Park City, UT

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Current Issues in Spine

February 2-4, 2017

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November 16, 2017 OrthoSpineNews

November 16, 2017

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced the first surgeries in Australia using the Company’s proprietary Endoskeleton® interbody fusion devices and surface technology, marking the Company’s entry into a robust new market. The first two ALIF cases were performed successfully in October by Dr. Richard Laherty, MBBS FRACS CIME, spine surgeon at Queensland Neurosurgery and Spine Surgery at the Princess Alexandra Hospital near Brisbane.

Dr. Laherty commented, “I have been keeping up on the wealth of studies Titan Spine has published on their proprietary surface technologies over the years that have consistently shown the ability to create a superior osteogenic environment over other materials and surfaces. I was pleased to finally have the opportunity to use the Endoskeleton® titanium devices featuring Titan’s unique surface technology at the macro, micro and cellular level for these procedures. In the first few weeks following these initial cases, we have observed favorable patient outcomes in both cases, and I look forward to offering the Endoskeleton® devices to more of my patients moving forward.”

Titan Spine received registration approval from the Australian Therapeutic Goods Administration (TGA) in June 2014 to commercially market its full line of Endoskeleton® interbody fusion devices in the country.

Kevin Gemas, President of Titan Spine, added, “Over the past few years we have focused our attention primarily in the U.S. and portions of the EU to educate on and demonstrate the value of our titanium devices featuring our differentiated surface technology. After securing the CMS new technology ICD-10 code, expanding our U.S. sales force, and achieving strong domestic revenue acceleration, we are also now focusing on select OUS markets, such as Australia, that we feel can add to our top and bottom lines. We anticipate tremendous growth in this new region to drive substantial growth for Titan in the coming quarters and beyond.”

Titan Spine offers a full line of Endoskeleton® titanium implants that feature its proprietary surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and cellular levels. This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.1,2,3 All Endoskeleton® devices are covered by the company’s risk share warranty.

About Titan Spine

Titan Spine, LLC is a surface technology company focused on the design and manufacture of unique interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface in the U.S., portions of Europe, and Australia through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.

Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate osteoblast production of angiogenic factors. The Spine Journal, 13, 1563-1570.

Contacts

Company
Titan Spine
Andrew Shepherd, 866-822-7800
ashepherd@titanspine.com
or
Media
The Ruth Group
Kirsten Thomas, 508-280-6592
kthomas@theruthgroup.com


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November 14, 2017 OrthoSpineNews

11-14-2017 – By   –  Reporter, Boston Business Journal

New England Baptist Hospital will create a new spine institute, thanks to a $3 million gift from one of its board members.

Jeffrey Libert, a trustee of the hospital, recently gifted the hospital $3 million on behalf of his family to form the Libert Family Spine Institute, which will look to create a new singular door for patients suffering from back pain and find approaches and treatments beyond surgical interventions.

The donation is the largest in the hospital’s history, and is on top of $2 million Libert had already donated to the hospital for medical education and research.

“With the largest number of spine surgery patients regionally, and a significant volume of non-surgical patients, NEBH is uniquely positioned to enhance clinical care by leveraging data with predictive analytics to improve existing treatments and design better options for patients with spine disease or injury,” said Dr. Scott Tromanhauser, chief of spine surgery, chief medical quality officer and director of research administration for the hospital, in a statement. “By establishing this institute, we will be able to make a significant difference in how back pain is treated.”

 

READ THE REST HERE


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November 14, 2017 OrthoSpineNews

NEW YORKNov. 13, 2017 /PRNewswire/ — Russo Partners LLC and Medovex Corp. (NASDAQ: MDVX) have teamed to call attention to the need for new treatments for chronic back pain and the Company’s innovative solution known as the DenerveX® System. Currently approved for use outside of the U.S., DenerveX is a new device designed to enable doctors to provide patients with enduring relief of back pain caused by Facet Joint Syndrome.

