Kategorie: Information

San Diego, Oct. 20, 2011 – The Society for Minimally Invasive Spine Surgery (SMISS), San Diego, CA and joimax^®, Karlsruhe, Germany announced today the signing of an agreement to support the SMISS Registry as a founding sponsor for creation and launch of the SMISS Spine Registry for Minimally Invasive Endoscopic Spine Surgery. The SMISS Spine Registry was designed to collect valuable data concerning decreased hospitalization, recovery times, and complication rates of endoscopic spine procedures, as well as increased quality of life measures, subject satisfaction, and cost effectiveness. In today’s rapidly changing healthcare climate, it is imperative to ensure the ongoing availability of this data regarding efficiencies of care and quality of outcomes.

SMISS has assembled an outstanding research team with extensive experience within the spine field. The Principal Investigator for the Registry, Choll Kim, M. D., Ph.D, Executive Director and Board of Directors Member of SMISS states, “We are excited to partner with joimax^® in the launch of the SMISS Registry, a project that will produce the relevant data collection and management necessary for the continued growth of minimally invasive endoscopic spine surgery. The Society will lead the way in the collection of minimally invasive spine surgery outcomes and cost data. SMISS is positioned to become the model for successful spine research.”

“joimax^® and SMISS are ideal partners to begin this important project in spinal endoscopy. The data collected will assist both parties in furthering the development of minimally invasive endoscopic spinal surgery, which is a great benefit to patients around the world,” said Wolfgang Ries, CEO and Founder of joimax. “We are pleased to provide funding for this important project.”

This three year, multi-centered project will commence patient enrollment in late 2011. The Registry is expected to enroll a minimum of 250 patients during the first phase of the project.

Dr. Menno Iprenburg has previously been stationed in Tanzania and Zambia as well as in many countries in Asia. As a young physician, he went wherever he was needed. Today the world comes to him. “Apart from Australia – no idea why – we have already had people from all known nations here.” By here, the orthopedist means a spot around 20 miles south of Assen. In the middle of the green expanse of North Holland, by a canal that goes on for miles, lies Veenhuizen. A few pretty, well-kept little houses; that’s all there is. At the end of the village, however, a collection of brick buildings emerges. “It is the remains of an old state jail, renovated a few years ago,” the physician explains. In one of the buildings, which used to be the quaran-tine station, the ‘Rugkliniek Veenhuizen’, also known as ‘Spineclinic Iprenburg’, set up home three years ago. Today, in a place previously used to prevent infection, intervertebral disk surgery is performed.

TESSYS uses a natural keyhole

Patients who are plagued by pain after an inter vertebral disk prolapse undergo a special method of surgery with Dr. Iprenburg. “In Holland, we call it PTED (Percutaneous Trans-foraminal Endoscopic Discectomy),” explains the physician, “Internationally it is known as TESSYS (Transforaminal Endoscopic Surgical System).”This refers to an endoscopic procedure for removing the intervertebral disk prolapse with minimal surgical inter-vention. The special feature of TESSYS is that the surgeon can reach through the inter-vertebral foramen, a “natural keyhole,” with his smallest instruments to the location of the prolapse, where he can remove the press-ing tissue and free the trapped nerve. The patient lies on their side, the incision is only a few millimeters long, and there are few side effects as a result. Patients who come into the Rugkliniek stooping usually leave it a few hours later walking upright.

“I have my life back!”

“When you see the relief on the patient’s face it warms your heart.” Dr. Iprenburg puts on a video that shows himself and a patient immediately after surgery. Uncertain, but with astonishment in her eyes, the patient walks two or three steps. She stops in her tracks. Then she cries. “I have my life back”, she says, her voice breaking. Speechless. It is understandable, when faced with these kinds of images, that even the experienced physician concluded: “This is the best thing I’ve ever done.” Yet TESSYS has nothing to do with miracle cures à la Lourdes, as the physician made it sound. The procedure is internationally established and validated. In studies it has been described as “signifi­cantly ­superior” ­in­ comparison­ with ­the­ standard method (e.g. with the patient in a
prone position). Apparently, around 10,000 inter vertebral disk operations have been carried out to date across the world using the TESSYS method. Of those, and there is evidence to prove it, 1,700 had taken place in Veenhuizen alone as of the start of 2013. Surgery is only carried out in the Rugkliniek when the pain has not reduced six to eight weeks after the intervertebral disk prolapse. Dr. Iprenburg learnt the double keyhole procedure in Germany and practiced it as an orthopedist in Assen, before founding his own private clinic in Veenhuizen. “Although the procedure is more expensive than the
standard method, it is cheaper from a macro-economic perspective, because patients can start work again sooner,” said the physician.

For further information about Dr. Menno Iprenburg please visit www.herniaklinik.nl

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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