Philadelphia, PA, April 6, 2018 — Premia Spine, Ltd. announced today that it will sponsor a hands-on cadaver lab for participants at the International Society for the Advancement of Spine Surgery in Toronto. The event will take place on Thursday, April 12th and feature both the ProMIS™ Fixation System and the TOPS™ System. This will be the first time that surgeons in North America will have the opportunity to try both technologies in an open cadaver lab setting.
“I am very pleased to offer surgeons the opportunity to experience the advantages of our One-Step, direct Skin-to-Screw technique,” stated Tom O’Hara, recently appointed President of Premia Spine, Inc. “We are the first company to launch this patented approach—a technique that reduces x-ray exposure and saves screw placement time.” Surgeons will also gain hands-on experience with other unique features to the ProMIS™ Fixation System.
In addition, Premia Spine will be offering surgeons a chance to work with the TOPS™ System—a posterior motion preservation system for patients with degenerative lumbar spondylolisthesis and spinal stenosis. The TOPS System is approved in Europe and Australia, and under investigation in the United States.
Premia Spine launched the US IDE study among leading centers in the United States, including the Cleveland Clinic, Mayo Clinic, UPenn, UPMC Harrisburg, Carolina Neurosurgery, Ascension Jacksonville, Allegheny Health Network, Florida Spine Institute, Johns Hopkins-Sibley, and Wisconsin Bone and Joint.
“We want to showcase our solution before leading surgeons from around the world. In addition, we are offering US surgeons the opportunity to join our IDE study—which still has a few remaining slots,” said Ron Sacher, CEO of Premia Spine.
The new TOPS device, with a 30% smaller footprint and a simpler surgical technique from the original device, has been in commercial use in Europe for over 6 years.
The IDE study will take place in 30 institutions and enroll 330 subjects. Patients will be randomized to either the TOPS™ System or lumbar fusion (i.e., an interbody cage plus screws and rods), with a 67% likelihood of receiving the TOPS device.
Clinical sites will be measuring ODI, VAS, neurologic function, device integrity, reoperation rates and other quantitative outcomes for the study device and the fusion control. “Our goal is to establish the superiority of the TOPS™ System versus traditional lumbar spinal fusion,” explains Mr. Sacher.
About Premia Spine. Premia Spine licensed the TOPS System technology in 2011 from Impliant, Ltd. Over $100 million has been invested to design, develop, and commercialize the TOPS System, with over 12 years of clinical use and 1,000 patients.
Ron Sacher, CEO