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February 2-4, 2017
RegulatorySpineTop Stories

Implanet Announces CE Mark Clearance for JAZZ® Passer

October 19, 2017 OrthoSpineNews

October 19, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:IMPL) (OTCQX:IMPZY)(Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has received European regulatory clearance through the CE Mark to market the new JAZZ® Passer.

Following 510(k) marketing clearance from the FDA in September for the US market, Implanet has just received the CE Mark for its new JAZZ® Passer product line.

This new milestone will allow Implanet to offer its latest technological development in the world’s second largest spine surgery market, worth an estimated $800 million1.

Ludovic Lastennet, CEO of Implanet, says: “This innovation will accelerate the adoption of JAZZ® technology by new European surgeons. This highly dynamic market is driven by France and Germany, regions where we are active, notably in the high potential adult degenerative bone disorder segment. At the recent Eurospine conference in Dublin, we saw enthusiasm for our solution from health professionals and surgeons. We were able to show, during a thematic evening with more than 50 participants and throughout this conference, how easy to use our latest innovations are.”

As a reminder, JAZZ® Passer is a compatible solution with the JAZZ® Platform, providing new options in terms of accessing and working around anatomical structures.

IMPLANET will participate in the following scientific conventions in Q4-2017
NASS in Orlando, October 25 to 28, 2017
SOFCOT in Paris, November 6 to 9, 2017
ICEOS in San Diego, November 15 to 17, 2017

Next financial press release: 2017 annual revenue, on January 16, 2018 (before market)

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.

IMPLANET is listed on Euronext™ Growth market in Paris.

Disclaimer

This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 26, 2016 under number R.16-035 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.

1 Source : Global Data

Contacts

IMPLANET
Ludovic Lastennet, +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot, +33 (0)1 44 71 20 40
implanet@newcap.eu
or
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, +1 917 385 21 60
implanet@alphabronze.net

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Spine

Nexxt Spine to Showcase NEXXT MATRIXX™ at the 2017 North American Spine Society Annual Meeting

October 19, 2017 OrthoSpineNews

October 18, 2017

NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine, LLC, a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions, announced that it will introduce the NEXXT MATRIXX™ System, the company’s new 3D printed porous titanium interbodies and vertebral body replacement (VBR) devices, during the 2017 North American Spine Society (NASS) Annual Meeting in Orlando at Booth #1550.

The NEXXT MATIRXX™ implants which are now available nationwide have been successfully implanted as indicated for use as cervical intervertebral fusion devices and lumbar intervertebral fusion devices. To date, all surgeon feedback has been overwhelmingly positive.

The NEXXT MATRIXX™ System leverages Nexxt generation technology to create interbody and VBR devices with optimized open architectural porosity, residue-free surface technology, and robust radiographic imaging performance.

“We are extremely excited to introduce the Nexxt generation technology with our 3D printed porous titanium devices along with our comprehensive product portfolio during the largest spine meeting and exhibition in the world,” said Andy Elsbury, Nexxt Spine’s President.

For more information about NEXXT MATRIXX™, visit www.nexxtspine.com.

Contacts

Nexxt Spine
Sarah Koch
Info@NexxtSpine.com

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SpineTop Stories

Relievant Medsystems Names Ray M. Baker, M.D. as Chief Medical Officer

October 19, 2017 OrthoSpineNews

SUNNYVALE, Calif, Oct. 18, 2017 (GLOBE NEWSWIRE) — Relievant Medsystems, a privately held medical device company that has developed the Intracept® Procedure, a minimally invasive and clinically proven approach for the treatment of chronic low back pain, today announced the appointment of Ray M. Baker, M.D., as Chief Medical Officer. Dr. Baker will report to Relievant’s Chief Executive Officer, Kevin Hykes.

