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® announces 510(k) clearance for its Endovapor® 2 Multi Radio Frequency System with its first presentation at the Annual Scientific Meeting of the American Association of Neurological Surgeons (AANS) 2017, in Los Angeles

Irvine, CA – April 26, 2017 – joimax®, the German based market leader of technologies and training methods for endoscopic minimally invasive spinal surgery, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Endovapor® 2 Multi Radio Frequency System.

The patented device generates electrical power for monopolar and bipolar cutting and coagulation of tissue structures in surgical operations. The joimax® Endovapor® 2 is an all-in-one generator with specially integrated programs for spinal surgery with interdisciplinary application. The device is equipped with two monopolar and two bipolar sockets and an easy and intuitive touchpad technology. With arc control for safe application and easy neutral electrode monitoring, it combines a variety of different electro-surgical modes and effects.

“After receiving the FDA clearance for the joimax® Vaporflex® and Legato® electrosurgical probes in early  November 2016, this is another milestone in strengthening the joimax® position as an expert in endoscopic minimally invasive spine surgery,” states Wolfgang Ries, Founder and CEO of joimax®.

During the AANS, joimax®  participated in the CME endoscopic cadaveric workshop with two stations and held a very successful US-expert meeting including topics such as training procedures, clinical Research and future technologies.

"This is the best thing I’ve ever done"

bauerfeind life magazine 2013/1- In the small Dutch village of Veenhuizen, Dr. Menno Iprenburg performs endoscopic surgery on his back patients. The results of his endoscopic operations with the joimax® TESSYS® method sometimes make patients weep for joy.

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

Menno-Iprenburg_joimax-TESSYS

joimax® Launches NAVENTO® Navigation Endoscopic Tower at NASS and EUROSPINE

IRVINE, CA – joimax®, the German-based market leader in technologies and training methods for full-endoscopic and minimally invasive spinal surgery, is excited to announce the global launch of its new generation tower, NAVENTO® Navigation Endoscopic Tower. Optimized for endoscopic spine surgery with special settings for the safe treatment of sensitive structures, NAVENTO® will be featured at the North American Spine Society (NASS) meeting in Boston later this month and at EUROSPINE in Vienna this October.

joimax endoscopic tower NAVENTO

NAVENTO®, the fully integrated fourth generation endo-tower, contains everything a surgeon needs to perform a successful procedure. The tower boasts updated design features for enhanced usability and is composed of six devices that work in unison to give the user the best possible surgical experience:

  1. Vitegra®, the brain of NAVENTO®, offers complete documentation and data management.
  2. Camsource® LED provides optimal clarity up to 4K resolution.
  3. Intracs®, the newest device from joimax®, delivers electromagnetic navigation at the instrument’s tip.
  4. Shrill®, the shaver drill system, with the newest generation recently launched, provides optimal RPMs and torque management.
  5. Endovapor® 2 poses electrosurgical offerings for monopolar and bipolar settings.
  6. Versicon®, delivers fluid and pressure regulation.

“joimax® continues to lead the endoscopic spine market through innovations in technologies aimed to increase the user experience and provide spinal patients with an ultra-minimally invasive treatment option,” stated Christoph Hofstetter, M.D., Ph.D., associate professor in the Department of Neurological Surgery at the University of Washington.

Wolfgang Ries, CEO and founder of the joimax® group, confirmed, “NAVENTO® pulls together the latest technologies forming one complete, seamlessly integrated spinal endoscopic package.”

NAVENTO®, along with the full suite of joimax® endoscopic technologies will be showcased at NASS, booth #3512, and at EUROSPINE, booth #04.

joimax® hosts SpineWeek symposium, leads live surgery broadcast during CAOS-NASS

Karlsruhe, Germany and Singapore, Chengdu/Shanghai, China (May 25, 2016) – joimax®, the global developer and marketer of technologies and treatment methods for minimally invasive endoscopic spinal surgery, recently hosted an educational symposium and exhibited at SpineWeek in Singapore. SpineWeek takes place every four years and is viewed as one of the most important congresses, representing numerous international society leaders.

