BONESUPPORT creates its own US Commercial Platform

Posted On May 17, 2018 By OrthoSpineNews In Biologics, Top Stories /

Lund, Sweden, 08.45 CET, 17 May 2018 – BONESUPPORT HOLDING AB (publ) announces today that the current distribution agreement has been terminated and will be replaced by a network of independent distributors and its own commercial organization. This will allow BONESUPPORT to increase its market penetration while creating a stronger platform for current products and future launches in the US market.

“Taking control of our commercial platform in the US is crucial to the execution of our strategy to become a leading global orthobiologics company. We will be able to create a more direct relation with the US customers while better capitalizing the potential of our highly differentiated products, particularly CERAMENT G, which we hope will take to the market in 2021”, says Emil Billbäck, CEO of BONESUPPORT.

The company intends to create the optimal US commercial platform by:

Building its own network of independent distributors driving the sales of the BONESUPPORT’s products, to a broad range of orthopedic indications.
Extend the product offering based on new formulations of CERAMENT as well as synergistic bone graft substitute products.
Increase the own commercial organization from 12 to 23 persons.

BONESUPPORT will start selling direct on October 20th 2018.

“CERAMENT G will be a highly innovative product – the first of its kind in the US market – the recruitment of the FORTIFY IDE study, which will provide data for the PMA application of CERAMENT G in 2020, is running according to plan. Expanding our commercial footprint, establishing direct access with our customers, and bolstering our product offering in the US will allow us to build a strong and increasing foundation in the world’s largest market for bone graft substitutes.”, comments Patrick O’Donnell, Executive Vice President of Commercial Operations, North America.

The Company expects that this decided change in market commercialization eventually will generate higher sales volumes in the US. In the short term, the turnover will be less in the US. This could also lead to that the 2020 targets will be achieved later than previously communicated. We will present updated objectives during Q3 2018 after the initiated strategic review is completed.

Conference Call/Webcast Details

The Company will host a conference call and an online presentation at 09:30 am CET on Thursday 17 May.

The dial-in numbers for the conference call are:

UK: +44 20 3008 9808
SE: +46 85 063 95 49
US: +1 85 5831 5946

Webcast

The presentation will also be webcast and can be accessed from the following web address:

https://tv.streamfabriken.com/2018-05-17-bonesupport-pressconference

Hosts: Emil Billbäck, CEO and Björn Westberg, CFO

For more information contact: BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform. The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com.

*CERAMENT G: Not available in the United States, for investigational use only.
CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 07.45 CET on 17 May 2018.

K2M Announces US Launch of First-to-Market 3D-Printed Expandable Interbody MOJAVE™ PL 3D Expandable Featuring Lamellar 3D Titanium Technology™

Posted On May 16, 2018 By OrthoSpineNews In Spine, Top Stories /

LEESBURG, Va., May 16, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance^™, today announced the U.S. commercial launch of its MOJAVE^™ PL 3D Expandable Interbody System. Designed with K2M’s Lamellar 3D Titanium Technology^™, MOJAVE PL 3D incorporates a porous structure in conjunction with rough surfaces, with the goal of allowing for bony integration throughout the endplates. K2M was the first leading spine company to market a 3D-printed titanium interbody device and offers the most comprehensive portfolio of 3D-printed spinal devices on the market.

The MOJAVE PL 3D Expandable Interbody System, which received a 510(k) clearance from the U.S. Food & Drug Administration (FDA) in June 2017, is a first-of-its-kind fusion device designed to allow for independent control of the anterior and posterior heights in the lumbar spine. Featuring infinite adjustment within the expansion range, the implant may be locked at any desired height and lordosis to aid in the restoration of sagittal balance.

“Advancements in expandable interbody technology are giving new hope to surgeons who treat sagittal imbalance, which often causes patients to live in chronic pain and discomfort,” said Michael P. Donahue, DO, Director of Spine Surgery and President at the Center for Advanced Orthopedics and Sports Medicine in Auburn Hills, MI. “The MOJAVE PL 3D Expandable Interbody System is a first-of-its-kind solution. Designed with Lamellar 3D Titanium Technology, it uses a breakthrough 3D-printing method to allow for bony integration throughout the implant, and its infinite adjustment tools allow me to precisely match the implant to the unique anatomies of my patients.”

K2M’s Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques. Starting with a titanium powder, the MOJAVE endplates are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and a rough surface architecture that pre-clinical data have associated with bone growth activity.

“The launch of the MOJAVE PL 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology marks a significant advancement in expandable interbody technology,” said K2M Chairman, President, and CEO Eric Major. “Its infinite adjustment and comprehensive height and lordotic expansion capabilities provide surgeons with a more flexible means to facilitate 3D sagittal balance in their patients. We are proud to reiterate our commitment to excellence in 3D spinal innovation by inventing new solutions, that when supported by our Balance ACS platform, allow spine surgeons worldwide to facilitate quality outcomes in their patients.”

Balance ACS^® (or BACS^®) provides surgical solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach of the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

For more information about the MOJAVE PL 3D Expandable Interbody System and K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.

About K2M

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

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects. In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.

Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons 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 payers; 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.

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

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

Laser Spine Institute Welcomes M. Kathleen Donald as Chief Marketing Officer

Posted On May 16, 2018 By OrthoSpineNews In Spine, Top Stories /

May 16, 2018

TAMPA, Fla.–(BUSINESS WIRE)–Laser Spine Institute, the leader in minimally invasive spine surgery, is pleased to announce the appointment of marketing, branding and operations veteran M. Kathleen Donald as Chief Marketing Officer.

