Mainstay Medical ReActiv8-A sustains performance at one year in clinical trial

Posted On September 27, 2016 By OrthoSpineNews In Neuro, Spine /

27th September 2016

Mainstay Medical has announced the one-year results from the ReActiv8-A Clinical Trial, an international, multi-centre, prospective, single arm trial for ReActiv8 in people with disabling chronic low back pain and few other treatment options.

The one-year results show sustained performance in the ReActiv8-A Clinical Trial at the one-year follow-up with a clinically important, statistically significant and lasting improvement in the study’s key endpoints for pain (NRS), disability (ODI) and quality of life (EQ-5D).

Peter Crosby, chief executive officer of Mainstay, says, “We are very encouraged to see such strong and lasting benefits in this difficult-to-treat population. After one year of ReActiv8 treatment, 88% of subjects reported a clinically important improvement in one or more of the study endpoints, 81% were satisfied or very satisfied with the treatment and the majority continued to use the ReActiv8 treatment.”

The results presented are based on data from the first 47 subjects implanted in the ReActiv8-A Trial of whom 46 have completed the 90-day follow-up, 45 the 180-day follow-up and 41 the one-year follow-up.

To facilitate future comparison of results in the ReActiv8-A and the ReActiv8-B trial, all outcomes are presented relative to the data collected at the enrolment visit, according to a company release.

Results for all subjects at 90 days, 180 days and 1 year respectively are:

Ninety-three per cent, 87% and 88% with clinically important improvement in one or more of the study’s key endpoints.
Sixty-three per cent, 58% and 56% with clinically important improvement in low back pain NRS on the day.
Fifty per cent, 53% and 59% with clinically important improvement in ODI.
Eighty-nine per cent, 82% and 80% with clinically important improvement in EQ-5D.
Sixty-one per cent, 67% and 62% reported>50% pain relief.
Eighty-nine per cent, 84% and 81% were satisfied with ReActiv8 treatment.

The results for EQ-5D and ODI previously announced were relative to data collected at the pre-implant visit to 90 days and 180 days and were:

Fifty-sevent per cent and 60% with clinically important improvement in ODI.
Sixty-seven per cent and 73% with clinically important improvement in EQ-5D.

Adverse events incidence and type were comparable to those in clinical trials reported for other neurostimulation devices, according to the release, with no unanticipated adverse events, and no serious adverse events related to the device, therapy or procedure.

Amendia Launches New SYZYGY™ Spine Stabilization System

Posted On September 27, 2016 By OrthoSpineNews In Spine /

MARIETTA, GA (PRWEB) SEPTEMBER 27, 2016

Balanced spinal solutions provider Amendia Inc. is pleased to announce the commercial launch of its innovative Spondylolisthesis reduction system:, the Syzygy™ Stabilization System. Configured to provide immobilization and stabilization of spinal segments as an adjunct to fusion, Syzygy is ideal for use in the treatment of specific acute and chronic instabilities or deformities of the thoracic, lumbar, or sacral spine; and conditions such as fracture, dislocation, scoliosis, kyphosis, spinal tumor, or failed previous fusion.

Made of implant-grade titanium alloy, the Syzygy system features cannulated and non-cannulated screws, with self-tapping “grip quick” threads for maximum cortical bone purchase. Extended threads allow increased adjustability and control in 5mm increments for accurate reduction of spondylolisthesis. With available medial and cranial couplers, Syzygy facilitates up to 35mm of reduction with ±10° of cranial-caudal adjustment.

Dr. Hewatt M. Sims, MD, fellowship-trained orthopedic spine surgeon at Orthopedic Spine Center and Tift Regional Medical Center in Tifton, GA, performed recent spine surgeries with Syzygy. “Syzygy is a unique spinal system, providing quick, precise, and consistent reduction of the spondylolisthesis deformity,” Dr. Sims said.

The Syzygy system’s advanced design features, such as extended threads on each MAC Pin enable precise corrections and dual scales enhance optimal sagittal alignment.

“In working hand in hand with the medical community and spinal device marketplace, we know how important it is to provide patients and surgeons with a pedicle screw-based solution that consistently and accurately realigns the spine,” said Lawrence Boyd, Amendia’s Executive Vice President of Research & Development. “With surgeons providing care for a large number of patients who engage in athletics and rigorous physical activity, combined with a growing aging population, this critical addition to our line of lumbar fixation products will provide another way for surgeons to evolve and innovate their care.”

