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.”

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.

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

Acelity Acquires Crawford Healthcare to Create the World’s Most Expansive Wound Care Portfolio

Posted On June 8, 2018 By OrthoSpineNews In Biologics /

June 08, 2018

SAN ANTONIO & KNUTSFORD, United Kingdom–(BUSINESS WIRE)–Acelity L.P. Inc., the world’s largest wound care company, and Crawford Healthcare, a rapidly growing UK-based advanced wound care and dermatology company, today announced an agreement for Acelity to acquire Crawford and all of its assets. Terms of the agreement were not disclosed.

With the acquisition of Crawford, Acelity expands its portfolio of advanced wound dressings (AWD), further strengthening its position as the global leader in advanced wound healing.

Crawford Healthcare is a recognized leader in developing and commercializing innovative treatments for the care and repair of skin. Crawford’s wound dressing portfolio includes the market-leading superabsorbent KerraMax Care® range and KerraFoam and KerraCel in the foam and antimicrobial gelling fiber AWD categories, respectively.

Crawford’s advanced wound dressing lines complement Acelity’s existing AWD portfolio, which includes the market-leading collagen dressing PROMOGRAN PRISMA™ Matrix, as well as the TIELLE^™ Dressing Family and ADAPTIC™ Dressings. This expanded line of advanced wound dressings combined with Acelity’s industry-leading negative pressure wound therapy platforms forms the world’s most expansive wound care portfolio. In addition to its commercial products, Acelity will acquire Crawford’s innovative R&D capabilities and manufacturing operations based in Cheshire, UK.

“Crawford’s talented team, highly complementary line of advanced wound dressings, and track record of patient-focused innovation make them a terrific partner to accelerate our global growth,” said R. Andrew Eckert, President and CEO of Acelity. “This transaction solidifies our ability to offer the most comprehensive line of wound care solutions and will enable us to create and consolidate leading positions in high-growth market segments; expand and strengthen our customer relationships; and enhance our innovation expertise for the benefit of clinicians and patients around the world.”

Richard Anderson, chief executive of Crawford Healthcare, said: “The rapid growth of the business has been possible due to our focused investment in innovative products which are clinically proven to improve patient outcomes. Becoming part of the world’s largest wound care company will provide us with the scale to optimize our potential within the US, the largest global market and the ability to further access and grow in other international markets with our best-in-class advanced wound care products.”

Richard Anderson will continue to lead the Crawford organization and its products will remain fully available to clinicians and customers as the two companies work together to form integration plans for the remainder of the year.

About Acelity

Acelity L.P. Inc. is a global advanced wound care company committed to developing innovative healing solutions for customers and patients across the care continuum. Its subsidiary, KCI, is the most trusted brand in advanced wound care. The unsurpassed KCI product portfolio is available in more than 90 countries and delivers value through solutions that speed healing and lead the industry in quality, safety and customer experience. Committed to advancing the science of healing, KCI sets the standard for leading advanced wound therapy innovation. Headquartered in San Antonio, Texas, Acelity employs nearly 5,000 people around the world.

About Crawford Healthcare

Crawford Healthcare is a rapidly growing international company dedicated to developing innovative treatments and effective dermatological, wound care, and diagnostic products for the care and repair of skin. The Company has worked closely with healthcare professionals for more than 15 years from the international head office of its parent company, Crawford Healthcare Holdings plc (the “Crawford Group”), in Knutsford, Cheshire, U.K. In early 2013, the Crawford Group expanded its operations and opened a United States office in Doylestown, Pa., that focuses on the Company’s portfolio of advanced wound care products.

Contacts

For Acelity:
Kathryn Skeen, +1 210-882-2067
kathryn.skeen@acelity.com
or
For Crawford:
John Sullivan, +44 161 236 1352
johns@thisismc2.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

MiMedx Announces Executive to Lead its International Operations and Provides Update on Company’s International Progress

Posted On June 7, 2018 By OrthoSpineNews In Biologics /

MARIETTA, Ga., June 7, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced that John D. Harris has joined the Company as its Senior Vice President of International, and also provided an update on the status of the Company’s international operations and the infrastructure progress the Company has made in specific regions of the globe.