“Ray is an internationally recognized, highly respected clinician bringing over 30 years of pain management expertise and industry leadership to Relievant,” said Kevin Hykes, President and Chief Executive Officer of Relievant Medsystems. “His deep experience as an interventional pain management specialist, and as past president of both the North American Spine Society and the Spine Intervention Society will be instrumental in shaping the commercial introduction of the Intracept® Procedure. We look forward to his contributions as the company enters its next phase of growth.”

As Chief Medical Officer, Dr. Baker will be an integral part of the executive team at Relievant, guiding technology development, clinical research strategy, and commercial initiatives. Prior to joining Relievant, Dr. Baker served as VP & Executive Medical Director at Evergreen Health in Kirkland, WA. He brings both academic and private practice experience to the position, having previously served as a Clinical Professor and Director of Interventional Pain Services at the University of Washington. In addition to presiding over the North American Spine Society and Spine Intervention Society, he has held a number of prominent board and leadership positions within the industry, including serving as the Founding Chairman of the CMS Multi-Society Pain Workgroup, and Chairman of the UnitedHealthcare National Spine Advisory Board.

“I have consulted for Relievant since the company’s inception – the depth, experience and talent of the executive leadership team are extraordinary, and I am thrilled to be on board,” said Dr. Baker. “Throughout my time as a practicing interventionalist, I have had the opportunity to be involved with the development of a number of novel technologies.  The FDA-cleared Intracept Procedure has been built on a foundation of level one evidence and clinical strength. I am acutely aware of how few options are open to these patients and am excited to be part of the team bringing this important new therapy to market.”

About Relievant Medsystems

Founded in 2006 and based in Sunnyvale, California, Relievant Medsystems is a privately held medical device company developing new solutions to improve the quality of life for millions of patients suffering from chronic low back pain. Relievant’s Intracept® System delivers targeted energy into the spine and blocks the transmission of pain signals from the basivertebral nerve (BVN).  This minimally invasive procedure provides orthopedic surgeons, neurological surgeons and interventionalists with a new way to provide clinically proven, lasting pain relief for chronic low back pain.  As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure.  Please see www.relievant.com for a discussion of the risks, contraindications, warnings, precautions and a summary of the pivotal clinical trial data on the device.

FDA has cleared the Intracept System for the following Indications for Use: The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

* Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART)

Contact
Lynn Lewis or Carrie Mendivil
Gilmartin Group
415-937-5402
investors@relievant.com

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Spine

NuVasive Launches New 3D-Printed Porous Titanium Implant In Expanding Advanced Materials Science Portfolio

October 18, 2017 OrthoSpineNews

SAN DIEGO, Oct. 18, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the launch of Modulus® XLIF® titanium implants. The new 3D-printed, fully porous device provides a differentiated offering for the Company’s flagship XLIF procedure, highlighting a continued commitment to innovation in developing first-of-its-kind technology to support its leading lateral spine procedure.

The new Modulus titanium implants are developed using additive manufacturing technology, or 3D printing, to create an organic, porous architecture that mimics the porosity and stiffness of bone for reduced stress shielding. By employing advanced microporous surface topography, Modulus XLIF creates an ideal environment for bone in-growth1. The device’s optimized architecture also leads to improved imaging characteristics compared to traditional titanium interbody devices.

“We’ve seen an increase in surgeon preference to use titanium interbody options in spine surgeries, and we were confident we could develop a titanium option that delivers the porous properties surgeons need,” said Matt Link, executive vice president of strategy, technology and corporate development of NuVasive. “Modulus XLIF maximizes the potential of 3D-printed spinal implants through the application of unique and advanced software optimization processes. This product launch further represents our continued commitment to advancing surgical materials, and delivering best-in-class implants that provide superior osseointegration and biomechanics.”

Modulus XLIF’s novel technology represents an advancement in the growing titanium interbody market. The implant expands the offerings used in the XLIF procedure, the only lateral approach spine procedure proven with over 15 years of clinical evidence and 400 peer-reviewed lateral-approach, XLIF specific publications.

