30 Mar

K2M Names Lane Major Chief Operating Officer

Mar 29, 2018

LEESBURG, Va., March 29, 2018 (GLOBE NEWSWIRE) -- K2M Group Holdings, Inc.(NASDAQ:KTWO) (the "Company" or "K2M"), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance, today announced the appointment of Lane Major as Chief Operating Officer, a new position within K2M, effective immediately.

“On behalf of our Board, I am thrilled that Lane will serve as Chief Operating Officer,” said John P. Kostuik, M.D., K2M Chief Medical Officer, Co-founder, and member of the Board of Directors. “Lane’s vision of excellence in medical innovation and his commitment to achieving superior organizational results have made K2M a global leader in the spinal devices market. I am confident that he will continue to positively influence our entire organization, our clients, and most of all—patients.” “Lane’s appointment to Chief Operating Officer is a strategic milestone for the Company as he embodies the values of K2M,” said K2M Chairman, President, and CEO Eric Major. “I deeply value Lane’s strategic insight, passion for innovation, and business acumen, all of which have been integral to K2M’s well-recognized global brand and best-in-class innovation engine. Lane, along with our accomplished team of executive leaders that represent the talent and diversity of our world-class organization, is committed to organizational excellence and poised to lead K2M well into the future.” Major brings more than 15 years of spine industry experience, most recently as K2M’s Chief Strategy Officer, a position held following his service as K2M’s Senior Vice President of Global Marketing & Product Development. He has been with K2M since the Company’s inception in 2004 and has been essential to the development and commercialization of K2M’s product portfolio. Major earned a B.B.A in Marketing and Computer Information Systems from James Madison University and an M.B.A from Northwestern University’s Kellogg School of Management. “I am incredibly honored to have the opportunity to work with such an impressive and proven team of leaders here at K2M and I look forward to serving as the Company’s first Chief Operating Officer,” said Lane Major. “Our Company is committed to developing innovative solutions that have transformed spinal surgery for the better, as evidenced by our suite of complex spine technologies, our comprehensive Balance ACS® platform and a market-leading portfolio of 3D-printed spinal devices featuring Lamellar 3D Titanium Technology. I passionately believe in K2M and our promise of creating a better tomorrow for people across the globe who suffer from debilitating spinal disorders. Building upon our remarkable success to date, I could not be more excited about contributing to an even brighter future for K2M.” For more information about K2M, visit www.K2M.com. About K2M K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques, and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.comand connect with us on FacebookTwitterInstagramLinkedIn 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 Statesand 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 Primary Logo Source: K2M Group Holdings, Inc., Photo: K2M Group Holdings, Inc.

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30 Mar

Ortho Kinematics Strengthens Leadership Team

March 30, 2018

AUSTIN, Texas--(BUSINESS WIRE)--Ortho Kinematics‚ Inc. (OKI), a privately held healthcare diagnostics company focused on spine imaging informatics, announced today that Erik Wagner has been appointed Interim Chief Executive Officer. Mr. Wagner has been an investor and advisor to OKI for several years. “The OKI Board of Directors recognized that as the company moves to expand its product offering and market footprint, it needs the experience of a seasoned spine industry executive to usher in the next phase of growth,” said Jerry DeVries, Board Member. “Erik has agreed to help transition the company from a development to a commercial enterprise focused on the launch of the company’s next-generation diagnostic technology.” Mr. Wagner added, “Ortho Kinematics has the potential to solidify and build on its status as the leader in spine diagnostics. Paul Gunnoe, OKI’s previous CEO, has positioned the company well for success and will be a strategic consultant to the company going forward. We have a tremendous opportunity ahead of us, and I am confident in our ability to accelerate our development and continue to generate value for our shareholders.” OKI’s core product, the VMA is a diagnostic test for the assessment of spinal motion, instability, and sagittal alignment. Spinal instability and alignment are important considerations for physicians when evaluating candidates for therapies such as surgery and pain management. The VMA has been shown in studies to increase the sensitivity in detecting spinal motion, including instability, with no decrease in specificity relative to the current standard test. About Erik Wagner Mr. Wagner has been a co-founder, board member, and held executive management positions in two venture-backed spinal implant companies including Spinal Concepts (1996-2004) and Flexuspine (2007-2014). At Spinal Concepts, he and his partners raised over $40 million in venture capital leading the company to profitability in less than six years on sales exceeding $10 million/month and growing at 70% CAGR. He left Spinal Concepts following the sale of the company to Abbott Labs for $170 million in 2003. His proven record for innovation and leadership continued at Flexuspine where he served as CTO & CEO and led the development and clinical investigation of the world’s first spinal segmental reconstruction device. He is a named inventor on over 80 patents for medical devices ranging from spinal implants to cardiovascular atherectomy devices. He continues to serve as a business consultant and advisor to medical device startups and investor groups. About Ortho Kinematics Ortho Kinematics is a privately held diagnostic technology company, focused on spine imaging informatics and committed to the idea that spine motion matters. The company is working with a group of leading clinicians, researchers, and developers who are passionate about leveraging spine biomechanical data to improve the diagnosis and treatment of back pain. Ortho Kinematics is located in Austin, Texas and at www.orthokinematics.com.