“John Harris brings a significant amount of international operations experience to MiMedx, particularly in Asia and Europe,” said Chris Cashman, Executive Vice President and Chief Commercialization Officer. “He has a proven track record of creating and deploying product commercialization strategies, and brings significant general management skills to lead the Company’s operations outside the United States (OUS). John has served on two long-term expatriate assignments, is fluent in Japanese, has extensive experience running global operations and has been successful in driving international results in both large and small organizations. I am very pleased to have John on our team.”

Prior to Joining MiMedx, Mr. Harris served as Vice President and General Manager of Cytori Therapeutics where he had P&L responsibility for their global product portfolio. Before Cytori, Mr. Harris served with Becton Dickinson (BD) as the President and Representative Director of BD Japan, where he led this $350 million division of BD and served on the Global BD Leadership Team. Mr. Harris’ experience prior to BD includes executive positions with TE Connectivity, Delphi Medical Systems, and Kimberly Clark Corporation / Ballard Medical.

“MiMedx has been quietly building our OUS infrastructure. Over the next several years, we expect our OUS business will show meaningful operational progress which will result in expanded revenue contribution for the Company,” said Parker H. “Pete” Petit, Chairman and CEO. “Under the leadership of Mike Carlton, Senior Vice President of Global Sales, we have now assembled sales and managerial talent focused on specific global markets. We have one executive focused on Eastern Europe, one focused on Western Europe and the UK, one focused on Canada and the Middle East, and another focused on the Asia-Pacific countries. Mike will be a member of the team reporting to John Harris, and Mike will continue to add his expertise to the growth of these regions. John Harris will report directly to Chris Cashman.”

Bill Taylor, President and COO, added, “With regard to Europe, our products are now marketed in Austria, Ireland, Slovenia, Switzerland, and the United Kingdom; pending regulatory approval in Italy; and will soon be filed for regulatory approval in Germany. We are in the last stages of approvals for Italy, and we expect to apply for regulatory approval in Germany in the second quarter of this year. German review and regulatory approval could take 6 to 12 months. In the Middle East, our products are marketed in Saudi Arabia and are in process in multiple countries in the region. Regarding North American countries other than the U.S., our products are also marketed in Canada. We have contracted with commercial partners in each country to focus on wound care and surgical, orthopedics and sports medicine opportunities.”

The Company also announced that the placental allografts category have been added to the European Wound Management Association (EWMA) document: Advanced Therapies in Wound Management which will include its dehydrated Human Amnion/Chorion Membrane (dHACM). The EWMA published its updated document prior to the recent EWMA 2018 Conference held from May 9 to 11, 2018 in Krakow, Poland. This initiative investigates the barriers and possibilities of advanced therapies in next generation wound management, including cellular therapies, tissue engineering and tissue substitutes associated with the clinical discipline of regenerative medicine. The 2018 EWMA Conference was EWMA’s 28^th annual conference offering high-level scientific presentations, knowledge and best practices exchange, and presentation of the most recent advances in wound management research and treatment. With up to 5,000 attendees, the EWMA is one of the largest and most prestigious wound management conferences in the world.

Chris Cashman, noted, “We are pleased to have our dHACM allografts highlighted at the influential EWMA annual conference. In addition to the EWMA, we have been very active in attending major conferences held in the European Union as well as numerous local specialty meetings and conferences highlighting our EpiFix® and AmnioFix® product lines, as well as our clinical and science compendium.”

