The Global Shoulder Arthroplasty Market is expected to reach $ 1,866.3 million by 2023

Posted On December 28, 2017 By OrthoSpineNews In Recon, Top Stories /

NEW YORK, Dec. 28, 2017 /PRNewswire/ — The Global Shoulder Arthroplasty Market was valued at $ 1,090.0 million in 2016, and is expected to reach $ 1,866.3 million by 2023, registering a CAGR of 8.1% during the forecast period. The growth of the global shoulder arthroplasty market is driven due to factors such as increasing incidences of arthritis-associated disorders such as osteoarthritis and rheumatoid arthritis, and growing geriatric population. Also, significant adoption of reverse shoulder arthroplasty by surgeons and growing sports-related injuries have further contributed to the growth of the market. Nevertheless, postoperative complications associated with shoulder arthroplasties and the cost associated with the shoulder arthroplasty devices is the factors that would limit the growth of the market.

Read the full report: https://www.reportlinker.com/p05258049

The shoulder arthroplasty market is segmented based on procedures, devices, indications, end users, and regions. Based on procedures, the market is segmented into partial shoulder arthroplasty, total shoulder arthroplasty, and revision shoulder arthroplasty. Based on devices, the market is segmented into shoulder arthroplasty resurfacing implants, shoulder arthroplasty trauma devices, and shoulder arthroplasty platform systems. Based on indications, the market is segmented into arthritis, fracture/dislocation, rotator cuff tear arthropathy, Hill Sachs defect, and others. Based on end users, the market is segmented into hospitals & clinics and outpatient surgical centers. Based on geography, the market is segmented into North America, Europe, Asia-Pacific, and LAMEA.

The market research report covers the analysis of key stake holders of the leading market participants are Integra LifeSciences Corporation, DJO Global, Zimmer Biomet, Wright Medical Group, Inc. /Tornier Inc., Johnson & Johnson (DePuy Synthes), Smith and Nephew Plc, Arthrex, Inc., Conmed Corporation, Evolutis, and Exactech, Inc.

Read the full report: https://www.reportlinker.com/p05258049

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Hartford HealthCare Pioneers Robotic-Assisted Spine Surgery

Posted On December 22, 2017 By OrthoSpineNews In Robotics, Spine, Top Stories /

HARTFORD, Conn., Dec. 22, 2017 /PRNewswire/ — Hartford HealthCare (HHC) has pioneered a new, advanced technology at The Hospital of Central Connecticut, which is the first hospital in all of New England to use the new Globus ExcelsiusGPS™, a sophisticated surgical guidance system for spine procedures. The new technology also will soon be available at Backus Hospital.

The ExcelsiusGPS™ brings an even greater level of precision to surgeons performing spine surgery and the patients they serve. The ExcelsiusGPS™ system is the first robotic assisted navigation system that is used by surgeons during the procedure, in real time. It is designed specifically to make surgery safer, and help surgeons ensure implants and hardware placement is even more precise. The technology also enables minimally invasive spine procedures which are often linked to less blood loss, less muscle damage, and a faster recovery.

“We are innovators at Hartford HealthCare, and we have a long history of bringing the latest and most valuable technology to the patients and communities we serve,” said Jeffrey Flaks, Hartford HealthCare President and Chief Operating Officer. “We believe technology is a true partner in care — enabling our talented experts to improve outcomes, enhance quality and deliver an exceptional experience for our patients. This is a fitting next step as we continue to pioneer guidance technology in healthcare.”

Hartford HealthCare is a leader in robotic-assisted surgery, with an extensive surgical robotics program, which is aimed at improving patient outcomes and improving the quality of care. Hartford HealthCare has been using the da Vinci® Surgical System for several years, combining the latest in minimally invasive surgical and robotics technologies to perform successful complex as well as routine surgeries. In March, Hartford HealthCare became the first healthcare system in the state of Connecticut and throughout the Northeast to debut Mazor X robotic-assisted surgical guidance system.

