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First Porous PEEK Spinal Implant Clinical Study Validates NuVasive Advanced Materials Science Technology In Treating Degenerative Cervical Disc Disease

Posted On June 22, 2018 By OrthoSpineNews In Spine /  

SAN DIEGO, June 20, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the results of the study “Early Outcomes of Anterior Cervical Discectomy and Fusion Using Porous PEEK™ Interbody Fusion Device,” published online in the Journal of Spine & Neurosurgery, which concludes that NuVasive patented porous polyetheretherketone (PEEK) technology is a clinically viable alternative for improving osseointegration and fusion rates of interbody implants to treat degenerative cervical disc disease.1

In the study, 50 patients (31 women and 19 men) with an average age of 60 with degenerative cervical disc disease underwent anterior cervical discectomy and fusion using a Cohere® cervical interbody fusion device from NuVasive—with 100 percent of participants experiencing positive results.

Cohere provides a unique three-dimensional Porous PEEK architecture to help elicit and encourage bone ingrowth without compromising implant strength. NuVasive incorporated the technology, which had been validated with 10 years of scientific research, into its portfolio with its acquisition of Vertera Spine in September 2017.

“This interbody fusion device with Porous PEEK surface technology provided improved osseointegration and supported spinal fusion in single level and multi-level cervical fusions,” said Dr. J. Kenneth Burkus of the Hughston Clinic in Columbus, Ga. “Twelve-month clinical outcomes have demonstrated the efficacy and stability of the Cohere Porous PEEK interbody device and shown that it is a clinically viable implant alternative for achieving successful clinical and radiological outcomes in cervical spine fusion surgery, particularly in multi-level or revision surgeries where fusion rates are lower.”

During the course of the clinical study, there were 11 1-level, 23 2-level and 16 3-level fusions between C3 and C7. Patients came from all walks of life and with various comorbidities. Thirteen of them had previously had an unsuccessful anterior cervical fusion procedure. It is notable that all patients who had revision surgery with Cohere achieved fusion six months after the surgery.

At 12 months post-operative ACDF surgery, all 50 patients demonstrated improved motion, decreased neck pain and average disc height increased by more than 4 mm. In addition, each of them showed radiographic fusion.

“NuVasive is the only company in the industry able to offer Porous PEEK technology so that surgeons can deliver life-changing clinical outcomes,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “The fact that all 50 patients in the clinical study experienced fusion is a testament to the enhanced osseointegration as well as biomechanical and imaging properties of Cohere and Porous PEEK technology, the entire NuVasive Advanced Materials Science™ portfolio, which also includes Modulus® titanium interbody implants, represents the future of porous implant technologies.”

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

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

1 Burkus, J. (2018). Early outcomes of anterior cervical discectomy and fusion using porous PEEK interbody fusion device. Journal of Spine & Neurosurgery. Doi: 10.4172/2325-9701.1000295

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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WishBone Medical, Inc. announces Randal R. Betz, M.D. as Chief Medical Officer

Posted On June 20, 2018 By OrthoSpineNews In Spine /  

WARSAW, Ind., June 20, 2018 (GLOBE NEWSWIRE) — WishBone Medical, Inc. is pleased to announce the appointment of Randal R. Betz, M.D. as Chief Medical Officer. Dr. Betz, on a part time consulting basis, will provide strategic expertise and guidance for the company’s product portfolio, support professional education and help with key opinion leader relationships consistent with WishBone Medical’s objectives.

Dr. Betz earned a Medical Degree from Temple University School of Medicine. His internship in general surgery and residency in orthopaedics was at Temple University Hospital. Dr. Betz’s fellowship in Pediatric Orthopaedics was at the Alfred I duPont Institute. He is a Pediatric Orthopedic Surgeon with a focus on Pediatric Deformity Correction.

He formerly was Chief of Staff at Shriners Hospitals for Children in Philadelphia. His current positions include a Private Practice at the Institute for Spine and Scoliosis in Lawrenceville, NJ, Clinical Professor at Mount Sinai Medical Center in New York City and Attending Surgeon at Mount Sinai Hospital in New York City and Saint Peter’s Children’s University Hospitals in New Brunswick, NY.