With nearly three decades of success at some of the nation’s most influential brands, Donald brings an impressive mix of strategic marketing, digital media, thought leadership and advertising savvy to the role. Her natural ability to consume and process large amounts of complex information, and then visualize, implement and drive organizational innovation, are some of the many reasons she was chosen to serve on the executive leadership team. Donald will work alongside Laser Spine Institute’s President and Chief Executive Officer, Roger Cary, to engineer the integrated marketing roadmap, further amplifying the organization’s strong commitment to providing the highest level of patient-centered care.

Donald is no stranger to back pain. In fact, it was her own search to find relief from a painful back condition that led Donald to her new role at Laser Spine Institute. She says the organization’s purpose-driven mission was what piqued her interest in becoming a part of an organization that helps people find hope and healing from the same pain that plagued her for years.

“Because I’ve walked that same, painful path so many of our patients are currently on, I understand what they’re going through,” she said. “It’s why I wanted to be part of helping them find a solution.”

Donald’s insatiable sense of curiosity and creative prowess are the bedrocks upon which her career was built. They also landed her key leadership roles where her big-picture thinking helped solve multi-level challenges. Prior to joining Laser Spine Institute, Donald was general manager at Dassault Systemes’ 3DXCITE, chief operating officer at Campbell Ewald, and regional group brand director/senior European account director at Ogilvy & Mather. She helped elevate brands such as Ford, USAA, Pier 1 Imports, Edward Jones and the United States Navy to new heights.

“Kathleen is a seasoned, results-driven professional who has developed a reputation as a collaborative and innovative leader who builds high performance, cross-functional teams,” Cary said. “We are absolutely thrilled to welcome Kathleen as a core member of our executive leadership team.”

As CMO, Donald will lead all aspects of Laser Spine Institute’s brand development, including direct marketing, advertising, internal communications, public relations, stakeholder engagement and strategic planning. She will also analyze all current direct marketing functions, including technological tools, analytic tools, agency relationships, other partnerships, communication objectives and/or strategies and reporting; work with the leadership team to implement necessary changes and maximize efficiencies, timelines and processes within the department.

Donald earned her certification in applied strategic marketing planning from the University of Michigan’s Ross School of Business. She holds a bachelor’s degree in business studies from Wayne State University in Michigan and holds a certification in Japanese language studies from the University of Detroit. Donald was named a Champion of the New Economy in 2016 by Business Magazine, and the 2014 Distinguished Alumna by Wayne State University’s School of Business Administration.

For more information, visit http://news.laserspineinstitute.com/.

About Laser Spine Institute

Headquartered in Tampa, Florida, Laser Spine Institute currently operates seven, state-of-the-art surgery centers across the country, in Tampa, Florida; Scottsdale, Arizona; Philadelphia; Oklahoma City; Cleveland, St. Louis and Cincinnati. Laser Spine Institute has performed more than 75,000 patient procedures to help patients find relief from debilitating neck and back pain caused by spinal stenosis, degenerative disc disease, pinched nerves, bone spurs, bulging/herniated discs, sciatica and other chronic conditions. Laser Spine Institute has been repeatedly recognized for outstanding patient satisfaction and reports an enterprise-wide patient satisfaction score of more than 96.

Laser Spine Institute has been named a top employer by Modern Healthcare, Tampa Bay Times, Tampa Bay Business Journal, Philly.com and okc.BIZ and a Most Admired Company by BestCompaniesAZ. Opening in Tampa in 2005 with one just operating room and nine employees, Laser Spine Institute has grown to seven, state-of-the-art facilities with nearly 1,000 corporate and health care professionals across the country.

Contacts

Edelman
Maura Devetski, 404-832-6788
maura.devetski@edelman.com

OMNIlife science™ Inc., Appoints Rick Epstein as Chief Executive Officer

Posted On May 14, 2018 By OrthoSpineNews In Recon, Top Stories /

RAYNHAM, Mass., May 14, 2018 /PRNewswire/ — OMNIlife science, Inc. (“OMNI”), a privately-held, established medical technology company targeting the $15 billion global hip and knee replacement device market, reported today that Rick Epstein has joined OMNI as CEO. Before joining OMNI, Mr. Epstein served as President and CEO of Sonoma Orthopedic Products for 5 years. Prior to Sonoma, Rick held several executive leadership positions in prominent organizations including Baxter International and Cardinal Health.

“We are pleased that Rick is joining the OMNI team as our CEO and member of our Board of Directors,” commented Guy Mayer, Executive Chairman of OMNI. “Rick’s experience successfully leading medical device companies through new product introductions will bring great value as we begin launching our new OMNIBotics® Active Spacer™ technology for robotically balancing the ligaments in a total knee replacement surgery.”

“I’m looking forward to leading OMNI through an exciting growth stage as surgeons, hospitals and surgery centers begin to experience the benefits OMNI’s products and services will bring to them,” Mr. Epstein stated. “The recent FDA clearance of OMNI’s Active Spacer along with the OMNIBotics surgical robot and OMNI’s knee implants provide surgeons with the most advanced tools available for balancing soft tissue, implanting total knees and ultimately providing the best possible outcomes for their total knee patients.”

ABOUT OMNI
OMNI is a privately held company with a proprietary robotic platform, OMNIBotics®, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and enhance a surgeon’s ability to help patients live active and pain-free lives. For more information about OMNI, please visit www.omnils.com.