About Hartford HealthCare. Hartford HealthCare is Connecticut’s most comprehensive health care network. Our fully integrated health system includes a tertiary-care teaching hospital, an acute-care community teaching hospital, an acute-care hospital and trauma center, two community hospitals, the state’s most extensive behavioral health services network, a large primary care physician practice group, a regional home care system, an array of senior care services, a coordinated cancer institute with five cancer centers, and a large physical therapy rehabilitation network. Visit us at www.hartfordhealthcare.org.

SOURCE Hartford HealthCare

Centinel Spine Completes Acquisition of Prodisc Assets

Posted On December 22, 2017 By OrthoSpineNews In Spine, Top Stories /

NEW YORK, Dec. 22, 2017 /PRNewswire/ — Centinel Spine, LLC (CS) is pleased to announce the acquisition of the worldwide assets of the prodisc® Total Disc Replacement portfolio from DePuy Synthes Products, Inc. The prodisc line of products are total disc replacement (TDR) products with the longest history of use globally. The prodisc® portfolio includes prodisc® C and prodisc® L in the United States and prodisc® VIVO, prodisc® NOVA, prodisc® C, prodisc® L, and prodisc® O, along with DISCOVER™ Cervical outside the United States.

This acquisition complements Centinel Spine’s existing spinal implant portfolio of leading technologies for anterior column support of the spine from cervical to lumbar. This includes the company’s standalone portfolio of STALIF C®, STALIF C-Ti™, MIDLINE II™, MIDLINE II-Ti™, and STALIF L™, as well as additional products ACTILIF™ Cervical Cage TRANSOM™ Plate, and ALTOS® PCT.

Centinel Spine, the pioneer of the No-Profile®, Integrated Interbody™ has a 30 year history of developing integrated interbody devices into a standard treatment for patients with degenerated disc disease. Centinel Spine will utilize the same clinical, regulatory, and development expertise to broaden acceptance and to increase carrier coverage and surgeon adoption of total discs worldwide.

“This transaction is the next step in the evolution of Centinel Spine executing on its mission to become the worldwide leading company addressing spinal disease through anterior access to the spine with the widest breadth and depth of technology platforms,” said John J. Viscogliosi, Centinel Spine Chairman & CEO.

For background in understanding the acquisition, Viscogliosi Brothers, LLC, a lead investor in Centinel Spine, was the founder of Spine Solutions, Inc., the company that led the original IDE study to bring prodisc to the United States.

The company also completed debt and equity financing to close on the transaction and provide working capital. Piper Jaffray & Co. served as the sole placement agent for Centinel Spine.

About Centinel Spine, LLC.

Centinel Spine, LLC. is a privately-held spinal device company leading the development and commercialization of the No- Profile, Integrated Interbody fusion technologies. For more information on Centinel Spine products and technologies, please visit the Company’s web site at www.CentinelSpine.com.

The company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica LLC and Surgicraft LTD. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies and continues its corporate mission of becoming the leading anterior column support spine franchise, providing elegantly simple implants and instruments that are tissue-sparing and generate superior clinical outcomes.

Centinel Spine derived its name from the “Sentinel Sign” – the radiographic confirmation of a successful fusion anterior to the interbody device.

For more information, please contact:

Varun Gandhi	Wendy F. DiCicco
SVP, Corporate Finance & Strategic Planning	Chief Operating and Chief Financial Officer
Centinel Spine, LLC	Centinel Spine, LLC
900 Airport Road, Suite 3B	900 Airport Road, Suite 3B
West Chester, PA 19380	West Chester, PA 19380
Phone: 484-887-8871	Phone: 484-887-8837
Email: v.gandhi@centinelspine.com	Email: w.dicicco@centinelspine.com

SOURCE Centinel Spine, Inc.

Paragon 28® launches the Gorilla® Lateral Column Plating System designed to address the cuboid and lateral column in cases of Charcot deformity

Posted On December 22, 2017 By OrthoSpineNews In Extremities, Top Stories /

ENGLEWOOD, Colo., Dec. 22, 2017 /PRNewswire/ — Since its inception, Paragon 28® has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28® has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefitting both the surgeon and patient.