In the Asia-Pacific region, MiMedx products are now registered and permitted for marketing in New Zealand and South Korea, and the Company’s products have been submitted for TGA regulatory approval for Australia. The product lines submitted in Australia will include the Company’s EpiFix, AmnioFix and injectable product lines for commercialization. The Company has already contracted with a leading in-country commercial distribution partner with plans for a full launch this fall.

In Japan, MiMedx has been preparing regulatory submissions for its EpiFix product with the Pharmaceutical and Medical Devices Agency, the affiliate of the Japanese Ministry of Health, Labor and Welfare that governs the approval of pharmaceuticals and medical devices. Additionally, we are preparing for reimbursement filings to support established payment once approved for market commercialization.

Cashman concluded, “We believe that the Japanese market has a significant unmet need for chronic non-healing wounds associated with a lower limb and foot. Furthermore, the Japanese medical community has embraced and is emphasizing regenerative medicine and therapies as a critical area of medicine to heal damaged tissues and organs that today are considered beyond repair. We expect to establish a MiMedx infrastructure in Japan and hire local direct employees to manage the commercialization in Japan. The commercialization activities could culminate as early as summer 2019.”

Shareholder Conference Call

MiMedx will host a conference call on Thursday, June 7, 2018 at 8:30 a.m. eastern time to provide a business update. A listen-only simulcast of the MiMedx conference call will be available in the Investor Relations section of the Company’s website at www.mimedx.com. A 30-day online replay will be available approximately one hour following the conclusion of the live broadcast. The replay can also be found on the Company’s website at www.mimedx.com.

About MiMedx

MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind the Company’s mission to give physicians products and tissues to help the body heal itself. The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes forward-looking statements. Statements regarding the amount and timing of OUS revenues; the timing of regulatory submissions and applications, and regulatory approvals; and the timing of hires, commercialization, and establishment of local country infrastructure, are forward-looking statements. Additional forward-looking statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “preliminary,” and similar expressions, and are based on management’s current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements.

Actual results may differ materially from those set forth in the forward-looking statements. For more detailed information on the risks and uncertainties, please review the Risk Factors section of the Company’s most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Centinel Spine Announces 510(k) Clearance of FLX™ Platform of 3D Printed All-Titanium Interbodies

Posted On June 7, 2018 By OrthoSpineNews In Regulatory /

NEW YORK, June 7, 2018 /PRNewswire/ — Centinel Spine, LLC is pleased to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its FLX™ Platform of Integrated Interbody™ and non-integrated interbody fusion devices. Centinel Spine is the largest privately-held spine company, focused on anterior column reconstruction.

FLX devices are 3D-printed, all-titanium devices which feature a combination of solid and porous radiolucent sections designed to reduce mechanical stiffness and improve visibility, compared to solid titanium implants. The devices also feature a proprietary FUSE-THRU™ trabecular scaffold, designed to allow for bony in-growth and on-growth throughout the implant.

“We are excited to announce the clearance of the FLX Platform, which represents the next evolution in STALIF technology. Utilizing 3D-printing, we are able to offer the proven benefits of the STALIF design in a truly novel, all-titanium lattice option. This allows our surgeons the flexibility to use multiple implant material options through a single set of instruments to address each patient’s unique pathology,” says Centinel Spine Chairman & CEO, John Viscogliosi.

STALIF FLX Integrated Interbody devices offer a unique advantage over other all-titanium implants, as they are indicated for use at one or two contiguous levels with both autograft and/or allogenic bone graft.

Mr. Viscogliosi added, “This clearance is a significant achievement in the development of 3D-printed titanium devices, as the 510(k) included multiple interbody fusion device families, representing thousands of potential Cervical and Lumbar fusion implants.”

Centinel Spine, the pioneer of the No-Profile^®, Integrated Interbody™ has a 30-year global clinical history of success behind these devices for the treatment of degenerative disc disease. The FDA clearance of the FLX platform is the next step in the evolution of Centinel Spine executing on its mission to become the worldwide leading spine company, addressing spinal disease anteriorly with the widest breadth and depth of technology platforms.