Research and product development is important to Dr. Betz. He has 17 patents. He belongs to several national and international professional societies. He has published 5 books, authored many medical texts and books; including 52 chapters for medical books and written 330 peer-reviewed articles.

Nick Deeter, Chairman of the Board and CEO at WishBone Medical, said, “We look forward to working with Dr. Betz on pediatric orthopedic products designed just for kids. He is well known and respected for his pediatric orthopedic expertise around the world.” Mr. Deeter added, “With his extensive background and experience, he will help build our surgeon teams and focus our strategic direction on helping children globally with orthopedic issues.”

About WishBone Medical, Inc.

WishBone Medical is a Global pediatric orthopedic company, committed to providing anatomically appropriate innovative implants and instruments in sterile packed, single use, disposable kits to prevent infection, reduce overall costs for our customers and achieve the best outcomes for children around the world who are still growing

For further information, visit WishBoneMedical.com or call Andrew Miclot, Vice-Chairman and President at 574-306-4006.

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Zavation Medical Products Announces Brian K. Hutchison as Newest Member of its Board of Directors

Posted On June 20, 2018 By OrthoSpineNews In Spine, Top Stories /  

JACKSON, Miss., June 20, 2018 /PRNewswire/ — Zavation Medical Products (“Zavation” or “the Company”), a LongueVue Capital Partners (“LVC”) portfolio company that designs and manufacturers high-quality spinal implants, instruments, and biologics, announced today that Brian K. Hutchison has joined its Board of Directors.

Zavation Chairman and LVC Managing Partner Rick Rees stated, “My colleagues and I are excited to welcome Brian to the Zavation family. His extensive relationships and leadership experience building orthopedic and spine businesses, first at Stryker and then as CEO of RTI Surgical, will be an invaluable resource to our team. Ultimately, his relationships are a testament to his character, which makes him a great addition to the Board of Directors. We look forward to benefiting from his accomplished career within the orthopedics and spine industry.”

“Brian has been in our shoes before and will serve as a valuable strategic resource as Zavation continues to grow,” said Jeffrey Johnson, Founder and CEO of Zavation. “But, more importantly, Brian is a cultural fit who shares our vision and understands that our priority is providing excellent customer service and quality products.”

Hutchison added, “I am delighted to join Zavation, a high growth and innovative spine company with a full-bag of products. I’ve admired Jeffrey and his team for many years, as they’ve managed remarkable growth without sacrificing customer service. I look forward to supplementing the team to further accelerate the Company’s growth trajectory.”

Hutchison brings 30 years of healthcare industry experience with him to Zavation. Most recently, Hutchison retired after serving 15 years as the Chief Executive Officer of RTI Surgical, Inc. (NASDAQ: RTIX). At RTI Surgical, he grew annual revenue from $55 million to $300 million, positioning the company as a leader in advanced biologic products. As CEO, Hutchison successfully merged RTI Surgical with Tutogen Medical in 2013 and subsequently acquired Pioneer Surgical Technologies. From 2014 to 2016, RTI Surgical was recognized as one of the fastest-growing spine companies in the world, with nearly 20% quarter-over-quarter growth.

Before RTI Surgical, Hutchison held various positions at Stryker Corporation, including serving as President of its Medical Division and Vice President of Worldwide Product Development and Distribution.

Hutchison currently serves on the Board of Directors of the University of Florida Research Foundation. He received a BBA with a focus in Accounting from Grand Valley State University in 1981 and attended Harvard Business School’s Program for Management Development in 1995.

ABOUT ZAVATION MEDICAL PRODUCTS

Based in Jackson, MS, Zavation designs, engineers, and manufactures a portfolio of spinal hardware covering key areas including thoracolumbar, cervical, interbody fusion, minimally invasive surgery, and vertebral compression fractures. Founded in 2010 with its first sale in 2012, the Company has experienced exceptional growth and created a national network of over 200 distributors across approximately 40 states. Zavation has commercialized over 12 product families since inception, with 10 additional novel products expected to launch over the next year. The Company operates a 24,000 square foot vertically integrated manufacturing facility with 70 employees.

