Implanet Announces: Liquidity Contract Transferred From ODDO Corporate Finance to Tradition Securities And Futures (TSAF)
November 30, 2017
ContactsIMPLANET Ludovic Lastennet CEO Tel. : +33 (0)5 57 99 55 55 email@example.com or NewCap Investor Relations Julie Coulot Tel. : +33 (0)1 44 71 20 40 firstname.lastname@example.org or NewCap Media Relations Nicolas Merigeau Tel. : +33 (0)1 44 71 94 98 email@example.com or AlphaBronze US-Investor Relations Pascal Nigen Tel.: +1 917 385 21 60 firstname.lastname@example.org
LEESBURG, Va., Nov. 30, 2017 (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 completion of 300 surgical cases using the RHINE™ Cervical Disc System*. The announcement was made during the 12th Annual Meeting of the German Spine Society, occurring November 30–December 2, 2017, in Stuttgart, where the Company will exhibit its comprehensive product portfolio and the Balance ACS® (BACS®) platform at Stand #73.The RHINE Cervical Disc System* is an artificial disc replacement that features a one-piece compressible polymer core design with dome-shaped, plasma-coated endplates and a central-split keel. Proprietary molding technology is incorporated to minimize wear between the polymer core and metal endplates. The system’s instrumentation simplifies spinal surgery by integrating trialing and keel cutting into one instrument. A built-in adjustable stop allows for customized anterior or posterior positioning of the disc based on surgeon preference. “The RHINE Cervical Disc was designed to mimic the characteristics of a normal healthy disc,” said Dr. Ardavan Ardeshiri, a neurosurgeon and spine surgeon at the Hessing Klinik in Augsburg, Germany, and an Investigator of the RHINE Cervical Disc Prospective Observational Clinical Study. “The product design, combined with easy-to-use modular instrumentation and a simple surgical technique, provides surgeons with an advanced solution for cervical disc replacement.” The RHINE Cervical Disc Prospective Observational Clinical Study is presently gathering additional operative data and feedback to confirm device performance, including radiographic data and clinical outcomes. “K2M is proud to acknowledge the 300 surgeries that have been completed using our RHINE Cervical Disc System*,” said K2M Chairman, President, and CEO Eric Major. “RHINE, which received a CE Mark last year, is an advancement in cervical disc technology, and its continued commercialization and clinical validation in Europe is an important piece of our corporate strategy. We look forward to showcasing RHINE, our Balance ACS platform, and many of our innovative spinal solutions at this year’s meeting of the German Spine Society.” K2M to Exhibit Spinal Innovations and Balance ACS Platform In addition to the RHINE Cervical Disc System*, K2M will showcase differentiated spinal technologies from its comprehensive complex spine, minimally invasive, and degenerative portfolios. These products include the 3D-printed CASCADIA™ Interbody Systems featuring K2M’s Lamellar 3D Titanium Technology™, the EVEREST® Minimally Invasive XT Spinal System, the NILE® Alternative Fixation and NILE Proximal Fixation Spinal Systems, the MESA® Deformity Spinal System, the SAHARA® AL Expandable Stabilization System, and more. K2M will also feature its Balance ACS platform, which provides solutions focused on achieving 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. K2M will demo the BACS Surgical Planner, a surgical image measuring technology that assists in planning and preoperative implant selection. For more information on K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com. *This product is intended for export and is not sold or offered for sale in the United States. About K2M K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn and YouTube. Forward-Looking Statements This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects. In some cases, you can identify these forward-looking statements by the use of words such as, "outlook," "guidance," "believes," "expects," "potential," "continues," "may," "will," "should," "could," "seeks," "predicts," "intends," "plans," "estimates," "anticipates" or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products and retain their use of our products; pricing pressures and our ability to compete effectively generally in our industry; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; 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 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, 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 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 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 the 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; continuing 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; 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; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; increased costs and additional regulations and requirements as a result of no longer qualifying as an emerging growth company as of December 31, 2017; 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 and our Quarterly Report filed with the SEC on August 2, 2017, 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 Read More
Rotation Medical Bioinductive Implant Promotes Consistent Rotator Cuff Healing, Mitigates Tear Progression
November 30, 2017
- Clinical scores improved significantly (p<0.0001), and mean tendon thickness increased by 2.0 mm (p<0.0001); new tissue was indistinguishable from the underlying tendon.
- 94 percent of patients experienced complete healing or considerable reduction in defect size; consistent partial to complete fill-in of the original bursal, intrasubstance and articular partial-thickness tear defects were observed as early as three months postoperatively, with sustained efficacy through 12 months.
- 94 percent of patients either agreed or strongly agreed that they were satisfied with the results of their surgery.
- No tears progressed to full-thickness in patients who followed the postoperative rehabilitation protocol.
- No serious adverse events related to the implant were reported.