The Syzygy Stabilization system is part of Amendia’s growing list of products for balanced solutions for lumbar fixation systems. To learn more about Syzygy, including features and benefits and 510(k) information, please visit us at http://www.amendia.com.

About Amendia

Headquartered in a state-of-the-art manufacturing facility in Marietta, GA, Amendia is a leading designer, developer, manufacturer and marketer of medical devices used in spinal surgical procedures. Amendia’s mission is to exceed surgeon and patient expectations by creating balanced solutions with disruptive technologies for medical devices paired with biologics and instrumentation. Amendia’s vertically-integrated strategy focuses on improving surgical outcomes and the lives of patients with spinal disorders. For more information, please visit http://www.amendia.com.

Spineology Inc. Announces Unique TLIF Insertion Options for the Posterior Midline Approach ACT MediaLIF™

Posted On September 27, 2016 By OrthoSpineNews In Spine /

September 27, 2016

MINNEAPOLIS & ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., the innovator in anatomy-conserving spine surgery, announced today the availability of multiple transforaminal lumbar interbody fusion (TLIF) technologies as part of the Anatomy-Conserving Medial Lumbar Interbody Fusion (ACT MediaLIF™) platform. These TLIF technologies allow for TLIF placement of interbody devices using a direct posterior, or ACT MediaLIF, approach.

“Surgeons frequently prefer placing a single cage using the TLIF technique over more traditional PLIF techniques, but experience difficulty with TLIF when using the latest mini-midline techniques,” said John Booth, CEO of Spineology Inc. “These unique technologies allow surgeons to use a TLIF technique and still take advantage of the benefits that the ACT MediaLIF procedure provides.”

Dr. Vivek Mohan, MD, of Dupage Medical Group in Chicago added, “Having technology that allows me to do a TLIF in conjunction with the ACT MediaLIFprocedure provides the best solution for my patients. The procedure allows me to reduce the incision size and muscle trauma, and minimize the amount of bony removal to place the cage. It also facilitates anterior cage placement to maximize lordosis restoration.”

The ACT MediaLIF procedure combines Spineology’s Medius Retractor, Rampart Interbody and Fortress Pedicular Fixation Systems to provide an anatomy-conserving approach to posterior lumbar surgery that can reduce incision length, dissection and retraction requirements compared to traditional open surgery.

About Spineology Inc.
Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall Public Relations
Dave Folkens, 651-286-6713
dave@risdall.com

joimax® Announces Release of First Endoscopic AMA CPT Code

Posted On September 26, 2016 By OrthoSpineNews In Spine /

September 26, 2016

IRVINE, Calif.–(BUSINESS WIRE)–The AMA (American Medical Association) released the CPT 2017 Codebook (Current Procedural Terminology), now containing the first endoscopic spinal surgery code no. 62380. This new code covers endoscopic decompression of the spinal cord, nerve root(s), including laminotomy, partial facetectomy, foraminotomy, discectomy and/or excision of herniated intervertebral disc, 1 interspace, lumbar, and will be enforced as of January 1^st, 2017. Under this code the specific transforaminal (TESSYS^®) and/or interlaminar (iLESSYS^®) procedures are fully covered in the USA herewith, which are already marketed by joimax^®in 45 countries.

“The definition of this new code in the CPT codebook 2017 is a major milestone towards the acceptance of endoscopic minimally invasive spine surgery techniques and its benefits to both the surgeon and their patients,” states Wolfgang Ries, Founder and CEO of joimax^®. Since 2012 joimax^® had been driving this effort to obtain CPT codes as these procedures required submission to payors for reimbursement coverage which was granted only in single cases under temporary codes, so-called T-codes.

“joimax^®has been instrumental in driving the effort to obtain full code coverage of endoscopic spinal surgery,” says Daniel Laich, DO, Swedish Convenant Hospital, Chicago, who had been participating and presenting in almost every AMA meeting over the last five years. Due to the high research and publication activities by key users like Albert Telfeian, MD, PhD, at Rhode Island Hospital at Brown University, and a group of users around him, strong evidence has been accepted by AMA authorities, justifying the release of this new CPT code.