To learn more information about Zavation and its products, visit www.zavation.com

ABOUT LONGUEVUE CAPITAL

LongueVue Capital is a private equity firm focused on making situation-driven, value-oriented investments in lower middle market companies (up to $150 million in annual revenue) to support buy-outs, recapitalizations, acquisitions, and growth. LVC currently has $425 million under management across two funds. Since its formation in 2001, LVC has made successful investments in a wide variety of industries, including healthcare, business services, transportation and logistics, energy services, and niche manufacturing. LVC is based in New Orleans with additional offices in New York and Salt Lake City. For more information, please visit www.lvcpartners.com.

SOURCE LongueVue Capital Partners

Related Links

http://www.lvcpartners.com

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OrthoPediatrics Corp. Announces First RESPONSE Spine Surgery

Posted On June 19, 2018 By OrthoSpineNews In Spine /  

WARSAW, Ind., June 18, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, is pleased to announce the first spine surgery in Japan utilizing the RESPONSE™ Spine System (“RESPONSE”) through its exclusive agreement with Tokyo-based Robert Reid Inc. The first surgery performed represents OrthoPediatrics’ expansion into the market, providing Japanese surgeons a superior solution to treat the distinct needs of pediatric patients with spinal deformities.

Mark Karshner, OrthoPediatrics’ Senior Vice President of International Sales, stated, “We are extremely pleased by the success of the first OrthoPediatrics spine case in Japan. As one of the largest medical device markets in the world, our expansion in Japan represents a significant step forward in our ability to help children all over the world. Our exclusive agreement strengthens our international market strategy, and we look forward to future procedures.”

Hideo Shitoto, President & CEO of Robert Reid, commented, “Completing the first RESPONSE case in Japan represents a significant milestone for both Robert Reid and OrthoPediatrics. We are excited by our partnership with OrthoPediatrics in order to introduce innovative and dedicated solutions to this market. We look forward to treating many more patients in Japan.”

About RESPONSE™ Spine System
Designed with a complete focus on children, the RESPONSE system offers a simple, technologically advanced system of instruments and implants to treat spinal deformity. The system is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

About Robert Reid Inc.
Robert Reid Inc. is a privately-held Japanese corporation headquartered in Tokyo. The Company imports and distributes a diverse range of surgical products from the United States and Europe. Robert Reid also designs and manufactures its own original orthopedic surgical products.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

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

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Centinel Spine Announces Lumbar Total Disc Replacement coverage by TRICARE

Posted On June 14, 2018 By OrthoSpineNews In Spine, Top Stories /  

NEW YORK, June 14, 2018 /PRNewswire/ — Centinel Spine, LLC is pleased to announce that TRICARE, the Military Health System for almost 10 million beneficiaries world-wide, has updated its coverage policy to now cover the company’s prodisc® L Anterior Lumbar Total Disc Replacement system, the most studied total disc replacement platform in the world.  More patients globally now have access to this market leading technology, a potential alternative to spinal fusion that is designed to relieve pain, maintain spinal motion and reduce post-operative recuperation time. The TRICARE extended coverage has far-reaching impact as it applies to both active duty and retired military personnel.  “With years of total disc replacement experience, I have witnessed extreme patient recovery with this technology.  This extended coverage policy will provide more patients with access to a proven surgery that offers better mobility and faster return to an active lifestyle,” stated spine surgeon Robert Masson, M.D. (Masson Spine Institute, Orlando FL).

The coverage policy was changed in a communication published on May 8, 2018, and made effective retroactively to November 16, 2017. The bulk of the TRICARE beneficiaries are Active Duty Service Members and their family members, along with retired service members.

