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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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Wright Medical Group N.V. Announces FDA Premarket Approval for AUGMENT® Injectable Bone Graft

Posted On June 13, 2018 By OrthoSpineNews In Regulatory /  

AMSTERDAM, The Netherlands, June 13, 2018 (GLOBE NEWSWIRE) —  Wright Medical Group N.V. (NASDAQ:WMGI) today announced that it has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for AUGMENT® Injectable Bone Graft for the same clinical indications as AUGMENT® Bone Graft.  AUGMENT Injectable is a combination product consisting of recombinant human platelet derived growth factor (rhPDGF-BB) and a blend of Type I collagen and Beta tri-calcium phosphate, which provides a clinically proven and safe and effective alternative to autograft for use in hindfoot and ankle fusion in an easy to use flowable formulation.

Robert Palmisano, president and chief executive officer, stated, “Building on the commercial and clinical success of AUGMENT Injectable in the Canadian and Australian markets, this important milestone allows Wright to expand our proven AUGMENT franchise and meet the needs of foot and ankle surgeons in the U.S. with a safe and effective alternative to autograft that includes significantly improved handling characteristics to enable easier and more precise delivery to the fusion site.  In addition to the significantly improved handling characteristics with AUGMENT Injectable, one of the key differentiators continues to be the strength of the clinical evidence.  Our approved PMA supplement for AUGMENT Injectable builds upon the existing body of evidence supporting the safety and effectiveness of AUGMENT Bone Graft and leverages clinical data from the U.S. and Canada for the injectable formulation.”

The U.S. launch of AUGMENT Injectable is expected to deliver sustained growth in the U.S. for the AUGMENT Regenerative Solutions platform over the next several years with a gradual ramp as the injectable form is reviewed by hospital value analysis committees and physician education programs are executed.  The company will immediately start the process of finalizing its packaging carrying the FDA approved labeling and expects to begin selling product in the U.S. shortly and complete the rollout in the next four to six weeks.

Dr. Timothy Daniels, Chief of the Division of Orthopaedic Surgery of St. Michael’s Hospital and Professor at the University of Toronto in the Department of Surgery, commented, “In Canada, my colleagues and I have been using AUGMENT Injectable since 2011 based upon its ideal handling characteristics and impressive clinical results.  FDA approval of AUGMENT Injectable provides a valuable enhancement to the existing AUGMENT product line for U.S. foot and ankle surgeons as a front-line biologic alternative that drives the biological healing process and eliminates the costs and clinical impacts of autograft harvesting.”

Dr. Jeremy McCormick, Associate Professor of Orthopaedic Surgery at Washington University School of Medicine in St. Louis, Missouri, added, “I adopted AUGMENT Bone Graft shortly after it launched as a clinically proven tool that has improved patient outcomes. As my confidence in the product has grown, so too has my use of AUGMENT.  Now, with the introduction of the new injectable version, delivery of the product to the fusion site will be simplified and more consistent, helping foot and ankle specialists use it more dependably in patients.”

AUGMENT Injectable is the first clinically proven injectable protein therapeutic to come to the U.S. orthopaedic market offering an alternative to autograft in ankle and/or hindfoot fusion procedures, which translates into an estimated market opportunity of approximately $300 million in the U.S. As FDA-approved alternatives to autograft in ankle and/or hindfoot fusion procedures, AUGMENT Bone Graft and AUGMENT Injectable offer a clear patient benefit by avoiding secondary surgical sites for the harvest of autograft tissue, which can result in prolonged harvest site pain and other comorbidities in some patients.

As a result of this approval, the company plans to update its 2018 annual guidance on its second quarter earnings call scheduled for August 8, 2018.

Internet Posting of Information

Wright routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.wright.com.  The company encourages investors and potential investors to consult the Wright website regularly for important information about Wright.

About Wright Medical Group N.V.

Wright Medical Group N.V. is a global medical device company focused on extremities and biologics products. The company is committed to delivering innovative, value-added solutions improving the quality of life for patients worldwide.  Wright is a recognized leader of surgical solutions for the upper extremities (shoulder, elbow, wrist and hand), lower extremities (foot and ankle) and biologics markets, three of the fastest growing segments in orthopaedics.  For more information about Wright, visit www.wright.com.