The Gorilla® Lateral Column Plating System was developed to offer surgeons a dedicated plating system designed to aid in the stabilization, fusion and fixation of the lateral column. This construct allows for strength, stability and compression throughout the lateral column which can help address certain cases of Charcot reconstruction where plantar subluxation of the cuboid may result in ulceration. This plate and screw construct consists of a dorsal plate placed on the 4^th metatarsal, 5^th metatarsal and cuboid that can accept a 5.5 mm Type II Anodized, non-locking, solid plate screw. This screw interfaces with the plate and is intended to span from the space between the 4^th and 5^th metatarsals, through the cuboid and into the posterior aspect of the calcaneus.

The Gorilla® Lateral Column Plating System contains system specific instrumentation to help facilitate insertion of the 5.5 mm solid plate screw as well as a unique templating system. This templating system not only aids in determining the correct size and location of the plate, but more importantly aids in the creation of a reamed space in a specific location between the 4^th and 5^th metatarsals. A Joint Finding Paddle is included and is intended to center the template allowing for equal reaming of the 4^th and 5^th metatarsals to allow room for the 5.5 mm solid plate screw to be placed and achieve optimal screw trajectory.

This addition to the Gorilla® R3CON Plating System family leverages all the benefits of the Gorilla System including the ability for all of the standard plate holes to accept either 2.7 mm, 3.5 mm or 4.2 mm locking and non-locking plate screws as well as a robust assortment of foot and ankle specific instrumentation.

Paragon 28® is grateful for the significant contributions Dr. Douglas Blacklidge, DPM has made as the surgeon designer of this system.

CONTACT:
Jim Edson
Director of Product Management and Marketing
jedson@paragon28.com

SOURCE Paragon 28

Histogenics Corporation and MEDINET Co., Ltd Enter Into Licensing Agreement for Development and Commercialization of NeoCart for the Japanese Market

Posted On December 22, 2017 By OrthoSpineNews In Biologics, Top Stories /

WALTHAM, Mass., Dec. 21, 2017 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, announced that it has entered into an agreement with MEDINET Co., Ltd. (MEDINET), a pioneering leader in the development and commercialization of cancer immuno-cell therapy technologies, for the development and commercialization of NeoCart^® for the Japanese market.

“This transformative collaboration for Histogenics is a clear validation of the value NeoCart potentially provides to the physicians and patients who suffer from painful cartilage defects and related loss of function. MEDINET is one of the leaders of the burgeoning regenerative medicine sector in Japan, with strong capabilities in development and manufacturing of cell therapy products. We believe their recent initiatives to further develop their therapeutic capabilities with the addition of innovative products such as NeoCart will provide a rapid entry into the Japanese market,” stated Adam Gridley, President and Chief Executive Officer of Histogenics. “Our ability to leverage our long clinical and translational medicine history in the U.S. in markets such as Japan was a first step in bringing NeoCart to other regions, and we look forward to expanding our global presence more broadly in 2018 into other potential territories in Asia and Europe.”

Histogenics’ formal consultations with the Office of Cellular and Tissue-based Products of the Japan Pharmaceuticals and Medical Devices Agency (the PMDA) concluded in the second quarter of 2017 and the positive conclusion of those consultations played an integral role in enabling this collaboration. Formal feedback from the PMDA regarding the development and approval pathway for NeoCart in Japan included:

A 30-patient, one-year confirmatory clinical trial in Japanese patients, comparing NeoCart to microfracture, would be sufficient for applying for full Marketing and Manufacturing Authorization in Japan in conjunction with data from Histogenics’ fully enrolled U.S. Phase 3 clinical trial.
NeoCart would be regulated as a Regenerative Medical Product, as covered by the recently enacted laws in Japan, and Histogenics can supply the confirmatory clinical trial from the U.S. using the current good manufacturing process (cGMP) for NeoCart.

