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Current Issues in Spine

February 2-4, 2017

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December 7, 2018 OrthoSpineNews

Magal, Israel, December 7, 2018 – MinInvasive Ltd., developer of the OmniCuff™ device for treatment of rotator cuff repair, reported positive progress following its initial two months of limited market release activity in the US with 26 OmniCuff™ System cases successfully concluded to date.

Shoulder rotator cuff repair is a fast-growing market segment within the sports medicine market, with over one million procedures performed annually worldwide. The OmniCuff™ System is an arthroscopic transosseous rotator cuff repair device that eliminates the need for suture anchors. The device provides the advantages of minimally invasive transosseous repair in a disposable device. MinInvasive CEO Ronen Raz stated, “We are very pleased that within the first 8 weeks of limited US market release, the OmniCuff™ System has been successfully used by several very reputable sports medicine surgeons in 26 rotator cuff repair procedures”.

Joseph Abboud, MD, Professor of Orthopedic Surgery at the Rothman Institute at Thomas Jefferson University in Philadelphia, recently performed several OmniCuff cases and confirmed that he is “extremely pleased with the technical ease and reproducibility of the device, as well as the tremendous potential for direct cost savings.”

Walter Stanwood, an Orthopedic surgeon at Beth Israel Deaconess Hospital in Plymouth, Massachusetts has completed over a dozen surgeries with the Omnicuff, and commented that the System offers “a very straightforward technique that minimizes steps, with an elegant device to consistently create transosseous fixation in a rotator cuff repair model. OmniCuff has enormous potential in any location that a tendon-bone repair is performed.”

Nikhil Verma, MD Professor and Director of the Division of Sports Medicine and Shoulder Surgery at Rush University Medical Center in Chicago, remarked that the device “allows for a seamless transition between traditional anchor-based repair, and an anchorless solution. In addition, the availability of a technologically advanced and easy to use anchorless device has the potential to disrupt the market with a lower cost solution which is of paramount importance given recent movement of these types of cases to outpatient facilities and the emphasis on value-based care.”

Frank Cordasco, MD, MS, Professor of Orthopaedic Surgery at the Hospital for Special Surgery and the 35th President of the American Shoulder and Elbow Surgeons has observed “remarkably diminished pain in the post-operative period in patients treated with the OmniCuff System compared to those treated with the transosseous equivalent rotator cuff repair technique during the first 3 weeks following surgery. This has resulted in a decreased need for Opioid medications in the patients treated with the OmniCuff System”.

MinInvasive plans to gradually expand the availability of the device in the US and is currently in the process of securing CFDA approval for OmniCuff™ in China, another huge potential market for innovative medical technologies.

MinInvasive Ltd.

MinInvasive has developed the OmniCuff™ System – an innovative device enabling arthroscopic, transosseous rotator cuff repair. In 2016, MinInvasive entered into a strategic partnership with MicroPort Scientific Corporation to obtain CFDA approval for the OmniCuff™ system. MinInvasive has validated manufacturing of its new OmniCuff™ disposable version and initiated a limited market release in early October in the US.

Contact:

Ronen Raz, CEO, MinInvasive Ltd. 137 Hashachaf, Magal, Israel

ronen.raz@mininvasive.com

+972-54-6222410


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December 7, 2018 OrthoSpineNews

AUDUBON, Pa., Dec. 06, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, recently announced the entrance of ExcelsiusGPS®, a revolutionary robotic guidance and navigation system, to the international market with system installations completed in several European countries. This past October, the first European Excelsius GPS® procedure was performed at the Metropolitan Hospital in Neo Faliro, Athens, Greece by Mr. Panagiotis E. Zoumpoulis. Since then, numerous open and minimally invasive spine procedures have been performed at Bonifatius Hospital in Germany and at the Fornaca Clinic in Italy.

“Surgeons and hospital administrators in the United States have shown tremendous levels of interest in ExcelsiusGPS® since it first launched domestically at the end of 2017,” said Dave Demski, Chief Executive Officer at Globus Medical. “Users have realized the system’s ability to help advance patient care and provide tangible benefits for surgeons and their staff. As we begin to scale our efforts abroad, we have seen similar levels of enthusiasm within the international surgeon community and look forward to the continued adoption of ExcelsiusGPS® into these markets.”

Italy’s first surgeries were performed by Prof. Franco Benech, and Dr. Carlo Alberto Benech, from Benech Neurosurgery and Spine Specialists in Turin, Italy at the Fornaca Clinic. “With the addition of ExcelsiusGPS® we now offer patients seeking spine surgery a level of accuracy that was not possible without this technology,” said Prof. Benech. “Our team is committed to providing the highest level of care to our patients by offering the latest advancements in robotic-assisted spine surgery at our facilities.”

Professor Peter Douglas Klassen with Bonifatius Hospital in Lingen, Germany echoes a similar sentiment, commenting, “ExcelsiusGPS® is truly a revolutionary technology designed to improve surgeon wellness and patient care. We are excited about the potential impact that robotic guidance and navigation may have in improving screw placement accuracy, MIS efficiency, and reducing radiation exposure.”