FORWARD LOOKING STATEMENTS
Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including its plans specific to OMNIBotics systems, as well as statements using the terms “plans,” “believes” or similar expressions are “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI’s markets, decrease in the demand for OMNI’s products, delays in OMNI’s product research and development cycles, decreases in the use of OMNI’s principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI’s current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI’s current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI, increases in costs of OMNI’s sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI’s products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release.

CONTACT
Cindy Holloway, Director of Marketing Communications
Phone: (508) 824-2444
cholloway@omnils.com

SOURCE OMNIlife science, Inc.

Medical Devices with Aptitude: How Smart Implants Improve Patient Outcomes

Posted On May 11, 2018 By OrthoSpineNews In Extremities, Top Stories /

S. Himmelstein – 09 May 2018

Traditionally manufactured implants have their limitations, as they can only be produced in a certain number of shapes and sizes, posing problems in terms of patient fit. Joint replacement devices can be agents of stress shielding — the process whereby metal implants remove stress from the patient’s bone, which responds by reducing in density and becoming weaker. Cardiac implants require routine removals to replace batteries.

What’s a medical device designer to do? Make the implants smarter. The smart implant is medicine’s latest innovation, a tiny chip implanted in surgery which is able to measure patients’ pH and hormone levels, blood glucose concentration, bacteria, electrical activity and temperature, providing doctors with real-time biofeedback. Patients equipped with smart implants have a lower risk of serious infection post-op, suffer from less discomfort and pain, and could also be less likely to need revision surgeries in the future.

The advent of additive manufacturing offers a route to the design of patient-specific implants (PSIs). The manufacturing method also imposes fewer geometric constraints than subtractive manufacturing. PSIs designed and manufactured according to a patient’s computed tomography scan encourages the implant to integrate with the patient’s bone, reducing the risk of loosening. The use of 3D printing enables surgeons to control additional material properties and design implants that mimic a patient’s bone stiffness, density and trabecular structure, which can reduce stress shielding and improve physical function.

The European Union’s PRosPERoS (PRinting PERsonalized orthopedic implantS) research project is developing smart, 3D-printed implants for the repair of large bone defects. Personalized and biodegradable implants are being engineered based on magnesium and zinc alloys. By accurately scanning the vertebrae with advanced imaging techniques, PSI implants can be designed and printed.

Built-in sensors represent another opportunity for smartening up implants. Advanced sensor technology is fostering development of implants that can detect an infection and subsequently secrete the appropriate dose of antibiotic. Sensors can measure the strain exerted on the implant, which indicates the extent the fracture has healed.

READ THE REST HERE

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FDA seeks permanent injunctions against two stem cell clinics

Posted On May 10, 2018 By OrthoSpineNews In Regulatory, Top Stories /

SILVER SPRING, Md., May 9, 2018 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration, in two complaints filed today in federal court, is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements.

“Cell-based regenerative medicine holds significant medical opportunity, but we’ve also seen some bad actors leverage the scientific promise of this field to peddle unapproved treatments that put patients’ health at risk. In some instances, patients have suffered serious and permanent harm after receiving these unapproved products. In the two cases filed today, the clinics and their leadership have continued to disregard the law and more importantly, patient safety. We cannot allow unproven products that exploit the hope of patients and their loved ones,” said FDA Commissioner Scott Gottlieb, M.D. “We support sound, scientific research and regulation of cell-based regenerative medicine, and the FDA has advanced a comprehensive policy framework to promote the approval of regenerative medicine products. But at the same time, the FDA will continue to take enforcement actions against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by purporting to have treatments that are being manufactured and used in ways that make them drugs under the existing law but have not been proven safe or effective for any use.”

A permanent injunction is being sought against US Stem Cell Clinic LLC of Sunrise, Florida, its Chief Scientific Officer Kristin Comella and its co-owner and managing officer Theodore Gradel for marketing to patients stem cell products without FDA approval and while violating current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk. The FDA is taking this action because US Stem Cell Clinic did not address the violations outlined in a warning letter to the clinic and failed to come into compliance with the law. The FDA is seeking an order of permanent injunction requiring US Stem Cell and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.

The FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center Inc., with locations in Rancho Mirage and Beverly Hills, California; Cell Surgical Network Corporation of Rancho Mirage, California; and Elliot B. Lander, M.D. and Mark Berman, M.D., from marketing to patients stem cell products without FDA approval. Berman and Lander control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center. The FDA is seeking an order of permanent injunction requiring California Stem Cell Treatment Center Inc. and Cell Surgical Network Corporation and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.

US Stem Cell Clinic

The FDA issued a warning letter to US Stem Cell Clinic in August 2017 for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products. The warning letter also cited an FDA inspection of the clinic which found that it was processing adipose tissue (body fat) into stromal vascular fraction (a cellular product derived from body fat) and administering the product both intravenously or directly into the spinal cord of patients to treat a variety of serious diseases or conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis. The FDA has not approved any biological products manufactured by US Stem Cell Clinic for any use.

During the inspection of US Stem Cell Clinic in April and May 2017, FDA investigators also documented evidence of significant deviations from current good manufacturing practices in the manufacture of at least 256 lots of stem cell products by the clinic. For example, the clinic was cited for its failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections.

The complaint for permanent injunction against US Stem Cell Clinic was filed by the U.S. Department of Justice on behalf of the FDA in the U.S. District Court for the Southern District of Florida.

