NASS, 2015: joimax® launches its new EndoLIF® On-Cage and new iLESSYS® Delta interlaminar endoscopy system

Chicago, Illinois – October 14, 2015 (BUSINESS WIRE) – joimax®, the global German developer and marketer of technologies and training methods for minimally invasive endoscopic spinal surgery, launches its two newest products – the EndoLIF® On-Cage and iLESSYS® Delta interlaminar system, during the 30th annual North American Spine Society (NASS) meeting in Chicago.

“With the new EndoLIF® program, combined with the TESSYS® technology, and now the iLESSYS® Delta, joimax® offers complete endoscopic solutions for spinal decompression, stabilization and fusion.”

The EndoLIF® On-Cage is a 3D-printed titanium alloy, manufactured utilizing a special electron beam melting (EBM) technology. The cage displays a porous surface with a diamond cell structure, which provides an optimal base for cell proliferation and bone growth. Two large implant graft windows, which are filled with autogenous bone, allow for bridging bone to further support fusion. The EndoLIF® On-Cage implant allows surgeons to utilize a mini-open or an inter-muscular approach, similar to a mini-transforaminal lumbar interbody fusion (TLIF) approach, into the intervertebral disc space facilitating endoscopic-assisted fusion.

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Dr. Ralf Wagner, LIGAMENTA Spine Center, Frankfurt, and Dr. Bernd Illerhaus, ONZ Spine Center, Recklinghausen, are two German spine specialists who have already performed more than 200 of the 800 EndoLIF® On-Cage procedures in Europe. “The access is dura and nerve-gentle, preserves better dorsal bony structures and limits scar tissue formation because of the stepwise tissue dilation,” said Dr. Wagner.

iLESSYS® Delta, an advanced development of the joimax iLESSYS® standard technology, is suitable for dorsal and dorso-lateral treatment of central spinal canal stenosis. The iLESSYS® Delta system enables a large area to be decompressed by means of a more widened interlaminar approach, guided by a full endoscopic direct visualization technique. The new and specific instrument set includes specially developed tools that permit an extensive, yet gentle, tissue-sparing decompression. A new endoscope with a 6 mm working channel allows the use of large shaver blades designed for bone and tissue resection, along with a range of instruments to be applied under full endoscopic view.

“We are impressed by the new endoscope which delivers outstanding image quality. With the specialized instrument set, it is finally possible to achieve decompression of central spinal canal stenosis,” said Albert E. Telfeian, M.D., Ph.D., Department of Neurosurgery, Rhode Island Hospital, Providence, RI. Jian Shen, MD, PhD, of Mohawk Valley Orthopedics, P.C., NY, concurs. The two surgeons gained experience with the new system during a meeting at the Anatomy Department of the University of Mainz, Germany, earlier this year, and during the cadaveric training course at Vitruvian lab in Baltimore, MD, held last week.

“Albert Telfeian and Jian Shen will be the first spinal surgeons in the USA to perform surgeries with the new iLESSYS® Delta endoscopic technology and the EndoLIF® On-Cage implants,” says Wolfgang Ries, CEO and founder of joimax®. He adds, “With the new EndoLIF® program, combined with the TESSYS® technology, and now the iLESSYS® Delta, joimax® offers complete endoscopic solutions for spinal decompression, stabilization and fusion.”

With the FDA approval of Percusys® percutaneous screw-rod-system earlier this year, and the FDA approval of EndoLIF® On-Cage in July, joimax® is positioning itself as a clear leader in minimally invasive endoscopic spinal surgery, providing a full spectrum of product technologies, now fully available in the U.S. market.

FDA Clearance for joimax EndoLIF On-Cage: 3D-Printed Fusion Implant

Irvine, California – July 13, 2015 (BUSINESS WIRE) – The German company joimax®, developer of technologies and training methods for minimally invasive endoscopic spinal surgery, today announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Endoscopic Lumbar Interbody Fusion, or EndoLIF® On-Cage.

The EndoLIF On-Cage® consists of titanium alloy, produced with Electron Beam Melt (EBM) technology. The cage displays a porous surface with diamond cell structure, providing an optimal base for cell proliferation and bone growth. Two large openings, which may be filled with autogenous bone, support the creation of a straight column for fusion.

The EndoLIF® implant allows surgeons to utilize an inter-muscular approach, similar to a mini transforaminal lumbar interbody fusion (TLIF), into the intervertebral disc, enabling endoscopic-assisted fusion. Dr. Ralf Wagner, LIGAMENTA Spine Center, Frankfurt and Dr. Bernd Illerhaus, ONZ, Datteln/Recklinghausen, two German spine specialists, have already performed more than 200 out of 600 EndoLIF procedures in Europe. “The access is dura and nerve-gentle, preserves the dorsal bony structures and we can avoid scar tissue because of the stepwise tissue dilation,” said Dr. Illerhaus.

The EndoLIF® On-Cage is designed to be used with supplemental posterior fixation, such as the joimax Percusys® percutaneous pedicle screw-rod system. Cage implantation can be performed with a posterior or postero-lateral approach, either using an open or endoscopic-assisted method.