™ and ® denote trademarks and registered trademarks of Wright Medical Group N.V. or its affiliates, registered as indicated in the United States, and in other countries.  All other trademarks and trade names referred to in this release are the property of their respective owners.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS  

This release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this release include, but are not limited to, statements about the performance, market availability and market acceptance of the company’s products. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, physician acceptance, endorsement, and use of company products; the effect of regulatory actions, changes in and adoption of reimbursement rates; product liability claims; product recalls; the effects of industry, economic or political conditions outside of the company’s control; competitor activities; and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 31, 2017 filed by Wright with the SEC on February 28, 2018 and in other subsequent SEC filings by Wright. Investors should not place considerable reliance on the forward-looking statements contained in this release. Investors are encouraged to read Wright’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this release speak only as of the date of this release, and Wright undertakes no obligation to update or revise any of these statements. Wright’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Investors & Media:

Julie D. Dewey
Sr. Vice President, Chief Communications Officer
Wright Medical Group N.V.
(901) 290-5817
julie.dewey@wright.com

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K2M Group Holdings, Inc. Announces Private Offering of $65.0 Million Aggregate Principal Amount of Convertible Senior Notes due 2025

Posted On June 13, 2018 By OrthoSpineNews In Financial /  

LEESBURG, Va., June 13, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq:KTWO) (“K2M”) today announced that it intends to offer, subject to market and other conditions, $65.0 million aggregate principal amount of Convertible Senior Notes due 2025 (the “Notes”), to be sold only to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). K2M also expects to grant to the initial purchasers of the Notes an option to purchase up to an additional $10.0 million aggregate principal amount of the Notes during a 13-day period beginning on, and including, the first date on which the Notes are issued.

The Notes will be K2M’s senior unsecured obligations. The Notes will mature on June 30, 2025, unless earlier converted, redeemed or repurchased.

K2M will satisfy its conversion obligation by paying or delivering, at its election, cash, shares of its common stock or a combination of cash and shares of its common stock, as applicable. The maturity date, interest rate, the initial conversion rate and the other terms of Notes will be determined by negotiations between K2M and the initial purchasers of the Notes.

K2M expects to use the net proceeds of this offering to repay approximately $18.0 million of borrowings under our revolving credit facility and the remaining net proceeds for general corporate purposes, which may include working capital, purchasing inventory, continued expansion of our distribution channels and supporting our organic growth initiatives.

The offer and sale of the Notes and any shares of K2M’s common stock issuable upon conversion of the Notes have not been registered under the Securities Act, or any state securities law, and the Notes and such shares may not be offered or sold in the United States or to any U.S. persons absent registration under, or pursuant to an exemption from, or in a transaction not subject to, the Securities Act and applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the Notes or any shares of K2M’s common stock issuable upon conversion of the Notes, nor shall there be any offer, solicitation or sale of any Notes or any shares of K2M’s common stock issuable upon conversion of the Notes in any jurisdiction in which such offer, solicitation or sale would be unlawful.

About K2M Group Holdings, Inc.

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 and proprietary complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations, financial performance, the offering of the Notes, the anticipated terms of the Notes, the expected use of proceeds therefrom and our expectations concerning market conditions for an offering of convertible notes. Forward-looking statements include all statements that are not historical facts. 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 and hospital customers the merits of our products and to retain their use of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to maintain adequate working relationships with healthcare professionals; 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 or those of our suppliers, 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 remediate the material weaknesses in our IT general controls; 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 associated with the exit of the United Kingdom from the European Union; 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 a fiscal 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; 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; increased costs and additional regulations and requirements as a result of being a public company; 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; 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, 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.

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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

Related Links

http://www.researchandmarkets.com

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Cerapedics Receives 2018 MedTech Breakthrough Award for Best New Surgical Technology Solution

Posted On June 13, 2018 By OrthoSpineNews In Biologics, Top Stories /  

WESTMINSTER, Colo., June 13, 2018 /PRNewswire/ — Cerapedics, a privately-held orthobiologics company, today announced that it has been selected as a winner in the 2018 MedTech Breakthrough Awards program. The award recognizes the company’s i‑FACTOR™ Peptide Enhanced Bone Graft as the best new surgical technology solution.