California Stem Cell Treatment Center, Inc. and Cell Surgical Network Corporation

In August 2017, the FDA took action to prevent the use of a potentially dangerous and unproven treatment belonging to StemImmune Inc. in San Diego, California and administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills. On behalf of the FDA, the U.S. Marshals Service seized five vials of Vaccinia Virus Vaccine (Live) – a vaccine that is reserved only for people at high risk for smallpox, such as some members of the U.S. military. The seizure came after FDA inspections at StemImmune and the California Stem Cell Treatment Centers confirmed that the vaccine was used to create an unapproved stem cell product (a combination of excess amounts of vaccine and stromal vascular fraction – a cellular product derived from body fat). The product was then administered to cancer patients with potentially compromised immune systems and for whom the vaccine posed a potential for harm, including the possibility of inflammation and swelling of the heart and surrounding tissues. The unproven and potentially dangerous treatment was being injected intravenously and directly into patients’ tumors.

California Stem Cell Treatment Center products are also being used for the experimental treatment of patients who suffer from a variety of serious diseases or conditions, including cancer, arthritis, stroke, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), macular degeneration, Parkinson’s disease, chronic obstructive pulmonary disease (COPD) and diabetes. The FDA has not approved any biological products manufactured by California Stem Cell Treatment Center for any use.

During inspections of California Stem Cell Treatment Center’s Beverly Hills and Rancho Mirage facilities in July 2017, FDA investigators documented, among other violations, evidence of significant deviations from current good manufacturing practice requirements. For example, the clinics were cited for failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections.

The complaint for permanent injunction was filed by the U.S. Department of Justice on behalf of the FDA in the U.S. District Court for the Central District of California.

Regenerative medicine regulatory framework

These cases support the FDA’s comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies. The FDA issued four guidance documents in November 2017, two final and two draft, that build upon the FDA’s existing risk-based regulatory approach. Under this framework the FDA detailed its efficient, science-based process for helping to ensure the safety and effectiveness of these therapies, while supporting development in this area. One of the two draft guidance documents laid out a novel and efficient clinical development model by which promising cell-based products could pursue review and approval by the FDA. The suite of guidance documents also describes a risk-based framework for how the FDA intends to focus its enforcement actions against those products that raise reported safety concerns or potential significant safety concerns.

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Lyndsay Meyer, 240-402-5345; lyndsay.meyer@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

ATTUNE Knee System Linked to Improvements in Patient Quality of Life and Reduced Length of Hospital Stay

Posted On May 10, 2018 By OrthoSpineNews In Recon, Top Stories /

WARSAW, Ind., May 10, 2018 /PRNewswire/ — DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies**, today announced clinical findings outlining the potential benefits patients may experience when undergoing knee replacement with the ATTUNE Knee System.

First, a study¹ presented at the 2^nd World Arthroplasty Congress in Rome on Patient Reported Outcome Measures (PROMS) reported a statistically significant improvement in knee physical function at six months with the ATTUNE Knee compared to preoperative baseline, using the Knee injury and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS). The multicenter study of 200 cases from The Netherlands found that 80 percent of those ATTUNE Knee patients’ KOOS-PS improvements were realized by six months, with statistically significant improvements observed at intervals prior to six months. Also, pain and other PROMS were statistically significantly better at six weeks compared with pre-operative baseline.

“This multi-center outcomes study is further evidence of the positive performance of the ATTUNE Knee, and this study provides additional evidence on the rate of recovery – information that is useful when counseling patients before surgery,” said Geert Meermans, MD, Bravis Hospital, The Netherlands. “From my intraoperative and patient follow up experiences, the ATTUNE Knee appears to provide greater stability than other implants I have used, which may be a contributing factor to these positive results.”

Secondly, a report² generated by DePuy Synthes summarized a series of studies across several countries with differing healthcare systems. This report, entitled “The Impact of Implant Design on Hospital Length of Stay and Discharge Destination: Evidence Summary Report,” evaluated the connection between implant design and patient hospital length of stay (LOS), and encompassed some data that has been presented or accepted at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).^3-7 This retrospective review of five real-world evidence studies, conducted by DePuy Synthes in the US, UK, Germany, Italy and The Netherlands, was designed to evaluate whether patients treated with the ATTUNE Knee had a shorter hospital length of stay (LOS) versus a number of comparative implants. The report concluded that in each of these studies, the ATTUNE Knee patients were discharged from the hospital sooner than with the comparative implants used.^3-7

Reducing LOS is recognized as an effective way to lessen the financial burden of elective orthopaedics by reducing resource utilization, thereby lowering the overall cost of care.⁸ In addition, reducing LOS may also positively impact patient satisfaction. Emerging evidence detailed in this report² suggests the ATTUNE Knee may facilitate earlier hospital discharge, with these studies observing a reduced length of stay between 0.19 and 4 days on average, depending on the comparative implants/countries compared against.^3-7 While differences in healthcare systems limit the direct comparison of these observed statistically significant improvements in LOS, this report highlights the positive impact the ATTUNE Knee may deliver in various rehabilitation settings.

Commenting on the LOS findings to which his Center also contributed, Dr. Meermans concluded, “While it’s important to acknowledge that many factors can contribute to differences in length of stay, the data seems to suggest that implant design may be an important factor to consider in total knee arthroplasty procedures. This latest evidence gives me greater confidence that the device could help hospitals cost-effectively keep pace with the growing total knee arthroplasty demand.”

