SDRI appoints joimax® as exclusive distributor for Synergy Cervical Disc in Germany, Austria and Switzerland

TORONTO, Dec. 12, 2014 (GLOBE NEWSWIRE) — SDRI, developer of SYNERGY Disc and alternative spine technologies, enters into a five-year agreement with JOIMAX GmbH for exclusive rights to market and distribute the company’s SYNERGY family of products in Germany, Austria and Switzerland.

Karlsruhe-based Joimax, one of the leading medical device companies for minimally invasive spinal surgery, officially kicked off the alliance during an evening reception on December 11, during the 9th Annual German Spine Surgeons Meeting 2014 in Leipzig, Germany. Joimax also sponsored a luncheon symposium on December 12, where Dr. Thomas Bierstedt, and Dr. Bernd Illerhaus, both neurosurgeons from Orthopedic Neurosurgery Center (ONZ) in Datteln, shared their initial clinical experience and preliminary results utilizing the SYNERGY Disc for motion preservation procedures.

The SYNERGY Disc is the world’s first cervical disc replacement that is designed specifically to actively correct pre-operative deformity, prevent post-operative misalignment and provide optimal stability for multi-level procedures. The SYNERGY Disc incorporates a revolutionary geometry, offering multiple alignment corrections to provide surgeons with reliable and precise control of lordosis and sagittal balance.

The first clinical cases with the SYNERGY Disc were performed in 2009, in Europe. These pilot cases with the long-term, follow-up data have recently been submitted for publication.

“We are very excited with the initial results from Germany, which have validated our pilot cases,” commented SDRI’s Chief Executive Officer, Devesh Menawat. “We are eagerly anticipating the next follow-up periods and engaging in the next steps of our strategy designed to gain regulatory approval for our SYNERY Disc in the United States.”

Dr. Kemal Yucesoy, a neurosurgeon involved in the pilot study, stated: “The gold standard (cervical fusion) involves proper reconstruction of sagittal balance following decompression. Conventional disc replacements, however, do just the opposite; they restore range of motion but they have an unpredictable impact on sagittal balance. The Synergy Disc combines the best of both of these very successful treatments by restoring range of motion and normal sagittal balance to the patient. Restoring alignment of the spine is vital for long-term success of cervical disc replacements. Our long-term follow-up has demonstrated outstanding results. The SYNERGY Disc will help to expand the indications for cervical arthroplasty.”

“SDRI’s SYNERGY Disc addresses a significant unmet clinical need in patients suffering from alignment problems who, today, have no viable option,” said Wolfgang Ries, Joimax founder, chief executive officer and president. “We have begun to commercialize the product in Germany and early feedback from surgeons is very positive. We look forward to broadening the penetration for SYNERGY in German hospitals and delivering this surgical solution to doctors and hospitals in Austria and Switzerland.”

“Germany, Austria and Switzerland represent key international markets for our company,” added SDRI President Glenn Webb. “The size of these markets for spine products, combined with Joimax’s reputation for delivering relevant solutions and effective training for spine surgeons, provides us with a great opportunity for growth and to expand the adoption of our Synergy technologies into other markets. This alliance further supports our mission to give options to patients, who, otherwise, have no alternative treatments available.”

Synergy Disc is a registered trademark of SDRI. Joimax is a registered trademark of Joimax GmbH.

About Joimax GmbH.

Joimax GmbH, based in Karlsruhe, Germany, focuses on the development, production and marketing of technologies and methods of endoscopic spinal surgery. The complete Joimax systems provide the best possible visualization, tissue removal, stabilization and documentation in one, so the surgeon can work flexibly, independently and cost-effectively. The Joimax CM3, which includes surgery visitations, cadaver workshops and surgery support by experienced medical trainers and application specialists, employs a three-stage education program to train surgeons on the safe application of each specific surgery technique.

About SDRI, Inc.

Synergy Disc Replacement, Inc. (SDRI), headquartered in Toronto, Ontario, delivers alternative spinal technology solutions to solve complex surgical problems. The SDRI family of products include the SYNERGY® Cervical Disc. SYNERGY 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 in patients with pre-operative spine alignment issues.

A photo accompanying this release are available at: http://www.globenewswire.com/newsroom/prs/?pkgid=29639

Suzie Robinson, APR
Media and Investor Relations
| 214-577-9329

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joimax® – The experts in minimally invasive endoscopic spinal surgery show flag at the EUROSPINE in Lyon

Karlsruhe – joimax® is participating with an industrial exhibition at the annual meeting of the european spine society „EUROSPINE“ from October 1st to October 3rd at the Congress Center in Lyon. In Forum N° A43 the company, located in Karlsruhe, exhibits its now highly diversified product portfolio for 360° surgery in nearly all areas of the spine including endoscopic or percutaneous stabilization. In various lunch symposia, numerous european experts will show their experiences and results. During a 2 hours lunch symposium on the first day of the Congress in Hall Rhône 1 internationally recognized spine specialists under the leadership of Dr. Menno Iprenburg (Veenhuizen / Netherlands) and Dr. Alastair Gibson (Edinburgh / United Kingdom) will provide insights of their experience and into their scientific results.

