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.
³Vizesi F, Cunningham B, Hu N, et al. Nanostructured TCP in the sheep posterolateral fusion model. 9th World Biomaterials Congress 2012. Chengdu, China.
⁴Ismailoglu 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.
⁵Fredericks 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.
⁶Walsh 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.

RTI Surgical® Announces Commercial Launch of Fortilink®-TS and -L IBF Systems with TETRAfuse® 3D Technology

Posted On June 12, 2018 By OrthoSpineNews In Spine, Top Stories /

June 12, 2018

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, announced the full commercial launch of its Fortilink®-TS and -L IBF Systems, adding to a growing series of interbody fusion devices featuring proprietary TETRAfuse® 3D Technology. The Fortilink-TS and -L Systems are intended for use in lumbar interbody fusion procedures at one or two adjoining levels in patients with degenerative disc disease. TETRAfuse 3D Technology is the first 3D printed polymer-based interbody fusion device to incorporate a nano-roughⁱsurface that has demonstrated, in a pre-clinical study, more notable trabecular bone ingrowth compared to PEEK and titanium-coated PEEKⁱⁱ.

“The Fortilink-L System is the first osteointegrative, radiolucent cage,” said Joseph O’Brien, M.D., M.P.H., founder of the Washington Spine & Scoliosis Institute at OrthoBethesda in Bethesda, Maryland, and one of the first surgeons to implant the Fortilink-L device. “While other companies are focusing on titanium, TETRAfuse 3D Technology offers ingrowth features that help the implant to fully integrate with the fusing bone. It also has best-in-class X-ray compatibility, which allows me to track my patients’ progress with more confidence.”

John O’Toole, M.D., M.S., Professor of Neurosurgery at Rush University Medical Center in Chicago, Illinois, and one of the first surgeons to implant the Fortilink-TS device, added, “The introduction of TETRAfuse 3D Technology revolutionizes the interbody device market by combining a favorable modulus of elasticity, optimal imaging characteristics and a surface design promoting vigorous bone ingrowth. I believe TETRAfuse 3D Technology meets all the criteria for an interbody through enhanced biology, biomechanics and ease of use to help improve outcomes for patients.”

The Fortilink-L IBF System is intended for a lateral transpsoas approach to the lumbar spine, also known as lateral lumbar interbody fusion (LLIF) surgeries. The Fortilink-TS System is intended for traditional posterior approaches known as transforaminal lumbar interbody fusion (TLIF) or bilateral posterior lumbar interbody fusion (PLIF) surgeries. TETRAfuse 3D Technology features a nano-roughⁱ surface with antibacterial characteristics^†iii and is designed to participate in fusionⁱⁱ without compromising mechanical integrityⁱ or radiographic visibility.ⁱ

“Based on the positive feedback from our surgeon customers and its unique design, we believe TETRAfuse 3D Technology is a new frontier in spine surgery,” said Camille Farhat, President and CEO, RTI Surgical. “RTI is committed to ongoing clinical research and development of innovative spine-focused solutions that meet the demands of surgeons and improve patient outcomes.”

RTI commercially launched its first implant using TETRAfuse 3D Technology, the Fortilink-C IBF System, in October 2017. It is used as an interbody fusion device in anterior cervical discectomy and fusion (ACDF) surgeries. All Fortilink implants have received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

For more information about the Fortilink series of devices and TETRAfuse 3D Technology, visit www.tetrafuse3D.com.

About Degenerative Disc Disease (DDD)

Degenerative disc disease (DDD) is an age-related condition when one or more discs between the vertebrae of the spinal column deteriorate or break down.^iv A symptom of DDD can include low back pain (LBP)^iv, which is the most common musculoskeletal condition affecting adults and the leading cause of disability worldwide.^v Approximately 40 percent of adults suffer from chronic low back pain at some point in their lifetime^vi, and health care costs and productivity losses associated with it are more than $50 billion annually.^vii Spinal fusion surgery is considered a viable treatment option for reducing pain and improving function in individuals diagnosed with DDD and LBP, who have not found relief with non-surgical care.^viii

About RTI Surgical, Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic and trauma procedures and are distributed in nearly 50 countries. RTI has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements, gaining market share and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

