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February 2-4, 2017
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SpineTop Stories

NuVasive Announces Acquisition Of Vertera Spine

September 7, 2017 OrthoSpineNews

SAN DIEGO, Sept. 7, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the acquisition of Vertera Spine, a privately-held medical device company developing and commercializing highly innovative interbody implants for spinal fusion using patented porous polyetheretherketone (PEEK) technology. Terms of the acquisition were not disclosed.

The acquisition of Vertera Spine reflects NuVasive’s continued commitment to pursue strategic opportunities as it builds out its advanced materials science portfolio to complement the Company’s position as the innovation leader in spine. As a result of this acquisition, NuVasive is now the only medical device company to offer porous interbody technology across both PEEK and titanium materials, thereby addressing the spectrum of surgeons’ needs and preferences for interbody implants. Vertera Spine’s technology provides a unique three-dimensional porous PEEK architecture to help elicit and encourage bone ingrowth based on pre-clinical studies, a key factor in improved patient outcomes in spinal fusion procedures, using a proprietary processing method that retains strength and durability.

“With the addition of porous PEEK technology, NuVasive takes the next step in building out its advanced materials science technology focused on delivering the highest level of scientifically driven properties for best spinal fusion rates, including porosity, visualization, surface and structure. This in turn helps to create more predictable, improved outcomes for patients undergoing spine surgery,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “Our go-to-market plans include adding Vertera Spine’s FDA-cleared products to NuVasive’s commercial offerings, as well as applying the porous PEEK technology to our innovation roadmap as we further build out our pipeline of highly differentiated products to increase our market penetration.”

Chris Lee, chief executive officer of Vertera Spine, said, “Vertera Spine is excited to join NuVasive to further proliferate our game-changing material technology, as they bring to bear the industry’s leading product innovation capability as well as the scale and resources necessary to realize our full potential. Since founding the company in 2013, our goal has been to help reach more surgeon customers and their patients with this disruptive technology. Together, we will now be able to better serve the market and change the lives of patients around the world.”

Ken Gall, chair of Mechanical Engineering and Materials Science at Duke University, said, “The development of porous PEEK was a breakthrough discovery based on nearly ten years of scientific research. The end result of this fundamental materials work was the first load bearing porous polymer scaffold used in the human body that is both high-strength and finely tuned to promote bony attachment.”

Vertera Spine’s existing interbody product lines will be added to NuVasive’s portfolio for U.S. commercial sale and distribution including:

  • COHERE® Cervical Interbody Fusion Device: COHERE is FDA-cleared and recently received a new ICD-10 code, issued by the Center of Medicare & Medicaid Services (CMS), effective October 1. COHERE is the only product approved for use with the new code, signifying CMS’ recognition of the innovation and potential clinical and tracking benefits of using porous PEEK.
  • COALESCETM Lumbar Interbody Fusion Device: COALESCE recently received FDA 510(k) clearance for use in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures. Additional extensions for the device are planned for TLIF and PLIF procedures in multiple footprint, height, and lordotic angle configurations.

About NuVasive

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

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with the integration of Vertera Spine into the Company’s business, 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.

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Spine

K2M to Showcase New Spinal Solutions, Industry-Leading 3D-Printed Portfolio & Balance ACS™ at the 2017 SRS Annual Meeting

September 6, 2017 OrthoSpineNews

LEESBURG, Va., Sept. 06, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that it will serve as a Double Diamond Sponsor for the 52nd Annual Meeting & Course of the Scoliosis Research Society (SRS), taking place September 6–9 in Philadelphia, PA. The Company will offer product demonstrations of its newest surgical solutions, industry-leading 3D-printed portfolio, and Balance ACS™ platform in meeting room #403.

“K2M is a proud Double Diamond Sponsor of this year’s SRS meeting, a keynote forum for advancing new surgical solutions that improve the lives of patients living with spinal deformities,” said John P. Kostuik, MD, Chief Medical Officer, Co-founder, and Member of the Board of Directors at K2M, and Past President of the SRS. “We remain committed to the highest level of excellence in developing new technologies that facilitate spinal deformity correction in both adolescents and adults, while emphasizing Total Body Balance as a critical component for improving quality outcomes in patients.”