These findings come at a time when healthcare systems are facing unprecedented challenges due to demographic shifts and increases in demand due to the predicted global growth of knee replacement procedures.⁹ It is increasingly important for healthcare providers to demonstrate improved clinical, economic and patient reported outcomes to help minimize the total cost per procedure while maintaining and, where possible, improving quality of care.

Torbjorn Skold, Vice President, DePuy Synthes EMEA Joint Reconstruction added: “I’m delighted that this data demonstrated that study patients receiving the ATTUNE Knee experienced positive outcomes related to the rate of return of functional outcomes and reduced length of stay, allowing these patients to get back to a positive quality of life.”

Notes to Editors

About the Length of Stay (LOS) Report “The Impact of Implant Design on Hospital Length of Stay and Discharge Destination: Evidence Summary Report”²

The purpose of this report was to summarize a series of 5 studies that were designed to evaluate whether patients treated with the ATTUNE Knee had a shorter LOS versus certain comparative implants. The studies were conducted in several countries with differing healthcare systems. All the studies in this report defined LOS as the primary endpoint. An additional study by Clement et al., (2017) conducted in Scotland also observed a statistically significant 1.2-day reduction (P<0.001) in LOS versus another leading knee system but is not included in this report as LOS was not the primary outcome.¹⁰

There are several important aspects of this report that limit the comparability of results among the studies and the generalizability to other institutions/countries. Due to factors within each country’s healthcare systems, baseline mean LOS will vary, which limits direct comparison of the means and differences between studies. Statistical analyses also differ by study as they controlled for different factors because of the feasibility of retrospective chart review/data collection at each site, which further limits the comparability of the results. This review however, was not intended to aggregate the data, it was to report each study in isolation and highlight the reductions in LOS seen in multiple healthcare settings following the adoption of the ATTUNE Knee.

Study summary

Study 1 examined insurance claims data across a range of US geographies and institution types (38 hospitals) including 1,178 US patients who received the ATTUNE Knee and 5,707 patients who received the Triathlon® Knee, with the patients receiving the ATTUNE Knee having a shorter average LOS (<0.19 day) compared to the Triathlon® Knee patients. ATTUNE Knee patients were also 39% less likely to be discharged to a skilled nursing facility.³

Study 2 evaluated patients at a University Teaching Hospital in the UK, 238 of whom were implanted with an ATTUNE Knee, 332 with a SIGMA Knee and 149 with a Columbus® Knee. Patients implanted with the ATTUNE Knee on average experienced a 0.8-day shorter LOS compared to SIGMA Knee patients and a 1-day reduction compared to patients treated with the Columbus® Knee. Both comparisons were statistically significant.⁴

Study 3 evaluated patients at a private German hospital, 85 of whom were implanted with the ATTUNE Knee compared to 85 implanted with the LCS Complete Knee System. Patients in this study implanted with the ATTUNE Knee were discharged from hospital on average 2.1 days earlier than patients implanted with the LCS Complete Knee. This reduction in LOS was statistically significant.⁵

Study 4 evaluated two groups at a private Italian hospital: 100 patients implanted with the ATTUNE Knee and 100 patients who received a SIGMA Knee. A statistically significant difference in LOS was observed: the patients implanted with an ATTUNE Knee were discharged from the hospital on average 4 days earlier than the patients implanted with a SIGMA Knee. ⁶

Study 5 evaluated two groups at a public hospital in The Netherlands: 100 patients implanted with the ATTUNE Knee and 100 patients implanted with the SIGMA Knee. Both groups were treated with the same rehabilitation protocol. Patients in this study who were implanted with the ATTUNE Knee were discharged from the hospital on average 0.67 days earlier than patients implanted with the SIGMA Knee. Similar to study 1,³ ATTUNE Knee patients were also less likely to be discharged to a rehabilitation center (referred to as a skilled nursing facility in the US). For Study 5, the statistically significant improvements were achieved in a hospital environment with an established enhanced recovery program and a low baseline LOS.⁷

All the studies defined LOS as the primary endpoint. A copy of the full report can be found on ATTUNEevidence.com.

About the Johnson & Johnson Medical Devices Companies
The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, interventional solutions and specialty surgery with an offering directed at delivering clinical and economic value to health care systems worldwide.

About DePuy Synthes

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.

The third-party trademarks used herein are the trademarks of their respective owners.