Contacts

Ortho Kinematics‚ Inc. Annie Burke, 512-334-5490

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30 Mar

Amplitude Surgical: Good operational performances in H1 2017-18

March 28, 2018

VALENCE, France--(BUSINESS WIRE)--Regulatory News: Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading French player on the global surgical technology market for lower-limb orthopedics, today announces its results for the first half of its 2017-18 financial year (July to December 2017). Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “The growth in our activity and improvement in our EBITDA prove the pertinence and the quality of delivery of Amplitude Surgical’s internationalization strategy with, over the first half, more than half of EBITDA generated by the Group’s international subsidiaries. Launching our activity in the United States is our priority, in order to make our innovative technologies available to American surgeons. Our buoyant momentum further bolsters our target of doubling sales over the five years to June 2021.” During the first half of its 2017-18 financial year, Amplitude Surgical continued to deploy its strategy and recorded sales of €44.7 million, up +6.6% in actual terms and 8.1% at constant currency, and EBITDA of €6 million, up 7.9%, giving a slight improvement in the margin to 13.3%. 1st half highlights:
  • In October 2017: finalization of the recruitment of a US Director of Sales, Mark Johnson. With substantial experience of this market, his aim is to put together his team and a network of distributors to market the Group’s implants to American surgeons. At the same time, Amplitude Surgical established its US subsidiary near Dallas, Texas; and first and the first instruments for inserting hip and knee prostheses and the corresponding sets of implants have been sent out;
  • In December 2017: Amplitude Surgical announced the commercial launch of the AClip®, an innovation in anterior cruciate ligament reconstruction surgery. Repairing the anterior cruciate ligament is one of the most frequent knee pathologies, with almost 250,000 operations undertaken each year in Europe alone. AClip® is a highly-differentiating innovation resulting from the Group’s R&D, and is protected by a number of patents;
  • lastly, during the first half, the Group completed the acquisition of two companies of sales agents in France, in the east of the country and in the Paris region, in order to intensify its commercial presence and reinforce its leadership in these regions.
Financial summary (actual currency):
€ thousands - IFRS H1 2017-18 H1 2016-17 Δ
Sales 44,657 41,901 +6.6%
Gross margin 33,742 31,232 +8.0%
as a % of sales 75.6% 74.5% +110 bp
Sales & Marketing costs 19,721 17,815 +10.7%
General & Administrative costs 5,450 4,242 +28.5%
R&D costs 2,616 3,655 -28.4%
EBITDA 5,955 5,521 +7.9%
as a % of sales 13.3% 13.2% +10 bp
Core Operating Profit -1,876 -1,455
Non-core operating expenses -1,358 843
Operating Profit/Loss -3,202 -612
Financial Profit/Loss -4,657 -4,354
Attributable Net Profit/Loss -8,602 -5,951
Net financial debt 90,320 74,030
Net cash position 34,105 41,636
EBITDA margin of 13.3% and of 14,4% excluding the costs associated with the launch of the US and Japanese subsidiaries Over the first half of its 2017-18 financial year (from July to December), Amplitude Surgical generated sales of €44.7 million, an increase of +6.6% in actual terms and 8.1% at constant currency. The Group’s performance benefited from the mobilization of the teams in France and in its subsidiaries, but was still negatively impacted by a high basis for comparison (+19.8% at constant currency in H1 2016-17), notably regarding activity with distributors.
  • In France, Amplitude Surgical continued to increase its market share with numerous new clients, and sales grew by 8.1% to €28 million. This performance incorporates the 3.5% reduction applied to all implants since August 2017, on the initiative of the health authorities. The recent acquisition of companies of sales agents responsible for directly managing key regions in eastern France and the Paris region will soon have a positive impact by enabling Amplitude Surgical to strengthen its sales presence in these regions.
  • Abroad, the activity of the Group’s subsidiaries continued to record very solid performances with sales of €12.9 million, up +12% in actual terms and +17.5% at constant currency. This sales momentum was particularly satisfactory in Australia, South Africa, Switzerland and Benelux, while Brazil and Germany remained stable. Japan doubled its activity.