“We are pleased to be recognized as one of the top companies, technologies, and products in the global health and medical technology market,” said Glen Kashuba, chief executive officer of Cerapedics. “i‑FACTOR Peptide Enhanced Bone Graft is an innovative solution for orthopedic surgeons who are looking for a safe, clinically proven and cost-effective bone graft that is supported by Level 1 human data, and we are focused on gathering additional clinical evidence supporting its use and addressing the evidence gap around commercial bone grafts often used in spinal fusion procedures.”

i‑FACTOR Peptide Enhanced Bone Graft is based on proprietary biomimetic small peptide (P-15) technology that has a novel mechanism of action (attract, attach, and activate) that induces osteoblast cell proliferation and differentiation to accelerate new bone formation in patients with degenerative disc disease. This unique drug-device technology enhances the body’s natural bone healing process through cellular activity that is directional and predictable. i‑FACTOR Peptide Enhanced Bone Graft is only the second bone graft to receive Premarket Approval (PMA) in the spine, and it is supported by proven safety and efficacy data through an investigational device exemption (IDE) clinical trial.

“For the hundreds of thousands of people suffering from severe back pain, degenerative disc disease and need a spinal fusion, Cerapedics has developed an innovative therapy to enhance bone healing with i‑FACTOR Peptide Enhanced Bone Graft, a novel PMA-approved small peptide bone graft,” said James Johnson, managing director at MedTech Breakthrough. “We congratulate Cerapedics on developing an innovative, evidence-based technology that has the opportunity to become an industry standard of care, and we are thrilled to recognize them as a 2018 MedTech Breakthrough Award – Surgery winner.”

About Cerapedics
Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary biomimetic small peptide (P-15) technology platform. i‑FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors. More information can be found at www.cerapedics.com.

i‑FACTOR Peptide Enhanced Bone Graft Indications for Use
USA: i‑FACTOR Peptide Enhanced Bone Graft is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and corresponding to at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels, after failure of at least 6 weeks of conservative treatment. i‑FACTOR™ Peptide Enhanced Bone Graft must be used inside an allograft bone ring and with supplemental anterior plate fixation.

Media contact:
Jenna Iacurci
Berry & Company Public Relations
212-253-8881
jiacurci@berrypr.com

SOURCE Cerapedics

Related Links

https://cerapedics.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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NuVasive Launches AttraX Scaffold Biologic And Reports First Clinical Use

Posted On June 12, 2018 By OrthoSpineNews In Biologics, Spine /  

SAN DIEGO, June 12, 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 U.S. launch of AttraX® Scaffold, an absorbent ceramic-collagen bone graft with an optimized surface that has been validated in preclinical testing to drive increased bone formation and faster fusion than traditional ceramic bone grafts.1

Unlike traditional ceramic materials that do not by themselves generate bone formation when implanted in an intramuscular site, AttraX Scaffold has unique microstructure and microporosity that are optimized for bone formation in this environment. The AttraX surface technology, through its carefully defined and tightly controlled features at the submicron scale, drives the differentiation of mesenchymal stem cells into bone-forming osteoblasts without added growth factors.2

“AttraX Scaffold was easy to use and maintained excellent handling characteristics throughout the procedures,” said Dr. J. Kenneth Burkus of the Hughston Clinic in Columbus, Ga., after performing the first clinical cases with the NuVasive biologic. “The material was highly absorbent of bone marrow aspirate and easily cut or molded to the desired shape. After experiencing AttraX Scaffold firsthand, I am very pleased to offer this scientifically advanced ceramic bone graft to my spinal fusion patients.”

Available in strips, blocks and morsels, AttraX Scaffold can be used in the posterolateral spine to promote fusion. AttraX Scaffold complements the currently marketed AttraX Putty product line to offer spine surgeons a suite of surface-optimized ceramic graft materials to meet surgical needs. During preclinical testing in posterolateral fusion (PLF) models, AttraX fusion rates were equivalent to or better than autograft, and faster than traditional ceramic grafts.1,3-5 In addition, spinal segments fused with AttraX had greater biomechanical strength than segments treated with ACTIFUSE ABX or Vitoss BA in a rabbit PLF model.6

“With AttraX Scaffold we have enhanced the NuVasive Biologics portoflio to better serve our surgeons,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “We are delivering the only ceramic-collagen scaffold for spine surgery that achieves desirable handling characteristics, elicits an osteogenic response from the body’s cells and performs with remarkable fusion rates. Surface optimization represents the next leap forward in ceramic bone grafting technology and has the potential to deliver outstanding clinical outcomes for surgeons and their patients.”

The addition of AttraX Scaffold strengthens the NuVasive biologics portfolio by providing differentiated clinical options in each of the major biologics categories: Osteocel® in the cellular allograft category, Propel™ in the DBM category and AttraX in the synthetic category.