“Surface architecture is an increasingly important part of the fusion process,” said Kade Huntsman, MD, orthopedic spine surgeon with the Salt Lake Orthopaedic Clinic in Salt Lake City, Utah. “The design of Modulus XLIF maximizes the potential of additive manufacturing through the combination of highly porous endplates with an optimized internal structure.”

NuVasive will showcase its market-leading, procedurally-integrated technologies, including the new Modulus XLIF in NuVasive Booth #713 at the North American Spine Society Annual Meeting held October 25-28, 2017 in Orlando, Fla.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

1 Preclinical data on file. Data may not be representative of clinical results.

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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SpineTop Stories

American Surgical Team Successfully Completes First 3D Printed Titanium and Polymer Sternum Implant Procedure in the United States

October 18, 2017 OrthoSpineNews

October 18, 2017

NEW YORK: On August 2, 2017, an American surgical team conducted a surgery to replace the sternum and partial ribcage of a 20 year-old woman using a custom 3D-printed composite titanium/porous polyethylene implant. It is the first time this technology has been used in the United States and only the second time in the world that a 3D-printed composite sternum and ribcage has been implanted. 

The implant was designed and created for a patient named Penelope Heller by Anatomics, an Australian company that specializes in the manufacture of patient specific implants for surgeons around the world, and was made available to the patient via the United States Food & Drug Administration’s (FDA) Expanded Access (Compassionate Use) Program. Anatomics’ custom 3D printed implants do not have marketing approval in the US. The FDA’s Expanded Access Program provides a path to accessing devices for patients whom the treating physician believes may provide a benefit, but have not received FDA marketing approval.

The surgical team, led by Jeffrey L. Port M.D., attending cardiothoracic surgeon at NewYork-Presbyterian/Weill Cornell Medical Center and professor of clinical cardiothoracic surgery at Weill Cornell Medicine, undertook the operation to revise a prior sternum/ribcage removal and reconstruction conducted in 2014. The patient underwent the original procedure to remove a malignant bone tumor after she was diagnosed with chondrosarcoma, a rare cancer affecting the bones and joints that is resistant to chemotherapy and radiotherapy and requires surgical removal.

In the original resection surgery, the cancer was successfully removed and the previous surgeon created an implant for the patient, using off-the-shelf Gore-Tex (low-density porous polytetrafluoroethylene, or PTFE) and Bone Cement (methyl methacrylate, or MMC). Afterward, the patient was cancer-free but continued to experience pain and issues with breathing that did not improve with time. Online research led the patient to a similar surgery performed in Spain using a custom implant also developed by Anatomics. The patient and her family then worked with the staff at NewYork-Presbyterian/Weill Cornell Medical Center and Anatomics to access the implant under the FDA’s Expanded Access program.

The custom implant was designed using high-resolution CT scans of the patient’s chest that were sent to Anatomics engineers via the secure AnatomicsRx software platform. After Dr. Port reviewed and confirmed the design on-line with the engineers, a biomodel of the patient’s sternum and ribcage was created and a build code was sent to Australia’s Commonwealth Scientific & Industrial Research Organisation’s (CSIRO) 3D printing laboratory, Lab 22. The patient’s custom sternum implant is the second in the world to also use Anatomics’ PoreStar technology, a proprietary porous polyethylene material with bone-like architecture. PoreStar is currently awaiting FDA marketing approval.

The surgical team, led by Jeffrey L. Port M.D., attending cardiothoracic surgeon at NewYork-Presbyterian/Weill Cornell Medical Center and professor of clinical cardiothoracic surgery at Weill Cornell Medicine, undertook the operation to revise a prior sternum/ribcage removal and reconstruction conducted in 2014. The patient underwent the original procedure to remove a malignant bone tumor after she was diagnosed with chondrosarcoma, a rare cancer affecting the bones and joints that is resistant to chemotherapy and radiotherapy and requires surgical removal.