During the meeting, K2M President and CEO Eric Major and members of the Company’s executive team will be onsite to showcase new and differentiated technologies for spinal deformity correction, including its industry-leading, 3D-printed Lamellar 3D Titanium Technology™portfolio of products. In addition to the company’s comprehensive adolescent and adult deformity portfolio, K2M will highlight several of its latest offerings:

The Company will feature its Balance ACS (BACS™) platform, which provides solutions to balance the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success. K2M will demo the BACS System—which includes BACS Preauthorization, BACS Surgical Planner, BACS Anatomical Models, and BACS Data Management—and the BACS app, a convenient portal for surgeons to access the BACS System.

Further, Major will accept an honorary plaque acknowledging K2M’s Double Diamond sponsorship of the SRS meeting. The presentation will occur on September 6 from 6:25–6:35 p.m. at the Philadelphia Marriott Downtown in Ballroom–Salon A-F.

For more information on K2M’s product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques, and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn, and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems;  our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability  to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations;  our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible  senior notes and our credit facility;  continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; increased costs and additional regulations and requirements as a result of no longer qualifying as an emerging growth company as of December 31, 2017; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC and our Quarterly Report filed with the SEC on August 2, 2017, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment.  New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release.  We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made.  We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.  We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Media Contact:
Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Christian.Emering@ZenoGroup.com  

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com
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RegulatorySpineTop Stories

NuVasive Receives FDA 510(k) Clearance For Leading EOS Innovation

September 6, 2017 OrthoSpineNews

SAN DIEGO, Sept. 6 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of the Company’s redesigned MAGEC® system with its RELINE® Small Stature system. NuVasive will feature these new product offerings at the Scoliosis Research Society (SRS) 52nd Annual Meeting & Course to be held September 6-9, 2017 in Philadelphia.

The MAGEC system uses innovative magnetic technology within adjustable growing rods to treat early-onset scoliosis in a less invasive manner. The latest advancements to the MAGEC system include redesigned components to help provide ease-of-use for the surgeon and help make surgical outcomes more reproducible. In addition, the MAGEC system is introducing a new 5.0 millimeter rod diameter offering, that when paired with the low-profile RELINE Small Stature system, is designed to provide optimal strength to growing-rod constructs to help improve clinical outcomes.

RELINE Small Stature is a comprehensive pediatric deformity fixation system allowing to achieve optimal construct strength with a reduced implant profile. RELINE Small Stature is the only small stature system that is compatible with the new 5.0 millimeter MAGEC rod.

“As a low-profile pediatric fixation system, RELINE Small Stature is the first-of-its-kind system to offer competitively-sized pediatric implants that accept up to a 5.0mm rod,” said Matt Link, executive vice president of strategy, technology and corporate development at NuVasive. “The clearance for our redesigned MAGEC system with RELINE Small Stature highlights our speed to market and our further commitment to bringing procedural solutions that transform care to the pediatric deformity market.”

NuVasive has reached meaningful gains in both the adult and pediatric deformity markets, a $2.5 billion opportunity over the last two years and is a leading sponsor of SRS. The Company’s ‘Embracing the Journey Together’ initiative includes pediatric spinal deformity research, education and spinal deformity event support, assisting leading surgeons as they educate other surgeons around the world.

NuVasive will showcase its market-leading, procedurally-integrated technologies in Meeting Room #406 at the Philadelphia Marriot Downtown. Visit here for more details.

About NuVasive

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

Forward-Looking Statements

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

 

SOURCE NuVasive, Inc.

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SpineTop Stories

SpineGuard Announces 3 Promotions to Strengthen Its Organization

September 6, 2017 OrthoSpineNews

September 06, 2017

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

SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that designs, develops, and markets disposable medical devices intended to make spine surgery safer, announced today three promotions to optimize its organization toward its goal of operational profitability by the end of 2018.

Stéphane Bette, CEO of SpineGuard, said: ‘We are very proud to announce these internal promotions as they reward highly talented members of our team with significant experience: Patricia, Olivier and Steve all contributed greatly to the development of our company over many years. Through their new responsibilities and expanded scope, they will further support me in executing on our strategic goals in particular to reach operational profitability.’