Many papers and publications on joimax^® products can now be downloaded from the newly released joimax^® homepage. The completely redesigned website offers visitors richer insight into the company’s innovative products and systems. A quick and easy access to essential information and features is available, including the latest workshop and education activities, which are essential in endoscopic minimally-invasive spinal surgery.

Meanwhile joimax^® offers basic and advanced workshop training courses mainly in the USA, Germany and Austria, and oversees a participation population of almost 3,000 physicians. Independent training courses are also performed in China and Korea to support the fast growing Asian markets. Detailed information about those courses are updated regularly at www.joimax.com.

About joimax^®

Founded in Karlsruhe, Germany, in 2001, joimax^® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS^® (transforaminal), iLESSYS^® (interlaminar) and CESSYS^® (cervical) for decompression procedures, Multiuse RT (e.g. for rhizotomy) or with EndoLIF^® and Percusys^® for minimally-invasive endoscopic assisted stabilizations, proven endoscopic systems are provided that, together, cover a variety of indications.

In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax^® technologies to operate through small incisions – under local or full anesthetic – via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”).

Contacts

joimax^® GmbH
Sabine Jarosch, 49 721 25514 0
sabine.jarosch@joimax.com

ulrich medical USA® Announces Product Line Extension, Releases uCerv® Titanium Cervical Interbody System

Posted On September 26, 2016 By OrthoSpineNews In Spine /

ST. LOUIS, Sept. 26, 2016 /PRNewswire/ —ulrich medicalUSA, Inc., a medical device company focused on developing and commercializing musculoskeletal implant technologies in the United States, today announced the U.S. market release of uCerv titanium spinal implants as an adjunct to its current uCerv PEEK OPTIMA® Interbody System which is an existing product used for anterior cervical discectomy and fusion (ACDF) surgical procedures.

“Spinal implants made from solid titanium alloy can support bone growth at the fusion site by providing proven and reliable structural integrity,” said Ali A. Baaj, M.D., Assistant Professor of Neurological Surgery at Weill Cornell Medical College in New York. “I like the easy-to-use uCerv instrumentation which incorporates a slim designed inserter that allows for superior visualization and unimpeded work space at the surgical site.” Dr. Baaj went on to say, “This product line also features a beneficial large graft window which allows for the usage of maximum bone graft material and it is available in a wide variety of sizes.”

The uCerv titanium implants have a roughened-surface design with a trapezoidal shape and are available in parallel or lordotic configurations of various heights in small, medium and large footprints. In addition, these implants feature optimal teeth patterns on the superior and inferior surfaces to limit migration.

For more information, please visit www.ulrichmedicalusa.com.

About ulrich medical USA, Inc.
ulrich medical USA, Inc. is a privately-held subsidiary of ulrich medical®, an innovative medical technology company headquartered in Ulm, Germany which is celebrating 104 years in business in 2016.

Company Contact: e.laskey@ulrichmedicalusa.com

Photo – http://photos.prnewswire.com/prnh/20160913/407241

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/ulrich-medical-usa-announces-product-line-extension-releases-ucerv-titanium-cervical-interbody-system-300329631.html

Zimmer Biomet to Feature Clinical Data on the Aspen® MIS Fusion System and the Timberline® Systems during the Congress of Neurological Surgeons (CNS) Annual Meeting

Posted On September 26, 2016 By OrthoSpineNews In Spine /

Broomfield, CO – September 26, 2016 – Zimmer Biomet Spine, Inc. today announced positive topline data on the Aspen MIS Fusion System and the Timberline Systems from three studies validating less invasive treatment methods for degenerative disc disease and spondylolisthesis. The studies will be presented as ePosters during the Congress of Neurological Surgeons Annual Meeting (CNS), September 24 to 28 in San Diego.

“Zimmer Biomet’s clinical data demonstrates the benefits of less-invasive spinal fusion techniques, at a time when the industry is continuing to improve minimally invasive treatment options for patients,” said Adam Johnson, Group President of Zimmer Biomet Spine, Dental, CMF and Thoracic. “We look forward to discussing the one-year outcomes of our randomized controlled trial, as well as executing more research in the future so we can continue to develop the evidence necessary to support excellent patient outcomes.”

