Sam Brusco, Associate Editor01.31.24
Synergy Spine Solutions, a company focused on artificial cervical disc replacement, has closed on $30 million in Series A equity financing.
The proceeds, led by new institutional investor Amzak Health, will be used to finish enrollment of Synergy’s U.S. IDE (investigation device exemption) 2-level clinical trial. They will also be used to continue patient follow-up on both the 1-level and 2-level clinical trials, submit premarket approval applications to the U.S. Food and Drug Administration (FDA), and support commercialization in markets outside the U.S.
The 2-level trial will evaluate the Synergy Disc artificial cervical disc replacement’s safety and effectiveness compared to anterior cervical discectomy and fusion (ACDF) to treat degenerative disc disease in subjects that are symptomatic at two contiguous vertebral levels from C3 to C7. The study will be conducted on 200 patients at up to 25 trial sites.
"We are excited about this next chapter of Synergy's growth," said Synergy’s CEO Josh Butters. "We look forward to welcoming Amzak Health to the Synergy team that has worked incredibly hard to get to this point. We remain focused on completing the 2-level study and to bringing the Synergy Disc to the U.S. market, as it represents an important treatment option for patients suffering from degenerative disc disease and was specifically designed to restore both motion and alignment to the cervical spine."
Enrollment for the Synergy Disc 1-level IDE trial was completed in June 2023. With this investment, Joyce Erony of Amzak Health has joined Synergy's board.
The proceeds, led by new institutional investor Amzak Health, will be used to finish enrollment of Synergy’s U.S. IDE (investigation device exemption) 2-level clinical trial. They will also be used to continue patient follow-up on both the 1-level and 2-level clinical trials, submit premarket approval applications to the U.S. Food and Drug Administration (FDA), and support commercialization in markets outside the U.S.
The 2-level trial will evaluate the Synergy Disc artificial cervical disc replacement’s safety and effectiveness compared to anterior cervical discectomy and fusion (ACDF) to treat degenerative disc disease in subjects that are symptomatic at two contiguous vertebral levels from C3 to C7. The study will be conducted on 200 patients at up to 25 trial sites.
"We are excited about this next chapter of Synergy's growth," said Synergy’s CEO Josh Butters. "We look forward to welcoming Amzak Health to the Synergy team that has worked incredibly hard to get to this point. We remain focused on completing the 2-level study and to bringing the Synergy Disc to the U.S. market, as it represents an important treatment option for patients suffering from degenerative disc disease and was specifically designed to restore both motion and alignment to the cervical spine."
Enrollment for the Synergy Disc 1-level IDE trial was completed in June 2023. With this investment, Joyce Erony of Amzak Health has joined Synergy's board.