Steve McAdoo, adds: ‘I am very excited to assume my new role within SpineGuard as we to continue to leverage our DSG™ technology in medical device markets, drive additional growth and progress toward profitability. We will continue to work with our customers and partners in the mission of making surgery safer through implementation of DSG Technology, a unique differentiating factor in the market.’

Olivier Frézal, continues: ‘I am thrilled by this this new position. I have been involved in the technical activities of the company over the last years and I have the privilege to lead a strong, dedicated and experienced team. Our current Research projects and subsequent patent filing activities will materialize the incredible potential of our DSG technology.’

Patricia Lempereur concludes: ‘I look forward to taking on these expanded responsibilities as we continue to develop our disruptive technology. Over the years, I have been intimately involved in the international sales process and feel confident in embracing this new role. With our Marketing and Sales teams, we will continue to provide the same quality of support and service to our customers and we are poised to positively impact our international business in line with the new strategy of the company.’

Broadened missions

  • Steve McAdoo (over 28 years of experience with Sales, Marketing and Business Development of Medical Devices, Bachelor of Science in Biology, Smith & Nephew, Danek, Medtronic, Cerapedics, Biomet, with SpineGuard since 2016) will manage the American subsidiary SpineGuard, Inc. replacing Stephane Bette who was appointed CEO on July 13th. Steve will continue to lead global initiatives in Business Development.
  • Olivier Frézal (17 years of experience in R&D and Management in the Spine Industry, ENSAM Master of Engineering and Biomechanics, LBM, SpineVision, worked on the DSG™ technology for 12 years, with SpineGuard since 2009) will lead the innovation strategy, IP, development of new products and technologies and will supervise Manufacturing and RAQA activities.
  • Patricia Lempereur (15 years of experience in Medical Device, Master in Biotechnologies & Management, SpineVision, Medicrea, with SpineGuard since 2009), will be in charge of the International Sales in addition to International Marketing and Worldwide lead for marketing tools and programs.

Next financial press release: H1 2017 results on Sept 14th 2017.

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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SpineTop Stories

Medtronic Launches Long Term Clinical Study Program of INFUSE Bone Graft in Two Common Spine Procedures: PLF and TLIF

September 5, 2017 OrthoSpineNews

DUBLIN – September 5, 2017 – Medtronic plc (NYSE: MDT) today announced the launch of a long term clinical study program to collect prospective data on INFUSE® Bone Graft in Posterolateral Fusion (PLF) and Transforaminal Lumbar Interbody Fusion (TLIF) spine procedures. The first patient has been enrolled in the PLF study at Fort Wayne Orthopedics in Fort Wayne, Ind. The Spine team led by Dr. Kevin Rahn and Dr. Robert Shugart performed the procedure. The use of INFUSE Bone Graft in PLF and TLIF procedures is investigational only.

“Failed back surgery is a real concern with long-term implications, and successful outcomes in PLF and TLIF procedures require solid fusion,” said Dr. Brian Subach, president at The Virginia Spine Institute. “We believe there is significant data on the safety and efficacy profile of INFUSE in approved ALIF and OLIF procedures, and we are hopeful this clinical study program can generate evidence about the potential to use this important technology to help a broader group of patients.”

INFUSE Bone Graft is used with certain Medtronic interbody fusion devices to treat lumbar degenerative disc disease, and eliminates the need to harvest bone from the patient’s body in a secondary surgical procedure.

The global clinical program, called B.O.N.E (BMP Outcomes and New Evidence in PLF and TLIF Procedures), is designed to expand the clinical understanding of INFUSE and to evaluate efficacy, safety and health-economic outcomes for use in PLF and TLIF spine procedures. The current plan for the prospective, multi-center, ten-year program will include approximately 40-50 sites and 550-700 patients between the Pilot and Pivotal studies of both procedures. The PLF Pilot dosing study, which will include approximately 125 patients, will be followed by a TLIF Pilot dosing study in 2018. If successful, the Pilot studies would be followed by a larger Pivotal study. The results may also potentially be used to support peer-reviewed publications and regulatory filings.