The Medovex public relations initiatives include an extensive video campaign featuring spine surgeons worldwide. Wilcots, an NFL broadcaster, former professional football player and leader of Russo Partners’ Sports-Health Alliance, recently interviewed doctors at the EUROSPINE 2017 annual meeting in Dublin and the North American Spine Society (NASS) conference in Orlando, where he also taped a demonstration of the DenerveX System in use in a surgical cadaver lab. Russo Partners and Medovex will integrate the content into ongoing social and traditional media initiatives this quarter as Medovex continues its country-by-country roll-out of the medical technology.

“Solomon has the natural ability to bring professionals together and craft medical stories in a natural and impactful manner,” said Patrick Kullmann, president and COO of Medovex. “We look forward to using the output of his work to increase the visibility and awareness of what we are doing at Medovex to transform how surgeons and pain management physicians treat a common source of chronic back pain. This is a meaningful change with our DenerveX system that is focused on long-term relief.”

Wilcots added, “Chronic back pain, including that caused by Facet Joint Syndrome, is common among former professional athletes. The opportunity presented by the DenerveX System is one of giving people back quality of life without reliance on prescriptive pain relief medicines. This is exciting technology about which physicians were eager to speak with me and share their perspectives on how it will change their practices and patients’ lives. We will continue with these initiatives throughout 2018.”

The DenerveX System is a non-addictive opioid drug alternative capable of restoring a patient to a more normal and active lifestyle. It was designed by medical professionals for medical professionals to enhance a patient’s quality of life. Using highly differentiated technology, the DenerveX System 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 radio frequency 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. To learn more about the DenerveX System, visit http://medovex.com/us/denervex-system/.

Facet Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem in countries worldwide, including the U.S. and countries in the EU. This condition affects millions of people each year, and current treatment options are generally temporary with no proven long-lasting option.

About Medovex

Medovex Corp. 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 System, is intended to provide long lasting relief from pain associated with Facet Joint Syndrome at significantly less cost over time than currently available options. To learn more about Medovex, visit www.medovex.com.

About Russo Partners’ Sports-Health Alliance

The Sports-Health Alliance is an award-winning public relations service at the intersection of health, medicine and sports. Launched by Russo Partners in 2017, this offering leverages the agency’s inside access to athletes, broadcasters and sports business leaders who have a shared passion with their clients for a disease or treatment. The Alliance was cultivated over a two-year span and involves Russo Partners’ Team Leader Solomon Wilcots. Visit https://russopartnersllc.com/services/sports-health-alliance/ for more information.

About Russo Partners

Since 1988, Russo Partners, formerly Noonan/Russo Communications, has provided public and investor relations and corporate communications services to both emerging and established healthcare and technology-centric companies worldwide. The agency’s staff is comprised of senior executives with extensive backgrounds in science, medicine, finance and communications. Visit www.russopartnersllc.com for more information.

CONTACT INFORMATION

Medovex Corp.
Jason Assad
470-505-9905
Jassad@medovex.com

GLOBAL MEDIA CONTACTS

David Schull
Russo Partners LLC
212-845-4271 (office)
858-717-2310 (mobile)
David.schull@russopartnersllc.com

Caroline Cunningham
Russo Partners LLC
212-845-4292 (office)
203-969-4308 (mobile)
Caroline.cunningham@russopartnersllc.com

SOURCE Russo Partners, LLC

Related Links

http://www.russopartnersllc.com


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November 14, 2017 OrthoSpineNews

November 13, 2017

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:

SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices to make spine surgery safer, announced today that XinRong Medical Group will officially launch the Classic PediGuard product range in China during the Chinese Orthopedic Association (COA) annual meeting being held in Zhuhai, China from November 15-18.

The COA meeting is the largest and most influential Orthopedic Surgery Society in China with 14 sub-specialties such as spine surgery. This annual meeting is widely attended by Chinese surgeons (over 21,000 attendees in 2016) and is a unique opportunity to launch the PediGuard®. Over recent years, the Chinese orthopedic market has become the second largest in the world, after the USA.

