Spine believes that it can benefit these patients with a single injection and reduce the number of patients that ultimately need surgery.Minimus Spine is developing ozone injection technology specifically for spinal applications. Ozone has been used to treat disc herniations in Europe for over 15 years and there are over 20 peer-reviewed papers documenting over 8,000 patients.

We have improved upon the existing technology through a system that creates ozone, and measures its concentration, within in a sterile, syringe-cartridge (patents pending). This has advantages in terms of sterility and dose assurance, as well as material compatibility, which are vital to the advancement of this technique.

Minimus will commercialize its product outside the United States and then begin working with FDA to offer this technology in the U.S. This will involve rigorous clinical trials conducted by spine surgeons and interventional radiologists. The study will seek to confirm that an injection of ozone into a herniated disc is both safe and effective. The results of these trials will be submitted to FDA for marketing approval. Currently, ozone cannot be legally marketed for medical application in the U.S. and FDA has justifiably taken enforcement actions against manufacturer’s that promote this treatment without FDA approval.

This product is not yet available but the push is being made to begin clinical trials in 2011. Check back periodically for more information.

Minimus hopes to improve patient care and believes it can save the health care system significant resources on unnecessary steroid injections and surgeries.