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Brian Kearns
Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email:  investors@globusmedical.com
www.globusmedical.com


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December 6, 2018 OrthoSpineNews

SCHLIEREN (ZURICH), Switzerland, Dec. 06, 2018 (GLOBE NEWSWIRE) — Kuros Biosciences (SIX: KURN) today announced the publication of data from a clinically-relevant preclinical model comparing MagnetOs with autologous bone in instrumented posterolateral spinal fusion in sheep. Utilizing multiple assessments for fusion, the study concluded that MagnetOs is a suitable alternative to autograft when used as a standalone graft.

The publication, which is entitled “Biphasic calcium phosphate with submicron surface topography in an Ovine model of instrumented posterolateral spinal fusion” was included in the December issue JOR Spine, an open-access Orthopaedic Research Society (ORS)journal.

Joost de Bruijn, Chief Executive Officer of Kuros, said: “This latest study demonstrates early bone healing and physiologically-appropriate graft resorption for MagnetOs in this clinically-relevant model of posterolateral spinal fusion and adds to the growing body of evidence proving that MagnetOs is a reliable alternative to autologous bone graft.”

Professor Bill Walsh, University of New South Wales, Australia, who was principal investigator of the study said: “I’ve investigated many of the leading synthetic bone grafts in this model and, in my experience, MagnetOs leads to the most compelling fusion outcomes of all the grafts I’ve tested.”

About the study
MagnetOs Granules and MagnetOs Putty were implanted standalone and compared to autograft bone. Twenty-five adult, female Merino sheep underwent posterolateral spinal fusion at L2-3 and L4-5 levels with instrumentation. After 6, 12, and 26 weeks, outcomes were evaluated by manual palpation, range of motion testing, micro-computed tomography, histology and histomorphometry. Fusion assessment by manual palpation 12 weeks after implantation revealed 100% fusion rates in all treatment groups. Similarly, the three treatment groups showed a statistically significant decrease in lateral bending at the fusion levels at 12 weeks and 26 weeks compared to the 6-week time-point, which further confirmed spinal fusion. No significant differences in range of motion were observed between the treatment groups at any of the time-points investigated. Histological assessment at 12 weeks showed fusion rates of 75%, 92%, and 83% for autograft, MagnetOs Granules and MagnetOs Putty, respectively. The fusion rates were further increased 26 weeks post-implantation. Similar trends of bone growth were observed by histomorphometry.

Citation 
https://onlinelibrary.wiley.com/doi/pdf/10.1002/jsp2.1039

For further information, please contact: 
Kuros Biosciences AG
Michael Grau
Chief Financial Officer
Tel +41 44 733 47 47
michael.grau@kurosbio.com

Media & Investors
Hans Herklots
LifeSci Advisors
+41 79 598 7149
hherklots@lifesciadvisors.com

About MagnetOs
MagnetOs promotes local bone formation equivalent to current gold standard, autograft. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

US indications statement
MagnetOs is an implant intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. MagnetOs must be used with autograft as a bone graft extender in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure.

EU indications statement
MagnetOs is intended for use as bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. MagnetOs is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. MagnetOs is intended to be packed into bony voids or gaps of the skeletal system (i.e. extremities, spine, cranial, mandible, maxilla and pelvis) and may be combined with autogenous bone. MagnetOs should not be used to treat large defects that in the surgeon’s opinion would fail to heal spontaneously. In load bearing situations, MagnetOs is to be used in conjunction with internal or external fixation devices.

About Kuros Biosciences AG 
Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

Forward Looking Statements 
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.


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December 6, 2018 OrthoSpineNews

LOGAN, UtahDec. 6, 2018 /PRNewswire/ — IntraFuse, a start-up medical device company operated by Surgical Frontiers, is focused on advanced surgical devices for improving outcomes for orthopedic extremity procedures, announced today that the United States Patent and Trademark Office has recently granted the company a key patent related to its FlexThread Intramedullary Fracture Fixation system.

US Patent 10,136,929 entitled “Flexible Bone Implant” is the first patent to issue from the intellectual property portfolio held by the company that includes additional pending US and international patent applications. The patent covers the novel combination of an intramedullary rod with cross fixation on end and a flexible bone screw on the other end. This platform technology enables percutaneous, secure fracture fixation of long bones of the extremities, especially for curved bones or where the surgical technique requires an off-axis approach to the intramedullary canal.

The simple and elegant design is easier to implant and lower cost than today’s standard-of-care fracture fixation hardware. Incorporating IntraFuse’s proprietary FlexThread technology, the distal end of the implant is a flexible, intramedullary screw and the proximal end is a rigid, high-strength intramedullary rod. Upon insertion of the implant into the bone, the rigid rod portion of the implant spans and supports the fracture and the flexible screw portion bends as needed to thread into the intramedullary canal. With internal screw fixation on one side of the fracture and cross screw fixation through the rod on the other side of the fracture, proper bone alignment and length can be maintained during the healing period.