  • Amplitude Surgical’s direct activity – the French market and international subsidiaries – increased by +11% at constant currency and accounted for almost 92% of total Group sales.
  • Novastep, which markets innovative solutions for extremities (foot and ankle) surgery, saw its sales continue to grow, notably in France (+38%), with international sales accounting for 60% of its total sales over the first half. Globally, 4 years after its first products were marketed, Novastep’s activity accounts for over 7% of Amplitude Surgical’s sales.
Amplitude Surgical generated a gross margin of 75.6%, a 110 bp improvement compared with the first half of 2016-17, mainly attributable to the benefits of the industrial integration and the growth in sales with a decline in distributor’s sales, this business having traditionally a lower margin. The Group’s total operating expenses came to €27.8 million, a limited increase of 6.8%, reflecting the human and commercial investments of the Group to develop new territories and further increase its market share. At the end of December 2017, Amplitude Surgical had a workforce of 392 staff, versus 368 at end-June 2017 and 306 at end-December 2016, and personnel costs increased by 19% compared with the first half of 2016-17, including the various acquisitions. During the semester, the Group reclassified expenses related to the Quality and Regulatory Affairs departments as Administrative instead of R&D expenses as previously accounted (€0.4 million for 1st half 2016-17). With 46 employees at end-December 2017, total R&D expenses stood at 5.8% of sales compared to 7.6% for FY 2016-17. EBITDA was thus €6.0 million, up 7.9%, giving an EBITDA margin of 13.3%, up 10 bp compared with the first half of 2016-17. Excluding the costs associated with the start-up costs from the American and Japanese subsidiaries, Amplitude Surgical’s EBITDA was €6.4 million, up 5% with a margin of 14.4%. The Group recorded a Core Operating Loss of €1.9 million and an Operating Loss of €3.2 million, versus -€0.6 million over the first half of 2016-17, the latter having benefited from a one-off profit from the settlement of the Australian dispute. At December 31, 2017, the Group booked an additional provision of €1.4 million and continued to provision the entire risk associated with its dispute with URSSAF regarding taxation on medical devices. The Financial loss was €4.7 million, which includes a net interest expense of €3.4 million and the booking of currency exchange losses of €1.2 million. The Net loss was €8.6 million, compared with a loss of €6.0 million in H1 2016-17. Excess in operating cash-flow, +1,8M - net cash position of €34 million at end-December 2017 Net cash flow generated by operating activity was up €1.8 million over the first half year, versus cash burn of €8.2 million in the first half of 2016-17, notably driven by a significant improvement in Working Capital, +€4 million vs. -€1.8 million in H1 2016-17. First-half investment totalled €11.8 million, down on the €16.3 million in H1 2016-17, and was notably attributable to the acquisition of sales agents in France, the putting in place of instruments for €3.5 million, the acquisition of a major patent for Novastep and the ongoing setting up of a clean room on the Valence site for €1 million. Despite these capex and a €2.4 million settlement of two disputes, fully provisioned, the Group continues to enjoy a very solid financial structure, with Cash & Cash Equivalents of €34.1 million at end-December 2017 and Net Financial Debt of €90.3 million, giving gearing (Net Financial Debt over Shareholders’ Equity) of 0.95, vs. 0.78 at end-June 2017 and 0.65 at end-December 2016. The Half-Year Financial Report can be found on Amplitude Surgical’s website: www.amplitude-surgical.com/fr/documentationold/documents-de-reference Next financial press release: Q3 2017-18 sales, on Thursday April 26, 2018, after market. About Amplitude Surgical Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents distributing its products in more than 30 countries. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. At June 30, 2017, Amplitude Surgical had a workforce of nearly 370 employees and recorded sales of over 93 million euros.