In the original resection surgery, the cancer was successfully removed and the previous surgeon created an implant for the patient, using off-the-shelf Gore-Tex (low-density porous polytetrafluoroethylene, or PTFE) and Bone Cement (methyl methacrylate, or MMC). Afterward, the patient was cancer-free but continued to experience pain and issues with breathing that did not improve with time. Online research led the patient to a similar surgery performed in Spain using a custom implant also developed by Anatomics. The patient and her family then worked with the staff at NewYork-Presbyterian/Weill Cornell Medical Center and Anatomics to access the implant under the FDA’s Expanded Access program.

The custom implant was designed using high-resolution CT scans of the patient’s chest that were sent to Anatomics engineers via the secure AnatomicsRx software platform. After Dr. Port reviewed and confirmed the design on-line with the engineers, a biomodel of the patient’s sternum and ribcage was created and a build code was sent to Australia’s Commonwealth Scientific & Industrial Research Organisation’s (CSIRO) 3D printing laboratory, Lab 22. The patient’s custom sternum implant is the second in the world to also use Anatomics’ PoreStar technology, a proprietary porous polyethylene material with bone-like architecture. PoreStar is currently awaiting FDA marketing approval.

“After my initial resection and reconstruction surgery, I continued to experience breathing issues and pain,” said Ms. Heller. “With a long, active life ahead of me, I wanted to participate in activities that I love fully and without pain. Electing to have this procedure was a big decision, and I’m coming forward to empower other people in the same position.”

Anatomics’ Executive Chairman Paul D’Urso, MBBS (Hons) Ph.D. FRACS said, “Anatomics is humbled by the strength of the thousands of patients we have helped over 25 years since inventing BioModeling technology. The patient’s story is one of many, but what makes it truly remarkable is how the patient and her family, Dr. Port and the staff at  NewYork-Presbyterian/Weill Cornell, Anatomics, and the FDA came together to make this story a reality. It was a group effort that began with the patient’s pursuit of information.”

About Anatomics

Anatomics is an Australian medical device company that has been manufacturing and marketing surgical products to surgeons locally and internationally since 1996. Anatomics pioneered CT scan derived surgical implant technology and was first to market with an innovative, quality product that assists surgeons to produce better surgical outcomes and reduce expensive operating time. For more information, visit http://www.anatomics.com and follow the company on twitter at https://twitter.com/anatomicsrx. 

 

For further information contact: 

(Media) Tiberend Strategic Advisors, Inc

Janine McCargo, Senior Vice President

Telephone: +1 (646) 604-5150

e-mail: jmccargo@tiberend.com

 

Anatomics United States

Dr. Dean Carson, Vice President US Operations

951 Mariners Island Blvd. San Mateo, CA 94404 (CSIRO Office)

Telephone: +1 (415) 806-2599

e-mail: dean.carson@anatomics.com

 

Anatomics Australia

Dr. Paul D’Urso, Executive Chairman

Suite 1, 23-27 Wellington Street, St Kilda, Victoria, 3182, Australia

Telephone: +61 3 9529-8088

e-mail: contact@anatomics.com

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SpineTop Stories

Life Spine Announces Alpha Release of the SENTRY™ ALIF Plating System

October 18, 2017 OrthoSpineNews

October 18, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures, and markets products for the surgical treatment of spinal disorders today announced the Alpha launch of the SENTRY ALIF Plating System.

SENTRY ALIF is a plating system designed to eliminate the need for posterior stabilization with anterior lumbar interbody fusion. The low profile plate design provides a rigidly stable construct without disturbing surrounding vasculature. An Anterior Lumbar Interbody Fusion prevents the need to disturb the muscles of the lower back potentially reducing post-operative pain and complications.

The SENTRY ALIF system incorporates a Cam style locking mechanism, which provides visual, tactical, and audible feedback to prevent screw back out. This innovative and proven feature allows for easy screw removal and repositioning of the plate for streamlined surgeon usage. SENTRY ALIF has an S1 anchor ledge feature to accommodate L5-S1 surgical procedures, which provides better guidance for proper positioning of the plate.