References

van Loon C, Meermans G, Baas N, Vergroesen D, van Kampen P, Dwyer K, Lesko J, Huey V. Early Recovery Rate After A New Design Total Knee Arthroplasty (TKA): A Prospective, Multicenter Cohort of 200 Cases. Poster Accepted to World Arthroplasty Congress April 19-21, 2018. Rome, Italy, Poster # P101.
The Impact of Implant Design on Hospital Length of Stay and Discharge Destination Evidence Summary Report. 090088-180413. Available at ATTUNEevidence.com. Accessed April 2018.
Etter K, Lerner J, Kalsekar I, de Moor C, Yoo A, Swank M. Comparative Analysis of Hospital Length of Stay and Discharge Status of Two Contemporary Primary Total Knee Systems. The Journal of Knee Surgery. 2017 Aug 25.
Mantel J, Corso KA, Wei D, Holy CE, Muehlendyck C, Jayakumar P, Higgins M, Westbrook A. Economic Effectiveness Of The ATTUNE® Knee System-Analysis Of Real World Hospital Length Of Stay And Incidence Of Early Complications. Value in Health. 2017 Oct 1;20(9): A579.
Brüggenjürgen B, Muehlendyck C, Gador L, Katzer A. Length of Hospitalisation After ATTUNE® Knee Joint Arthroplasty (TKA)-Results of A German Retrospective Database Analysis. Value in Health. 2017 Oct 1;20(9):A597.
Pipino G, Paragò V, Corso KA, Wigham R, Holy CE, Do Rego B. Economic Outcomes Of The ATTUNE® Knee System: Analysis Of Real World Length Of Stay In An Italian Hospital. Value in Health. 2017 Oct 1;20(9):A595.
Meermans G, Galvain T, Wigham R, Do Rego B, Schröer D. Comparative analysis investigating the impact of implant design on hospital length of stay and discharge destination in a Dutch hospital with an established enhanced recovery program. DSEM/JRC/0118/0984. Poster Accepted to ISPOR Annual Meeting May 19-23, 2018. Baltimore US. Presentation code PMD23.
Briggs TWR. A national review of adult elective orthopaedic services in England: Getting it right first time. Available at: https://www.boa.ac.uk/wp-content/uploads/2015/03/GIRFT-National-Report-Mar15..pdf. Accessed April 2018.
Patel A, Pavlou G, Mújica-Mota RE, Toms AD The epidemiology of revision total knee and hip arthroplasty in England and Wales: a comparative analysis with projections for the United States. A study using the National Joint Registry dataset. Bone & Joint J. 2015 Aug;97-B(8):1076-81.
Clement N, Brenkel I, Walmsley P. IMPROVED EARLY FUNCTIONAL OUTCOME WITH THE ATTUNE TOTAL KNEE REPLACMENT: A PROPENSITY SCORE MATCHED TRIAL. 2017. Poster session presented at British Association for Surgery of the Knee, Southport, United Kingdom.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the ATTUNE Knee System*. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes, any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither DePuy Synthes, the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.

091374-180507

SOURCE DePuy Synthes

Permira funds to acquire Corin a leading orthopaedic company

Posted On May 9, 2018 By OrthoSpineNews In Financial, Top Stories /

London, 9 May 2018 – Global investment firm Permira and Corin Orthopaedics Holding Ltd (“Corin”), one of the fastest growing orthopaedic firms, today announced that a company backed by the Permira funds has signed a definitive agreement to acquire a majority stake in Corin from DeA Capital Alternative Funds SGR (controlled by DeA Capital Group), Hunt Capital, IP (Investimenti e Partecipazioni) and other investors, for an undisclosed sum. The investment provides substantial new funding to fuel the next stage of Corin’s development after 5 years of outstanding growth. Chief Executive Stefano Alfonsi and the management team will continue to lead Corin and will remain significant investors in the Company alongside the Permira funds.

Headquartered in Cirencester, UK, Corin is an international orthopaedic company with a direct presence in a majority of the world’s orthopaedic markets and a track record of strong double-digit growth. Corin aims to revolutionise orthopaedics by gaining, understanding and sharing insight at every stage of the arthroplasty experience. This unique combination of shared knowledge and clinically-proven implants delivers better outcomes and maximise healthcare value for patients, surgeons and healthcare providers.

Permira identified Corin as an attractive med-tech investment opportunity based on:

A very large orthopaedic implant market ($17.5bn) growing at 3% – 5% per annum as a result of increasing healthcare expenditures driven by long-term trends including a growing ageing population, more active elderly people and increasing obesity levels;
Challenger Original Equipment Manufacturers (OEMs) gaining market share in the orthopaedic industry through better product innovation, focus on customer service and enhanced software including positioning, patient monitoring and robotics;
A robust and scalable international platform with actionable organic and M&A growth opportunities;
A high-quality and experienced management team with a clear vision for the business.

Stefano Alfonsi, CEO of Corin, commented:

“We are delighted to partner with a leading investment firm like Permira to support us in achieving our ambitious growth plan. In the last five years we have laid the foundations for Corin to become a very competitive player in the orthopaedic industry. We are ready and excited for Corin’s future. I would like to thank our team for all their hard work which has been critical to the company’s success over the last 5 years and will be even more critical for the future.”

Silvia Oteri, Partner in Permira’s Healthcare Team, added:

“We are extremely excited to support Stefano Alfonsi and his outstanding management team in the next phase of Corin’s development. We have been following the orthopaedic industry for a long time and have been impressed by the rapid growth of challenger innovative companies like Corin. Since 2012, the Company has transformed from a basic orthopaedic manufacturer into a fast-growing international software-led orthopaedic-implant designer. We look forward to working with the team, and drawing on our significant healthcare and technology experience, to help the company capture further growth opportunities.”

Permira has an established track record of successfully partnering with market leading healthcare businesses, having deployed circa €1.5 billion of equity in the sector to date. The announced acquisition of Corin marks the Permira funds’ first investment in the orthopaedics’ market and 14th investment in the healthcare industry since inception.

Other recent healthcare investments have included: I-MED Radiology Network, the largest provider of diagnostic imaging services in Australia; LSNE a lyophilization contract manufacturing pharma specialist; Althea, a leading integrated provider of healthcare technology; Atrium Innovations, a global leader in the manufacturing, development and commercialisation of innovative, science-based health and nutrition products; PHARMAQ, one of the world’s leading manufacturers of vaccines and therapeutic products for the aquaculture industry and Creganna Medical, a global leader in the design and manufacture of “minimally invasive” surgical devices.

The transaction is expected to close in July 2018 following Antitrust approvals. The fund’s equity for the investment came from Permira’s dedicated global buyout fund Permira VI (€7.5bn, 2016). Following the completion of this investment, Permira VI will be circa 50% deployed.

