Park City, UT

3 days / 6 sessions
Current Issues in Spine

February 2-4, 2017

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December 18, 2018 OrthoSpineNews

PITTSBURGH, PA, December 5, 2018 // — Dr. Jocelyn Idema, Orthopaedic Spine Surgeon at The Center for Disc Replacement Surgery at Advanced Orthopaedics and Rehabilitation (AOR), recently implanted Centinel Spine’s newest generation of the prodisc L lumbar artificial disc replacement.  The prodisc L® is a Total Disc Replacement (TDR) technology platform that offers a surgical alternative to spinal fusions. Patients usually suffer from a single level degenerated disc in the lower (lumbar) spine and this technology works to relieve pain while allowing the potential for motion at the diseased spinal segment. 

As lower spine treatments continue to make advancements through innovative technologies and motion preserving techniques, patients are seeking out alternatives to lumbar fusions.  The goal at The Center for Disc Replacement Surgery at AOR is to improve the motion and function of the spine while maintaining the highest quality and highest standards of care related to both surgical and non-surgical spine interventions through evidence based medicine practices.  “By using newer motion preserving techniques, spinal discs can help retain the forward-to-back, bending side-to-side, and turning left-to-right spinal motion you were intended to have.” says Dr. Idema.  “This in turn helps to reduce the wear and tear associated with your spine above and below the damaged area.”  “I can’t begin to describe how this newest generation of lumbar artificial discs will continue to be a game-changer for patients.” reports Dr. Idema after the procedure.  She further  continues  “I have been doing cervical (neck) artificial disc replacement for years with really high success rates but the lumbar artificial discs only recently are making a resurgence because of various limitations including insurance companies authorizing the procedures.”

Centinel Spine is currently the only company in the United States to offer both upper and lower spine Total Disc Replacement devices.  The prodisc I implant, the predecessor of the prodisc L implant, was first implanted in 1990. The prodisc L implant that is used today was introduced outside the United States in 1999. It was approved by the Food and Drug Administration (FDA) for use in the United States in August 2006.   A prodisc L IDE clinical study evaluated the prodisc L Total Disc Replacement surgery compared to spinal fusion surgery*. The study demonstrated that prodisc L surgery is a safe and effective alternative to fusion surgery* for qualified patients.

About Centinal Spine
From the foundation of knowledge gained from the long-term clinical success of its lumbar products, Centinel launched its cervical product in 2008. Today, Centinel Spine still embraces the pioneering culture from 1924.  In 2006, the FDA Approved the prodisc L—the 2nd U.S. Lumbar Total Disc Replacement device and in 2007, the  FDA approved the  prodisc C—the 1st Complete U.S. Cervical and Lumbar offering.

For more information, please visit www.centinelspine.com and connect on Twitter and Facebook.


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December 13, 2018 OrthoSpineNews

WARSAW, Ind., Dec. 13, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today the full-scale U.S. launch of its 26th surgical system, the RESPONSE 4.5/5.0mm System following U.S. Food and Drug Administration (FDA) 510(k) clearance in October. The Company’s newest system represents a significant product expansion for physicians to treat complex scoliosis in smaller stature patients at a younger age.

The RESPONSE 4.5/5.0mm System, designed in collaboration with pediatric orthopedic surgeons, builds upon the successful implant and instrument technology of the RESPONSE 5.5/6.0mm System to expand the platform offering. The new small stature scoliosis system offers a hybrid implant technology allowing the option of either a 4.5mm rod in cobalt-chromium or 5.0mm rod in titanium or cobalt-chromium, multiple implant connector options, and innovative, new instrumentation.

Dr. Jonathan Phillips, Pediatric Orthopedic Surgeon & Associate Professor of Orthopedics at University of Central Florida, College of Medicine, served as a design surgeon for the small stature system and commented, “I am excited for the launch of the highly anticipated small stature RESPONSE system from the leader in children’s orthopedic technologies. Conceived to mesh seamlessly with the exceptionally successful RESPONSE system for larger statures, this instrumentation has been designed to serve a unique weight and size demographic in children’s orthopedics and extends the versatility of OrthoPediatrics’ spinal instrumentation options. I look forward to this radical improvement to care for a diverse cohort of the most underserved children.”