“I am excited about the potential to bring this exciting therapy to Japanese patients and physicians through this new partnership,” stated Dr. Shuichi Mizuno, Ph.D., a scientific founder of NeoCart, Assistant Professor, Orthopedic Surgery, Brigham and Women’s Hospital, and Harvard Medical School, in whose laboratory the underlying technology for NeoCart was discovered.

Japanese Cartilage Repair Market

The Japanese cartilage repair market is estimated to be the second largest market in the world after the U.S. and it is estimated that there may be at least 10,000 NeoCart treatments per year. If left untreated, cartilage defects may result in Osteoarthritis (OA) and ultimately, total knee replacements. Market forecasts predict that the number of OA patients in Japan aged 40 and older amounts to more than 25 million and is expected to accelerate as the population ages.

In the first half of 2017, Histogenics conducted market research in Japan with approximately 80 leading surgeons with the findings summarized below:

Approximately 60% of patients with knee cartilage defects are either not treated, or treated solely for temporary pain relief.
Approximately 60-70% of patients with knee cartilage defects that are left untreated will likely progress to OA in the knee.
Cartilage defects are believed to have caused OA in 15-20% of patients suffering from knee OA.
More than 85% of orthopedic surgeons are not satisfied with the current options to treat knee cartilage defects.
Approximately 80% of orthopedic surgeons consider early improvement in pain and function to be important and more than half of the surgeons feel they would prescribe NeoCart based on published data.

“This licensing deal has been realized based on our longtime close relationship with Histogenics. I am excited about and proud of, the big challenge to enter into the regenerative medical product market with NeoCart in collaboration with the excellent team of Histogenics,” stated Yoshiji Kimura, Chief Executive Officer of MEDINET. “We believe this restorative cell therapy will contribute to better treatment by the physicians and quality life, of the patients with knee cartilage defects in Japan.”

Locust Walk served as transaction advisor to Histogenics.

Conference Call and Webcast Information

Histogenics’ management will host a conference call on Thursday, December 21, 2017 at 9:00 a.m. ET. A question-and-answer session will follow Histogenics’ remarks. To participate on the live call, please dial 877-930-8064 (domestic) or 253-336-8040 (international) and provide the conference ID: 5982636 five to ten minutes before the start of the call.

A live audio webcast of the presentation will be available via the “Investor Relations” page of the Histogenics website, www.histogenics.com, or by clicking here. A replay of the webcast will be archived on Histogenics’ website for approximately 45 days following the presentation.

About Histogenics Corporation

Histogenics (Nasdaq:HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function. Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis. NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use. Histogenics recently completed enrollment of its NeoCart Phase 3 clinical trial and expects to report top-line, one-year superiority data in the third quarter of 2018. NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications. For more information on Histogenics and NeoCart, please visit www.histogenics.com.

About MEDINET Co., Ltd.

MEDINET is a pioneering leader in the development and commercialization of cancer immuno-cell therapies. MEDINET is also rigorously preparing to enter into the regenerative medical product market to leverage its long clinical and translational medicine history responding to the expected aging of the population. MEDINET went public in October, 2003 on the MOTHERS, Tokyo Stock Exchange. For more information, visit http://www.medinet-inc.co.jp/english/.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others: the timing and success of Histogenics’ NeoCart Phase 3 clinical trial, including, without limitation, possible delays in generating the data from the clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; NeoCart’s regulation as a Regenerative Medical Product; the market size and potential patient population in Japan; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

K2M Introduces World’s First 3D-Printed Expandable Corpectomy Cage with Cervical Spine Indications Following CE Mark of CAPRI® Cervical 3D Expandable Featuring Lamellar 3D Titanium Technology™

Posted On December 21, 2017 By OrthoSpineNews In Spine, Top Stories /

LEESBURG, Va., Dec. 20, 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 received a CE Mark for its CAPRI^® Cervical 3D Expandable Corpectomy Cage System* featuring Lamellar 3D Titanium Technology™, and the successful completion of its first surgical case. CAPRI Cervical 3D Expandable is the world’s first and only 3D-printed expandable device on the market to facilitate continuous in-situ height expansion and endplate angulation in the cervical spine. K2M was the first leading spine company to introduce a 3D-printed spinal implant and offers the most comprehensive portfolio of 3D-printed spinal devices on the market.