Contacts

Amplitude Surgical Philippe Garcia, +33 (0)4 75 41 87 41 CFO finances@amplitude-surgical.com or NewCap Investor Relations Marc Willaume, +33 (0)1 44 71 00 13 amplitude@newcap.eu or NewCap Media Relations Nicolas Merigeau, +33 (0)1 44 71 98 55 amplitude@newcap.eu

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30 Mar

Medicrea Partners with Key Distributor to Form Joint Venture in Belgium

March 29, 2018

LYON, France & NEW YORK--(BUSINESS WIRE)--The Medicrea® Group (Euronext Growth Paris: FR0004178572 - ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered spinal device design and manufacturing with UNiD ASI™ (Adaptive Spine Intelligence) technology, announced today that the Company has signed a joint-venture agreement with Motion Medical, Medicrea’s existing distribution partner, to accelerate the adoption of the Group’s products and technologies in Belgium. Medicrea Belgium capitalizes on Medicrea’s long-standing relationship with its key distributor who has approximately a 15% market share. Motion Medical is headed by Steven Mesdom, who will remain on board with his team to lead the newly-formed subsidiary. Mr. Mesdom, who brings more than a decade of experience with Medicrea’s innovative family of products, stated, “We have had an exceptional track record introducing Medicrea’s flagship platforms to Belgium, including PASS® thoracolumbar fixation. This partnership marks an important step for our continued penetration of the Belgian market.” Denys Sournac, President and Chief Executive Officer of Medicrea, added, “We are extremely pleased to have successfully negotiated this mutually-beneficial agreement with Mr. Mesdom and to announce the creation of Medicrea Belgium, a direct sales subsidiary. Our collective experience in this market will allow us to capitalize on a direct sales model and immediately generate additional revenue for the group. In addition, we will create new opportunities for growth with the latest patient-specific UNiD ASI™ technologies.” Medicrea International holds a 51% majority stake in the Medicrea Belgium joint-venture and plans to transition the entity to a fully-owned Medicrea subsidiary over the next years. All revenue generated through the sale of Medicrea products in Belgium will be aggregated in Medicrea’s group consolidated numbers and reported effective from February 2018. About Medicrea (www.medicrea.com) Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 150,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room. Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants. For further information, please visit: Medicrea.com.

Connect with Medicrea: FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on EURONEXT Growth Paris ISIN: FR 0004178572 Ticker: ALMED LEI: 969500BR1CPTYMTJBA37

Contacts

Medicrea Denys Sournac Founder, Chairman and CEO dsournac@Medicrea.com or Fabrice Kilfiger, Chief Financial Officer fkilfiger@Medicrea.com Tel: +33 (0)4 72 01 87 87

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30 Mar

Research Shows NuVasive Porous PEEK Structure Maintains High Porosity After Impaction