Demonstrations of the Aspen MIS Fusion System and the Timberline Systems will be available at Zimmer Biomet Booth #429.

ePosters:

Interspinous Process Fixation versus Pedicle Screw Fixation in Circumferential Arthrodesis: Outcomes from a Prospective Randomized Multi-Center Trial(ePoster 1287)

Lead Investigator: Dr. Kee Kim; UC Davis Health System, Dept. of Neurosurgery

Product Focus: Aspen MIS Fusion System

Lateral Lumber Interbody Fusion with Integrated Lateral Modular Plate Fixation: Intraoperative and Follow-Up Outcomes (ePoster 1312)

Lead Investigator: Dr. Ryan DenHaese; AXIS Neurosurgery and Spine

Product Focus: Timberline MPF Lateral Fixation System; Aspen MIS Fusion System

Anterior Versus Lateral Circumferential Lumbar Arthrodesis: Outcomes from a Prospective Multi-Center Study (ePoster 1301)

Lead Investigator: Dr. Kee Kim; UC Davis Health System, Dept. of Neurosurgery

Product Focus: Timberline Lateral Fusion System; Aspen MIS Fusion System

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

PROFILE – Musculoskeletal New Ventures Conference (MNVC)

Posted On September 26, 2016 By OrthoSpineNews In Recon, Spine, Top Stories /

A Conversation with Gary Stevenson, Co-Founder and Managing Partner at MB Venture Partners, LLC

Let’s start by having you give a brief background on who you are, what MB Ventures is and why you started MNVC.

My name is Gary Stevenson and I am co-founder and managing partner of MB Venture Partners in Memphis. We started in 2001 and raised our first fund in 2002. In our first 15 years, we have focused a disproportionate amount of our investment capital on the musculoskeletal niche where we have domain expertise and relationships that have resulted in high-quality investment opportunities. Over the years, our start-ups have been acquired by Wright Medical, Medtronic, Smith & Nephew, and Zimmer Biomet.

One of our venture partners, with the help of the Memphis Bioworks Foundation, started in the MNVC in 2003, so this will be our 14th annual event. The goal then was to feature the relative strengths of Memphis in the musculoskeletal industry. MB Venture Partners has been Conference Host and the largest sponsor every year since then. Our goal is to bring together the 20-25 most exciting new start-ups so they can engage with investors (both venture capitalists and angels) and strategic partners (Medtronic, Smith & Nephew, Wright Medical, and may others).

MNVC being October 18-19^th, it falls right in the middle of the busy season for orthopedic industry meetings, yet many of us industry “junkies” consider MNVC to be a “Can’t Miss” meeting. Why do you think that is?

I appreciate the compliment – I do think MNVC is the “can’t miss” event of the year for musculoskeletal start-ups and the people who love them. We don’t aim to be the largest event of the year, but we do want to be the best. As one example, we give presenters plenty of time at the podium to tell their story – 30-minute time slots. This is less superficial than other events and allows the depth that industry insiders are looking for. I think insiders want more than a 6-minute or 10-minute presentation can give them and that’s one reason why we all come to the MNVC. That and the barbecue.

What kind of companies typically present at MNVC?

We strive for balance when we curate the presenter list. It’s by invitation only and we’re looking for a mix of spine and orthopedics. We’re also looking for a mix of early and later-stage opportunities. We have been told many times that the MNVC is the one place where start-ups like to “break stealth”, that moment in time when management thinks they’re ready to tell the industry more about what they’re up to. We’re flattered to hear that, obviously.

Tell our readers about the beneficiary of the meeting proceeds and your passion about giving back to your community.

As returning attendees already know, MB Venture Partners doesn’t host the MNVC with an eye towards making a profit. If we were, we would be selling presentation slots (they’re free) and we’d be dividing the hour into 6 10-minute slots or even worse, 10 6-minute slots. Also, we don’t hire an outside firm to manage the conference for us. Truth is, MB Venture Partners donates all of its time putting the event on every year and pays for the privilege – we’ve written the largest sponsorship check every year. We do all that because we’re trying to keep costs low. A portion of each year’s proceeds is donated each year to the Memphis Academy of Science and Engineering (“MASE”), Tennessee’s first charter school. MASE helps inner-city students achieve their dream of a job in the technology and medical device fields. MASE was founded by the Memphis Bioworks Foundation and it warms our heart to know that more than $120,000 has been donated from the MNVC to benefit the teachers and students of MASE.