The CAPRI Cervical 3D Expandable Cage System* stabilizes the cervical spine in cases of vertebral body resections resulting from trauma or tumor. Offered in various footprint options, its continuous in-situ adjustment capabilities allow surgeons to lock the cage with set screws at desired heights and lordotic angles within the expansion range of the implant. The system also allows for fixed endplate angulation of 0°, 5°, and 10° to accommodate surgeon preference and vertebral anatomy.

“Never before has a cervical corpectomy cage combined the capabilities of 3D printing with the functionality of continuous in-situ height and lordotic adjustment,” said Lars Valentin, MD, of Rigshospitalet in Denmark. “Using the CAPRI Cervical 3D Expandable Corpectomy Cage,” explained Martin Gehrchen, MD, PhD, chief of spine surgery at Rigshospitalet in Denmark, “we were able to dial in a precise height and lordotic angle in-situ while also utilizing a 3D-printed device designed to allow for bony integration.”

K2M’s Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques. Starting with a titanium powder, the CAPRI Cervical 3D Expandable Corpectomy Cages are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and rough surface architecture that pre-clinical data have associated with bone growth activity. Lamellar 3D Titanium Technology incorporates a porous structure along with rough surfaces to allow the potential for bony integration throughout the cage.

K2M Chairman, President, and CEO Eric Major said, “We are pleased to receive a CE Mark for our CAPRI Cervical 3D Expandable Cage System*, which reinforces our commitment to excellence in 3D-printed spinal innovation and the further integration of expandable technologies across our comprehensive complex spine, minimally invasive, and degenerative product portfolios. We look forward to further strengthening our market-leading portfolio of 3D-printed spinal devices that, when supported by our comprehensive Balance ACS platform, help surgeons facilitate three-dimensional spinal balance in their patients.”

Balance ACS^® or (BACS^®) is a comprehensive platform applying three-dimensional solutions across the entire clinical care continuum to help drive quality outcomes in spine patients. BACS provides solutions to help surgeons achieve balance of 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.

For more information on the CAPRI Cervical 3D Expandable Corpectomy Cage System* and K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.

*This product is intended for export and is not sold or offered for sale in the United States.

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 and retain their use of our products; pricing pressures and our ability to compete effectively generally in our industry; 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 to our corporate headquarters and operations facilities or critical information technology systems, distributors or surgeon users; 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 price; 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

LivaNova Names ECA Medical Instruments 2017 Supplier of the Year Award Winner

Posted On December 20, 2017 By OrthoSpineNews In Spine, Top Stories /

December 20, 2018

Thousand Oaks, CA. — ECA Medical Instruments, the leading global designer and manufacturer of single-procedure torque-limiting instruments and procedural kits for the medical industry, was named LivaNova 2017 Supplier of the Year Award winner. ECA was one of just 3 strategic partner firms out of 300 LivaNova suppliers worldwide to win the prestigious award.

“We have the pleasure to recognize ECA Medical Instruments as the LivaNova 2017 Supplier of the Year,” said Pascal Chaussepied, Purchasing Director, CRM and Neuro. “This award honors ECA’s overall performance in areas including quality, logistics, cost and customer service and support. Supplier performance is fundamental to LivaNova’s success to remain competitive within the challenging CRM market and global environment. We congratulate the ECA team and its management for the continuous outstanding level of performance,” he said.