RESPONSE™ Spine System
Designed with a complete focus on children, the RESPONSE system offers a simple, technologically advanced system of instruments and implants to treat the distinct needs of pediatric patients with spinal deformities. The system features advanced instrument & implant technology including 1) innovative, low profile screw design including a proprietary set screw thread design for improved fixation and reduced potential for cross threading, and 2) unique pedicle screw head accepts multiple rod diameters in either cobalt chrome or titanium. Additionally, the system has versatile reduction & de-rotation capabilities with rod reducer instrument designed for easy snap on and off 2-in-1 rod reduction instrument enables each surgeon to perform reduction and de-rotation technique of choice and serves as a rod reducer and de-rotator in one.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 26 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com


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December 12, 2018 OrthoSpineNews

Reston, Virginia, Dec. 12, 2018 (GLOBE NEWSWIRE) — The Virginia Institute of Robotic Surgery at Reston Hospital Center has acquired a second Mazor X System for their rapidly growing spine program, making it the first in the nation to have two of these robotic systems at one hospital location.

The Reston Hospital Center (RHC) Spine Team is comprised of nationally-recognized spine surgeons who excel in implementing the latest in surgical advancements for spinal procedures. One of the first in the country to acquire and use Mazor Technology in 2012, RHC, in collaboration with its surgeons, has been a pioneer in using advanced technology and procedures in the operating room.  In 2016, the facility was the first in the Mid-Atlantic to acquire and perform a procedure using the latest Mazor X platform. More than 1,500 spine surgeries are performed annually at RHC, with over 600 of these procedures utilizing the advanced technology of the Mazor X system, offering patients an advanced, minimally invasive surgical option for the spine.

“Providing our surgeons with the technology and resources they need to keep our surgical program at the forefront of innovation means that our patients receive the most advanced care in the safest environment,” said John Deardorff, CEO of Reston Hospital Center and President of HCA’s Northern Virginia Market. “As a leader in spine surgery we are committed to delivering exceptional care and the best possible outcomes for our patients.”

Reston Hospital Center is one of only eight Visiting Clinician Programs (VCP) in the United States where surgeons from around the world come to train on the latest in Mazor technology.  The VCP gives surgeons the opportunity to learn about the latest in robotic-assisted spine surgery capabilities from the proctoring surgeon, Dr. Christopher Good of the Virginia Spine Institute. In addition to the surgical training, surgeons also learn how a comprehensive robotic surgical program runs from an operational and administrative perspective.

About Reston Hospital Center

Part of HCA Virginia Health System, Reston Hospital Center is a 197-bed, acute-care medical and surgical facility that has garnered high honors for attentive patient care and nursing excellence.  Reston Hospital Center is home to the region’s newest Level II Trauma Center and the most comprehensive robotic surgery in the Mid-Atlantic. Statewide, HCA Virginia Health System operates 14 hospitals and more than 30 outpatient centers and is affiliated with 3,000 physicians. It is Virginia’s fourthlargest private employer, provides $190.8 million in charity and uncompensated care, and pays $72.6 million in taxes annually. For more information about Reston Hospital Center visit www.restonhospital.com

Erin Echelmeyer
Reston Hospital Center
703-689-9030
Erin.Echelmeyer@hcahealthcare.com

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December 10, 2018 OrthoSpineNews

MISGAV, IsraelDec. 10, 2018 /PRNewswire/ — ZygoFix Ltd. (“ZygoFix”), a portfolio company of The Trendlines Group Ltd.(“Trendlines”) (SGX: 42T) (OTCQX: TRNLY), announced the successful start of a first In human clinical study for its zLOCK spinal facet joint fixation system. The clinical study comprised several procedures to date and a 6-month follow-up of the first case. The first case, a fusion procedure using the zLOCK system, was performed on a 67-year-old female suffering from severe back and leg pain. The patient reported a drop in her VAS (Visual Analog Scale of 0-10 for pain measurement) from 9 pre-operation, to 1 one day post-operation and to 0 at 6 months post-op.

Spinal fusion is a common surgical procedure for the treatment of severe back and leg pain due to conditions such as degenerative discs or “slipped” discs. Spinal fusion is one of the most common surgical procedures – fifth in terms of OR procedure frequency1.

The zLOCK implant is designed as a miniature facet fusion cage to stabilize the segment. Its unique combination of rigid and flexible elements withstands loads and accommodates the anatomy of any facet joint. zLOCK utilizes the natural anatomy of the spine to form a “bridge” between the two adjacent vertebrae, without screws and rods. A percutaneous approach allows placement of zLOCK with only one small incision per side, making it significantly less invasive than the standard pedicle screw procedure.