“The decision to participate in this congress was the right step to demonstrate our presence in the Asian region,” says Wolfgang Ries, CEO and founder of joimax®. “This year, there was a clear focus on endoscopic treatments by the participating societies, which created a strong interest in our lunch symposium. Approximately 200 attendees gathered to learn about the techniques of endoscopic minimally invasive spine surgery and the benefits of these techniques to both the surgeon and their patients,” continued Ries.

To further validate the company’s expansion and presence in China, joimax® participated in the 9th Congress of the Chinese Association of Orthopaedic Surgeons – North American Spine Society (CAOS/NASS) meeting in Chengdu, China. The company was also involved with the Master Techniques in Spine Surgery Workshop, held on May 20, 2016 in Shanghai, China. Dr. Ralf Wagner, of the Ligamenta Spine Center in Frankfurt, Germany, led the technique-focused workshop and surgery, which was broadcast live to the meeting in Chengdu, as well as online to 30,000 Chinese surgeons.

joimax® Launches Numerous Innovations at EuroSpine Milan From 19 To 21 October 2011

Karlsruhe/Milan, October 17th, 2011. In its anniversary year joimax® presents numerous innovations – at EuroSpine Milan for the first time, opening up the series of the big autumn congresses and exhibitions.

For the first time joimax® presents the now complete product range for endoscopic spinal surgery, showing the novel pain therapy product “Multiuse”. The new Multiuse-Set comprises instruments for endoscopic facet joint denervation or so-called rhizotomy. Subsequent to the iLESSYS® system for 360° decompression launched in spring 2011, it completes the joimax® product range that was kicked off with TESSYS® years ago. Further special blades for the successfully launched Shrill® shaver-drill resection and ablation system will be introduced to the market also.

At EuroSpine joimax® will display its complete endoscopic system of the 3rd generation with Vitegra®3 for the first time. This is the most recent generation of fully integrated documentation systems. With D-Camsource® HD LED, the first fully integrated HD camera technology with LED light source will be introduced. The joimax® proprietary radio frequency system Endovapor® will be presented to the public with new bi-polar probes.

This rapid-fire launching of a variety of new products proves again the leading position of joimax® in the field of endoscopic spinal surgery. To accompany this, joimax® offers a lunch workshop on October 20th, 2011. Congress attendees can register directly at the joimax® booth. Members of the international joimax® faculty team will present their experiences when applying the joimax® instruments, devices and surgery methods.

Further important events right after EuroSpine on the joimax® agenda are the SMISS in Las Vegas, USA, the NASS in Chicago with a big workshop to be held at the renowned Chicago Back Institute, the MEDICA in Duesseldorf, Germany, the Rome Spine Conference in Italy and finally the DWG annual congress in Hamburg early December, with another lunch symposium and an evening reception celebrating the 10th anniversary of the company.

New partnership: joimax® joins forces with JAPAN MEDICALNEXT CO., LTD.

(Karlsruhe-GER, 16 June 2020)

Karlsruhe (GER) – joimax®, the German-based market leader in technologies and training methods for full-endoscopic and minimally invasive spinal surgery, is starting as of now a new partnership in Japan. The distributor JMC- JAPAN MEDICALNEXT CO., LTD. and joimax® are pursuing a long-term sales cooperation that will result in an extensive distribution agreement for the entire Japanese market.

“joimax® is looking forward to working with a partner strong as JMC, says joimax® Founder and CEO Wolfgang Ries and adds, “a company that has the necessary personnel, expertise, as well as the corresponding specialization and penetration of the market”. Masayuki Yoshimura, President and CEO of JMC, explains, “We are very excited to partner with joimax®. With our shared vision for advancing the field of minimum invasive spinal surgery, we are looking forward to introducing the globally recognized joimax® products in Japan”. Thus, joimax® strengthens its sales activities in Japan and enters into another important partnership in Asia.

JAPAN MEDICALNEXT CO., LTD. founded in 1992 is located in Osaka, Japan. With 314 employees at its locations and an Orthopedics Division that will focus on joimax® products, the company is a wholly-owned entity of MC Healthcare, Inc. (subsidiary of Mitsubishi Corporation) and prominent supplier of medical devices in Japan.

