After an initial market launch of its revolutionary SYNERGY DISC that exceeded expectations in Germany last year, closely-held Synergy Disc Replacement Inc. (SDRI) is planning to expand distribution aggressively in Europe, Asia Pacific and other parts of the world.
“We are also in the early stages of developing our U.S. regulatory strategy to gain FDA approval for the SYNERGY DISC,” CEO, Devesh Menawat, says in an interview with BioTuesdays.com.
Cervical disc replacement is the fastest growing segment in the spinal care market as degenerative disc disease universally affects people as they age. An estimated 51% of the population experiences disc degeneration, which can lead to severe pain in the neck and arms, and to spinal compression.
According to Mr. Menawat, growth drivers for cervical disc replacement include improving technology and patient outcomes, reimbursement for the procedures in most major markets and an aging, but more informed, population that is more demanding of motion preservation than ever before.
He explains that the SYNERGY DISC is the first and only artificial cervical disc to unite the needs for sagittal balance and motion, making it the only viable alternative to fusion surgery in patients with pre-operative spinal alignment issues. Approximately 40% of patients with degenerative disease will present with misalignment.
“SYNERGY is the world’s first cervical disc replacement product designed to actively correct pre-operative deformity, prevent post-operative misalignment and provide optimal stability for multi-level disc replacements,” he adds.
The SYNERGY DISC incorporates a revolutionary geometry, which offers multiple alignment corrections to give surgeons precise control of lordosis, or spinal curvature.
In addition, he says the SYNERGY DISC, which is covered by more than 50 patents worldwide, provides a resting angle of 0 degrees or 6 degrees, which facilitates treatment of 100% of patients with degenerative disc disease.
“This is our biggest differentiator and the reason patients who are currently not candidates for cervical disc replacement will benefit from our product,” he adds. “The SYNERGY DISC will expand the indications for cervical disc replacement and the number of patients who can benefit by solving the problem of alignment.”
In fusion surgery, a bone graft or spacer replaces the degenerative disc and is used to reconstruct the alignment of the spine. However, a fusion eliminates motion at the site of surgery, transferring new stresses to the adjacent levels of the spine and causing an increased prevalence of further degenerative disc disease.
According to Mr. Menawat, the SYNERGY DISC is ready to go head to head with major competitors, including Spinal Kinetics’ M6 disc, DePuy Synthes’ ProDisc and Medtronic’s Prestige product. Each of the three companies has an approximate 25% share of the European cervical disc replacement market and that none can correct pre-operative deformity and the alignment issues like the SYNERGY DISC can, he contends.
In conjunction with traditional diameter and height offerings, Synergy-Disc has been designed to include a 6 degree lordotic angle. This angle can be used to correct pre-operative deformities and prevent post-operative complications.
The SYNERGY DISC received CE Mark approval in November 2013, and the company began working with two leading surgeons in Germany approximately 12 months ago. “The surgeons liked our product so much that they switched to the SYNERGY DISC for multi-level disc replacement surgery,” he recalls.
Between the trial period of March and September 2014, the two surgeons inserted significantly more implants than the company had originally anticipated. “This was a big win for us. The surgeons’ enthusiasm and the positive clinical results validated the need for alignment correction in an artificial cervical disc,” Mr. Menawat explains.
In December, the company inked a five-year agreement with JOIMAX GmbH for exclusive rights to market and distribute the company’s SYNERGY DISC products in Germany, Austria and Switzerland.
JOIMAX recently reported that momentum for the SYNERGY DISC is growing in the region, with implants being performed in 10 hospitals in Germany and three in Austria.
“Because our SYNERGY DISC offers significant advantages over the competition and because our addressable market includes 40% of patients who are not being treated with disc replacement today, we anticipate achieving 33% market share in the EU within the next five years,” Mr. Menawat predicts.
He says that in the Asia Pacific region, where SDRI plans to leverage its CE Mark to obtain fast-tracked regulatory approvals in certain markets, the company has signed an agreement with a major orthopedic and spine distributor who expects to begin the regulatory registration process and launch the SYNERGY DISC in certain markets soon.
The company also has entered into discussions with potential distributors in other parts of the world, including Central and South America.
SDRI is currently in the process of raising private capital to support expanding sales in Europe, Asia Pacific and other emerging markets, begin clinical studies and data collection to support U.S. FDA regulatory approval for the SYNERY DISC and bring new innovative products to global markets.
One of those new products is the EnCap screw, which is used to treat facet disease in the lumbar spine and relieve lower back pain. Mr. Menawat says the company plans to submit EnCap for CE Marking and FDA 510(k) clearance in the second half this year and anticipates launching the device in the first half of 2016. SDRI’s product pipeline also includes other cervical implants, which are currently in the concept stage.
“Our plan is to radically expand the indications for cervical disc replacement and bring to market new, innovative devices,” Mr. Menawat contends. “We believe we can change the current landscape in disc replacement surgery by advancing the concept of alignment.”