Prof. Attila Schwarcz, Vice-Chairman and Leader of Spine Surgery, Department of Neurosurgery, University of Pecs, Hungary, and principal investigator in ZygoFix’s study, commented, “The zLOCK implantation is a significantly less invasive procedure compared to other posterior spinal stabilization systems. It appears superior to pedicle screw procedures, since zLOCK has an almost zero risk of causing nerve root injury that can happen in pedicle screw misplacement. Additionally, the zLOCK implant may have the ability to provide better long-term stabilization due to solid bony fusion of the facet joints.”

ZygoFix CEO Ofer Levy remarked, “We are extremely pleased with this successful start to our clinical study – another step toward making spinal fusion simpler, faster and less invasive. zLOCK’s unique design simplifies fusion procedures by self-adjusting to the spine’s anatomy, eliminating the need for pedicle screw placement.”

1 https://www.hcup-us.ahrq.gov/reports/statbriefs/sb186-Operating-Room-Procedures-United-States-2012.jsp

Contact:    
Ofer Levy, CEO ZygoFix   
ofer@zygofix.com    
+972-52-2664-981

www.zygofix.com

SOURCE ZygoFix Ltd


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December 10, 2018 OrthoSpineNews

SAN DIEGODec. 10, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded use of its Monolith®Corpectomy System, providing surgeons with a modular PEEK interbody solution for cervical corpectomy procedures.

The FDA 510(k) indications for expanded use of the Company’s Monolith Corpectomy System include procedures in the cervical spine (C3-C7 vertebral bodies) to treat a diseased or damaged vertebral body caused by fracture, tumors, osteomyelitis or to support reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissue in cervical degenerative disorders.

“Expanding the indicated use of our Monolith Corpectomy System to include cervical corpectomy procedures demonstrates the Company’s continued commitment to expanding our cervical spine interbody portfolio,” said Matt Link, president, Strategy, Technology and Corporate Development for NuVasive. “We are pleased to provide surgeons with a PEEK cervical interbody solution to help round out our cervical portfolio as we continue to advance our mission to improve patient lives.”

NuVasive’s Monolith Corpectomy System was initially cleared by the FDA for indicated use in thoracolumbar corpectomy procedures in 2015, offering a fully modular, imaging-friendly PEEK implant solution. The system is comprised of a monolithic core with modular endcaps that allow surgeons to customize the device to meet the patient’s specific anatomical requirements. The endcaps are available in multiple footprint and lordosis options intended to help maximize endplate coverage while addressing the surgeon’s alignment goals. The Monolith cage is constructed entirely from PEEK and includes radiographic markers, which provides increased clarity in postoperative x-rays and imaging, allowing surgeons to more easily assess fusion following procedures. The cage also includes large central graft apertures designed to help facilitate bony through-growth and fusion.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, 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 over $1 billion in revenues, NuVasive has an approximate 2,400-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.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com


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December 6, 2018 OrthoSpineNews

Dec 05, 2018 (Heraldkeeper via COMTEX) — New York, December 05, 2018: The Global Spine Biologics Market is expected to exceed more than US$ 2.5 Billion by 2022, at a CAGR of 4.4% in the given forecast period.

The report covers detailed competitive outlook including the market share and company profiles of the key participants operating in the global market. Key players profiled in the report include DePuy Spine, Precision Spine, Medtronic, Stryker Corporation, Smith & Nephew Plc, Orthovita Inc., Zimmer Spine Inc., K2M, Nuvasive, Arthrex, Inc., DMP Spine, Alphatec Spine, Orthofix Holdings, RTI Surgical, Wright Medical Technology, Cesca Therapeutics, and Lattice Biologics. Company profile includes assign such as company summary, financial summary, business strategy and planning, SWOT analysis and current developments.

You Can Browse Full Research Report: https://www.marketresearchengine.com/spine-biologics-market

The Global Spine Biologics Market has been segmented as below:

The Global Spine Biologics Market is Segmented on the lines of By Product Analysis, By Surgery Analysis and By Regional Analysis. By Product Analysis this market is segmented on the basis of Bone graft substitutes, Platelet rich plasma (PRP), Bone grafts and Bone marrow aspirates concentrate (BMAC) therapy.