ContactsMerryman Communications Joni Ramirez, 323-532-0746 email@example.com
November 28, 2017
ContactsInvestors LHA Investor Relations Kim Sutton Golodetz, (212) 838-3777 firstname.lastname@example.org or Media RooneyPartners Marion Janic, (212) 223-4017 email@example.com
Kleinostheim, Germany / Research Triangle Park, NC, USA, November 2, 2017 - curasan Inc., the US-subsidiary of curasan AG (ISIN DE0005494538), a leading medical supplier specializing in dental and orthopedic biomaterials, announced a private label distribution agreement with Xtant Medical (NYSE:XTNT Belgrade, Montana USA), a leader in the development and distribution of regenerative and orthopedic fixation medicine products. Xtant Medical will distribute several key orthopedic curasan products in the USA and Canada utilizing curasan's flagship CERASORB foam technology using Xtant's brand Matriform. With the addition of Matriform foam to Xtant's portfolio, Xtant will now offer an innovative synthetic platform with demonstrated clinical results and excellent handling characteristics complementing their current allograft and hardware portfolio ultimately providing surgeons with a choice in grafting materials. "We are excited to be enhancing our biologic portfolio offering with a line of synthetic scaffolds, which will make us a comprehensive biologic supplier for our customers and their patients," said Carl O'Connell, CEO of Xtant Medical. "Our team has been very strategic in finding a partner with a product that meets our expectations for superior handling and clinical efficacy with proven mechanisms of action." "Thanks to the cooperation with such a forward-thinking company as Xtant Medical we will expand our distribution footprint within North America substantially," said Michael Schlenk, CEO of curasan AG. "Xtant has a great reputation for providing innovative and relevant products to orthopedic surgeons." Therefore, curasan expects the first significant sales from the cooperation in 2018. Contact at curasan AG: Investor Relations & Corporate Communications +49 6027 40 900-51 firstname.lastname@example.org About curasan AG: curasan develops, manufactures and markets biomaterials and medical devices in the field of bone and tissue regeneration, wound healing and osteoarthritis therapy. As a pioneer and global technology leader in the growing field of regenerative medicine, curasan is specialized primarily on biomimetic bone grafting materials for dental, oral/maxillofacial, orthopedic and spinal applications, i.e. materials mimicking biological structures. Numerous patents and a broad record of scientific publications demonstrate the clinical success of the products and the highly innovative strength of curasan. Dental and orthopaedic clinicians worldwide benefit from the broad range of the premium quality and easy to use portfolio offered by the technology leader curasan. curasan maintains its own high-tech facilities for research, development and manufacturing of biomaterials in Frankfurt/Main, Germany. In addition to its headquarters, the company has a subsidiary, curasan, Inc., in the Research Triangle Park area, near Raleigh, N.C., USA. curasan's innovative products are cleared by the US Food and Drug Administration (FDA) and many other international authorities and available in almost 50 countries worldwide. curasan AG is a public company listed in the General Standard at the Frankfurt Stock Exchange.
|Phone:||06027/40 900 0|
|Fax:||06027/40 900 29|
|Listed:||Regulated Market in Frankfurt (General Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange|
|End of News||DGAP News Service|
Kleinostheim, 30 November 2017 - curasan AG (ISIN DE0005494538), a leading specialist for medical products in the field of orthobiologics, has signed an exclusive distribution agreement with Implantcast GmbH, Buxtehude, Germany. Already starting mid-December the worldwide acting orthopedics company, specialized on primary-, revision- and tumor endoprosthesis will market curasan AG's bone regeneration materials (CERASORB(R)) in Germany, Austria and Switzerland. "For many years Implantcast has established itself as a specialist for orthopedics in the DACH-region, especially in the field of endoprosthesis. The company has built up a successfully working worldwide sales structure, which we consider a significant improvement for the distribution of our CERASORB(R) orthopedics portfolio", explains Michael Schlenk, CEO of curasan AG. "This cooperation will give us to access a considerable number of new potential customers. Together we are going to increase the awareness for our bone regeneration materials and expand our market share. " "The cooperation of the two companies will go beyond pure distribution. For example, we also agreed on a joint concept for the inclusion of key opinion leaders, on common medical monitoring projects and studies with leading centers for endoprosthesis as well as on collaborative participation in congresses, symposia and advanced training courses for clinical users", adds Florian Früh, Head of Product Management of curasan AG. "Our joint measures shall emphasize the importance of the synergies existing between innovative individual implant solutions for the patient and therapies for complete bone regeneration". "With curasan's innovative bone regeneration materials we shall be able to offer a comprehensive treatment concept for various degenerative and pathological diseases of the human skeletal system to clinical surgeons", says Jens Saß, Managing Director and CEO of Implantcast GmbH. "By combining our resources and our medical and scientific expertise and competence as well as our long-time experience in orthopedics we are going to create a much higher awareness in the market. " Both parties consider to expand the