Minimus Spine, Inc. (www.minimusspine.com) announces that the company has successfully secured ISO 13485 certification of its Quality Management System and also the EC Certificate for its TrioJection™ System for delivering ozone to a herniated spinal disc. TrioJection™ offers a sterile and accurate means of delivering ozone. Minimus Spine’s Notified Body is British Standards Institute.
“These are obviously two very important milestones and keep the company on track with its strategy to provide a safe, effective, non-surgical treatment for disc herniation.” said David Hooper, Ph.D., Minimus Spine’s Founder and CEO. “Specifically, their achievement gives us the ability commercialize TrioJection™ in Europe and to initiate a user validation study there by the end of the year. We are now identifying clinical sites to participate in the study and welcome investigators to contact us to learn more about the study protocol. These data will play a key role in supporting the launch of TrioJection™.”
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 info@minimusspine.com.