“INFUSE is one of the most extensively-researched biologic agents commercially available today and Medtronic continues to invest in research of INFUSE to deepen the understanding of the benefits and risks of this novel treatment,” said Doug King, senior vice president and president of Medtronic’s Spine division, which is part of the Restorative Therapies Group. “We’re hopeful that if successful, the trials will generate additional data to expand indications and provide surgeons with additional options to help alleviate pain and restore health for more patients.”

About Degenerative Disc Disease 
Back pain, including degenerative disc disease (DDD), is a significant issue that is increasing as the population ages. One in four adults suffer from chronic low back pain and it causes 52 million health care visits annually. DDD is typically a result of an aging disc or repeated physical stresses over extended periods of time. In the United States, more than 300,000 individuals with a variety of spinal conditions, like DDD, undergo spinal fusions annually to treat degenerative changes in the lumbar spine.

About INFUSE BONE GRAFT
INFUSE Bone Graft is FDA-approved for certain spine, oral-maxillofacial and orthopedic trauma surgeries. The active ingredient in INFUSE Bone Graft (rhBMP-2) is a manufactured version of a protein already present in the body that promotes new bone growth. During surgery, INFUSE is applied to an absorbable collagen sponge (ACS). The ACS is a carrier to deliver the rhBMP-2 to the implant site and acts as a scaffold for the formation of new bone, and it will resorb, or disappear, over time. INFUSE has been on the market since 2002 and more than one million patients have used INFUSE.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 84,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Contacts:
Eric Epperson
Public Relations
+1-901-344-1435

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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Spine

Implanet Presents Independent Radiological Results of the JAZZ Band at the SRS 52nd Annual Meeting & Course

September 5, 2017 OrthoSpineNews

September 05, 2017

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

IMPLANET (Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible) (Paris:IMPL) (OTCQX:IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, announces the publication of a White Paper entitled “How to optimize axial correction without altering thoracic sagittal alignment in hybrid constructs with sublaminar bands: description of the ‘frame technique’”, which presents the results of clinical analyses based on 3D radiological reconstructions with EOS 3D Service.

This independent study, conducted at Robert Debré Hospital (APHP, Paris Diderot) Orthopedic Pediatric Surgery department, represents another step in the JAZZ system’s clinical validation, highlighting its safety and efficacy in the treatment of idiopathic scoliosis.

The study analyzed 3D radiological reconstructions of 60 patients treated with the ‘frame’ technique, using JAZZ Band and JAZZ Frame implants. The rigid frame facilitates posteromedial translation, resulting in comparable axial rotational correction as compared to the traditional ‘All-Screw’ technique, while preserving the unique advantage of sublaminar implants for restoration of sagittal balance.

“Although, for many surgeons, pedicle screws represent the Gold Standard in treating idiopathic scoliosis, sublaminar bands should be considered as part of the therapeutic arsenal, as their beneficial action on the sagittal balance has been proven. Their excellent biomechanical properties enable considerable correction forces to be applied without running the risk of pulling out the concave screws”, says Professor Brice Ilharreborde, M.D., Ph.D., continuing: “The frame technique combined with the use of JAZZ implants makes it possible to optimize axial correction while respecting the patient’s sagittal alignment”.

Ludovic Lastennet, CEO of Implanet, adds: “This highly-anticipated study confirms that the use of JAZZ implants, combined with the frame technique, offers surgeons a safe and efficient alternative to traditional techniques. These results notably confirm the derotation capabilities of JAZZ implants associated with the JAZZ Frame. Henceforth, we have objective and irrefutable clinical evidence concerning the added value provided by JAZZ implants and the frame technique favoring their use. These results will be presented to surgeons and our commercial partners at the SRS Annual Meeting, which begins today in Philadelphia and will be attended by more than 1,300 global specialists in complex spine surgery.”