distribution agreement also to other countries with an existing Implantcast sales network. About curasan AG: curasan develops, manufactures and markets biomaterials and medical devices in the field of bone and tissue regeneration, wound healing and osteoarthritis therapy. As a pioneer and global technology leader in the growing field of regenerative medicine, curasan is specialized primarily on biomimetic bone grafting materials for dental, oral/maxillofacial, orthopedic and spinal applications, i.e. materials mimicking biological structures. Numerous patents and a broad record of scientific publications demonstrate the clinical success of the products and the highly innovative strength of curasan. Dental and orthopaedic clinicians worldwide benefit from the broad range of the premium quality and easy to use portfolio offered by the technology leader curasan. curasan maintains its own high-tech facilities for research, development and manufacturing of biomaterials in Frankfurt/Main, Germany. In addition to its headquarters, the company has a subsidiary, curasan, Inc., in the Research Triangle Park area, near Raleigh, N.C., USA. curasan's innovative products are cleared by the US Food and Drug Administration (FDA) and many other international authorities and available in almost 50 countries worldwide. curasan AG is a public company listed in the General Standard at the Frankfurt Stock Exchange. About Implantcast GmbH: Implantcast GmbH is a highly-specialized and innovative medical technology company based in Buxtehude near Hamburg, Germany. Today, Implantcast has more than 480 employees. The company operates in the fields of product development, manufacturing, sterile packaging as well as sales and distribution of primary, revision and tumor endoprosthesis to offer an ideal solution for each individual patient. The company also has a worldwide sales network with 10 sales offices and more than 65 sales partners. Its headquarters and R&D are located at Buxtehude, the place of foundation. From here all cooperation partners are provided with endoprosthetics and instruments and in the future also with bone regeneration materials. www.implantcast.de
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Nov. 27, 2017 - By Kathleen Doheny/WebMD Health News
Stopping Excess Bone Breakdown
A treatment known as MIV-711 targets an enzyme called cathepsin K that is thought to play a role in the destruction of cartilage and the breakdown of too much bone.
In adults, bones are constantly being broken down and built up or replaced to maintain a healthy skeleton. "This [treatment] stops the increased breakdown of bone that happens in OA," says researcher Philip Conaghan, MD, a professor of musculoskeletal medicine at the University of Leeds in Great Britain. "It inhibits the cathepsin K.'' The bone changes happen before the cartilage loss does, he says.
In the study, researchers assigned 244 men and women who have knee arthritis to get one of two oral doses of the treatment or a placebo pill for up to 28 days. The participants’ average age was 62, and many were overweight or obese.
The researchers did MRIs at the beginning of the study and at week 26 to find changes around the bone, which reflect cartilage change. They found 65% less bone disease progression in the treated groups, regardless of dose, Conaghan says.
But they found no less pain. "It did not help symptoms," he says.
MARIETTA, GA. (PRWEB) NOVEMBER 28, 2017
Spinal Elements, Inc. today announced plans to move its global headquarters to its Carlsbad, California location. Concurrent with this move, Jason Blain, co-founder of Spinal Elements and currently its President and COO, will assume the role of President and CEO. This change is effective immediately.
“I am excited by the opportunity to lead our talented team of employees and partners and create an even more vibrant and dynamic Spinal Elements in the years to come,” said Jason Blain, Spinal Elements’ new President and CEO. “I thank Chris Fair and the other members of our board of directors for their confidence. Going forward, Spinal Elements will continue to be focused on innovation and execution, driven by differentiated technologies and premium customer service, and we will move quickly to scale new ideas and opportunities into this dynamic marketplace.”
The company’s headquarters move will have minimal impact on Spinal Elements’ Marietta, Georgia-based operations and employees. Added Blain, “The company remains committed to its Marietta campus and our employees based there.”
Mr. Blain’s ascension to CEO will build on the strong foundation and momentum achieved by the Spinal Elements team under Chris Fair’s leadership. “Jason has inspired many of Spinal Elements’ most exciting technologies – past, present and future – while also fostering a team-oriented culture in each position he has held during his career," said Mr. Fair. “I look forward to supporting Jason and the company across all future endeavors.” Mr. Fair, who resides with his family in the Atlanta metro area, will continue as a member of Spinal Elements’ Board of Directors.
Prior to co-founding Spinal Elements in 2003, Mr. Blain had roles of increasing responsibility in product development, manufacturing, regulatory affairs and quality assurance with Smith & Nephew, Alphatec, and NuVasive.
About Spinal Elements
Spinal Elements is an outcomes-driven spinal surgical solutions company with locations in Carlsbad, CA and Marietta, GA. A leading designer, developer, manufacturer and marketer of innovative medical devices used in spinal surgical procedures, our mission is to combine leading medical device technologies, biologics and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. For more information, please visit http://www.spinalelements.com.Read More