By Surgery Analysis this market is segmented on the basis of Anterior cervical discectomy and fusion (ACDF), Anterior lumbar interbody fusion (ALIF), Transforaminal lumbar interbody fusion (TLIF), Lateral lumbar interbody fusion (LLIF) and Other surgeries. By Regional Analysis this market is segmented on the basis of North America, Europe, Asia-Pacific and Rest of the World.

A biologic is a material which energetically alters its surrounding atmosphere and effects a change during a biological process. Spine biologics are used through spine fusion surgical procedure for the treatment of spinal defect includes wound, degenerative disc disease, tumors, and spinal cord injuries and wounds by stimulating bone expansion formation through inflammatory repair stage, stage and remodeling stage. Therefore flow in the quantity of spinal fusion surgeries has fueled the acceptance of biologics.

The scope of the report includes a detailed study of global and regional markets for Global Spine Biologics Market with the reasons given for variations in the growth of the industry in certain regions.

Reasons to Buy this Report:

1) Obtain the most up to date information available on all Global Spine Biologics Market.
2) Identify growth segments and opportunities in the industry.
3) Facilitate decision making on the basis of strong historic and forecast of Global Spine Biologics Market data.
4) Assess your competitor’s refining portfolio and its evolution.

The major driving factors of Global Spine Biologics Market are as follows:

  • Innovative technological advancements
  • Advantages of biologics include faster recovery, minimal postoperative time and ability to activate cellular expansion.
  • Demand of minimally invasive spine surgeries is growing
  • Increasing ageing population
  • Incidences of spinal disorders are raising
  • Newly developed spine treatment techniques and devices

The restraining factors of Global Spine Biologics Market are as follows:

  • Unfavorable reimbursement policy
  • High cost of bone grafts
  • Ethical issues associated to bone grafting procedures
  • Lack of professional expertise
  • Lack of patient awareness and knowledge

Request Sample Report from here: https://www.marketresearchengine.com/spine-biologics-market

Table of Contents

1 INTRODUCTION

2 Research Methodology

3 Executive Summary

4 Market Overview

5 Spine Biologics Market, By Surgery Type

5.1 Introduction
5.2 Anterior Cervical Discectomy and Fusion (ACDF)
5.3 Posterior Lumbar Interbody Fusion (PLIF)
5.4 Transforaminal Lumbar Interbody Fusion (TLIF)
5.5 Anterior Lumbar Interbody Fusion (ALIF)
5.6 Lateral Lumbar Interbody Fusion (LLIF)
5.7 Others

6 Spine Biologics Market By Product Type

7 Spine Biologics Market, By Geography

8 Competitive Landscape

9 Company Profiles

9.1 Zimmer Holding, Inc.

9.2 Depuy Synthes

9.3 Medtronic, Inc. (U.S.)

9.4 Nuvasive, Inc.

9.5 Stryker Corporation

9.6 Orthofix International N.V.

9.7 K2M, Inc.

9.8 Exactech, Inc.

9.9 Wright Medical Technology, Inc.

9.10 Nutech

9.11 Arthrex, Inc.

9.12 X-Spine Systems, Inc. (Bacterin International Holdings, Inc.)

9.13 DR PRP USA LLC

Other Related Market Research Reports:

Spinal Implants and Surgical Devices Market is Projected to Reach US$ 17 Billion By 2022

Spinal Implants Market is Expected to Exceed US$ 19.5 Billion by 2024

Spine Surgery Devices Market is Projected to Reach US$ 3 Billion by 2022

Media Contact

Company Name: Market Research Engine

Contact Person: John Bay

Email: john@marketresearchengine.com

Phone: +1-855-984-1862

Country: United States

Website: https://www.marketresearchengine.com/

The post Spine Biologics Market Share will Increase US$ 2.5 Billion by 2022 appeared first on Herald Keeper.

The MarketWatch News Department was not involved in the creation of the content.


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December 6, 2018 OrthoSpineNews

December 06, 2018

KARLSRUHE, Germany & IRVINE, Calif.–(BUSINESS WIRE)–joimax®, the Germany-based market leader of technologies and training methods for full-endoscopic minimally-invasive spinal surgery, is well positioned for Germany’s principal spine convention, German Spine Society (DWG), taking place December 6 to 8 in Wiesbaden, Germany.