ECA designs and manufactures a variety of precision single-use torque-limiting instruments used by surgeons to secure delicate electrodes and leads that connect LivaNova pacemakers and defibrillators to the heart. ECA’s instruments also secure electrodes to LivaNova’s Vagus Nerve neuromodulation devices used to treat people affected by treatment-resistant epilepsy, depression, heart failure and other disorders. ECA’s instruments are single-use meaning a pristine instrument is used for each mission critical implant and for each patient.

“This is a tremendous honor for ECA and our global team of medical device employees, who are dedicated to providing LivaNova with pristine single-procedure instrumentation. ECA has been successfully supporting LivaNova across multiple life sustaining product lines for many years,” said Lane Hale, President and CEO of ECA Medical Instruments.

“Winning the LivaNova 2017 Supplier of the Year Award underscores our commitment to providing single-procedure instrumentation that offers clinical and economic value. We are always striving with our customers and partners to jointly improve the quality of people’s lives—one instrument, one patient at a time,” he said.

Single-procedure torque-limiting instruments and procedural kits provide surgeons and patients alike with a pristine set of surgery ready instruments for addressing a wide range of procedures. Sustained benefits include elimination of reprocessing costs, improved OR efficiency, reduced risk of surgical site infection, and reduction in hospital and outpatient surgery center inventory management.

ECA is a one-stop shop OEM instrument company providing medical device implant firms with complete product design and development, product and packaging validations, CE Mark and dock to stock operations. This reduces OEM costs and accelerates time to market.

About ECA Medical Instruments
ECA Medical Instruments®, headquartered in Thousand Oaks, CA., is the industry leader in designing and manufacturing precision single-procedure torque-limiting instruments and surgical fixation kits. Founded in 1979, the company has delivered over 35 million torque limiting instruments and procedural kits to the world’s leading cardio, neuromodulation, orthopaedic and spine implant companies. Every 15 seconds of every day an ECA torque
instrument or procedural kit is used to secure a medical implant—One Instrument, One Patient at a Time™. ECA, a LongueVue Capital Partners company, is an ISO 13485, CE Mark certified and FDA registered firm and was named Business of the Year 2017 by LivaNova and earned the LivaNova 2017 Supplier Excellence Award. www.ecamedical.com

About LivaNova
LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London and with a presence in more than 100 countries worldwide, the company employs more
than 4,500 employees. LivaNova operates as three business franchises: Cardiac Surgery, Neuromodulation and Cardiac Rhythm Management, with operating headquarters in Mirandola (Italy), Houston (U.S.A.) and Clamart (France), respectively. For more information, please visit www.livanova.com.

Media Contact: James Schultz, EVP Sales & Marketing Phone: +1 805-990-6177 Email: jschultz@ecamedical.com

SpineGuard: 60,000 Spine Surgeries Performed with PediGuard® and DSG™ Devices

Posted On December 20, 2017 By OrthoSpineNews In Spine, Top Stories /

December 19, 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 that 60,000 spine procedures have been performed using its family of PediGuard and Dynamic Surgical Guidance (DSG™) equipped devices for accurate pedicle screw placement.

The PediGuard product line includes the PediGuard Straight, PediGuard Curved, PediGuard Cannulated and PediGuard Threaded each of them matching specific clinical needs and adapted to surgeons preferences in the OR. DSG is also integrated into the Z-Direct screw system (partnership with Zavation) and G2S screw system (partnership with Neuro France Implants), which enables single-step insertion of pedicle screws.

“This significant milestone is the clear demonstration of the robustness and clinical value of our DSG™ technology that helps to make spine surgeries safer. It also reinforces our confidence in reaching our announced goal of operational breakeven by the end of 2018. Beyond our existing products, we also have exciting DSG applications in our R&D pipeline for surgical robots in spine and visual feedback, as an enhancement to audio feedback, that will come into fruition in 2018” concludes Stéphane Bette, CEO and co-founder of SpineGuard.”

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

About SpineGuard®
Founded in 2009 in France and the USA, by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 60,000 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

IMPLANET fully paid off the Kreos bond loan

Posted On December 20, 2017 By OrthoSpineNews In Financial, Top Stories /

December 19, 2017

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

IMPLANET (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, announces that it has paid off the bond loan taken out with Kreos Capital IV (UK) Ltd. in 2013.