On November 16th, XinRong Medical Group will offer a PediGuard® workshop at their booth #3A11 with Prof. Chen Zhong Quing (China), Prof. Wong Hee Kit (Singapore) and Prof. Liang Yu (China) as faculty.

We believe the COA annual meeting is the best congress with the right timing to launch the PediGuard® in China. The workshop given by XinRong Medical Group will be the opportunity for the Chinese spine surgeons who have been waiting for SpineGuard’s DSG™ technology since its clearance by CFDA, to learn more about the products from experienced key opinion leader surgeons and facilitate first use. We are delighted by the collaboration with our very dynamic partner XinRong and are looking forward to supporting our common success in China with PediGuard®” said Stéphane Bette, CEO and co-founder of SpineGuard.

“We are very excited to hold the official PediGuard® China Launch Meeting during COA supported by top key opinion leaders in spine surgery in China. PediGuard® can alert surgeons of potential pedicular or vertebral breaches and provides real-time feedback through audio and visual signals. With the introduction of this device, we could help Chinese surgeons reduce the risk of pedicle screw misplacement and dramatically improve outcomes for patients. Moreover and looking forward, SpineGuard has received the patent for its smart screw concept integrating its DSG™ sensor into the implantable pedicle screw through imbedding electronics into the screwdriver handle, opening new opportunities for further collaborations.”, added Christine Zhang, XinRong Medical Group’s CEO.

More information on the DSG™ technology and surgeons’ testimonials here.

Next financial press release: 2017 full year revenue, January 4, 2018

About SpineGuard®
Founded in 2009 in France and the USA, by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 55,000 surgical procedures have been performed worldwide with DSG™ enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard® delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG™ platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

About XinRong Medical Group
XinRong Medical Group, a leader in medical technology, is dedicated to increasing patient affordability and providing the most advanced solutions for surgeons such that they can deliver the best patient care. XinRong Medical offers innovative solutions in orthopedic surgery, neurosurgery, reconstructive surgery, and minimally invasive therapy. Established in 2000 in Jiangsu Province, China, XinRong Medical was one of the first companies in China cleared by CFDA to manufacture Orthopedic Implants. In 2014, the Company received a strategic investment from The Blackstone Group (NYSE: BX). For additional information about XinRong Medical, please refer to our website www.XRBest.Com, or contact us directly at +86-512-58100828 or info@xrmed.com.

Disclaimer
The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Stéphane Bette
Chief Executive Officer
Tel: +33 (0) 1 45 18 45 19
s.bette@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
Tel: +33 (0)1 45 18 45 19
m.lanfossi@spineguard.com
or
NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
spineguard@newcap.fr


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November 13, 2017 OrthoSpineNews

Alpharetta, Ga., Nov. 9, 2017 —Solvay, a leading global supplier of specialty polymers, announced that medical device-maker DiFusion Technologies chose Zeniva® ZA-500 polyetheretherketone (PEEK) as the base polymer for its ZFUZE osteoconductive PEEK composite for spinal implants. The new compound exhibited large areas of new bone formation on all bone implant surfaces in recent testing by DiFusion, who shared its results at the recent NASS 2017 event in Orlando.