This year, joimax® is focusing on their Endoscopic Tower Generation 4 Devices, an expert solution for spinal surgery. They will showcase the new Camsource® LED, a fully integrated camera and light source system that delivers brilliant images up to 4K; and the Vitegra®, the integrated visualization, documentation and commanding device. This marks the global launch of both devices, including in Europe, Asia, and the United States.

Moreover, joimax® will exhibit its EndoLIF® product line: the well-known 3D-printed EndoLIF® O/On-Cage, the EndoLIF® Delta Cage, and the EndoLIF® Double Wedge Cage (approval expected shortly).

“The main advantage of the EndoLIF® Implants is the gentle and atraumatic access via gradual tissue dilatation — muscles remain intact and infection risk is reduced. Using 3D-printing technology, an open diamond cell structure, and a rough and porous surface, leads to optimal bone ingrowth, stability and finally fusion,” states Wolfgang Ries, Founder and CEO of the joimax® Group. “Even awake, fusion with very fast patient recovery has started to be realized on the base of endoscopic minimally-invasive techniques.”

Additionally, joimax® will show Intracs® em, the first complete electromagnetic navigation system for endoscopic minimally invasive spine surgery. Intracs® is an easy to set up, user-friendly system that can serve as a stand-alone device. It relies on electromagnetic tracking and was designed specifically for simple and safe access to any spinal target. It’s the only device on the market that allows for simultaneous navigation of multiple instruments such as needles, guiding rods, reamers, and endoscopes, also developed by joimax®.

Besides an expanded booth presence with daily Meet-the-Expert Sessions, joimax® will again host two lunch symposiums on endoscopic spinal procedures: one covering endoscopic pain therapy, and the other addressing diverse intracanal surgical treatment modalities, including endoscopic fusion.

About joimax®

Founded in Karlsruhe, Germany, in 2001, joimax® is the leading developer and marketer of complete systems for full-endoscopic and minimally invasive spinal surgery. With the Endoscopic Surgical Systems TESSYS®(transforaminal), iLESSYS® (interlaminar) and CESSYS® (cervical) for decompression procedures, MultiZYTE®for facet and sacroiliac joint pain treatment and EndoLIF® and Percusys® for minimally-invasive endoscopically assisted stabilizations, established systems are provided, addressing a whole range 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 anesthesia, via tissue and muscle-sparing corridors and through natural openings in the spinal canal, e.g. the intervertebral foramen, the so-called “Kambin triangle.”

Contacts

Press Contact Germany: joimax® GmbH
Sabine Jarosch
sabine.jarosch@joimax.com
0049 721 25514 0

Press Contact USA: joimax® Inc.
Melissa Brumley
melissa.brumley@joimaxusa.com
001 949 859 3472


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December 6, 2018 OrthoSpineNews

December 05, 2018

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that designs, develops, and markets disposable medical devices intended to make spine surgery safer by bringing real-time digital technology into the operating room, announced today a partnership agreement with Carnot Interfaces for the combination of its DSG technology with surgical robots.

In November 2017, the collaborative experimental feasibility study successfully demonstrated how the DSG technology can automatically stop a surgical robot when a near-breach situation is detected, and thereby prevent grave complications. Encouraged by this first positive outcome, SpineGuard and Carnot Interfaces have decided to move to the next development phase materialized by the execution of this 3-year partnership.

Stephane Bette, CEO of SpineGuard, declares: « We are enthused to launch this partnership that will support our progress toward industrial applications of our DSG® technology in surgical robotics as well as advancement of corresponding intellectual property. We are convinced that our partnership with Carnot Interfaces will trigger major technologic advances that will allow robots to execute autonomous and safe drillings in the human skeleton and ultimately the direct insertion of implants. Our smart DSG® sensor is to our knowledge the only clinically proven technology for differentiating bone tissues in-situ and in real time. This major partnership with Carnot Interfaces exemplifies excellent collaboration between Industry and French Research.”

Guillaume Morel, Professor at the Sorbonne University, adds: « Our team at ISIR (Institut des Systèmes Intelligents et de Robotique), one of the five laboratories of Carnot Interfaces) was highly expecting this partnership. Our approaches of robotics, collaborative and sensor-guided, are perfectly in line with SpineGuard’s vision of surgical instrumentation: the surgeon remains at the heart of the decision and control of the gesture; technologies are there to secure and simplify procedures, not for replacing the surgeon. We are in the rare situation of preparing a breakthrough innovation with a good visibility on the R&D roadmap, in part thanks to the results from our feasibility study. The team at SpineGuard and ISIR gathers sharp and multi-disciplinary experts. All conditions are converging for rapid progress toward major advances.”

