Minimus Spine, developer and manufacturer of the Triojection® System, offering an alternative to surgery for patients with leg pain associated with a disc herniation, announced today it has initiated enrollment in a randomized study comparing Triojection® to surgical discectomy.
The first patient was treated at Papa Giovanni XXIII hospital in Bergamo, Italy by interventional radiologists Dr. Giuseppe Bonaldi and Dr. Gabriele Gallizioli in collaboration with their neurosurgeon colleagues Dr. Claudio Bernucci and Dr. Carlo Brembilla. Shortly following, Dr. Alexis Kelekis and Dr. Dimitris Fillipiadis treated the first patient enrolled at Attikon University in Athens, Greece, in collaboration with neurosurgeons Dr. Christos Gogos, Dr. George Stranjalis and Dr. Alkis Bouras.
Dr. Bonaldi commented, “Triojection® is well made and uses a novel approach to standardize the way an intradiscal injection of ozone is performed. Other systems lack standardization and because of that, this is the first time I have incorporated the use of ozone in my practice. Our cases went smoothly and patients have improved without surgery. That first patient was doing very well at their one month visit with no leg or back pain reported.”
Dr. Kelekis noted, “While I have been following the literature on ozone for several years, I was waiting for a system that offers the features and benefits of Triojection®. Our first patient was successfully treated with Triojection® and released from hospital two hours later reporting no pain. We just completed the one month visit on that patient and their leg pain has improved from 7 out of 10 to 2 (out of 10). I see a large number of patients that can benefit from this procedure.”
“This is the first study to randomize between ozone and surgical discectomy and the primary endpoint is improvement in leg pain”, said David Hooper, Ph.D., Minimus Spine’s President and Chief Executive Officer. “As the early follow-up data are received, we are now charting a plan to accelerate our key objectives, whether that be a strategic partnership, sale, or raising funds to support a study for FDA approval. This study will provide us with a solid base of experience that can be used to fine tune the regulatory strategy with FDA. Also important, these data will enable the determination of Triojection®’s value relative to surgery.” added Dr. Hooper.
For more information about the Triojection Study: Go to clinicaltrials.gov and search identifier NCT02525120.
About Minimus Spine
Established in 2006, Minimus Spine is a privately held medical device company dedicated to developing its ozone technology for medical applications. The company is focused on the treatment of spinal disorders related to herniated discs. Minimus Spine is headquartered in Austin, TX. For more information on Minimus Spine, please visit http://www.minimusspine.com or email [email protected].