Medicrea is listed on EURONEXT Growth Paris ISIN: FR 0004178572 Ticker: ALMED LEI: 969500BR1CPTYMTJBA37
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 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 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 Source: K2M Group Holdings, Inc., Photo: K2M Group Holdings, Inc. Read More
March 30, 2018
ContactsOrtho Kinematics‚ Inc. Annie Burke, 512-334-5490
March 28, 2018
- 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.
|€ thousands - IFRS||H1 2017-18||H1 2016-17||Δ|
|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%|
|as a % of sales||13.3%||13.2%||+10 bp|
|Core Operating Profit||-1,876||-1,455|
|Non-core operating expenses||-1,358||843|
|Attributable Net Profit/Loss||-8,602||-5,951|
|Net financial debt||90,320||74,030|
|Net cash position||34,105||41,636|
- 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.
ContactsAmplitude Surgical Philippe Garcia, +33 (0)4 75 41 87 41 CFO firstname.lastname@example.org or NewCap Investor Relations Marc Willaume, +33 (0)1 44 71 00 13 email@example.com or NewCap Media Relations Nicolas Merigeau, +33 (0)1 44 71 98 55 firstname.lastname@example.org
March 29, 2018
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.
NeoSpine Founder, President Richard Wohns, MD, to Speak at 16th Annual Future of Spine + The Spine, Orthopedic and Pain Management-Driven ASC Conference
CHICAGO (PRWEB) MARCH 26, 2018
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 email@example.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.Read More
March 29, 2018
ContactsBone Biologics Jeff Frelick, Chief Operating Officer firstname.lastname@example.org or Compass Investor Relations Mark Collinson, 714-222-5161 email@example.com or Media Inquiries: Tracy Williams, 310-824-9000 firstname.lastname@example.org