SAN DIEGOMarch 29, 2018 /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the results of the study "Impaction durability of Porous PEEK™ and titanium-coated PEEK interbody fusion devices," published online in The Spine Journalwhich concluded advantages of the NuVasive Porous PEEK material over titanium-coated PEEK devices1.
In the study, titanium-coated PEEK, smooth PEEK and NuVasive Porous PEEK interbody implants were subjected to impaction loading conditions. Analysis of Porous PEEK showed the surface structure maintained a high porosity (>65%) and exhibited minimal changes to pore size and depth following impaction. This maintenance of porosity and pore depth gives a surgeon confidence that the porous architecture will not collapse during insertion. The titanium-coated devices demonstrated titanium coating loss after impaction that was corroborated with a decrease in surface roughness. Smooth PEEK showed minimal signs of damage, but demonstrated a decrease in surface roughness. "The findings in this study are significant because they demonstrate the durability and impaction resistance of interbody implants made from Porous PEEK," said Kevin T. Foley, M.D. "Knowing that the porous structure is seamlessly integrated with the implant, without sacrificing implant strength, and that the implant maintains porosity following impaction means that the opportunity for bony ingrowth is optimized." Porous PEEK is manufactured through a proprietary extrusion process which produces a unified porous-to-solid structure designed to enhance osseointegration and maximize bone-to-implant contact. Available for cervical and thoracolumbar applications, Cohere® and Coalesce™ Interbody Fusion Devices are the only Porous PEEK interbody implants available in the market. "Porous PEEK exemplifies our focus on disruptive technology and materials science. Born out of years of pre-clinical research, this durable implant technology combines the inherent benefits of porosity with the advantageous material properties of PEEK," said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. "Designed for enhanced osseointegration, biomechanical, and imaging properties, Porous PEEK and the entire NuVasive Advanced Materials Science™ portfolio, which also includes Modulus® titanium interbody implants, represent the future of porous implant technologies." About NuVasive NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company's portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com. Forward-Looking Statements NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive's results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company's surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive's products (including the iGA® platform), the Company's ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive's news releases and periodic filings with the Securities and Exchange Commission. NuVasive's public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made. 1 Torstrick, B., Klosterhoff, B., Westerlund, E., Foley, K., Gochuico, J., Lee, C., Gall, K., Safranski, D. (2018). Impaction durability of porous polyether-ether-ketone (PEEK) and titanium-coated PEEK interbody fusion devices. The Spine Journal. Doi: 10.1016/j.spinee.2018.01.003   SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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29 Mar

Stryker Brings The Mobility Zone™ and Joint Health Education to Houston Open

MAHWAH, N.J.March 29, 2018 /PRNewswire/ -- Stryker Orthopaedics is pleased to announce its second PGA TOUR stop of 2018, its fifth consecutive year as the "Official Joint Replacement Products of the PGA TOUR® and PGA TOUR Champions," with an appearance at the Houston Open in Humble, TX. During the tournament, Stryker will continue its commitment to educating golf fans about the importance of joint health through an interactive experience in The Mobility Zone, featuring an Accuracy Challenge and Stryker's Mako Technology.
As the premiere feature of The Mobility Zone, the new Accuracy Challenge will invite visitors to take a shot at surgery with a hands-on experience introducing Art H. Ritis, a life-size model that aims to provide tournament-goers a basic understanding of joint replacement surgery and Stryker's Mako Technology. Additionally, orthopaedic surgeons who use Mako Technology will be on-site at The Mobility Zone to discuss joint health and treatment options with fans who are experiencing joint pain or want to learn more. "The Mobility Zone is a phenomenal opportunity for fans to stop by and learn about joint replacement with our Mako Technology," said Stuart Simpson, President, Stryker's Joint Replacement Division. "We are truly committed to our mission of making healthcare better, and this is a great way for us to do that." Continuing a relationship that began in 2015, Stryker is proud to support K9s For Warriors at tournaments throughout the year. Tournament-goers can show their support for veterans by purchasing the same hat that PGA TOUR professional and longtime brand ambassador Fred Funk wears on TOUR at The Mobility Zone. With each hat purchase, Stryker will make a donation to K9s For Warriors, the nonprofit organization dedicated to providing service canines to military veterans suffering from Post-Traumatic Stress Disability, traumatic brain injury or other military trauma as a result of military service post 9/11. Finally, as part of Stryker's dedication to motivating fans to stay active, Stryker will host the Health Walk at the Houston Open. The Health Walk highlights joint health and golf facts along the course to educate fans as they follow their favorite golfers. For additional information on the Stryker Accuracy Challenge as well as K9s For Warriors involvement, please visit: www.patients.stryker.com.  About Stryker Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. About PGA TOUR By showcasing golf's greatest players, the PGA TOUR engages, inspires and positively impacts our fans, partners and communities worldwide. The PGA TOUR co-sanctions more than 130 tournaments on the PGA TOUR, PGA TOUR Champions, Web.com Tour, PGA TOUR Latinoamérica, Mackenzie Tour-PGA TOUR Canada and PGA TOUR-China. Members on the PGA TOUR represent the world's best players, hailing from 25 countries (84 members are from outside the United States). Worldwide, PGA TOUR tournaments are broadcast to more than 1 billion households in 226 countries and territories in 23 languages. Virtually all tournaments are organized as non-profit organizations to maximize charitable giving. In 2017, tournaments across all Tours generated a record of more than $180 million for local and national charitable organizations, bringing the all-time total to $2.65 billion. The PGA TOUR's web site is PGATOUR.COM, the No. 1 site in golf, and the organization is headquartered in Ponte Vedra Beach, Florida. SOURCE Stryker Orthopaedics

