joimax Receives 510(k) Clearance for Percusys Pedicle Screw-Rod System

IRVINE, Calif., March 4, 2015 (GLOBE NEWSWIRE) — The German company joimax®, developer of technologies and training methods for minimally invasive endoscopic spinal surgery, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Percusys® percutaneous pedicle screw-rod system.

The patented Percusys system is a multi-functional implant for use during spinal stabilization procedures. Its unique screw and instrument design enables a safer and more effective surgical technique with minimal steps for the surgeon. The single, small instrument set allows flexibility to perform surgery through a percutaneous, minimally invasive or open approach.

“During development, the main focus was on the ease-of-use of the system,” says Dr. Frank Hassel, specialist for spine surgery from Freiburg, Germany, who was instrumental to the Percusys development. “The idea was to reduce the complexity in instrumentation and simplify stabilization procedures to minimize the potential damage of soft tissues and improve overall patient outcomes.”

Percusys implants comprise single packaged, sterile, and pre-assembled pedicle screws with lengthening shaft and set-screw. All screws are color coded according to their diameter, cannulated, fenestrated, self-cutting and self-drilling. Each surgical step is carried out using the lengthening shaft, which is tightly connected to the tulip. The assembly allows for direct manipulation and does not require additional instrumentation. Shearing off the lengthening shaft can be done by a 360-degree rotation of the shaft breaker.

Percusyscan be usedin combination with the joimax® EndoLIF® O-Cage. “This offers an optimal solution for minimally invasive, endoscopic-assisted access to the intervertebral disc,” says Wolfgang Ries, CEO and founder of joimax. “Percusys® represents the next logical step in the development of endoscopic surgery and further strengthens the joimax position as an expert in this special market segment.”

joimax® Experiences Major Growth, Launches TESSYS® TransSAP Endoscopic Surgical System

KARLSRUHE, Germany – (BUSINESS WIRE) – joimax® is continuing its year-over-year double digit growth. Over the past 9 months, joimax® has grown more than 25% globally and in the United States alone, more than 35%. Among this major spurt, the market leader in technologies and training methods for full-endoscopic and minimally invasive spinal surgery is launching a new endoscopic surgical system, TESSYS® TransSAP.

“This allows for more extensive foraminal decompression and provides an optimal basis for transforaminal endoscopic fusion”

The company attributes strong growth to their popular workshop and educational program, which is now offered worldwide under the ESPINEA® training academy. To keep momentum, joimax® is releasing the TESSYS® TransSAP — the fourth addition to the TESSYS® family encompassing the standard TESSYS® Std, TESSYS® XT featuring longer reach instruments, and TESSYS® Thx, the optimized version for the thoracic spine.

The system is based on the proven TESSYS® method introduced in 2004. Since then, the technology has been enhanced and can be used for more complex indications, widening the spectrum of disease and vertebral level applications.

joimax® faculty surgeon masters, Dr. Christof Hofstetter and Dr. Ralf Wagner, demonstrate TESSYS® and iLESSYS® to an at capacity crowd during NASS 2022 in Chicago. (Photo: Business Wire)

“The TransSAP method follows an adopted access path to the spine, directly targeting the Superior Articulating Process,” says Dr. Christoph Hofstetter, associate professor in the Department of Neurological Surgery at the University of Washington. “This allows for more extensive foraminal decompression and provides an optimal basis for transforaminal endoscopic fusion,” adds Dr. Ralf Wagner, a longstanding joimax® ESPINEA® Faculty orthopedic surgeon based in Frankfurt.

In addition, joimax® provides a series of implants for fusion indications, such as the percutaneous pedicle screw system, Percusys® Plus, and a family of 3D-printed titanium cages within the EndoLIF® program. The EndoLIF® suite of products consists of the static implants O/On-Cage, Delta-Cage and DoubleWedge-Cage. “There are plans to add a new fully-expandable cage, as well as a navigated solution for endoscopic disc preparation and implant positioning to provide a full endoscopic assisted fusion platform,” says Wolfgang Ries, CEO and founder of joimax®.

All joimax® implants can be safely inserted using the “Over-the-Wire” technique for precise implantation, making them ideal for endoscopically-assisted fusion procedures established and protected by joimax®.

These new products have been exhibited at the following trade shows: SMISS in Las Vegas, CNS in San Francisco, and NASS in Chicago, and will be featured at EUROSPINE in Milan and at the German Spine Congress, DWG, in Berlin later this year.

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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