Spineology Inc. Expands Relationship with Nation’s Leading Tissue Bank

Posted On September 23, 2016 By OrthoSpineNews In Spine /

September 23, 2016

MINNEAPOLIS & ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., the innovator in anatomy-conserving spine surgery, announced today it has expanded its relationship with Musculoskeletal Transplant Foundation (MTF), the nation’s leading tissue bank. MTF will now be the sole tissue provider for Spineology’s allograft product lines, including the newly launched Incite™ Cortical Fibers, a unique and versatile bone grafting solution.

“MTF has a long track record of delivering safe, high quality tissue products using the most stringent standards in the industry,” said John Booth, CEO of Spineology Inc. “Our expanded relationship allows us to pass along that safety and quality to our customers.”

Incite Cortical Fibers are ultra-thin, entangled cortical bone fibers which provide a significant surface area of exposed growth factors to stimulate bone growth, and an osteoconductive matrix for cellular attachment and proliferation. The fibers also offer excellent handling properties, in-situ expansion and placement through a variety of delivery methods.

“The Incite Cortical Fibers give me great intra-operative flexibility because of the handling properties and versatility of the product,” said Charles C. Park, M.D., Ph.D., Director of the Minimally Invasive Brain and Spine Center at Mercy Medical Center in Baltimore, Maryland.

About Spineology Inc.
Spineology Inc. provides innovative, anatomy conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall Public Relations
Dave Folkens, 651-286-6713
dave@risdall.com

LES Society to Sponsor Spine Surgeon Symposium Featuring Groundbreaking Innovations in Viscoelastic Total Disc Replacement Technology

Posted On September 22, 2016 By OrthoSpineNews In Spine /

SAN DIEGO, CA (PRWEB) SEPTEMBER 22, 2016

During the 2016 Congress of Neurological Surgeons Annual Meeting, surgeons will gather to discuss less invasive surgery techniques and technologies for moving elective spine surgeries from hospitals to outpatient surgery centers with a focus on Axiomed LLC’s revolutionary cervical and lumbar viscoelastic total disc replacements. This discussion will compare newer spine surgery techniques to fusion.

The the Symposium will be centered around a new philosophy of less invasive surgery entitled Less Exposure Surgery (LES). Minimally invasive surgery is focused on smaller incisions. LES improves on minimally invasive surgery to achieve less tissue disruption and a faster recovery. It uses more fluoroscopy to achieve indirect visualization. Open surgery uses maximum exposure to improve ease and accuracy of the techniques.

Less exposure surgery utilizes the fundamental principles and goals of open surgery techniques but achieves the same results using smaller incisions and greater precision under direct visualization instead of relying on fluoroscopy, so there is higher degree of safety. LES surgical techniques are also more straight forward. Many companies are continuing to develop improvements to LES technology.

The LES Society has sponsored a growing body of peer reviewed and published research studies demonstrating that patients can safely undergo spine surgery using LES fusion techniques and technologies in outpatient surgery centers and go home the same day to recover rapidly. With this summer’s completion of the IDE study of the Axiomed Freedom viscoelastic lumbar total disc replacement and the completion of the European pre-clinical trial of the Freedom Cervical viscoelastic total disc replacement, surgeons will have access to spine technology that most closely emulates the human disc. This could have revolutionary effects on spine surgery, as it allows for a much less invasive technique than fusion and better, faster outcomes.

Surgeons will discuss topics such as comparing anterior cervical fusion using plates and screws, standalone cages with screws and total disc replacement. Featured speakers include neurosurgeons, Dr. Fassil Mesfin and Dr. Juan Valdivia and moderator, professor Dr. Kingsley Chin, an orthopedic surgeon and the founder of the LES Society. The event will take place on September 24, 2016, from 5:00-7:00 pm.

“The LES Society consistently provides education and training concerning Less Exposure Surgery techniques and technologies in annual meeting forums such as CNS and locally in cities via journal clubs where surgeons get to share their experiences and cases as well as network around business and innovation,” said Jessica Morgan, program director of the LES Society. “There is a growing movement towards LES and companies like SpineFrontier Inc and Axiomed Inc are pioneering the technologies with surgeon inventors who want to safely move surgeries to same day outpatient recovery centers.”

