defect.
The implant engages the vertebral endplates through eight low-profile anchoring surfaces, providing mechanical stability without the need for screws, sutures, or bulky external components. This intradiscal anchoring strategy is intended to preserve surrounding tissue, maintain the native surgical corridor, and reduce procedural complexity. By avoiding additional disruption to bone or soft tissue, OctaSeal is designed to support faster recovery and make annular repair more accessible in outpatient and ambulatory surgery center (ASC) settings.
Spinol Medical emphasizes that OctaSeal is engineered to preserve motion and anatomy rather than constrain it. By stabilizing the disc early and maintaining the integrity of the annulus, the technology aims to interrupt the cycle of degeneration and re-herniation that often leads patients toward more aggressive interventions such as spinal fusion.
Addressing a Multi-Billion-Dollar Market Opportunity
The U.S. market for annular repair represents a multi-billion-dollar opportunity, driven not only by the high incidence of lumbar disc herniation but also by the substantial costs associated with repeat surgeries, chronic pain management, and long-term disability. Recurrent herniation often results in additional procedures that are more complex, more invasive, and more costly than the initial discectomy. These downstream interventions place a significant burden on healthcare systems, payers, and patients alike.
With only one annular closure device currently available in the U.S., surgeons have limited options when seeking to proactively address annular defects at the time of discectomy. Spinol Medical views this as a critical “whitespace” in spine care—an area where innovation has lagged behind clinical need. OctaSeal’s advancement into FDA review signals the company’s intent to introduce meaningful competition and expand the range of treatment options available to spine surgeons.
Key Technology Attributes of OctaSeal™
OctaSeal has been designed with both clinical performance and procedural efficiency in mind. Key attributes of the technology include:
- Micro-invasive delivery: The system is implanted through a 5mm tube-based working channel, minimizing tissue disruption and supporting minimally invasive and endoscopic approaches.
- Intradiscal, anatomic placement: The implant resides entirely within the disc space, aligning with native anatomy and avoiding external fixation.
- Self-deploying architecture: OctaSeal utilizes a single-step, single-instrument deployment mechanism, simplifying the procedure and reducing operative time.
- Tissue- and motion-preserving design: By avoiding bone removal and defect enlargement, the system is designed to maintain spinal biomechanics and reduce surgical trauma.
- Workflow compatibility: The device is compatible with standard microdiscectomy and endoscopic techniques, facilitating adoption without the need for major changes to existing practice patterns.
- Outpatient and ASC friendly: The minimally invasive nature of the system supports use in outpatient settings, aligning with broader trends toward site-of-care optimization.
- Single-use, pre-sterile kit: OctaSeal is provided as a ready-to-use, single-use system, streamlining logistics and enhancing procedural efficiency.
Collectively, these attributes reflect Spinol Medical’s focus on delivering an elegant, surgeon-friendly solution that addresses a critical unmet need while aligning with modern spine surgery practices.
Leadership Perspectives on the FDA Review Milestone
Michael S. Butler, Executive Chairman of Spinol Medical, highlighted the broader significance of advancing OctaSeal into FDA review.
Advancing OctaSeal into FDA review represents a significant inflection point, not just for Spinol, but for a market that has been underserved for decades,” Butler said. “With only one competitor in a multi-billion-dollar category, the opportunity to deliver a novel, minimally invasive solution supported by five-year clinical 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 and Chief Executive Officer of Spinol Medical, emphasized the importance of long-term clinical durability in the context of FDA review and market adoption.
Few spine technologies enter FDA review with validated, multi-year clinical durability,” Shafrir said. “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.”
Toward a New Standard in Annular Repair
As OctaSeal progresses through FDA review, Spinol Medical is positioning the technology as a potential new standard for annular closure following lumbar discectomy. The company believes that combining minimally invasive delivery with intradiscal, tissue-preserving design and long-term clinical data sets OctaSeal apart from existing solutions.
If cleared by the FDA, OctaSeal could enable surgeons to address annular defects proactively at the time of discectomy, rather than waiting for re-herniation to occur. This paradigm shift has the potential to reduce repeat surgeries, lower overall healthcare costs, and improve quality of life for patients suffering from lumbar disc disease.
Spinol Medical continues to invest in clinical research, product development, and surgeon education as it advances OctaSeal toward commercialization. With a strong focus on innovation, simplicity, and anatomical preservation, the company aims to expand the role of annular repair in spine surgery and deliver meaningful improvements in patient care.
As the burden of degenerative spine disease continues to grow globally, technologies like OctaSeal underscore the importance of addressing not only symptoms, but also the underlying structural drivers of recurrence and progression. Spinol Medical believes that minimally invasive, intradiscal solutions represent the future of spine care—and that OctaSeal is poised to play a central role in that evolution.
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.
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.