Mariusz Knap, Vice President of Global Marketing and Business Development noted, “We are thrilled to launch the SENTRY ALIF Plating System and add to our Anterior Lumbar solutions portfolio. We have had great success with predicate devices that incorporate the Cam style locking mechanism. It made perfect sense to add the same technology to an anterior lumbar plate. SENTRY ALIF’s low profile design and multiple plate options strengthen Life Spine’s commitment to providing differentiated products to surgeons and their patients.”

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Life Spine is a registered trademark.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

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Spine

Medovex Corporation to Participate in World’s Largest Spine Exhibition, NASS 2017

October 18, 2017 OrthoSpineNews

ATLANTA, GA — (Marketwired) — 10/18/17 — Medovex Corp. (NASDAQ:MDVX) (“Medovex” or the “Company”), the developer of the DenerveX® System, a new and novel device designed for enduring relief of Facet Joint Syndrome related to back pain, today announced the Company will be participating in NASS 2017, being held in Orlando, Florida, October 25-28, 2017.

The North American Spine Society (“NASS”) is a one of a kind annual meeting where spine care professionals from around the globe will share the latest information, innovative techniques and procedures, best practices, and new technologies.

A copy of the Company’s invitation to The Surgical Innovation Cadaver Lab may be found at the following link: Medovex Invitation

The lab will be led leading spine surgeons and key opinion leaders including Vik Kapoor, MD, Manchester, UK, Martin Deeg, MD, Stuttgart, Germany, Jan Spiller, MD, Stenum-Bremen, Germany, and Gabriel Davila, MD, Medellin, Columbia.

Manfred Sablowski, Medovex Sr. Vice President of Sales and Marketing, stated, “We are excited to again participate at NASS. We developed the DenerveX System to enhance a patient’s quality of life. The agony of pain associated with the Facet Joint can be life-altering, robbing people of even the simplest joys of daily life like bending over to hug a grandchild, taking a walk or gardening. Powerful painkillers often prescribed for severe back pain are fanning the flames of the nation’s opioid epidemic. The DenerveX System involves a simple, minimally invasive, ‘keyhole’ procedure that is designed to bring faster, longer-lasting relief.”

Videos of leading spine surgeon Dr. Vik Kapoor talking about FJS and the DenerveX Device may be viewed at the following links:

https://youtu.be/6Q7hpEsF2mg 

https://youtu.be/GIgPaIenXp4

Facet Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem in the United States and other countries in the EU and Rest of World affecting millions each year. Current treatment options are generally temporary and there is no proven long-lasting option for FJS.

The DenerveX System is a highly differentiated technology. It denervates and removes capsular tissue from the Facet Joint in one single procedure. Treatment results from the combined effect of a deburring or polishing action and RF ablation treatment on the Facet Joint. Using this new technique, the slowly rotating burr removes the targeted facet joint synovial membrane and joint surface while the heat ablation destroys tissue and denudes any residual nervous and synovial membrane overlying the joint, removing the end point sensory tissue of the joint.

The DenerveX System consists of the DenerveX Kit which contains the DenerveX Device, a single use medical device and the DenerveX Pro-40 Power Generator. DenerveX system is CE marked and for sale in countries outside the US accepting the CE mark, but is not yet FDA cleared.

Please also follow us on Facebook at https://www.facebook.com/medovex/.

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

Medovex Corp.

Jason Assad

470-505-9905

Jassad@medovex.com

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SpineTop Stories

Southern Spine Announces “Clinical and Biomechanical Advantages of Interspinous Process Fixation: A Review”

October 17, 2017 OrthoSpineNews

October 17, 2017

MACON, Ga.–(BUSINESS WIRE)–Southern Spine, LLC, an ISO 13485:2003 certified manufacturer of implants and instruments for spinal surgery, announced today the release of a current literature review on the “Clinical and Biomechanical Advantages of Interspinous Process Fixation.” This in-depth review covers the use of interspinous process fixation devices such as their StabiLink®MIS Interlaminar Spinal Fixation System that offer the benefits of fewer intraoperative complications, quicker recovery times and lower adjacent segment disease while providing comparable rigidity, fusions rates and patient-reported outcomes when compared to pedicle screw fixation.