About Centinel Spine, LLC

Centinel Spine, LLC. is a privately-held spinal device company leading the development and commercialization of the No-Profile, Integrated Interbody fusion technologies. The company recently acquired the prodisc® Total Disc Replacement portfolio, an extensive cervical and lumbar disc replacement platform with the longest history of global clinical use. For more information on Centinel Spine products and technologies, please visit the company’s website at www.CentinelSpine.com.

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

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

For more information, please contact:

Varun Gandhi
SVP, Corporate Finance & Strategic Planning Centinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8871
Email: v.gandhi@centinelspine.com

Wendy F. DiCicco
Chief Operating and Chief Financial Officer Centinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8837
Email: w.dicicco@centinelspine.com

SOURCE Centinel Spine, LLC

DePuy Synthes Launches Innovative Nailing System Aimed at Improving Treatment of Femoral Shaft Fractures in the U.S.

Posted On June 7, 2018 By OrthoSpineNews In Recon, Top Stories /

WEST CHESTER, Pa., June 7, 2018 /PRNewswire/ — DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies**, today announces the U.S. launch of its Femoral Recon Nail System, a nailing system that provides new options for the surgical treatment of a wide variety of long thigh bone fractures. This new system builds on the company’s comprehensive trauma portfolio of innovative solutions designed to improve outcomes for patients with hip and femur fractures.

The overall annual number of femoral shaft fractures in the U.S. is estimated at approximately 90,000.¹ The DePuy Synthes Femoral Recon Nail System is a fixation system that utilizes an intramedullary nail to repair femoral shaft fractures. The system provides a surgeon with a state of the art nailing system that is designed to provide stability and allow patients to move soon after surgery while optimizing patient outcomes.

The Femoral Recon Nail System offers surgical entry point and locking options to accommodate varying preferences, and enables surgeons to treat a broad range of complex fractures. The system also features radiolucent insertion handles that aim to reduce surgical complexity, facilitate intraoperative and X-ray visualization, and assist with guide wire placement.

“I believe the DePuy Synthes Femoral Recon Nail System offers the most streamlined insertion instruments on the market,” said Pete Nowotarski M.D., Professor Orthopaedic Surgery, University of Tennessee College of Medicine, Chattanooga & Orthopaedic Trauma Director, Erlanger Health Systems***. “This system, coupled with the most advanced design features in both the piriformis fossa and greater trochanter entry points, offers greater versatility in treating complex femur fractures.”

In addition, the DePuy Synthes system is also designed to address a potential operative complication called distal cortical impingement, which is often the result of the curve of the patient’s femoral anatomy being greater than the curve of the nail.² The Femoral Recon Nail System addresses this issue as it is specifically designed to enhance anatomical fit³ by reducing the rate of nail curvature to more closely match the patient’s anatomy that may also further improve the patient’s experience.

“DePuy Synthes has a long history of innovation in the hip and femur fracture repair market with a comprehensive portfolio of implants that address a variety of patient needs,” said I.V. Hall, Global Platform Leader, DePuy Synthes Trauma. “This launch allows DePuy Synthes to offer the most comprehensive, best-in-class portfolio for hip and femur fractures as we continue to advance the standard of care for patients and improve the surgeon experience.”

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, and interventional solutions 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 the Johnson & Johnson’s Medical Devices segment.
***Consultant to DePuy Synthes Trauma

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 Femoral Recon Nail 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 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.