PEEK is an attractive alternative to titanium for spinal implants because it shares similar modulus to bone, and its radio transparency allows for easy visualization in X-rays. The polymer is also inert, which means it does not interact with human tissue. While this quality supports biocompatibility, it means that PEEK does not naturally lend itself to bone growth. DiFusion solved this problem by compounding negatively charged zeolites into Solvay’s Zeniva® PEEK polymer.
“It was sort of a penicillin moment,”said Derrick Johns, CEO of DiFusion Technologies. “We started out engineering anti-microbial polymers by first loading zeolite particles with silver before compounding them. But we discovered if we took the silver cations out of the zeolite, they imbued PEEK with a negative charge. Osteoblast cells are attracted to the negatively charged surface at a far higher rate than titanium, and yet we were able to preserve the polymer’s outstanding visualization, modulus and strength benefits.”
Solvay was an early collaborator in the development of DiFusion’s patented ZFUZE composite, combining industry-leading materials expertise with technical and regulatory support for medical devices. Zeniva® ZA-500 PEEK was of particular interest to DiFusion due to the polymer’s higher flow, which facilitates both the compounding process and the extrusion of osteoconductive implants.
“In addition to our materials expertise, Solvay’s open innovation business model was instrumental to the successful innovation of DiFusion’s ZFUZE osteoconductive composite,”said Jeff Hrivnak, global business manager for Healthcare at Solvay’s Specialty Polymers Business Unit. “Our uniquely collaborative approach to customer projects differentiates us from other PEEK suppliers in this industry, and it allowed us to pool our respective capabilities and resources with DiFusion to solve this demanding challenge.”
DiFusion’s ZFUZE composite technology is in the final stages of its 510K approval process with the U.S. Food and Drug Administration. It is expected to be commercially available in the U.S. early next year.
® Zeniva is a registered trademark of Solvay

Solvay Specialty Polymers manufactures over 1500 products across 35 brands of high-performance polymers – fluoropolymers, fluoroelastomers, fluorinated fluids, semi-aromatic polyamides, sulfone polymers, aromatic ultra-high performance polymers, and high barrier polymers – for use in Aerospace, Alternative Energy, Automotive, Healthcare, Membranes, Oil and Gas, Packaging, Plumbing, Semiconductors, Wire & Cable, and other industries. Learn more at www.solvayspecialtypolymers.com.

Solvay is a multi-specialty chemical company, committed to developing chemistry that addresses key societal challenges. Solvay innovates and partners with customers in diverse global end markets. Its products and solutions are used in planes, cars, smart and medical devices, batteries, in mineral and oil extraction, among many other applications promoting sustainability. Its lightweighting materials enhance cleaner mobility, its formulations optimize the use of resources and its performance chemicals improve air and water quality. Solvay is headquartered in Brussels with around 27,000 employees in 58 countries. Net sales were € 10.9 billion in 2016, with 90% from activities where Solvay ranks among the world’s top 3 leaders. Solvay SA (SOLB.BE) is listed on Euronext Brussels and Paris (Bloomberg: SOLB.BB – Reuters: SOLB.BR) and in the United States its shares (SOLVY) are traded through a level-1 ADR program.

Founded in 2008 in Austin, Tex., DiFusion Technologies, Inc. is a medical device company focused on reducing the rising incidence of surgical site infections in orthopedic and spine surgery through the development of a suite of patented antimicrobial orthobiologic polymeric implants. Initially focusing on the multi-billion dollar spinal implant market, the company has developed a technology with applicability across a variety of orthopedic segments using well characterized implants with benefits for the patient, surgeon, hospital and payer. For more information about DiFusion Technologies, visit www.difusiontech.com.

Follow us on twitter @SolvayGroup


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November 10, 2017 OrthoSpineNews

November 09, 2017

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:

SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices to make spine surgery safer, announced today the successful completion of an experimental feasibility study in collaboration with the Institut des Systèmes Intelligents et de Robotique (UPMC /CNRS), Paris, France.

The study demonstrates how DSG™ technology can stop a robot automatically when an impending bone breach is detected and thus can prevent serious surgical complications. Practically, during a vertebral drilling, a DSG™ drill bit mounted on a robot transmits in real time an alert signal to the control unit of the robot.

Olivier Frézal, VP Technical Operations at SpineGuard declared: “We are very satisfied by this result which confirms the potential of our DSG™ technology in surgical robotics thanks to its ability to measure tissue electrical conductivity locally and in real time. A technology breakthrough is now possible, because the robot will be able to automatically drill into the human skeleton, and allow the direct insertion of DSG™ sensing “smart” implants.” I am also delighted by our collaboration with UPMC which again underlines French research excellence.”

