DiscSealTM is intended to be a treatment option for patients who have failed first tier conservative care (i.e., bed rest, physical therapy, and oral medications). This unique investigational product is designed to provide a reparative treatment approach. This is as opposed to the disruptive or destructive percutaneous measures used to shrink or remove disc material that is currently utilized as secondary treatments for chronic low back pain, before turning to the costly and invasive surgical intervention procedures (e.g., discectomy, laminectomy, total disc replacement, spinal fusion).
DiscSealTM Stage of Development
DiscSeal’s is currently in clinical development. A prospective, single-arm first-in-human clinical study with DiscSealTM to investigate the safety, tolerability, and exploratory efficacy for the treatment discogenic low back pain has been successfully completed. The study met the primary safety objective and showed a clear trend in reduction of pain and disability following injection of DiscSealTM into the intervertebral disc.
The company is planning a prospective, randomized controlled clinical efficacy and safety study of DiscSealTM in European and other countries to support CE Mark application.
The preclinical development of DiscSealTM has included multiple studies. The company completed large animal model studies in sheep and other species. The preclinical studies indicated DiscSealTM is well tolerated with no notable adverse events, stays in place in the intervertebral disc under loading, and disc degeneration is inhibited. DiscSealTM demonstrated the expected mechanical benefits of structural support, increasing bulk, and sealing in diseased discs.
DiscSealTM Commercialization Strategy
SpineOvations plans to conduct a clinical efficacy and safety study in Europe and other countries, which it will then use to file for CE Mark. Upon CE Mark approval of DiscSealTM, the company will be able to commercialize in the EU which will generate near term revenues.
In the US, SpineOvations intends to register DiscSealTM as a device by the Expedited Access Program. The company plans to conduct a US pivotal trial after the CE Mark approval.
SpineOvations intends to enter into collaboration or product licensing and distribution agreements with regional or global medical technology companies to enable full development, registration, and commercialization in Europe and the U.S.
DiscSealTM Market Opportunity
Global orthopedics device sales are valued at $34 billion and growing to $44 billion.
There are over 10 million IDD and DDD patients in the US and EU and the estimated cost of medical device treatments for this group is $6 billion. SpineOvations believes millions of back pain sufferers worldwide could clinically benefit from DiscSealTM, creating a greater than $1 billion opportunity in Europe and the U.S.
DiscSealTM Potential Benefits
- Minimally invasive injection
- Semi-permanent volume
- Local anesthesia with conscious sedation
- Single injection 20 minutes after patient prep.
- Patients mobile after procedure