Synergy Disc Replacement Inc. (SDRi) is a medical device technology company founded by a Canadian Neurosurgeon that is dedicated to designing and commercializing next generation, minimally invasive spinal technologies. SDRi’s marquee technology, the Synergy Disc®, is the only artificial disc currently on the market that addresses motion and alignment for the treatment of degenerative disc disease in the cervical spine.
With more than 1.4M annual procedures being done in the United States for degenerative disc disease and its related symptoms, the world-wide cervical implant market is approaching over $3B annually with motion preservation being the fastest growing segment within the cervical spine implant market.
Degenerative disc disease (DDD) or arthritis of the spine occurs naturally as the population ages. When spinal discs “herniate” in the neck, they cause neck and arm pain. Current treatment options include (a) fusion surgery, which corrects the alignment of the neck, but eliminates motion, or (b) total disc replacement (TDR) surgery in which an artificial disc is used to preserve motion, but cannot correct alignment.
Through a novel core geometry protected by over 55 patents, the Synergy Disc solves the issue of “alignment” correction that other devices on the market currently cannot. This enables the Synergy Disc to expand the addressable patient population by over 50%. The benefit extends beyond market expansion and opens up pathways for future reimbursement scenarios currently not available. With its unique geometry and Stability Zone technology, the Synergy Disc is also optimized for usage in multi-level procedures. Furthermore, its intuitive and elegant design allows for a simpler, safer, and more streamlined technique for the surgeon user.
SDRi has achieved a CE mark for the Synergy Disc technology, which is a regulatory certification providing commercial access opportunity to the European Union countries. With this and other approvals, SDRi has recently commercialized the system in select strategic markets including the United Kingdom, Germany, and Australia/New Zealand. SDRi plans to grow revenues in 2020 and beyond by continuing its expansion in Europe, focusing and growing sales with existing distributors, and taking competitive market share. Identifying new territories, obtaining additional registrations and developing additional distribution channels will increase the global footprint and market opportunity for the company.
Over 60% of the cervical implant market is in the USA, and accordingly this is a major market focus for SDRi. In the USA, artificial disc replacement devices are Class III devices requiring a highly controlled clinical trial. SDRi has received approval by the FDA to conduct an Investigational Device Exemption (IDE) Clinical Trial to pursue full device approval in the USA. This regulatory pathway is a well-known process, completed by every other artificial disc technology currently on the market in USA. SDRi has a particular advantage, as we have approval to conduct a single-armed, 175 patient clinical trial with 2-year follow-up to support full approval of the device. We will leverage historical fusion control data from our strategic shareholder to serve as the control arm for the trial, limiting costs and expediting overall trial timelines. We have initiated preparation activities for this trial and plan to begin enrollment in early Q4 2020. Additionally, with this control data and our approved inclusion criteria, SDRi has the potential to achieve a unique marketing and reimbursement advantage for usage of the Synergy Disc next to a prior fusion surgery.
SDRi is seeking a capital raise of $15M that will enable the company to achieve these significant value building milestones for the company, and has already received more than $3M in commitments from existing shareholders. The funds will be utilized to complete patient enrollment in the IDE clinical trial, complete patient follow-up, and complete the FDA pre-market approval (PMA) application for the 1-Level study. Additionally, the funds will be utilized to fuel SDRi’s international sales growth and territory expansion plans. We are not the only technology in this space, however previous technology companies that have developed artificial disc technologies have been acquired by major strategic orthopedic device companies in deal sizes ranging from ~$100M to $1B as they neared or achieved their FDA approval.
For information, please contact Josh Butters, CEO at [email protected], tel: +1-720-787-9063