ⁱ Data on file at RTI Surgical, Inc.
ⁱⁱ Data on file at RTI Surgical, Inc. Performance data from animal studies may not be representative of performance in humans.
ⁱⁱⁱ Wang M, Bhardwaj B, Webster T; Antibacterial properties of PEKK for orthopedic applications. Int’l Journal of Nanomedicine. 2017: 12 6471-6476. ^iv Donally C, Dulebohn S. Lumbar Degenerative Disk Disease. StatPearls. Oct 2017. Online at https://www.ncbi.nlm.nih.gov/books/NBK448134/. Last accessed May 25, 2018.
^v Allegri M, Montella S, Salici F, et al. Mechanisms for low back pain: a guide for diagnosis and therapy. F1000Research. Oct 2016. Online at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4926733/. Last accessed May 25, 2018.
^vi Manchikanti L, Singh V, Falco FJ, et al. Epidemiology of low back pain in adults. Neuromodulation. 2014 Oct;17 Suppl 2:3-10. Online at https://www.ncbi.nlm.nih.gov/pubmed/25395111. Last accessed May 25, 2018.
^vii Licciardone JC. The epidemiology and medical management of low back pain during ambulatory medical care visits in the United States. Osteopath Med Prim Care. 2008; 2: 11. Online at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2631527/. Last accessed May 25, 2018.
^viii Phillips FM, Slosar PJ, Youssef JA et al. Lumbar spine fusion for chronic low back pain due to degenerative disc disease: a systematic review. Spine (Phila Pa 1976). 2013 Apr 1;38(7):E409-22. Online at https://www.ncbi.nlm.nih.gov/pubmed/23334400. Last accessed May 25, 2018.

^†Lab data may not be representative of the effects with all bacteria or performance when implanted in humans. Staphyloccocus epidermidis and Pseudomonas aeruginosa were subject bacterial strains in this study.

Please refer to the labeling for clinical applications, warnings, precautions and other instructions for use.

Contacts

RTI Surgical, Inc.
Media Contacts
Annie Claggett, +1 312-995-2856
aclaggett@rtix.com
or
Molly Poarch, +1 224-287-2661
mpoarch@rtix.com
or
Investor Contact
Nathan Elwell, +1 847-530-0249
nelwell@lincolnchurchilladvisors.com

NuVasive Announces Key Finance Appointments

Posted On June 11, 2018 By OrthoSpineNews In Spine /

SAN DIEGO, June 11, 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 appointments of Lisa Pecora as vice president, Global Commercial Finance and Tristan Ribar as vice president, Corporate Finance and Treasury. In addition, Marc Rosenbaum is promoted to corporate controller.

As the head of Global Commercial Finance, Ms. Pecora manages the U.S. and International Commercial finance functions with a focus on driving revenue growth and go-to-market strategy. Ms. Pecora is a seasoned finance professional who most recently served as executive vice president and chief financial officer of Carling Communications. In this role, she oversaw all financial and operational functions across the three companies that comprised the Carling Group of Companies. Prior to that, she served as director of financial planning and analysis (FP&A) at CareFusion, where she transformed reporting and forecasting processes as the company stood up operations after the spin-off from Cardinal Health and guided strategic and operational decisions to support business unit growth. Ms. Pecora earned a bachelor of science in Finance and a master of business administration from the University of Maryland’s Robert H. Smith School of Business in College Park.

Mr. Ribar oversees the NuVasive Corporate Finance and Treasury functions, including FP&A, treasury operations, along with supporting investor relations. His strong finance and FP&A experience in the medtech industry includes his most recent position at Alere, where he led the budgeting, forecasting, reporting and business analysis for the company before it was acquired by Abbott Laboratories in October 2017. Prior to that, he was the director of investor relations at CareFusion where he previously held multiple finance leadership roles within the organization since its spin-off from Cardinal Health, as well as leading the finance integration when the company was acquired by Becton Dickinson in March 2015. Mr. Ribar earned a bachelor of science in Business and a master of business administration from Ohio Dominican University in Columbus, Ohio.

Mr. Rosenbaum has been with NuVasive for more than four years and expands his senior accounting duties to now include serving as the corporate controller for the Company. He began his accounting career at Deloitte, and has held a variety of senior accounting roles at Dura Pharmaceuticals, Elan Pharmaceuticals, Gen-Probe and Hologic overseeing both internal and external financial reporting. He graduated with a bachelor of arts in Business Economics from the University of California, Santa Barbara.