Southern Spine is making this 10-page publication available to anyone who would like a copy. Please email your request to Southern Spine at info@southernspine.net and state that you would like either an electronic or hard copy of this comprehensive literature review and bibliography sent to your attention.

“We have confidence that our latest designs of the Dual Lamina and eZ Lamina StabiLink® Systems with our Laminar-LockTMtechnology offer surgeons and patients one of the best clinical choices for treating their pain and instability without limiting any of their future options,” stated David Field, CEO of Southern Spine. “We believe that choosing an Interspinous Process Fixation device is the best first option for many patients and that our StabiLink® MIS System is the ultimate interlaminar fixation system available.”

The StabiLink® MIS Spinal Fixation System is FDA Cleared and CE Marked and has been successfully used in thousands of clinical procedures. You can get a “Hands On” demonstration of the innovative StabiLink® MIS System at the upcoming 2017 North American Spine Society (NASS) in Orlando, FL, October 25-27 at Booth #229.

www.SouthernSpine.net

Patent Information at http://www.SS-IP.com

StabiLink is a registered trademark of Southern Spine, LLC

PG, Laminar-Lock and Southern Spine Logo are trademarks of Southern Spine, LLC

© 2017 Southern Spine, LLC All rights reserved

Contacts

Southern Spine, LLC
Calder Clay III, 1-478-745-0000
info@SouthernSpine.net

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Spine

MICRO INVASIVE EXPANDABLE TECHNOLOGY AT NASS 2017

October 17, 2017 OrthoSpineNews

Huntley, IL, October 17, 2017–

Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it will be participating in the 32nd North American Spine Society (NASS) Annual Meeting, taking place in Orlando, October 24-27th, 2017. The meeting is expected to attract over 3,000 surgeons and other healthcare professionals from across the globe.

Life Spine is excited to showcase its Procedural Solutions Product Portfolio highlighted by Micro Invasive Expandable Technology.

Life Spine’s Micro Invasive Expandable Technology is a series of innovative implants that offer surgeons various methods of expansion. ProLift® Expandable TLIF/PLIF Spacer System expands cephalad/caudal for maximum disc height restoration and decompression of neural elements. TiBOW™ Expandable TLIF Spacer System expands anterior/posterior for maximum endplate coverage and stability. LONGBOW® Lateral Expandable Spacer System, winner of the 2016 RYOrtho Innovations Award, is an anterior/posterior expanding interbody designed to minimize psoas disruption while maximizing endplate coverage.

ProLift® and TiBOW™ Expandable Spacer Systems incorporate OSSEO-LOC™ Titanium Surface Treatment Technology that creates a unique osteophylic surface architecture designed to maximize boney on-growth potential. OSSEO-LOC is featured on other key Life Spine implants including PLATEAU®-C Ti, PLATEAU-Z Ti, PRO-LINK® Ti, and PLATEAU Ti, providing surgeons with a full portfolio of titanium solutions.

Life Spine will be presenting its Micro Invasive Expandable Technologies, as well as their full procedural solutions portfolio at booth #1109 during the 2017 NASS conference.

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Spine

Camber Spine Announces Surgeon Presenters For NASS 2017

October 17, 2017 OrthoSpineNews

WAYNE, Pa., Oct. 17, 2017 /PRNewswire/ — Camber Spine is pleased to announce that Dr. John Malloy IV, D.O. of East Coast Orthopaedics and Dr. Luis E. Duarte, M.D. of Shannon Medical Center will be featured presenters for the company during North American Spine Society’s 2017 Annual Meeting to be held in Orlando, Florida later this month. Camber Spine is focusing on two quickly-growing subsegments within spine: SI Joint Disease Diagnostics and Treatment and Anterior to Psoas (ATP) Lumbar Approach for Fusion.