TRICARE has supported cervical total disc replacement for many years, but this is the first time that it has extended coverage to lumbar total disc replacement.  “I look forward to extending the access to this technology in the lumbar spine – I have had significant experience with enabling military personnel to rapidly return to active duty, and appreciate the opportunity to provide lumbar total disc replacements to other TRICARE beneficiaries,” stated spine surgeon John F. Hall, M.D. (Flagstaff Bone & Joint, Flagstaff, AZ).

prodisc L has the longest use of any lumbar total disc replacement system in the U.S. (FDA approval in 2006), and has received coverage by numerous insurance providers since FDA approval. The prodisc technology platform has been the subject of over 400 articles, which have reported on over 13,000 patients’ lives.

“The TRICARE approval is the latest in a continuing trend of positive coverage decisions by carriers, and we welcome TRICARE beneficiaries to the pool of patients that are able to benefit from this life-changing treatment option.  More patients will now have access to the most proven technology in the world, with global clinical usage of almost thirty years,” stated John Viscogliosi, CEO of Centinel Spine.

About Centinel Spine

Centinel Spine, LLC is the largest privately-held spine company, focused on anterior column reconstruction. 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
SVP, Corporate Finance & Strategic Planning

Centinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8871
Email: v.gandhi@centinelspine.com

Wendy F. DiCicco
Chief Operating and Chief Financial Officer

Centinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8837
Email: w.dicicco@centinelspine.com

SOURCE Centinel Spine, LLC

Related Links

http://www.centinelspine.com

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Tyber Medical Promotes Gary Thomas To Chief Operating Officer And Adds Wesley Johnson As Executive Vice President Of Product Development

Posted On June 13, 2018 By OrthoSpineNews In Extremities, Spine /  

BETHLEHEM, Pa., June 12, 2018 /PRNewswire/ — Tyber Medical, LLC, a privately held company focusing on developing innovative medical devices for private label opportunities and advancing the science of bioengineered surfaces, announces the promotion of Gary Thomas to Chief Operating Officer and the addition of Wesley Johnson as Executive Vice President of Product Development.

Gary Thomas has been with Tyber Medical since 2017 as the Executive Vice President of Operations.  As a key member of the leadership team, his direct role is to help Tyber Medical achieve record growth through seamless execution.  He is accountable for the supply chain including customer/project management, information systems, product launches, and innovative driven solutions to optimize operational performance.  Mr. Thomas has over 28 years of experience in operations management, product development, quality, and regulatory areas.  Before joining Tyber Medical, he was the Vice President of Operations for Musculoskeletal Transplant Foundation (MTF), an orthopaedic biologic company. While there, he was responsible for multiple sites (approx. 300 employees) including: Operations, Distribution, Development, Supply Chain, and Business Unit Operations. Prior to MTF, he was the Group Vice President of Portfolio and Project Management at Biomet overseeing spine, bone healing, and microfixation. Mr. Thomas has also held top management positions for Norman Noble, Howmedica (Stryker), and Pfizer.  Mr. Thomas holds a Master’s degree in Management from NJIT and a Bachelor’s in Business Management from Ramapo College.

As the Chief Operating Officer for Tyber Medical Mr. Thomas will be responsible for management and strategic leadership over the company’s day-to-day operations as well as developing future organic operational growth.  He will be directly responsible for the business organization and strategic alignment in Operations, Inventory (SIOP) and Supply Chain Management, Customer Service, Manufacturing, Facilities, IT/Business Systems, and other customer centric services.

Tyber Medical is happy to announce the addition of Wesley Johnson to the management team as Executive Vice President of Product Development.  Mr. Johnson has an extensive background in Product Development and Business Management in the joint reconstruction, spine, trauma, and biologics fields.  Prior to Tyber Medical he was a Vice President of Research & Development at Medacta in Chicago, Illinois.  Other key management roles have included General Manager and Vice President of Arthroplasty Division at Cayenne Medical, Co-founder/President and CEO at Alexandra Research Technologies, Director of Product Development at Spine-Tech (now Zimmer Spine), and Founder of Insight Medical as well as several other management titles.  With Mr. Johnson’s knowledge and expertise, he will lead a team that is responsible for Research, Clinical, Product Development, and innovative customer focused/driven services.  He will provide guidance and mentorship to the engineering team while creating new product innovation, product launches, and product renovations to meet broad business objectives.  Mr. Johnson holds a Bachelor’s of Science Degree and a Master of Science Degree in Mechanical Engineering from the University of Minnesota, Institute of Technology.