“With these new leadership appointments, along with the rest of the finance team, we are building out the depth of the function through an excellent mix of finance and operations prowess as we focus on key areas to drive growth for NuVasive,” said Raj Asarpota, executive vice president and chief financial officer of NuVasive. “Specifically, this growth will be supported by our insourcing efforts at our manufacturing facility where we will continue to invest in the processes, tools and people with the financial expertise in costing and productivity enhancement to accelerate our profitability.”

SOURCE NuVasive, Inc.

Medacta International Announces First U.S. Surgery Utilizing New M.U.S.T. SI Joint Screw System for Sacroiliac Joint Fusion

Posted On June 11, 2018 By OrthoSpineNews In Spine, Top Stories /

June 11, 2018

CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–Family-owned orthopedics leader Medacta International today announced the first surgery utilizing its Medacta Unconstrained Screw Technology Sacro-Iliac Joint Screw System (M.U.S.T. SI) for sacroiliac joint fusion surgery, following clearance by the U.S. Food and Drug Administration (FDA). The M.U.S.T. Sacro-Iliac Joint Screw System is designed for sacroiliac joint fusion for patients suffering from degenerative sacroiliitis, sacroiliac joint disruptions and degenerative sacroiliac arthritis to ease chronic back pain. The system’s corresponding procedure is minimally invasive and can be optimized for the outpatient surgical setting. The first surgery employing M.U.S.T. SI in the U.S. was performed by Ashish Sahai, M.D., at West Boca Medical Center, in Boca Raton, Florida in mid-May.

Dr. Sahai’s patient had adjacent segment degeneration in the lumbar spine, secondary to previous lumbosacral fusion. “The M.U.S.T. SI provided a niche solution that was the best fit for my patient’s unique case,” said Dr. Sahai of the surgery. “I was impressed with the solid engagement the M.U.S.T. SI system provided, with strong stability in the interface between the system and its dedicated instrumentation. The added stability instilled greater confidence in the OR that my screw trajectory would be as accurate as possible, and my patient is doing extremely well as a result.”

The M.U.S.T. SI system features screws coated with porous and rough hydroxyapatite that are designed with hollow-body and multiple fenestrated patterned shafts to promote biological fixation and optimal arthrodesis. The self-tapping screws have radial windowed slots to optimize surrounding bone access to the bone substitute, allowing greater bone growth; a long pitch and dual lead thread for accelerated screw insertion and removal; and a tapered tip to aid in guidance through the pilot hole. The system also offers “one-size-fits-all” washers with favored angles, capable of accommodating extreme angulation and allowing optimal compression, as well as a comprehensive range of lengths suited for diverse patient anatomies.

“The M.U.S.T. SI System addresses another area of spine impairment, allowing us to continue enhancing our already comprehensive spine portfolio and build out our offerings that are well suited for both traditional and outpatient settings,” said Francesco Siccardi, Executive Vice President, Medacta International. “Congratulations to Dr. Sahai and team on a successful surgery; we’re always thrilled to see positive patient outcomes and look forward to rolling out this effective product throughout the U.S.”

M.U.S.T. SI is the newest addition to the M.U.S.T. Screw System portfolio, designed to deliver flexibility and versatility for surgeons. When paired with Medacta’s MectaLIF family of inter-body fusion devices and suite of specialized surgical instruments, the result is a harmonized, single-system approach for most spine stabilization applications.

For more information, visit Medacta’s M.U.S.T. SI webpage.

About Medacta International

Medacta^® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS^® system and total knee replacement with MyKnee^® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

Contacts

For Medacta International, Inc.
Emy Gruppo, 203-247-5856
Emy@torchcomllc.com

K2M Surpasses 100th Product Milestone with FDA Clearance and Launch of OZARK™ Cervical Plate Systems

Posted On June 7, 2018 By OrthoSpineNews In Spine /

LEESBURG, Va., June 07, 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 surpassed its 100^th product milestone with the announcement of U.S. Food and Drug Administration (FDA) 510(k) clearance and commercial launch of its OZARK™ Cervical Plate Systems—designed for anterior screw fixation to the cervical spine (C2-T1) in patients with degenerative disease, deformity, tumor, or trauma. This milestone highlights the depth and breadth of K2M’s 3D spinal balance portfolio, its cervical solutions offering, and crystalizes the Company’s commitment to improving surgical outcomes for people living with spinal disease.