The White Paper is available on the Company’s website at the following address: www.implanet.com

Implanet will participate in the following scientific conferences:

  • Eurospine – Dublin (October 11 through 13, 2017)
  • NASS – North American Spine Society – Orlando (October 25 through 28, 2017)
  • SOFCOT – Paris (November 6 through 9, 2017)

About the Scoliosis Research Society

The Scoliosis Research Society Annual Meeting & Course with about 1,400 attendees is a forum for the realization of the Society’s mission and goals, to foster the optimal care of all patients with spinal deformities. Presentations at the Annual Meeting & Course are given by leading experts in the field and have value for health care professionals who treat spinal deformities at all levels and in all ages. Over 125 papers will be presented on an array of topics, including adolescent idiopathic scoliosis, growing spine, kyphosis, adult deformity, trauma, neuromuscular scoliosis and tumors. The Annual Meeting & Course is open to anyone involved in the treatment of spinal deformities including spine surgeons, residents and fellows, physician assistants, nurses and other allied health professionals, and researchers. The presentations selected from over 1,600 submissions provide valuable information to all individuals caring for patients with spinal deformities. www.srs.org

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.
Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.
IMPLANET is listed on Euronext™ Growth market in Paris.

Contacts

IMPLANET
Ludovic Lastennet, Directeur Général
David Dieumegard, Directeur Financier
Tél. : 05 57 99 55 55
investors@implanet.com
or
NewCap
Relations Investisseurs
Florent Alba, Tél. : 01 44 71 94 94
implanet@newcap.eu
or
NewCap
Relations Médias
Nicolas Merigeau, Tél. : 01 44 71 94 94
implanet@newcap.eu

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Spine

EOS imaging Introduces Personalized Biomechanical Simulation in Spine Surgery Planning

September 5, 2017 OrthoSpineNews

September 05, 2017

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, today announced that it will introduce a new version of spineEOS, the Company’s online 3D planning software for spine surgery based on EOS stereo-radiographic 2D/3D imaging. spineEOS is the first software to incorporate biomechanical patient data into surgery simulation and planning to help physicians optimize the patient’s spinal treatment. It has received CE Mark approval in Europe and has been submitted to the U.S. Food and Drug Administration (FDA) for approval.

Marie Meynadier, CEO of EOS imaging, said, “Spine flexibility, which varies from patient to patient, is a key component of how a patient will react to spinal surgery. We are very excited to introduce, for the first time, biomechanical algorithms that take into account the specific flexibility of the patient spine, further improving the spineEOS treatment simulation and planning to accurately reflect the patient’s post-surgical reaction. We believe this will be particularly beneficial for patients with complex spinal disorders, where proper pre-operative simulation can help surgeons choose the right surgical strategy, optimize the shape and position of the implant across different spinal levels, and positively impact the final alignment and long-term outcomes.”

EOS imaging will introduce the new spineEOS software in a symposium during the Scoliosis Research Society (SRS) 52nd Annual Meeting & Course, which is taking place in Philadelphia, PA from September 6-9, 2017.

The symposium will be held on Thursday, September 7, 2017 from 4:45 to 6:00 pm EDT and will include presentations from the first physicians to utilize the new spineEOS software. The physicians presenting in the symposium include:

  • Dr. Lawrence Lenke, New York Presbyterian/Columbia University Medical Center, New York
  • Dr. Salil Upasani, Rady Children’s Hospital, San Diego
  • Dr. Stefan Parent, Sainte Justine Hospital, Montréal
  • Dr. Brice Ilharreborde, Robert Debré Hospital, APHP, Paris

For more information, please visit www.eos-imaging.com.

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

About EOS imaging

EOS imaging designs, develops, and markets EOS®, an innovative medical imaging system dedicated to osteo-articular pathologies and orthopaedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States (FDA), Japan and the European Union (EC). The Group posted 2016 revenues of €30.8 million and employs 132 people at December 2016, including an R&D team of 43 engineers. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

Contacts

EOS imaging
Pierre Schwich, +33 (0)1 55 25 61 24
Chief Financial Officer
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Pierre Laurent / Valentine Brouchot, +33 (0)1 44 71 94 96
eosimaging@newcap.eu
or
Media Relations
Annie-Florence Loyer, +33 (0)1 44 71 00 12 / 6 88 20 35 59
or
The Ruth Group (US)
Press relations
Joanna Zimmerman, 646-536-7006
jzimmerman@theruthgroup.com

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NeuroSpine

Mainstay Medical Announces CEO Leadership Transition

September 5, 2017 OrthoSpineNews

Dublin – Ireland, 5 September 2017 – Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), announces that Mr. Jason Hannon will succeed Mr. Peter Crosby as Chief Executive Officer with effect from October 9, 2017.  Mr. Hannon’s appointment results from the Company’s succession planning associated with the retirement of Mr. Crosby at the end of October, 2017.  Mr. Hannon will also be appointed as a Director with effect from October 9, 2017.