Rothschild acted as financial advisers and Osborne Clarke as legal advisers to Corin. The Permira funds were advised by Vitale & Co, financial advisers, and Latham & Watkins LLP, legal advisers.

Media Contacts:

For Corin:

Elvio Gramignano, Global Strategic Marketing Director
+ 44 (0) 1285 884725
+ 44 (0) 7769 883 675

Rob Ashwell (Lucent Communication)
+44 (0) 7800 515 001

For Permira:

Noémie de Andia, Global Head of Communications

+44 207 632 1000
Noemie.deAndia@permira.com

James Olley (Montfort Communications)
+44 203 770 7909
jolley@montfort.london

About Corin
Since its inception, Corin has led the way in orthopaedic innovation — providing a faster, positive and more assured return to quality of life for people all over the world. Today, as a dynamic, growing, global business, Corin’s approach is revolutionising orthopaedics. We offer a unique combination of clinically-proven hip, knee, ankle and shoulder solutions and world-leading technologies that enable patients, surgeons and healthcare providers to connect more closely than ever. The deep insight we gain, understand and share at every stage of the connected orthopaedic experience leads to advanced, patient-specific solutions that exceed expectations, maximise value in healthcare and positively impact lives.

About Permira

Permira is a global investment firm that finds and backs successful businesses with growth ambition. Founded in Europe in 1985, the firm advises funds with a total committed capital of approximately €32 billion. The Permira funds make long-term investments in companies with the ambition of transforming their performance and driving sustainable growth. Over more than three decades, the Permira funds have made over 200 private equity investments in five key sectors: Consumer, Financial Services, Healthcare, Industrials and Technology. Recent announced and completed investments from Permira VI include: Allegro, Alter Domus, Cisco’s Service Provider Video Software Solutions, Diversitech, Duff & Phelps, Cybersecurity and cloud software distributor Exclusive group, I-Med Radiology Network, LSNE, La Piadineria and Schustermann & Borenstein. For more information visit www.permira.com.

Posted 9 hours ago by Hannah McCaughan

NuVasive Unveils Newest Additions To Early Onset Scoliosis Portfolio At POSNA Annual Meeting

Posted On May 8, 2018 By OrthoSpineNews In Spine, Top Stories /

SAN DIEGO, May 8, 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 Company will officially unveil MAGEC X, the newest offering in its Early Onset Scoliosis (EOS) procedural solutions portfolio at the POSNA Annual Meeting in Austin, Texas. NuVasive is a Double Diamond Sponsor of the conference, reflecting its continued support of advancing pediatric care.

The launch of MAGEC X is the culmination of over a decade of research and innovation. The new and improved MAGEC X features a strong, smart and sleek design with a new 5.0mm rod option that offers 68 percent improved fatigue-strength performance over the previous 4.5mm optionⁱ. The internal rod mechanism of the previous product generation has been redesigned with a robust actuator seal, a reinforced locking pin and anti-jam protection. Aesthetic improvements to the new design enhance ease-of-use by providing visual indicators for cutting and implanting the rod.

At its core, the MAGEC system features magnetically-controlled growing rods designed to eliminate planned distraction surgeries from the treatment for EOS. This innovative system simplifies care for EOS by helping to reduce the anxiety and complication risks associated with repetitive growing-rod surgeriesⁱⁱ.

“The MAGEC system continues to be the gold standard for the minimally-invasive treatment of Early Onset Scoliosis,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “With MAGEC X, we have found a way to take an exceptional solution to another level through internal rod mechanism advancements to boost performance and by providing surgeons with expanded size options. With MAGEC X clinicians can treat a greater variety of EOS cases—giving them a less invasive and traumatic experience as they work to achieve a straighter spine and a higher quality of life.”

Starting in summer 2018, NuVasive will kick-off the Journey Together Program featuring a limited warranty on MAGEC X rods when used with cleared NuVasive procedural solutions. Through this unique partnership with patients, families, surgeons and hospitals, NuVasive hopes to provide a healthcare solution that maximizes the value of EOS treatment.

During POSNA 2018, NuVasive is also showcasing RELINE Small Stature and LessRay within its pediatric spine solutions portfolio.

RELINE Small Stature is the first pediatric deformity fixation solution to accept both 4.5mm and 5.0mm rods in a low-profile tulip—eliminating the need to sacrifice strength for size in EOS patients. The instrumentation helps surgeons gain heightened anatomical awareness to optimize implant placement, and when paired with the new MAGEC X 5.0mm rod, the procedural solution may minimize the occurrence of revision surgeries.

In addition, as part of the Company’s Surgical Intelligence™ platform, LessRay offers the surgeon and hospital system the opportunity to use significantly reduced radiation imaging in the operating room. Following a recent procedure using LessRay, Dr. Amer Samdani, Chief of Surgery at Shriners Hospital for Children — Philadelphia, remarked, “I was amazed that the NuVasive LessRay technology allowed us to take less shots and reduce the radiation emission with every shot, which has significant impact for staff and patients of all ages.”

Attendees at the POSNA Annual Meeting are encouraged to stop by NuVasive booth # 25-26 to learn more about MAGEC X, RELINE Small Stature, LessRay and the Company’s comprehensive, industry-leading solutions for creating better clinical outcomes for pediatric spine procedures.

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.

ⁱData on File
ⁱⁱ Yoon WW, Sedra F, Shah S, et al. Improvement of pulmonary function in children with early-onset scoliosis using magnetic growth rods. Spine. 2014;39 (15):1196-1202.