“K2M is excited to celebrate our 100^th product milestone following regulatory clearance for the OZARK Cervical Plate Systems, the latest in our growing portfolio of cervical solutions designed to facilitate 3D spinal balance in patients,” said K2M Chief Medical Officer and Co-founder John P. Kostuik, MD. “At K2M, excellence in innovation is at the heart of all that we do. Since our founding we’ve focused on developing groundbreaking solutions for patients with spinal disease and remain dedicated to furthering this legacy.”

The OZARK Cervical Plate Systems are available in two designs, OZARK Guide and OZARK View, both featuring an advanced per-level, integrated locking cover that provides surgeons with clear visual and tactile confirmation of the final lock position. They both include a full range of plate and screw sizes and instrumentation for creating constrained, semi-constrained or hybrid screw constructs. The systems are compatible with K2M’s CASCADIA™ Cervical 3D Interbody Systems featuring Lamellar 3D Titanium Technology™, which uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques.

“K2M was founded on the idea of inventing the world’s most advanced technology for treating spinal deformity,” said K2M Chairman, President, and CEO Eric Major. “Today, we are proud to further realize this vision through our 100^th product milestone in the OZARK Cervical Plate Systems. We remain committed to continue building out our differentiated product portfolio, that when supported by our comprehensive Balance ACS Platform, helps surgeons address important surgical needs to improve the lives of spinal deformity patients worldwide.”

Balance ACS^® or (BACS^®) is a comprehensive platform applying three-dimensional solutions across the entire clinical care continuum to help drive quality outcomes in spine patients. BACS provides solutions to help surgeons achieve balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

For more information on the OZARK Cervical Plate Systems and K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.

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 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

NuVasive To Present At The Goldman Sachs Annual Global Healthcare Conference

Posted On June 6, 2018 By OrthoSpineNews In Spine /

SAN DIEGO, June 5, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today that management will present at the Goldman Sachs 39^th Annual Global Healthcare Conference at the Terranea resort in Rancho Palos Verdes, Calif., Tuesday, June 12, 2018, at 11:20 a.m. PT/2:20 p.m. ET.

A live webcast of the presentation will be available online from the Investor Relations page of the Company’s website at www.nuvasive.com. A replay of the presentation will remain available on the website for 30 days after the applicable live webcast.

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

SOURCE NuVasive, Inc.

IMPLANET Announces Opening of a United Kingdom Sales Branch

Posted On June 6, 2018 By OrthoSpineNews In Spine, Top Stories /

June 05, 2018

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

IMPLANET (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, announces the opening of a branch in the United Kingdom, accelerating expansion and direct growth in the growing adult degenerative market.

The Implanet UK branch will capitalise on the success of the approach adopted in France and the United States, where local teams have built up a mixed network of direct sales representatives and exclusive sales agents. Implanet is replicating this proven sales model, with focus on the main European markets. The Implanet UK branch is led by an experienced team, which will penetrate the market for adult degenerative spine disease, with first surgeries planned for June 2018. The partnership with Lindare Medical, the current distributor specialising in paediatric surgery, is continuing to progress.

Ludovic Lastennet, Chief Executive Officer of Implanet, comments: “Following the announcement of JAZZ Evo® last month, the opening of this branch in the United Kingdom confirms the roll-out of our strategy in the lucrative market of adult degenerative spine disease. This marks a major step forward in our commercial development in Europe, in particular the replication of the proven direct sales model used in France and the United States. This model facilitates direct customer contact and allows us to be more responsive to the clinical needs of surgeons and patients. The team is already operational, with in-depth knowledge of our JAZZ® technology. We are confident in the roll-out of JAZZ® in the British market for adult degenerative spine disease, estimated at over $100 million¹. This structural move fits in with our 2018-2019 strategic plan, which aims to promote the Implanet range directly in key European markets and prepare for the integration of the products offered by our partner L&K Biomed.”

Next press release: first-half 2018 sales on Wednesday 11 July 2018

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 46 staff and recorded 2017 sales of €7.8 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.

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

¹ Mordor Intelligence 2017 study

Contacts

IMPLANET
Ludovic Lastennet, +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot, +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, +1 917 385 21 60
implanet@alphabronze.net

Vertiflex Announces Appointments to Board of Directors, Ray Baker, MD, and Richard Mott

Posted On June 6, 2018 By OrthoSpineNews In Spine /

June 05, 2018

CARLSBAD, Calif.–(BUSINESS WIRE)–Vertiflex, Inc., a leading innovator of advanced, minimally invasive interventions for spinal stenosis, today announced two new members of its Board of Directors, adding strong clinical and industry expertise to the company’s leadership team.