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29 Mar

Nanovis Announces FDA Clearance of FortiCore® PLIF and TLIF Spinal Interbodies with Nanosurface Features

Carmel, Ind. (March 28, 2018) – Nanovis, today announced the successful FDA clearance of its FortiCore® TLIF and PLIF interbodies featuring a Nanosurface-enhanced deeply porous titanium scaffold intermolded with a PEEK core. “Implant nano surface science has advanced from the early days when we simply created nanoroughness for implants because tissues have nanoroughness. Now we understand the mechanisms by which nanotopographies can interact with cellular signaling pathways. I’m delighted that with Nanovis’ implants, patients can now benefit from a carefully designed and controlled nanotopography that harnesses this groundbreaking research,” said Thomas Webster, PhD, Chemical Engineering Department Chair, Northeastern University, who with Chang Yao, PhD, were early pioneers in the use of nanosurfaces to enhance bone growth. Nanovis’ foundational FortiCore interbody fusion platform is well proven with over 4,250 implanted to date. FortiCore interbodies have deeply porous interconnected titanium scaffolds intermolded with a PEEK core, giving surgeons important fixation and imaging advantages. Data comparing the osseointegration strength of the FortiCore scaffold, PEEK, and allograft to the strength of trabecular host bone was published in Spine in late 2016. Now the titanium scaffolds on the FortiCore TLIF and PLIF interbodies are enhanced with a carefully designed and controlled nanosurface. “The timing for this clearance is very good because surgeons are searching for the best surface technologies. I’ve watched Nanovis methodically develop technology platforms in a surface on a surface bone fixation strategy. Now they offer the most advanced interbody fixation technology with the best imaging profile on the market,” said Dr. Alan McGee, Orthopedics Northeast, a participant in the alpha launch of FortiCore. “My partners and I have implanted over 300 FortiCore interbodies. I can tell my patients I’m giving them the most advanced technology available today, and they have recovered quickly and have been very satisfied. It’s easy for me to assess bone growth through and around the FortiCore implants with plain X-ray. It’s a struggle to assess bone growth through 3D printed titanium interbodies with plain X-ray and I’m hesitant to expose my patients to the extra radiation from an unnecessary CT scan. I’m encouraged by Nanovis’ pre-clinical data for this nanotechnology enhanced surface and look forward to upgrading my use.” “The science behind this nano technology is very exciting and clearance of the surface provides Nanovis another highly differentiated platform designed to reduce fixation related complications across a wide range of implant systems. In the short term, this nanopatterned surface targets fixation related complications and in the intermediate term this nanopatterned surface is the foundation of a bactericidal program targeting infection related complications,” said Matt Hedrick, CEO, Nanovis. About Nanovis Nanovis’ clinical and scientific goals are to reduce fixation and infection related complications. The Company’s patented and proprietary regenerative technology platforms provide differentiated surface advantages enabling the potential for existing medical devices to achieve new outcomes. Nanovis is commercializing science-driven platforms: the deeply porous scaffold and nanopatterned surface on select FortiCore interbody fusion devices and developmental bactericidal technology. For more information about Nanovis, FortiCore or other proprietary Nanovis science-enhanced technologies, please visit www.nanovisinc.com or call 1-317-507-1058.

Media Contact:

Matt Hedrick

1-317-507-1058

Matt.hedrick@nanovistechnology.com

   

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29 Mar

NeoSpine Founder, President Richard Wohns, MD, to Speak at 16th Annual Future of Spine + The Spine, Orthopedic and Pain Management-Driven ASC Conference

Becker's Healthcare is pleased to welcome Dr. Richard Wohns and more than 222 other talented medical professionals as speakers for Becker's 16th Annual Future of Spine + The Spine, Orthopedic and Pain Management-Driven ASC Conference, June 14 to 16 at the Swissotel in Chicago.