On July 19, 2013, IMPLANET had signed a venture loan agreement with Kreos Capital IV (UK) Ltd. for the underwriting of a €5 million bond loan. As well as the loan itself, the contract foresaw the pledging of the Company’s business and intellectual property (IP).

David Dieumegard, CFO of IMPLANET says: “We are satisfied that this loan has now been entirely repaid, allowing IMPLANET to obtain the lifting of the pledges, including on its IP. Therefore, the reimbursement (principal and interest) of this loan in 2017 representing €1.1 million, IMPLANET should reduce its cash burn by the same amount.”

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. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

Contacts

IMPLANET
Ludovic Lastennet, +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot, +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, +1-917-385-2160
implanet@alphabronze.net

Zimmer Biomet Announces Appointment of Bryan C. Hanson as President and Chief Executive Officer

Posted On December 19, 2017 By OrthoSpineNews In Recon, Top Stories /

WARSAW, Ind., Dec. 19, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that Bryan C. Hanson has been appointed President and Chief Executive Officer and a member of the Board of Directors, effective today. Daniel P. Florin, who has served as Interim CEO since July 11, 2017, will continue in his role as Senior Vice President and Chief Financial Officer.

Larry C. Glasscock, Chairman of the Zimmer Biomet Board of Directors, stated, “On behalf of the Board, I am thrilled to welcome Bryan to the Zimmer Biomet team. The Board of Directors, with the assistance of a leading executive search firm, carefully identified, evaluated and interviewed a number of highly-qualified candidates and concluded that Bryan is the best fit to lead the Company. Bryan is a proven executive with a track record of successfully leading, growing and transforming global medical device businesses to achieve higher levels of innovation, commercial success and profitability. This leadership announcement comes at an important time in Zimmer Biomet’s history, and we look forward to working closely with Bryan to further leverage our leading portfolio of technologies, solutions and personalized services to enhance stockholder value.”

Mr. Hanson joins Zimmer Biomet with more than 20 years of experience in the medical device industry. Most recently, he served as a member of Medtronic’s Executive Committee and as the Executive Vice President and President of Medtronic’s Minimally Invasive Therapies Group, where he oversaw and provided strategic direction to this approximately $9 billion business. Prior to Medtronic, Mr. Hanson served in a number of executive roles of increasing responsibility. In 2013, he was named Group President of Covidien’s Medical Devices business. In 2011, as Surgical Solutions Group President, Mr. Hanson transformed two of Covidien’s largest divisions—Energy-based Devices and Surgical Devices—into one global business unit. Mr. Hanson also serves on the board of AmeriCares, an emergency response and global health organization committed to saving lives and building healthier futures for people in crisis.

Mr. Hanson stated, “I am honored and excited to join the talented team at Zimmer Biomet. I have long admired Zimmer Biomet, including its strong brand, commercial excellence and market-leading salesforce, healthy portfolio of marquee products and strong innovation pipeline. I share the Company’s purpose of improving the quality of life for patients and I look forward to deeply familiarizing myself with Zimmer Biomet’s global operations to ensure we have the right foundation in place to support our customers and the patients they serve around the world, while driving sustained shareholder value.”

Mr. Florin commented, “It has been a privilege to lead the Zimmer Biomet organization as Interim CEO. I join the rest of the management team in welcoming Bryan, and I am confident the Company will thrive under his leadership.”

Mr. Glasscock added, “On behalf of everyone at Zimmer Biomet, I want to thank Dan for serving as the Company’s Interim CEO for the past five months. We are grateful that Dan assumed this role at such an important time, and we look forward to continuing to benefit from his expertise through his ongoing service as CFO.”

About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements
This release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC. Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers of this release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this release.

ZBH-Corp

SOURCE Zimmer Biomet Holdings, Inc.