“With the EndoLIF® program, joimax offers a complete endoscopic-assisted solution for spinal stabilization and fusion. In the future, we will be able to treat patients with even more gentle techniques,” comments Wolfgang Ries, CEO and founder of joimax®. “Our next development will be an EndoLIF® Cage on the basis of our iLESSYS® Delta system for posterior lumbar inter-body fusion (PLIF).”

Parviz Kambin Award for three joimax® Faculty Members

During a special joimax® faculty meeting which was held at the institute of anatomy at the University of Mainz, Germany on June 20-21, joimax® honored three surgeons with the Parviz Kambin Award. Dr. Albert Telfeian, Rhode Island Hospital, Brown University, RI, US and Dr. Gabriele Jasper, Center for Pain Control, NJ, US received the award in recognition of their outstanding scientific and educational dedication to transforaminal surgery. The two surgeons tremendously contributed to this field with numerous high quality publications. Also they are treading new paths for spinal endoscopy. Just recently Dr. Telfeian did the first awake surgery to remove a thoracic spinal tumor. Dr. Menno Iprenburg, Iprenburg Herniakliniek, NL received the award for his lifetime achievement. Dr. Iprenburg is applying joimax techniques, especially TESSYS, since 2004. In his private clinic, he successfully treated more than 2000 patients suffering from disc herniations.

The award is named after Dr. Parviz Kambin who identified a workspace within the intervertebral foramen, through which the spinal canal can be accessed safely. Because this safe zone is somewhat triangular shaped, it was named the „Kambin triangle“.

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On the left: Award winner Dr. Menno Iprenburg (r.) with joimax® CEO Wolfgang Ries (l.) On the right: Award winners Dr. Albert Telfeian (r.) and Dr. Gabriele Jasper (l.) with Wolfgang Ries (m.)

joimax launches the iLESSYS® Delta system for treatment of spinal stenosis at DGNC 2015 annual meeting

Karlsruhe, Germany – June 8, 2015 (BUSINESS WIRE) – The German company joimax®, developer of technologies and training methods for minimally invasive endoscopic spinal surgery, today announced it will introduce the company’s new iLESSYS® Delta system to the market at the 66th Annual Meeting of the German Society of Neurosurgery (DGNC) taking place in Karlsruhe, Germany from June 7-10.

iLESSYS® Delta, an advanced development of the joimax iLESSYS® technology, is suitable for dorsal and dorso lateral treatment of central spinal canal stenosis. The iLESSYS® Delta system enables a large area to be decompressed by means of the interlaminar access, guided by endoscopic-assisted vision.

“Since the access to the spine is the same as with the already well-established iLESSYS® technique, usage is very straightforward.” said Dr. Guntram Krzok, orthopedic surgeon from Waltershausen, Germany after testing the new system at a joimax workshop early this year. “I was impressed by the new scope which delivers outstanding image quality. With the specialized instrument set, it is finally possible to achieve decompression of central spinal canal stenosis.”

The iLESSYS® Delta instrument set includes specially developed tools that enable extensive, yet gentle, tissue-sparing decompression. The 6 mm working channel of the new endoscope allows for the use of large shaver blades designed for bone resection and endo-kerrisons. An additional option is the plastic (PPSU) working tube for unimpaired X-ray examination.

“iLESSYS® Delta is a logical addition to our portfolio. Not only is the system suitable for endoscopic decompression, but it also allows the parallel implantation of cages. This way we can achieve dorsal decompression and stabilization in one step,” comments Wolfgang Ries, CEO and founder of joimax.

About joimax

Founded in Karlsruhe, Germany, in 2001, joimax® is one of the leading medical device companies in minimally invasive spinal surgery („joined minimal access“). The company’s U.S. subsidiary was established in Irvine, California, in 2005. The company is primarily focused on the development, production and marketing of technologies and methods for minimally invasive endoscopic spinal surgery. joimax is active in 40 countries around the globe and its methods have been successfully employed in approximately 130,000 surgeries. With a special focus on education, the company provides surgeons with specialized technique training through the three-step joimax CM3 education program. This program includes visitations, cadaver workshops and live-surgery support.

joimax® faculty member Dr. Albert Telfeian performs 1st endoscopic removal of a thoracic spinal tumor

We are proud to share this story about our joimax® faculty member Dr. Albert Telfeian and how he was able to help 17-year old Jenelle “Nelly” Camara who was suffering from a spinal tumor.

Already in 2014, Dr. Telfeian removed a thumb-sized tumor pressing the girl’s spine cord. The pathology was sent for identification but even the best U.S. labs weren’t able to figure out what the tumor was. Camara underwent radiation therapy and was free of symptoms for a while. But the tumor resumed growth soon and she and her family returned to Dr. Telfeian at Hasbro Children’s Hospital in Providence.

This time the surgeon decided to use an endoscopic approach with the girl under local anaesthetic. With Camara being awake during surgery, Dr. Telfeian was able to ask her to move her legs which is an important control for the surgeon operating in such close proximity to the spinal cord. With a tiny 8-millimeter incision on her back and specialized endoscopic instruments he was able to do a biopsy on the tumor without removing bony material like in the first surgery.