Jeff Tyber, CEO and President of Tyber Medical commented, “We are extremely lucky to have Wes and Gary on our leadership team.  As we grow the company, we are building an organization lead by experienced orthopedic leaders to execute our customer centric growth strategies; from creating innovative products which Wes will manage, to stream-lining the production process to deliver consistent reliability and scalability which Gary will continue to oversee.”

Visit Tyber Medical’s Booth #609, at OMTEC in Chicago, IL where the company will showcase innovative products available for private labeling as well as meeting Wesley Johnson, Tyber Medical’s new Executive Vice President of Product Development.

About Tyber Medical, LLC.

Tyber Medical, LLC is an orthopedic device manufacturer providing rapid access to portfolio enhancing, regulatory approved, orthopedic implants within the spine and extremity/trauma markets.  While focusing on rapid product commercialization, the company distributes products via private labeling; releasing 14 spine and 25 extremity/trauma systems since its founding in 2012.  Tyber Medical utilizes the differentiated, bioengineered technology such as TyPEEK® osteoconductive coatings and BioTy™, a new antimicrobial nano-textured surface modification to enhance the company’s growing portfolio.

Contact:
Eric Dickson
83 South Commerce Way, Suite 310
Bethlehem PA 18017
(610) 849-1710
edickson@tybermed.com

SOURCE Tyber Medical

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Globus Medical Launches Cement Augmented Pedicle Screw System

Posted On June 13, 2018 By OrthoSpineNews In Spine /  

AUDUBON, Pa., June 13, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced the launch of the CREO® Fenestrated Screw System used in the treatment of patients with advanced stage tumors of the thoracolumbar spine. CREO® fenestrated screws, when augmented with the company’s FORTRESS™ radiopaque bone cement, are designed to restore the structural integrity of the spine at vertebral levels affected by metastatic bone disease.

The spine is one of the most common locations for skeletal metastases, accounting for approximately 10% of new cancer diagnoses annually.  Advanced stage spinal tumors can result in compression of the spinal cord, pain, fracture, mechanical instability, and neurological deficit.  Surgical treatments involving pedicle screw fixation are challenging due to the compromised bone in this patient population.

“Patients with advanced stage tumors may require cement reinforcement due to compromised bone quality,” said Dr. Edwin Ramos, neurosurgeon at The University of Chicago Medicine and Biological Sciences.  “The CREO® system allows for cement augmentation after screw placement which integrates seamlessly with a traditional MIS or open pedicle screw technique. This affords a controlled cement delivery and increased stability to help prevent screw loosening that can occur in tumor patients.”

The CREO® Fenestrated Screw System is available with threaded, non-threaded, and MIS screw head options to accommodate surgeon preferences for complex tumor procedures.  The screws are cannulated with a series of fenestrations along the shank for targeted cement dispersion, and rigidly attach to specialized instruments for controlled cement delivery.

To learn more about the CREO® Fenestrated Screw System visit www.GlobusMedical.com

Indications

When used for posterior fixation in conjunction with FORTRESS™ or FORTRESS™-Plus bone cement, the CREO® Fenestrated Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit the achievement of fusion.  CREO® Fenestrated screws augmented with FORTRESS™ and FORTRESS™-Plus bone cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

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

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

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

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Global Vertebral Compression Fracture Repair Devices Market 2016-2018 & 2026: Rising Preference for Kyphoplasty as Compared to Vertebroplasty

Posted On June 13, 2018 By OrthoSpineNews In Spine /  

DUBLIN, June 13, 2018 /PRNewswire/ —

The “Global Vertebral Compression Fracture Repair Devices Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2018 To 2026” report has been added to ResearchAndMarkets.com’s offering.