NeoSpine Founder and President Dr. Richard Wohns will deliver exciting content June 14 and 15 on investing in early stage spine and device companies; the future of spine, private practice and more; and investing as a spine surgeon. A board-certified neurosurgeon, he has performed more than 3,000 outpatient cervical and lumbar surgeries and gives international lectures on the clinical, business and legal aspects of outpatient spine surgery.

Pablo Pazmino, MD, an orthopedic spinal surgeon and medical director of Santa Monica, Calif.-based Spine Cal, will share his expertise with Becker's audience June 16. He'll discuss techniques, tricks and tips for the cervical hybrid arthroplasty in the outpatient setting. Dr. Pazmino holds hospital privileges in spinal surgery at several locations, including Cedars-Sinai Medical Center and UCLA Medical Center in Los Angeles.

Board-certified neurological surgeon Ying Chen, DO, FACOS, will discuss the relationship between orthopedic and spine practices and their ASCs June 15. Dr. Chen practices at Columbus, Ohio-based OrthoNeuro, where he also serves as chairman on the IT committee. He is a member of the Ohio Osteopathic Association's House of Delegates with the Columbus chapter.

Conference attendees will have the opportunity to hear from Jamie Baisden, MD, a professor of neurosurgery at the Medical College of Wisconsin in Milwaukee. Dr. Baisden, who has been named one of the "Best Doctors in America" and listed in the "Guide to America's Top Physicians," will speak June 15 on key evolutions in the medical device arena.

Becker's thanks its corporate partner, Johnson & Johnson One Medical Device, for its title sponsor support of the event.

To hear Joe Montana and other great keynotes and speakers, join Becker's Healthcare at its Future of Spine + The Spine, Orthopedic and Pain Management-Driven ASC Conference, June 14 to 16 by registering here: https://www.regonline.com/registration/Checkin.aspx?EventID=2050742 or contact Jessica Cole by email at jcole@beckershealthcare.com or by phone at 312-929-3675.

For the complete conference brochure, click here: https://www.beckersasc.com/june-conference/.

About Becker's ASC Review Becker's ASC Review offers general business, legal and clinical guidance on topics relevant to outpatient surgery including joint ventures, development and expansion, and regulatory and compliance issues, as well as analysis and insight for specialties including orthopedics and spine, gastroenterology, neurosurgery, ophthalmology, ENT, and anesthesiology. Each of the nine annual issues of the publication reaches a qualified audience of more than 25,000 key ASC leaders, including surgeons, medical directors, directors of surgery and ASC administrators. Every ASC in the nation receives Becker's ASC Review.

About Becker's Spine Review Becker's Spine Review features news and analysis on business and legal issues relating to spine practices. Each issue of the quarterly publication reaches a qualified audience of approximately 12,500 key spine practice decision-makers, including surgeons and spine practice administrators.

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29 Mar

Bone Biologics Completes $500,000 of Financing

March 29, 2018

BURLINGTON, Mass.--(BUSINESS WIRE)--Bone Biologics (OTCQB: BBLG), a developer of orthobiologic products for domestic and international spine fusion markets, announced today the completion of $500,000 funding with Orthofix Holding, Inc. The funding represents the second round of a previously announced private placement. The securities offered have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. About Bone Biologics Bone Biologics (OTCQB:BBLG) was founded to pursue regenerative medicine for bone. Bone Biologics Corporation is undertaking groundbreaking work with the three founders and select strategic partners, building on unprecedented research on the Nell-1 molecule that has produced a significant number of studies and publications in peer reviewed scientific literature. Bone Biologics is currently focusing its development efforts for its bone graft substitute product on bone regeneration in spinal fusion. Nell-1 is a recombinant human protein growth factor that is essential for normal bone development. For more information, please visit the company’s website at www.bonebiologics.com. Bone Biologics trades on the OTCQB venture stage marketplace for early stage and developing U.S. and international companies. OTCQB companies are current in their reporting and undergo an annual verification and management certification process. Investors can find Real-Time quotes and market information for the company on www.otcmarkets.com. Forward-Looking Statements This press release contains forward-looking statements that reflect the Company’s current beliefs, expectations or intentions regarding future events. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “will,” “will be,” “anticipate,” “predict,” “continue,” “future,” and similar expressions are intended to identify such forward-looking statements. Disclaimer This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Contacts