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 Walsh, WR, Oliver RA, Pelletier MH, et al. Efficacy of a novel microstructured calcium phosphate-collagen bone graft in a rabbit posterolateral spine fusion model. International Society for the Advancement of Spine Surgery 2018 Annual Conference. Toronto, Canada.
2 Yuan H, Fernandes H, Habibovic P, et al. Osteoinductive ceramics as a synthetic alternative to autologous bone grafting. Proc Natl Acad Sci 2010;107:13614-9.
3 Vizesi F, Cunningham B, Hu N, et al. Nanostructured TCP in the sheep posterolateral fusion model. 9th World Biomaterials Congress 2012. Chengdu, China.
4 Ismailoglu AS, Vizesi F, Cunningham B, et al. Fibrillar collagen/TCP scaffold in the sheep posterolateral fusion model. Society for Biomaterials Annual Meeting 2012. New Orleans, LA, USA.
5 Fredericks DC, Smucker JD, Peterson EB, et al. Novel TCP compares favorably to autograft in posterolateral fusion: evaluation in rabbit and sheep models. International Society for the Advancement of Spine Surgery 2013 Annual Conference. Vancouver, BC, Canada.
6 Walsh WR, Degroot F, Bertollo N, et al. Nanostructured TCP in rabbit posterolateral fusion compared to commercial osteobiologics. American Academy of Orthopaedic Surgeons 2011 Annual Meeting. San Diego, CA, USA.

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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icotec AG Received FDA Clearance to Market BlackArmor® Carbon/PEEK Interbody Cages

Posted On June 12, 2018 By OrthoSpineNews In Regulatory /  

ALTSTAETTEN, Switzerland, June 12, 2018 /PRNewswire/ —

icotec AG, a Swiss company, today announced that its latest line of interbody cages, designed to optimize bony integration and post-operative visualization has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The clearance includes cages for a variety of surgical approaches, such as cervical fusion procedures like Anterior Cervical Discectomy and Fusion (ACDF) procedures as well as lumbar procedures like Posterior Lumbar Interbody Fusion (PLIF) and Transforaminal Lumbar Interbody Fusion (TLIF) procedures.

All the interbody cages have, at their core, icotec’s unique BlackArmor® Carbon/PEEK material, which consists of continuous carbon fibers combined with PEEK, and are produced using icotec’s Injection Molding CFM (Composite Flow Molding) manufacturing technology. This process allows reproducible product quality with the consistent orientation of the continuous carbon fibers, resulting in unparalleled strength and mechanical durability while providing excellent imaging quality and a modulus of elasticity close to half that of titanium. All cages are circumferentially (360°) coated with a rough Ti-iT® titanium coating, which is applied using a VPS (Vacuum Plasma Spray) procedure. The Ti-iT® commercially pure titanium coating from icotec enables bony ongrowth to the implant. Bone tissue attaches and integrates safely into the surface of the implant due to the rough structure.

icotec is the only company manufacturing spinal implants made of nonmetallic, radiolucent BlackArmor® Carbon/PEEK composite material. Implants made of BlackArmor® are biocompatible and have been successfully implanted for over 15 years. Their X-ray translucency makes a significant difference during intra- or postoperative assessments of the site of care and for spinal fusion.  Especially in patients with spinal tumors, optimal delineation of the tumor from healthy tissue can facilitate radiotherapy planning, optimize radiosurgery treatment and allow immediate and precise monitoring of possible relapses (tumor recurrence).

“Our ability to combine two unique technologies, BlackArmor® material and Ti-iT® coating, allows us to provide implants, that can truly make a difference for patients and their clinical outcome. With the combination of the two core technologies in our interbody cages, we see excellent fusion results without compromising the post-operative image quality”, said Roger Stadler, CEO of icotec AG in Switzerland. “Our focus has been on developing implants with comparable osseointegration and biomechanical strength to titanium while adding unparalleled postoperative X-ray, CT and MR imaging for any spinal pathology including but not limited to degenerative disc conditions and spinal tumor.”

The latest version of icotec’s cage line has been available in countries requiring CE Mark since 2011 and over 8,500 interbody cages have been successfully implanted to date. icotec cages will be widely available in the US starting in August 2018.

icotec will showcase its full line of cages at this year’s NASS convention from September 26-29 at the Los Angeles Convention Center – South Building, Los Angeles, California.

For updates and more information, please visit us at http://www.icotec-medical.com

– Cross reference: Picture is available at AP Images (http://www.apimages.com) –

Denise Marte
denise.marte@icotec.ch
+41-71-757-00-21

SOURCE icotec

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