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Lectures on the latest product developments are expected with great interest, hereby:
• The EndoLIF® system for endoscopic lumbar column stabilization. This system includes not only the fully endoscopic access technology to the disc space with the proven TESSYS® or iLESSYS® method, but also an implant, the so-called O-Cage (O = oblique).
• Percusys®, an innovative screw and rod system for the posterior percutaneous stabilization.

The advantages of this methods are obvious:
• Tissue sparing access by dilation
• Protection of dura and nerves through a proven access corridor
• Preservation of the posterior bony structures due to the special lateral access
• EndoLIF® O-Cage made of Ti6Al4V for optimized bone ingrowth
• Percutaneous stabilization by Percusys® and therefore minimally invasive

Both new systems are CE approved and the FDA approval is in progress.

Since 2004, more than 100,000 patients in 30 countries were successfully operated using the TESSYS® method and their further developments. Studies show the shorter reconvalescence time, faster recovery and thereby speed up the return of the patients to work and enhance quality of life.

Visit joimax® at EUROSPINE, Cité Internationale, Lyon Convention Centre, Forum N° A 43 and see for yourself the benefits of the new systems.

joimax® celebrates 10 years of TESSYS®

Karlsruhe – Since 2004 more than 100,000 patients in 30 countries (up to August 2014) have undergone surgery with the TESSYS® method and its later developments. The latest studies reveal a shorter recovery time, a quicker return to work and normal quality of life, and an associated reduction in the impact on welfare systems.

joimax® looks back on 10 years of successful application of the TESSYS® procedure for minimally invasive endoscopic removal of herniated discs – a particularly gentle surgical technique using the naturally occurring transforaminal opening to the spinal canal. TESSYS® was the first product that joimax® launched onto the market and it helped the company make its breakthrough. Since then, joimax® has greatly diversified its product portfolio for 360° surgery in virtually all areas of the spinal column, including endoscopic and percutaneous stabilization.

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joimax® presents the EndoLIF® system

Karlsruhe – As its latest development, joimax® presents the EndoLIF® system for endoscopic stabilization of the lumbar spine. The EndoLIF® system includes an O-cage
(oblique cage) in addition to fully endoscopic access technology to the intervertebral disc space with the proven TESSYS® or iLESSYS® technique. In addition, there is Percusys®, a screw and rod system for posterior percutaneous stabilization.

The advantages of this procedure are clear:

• Smooth, atraumatic access due to dilation of tissue
• Dura and nerves are protected by the working tubes
• Dorsal bone structures are unaffected
• O-cage made from titanium with honeycomb structure as optimal subsurface for cell growth
• Percutaneous stabilization with a screw and rod system, so minimally invasive too Both new systems are CE approved, not yet FDA cleared.

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joimax® and spine experts from across the world at COMINCO in São Paulo

Karlsruhe – Spine experts from across the world met at the beginning of August at COMINCO (Brazilian Congress of Minimally Invasive Spine Surgery) in São Paulo. This was the fifth time that COMINCO has taken place and it provided an opportunity for large numbers of experts to share information and ideas in the fields of neurosurgery and orthopedics.

Minimally invasive treatment methods and their successes from the patient’s perspective were the focus of the congress. The very latest surgical possibilities and techniques were presented in symposia, workshops, and numerous lectures to a very high scientific standard. joimax® GmbH trainer, Dr. med. Ralf Wagner from Frankfurt, Germany, notably introduced TESSYS® in his presentation “Endoscopy of the lumbar spine in degenerative diseases.” This technique provides transforaminal access to the lumbar spine for treatment of herniated discs and stenosis – an osseous narrowing of the spinal canal.

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A prime example of collaboration between China and Germany

Karlsruhe – joimax® opens the 3rd Training and Reference Center in Shanghai, China, at Changzheng Hospital, Tongji University, under the direction of Prof. Ye Xiaojian. The prestigious university and its affiliated Tung-Chee Hospital were founded in 1907 by the German government as its first major project in foreign cultural policy.

It is a prime example of Sino-German collaboration, which continues to this day at Tongji University and also at other centers in Chongqing at Xinqiao Hospital under the direction of Prof. Zhou Yue, and in Beijing at the General Hospital of the People’s Liberation Army (PLAGH) under the direction of Prof. Zhang Xifeng. The Training & Reference Centers provide targeted training to surgeons in endoscopic treatment methods on the spine as part of the joimax® Education Program. Above all, this features TESSYS®, the technique of transforaminal access to the lumbar spine for treatment of herniated discs and stenosis – an osseous narrowing of the spinal canal. Qualified and standardized training in these surgical techniques is essential. joimax® is therefore supporting the basic principle that patients should always receive high quality, reliable, and safe therapy in line with the very latest technology and scientific progress.

