DiscSealTM is intended to be a treatment option for patients who have failed first tier conservative care (i.e., bed rest, medications, physical therapy). This unique 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 are currently being 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 physical product design, formulation and development is complete. The company has also 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. Further, DiscSealTM demonstrated the expected mechanical benefits of structural support, increasing bulk, and sealing in diseased discs.
DiscSealTM Development Strategy
In 2018, The company plans to initiate human clinical trials sufficient for EU CE Mark application. The company plans to file for CE Mark in 2019, which will lead to potential CE Mark approval of DiscSealTM. CE Mark approval will enable commercialization in the EU.
In the US, SpineOvations intends to register DiscSealTM as a device by the Expedited Access Program. The company plans to conduct a US trial after the EU study.
DiscSealTM Commercialization Strategy
SpineOvations intends to enter into a collaboration or product licensing agreement with a large medical device company or specialty pharma company to enable commercialization in Europe and 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. Thus SpineOvations believes millions of back pain sufferers worldwide could clinically benefit from DiscSeal, 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