29 Jan Synergy Disc® Announces Enrollment of First Patient in US IDE Clinical Trial
LOUISVILLE, Colo.–(BUSINESS WIRE)–Synergy Disc Replacement Ltd., a Colorado-based spinal medical device company and wholly owned subsidiary of Synergy Disc Replacement Inc. (SDRi), announced today that it has enrolled the first patient in its U.S. IDE clinical trial. The Synergy Disc trial is a multi-center, prospective, historically controlled study that will be conducted on 175 patients at up to 15 sites in the U.S. This trial is designed to demonstrate that the Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion in patients with one-level symptomatic cervical degenerative disc disease (DDD).
Dr. Daniel Peterson, M.D. at Austin Neurosurgeons in Austin, Texas has performed the first surgery utilizing the Synergy Disc in the United States. After the procedure, Dr. Peterson commented, “The Synergy Disc procedure is intuitive and forgiving. I loved that I could see the immediate alignment correction – the importance of which I cannot overstate. This is a fantastic next generation device.”
Josh Butters, Chief Executive Officer of SDRi, said, “We are extremely excited to announce the beginning our US clinical study and that Dr. Peterson has successfully performed the first Synergy Disc in the United States. We are honored to be working with Dr. Peterson and his research team on this effort.” Dr. Neil Duggal, M.D., Chief Medical Officer of SDRi added, “This is a huge milestone and achievement for our company, reflecting a tremendous amount of hard work by our entire team.”
About Synergy Disc Replacement Inc. (SDRi)
SDRi is a privately held Ontario corporation with an office in Cambridge, Ontario and a wholly owned subsidiary located in Louisville, Colorado. SDRi was founded by Dr. Neil Duggal, M.D., a Canadian neurosurgeon who has dedicated his neurosurgery practice to advancing the treatment of patients with DDD and myelopathy. SDRi has developed an advancement in artificial cervical disc technology named the Synergy Disc® and has been issued more than 55 patents, which protect its novel design elements and features of alignment and motion restoration. SDRi has applied a CE mark on the Synergy Disc and has commercialized the technology in select countries in Europe and Australia. For additional information, please visit https://synergydisc.com.
CAUTION: Investigational device. Limited by United States law to investigational use.