Mr. Hannon most recently served as President and Chief Operating Officer of NuVasive (NASDAQ:NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions.  His prior roles at NuVasive, Inc. include Executive Vice President of International, Executive Vice President of Business Development and Strategy, and General Counsel. During his 12 year tenure at NuVasive, the company’s commercial presence was expanded globally to more than 40 countries and revenue grew from $61M to $962M.

Dr. Oern Stuge, Chairman of Mainstay commented: “Mainstay has made tremendous progress since the founding of the Company in 2008 under Mr. Crosby’s leadership, and as we move forward to the next phase we are delighted that Jason is joining as our new CEO. Jason’s broad medical device experience has spanned areas critical to the future success of Mainstay: commercialization of new products, penetration of new markets, product innovation, strategic and financial planning, raising capital, regulatory and clinical management and the building of a high-performance culture that will attract the most talented people to our company.”

Mr. Hannon said: “Mainstay has developed a strong foundation in its scientific, clinical and regulatory accomplishments to date. The dedicated team has done the pioneering work to establish a new market – ReActiv8 seeks to help the body repair itself rather than merely masking pain.  This has created the potential of bringing an entirely new option to people suffering from chronic back pain.  I am impressed by the work done to get to this point, and I look forward to working with the entire team to advance the mission.”  

In the period up to his retirement date, Mr. Crosby will act as Special Adviser to the new CEO, and will continue to work with the Company as a consultant up to the end of 2020.  He will also continue to act as a Director until the conclusion of the Company’s Annual General Meeting to be held on Friday, 22 September 2017, when he will retire as a Director.

Mr. Crosby led Mainstay in its development of ReActiv8 from concept to commercialization.  He was recruited as the Company’s first CEO in 2009 to build the Company and its team and to develop ReActiv8. Mr. Crosby led Mainstay through its Series A and Series B fundraisings to its IPO on Euronext Paris and the ESM of the Irish Stock Exchange in 2014, and its subsequent debt and equity fundraisings. In addition to fundraising, Mr. Crosby was a driving force in the development of ReActiv8 from concept stage through multiple clinical trials to CE Mark approval in 2016, start of the ReActiv8-B clinical trial to gather data for US approval, and first commercialization in Germany and Ireland in 2017.  Mr. Crosby said: “I am proud of what we have achieved as a team, and I am confident that the Company will be in good hands under Jason’s leadership. I look forward to remaining involved with the Company into the future, to ensure continuity with our employees, consultants and investigators.”

Dr. Stuge concluded: “On behalf of Mainstay’s Board, management team and staff, I would like to thank Peter for his substantial contribution to the Company’s growth over the last eight years. Peter’s tireless efforts in building the Company from start-up stage through multiple fundraisings, product development and clinical trials to initial commercialization has positioned the Company well for the future. We look forward to continuing to work with Peter into the future.”

ADDITIONAL INFORMATION:

Mr Hannon holds no interest in ordinary shares of Mainstay, and, other than as set out below, there is no further information to be disclosed under schedule 2(g) and Rule 17 of the ESM Rules in respect of Mr Hannon’s appointment to the board of Mainstay.

Mr Jason Marshall Hannon (aged 45) is, or has been, a director of the following companies during the previous five years:

Previous Directorships:

Nemaris, Inc.