Ray Baker, MD, brings extensive clinical experience to Vertiflex. He is currently chief medical officer at Relievant Medsystems, Inc. Dr. Baker has advised the Centers for Medicare and Medicaid Services (CMS), the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) on matters related to pain management. Dr. Baker previously chaired the multi-society pain workgroup for CMS and is past president of both the North American Spine Society and the Spine Intervention Society. His previous leadership experience includes vice president and executive medical director of EvergreenHealth Medical Group where he served on the Board of the Evergreen Surgical Center, chaired the EvergreenHealth Medical Group Leadership Council and was medical director of the Spine and Musculoskeletal Programs.

Richard Mott brings a tremendous wealth of experience in management and consulting of various private and public companies. He is currently a principal in Walkabout Consulting, LLC, a management consulting and private equity firm. Previously, he served as president, chief executive officer and director of Kyphon Inc., a NASDAQ-listed global medical device company, through its acquisition by Medtronic. Mr. Mott has held other executive positions, including chief operating officer at Wilson Greatbatch Technologies, Inc., a NYSE-listed medical technology company, and executive operating roles within Bristol-Myers Squibb.

“We are excited to welcome the proven expertise and leadership of Dr. Baker and Mr. Mott to our Board. They both have excelled in their respective fields, and I am confident they will help shape and strengthen the strategic direction of Vertiflex,” said Earl Fender, president and CEO of Vertiflex. “This is an exciting time for the company as the Superion® Indirect Decompression System is enjoying a steep growth trajectory. We see enormous potential for this therapy to help patients, with debilitating spinal stenosis, return to a full and functioning life.”

Vertiflex recently reached important milestones, including the completion in March of a $45 million financing to support the significant and accelerating commercial growth of the PMA-approved Superion® Indirect Decompression System. To date, Superion has been used in more than 2,500 commercial cases, after one of the most extensive, rigorous FDA clinical trials on spinal stenosis. The company is also conducting an extensive registry to track commercial safety and efficacy of Superion, which continues to show outcomes equivalent to, or better than, the clinical results that were part of the filing for FDA approval.

About Vertiflex, Inc.

Vertiflex is a privately held medical device company dedicated to the advancement of minimally invasive solutions for the treatment of lumbar spinal stenosis, which is the leading cause of spinal surgery in the elderly. Founded in 2005 and headquartered in Carlsbad, Calif., Vertiflex has developed proprietary, minimally invasive technologies for performing both indirect and direct decompressions of the lumbar spine. These procedures fill the gap in the stenosis treatment continuum between conservative care and traditional spine surgery. Vertiflex has compiled the largest, most rigorous body of device clinical evidence related to lumbar spinal stenosis. For more information, visit www.vertiflexspine.com.

Contacts

Vertiflex, Inc.
Kathryn Larson, Sr. Director, Strategic Marketing
+1 442.325.5941
klarson@vertiflexspine.com

Aesculap_LEAD_activLArtificialDiscAesculapLogo_WEB123A.jpg

Aesculap Implant Systems Announces U.S. Military’s TRICARE Now Covers Lumbar Total Disc Replacement

Posted On June 6, 2018 By OrthoSpineNews In Spine /

CENTER VALLEY, Pa., June 4, 2018 /PRNewswire/ — Aesculap Implant Systems, LLC announced today that TRICARE now covers the company’s activL^® Artificial Disc for active duty and retired military members and their families in need of Lumbar Total Disc Replacement (CPT^® procedure code 22857). Aesculap is a privately-held spine and orthopaedic implant company and a U.S. market leader in Lumbar Total Disc Replacement (TDR) with the activL Artificial Disc, a high-value alternative to spinal fusion for chronic low back pain.

In late 2017, Aesculap Implant Systems leadership met with the United States Defense Health Agency and provided critical decision makers from the agency with updated long-term evidence supporting the broader adoption of Lumbar Total Disc Replacement for single-level Degenerative Disc Disease. Evidence presented to the Agency included level 1a meta-analytic data demonstrating the superiority of Lumbar TDR to fusion in this patient population and five-year adjacent segment disease data from the activL Artificial Disc Investigational Device Exemption (IDE) study.

On May 8, 2018 the Agency published a policy stating that they found Lumbar TDR to be proven and medically necessary following their due diligence.