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

– See more at: http://globenewswire.com/news-release/2014/12/12/690985/10112195/en/SDRI-Appoints-JOIMAX-as-Exclusive-Distributor-for-SYNERGY-Cervical-Disc-in-Germany-Austria-and-Switzerland.html#sthash.Qxd2qOZ3.dpuf

joimax® celebrates its 10th anniversary presence with 900 users in China and reports a jump in Q1-2017 sales

Karlsruhe, Germany – April 11th, 2017 – joimax®, the German based market leader of technologies and training methods for endoscopic minimally invasive spinal surgery, just celebrated its 10 years’ birthday in China with an outstanding 3 days event in Chongqing. More than 900 surgeons out of 2,000 users in China only took part in live surgeries, workshops and a scientific program on endoscopic spinal technologies including MISS fusion techniques. Besides, joimax® organized the presentation of its latest systems like the TESSYS® ISeeU and iLESSYS® Delta in product trainings as well as newest tools for endoscopic treatment in an exhibition hall. The program was supported by joimax® Faculty Members from Europe, USA and other countries. In the course of the meeting a Chinese Faculty Team with 13 members was inaugurated by Wolfgang Ries, Founder and CEO of joimax® and Qin-Guang You, President of joimax® China. ”Due to the growing education and training needs in the Asian region the time has come to form a local team for this important market”, explains Wolfgang Ries. “It is a great honor to lead this team and to support the further growth of joimax®”, says the head of the Faculty Team, Prof. Yue Zhou from the Third Military Medical University in Chongqing. He was awarded with the joimax® Handshake Award in Gold for his exceptional commitment and the members of the group received the joimax® Handshake Award in Silver.

After very satisfying growing sales figures in 2016 (31 % growth vs. 2015), joimax® is proud to announce a jump in sales in the first quarter 2017. Consolidated figures show an increase of 60 % compared to the same period of last year. “This is a very encouraging development, showing the continuing expansion and growth of the group”, states Wolfgang Ries, Founder and CEO of joimax®.

joimax® presents EndoLIF® as a world premiere at the Annual Meeting of DGNC

Not yet FDA cleared

joimax® presents EndoLIF® as a world premiere at the Annual Meeting of DGNC

Karlsruhe, 24 May 2013. It has become a good tradition – but this time it will include a world premiere: As in previous years, joimax® will present a lunch symposium during the 64th Annual Meeting of the German Society of Neurosurgery DGNC to be held in Düsseldorf, Germany, on 27 May 2013. As a world premiere joimax® will introduce its novel EndoLIF® system for endoscopic stabilization of the lumbar spine. The joimax® Faculty Team had the chance to see this technology during its yearly User Meeting held at the Institute of Anatomy of the University of Mainz, Germany, in April. It will now be displayed to the broad expert audience of DGNC’s Annual Meeting.

Besides the endoscopic technology for the access to the disc compartment based on the well proven TESSYS® or iLESSYS® access method, the EndoLIF® system comprises an O-cage (oblique cage) and a screw and rod system for posterior percutaneous stabilization. The advantages of this procedure are obvious:
– Smooth, atraumatic access due to dilation of tissue
– Dura and nerves are protected by the working tubes
– Dorsal bone structures are generally not affected
– O-Cage with osteo-conductive surface providing the optimum substrate for cell growth
– Stabilization via screw and rod system for percutaneous i.e. minimally invasive positioning
Indications for this procedure are the degenerative disease of intervertebral discs, mechanical instabilities and spondylolisthesis grade I and II. CE approval is expected by summer 2013.

The joimax® lunch symposium will be chaired by Prof. Dr. Jürgen Kiwit (Berlin). Dr. Guntram Krzok (Friedrichroda) will present „TESSYS® and iLESSYS® for multiple decompression therapies“. Dr. Bernd Illerhaus (Recklinghausen) will then draw the line to the EndoLIF® technology with an outlook on future therapeutic options. „The EndoLIF® system is the next logical step in the evolution of endoscopic access technologies to the spinal canal for gentle and safe minimally invasive implantation of cages with subsequent percutaneous stabilization“, states Dr. Illerhaus with conviction.