Next financial press release: 2017 full year revenue, January 17, 2019

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 65,000 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.

About Carnot Interfaces

Founded in 2016 in Paris, Carnot Interfaces consolidates five labs (LIP6, ISIR, LIB, LIMICS and UMR.S1158) specializing in IT, Robotics and healthcare technologies with the vision of developping R&D partnerships with the industry. The institute holds the “Tremplin Carnot” labelling, a proof of excellence under the stewardship of Sorbonne University, CNRS and INSERM, all internationally recognized between the most innovative R&D actors. Carnot Interfaces regroups over 800 R&D professionals with standards of excellence in research, dynamic teams and a proven track of record in partnerships with the industry. It is a key player in the fields of digital with over 15 million euros of deals in its first year after inception. For further information, visit: www.carnot-interfaces.fr

Contacts

SpineGuard
Stéphane Bette
Directeur Général
Tél. : 01 45 18 45 19
s.bette@spineguard.com

Manuel Lanfossi
Directeur Financier
m.lanfossi@spineguard.com

Europe / NewCap
Investor Relations & Financial Communication
Mathilde Bohin / Pierre Laurent
Tél. : 01 44 71 94 94
spineguard@newcap.eu


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December 5, 2018 OrthoSpineNews

Jupiter, Florida, Dec. 05, 2018 (GLOBE NEWSWIRE) — JUPITER, FLORIDA (December 5, 2018) — Jupiter Medical Center is the first hospital in the southeastern United States to use SpineJack®, an implantable system that relieves the pain of acute vertebral compression fractures (VCFs), the most common fracture in patients with osteoporosis. The innovative device stabilizes and restores damaged vertebra to their original shape and height in a minimally invasive procedure that takes about 30 minutes.

“We take pride in offering the most advanced treatment options available,” said Don McKenna, president and chief executive officer of Jupiter Medical Center. “With this new technology, we are establishing Jupiter Medical Center as a leader in spine care not just locally, but nationally.”

Approved by the U.S. Food and Drug Administration in September, SpineJack® has been commercially available in Europe since 2008, with more than 70,000 units implanted worldwide.  It is produced domestically by the Stryker medical technology company.

“This is a revolutionary advancement for treating many patients suffering from acute osteoporotic vertebral compression fractures,” said Dr. Jeffrey Miller, medical director of Neuroendovascular Surgery and co-medical director of the Stroke Program at Jupiter Medical Center. “We know from its success in Europe over the last decade that it significantly improves the patient’s quality of life almost immediately.”

“SpineJack® is part of the expanding array of treatment options available in Jupiter Medical Center’s Interventional Radiology Program,” said Dr. Lee A. Fox, medical director of Imaging at Jupiter Medical Center. “Our program offers a full scope of advanced diagnostic procedures and minimally invasive therapies, and we are delighted to bring this new treatment option to our patients.”

Dr. Miller performed Jupiter Medical Center’s first SpineJack® on Nov. 6. His patient, 75-year-old Robert Fischer of North Palm Beach, is pleased with the outcome.  “It’s only been three weeks and I feel close to perfect – I’d say 95 percent,” said Fischer, who was diagnosed with osteoporosis earlier this year after he began suffering debilitating back pain.

VCFs are the most common medical condition experienced by those with osteoporosis or low bone mass. VCFs occur when the vertebral body in the spine collapses, which can lead to severe pain, spinal deformity and loss of height. The fractures more commonly occur in the middle (thoracic) and lower (lumbar) portions of the spine. While osteoporosis is the most common cause, these fractures may also be caused by trauma or metastatic tumors. The lifetime risk of osteoporotic fracture for those older than 50 years of age is one in two for women and one in four for men.

“SpineJack® treats back pain by targeting the cause and, as a result, it reduces the need for long-term use of pain medication,” Dr. Miller said. “In addition to enhancing our patients’ quality of life, this procedure could have a significant impact in the effort to combat opioid addiction.”