Guillaume Morel, ISIR, Professor, Director of the team AGATHE at INSERM: “For years it has been apparent that a sensing technology that could provide robots with a feedback loop would be an indispensable component of the progress of automation of surgical procedures. When SpineGuard contacted us about this research project and presented their DSG technology, we were immediately committed to a collaboration that revealed fruitful.”

Next financial press release: 2017 full year revenue, January 4, 2018

About SpineGuard®
Founded in 2009 in France and the USA, by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 55,000 surgical procedures have been performed worldwide with DSG™ enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard® delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG™ platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

Disclaimer
The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Stéphane Bette, Tel: +33 (0) 1 45 18 45 19
Chief Executive Officer
s.bette@spineguard.com
or
Manuel Lanfossi, Tel: +33 (0)1 45 18 45 19
Chief Financial Officer
m.lanfossi@spineguard.com
or
NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
spineguard@newcap.fr


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November 10, 2017 OrthoSpineNews

CENTER VALLEY, Pa.Nov. 9, 2017 /PRNewswire/ — Aesculap Implant Systems, LLC today announced the significance of the long-term data presented at the NASS 2017 podium during the NASS Annual Meeting in Orlando, FLOctober 25-27, 2017. At the meeting, three key presentations were made that greatly increase the body of evidence in support of lumbar total disc replacement (TDR) as a standard of care for a subpopulation of patients suffering from degenerative disc disease (DDD).

The five-year outcomes of the activL® Artificial Disc Investigational Device Exemption (IDE) Study, a 7-Year Multi-Center, Randomized Controlled Trial (RCT) which compares outcomes of the activL Artificial Disc and previous generation disc replacements such as ProDisc-L (DePuy Synthes) were presented by one of the co-investigators of the study, Jim Yue, MD (Quinnipiac UniversityNew Haven, CT). The data demonstrates that while both the activL device and the control were effective at addressing patient pain and disability at five years, the activL device was more likely to preserve segmental range of motion at five years (p = 0.03) and had a higher safety profile (p < 0.001).

Additionally, the outcomes of a landmark 5-Year Meta-Analysis of RCTs comparing lumbar disc replacement to fusion were presented by Jack Zigler, MD (Texas Back Institute, Plano, TX). The meta-analysis demonstrated that TDR was superior to fusion at addressing patient disability, reoperation and satisfaction at five years (p=0.05, p=0.002, p=0.01, respectively).

During the data presentations, one audience member posed to the panel, “Is it your opinion that lumbar disc replacement can now be considered a gold standard of care for DDD?” Dr. Zigler replied, “It’s hard to reconcile that insurers still label lumbar TDR as experimental given this five-year level 1a data.” Members of the panel concluded that the evidence supported lumbar TDR as a standard of care that spine surgeons should be offering a subpopulation of their patients and that payers need to make accessible.

Later in the week, Richard Guyer, MD (Texas Back Institute, Plano, TX) presented one of the 21 papers nominated for Best Paper at NASS detailing the outcomes of an ad hoc analysis from the activL IDE study looking at the adjacent segment disease (ASD) outcomes between disc replacement systems at five years. From the analysis conducted by an independent third party, Dr. Guyer presented a 9% ASD rate for the activL device and a 19% rate for the control. The investigators are currently conducting additional data analysis to compare these TDR device outcomes to previously reported fusion ASD rates. Dr. Guyer also presented evidence of a correlation between the protective effect that range of motion has on ASD. “Finally, for those of us that have dedicated our careers to motion preservation, there is holy grail evidence that our theories were correct,” concluded Dr. Guyer from the podium.