The global vertebral compression fracture repair devices market was valued at US$ 2,380.7 Mn in 2017 and expected to reach US$ 4,876.1 Mn by 2026, expanding at a CAGR of 8.25% from 2018 to 2026.

In 2017, vertebroplasty dominated the procedure segment owing to its low cost and huge popularity among orthopedic surgeons throughout the globe. It is the surgical procedure of first choice for patients suffering with impending fracture & pain and metastatic lesions. The limitations of vertebroplasty are post-surgery additional costs incurred by patients due to higher complication rates related to surgery such as nerve root irritation and the risk of cement flowing outside the bone before hardening. Kyphoplasty will eventually capture larger market share, as it is the most advanced technique used in VCF repair surgery. Implanting inflated balloon in the fractured vertebrae is helpful in restoring the vertebral height and flexibility. Moreover, excellent patient compliance post surgery and affordable reimbursement scenario together drive the kyphoplasty market.

North America is domicile to key players such as Stryker Corporation, Cook Medical DePuy Synthes and many more, which cater vertebroplasty and kyphoplasty devices for treatment of vertebral compression fracture. Moreover rising demand for minimally invasive procedures and affordable reimbursement scenario contribute towards the dominance of North America for VCF repair devices market. Asia Pacific is keen to display excellent growth during the forecast period from 2018 to 2026 owing to huge population base suffering with osteoporosis. Increasing morbidity in geriatric patients with vertebral compression fracture, and rampant growth in orthopedic specialty clinics drive the Asia Pacific VCF repair devices market.

Key Market Trends:

  • Increasing pool of geriatric population suffering with osteoporosis
  • Affordable reimbursement scenario for minimally invasive surgical procedures involved in treatment of vertebral fracture repair
  • Severe traumatic road accidents are on a rise and unhealthy lifestyle such as excessive smoking and consumption causing secondary osteoporosis which results in VCF
  • Rising preference for kyphoplasty surgical procedure as compared to vertebroplasty due to excellent clinical outcomes

Key Topics Covered:

Chapter 1. Preface
1.1. Report Scope and Description
1.1.1. Purpose of the Report
1.1.2. Target Audience
1.1.3. USP and Key Offerings
1.2. Research Scope
1.3. Research Methodology

Chapter 2. Executive Summary
2.1. Global Vertebral Compression Fracture Repair Devices Market Portraiture
2.2. Global Vertebral Compression Fracture Repair Devices Market, by Procedure, 2017 (US$ Mn)
2.3. Global Vertebral Compression Fracture Repair Market, by Geography, 2017 (US$ Mn)

Chapter 3. Vertebral Compression Fracture Repair Devices Market: Dynamics and Future Outlook
3.1. Market Overview
3.2. Drivers
3.3. Challenges
3.4. Opportunities
3.5. Porter’s Five Forces Model
3.6. Attractive Investment Proposition, by Geography, 2017
3.7. Competitive Landscape : Global Vertebral Compression Fracture Repair Devices Market, by Key Players, 2017

Chapter 4. Global Vertebral Compression Fracture Repair Devices Market, by Procedure, 2016 – 2026 (US$ Mn)
4.1. Overview
4.2. Vertebroplasty
4.3. Kyphoplasty
4.4. Spinal Fusion Surgery

Chapter 5. Global Vertebral Compression Fracture Repair Devices Market, by Geography, 2016 – 2026 (US$ Mn)

Chapter 6. Company Profiles

  • Cook Medical, Inc.
  • DFine, Inc.
  • DePuy Synthes, Inc.
  • Globus Medical, Inc.
  • Medtronic Plc
  • Orthovita, Inc.
  • Osseon LLC
  • Stryker Corporation
  • VEXIM SA
  • Zimmer Biomet Holdings, Inc.