¹ Ng AC, Drake MT, Clarke BL, Sems SA, Atkinson EJ, Achenbach SJ, Melton LJ 3rd. Trends in subtrochanteric, diaphyseal, and distal femur fractures, 1984-2007. Osteoporos Int. 2012;23(6):1721-6.
² Roberts JW, Libet LA, Wolinsky PR. Who is in danger? Impingement and penetration of the anterior cortex of the distal femur during intramedullary nailing of proximal femur fractures: preoperatively measurable risk factors. J Trauma Acute Care Surg. 2012;73(1): 249-254.
³ DePuy Synthes Trauma. Data on file. Analysis – Anatomical Study. #0000271671, 2017

SOURCE DePuy Synthes

The wound care biologics market is expected to reach USD 2.26 billion by 2023 from USD 1.42 billion in 2018, at a CAGR of 9.8%

Posted On June 7, 2018 By OrthoSpineNews In Biologics /

LONDON, June 7, 2018 /PRNewswire/ — The wound care biologics market is projected to grow at a CAGR of 9.8% during the forecast period.

Download the full report: https://www.reportbuyer.com/product/5436768

The wound care biologics market is expected to reach USD 2.26 billion by 2023 from USD 1.42 billion in 2018, at a CAGR of 9.8%. Market growth is mainly driven by factors such as the increasing incidence of diabetic foot ulcers, increasing geriatric population, and increasing burn injuries globally. On the other hand, the high cost of wound care biologics and the higher rejection rate associated with skin grafts & substitutes will restrain the growth of this market.

The biological skin substitute segment is anticipated to grow at the fastest rate in the next five years.

Based on product, the wound care biologics market is segmented into biologic skin substitutes and topical agents.The biological skin substitutes segment is estimated to account for the largest share in 2018 and grow at the highest rate from 2018 to 2023.

The rising incidence of hard-to-heal wounds and their growing adoption (due to their high efficacy) are driving the growth of this product segment. The biological skin substitutes segment is further categorized into human donor tissue-derived products, acellular animal-derived products, and biosynthetic products.

Asia Pacific is estimated to grow at the highest CAGR during the study period.

Geographically, the wound care biologics market was dominated by North America, followed by Europe in 2017. The Asia Pacific market is estimated to register the highest growth during the forecast period primarily due to the presence of a large patient population, increasing penetration of key market players, and the large number of research and development activities for wound care biologic products.

The primary interviews conducted for this report can be categorized as follows:
• By Company Type: Tier 1–35%, Tier 2–22% and Tier 3- 43%
• By Designation: C-level–15%, Director-level–32%, Others–53%
• By Region: North America–34%, Europe–27%, Asia Pacific–23%, Rest of the World–16%

The major players in this market are Smith & Nephew (UK), Mölnlycke Health Care AB (Sweden), Integra LifeSciences Corporation (US), Wright Medical (US), MiMedx Group (US), Vericel Corporation (US), Anika Therapeutics (US), Osiris Therapeutics (US), Organogenesis (US), Kerecis (Iceland), Solsys Medical (US), ACell (US), and Marine Polymer Technologies, Inc. (US).

Research Coverage:
The report analyses the wound care biologics market by product, wound type, method, end user, and region.Apart from a comprehensive geographic product analysis and market sizing, the report also provides a competitive landscape that covers growth strategies adopted by industry players over the last three years.

In addition, the company profiles include product portfolios, developments, and strategies adopted by prominent market players to maintain and increase their shares in the market. Market research data, current market size, and forecast of the future trends will help key market players and new entrants make the necessary decisions regarding product offerings, geographic focus, change in strategic approach, and levels of output to remain successful.

Key Benefits of Buying the Report:
This report will enable both established firms as well as new entrants/smaller firms to gauge the pulse of the market, which in turn will help firms garner greater market shares. Firms purchasing the report can use one or a combination of the below mentioned five strategies for strengthening their market shares.

The report provides insights on the following pointers:
• Market Penetration: Comprehensive information on the product portfolios of the top players in the wound care biologics market
• Product Development/Innovation: Detailed insights on upcoming technologies, R&D activities, and product launches in the wound care biologics market
• Competitive Assessment: In-depth assessment of the market strategies, geographic, and business segments and product portfolios of the leading players in the wound care biologics market
• Market Development: Comprehensive information about emerging markets. This report analyses the market for various wound care biologics across geographies
• Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the wound care biologics market.