The NASS abstracts are indexed and available for reference in The Spine Journal. The presenters and their co-authors are finalizing the full manuscripts relative to this data with the plan to present these outcomes to U.S. payers. In 2017, 16 million additional privately-insured patients now have a positive coverage policy giving them access to lumbar TDR.

About Aesculap Implant Systems, LLC
Aesculap Implant Systems, LLC, a B. Braun company, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com.

SOURCE Aesculap Implant Systems, LLC

Related Links

http://aesculapimplantsystems.com


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November 8, 2017 OrthoSpineNews

    Ecully, 7 November 2017

The Board of Directors of Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), has co-opted Mr. Joseph Brigneaud as an independent Board member.

Joseph Brigneaud, a partner at MAELO Capital – a private-equity investment firm, has over 15 years’ experience in supporting and financing companies. Having opened and headed Euronext’s regional office in Lyon for three years, he has considerable expertise in listed SMEs and mid-cap companies.

As from 23 October 2017, the composition of Spineway’s Board of Directors is as follows:

  • Stéphane Le Roux, Chairman of the Board – Chairman and CEO of Spineway.
  • Philippe Laurito, Board member – Managing Director of Spineway, President of Spineway USA, Inc.
  • Bérangère Boggio, Independent Board member – Director of Legal Affairs and HR at MEDAC since 2013 after seven years with the MYLAN pharmaceutical group.
  • Joseph Brigneaud, Independent Board member.

Stéphane Le Roux, Chairman and CEO of Spineway, said, “We are thrilled to welcome Joseph Brigneaud as a member of our Board of Directors. His perfect understanding of the stock markets and his expertise in growing SMEs will help us increase our development and successfully pursue our geographic expansion.”

SPINEWAY IS ELIGIBLE FOR THE PEA-PME

SPINEWAY will be attending the SFAF Mid-Caps conference on 14 November 2017

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its turnover comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), received the OSEO Excellence award as well as the Deloitte Fast 50 award in 2011. Rhône Alpes INPI Patent Innovation Award (2013) – Talent INPI award (2015). 
ISIN code: FR0011398874 – Euronext Growth

This press release is entered into in both English and French languages. In case of discrepancies, French language shall prevail.

Contacts:           

Investor Relations
David Siegrist – Finance Director
+33 (0)4 72 77 01 52
finance.dsg@spineway.com
 

 

 

 

 

 

 

 

 

Financial Communication
Jérôme Gacoin / Solène Kennis
+33 (0)1 75 77 54 68
skennis@aelium.fr

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/cba803a0-08bf-446d-b4fd-a2179bf35d7


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November 6, 2017 OrthoSpineNews

SALT LAKE CITY, Nov. 06, 2017 (GLOBE NEWSWIRE) — Amedica Corporation (Nasdaq:AMDA), an innovative biomaterial company that develops and manufactures silicon nitride as a platform for biomedical applications, announced that the company made a 510(k) submission to the U.S Food and Drug Administration for its  Valeo C+CSC with Lumen spinal implant.

The Valeo C+CSC with Lumen is a modified CSC (cancellous structured ceramic) that is similar to Amedica’s commercially available Valeo C and Valeo C+ CSC (cleared in Europe only) cervical implants. This device increases implant surface area and plays an active role in the spinal fusion process while maintaining the other benefits silicon nitride brings to patients and physicians.

“The Valeo C+CSC with Lumen submission is a key step in introducing our proprietary porous silicon nitride technology into the US market. We look forward to working with the FDA on this important company milestone,” said Dr. Sonny Bal, Amedica CEO

About Amedica Corporation

Amedica is focused on the development and application of spinal interbody implants made with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing implants for other biomedical applications, such as wear- and corrosion-resistant hip and knee bearings, and dental implants. The Company’s products are manufactured in its ISO 13485 certified manufacturing facility, and it has a partnership with Kyocera, one of the world’s largest ceramic manufacturers. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network, and OEM and private label partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on September 20, 2017, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.