The FlexThread System is currently FDA 510(k) cleared for fibula and clavicle indications, and the FlexThread™ technology is in further development for additional indications, include fractures of the fifth metatarsal bone, also known as a Jones fracture.

IntraFuse is a development stage medical device company incubated and operated by Surgical Frontiers.

About Surgical Frontiers
Surgical Frontiers develops advanced surgical technologies that are ready for clinical use.   Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Media Contact:
Mr. Wade Fallin 
CEO
205883@email4pr.com 
http://surgicalfrontiers.com/intrafuse/ 
800-230-3710

SOURCE Surgical Frontiers

Related Links

http://surgicalfrontiers.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 5, 2018 OrthoSpineNews

DALLASDecember 5, 2018 /PRNewswire/ —

FX Shoulder USA, Inc. will begin in December 2018 the FDA approved Investigational Device Exemption (IDE) clinical study of the Easytech Reversed stemless, a shoulder prosthesis, with its first implantation scheduled for December.

Easytech Reversed Stemless is an innovative shoulder arthroplasty implant that will be under clinical study with (9) sites and (12) surgeons across the U.S. participating. Building on the current success in France (home of FX Shoulder USA’sparent company, FX Solutions), where over 800 Easytech Stemless Reversed prostheses have been successfully implanted, FX Shoulder USA is slated to enroll patients at two (2) investigational sites in December and continue enrollment with additional sites beginning in January 2019.

“The Easytech Reversed may be exactly what the U.S. market is in need of, and a reversed stemless prosthesis could potentially be the future of shoulder arthroplasty,” said Baptiste Martin, CEO of FX Shoulder USA. “We are excited to begin our clinical study and enthusiastic to see the results with each successive case throughout. There is a lot of excitement among the surgeon investigators for Easytech Reversed,” he continued. In Europe, as per the article in Med Device Online dated April 11, 2018, stemless implants are projected to surpass stemmed implants by 2025.

Founded in 2011, FX Solutions has developed a large, unique and innovative range of prosthetic shoulder products, which include the Easytech Reversed Stemless. FX Solutions is now the second largest player in the French market, with more than 3,000 prostheses sold in 2018.

FX Shoulder USA, based in Dallas, Texas, is the direct provider of FX Solutions shoulder replacement devices in the U.S. FX Shoulder USA was founded in January 2018 and focuses exclusively on shoulder arthroplasty with a growing distribution network.

Forward-Looking Statements

Statements in this press release, other than statements of historical fact, are forward-looking statements, are based on our current plans and expectations and are subject to risks and uncertainties that might cause actual results to differ materially from those such statements express or imply. The business and operations of the company are subject to substantial risks which increase the uncertainty inherent in forward-looking statements. These risks and uncertainties include, but are not limited to, our ability to generate sufficient revenue to fund our commercial operations and development programs; and risks related to the development of Stemless Reversed shoulder prostheses, including regulatory approvals, mandates, oversight and other requirements. In this press release, forward looking statements include those concerning the development of the Stemless Reversed shoulder prosthesis, its safety and efficacy profile, its potential to benefit patients and our ability to make it available to those patients.  We disclaim any intention or duty to update forward-looking statements made in this press release.

http://www.fxshoulder.com

info@fxshoulder.com

SOURCE FX Shoulder USA

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(Photo: https://mma.prnewswire.com/media/794131/FX_Shoulder.jpg )


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December 5, 2018 OrthoSpineNews

By Susannah Luthi  | December 4, 2018

The American Hospital Association on Tuesday led a lawsuit against the Trump administration over the CMS’ final rule imposing a site-neutral payment policy, which cuts some Medicare rates for outpatient hospital sites to match the rates for physicians’ offices.

The lawsuit, filed in the U.S. District Court for the District of Columbia, challenges the “serious reductions to Medicare payment rates” as executive overreach. The rate reduction is scheduled to start Jan. 1. In 2019, hospitals’ reimbursements will drop approximately $380 million in 2018, according to the CMS.

“This court should reject CMS’ attempts to replace Congress’s unequivocal directives with the agency’s own policy preferences,” the hospitals wrote in their complaint. “CMS may not contravene clear congressional mandates merely because the agency wishes to make cuts to Medicare spending.”

The outpatient pay rule was finalized in November. The timing and strategy of this lawsuit resembles the hospitals’ effort in late 2017 to block roughly $1.6 billion in Medicare Part B drug reimbursement cuts for 340B providers before they went into effect in early 2018. At the last minute, the presiding federal judge tossed that suit as premature because the cuts had not yet gone into effect. Hospitals lost their appeal over the summer and in September lodged their complaint again.

The Association of American Medical Colleges, the trade group of academic centers that will see a big hit from the site-neutral policy, joined AHA, along with three independent health systems: Michigan’s Mercy Health Muskegon, Washington State’s Clallam County Public Hospital and Maine’s York Hospital.

The policy roiled the hospital industry when it was introduced in a proposed rule over the summer. Hospitals have been lobbying Congress to intervene with the administration and reverse the policy.

 

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