For more information about this report visit https://www.researchandmarkets.com/research/khxhrt/global_vertebral?w=5

Media Contact:

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

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http://www.researchandmarkets.com

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Simplify Medical Expands Leadership Team

Posted On June 12, 2018 By OrthoSpineNews In Spine /  

SUNNYVALE, Calif., June 12, 2018 (GLOBE NEWSWIRE) — Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, today announced that it has expanded its leadership team with the appointments of Brian Polonet as Vice President, Sales and Marketing and Kim Norton as Vice President, Reimbursement. Both appointments are effective immediately and together bring decades of executive experience in the medical device space to the Simplify Medical leadership team.  In addition, two key members of the leadership team have been promoted: Beth Neil to Vice President, Clinical Affairs and Mark Alvis, DVM to Vice President, Quality Assurance & Operations.

Mr. Polonet will lead the Company’s sales and marketing initiatives to drive increased adoption in Europe and prepare for expected commercial launch in the U.S. following requisite regulatory approval. Ms. Norton will manage payer relations and oversee the development and execution of the Company’s reimbursement strategy as it continues to expand the number of covered lives for both one and two-level implantation.

The appointments were made as the Company expands commercial efforts in Europe where it is CE marked and pursues the completion of one and two-level U.S. IDE clinical trials for the implantation of its cervical artificial disc between C3 to C7.  The Company completed enrollment of its one-level trial in February 2018 with 166 patients enrolled at 16 U.S. sites and anticipates complete enrollment of 200 patients at 18 centers in its two-level study by the end of 2018.

David Hovda, Chief Executive Officer of Simplify Medical, commented, “I am extremely pleased to announce the high caliber additions of Mr. Polonet and Ms. Norton to our team as we work diligently to expand our commercial and corporate presence and prepare to bring our innovative disc to the U.S. market following FDA PMA submission and approval. These appointments complement the progress we’ve made to date, especially in the enrollment for our one and two-level IDE clinical trials, and demonstrate our evolving focus as we build off our momentum and approach a critical juncture of growth.”

Mr. Polonet joins the Company with 25 years of experience in the medical device industry, with the last 17 years in Spine. Most recently he was a managing partner at TDR Associates, a consulting company which managed the one and two-level study enrollment for Simplify Medical.  He previously held positions as Vice President of Sales and Marketing at Paradigm Surgical, LLC and prior to that, as Vice President of Sales at SpinalMotion. He has had a leadership role in four IDE studies for artificial discs. Mr. Polonet holds a Bachelor of Arts in Business Administration from Austin College.

Ms. Norton has worked in the fields of reimbursement, outcomes research, and government relations for over 20 years. She has deep experience with artificial disc technologies, having led the reimbursement efforts at several companies, including as Head of Reimbursement and Payer Relations for Aesculap, Inc., a medical device company focused on spine and orthopedic implants based in Allentown, Pennsylvania, and Vice President of Reimbursement for both LDR Spine and DePuy Synthes. Kim earned a master’s degree in public policy from the University of California at Berkeley and a BA in political science from Wellesley College.

Ms. Neil has nearly 20 years of experience in the medical device industry, specializing in clinical research.  Prior to joining Simplify Medical as the Director of Clinical Affairs, she held positions with Link Spine Group and Healthtronics Surgical Services, as well as various contract research organizations.  Ms. Neil holds an M.S. degree in Physical Therapy from Duke University.

Dr. Alvis has been part of Simplify Medical since 2007, serving as Director, Quality Assurance. Prior to joining Simplify Medical, Dr. Alvis served as General Manager of Angiotech Biomaterials, where he was responsible for all business activities at their Palo Alto, CA facility. He also served as Vice President of Research and Development at NeuColl Inc. Dr. Alvis has 20 years of experience in the preclinical assessment of medical devices and pharmaceutical agents and holds a Doctor of Veterinary Medicine degree from Colorado State University.

About Simplify™ Disc

Simplify™ Disc is a motion preserving cervical artificial disc designed to allow for advanced imaging capability of MRI, and better match patients’ anatomies and kinematics. It is composed of advanced, primarily non-metal materials (PEEK-on-ceramic) to permit the full diagnostic imaging capability of MRI and eliminate the need for CT/Myelogram and CT imaging in order to minimize patient exposure to radiation. The Simplify™ Disc is anatomically designed, offering a broader range of disc heights including low height implant options to better fit patients’ anatomies. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. Implantation of the Simplify Disc is accomplished in a straightforward, three-step procedure.