This announcement contains inside information within the meaning of the EU Market Abuse Regulation 596/2014 

About Mainstay

Mainstay is a medical device company focused on bringing to market an innovative implantable restorative neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia and Germany, and its ordinary shares are admitted to trading on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About the ReActiv8-B Clinical Trial

The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham controlled blinded trial with one-way crossover conducted under an Investigational Device Exemption (IDE). The ReActiv8-B Clinical Trial is designed to generate data to form part of the Pre-Market Approval Application (PMAA) of ReActiv8 to the FDA. Further details can be found at https://clinicaltrials.gov/show/NCT02577354

About Chronic Low Back Pain

One of the recognized root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine in the low back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilization put a significant burden on individuals, families, communities, industry and governments.

Further information can be found at www.mainstay‑medical.com

CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.

 

PR and IR Enquiries:

Consilium Strategic Communications (international strategic communications – business and trade media)

Chris Gardner, Mary-Jane Elliott, Jessica Hodgson, Hendrik Thys

Tel: +44 203 709 5700 / +44 7921 697 654

Email: mainstaymedical@consilium-comms.com

 

FTI Consulting (for Ireland)

Jonathan Neilan
Tel: +353 1 765 0886

Email: jonathan.neilan@fticonsulting.com

NewCap (for France) 

Louis-Victor Delouvrier

Tel: +: +33 1 44 71 98 53

Email: lvdelouvrier@newcap.fr 

AndreasBohne.Com/Kötting Consulting (for Germany) 

Andreas Bohne

Tel : +49 2102 1485368

Email : abo@andreasbohne.com 

Investor Relations:

LifeSci Advisors, LLC

Brian Ritchie

Tel: +1 (212) 915-2578

Email: britchie@lifesciadvisors.com 

ESM Advisers:

Davy

Fergal Meegan or Barry Murphy

Tel: +353 1 679 6363

Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie

 

Forward looking statements

This announcement includes statements that are, or may be deemed to be, forward looking statements. These forward looking statements can be identified by the use of forward looking terminology, including the terms “anticipates”, “believes”, “estimates”, “expects”, “intends”, “may”, “plans”, “projects”, “should”, “will”, or “explore” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward looking statements include all matters that are not historical facts. They appear throughout this announcement and include, but are not limited to, statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, the Company’s results of operations, financial position, prospects, financing strategies, expectations for product design and development, regulatory applications and approvals, reimbursement arrangements, costs of sales and market penetration.

By their nature, forward looking statements involve risk and uncertainty because they relate to future events and circumstances. Forward looking statements are not guarantees of future performance and the actual results of the Company’s operations, and the development of its main product, the markets and the industry in which the Company operates, may differ materially from those described in, or suggested by, the forward looking statements contained in this announcement. In addition, even if the Company’s results of operations, financial position and growth, and the development of its main product and the markets and the industry in which the Company operates, are consistent with the forward looking statements contained in this announcement, those results or developments may not be indicative of results or developments in subsequent periods. A number of factors could cause results and developments of the Company to differ materially from those expressed or implied by the forward looking statements including, without limitation, the successful launch and commercialization of ReActiv8®, the progress and success of the ReActiv8-B Clinical Trial, general economic and business conditions, the global medical device market conditions, industry trends, competition, changes in law or regulation, changes in taxation regimes, the availability and cost of capital, the time required to commence and complete clinical trials, the time and process required to obtain regulatory approvals, currency fluctuations, changes in its business strategy, political and economic uncertainty. The forward-looking statements herein speak only at the date of this announcement.

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SpineTop Stories

ApiFix Signs Distribution Agreement in Canada; Completes First Cases in North America at IWK Health Centre Hospital, Halifax

September 5, 2017 OrthoSpineNews

ApiFix has invented and developed a non-fusion spinal implant system for the correction of Adolescent Idiopathic Scoliosis (AIS). The implant system is inserted in a minimally invasive surgical procedure. The ApiFix system aims to improve the quality of life of patients who undergo scoliosis surgery, save hospitalization and OR time, and substantially reduce costs and recovery time associated with standard scoliosis surgery. In contrast to standard scoliosis surgery, the ApiFix system represents a game-changer in the market, with a spinal implant system, inserted in a short procedure, followed by a brief recovery period, and maintains spine flexibility.

“With our vast experience in the spine surgical field, we instantly understood the significance of the device for scoliosis patients and its market potential. We are delighted to join forces with ApiFix and exclusively distribute their products in Canada,” stated Joint Solution Alliance President, Alan Tanner.