Each surgeon will be leading daily talks at the Camber Spine booth (550), as well as a lab on the show floor as part of the NASS Surgical Innovation Lab series. Dr. Malloy will be building off of his popular presentation from ISASS 2017. He will discuss how Camber Spine’s sacroiliac fusion products, PROLIX™ and SICONUS™, provide direct visualization and maximized fusion in the treatment of sacroiliac pain. Dr. Duarte will be discussing Right-Sided vs. Left-Sided Anterior to Psoas Approaches and the benefits of the newly FDA-cleared SPIRA™ Open Matrix ALIF.

“We are honored to have two well-esteemed surgeons who are leading innovation in alternative approaches to traditional fusion procedures,” stated Daniel Pontecorvo, Founder and CEO of Camber Spine Technologies. “Their enthusiasm for driving surgical advances aligns with Camber’s vision to solve surgeon frustrations through innovation.”

Sacroiliac Fusion by Camber Spine Technologies is a two-step minimally invasive procedure which consists of the implantation of Prolix™, a machined allograft implant, through direct visualization and a supplemental lateral fixation of the SI Joint using Siconus™ bone screws. The combined use of Prolix™ SI Joint Fusion System and Siconus™ SI Joint Fixation System may be the only MIS SI Joint Fusion technology to foster a True Fusion of the SI Joint.

SPIRA™ Open Matrix ALIF was designed specifically to increase fusion rates and stabilization. The spiral support arches decrease subsidence by load sharing over the entire endplate, while also maximizing bone graft capacity. The Surface by Design™ technology is a deliberately designed roughened surface that facilitates bone growth through an optimized pore diameter, strut thickness and trabecular pattern.

Camber Spine NASS 2017 Presentation Schedule
Wednesday, October 25th
 9:15AM: New Techniques For Fusion and Fixation Of The SI Joint with Dr. John Malloy IV, D.O.
11-1PM: Prolix/Siconus Lab with Dr. John Malloy IV, D.O.
Thursday, October 26th
9:30AM: New Frontiers in MIS Spine Surgery; Advanced Implants and Anteriorpsoas/Anterior Lumbar approaches with Dr. Louis Duarte, M.D.
Thurs 11-1 Spira Lab with Dr. Louis Duarte, M.D.

*For more information or to register please contact Mindy Elgart at melgart@cambermedtech.com

About John Malloy IV
Dr. John (Sean) P. Malloy is an orthopedic surgeon specializing in Lumbar and Cervical surgery as well as minimally invasive procedures used to treat musculoskeletal and spinal injuries or disorders. He completed his orthopedic surgery residency at Pinnacle Health Hospital System and Penn State Hershey medical center where he was named Chief Resident in the Department of Orthopedic Surgery. He has authored numerous publications in the orthopedic and spinal surgery literature and has presented and continues to speak at conferences both locally and on a national level.

About Luis Duarte
Dr. Luis E. Duarte, MD is a practicing Neurosurgeon in San Angelo, TX. Dr. Duarte graduated from Jefferson Medical College of Thomas Jefferson University in 1987 and has been in practice for 30 years. He completed a residency at Hahnemann University Hospital. He currently practices at Brain & Spine Institute and is affiliated with Shannon Medical Center.

About Camber Spine Technologies, LLP
Camber Spine Technologies, LLP, is a fast-growing musculoskeletal implant company founded in 2010 bringing innovative, best-in-class products to the market, providing surgeons and their patients with better treatment options. Camber Spine Technologies, LLP is an ISO 13485 certified medical device company located in Wayne, Pennsylvania, that markets a line of proprietary musculoskeletal products nationwide through its exclusive distributor, S1 Spine. The company is committed to delivering surgeon inspired new technologies to the spine market.

For further information please visit www.cambermedtech.com. For inquiries about any of our products or distribution opportunities please call 484-427-7060.

All of Camber Spine Technologies’ products are proudly MADE IN THE USA.

SOURCE Camber Spine Technologies

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