About Simplify Medical

Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.

Caution: The Simplify Disc is an investigational device in the United States and is limited by law to investigational use.

Simplify Medical Contacts:

Investor Contact:
Brian Johnston, The Ruth Group
Tel: +1 646-536-7028
Email: bjohnston@theruthgroup.com

Media Contact:
Kirsten Thomas, The Ruth Group
Tel: +1-508-280-6592
Email: kthomas@theruthgroup.com

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Safe Orthopaedics: Exclusive Commercialization Agreement with KiSCO on the Japanese Market

Posted On June 12, 2018 By OrthoSpineNews In Spine /  

June 12, 2018

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

Safe Orthopaedics (Paris:SAFOR) (FR0012452746 – SAFOR), a company specialized in the design and marketing of single-use implants and new generation of instruments improving the minimally invasive treatment of spinal fractures, announces today an exclusive commercialization and distribution rights agreement with KiSCO Co., Ltd, a subsidiary of Otsuka Medical Devices, on the Japanese market. KiSCO conducts its orthopedic activities in spinal and trauma fields, especially the hip.

Through this partnership, KiSCO aims to ramp up its market share by introducing Safe Orthopaedics’ products. The agreement includes milestone payment in cash upon the receipt of approval for SteriSpine products on the Japanese market, which is expected in 2019, while investment from KiSCO in Safe Orthopaedics via a capital increase launched on the 12th of June.

“Partnering with KiSCO, the Spine and Trauma entity of Otsuka Medical Devices, will open the Japanese market for Safe Orthopaedics, the third largest Spine market in the world behind the United States and China, estimated to be worth €400 million. We are glad to collaborate with its experimented sales team and its large surgeon’s network. By combining the knowhow of our two entities, we will continue to innovate and generate additional businesses both for Safe Orthopaedics and KiSCO,” said Pierre Dumouchel, Chief Executive Officer and co-founder of Safe Orthopaedics.

About KiSCO Co.,Ltd

KiSCO Co., Ltd. was established in 1961 and became a member of the Otsuka group of companies in 2011. We are dedicated to the creation, development and sale of high-quality orthopedic medical devices. Our mission statement, “KiSCO-people creating innovative medical devices for better health world”, harmonizes perfectly with that of Otsuka, our parent company, Otsuka Medical Devices Co., Ltd. which is the medical devices subsidiary of the Japanese listed Otsuka group, a global player on the nutrition and pharmaceuticals markets with approximately 46,000 employees worldwide. With strengths in the orthopedic field at our core, we work daily on challenges to satisfy medical professionals and improve patients’ quality of life.

KiSCO Co., Ltd.: https://www.kisco.jp/
Otsuka Medical Devices Co., Ltd.: http://www.omd.otsuka.com/en/

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that offers the safest technologies to treat spinal fracture. Delivered sterile, all implants and respective disposable instrumentation are available to the surgeon at any time, any place. These technologies enable minimally invasive approaches, reducing risks of cross contamination and infection in the interest of the patient. Protected by 17 patent families, the SteriSpine™ Kits are CE marked and FDA cleared. The company is based at Eragny-Sur-Oise (France), and has 37 employees.

For more information, visit: www.SafeOrtho.com

Contacts

Safe Orthopaedics
François-Henri Reynaud, +33 (0)1 34 21 50 00
CFO
investors@safeorthopaedics.com
or
Investor Relations
NewCap
Julien Perez / Valentine Brouchot
+33 (0)1 44 71 94 94
SafeOrtho@newcap.eu
or
Press Relations
Ulysse Communication
Bruno Arabian, +33 (0)6 87 88 47 26
barabian@ulysse-communication.com
or
Nicolas Daniels, +33 (0)6 63 66 59 22
ndaniels@ulysse-communication.com

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