Within a week the family received a diagnosis which now allows a targeted therapy for Camara who will be able to return to school and cheerleading in fall this year.
Read all the details about how endoscopy helped to identify Camara’s tumor in this article.

NBC also featured the story in NBC 10 News. 

A scientific paper (case report) about the procedure was published online in the journal, Clinical Neurology and Neurosurgery, and will appear in the July 2015 issue.

joimax® workshops continue to proof as highly efficient and successful in the education of surgeons worldwide

As the second step of the joimax® CM3 Education Program, surgeons are trained on joimax® methods during hands-on cadaver workshops taking place throughout the year in different locations and countries.
The typical workshop agenda includes theoretical sessions with expert lectures from joimax® Faculty members as well as practical sessions on human cadavers. The feedback joimax® receives from the trained doctors after each workshop and the increasing number of workshop registrants speak for themselves. “When we analyze the feedback forms after each course we find that participants highly value the hands-on time which also allows them to discuss with the instructors as well as the opportunity to share experience with surgeons that are new to endoscopy.” says Monika Gensert, Senior Product and Education Manager at joimax®.

From January to May 2015, joimax® organized and conducted four workshops in Germany and Austria and another four workshops in the US. In Europe alone joimax® trained 60 surgeons from various countries and disciplines. Surgeons can chose between basic and advanced courses which differ in the complexity of the techniques taught, i.e. the EndoLIF®, iLESSYS® stenosis and CESSYS® approach is only trained in advanced workshops.
Additionally, joimax® technologies were part of 4 DWG (German Spine Society) Modules for Board Certification of spine surgeons.
At the US workshops, whose attendees exclusively come from the US and Mexico, another 43 surgeons were instructed on TESSYS®, Multiuse, iLESSYS®, Percusys® and EndoLIF®.
“The workshop was excellent, with lots of great input from the joimax® team, as well as from the faculty surgeons.” stated a US-workshop attendee.

Your next opportunity to join one of our workshops will be in Mainz, Germany on June 19-20 and in Dallas, Texas, US on July 18. For more workshop dates click here.

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US workshop with joimax® Faculty Dr. Daniel Laich, Irvine, CA, US, March 2015

joimax® at CAOS in Beijing, China

The 8th Annual Congress of the Chinese Association of Orthopaedic Surgeons (CAOS) was held at the Beijing International Convention Center, Beijing, China on May 7-10.
joimax® joined this important international event both as an exhibitor and as an education partner.
CAOS, in collaboration with NASS, created the “Techniques in Complex Spine Surgery” program which featured six 1-hour live technique demonstrations, two 3-hour hands-on cadaver workshops, and five lectures with discussion. As expert support for this exciting program, CAOS invited two members of the joimax® Faculty Team: Dr. Guntram Krzok, Friedrichroda, Germany and Dr. Ralf Wagner, Frankfurt, Germany.
The two surgeons delivered well-visited lectures and demonstrated the joimax® TESSYS® technique. As a highlight of the event, the technique demonstrations were shared via webcast and more than 1000 surgeons viewed the program in the Beijing convention hall. More than 26,000 surgeons, surgical nurses and technicians viewed the demos online which enabled maximum visibility for joimax and its technologies.

The joimax® team members who supported the event on-site were deeply impressed by the strong interest in the latest spine surgery systems coming from many Chinese surgeons. Needless to say China is the largest medical market in the world and joimax® will continue to strengthen its relationship with local partners and training centers.

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Live webcast during joimax® TESSYS® technique demonstration at CAOS 2015.

joimax® at the AANS in Washington, D.C.

From May 2-6, the 83rd American Association of Neurological Surgeons (AANS) Annual Scientific Meeting welcomed more than 3,000 medical attendees to Washington, D.C., to celebrate and reflect on both the history and future of neurosurgery.

The team from joimax® Inc. (Irvine, CA, US) participated in this important event as a corporate partner and showcased its products for minimally invasive spine surgery (MISS). Traffic to the booth was high and the team was very satisfied with the outcome of the meeting. One topic that came up during many discussions with the visiting attendees was the screw-rod system Percusys® for spinal stabilization. The product received 510k clearance in March.

joimax® founder and CEO Wolfgang Ries from Karlsruhe, Germany, was invited as the keynote speaker for the Practical Clinic session “Invention and Innovation in Neuro- and Spine Surgery”. His one hour lecture on the first day of the AANS meeting presented a compelling picture on how joimax® evolved since 2001 when the company was founded. Key products and technologies were presented as well which led to engaged discussions after the lecture. Teodoro Forcht-Dagi, Co-Director of the session, commented: „joimax® is a remarkable example of an innovative start-up company that evolved to a successful mid-size local company. Its efforts to work with surgeons and refine MISS technology for the safety and benefit of patients are admirable. A large part of its success is attributable to the combination of technical quality and meticulous training. The company’s contribution to the development of MISS is huge.”

„The AANS Annual Meeting is extremely worthwhile to be at.” emphasized Wolfgang Ries. “For joimax® it was a great opportunity to interact with neurosurgeons and to discuss our well-established MISS techniques and products – made in Germany.”

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.”

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
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