Bone Biologics Jeff Frelick, Chief Operating Officer jfrelick@bonebiologics.com or Compass Investor Relations Mark Collinson, 714-222-5161 mcollinson@compass-ir.com or Media Inquiries: Tracy Williams, 310-824-9000 tracy@olmsteadwilliams.com

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28 Mar

Osteosynthesis Devices Market Is Expected to Reach US $11 Bn by the End of 2023

Albany, NY -- (SBWIRE) -- 03/28/2018 -- Zimmer Biomet, Stryker Corporation, and DePuy Synthes have been the three leaders in the global osteosynthesis devices market for 2014, with a giant collective share in the market stood at 83.7%, according to a research report recently published by Transparency Market Research. The leaders in this highly consolidated market have proven themselves through a extensive product portfolios added to a string of successful mergers and acquisitions. For example, merger between Johnson & Johnson or DePuy with Synthes enabled the formation of a leading provider for osteosynthesis devices in the world. The threat for new entrants is likely to remain moderate to low over the coming years, according to the TMR report. The presence of very strong players, high entry costs, and increasingly stringent regulations and guidelines are disbarring several hopefuls to the market. Patient compliance is becoming a core decisive element in the preference of osteosynthesis devices by patients and healthcare organizations, along with devices with superior safety certificates. Request for Sample Copy of Report @ https://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=5981 The research report reveals that the global market for osteosynthesis devices is expected to reach US$11 bn by the end of 2023, after expanding at a CAGR of 6.5% from 2015 to 2023 in revenue. This revenue was slated to go over US$6.6 bn in 2016. Asia Pacific is expected to be an attractive region for the supply of osteosynthesis devices over the coming years, due to a swiftly evolving healthcare infrastructure and growing healthcare expenditure. North America, on the other hand, is likely to continue dominating both revenue and demand for osteosynthesis devices for the given forecast period. Non-degradable materials have so far been the more popular material type for the manufacture of osteosynthesis devices till 2023 and are likely to remain in the lead over the given forecast period by TMR. Internal fixation devices are expected to continue being the more popular type of osteosynthesis devices over the coming years. Request for TOC @ https://www.transparencymarketresearch.com/report-toc/5981 Rising Patient Count Runs Higher, Pushes Production Rate "The number of people suffering from osteoarthritis and osteoporosis is usually found to be more common with the elderly. This number is currently very high and is creating a large enough demand for healthcare treatment options. For the coming years, this number is expected to increase even further and at a very swift alarming pace, thereby increasing the pressure of manufacture on the global osteosynthesis market," states a TMR analyst. According to information and statistics provided by the globally leading organizations in healthcare, osteoporosis is currently attributed to induce more than 8.6 mn fractures every year across the world. More concerning is the regular rate of increment in this statistic, owing to the alarming rate of increase in the obese demographic, especially in developed economies, coupled with the growing number of road accidents and sports injuries across the world. Enquiry for discount on this report @ https://www.transparencymarketresearch.com/sample/sample.php?flag=D&rep_id=5981 Market Growth Stifled by High Rate of Product Recalls The average rate of failure in metal hip implants is 40%, which is extremely high and needs to be addressed by osteosynthesis device manufacturers as soon as possible. In 2010, DePuy Synthes had to recall nearly 93,000 osteosynthesis devices and implants after being sued for poor product quality. Eventually a settlement of US$4 mn was reached for all patients who were inconvenienced by the faulty implants. Situations such as these are creating a more negative image of the leading osteosynthesis device manufacturers across the world and have created a significant loss of credibility among consumers. About Transparency Market Research Transparency Market Research (TMR) is a global market intelligence company providing business information reports and services. The company's exclusive blend of quantitative forecasting and trend analysis provides forward-looking insight for thousands of decision makers. TMR's experienced team of analysts, researchers, and consultants use proprietary data sources and various tools and techniques to gather and analyze information. Our business offerings represent the latest and the most reliable information indispensable for businesses to sustain a competitive edge. Contact Us Transparency Market Research State Tower, 90 State Street, Suite 700 Albany, NY 12207 United States Tel: +1-518-618-1030 USA - Canada Toll Free: 866-552-3453 Email: sales@transparencymarketresearch.com Website: http://www.transparencymarketresearch.com

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