Download the full report: https://www.reportbuyer.com/product/5436768

About Reportbuyer
Reportbuyer is a leading industry intelligence solution that provides all market research reports from top publishers

For more information:
Sarah Smith
Research Advisor at Reportbuyer.com
Email: sarah@reportbuyer.com
Tel: +1 (718) 213 4904
Website: www.reportbuyer.com

SOURCE ReportBuyer

Photo by: Jeff Miller

OrthAlign, Inc. Announces Clinical Milestone: 2,000 Cases with HipAlign®, Handheld Navigation for Direct Anterior Total Hip Replacement

Posted On June 6, 2018 By OrthoSpineNews In Recon /

Aliso Viejo, CA, June 05, 2018 (GLOBE NEWSWIRE) — OrthAlign, Inc., a privately held U.S. based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced another milestone achievement in its 2,000^thHipAlign case. HipAlign was commercially launched in early 2018 for direct anterior total hip replacement.

HipAlign acts as a GPS for surgeons, using micro-electromechanical sensors like accelerometers and gyroscopes to guide hip replacement surgery, ensuring accuracy and alignment in cup placement and in tracking changes in leg-length. All of this happens in a phone-like device that sits in the surgeon’s hands and on their surgical instruments.

“We are excited to reach this milestone after a diligent limited-market release throughout 2017 and a full-launch following the AAOS annual meeting earlier this year,” said Eric B. Timko, Chief Executive Officer and Chairman of OrthAlign. “HipAlign’s rapid adoption proves there is high demand for a cost effective, minimally disruptive technology that provides increased accuracy and consistency in total hip replacements. With HipAlign, we’re able to expand our orthopedic offering and continue to provide surgeons and healthcare facilities clinically beneficial and economically friendly technologies.”

“After performing over 3,000 navigated total hip arthroplasties using a variety of different navigation devices and techniques, HipAlign has fit my workflow and made my accuracy the best by far,” said Dr. Matthew Heinrich, Orthopedic Surgeon at the Texas Institute for Hip and Knee Surgery. “I said goodbye to lead aprons due to a minimal x-ray need for my anterior total hips. My clinical results have been excellent. I have found the lower cost technique is easily portable, and have used it at five different facilities, including two surgery centers where I perform outpatient total hips. My patients also appreciate that I utilize technology to help make sure that my accuracy is second to none!”

With no pre-operative CT-scan required, HipAlign delivers results without disruption. Patients receive the benefits of computer-guided surgery without additional time spent for pre-operative imaging procedures. With HipAlign, anatomic data is collected by the surgeon during the procedure, providing information not previously available using traditional hip surgery approaches.

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN® and UNIALIGN™ are registered trademarks of OrthAlign, Inc.

Adam Simone
OrthAlign
asimone@orthalign.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.

Month: June 2018

NuVasive Announces Key Finance Appointments

Related Links

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

Contacts

Acelity Acquires Crawford Healthcare to Create the World’s Most Expansive Wound Care Portfolio

Contacts

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

MiMedx Announces Executive to Lead its International Operations and Provides Update on Company’s International Progress

Related Links

Centinel Spine Announces 510(k) Clearance of FLX™ Platform of 3D Printed All-Titanium Interbodies

Related Links

DePuy Synthes Launches Innovative Nailing System Aimed at Improving Treatment of Femoral Shaft Fractures in the U.S.

Related Links

The wound care biologics market is expected to reach USD 2.26 billion by 2023 from USD 1.42 billion in 2018, at a CAGR of 9.8%

Related Links

OrthAlign, Inc. Announces Clinical Milestone: 2,000 Cases with HipAlign®, Handheld Navigation for Direct Anterior Total Hip Replacement

NuVasive To Present At The Goldman Sachs Annual Global Healthcare Conference

Related Links