ApiFix CEO Eran Feldhay, M.D. remarked: “We are excited to begin our penetration in the North American markets with Canadian patients. We are convinced that together with JSA we’ll succeed in delivering the ApiFix solution to more patients around the world.”

About ApiFix

ApiFix is an innovation-driven medical device company focused on providing less invasive solutions for scoliosis patients. ApiFix’s leading product for non-fusion treatment of adolescent idiopathic scoliosis (AIS) is used today in Europe. ApiFix is led by a team of highly-regarded spine surgeons and veteran spine specialists. The company has CE clearance and is marketed in Germany, Italy, Greece, The Netherlands, Spain, Australia and Israel.

ApiFix Principals will be available to discuss the ApiFix system, clinical cases and their follow-up to potential spine surgeons from all over the world during the annual meeting of the Scoliosis Research Society, (SRS) in Philadelphia, USA on September 5-8.

Contact:
Saar Wollach, 
ApiFix Sales & Marketing Manager, 
+972-54-4511512,
saar@apifix.com

SOURCE ApiFix

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SpineTop Stories

joimax®, Inc. Opens Its First Education & Training Center in Irvine, California, Posts Record Sales in the US and Continues to Make Gains with Endoscopic Reimbursement

August 31, 2017 OrthoSpineNews

August 31, 2017

IRVINE, Calif.–(BUSINESS WIRE)–joimax® announces the grand opening of its new state-of-the-art Training    and Education Center in Irvine, California. The company will be holding its first workshop at the Center on       September 8-9th.

As the market leader in endoscopic spine surgery, joimax® is fully dedicated to outstanding physician education, training and services worldwide. Due to the newly released US CPT reimbursement code, valid since January 1st, 2017, the demand for joimax® endoscopic procedures are growing monthly in the USA among patients as well as the physician community. This fast growing demand creates major needs which joimax®, Inc. is addressing with fast expansion of its US organization.

“This new wet lab facility provides a major base for supporting our fast growing education needs for both our new sales and clinical associates, but moreover it’s a place for physicians to be trained,” states Bob Wolownik, National Director of Sales for joimax® Inc.

joimax® also announced that they are taking the lead in supporting this years’ workshops and educational sessions at:

SMISS Sept 14-16, 2017 – Las Vegas, NV
Sole Supporter of the Endoscopic Lab Session

ISASS Sept 22-23, 2017 – Long Beach, CA
Endoscopic Lab Supporter

NASS Oct. 25-28, 2017 – Orlando, FL
Endoscopic Spine Surgery Session Sponsor
and Endoscopic Lab Supporter

joimax® has also made significant strides in reimbursement support for endoscopic spine procedures via a new external coding support hotline that it manages along with a payor correspondence package. joimax’s Vice President of Operations & Reimbursement, Brian Schneider, recently stated, “We have seen a significant rise in interest from both payors and physicians asking to receive information and streamline communication regarding the new endoscopic spine code.”

“As we received a first CPT reimbursement code for endoscopic spine surgery earlier this year and now invest wisely for future growth, joimax® will continue to write a major success story in the US, similar to what it has accomplished in Europe and Asia,” states Maximilian Ries, General Manager for joimax®, Inc. He announced that the company is continuing to post record sales by nearly doubling its year to date US revenues, which is in line with the company’s budget plan.

Overall joimax® is very pleased with the great strides achieved in the US market and sees continued sustainable growth globally. “All this is an important step towards the full acceptance of endoscopic minimally invasive spine surgery techniques and their benefits to both the physician and their patients in the US now as well,” echoes Wolfgang Ries, Founder and CEO of joimax®.

The company’s European and Asian sales also show record numbers. Earlier this year, joimax® also received multiple new product registrations in Asia and recently in Brazil to fully access this new market.

About joimax®

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

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

Contacts

Press contact USA:
joimax® Inc.
Melissa Brumley, +1 949 859 3472
Melissa.brumley@joimaxusa.com
or
Press contact Int.:
joimax® GmbH
Sabine Jarosch, +49 721 25514, ext.213
sabine.jarosch@joimax.com

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