Dr. Mesfin is the director of complex spine and spine oncology and an assistant professor at the University of Missouri School of Medicine in Columbia, Missouri. Dr. Valdivia specializes in reconstructive spine surgery, and is a member of the medical staff of the Baycare Medical Group in Tampa, Florida. He spent over 5 years at the University of Michigan teaching as an academic neurosurgeon.

CNS Annual Meeting attendees are invited to enjoy a wine and cheese tasting during the Symposium at the award winning San Diego restaurant, BiCE. Hor d’oeuvres will also be served at the event. To RSVP for the event or to get more information, email the LES Society program director, Jessica Morgan, at jessicamorgan(at)lessociety(dot)org.

About Less Exposure Surgery Society:

The Less Exposure Surgery Society is a non-profit organization, which aims to advance research, technology and education for minimal invasive surgery. Using smaller incisions and new technology, the surgeon exposes only the areas that need to be treated. The technique has improved recovery and outcomes for patients. The society is expanding its membership in order to provide education and networking for medical professionals globally. The LES Society is seeking experienced members in order to expand its board and administration.

Visit https://www.lessociety.org/about.html to learn more.

Medovex Corporation to Demonstrate Expanding EMEA Business During EuroSpine 2016, Berlin, Germany

Posted On September 22, 2016 By OrthoSpineNews In Spine /

ATLANTA, GA–(Marketwired – Sep 21, 2016) – Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that the Company will exhibit during EuroSpine which is being held from October 5-7, 2016 in Berlin, Germany.

As part of the product exhibition, Medovex will highlight its innovative DenerveX™ System, a minimally invasive surgical (MIS) procedure pioneered by Medovex that was built around the combination of denervation and capsulectomy with reproducible results, “A potential paradigm shift in the treatment of Facet Joint pain.”

Medovex will exhibit at stand #B100 and will feature a number of work stations to demonstrate DenerveX™ treatment modality which uses Rotablation™ technology, high heat and rotational capsular tissue shaving, in a minimally invasive posterior capsulectomy procedure of the Facet Joint.

Medovex’s presence at EuroSpine is an extension of the Company’s continued investment in its strategic expansion throughout the EMEA market. EuroSpine is the union from the European Spine Society and the European Spinal Deformity Society. The Spine Society of Europe has experienced strong growth in membership, activities and participants at annual meetings, including participants from all over the world.

During EuroSpine 2016, Medovex also will announce the official opening of the Company’s European Distribution Center in Berlin.

The Center will serve as Medovex’s European distribution service headquarters and function as the commercial hub for all European distributors and end users, as well as other support functions. The international operations center in Atlanta, GA (USA) will remain the Company’s international operational headquarters.

Patrick Kullmann, President and COO for Medovex, stated, “Region specific events such as EuroSpine are important to our expansion efforts in Europe as we prepare for the future launch of the DenerveX System. The Berlin distribution service center will provide further infrastructure for Medovex to execute our future market development strategy across Western Europe and the entire EMEA region. Medovex is well-positioned to drive surgeon adoption of our new innovative DenerveX™ System across Europe.”

Manfred Sablowski, Senior Vice President of Global Sales & Marketing, added, “The opening of the European distribution service center is an important milestone for Medovex and a key inflection point for our Company’s strategy to grow our business in EMEA. In past months, we have additionally expanded our footprint to include all of Scandinavia and Israel. Our future goal is to increase our world-class EMEA distribution in other key countries. With the recent appointment of Juan Davila as Director Sales & Marketing for Latin America, having extensive experience in this market, we expect to continue to execute our go to market strategy.”

The DenerveX System consists of the DenerveX device, a single use medical device and the DenerveX Pro-40 Power Generator, both designed to be less invasive with faster recovery time than current surgical treatment options. It consists of two procedures combined into one device and is expected to provide for a longer lasting treatment solution while offering potential savings to the health care system. DenerveX is not yet commercially available.

DenerveX system is not yet CE marked or FDA cleared and is not yet commercially available.

About Medovex

Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com

Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION

CONTACT INFORMATIONMedovex Corp.
Jason Assad
470-505-9905
Email Contact