SOURCE NuVasive, Inc.

Orthopedic Trauma Devices Market Expected to Account for US$ 14 Bn by 2028

Posted On May 8, 2018 By OrthoSpineNews In Extremities, Top Stories /

VALLEY COTTAGE, New York, May 8, 2018 /PRNewswire/ —

Primarily driven by increasing instances of fractures due to road accidents and sports related injuries, the global market for orthopedic trauma devices is anticipated to expand at a promising CAGR of 6.8% over the next decade. By the end of 2028, the orthopedic trauma devices market is estimated to attain the global revenues beyond US$ 14 Bn. As per the research presented in a recently published report by Future Market Insights, titled “Orthopedic Trauma Devices Market: Global Industry Analysis 2013 – 2017 and Opportunity Assessment, 2018 – 2028,” the market will also continue to be driven by impactful presence of some of the local players within respective regional markets.

“While the advent of 3D printing technology is likely to present the market a heap of new growth opportunities in 3D printed orthopedic implants, another significant opportunities lies in the popularly trending reverse shoulder arthroplasty. The rise of digital orthopedics will continue to fuel market growth through to 2028,” states a research analyst at Future Market Insights.

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Request a Sample Report with Table of Contents and Figures: https://www.futuremarketinsights.com/reports/sample/rep-gb-2840

Based on the regional analysis, the global orthopedic trauma devices market will continue to witness dominance of North America, which currently accounts for a major portion of the total revenues. With around 48% value share observed in 2017, North America’s orthopedic trauma devices market is estimated to attain a value in excess of US$ 6 Bnby the end of 2028. Western Europe is also identified to be a key market, holding the second largest position in terms of value. Manufacturers will however discover attractive opportunities in developing economies, including Asia Pacific, Latin America, and Middle East and Africa. Among the emerging regional markets, Asia Pacific excluding China and Japan (APECJ) is likely to emerge at a relatively higher pace, followed by MEA. China is expected to be the most lucrative market owing to the highest estimated CAGR value over 2018-2028. Strong presence of key companies will reportedly uplift the markets in North America and China.

Preview Orthopedic Trauma Devices Market Segmentation by Product Type – Internal Fixators, Screws, Plates, Intramedullary Nails, Others, External Fixators, Unilateral Fixators, Circular Fixators, Hybrid Fixators; by end user – Hospitals, Orthopedic and Trauma Centers, Ambulatory Surgical Centers: https://www.futuremarketinsights.com/reports/orthopedic-trauma-devices-market

A majority of the key companies operating in the global orthopedic trauma market are opting for strategic mergers and acquisitions, in addition to new product launches. According to the report, most of the revenue is contributed by the tier 1 companies, followed by the tier 3 players. The tier 1 includes DePuy Synthes Inc., Stryker Corporation, Zimmer Biomet Holdings Inc., and Smith & Nephew Plc., which collectively represent nearly 70% share of the total market revenues. Among these, DePuy and Stryker will continue to remain the top players worldwide over the next decade. Tier 3 accounts for a relatively decent revenue share and includes brands such as Arthrex, Inc., RTISurgical, Medartis, Integra LifeSciences Corporation, Japan MDM, S. H. Pitkar Orthotools Pvt Ltd, Weigao Group Co Ltd, and Invibio Ltd.

Others operating in the global orthopedic trauma devices market include Johnson & Johnson Services, Inc., Wright Medical Group NV, B. Braun Melsungen AG, Orthofix International, and OsteoMed. Growing outpatient surgical procedure demand and boosting funds for delivery of the top-notch trauma care are foreseen to collectively create a lucrative pool of opportunities for the leading bunch of companies in the global marketplace. The market is also witnessing the development of novel and effective products for use in trauma care, which stands to be another important opportunity.

Our advisory services are aimed at helping you with specific, customized insights that are relevant to your specific challenges. Let us know about your challenges and our trusted advisors will connect with you: https://www.futuremarketinsights.com/askus/rep-gb-2840

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Bone Growth Stimulators Market Segmentation By Product – Invasive Bone Growth Stimulators, Non-Invasive Bone Growth Stimulators and Ultrasound Bone Growth Stimulators; By End User – Hospital, Ambulatory Surgical Centers, Orthopedic Clinics, and Home Care; By Application – Trauma Injury and Fractures, Spinal Fusion, and Osteogenesis; Others – Market Size, Growth, Forecast, Sales, Pricing Forecast, Share, Export Value, Export Volume, Trade: https://www.futuremarketinsights.com/reports/bone-growth-stimulators-market
Platelet Rich Plasma (PRP) Market Segmentation By Types – Pure Platelet-Rich Plasma, Leukocyte Rich Platelet Rich Plasma; By Origin – Autologus PRP, Allogenic PRP, Homologus PRP; By Applications – Orthopedic Surgery, Cosmetic Surgery, General Surgery, Neurosurgery: https://www.futuremarketinsights.com/reports/platelet-rich-plasma-market
Ambulatory Surgical Centres Market Segmentation centre type – Single Speciality Centres, Multispecialty Centres; modality type – Hospital-based Ambulatory Surgical Centre, Freestanding Ambulatory Surgical Centre; service type – Diagnostic Services, Surgical Services; speciality area – Gastroenterology, Ophthalmology, Orthopedics, Pain/Neurology, Urology, Dermatology, Others: https://www.futuremarketinsights.com/reports/ambulatory-surgical-centre-market-092017

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