Contacts:
Amedica IR
801-839-3502
IR@amedica.com

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November 6, 2017 OrthoSpineNews

11-6-2017 – Press release from: Data Bridge Market Research

The report delivers a detailed study with present and upcoming Opportunities to clarify the future investment in the “Global XLIF surgery market” are expected to reach USD 2,557.74 million by 2024 from USD 1,644.68 million in 2016 at a CAGR of 5.7%. The new market report contains data for historic years 2015, the base year of calculation is 2016 and the forecast period is 2017 to 2024.

Segmentation:

By Product Type (XLIF interbody cages, XLIF interbody fusion systems) By End User (hospitals, spinal surgery centers, others)

Drivers:

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The major factors driving the growth of this market are the rising number of minimally invasive procedures, increasing number of spinal disorders and growing number of geriatric population. On the other hand, higher expenses of treatment procedures, increasing research on substitutive treatments and stringent reimbursement policies. These factors increase the demand for XLIF surgery in patient.

RISING NUMBER OF MINIMALLY INVASIVE PROCEDURES

XLIF is the latest and advanced minimally invasive method for the anterior spine which is avoiding the incision that navigates the abdomen also avoiding the cut or disrupts the muscles of the back. XLIF surgery market is growing due to increasing number of the minimally invasive surgery.

INCREASING NUMBER OF SPINAL DISORDERS

The XLIF surgery market is growing due to the growing number of the spinal disorders globally. Spinal cord damage is among the most traumatic events that occur in an individual’s life. Spinal cord injury affects friends, family, employers, community and the health care system.

Read more about the Global XLIF Surgery Market Report Visit @: databridgemarketresearch.com/reports/global-xlif-surgery-…

GROWING NUMBER OF GERIATRIC POPULATION

Another major factor contributing to the growth of the XLIF surgery market includes increasing number of the elderly population in the country. Furthermore, government support in the form of funding also drives the growth of this market.

Major Players:

• NUVASIVE INC.:
Incorporated in 1997 and headquartered at San Diego, California, United States. The company is medical device company in the global spine surgery market. It develops minimally-disruptive surgical products and procedurally-integrated solutions for spine surgery. Its wide range of products is focused on various applications of spine fusion surgery and spinal fusion process.

• RTI Surgical Inc.:
Founded in 1997 and headquartered at Alachua, Florida, U.S., RTI Surgicals, Inc., is engaged in the development and marketing of biologic, metal, and synthetic implants. The company operates through four business segments, namely, spine, sports medicine and orthopedics, surgical specialties and cardiothoracic.

Ask more details to our expert Visit @: databridgemarketresearch.com/speak-to-analyst/?dbmr=globa…

• K2M, INC.:
Founded in 2004 and headquartered at Virginia, United States. K2M is engaged in the development, design and commercialization of the spine and minimally invasive spine technologies and techniques for the treatment of the spinal pathologies. K2M operates in four product categories such as complex spine, minimally invasive, degenerative, and biologics.

Recent Development:
1. In July 2017, K2M Group Holdings, Inc. signed the agreement with Mitsubishi Corporation subsidiary Japan Medicalnext Co., Ltd. for the distribution of K2M’s innovative spinal technologies in Japan.
2. In October 2016, K2M Group Holdings, Inc. received 510(k) clearance from FDA for the expansion of the CASCADIA Lateral Interbody System, which consists of the Lamellar 3D Titanium Technology. The CASCADIA Lateral Interbody System expanded the portfolio of the company for the minimally invasive surgery products

Related Report

U.S. XLIF Surgery Market – Industry Trends and Forecast to 2024

U.S. XLIF Surgery Market by Product Type, By End-Users, By Distribution Channel, By Country (U.S.) – Industry Trends and Forecast to 2024

Read More: databridgemarketresearch.com/reports/u-s-xlif-surgery-mar…

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Data Bridge Market Research
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This release was published on openPR.