“I greatly respect the Agency’s willingness to listen to and truly hear the evidence available for Lumbar TDR and the activL Artificial Disc,” said Kim Norton, who heads the Reimbursement and Payer Relations strategy at Aesculap. “It is refreshing to experience their collaboration and appreciation for this procedure, which has been proven to provide better outcomes than fusion in a select patient population,” continued Norton.

Along with TRICARE, numerous commercial insurance plans have recently adopted positive coverage policies for Lumbar TDR over the last year. “Over 30 million more Americans now have access to this procedure due to the overwhelming evidence and our efforts,” said Norton.

“I have been able to offer my active duty military patients motion-preserving surgeries as an alternative to spinal fusion to treat degenerative disc disease of the lumbar spine,” said orthopaedic surgeon Anton Jorgensen, who treats military service members. “I am pleased that the same motion-preserving treatments will now be available for our retired military patients and dependents. The long-term value of motion preservation is supported by prospective studies and should be an option for select patients,” concluded Dr. Jorgensen.

“I am pleased to learn that I can now offer this life changing procedure to a segment of the population most qualified for it,” said orthopaedic surgeon William Reed, MD. Reed, who operates out of Blue Valley Hospital in Kansas City, KS, frequently sees patients with TRICARE. “In general, this population wants to get better and my experience so far has been that lumbar disc replacement with next generation technologies like the activL Artificial Disc makes a great deal of sense for them.”

The TRICARE policy is retroactive to November 2017.

About Aesculap Implant Systems, LLC
Aesculap Implant Systems, LLC, a B. Braun company, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com.

SOURCE Aesculap Implant Systems, LLC

CoreLink Acquires Expanding Orthopedics, Inc.

Posted On June 5, 2018 By OrthoSpineNews In Spine, Top Stories /

June 05, 2018

LITTLE ROCK, Ark.–(BUSINESS WIRE)–CoreLink, LLC (“CoreLink”), a portfolio company of The Stephens Group, LLC, has acquired the assets of Expanding Orthopedics, Inc. Terms of the transaction were not disclosed.

Expanding Orthopedics, founded in 2001, develops and commercializes innovative expandable devices for minimally invasive spine surgery. Along with the FDA-cleared expanding and articulating FLXfit™ and FLXfit 15™ titanium interbody systems, CoreLink has also acquired a broad array of additional patents and in-development products addressing the rapidly growing expandable interbody and spinal fusion market. CoreLink will provide enhanced support for existing users of both the FLXfit and FLXfit 15 systems, while utilizing its unique vertical integration to quickly incorporate system upgrades for a full commercial re-launch in Q3 2018.

“The acquisition of Expanding Orthopedics allows us to better serve our customers’ needs by adding important product lines and intellectual property in the fastest growing categories within the spine market. We look forward to supporting Expanding Orthopedics’ existing customer base with CoreLink’s broader product offering and leading sales, training, distribution and manufacturing infrastructure, and we’re particularly excited to introduce these new product lines to CoreLink’s customers,” said Jay Bartling, founder and CEO of CoreLink.

Clay Hunter, Managing Director at The Stephens Group, added, “We are very pleased to support CoreLink in this first complementary acquisition which adds a high-growth product line to CoreLink’s already broad portfolio. Jay and his team are great partners, and we look forward to continuing to support their efforts to build the leading vertically integrated manufacturer and distributor of highly engineered spinal implants and instrumentation.”

ABOUT CORELINK, LLC
Headquartered in St. Louis, Missouri, CoreLink is a leading provider of medical devices, primarily highly engineered spinal implants and instrumentation. The company employs both traditional precision manufacturing and additive manufacturing techniques to produce and sell a broad and growing line of pedicle screw systems, interbody spacers, plates, biologics and surgical instruments through a network of distributors and independent sales representatives as well as its internal salesforce to hospitals, surgery centers and other healthcare providers.

ABOUT THE STEPHENS GROUP, LLC
The Stephens Group is a private, family-owned firm investing its capital in companies with exceptional management teams and high returns on invested capital in growing industries. The Stephens Group has a long history of successfully investing in both minority and control positions across multiple industries. The Stephens Group, through its affiliates, has or has had significant investments in industrial products and services, healthcare, specialty distribution, telecom, media and technology, communications, financial services, consumer and specialty retail, energy services and gas exploration and production and other industries.

Contacts

The Stephens Group, LLC
Ronald M. Clark, 501-377-2356
General Counsel
rclark@stephensgroup.com

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