09.08.14
Austin, Texas-based Minimus Spine Inc. is marking two milestones.
The company reported securing ISO 13485 certification for its quality management system. In addition, the Lone Star State startup received CE mark for its TrioJection system for delivering ozone to a herniated spinal disc. Minimus Spine’s notified body is the British Standards Institute.
TrioJection is designed to offer a sterile and accurate means of delivering ozone, according to company officials.
"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.”
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.
The company reported securing ISO 13485 certification for its quality management system. In addition, the Lone Star State startup received CE mark for its TrioJection system for delivering ozone to a herniated spinal disc. Minimus Spine’s notified body is the British Standards Institute.
TrioJection is designed to offer a sterile and accurate means of delivering ozone, according to company officials.
"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.”
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.