For decades the only nonsurgical treatments for VCFs were bed rest, bracing (which limits mobility) and pain medication. Vertebroplasty has been used since the early 1990s and more recently kyphoplasty, which has become a mainstay in the treatment of VCFs. In vertebroplasty, bone cement is injected directly into the fractured vertebra, where it quickly hardens and acts like an internal cast. In kyphoplasty, a balloon is inserted into the fracture to expand the space before the cement is added. Neither procedure restores the vertebral body to its full height.

SpineJack® was invented by a French physician whose inspiration was a scissor jack, the diamond-shaped car jack that is commonly used to lift a vehicle when changing a flat tire. Instead of a kyphoplasty balloon, the procedure utilizes a titanium implant that resembles a tiny scissor jack, which is deployed into the fractured vertebral body. Once in place, the SpineJack® is expanded to lift the compressed vertebra and restore it to its normal height. Two implants are used in the procedure, one on each side of the vertebral body. They are locked into the desired expanded position and bone cement is then injected to stabilize the vertebra. The implant becomes encapsulated with bone cement resulting in pain relief for the patient.

Fischer proved to be the ideal patient to undergo the first SpineJack® at Jupiter Medical Center.  In August, while spending the summer in Rhode Island, he underwent a kyphoplasty procedure to treat a VCF in his upper back. While wintering in South Florida just a few months later, he suffered a second VCF during a round of golf—this time in his lower back. His primary care physician referred him to Dr. Miller, who thought he would be a good candidate for SpineJack®.

“My recovery was much quicker,” he said. “With (kyphoplasty), that recovery took about 10 weeks before I felt as good as SpineJack® feels now, just three weeks later. I would definitely recommend it.”

Performed on an outpatient basis, the procedure is appropriate for patients who have been diagnosed with a VCF within four to six months of treatment. For more information, visit https://www.jupitermed.com/spinejack or call 561-263-2200.

About Jupiter Medical Center

A not-for-profit 327-bed regional medical center consisting of 207 private acute-care hospital beds and 120 long-term care, sub-acute rehabilitation and Hospice beds, Jupiter Medical Center is reimagining how to restore the community’s health and wellness. Award-winning physicians, world-class partnerships and innovative techniques and technology enable Jupiter Medical Center to provide a broad range of services with specialty concentrations in cardiology, oncology, imaging, orthopedics & spine, digestive health, emergency and pediatric services, lung & thoracic, women’s health, weight management and men’s health.

Founded in 1979, Jupiter Medical Center has approximately 1,650 team members, 637 physicians and 640 volunteers. Jupiter Medical Center continues to perform in the top 10 percent of hospitals for patient quality and satisfaction. For more information on Jupiter Medical Center, please call (561) 263-2234 or visit www.jupitermed.com.

Attachments

Ernestine Williams
Jupiter Medical Center
5612633852
Ernestine.Williams@jupitermed.com

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December 4, 2018 OrthoSpineNews

December 04, 2018

NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine LLC, a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) and full commercial launch of its SAXXONY® Posterior Cervical Thoracic System—a system designed to stabilize cervical (C1 to C7) and thoracic (T1 to T3) spinal segments via posterior screw fixation in patients with degenerative disease, deformity, tumor, or trauma.

“The SAXXONY® System adds a robust posterior complement to our well received anterior cervical fixation offering as we continue to innovate and grow our fusion portfolio,” said Andy Elsbury, Nexxt Spine President.

The comprehensive offering includes standard and smooth shank screws available in a variety of diameter and length combinations, low profile cross connectors featuring multi-axis adjustability, and various configurations of offset, parallel, and axial connectors. The implant offering is complemented by streamlined instrumentation designed to ease rod placement and facilitate procedural efficiency.

In order to simplify longer complex constructs, the SAXXONY® Posterior Cervical Thoracic System has been designed to seamlessly link to the INERTIA® Pedicle Screw System with a variety of 3.5 to 5.5mm or 3.5 to 6.5mm rod-to-rod connectors and transition rods.

About Nexxt Spine

Nexxt Spine, LLC is a privately held medical device manufacturer dedicated to increasing procedural efficiency and patient outcomes through development of innovative products, manufactured on the most technologically advanced platforms, and utilizing irreproachable quality standards to treat painful and debilitating spinal pathologies. The company is growing rapidly and continues to recruit regional sales managers and independent distributors. For more information on Nexxt Spine and its products, please visit www.nexxtspine.com or email info@nexxtspine.com.

Contacts

Sarah Caito
scaito@nexxtspine.com