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joimax® at the WCMISST congress in Paris

joimax® at the WCMISST Congress in Paris Karlsruhe – joimax® presented the EndoLIF® system as the latest development for endoscopic stabilization of the lumbar spine at the 4th Congress. The EndoLIF® system includes an O-cage (oblique cage) in addition to fully endoscopic access technology to the intervertebral disc space with the proven TESSYS® or iLESSYS® technique. In addition there is Percusys®, a screw and rod system for posterior percutaneous stabilization.

The WCMISST (World Congress of Minimally Invasive Spine Surgery and Techniques) is one of the leading international congresses for minimally invasive techniques in spine surgery. The Congress brings together spinal surgeons and pioneers from over 65 countries.

About joimax® joimax® Inc. from Karlsruhe, Germany, is one of the leading medical technology companies for minimally invasive spine surgery (joined minimal access). It focuses particularly on the development, production, and marketing of technologies and techniques for endoscopic spine surgery. joimax® complete systems offer the best possible all-in-one visualization, tissue removal (if required), stabilization, and documentation to enable the surgeon to work flexibly, independently, and efficiently. A three-stage joimax® CM3 Education Program trains surgeons in how to apply the surgical techniques in a targeted manner. In addition to training visits and compound workshops, the program also includes support from experienced medical trainers or application specialists during operations. joimax®, TES®, TESSYS®, iLESSYS®, CESSYS®, intENTS®, EndoLIF®, Percusys®, Vitegra®, Camsource®, Shrill®, Versicon®, Endovapor®, Vaporflex®, Legato®, Kyverment®, Tigrip®, Intracs®, and SPOT® are registered trademarks of joimax® GmbH.

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TESSYS® pioneers receive the Parviz Kambin Honorary Award

Karlsruhe – At a ceremony in Paris two TESSYS® pioneers received the Parviz Kambin Honorary Award: Dr. Florian Maria Alfen from Würzburg, Germany, who in 2003 acquired the first TESSYS® complete system and has successfully performed more than 2,500 procedures. As a member of the joimax® Faculty, Dr. Alfen has trained many doctors. The second award winner is Dr. Daniel Laich from Chicago, U.S.A. He is the first TESSYS® user in the United States and has been a Faculty member since 2009, as well as a scientific adviser for the company with his extensive experience of TESSYS®.

Since 2004 more than 100,000 patients in 30 countries (up to August 2014) have undergone surgery with the TESSYS® method and its later developments. The latest studies reveal a shorter recovery time, a quicker return to work and normal quality of life, and an associated reduction in the impact on welfare systems.

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joimax® celebrates 10 successful years on the market with TESSYS® at the WCMISST in Paris

Karlsruhe, 11.06.2014. joimax® looks back on 10 years of success with the surgical application of TESSYS® for the minimally invasive, endoscopic removal of herniated discs; a particularly gentle surgical technique which utilizes the natural transforaminal access to the spinal canal. TESSYS® was the first product that brought joimax® to market and was a breakthrough for the company. Today, joimax® offers a highly diversified product portfolio for 360° surgery in almost all areas of the spine including endoscopic and percutaneous stabilization.

During the award ceremony in Paris, two TESSYS® pioneers will be awarded with the “Parviz Kambin Honorary Award”: Dr. Florian Maria Alfen of Würzburg, who bought the very first TESSYS® system in 2004 and has successfully operated on more than 2,500 patients. As a member of the joimax® Faculty Team, Dr. Alfen has trained a large number of surgeons. The second award winner is Dr. Daniel Laich of Chicago. He is the very first TESSYS® user in the U.S. and has been a faculty member since 2009. Since 2013, he has also been operating as a scientific advisor for the company.

Since 2004, more than 100,000 patients in 30 countries were surgically treated with the TESSYS® method and its subsequent surgical developments. Follow-up studies show a significantly shorter recovery time, faster return to work and normal activities with improved quality of life and ultimately, lower costs to the social system.

At the WCMISST, the 4th World Congress of Minimally Invasive Spine Surgery and Techniques, joimax® presents its latest development- the EndoLIF® system for endoscopic stabilization of the lumbar spine. Aside from fully endoscopic access via the proven TESSYS® and iLESSYS® methods, the EndoLIF® system contains an O-Cage for oblique interbody fusion. In addition, joimax® presents its new Percusys® System- a posterior, percutaneous screw and rod system. The advantages of these products and procedures are apparent:

– Smooth, atraumatic access due to gentle dilation of tissue
– Dura and nerves are protected by the working tubes
– Dorsal bone structures are generally not affected and remain intact
– O-Cage with an osteo-conductive surface provides the optimum substrate for cellular growth
– Posterior, percutaneous stabilization via the minimally invasive screw and rod system

Both of these systems are CE marked and FDA clearance is in progress.

Visit us at WCMISST, booth #15 at the Marriott Rive Gauche Hotel and discover for yourself the many advantages of our newest systems.

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