30 Nov

Implanet Announces: Liquidity Contract Transferred From ODDO Corporate Finance to Tradition Securities And Futures (TSAF)

November 30, 2017

BORDEAUX, France & BOSTON--(BUSINESS WIRE)--Regulatory News: IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext Growth: IMPL, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today is announcing that it has transferred the liquidity contract previously entered into with Oddo Corporate Finance to Tradition Securities And Futures (TSAF) effective December 1, 2017. The liquidity contract entered into with TSAF complies with the AMAFI Code of Conduct for Liquidity Contracts approved by the Autorité des Marchés Financiers on March 21, 2011. The liquidity contract has been agreed for a term of one year to enhance the liquidity of trading in Implanet shares (ISIN code: FR0010458729 – Ticker: ALIMP) listed on the Euronext Growth Paris market. The following funds and assets have been set aside for the implementation of this contract: • €36,689.25 in cash • 153,000 Implanet shares About IMPLANET Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com. Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013. IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

Contacts

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

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30 Nov

K2M Announces Completion of 300 RHINE™ Cervical Disc System Surgical Cases

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 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 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

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30 Nov

MiMedx Announces Expectation To Exceed Top End of Fourth Quarter Revenue Guidance Of $88 Million

MARIETTA, Ga.Nov. 30, 2017 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today its preliminary expectation for fourth quarter of 2017 revenue to exceed the $88 million high end of its fourth quarter revenue guidance range.
Parker H. "Pete" Petit, Chairman and CEO, commented, "October and November have been very strong revenue months for the Company, and we expect our revenue performance in December to be equally strong.  With two-thirds of the fourth quarter completed, and as we enter December, our current revenue pace gives us confidence that we are in a position to announce that we expect to exceed $88 million in revenue for the fourth quarter of 2017 and surpass our previously published guidance for the fourth quarter and full year 2017. If we execute as expected, this will be the fourth straight quarter of exceeding the upper end of our guidance." Bill Taylor, President and COO, said, "Our sales leadership team has never been stronger, and we are extremely pleased with the momentum they continue to build.  Each quarter, we are improving efficiencies in our sales organization and increasing effectiveness in pursuing and capturing market opportunities." Petit added, "We look forward to reporting our 2017 fourth quarter and full year revenue in January and our 2017 financial results in late February. We are holding a meeting of our Board of Directors during the week of December 11thto finalize our 2018 budget, and we are also looking forward to announcing our 2018 guidance later in that week." About MiMedx MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. "Innovations in Regenerative Medicine" is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts.  MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 1 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com. Important Cautionary Statement This press release includes forward-looking statements, including statements regarding its revenue expectations for the 2017 fourth quarter and full year and its expectations regarding the timing of additional guidance. These statements also may be identified by words such as "believe," "except," "may," "plan," "potential," "will" and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements.  Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that the Company's revenue for the 2017 fourth quarter and full year may not materialize as expected; sales momentum may slow at the end of the year; and the Company may be unable to meet expected dates for future guidance. For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement. SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

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30 Nov

Rotation Medical Bioinductive Implant Promotes Consistent Rotator Cuff Healing, Mitigates Tear Progression

November 30, 2017

PLYMOUTH, Minn.--(BUSINESS WIRE)--Rotation Medical Inc., a medical device company focused on developing new technologies to treat rotator cuff disease, today announced results of a study published online in the Journal of Shoulder and Elbow Surgery that shows the company’s Bioinductive Implant consistently heals rotator cuff tears and mitigates tear progression. The Rotation Medical Bioinductive Implant is part of the company’s novel rotator cuff system for rotator cuff repair and a new alternative to traditional surgical repair. “Partial thickness rotator cuff tears do not heal spontaneously and have a high propensity to increase in size and/or develop into full-thickness lesions,” said Theodore F. Schlegel, MD, lead investigator of the study and orthopedic surgeon at Steadman Hawkins Clinic Denver. “This study shows that the Bioinductive Implant not only repairs the tear and increases tendon thickness, but it also prevents tear progression. In addition, because the native tendon footprint remains intact around the location of the defect, the Bioinductive Implant may accelerate rehabilitation and recovery as compared with more conservative postoperative management when partial thickness lesions are taken down and repaired as full thickness tears.” The study enrolled 33 patients with chronic, degenerative, intermediate- (n=12) to high-grade (n=21) partial-thickness tears (11 articular, 10 bursal, four intra-substance, eight hybrid) of the supraspinatus tendon. Clinical outcomes were assessed using American Shoulder and Elbow Surgeons (ASES) and Constant-Murley scores preoperatively and at three and 12 months postoperatively. Magnetic resonance imaging (MRI) was performed to assess postoperative tendon healing and thickness at the original tear site. One-year results of the multi-center study include:
  • 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.
“In addition to further demonstrating that our Bioinductive Implant increases tendon thickness and prevents re-tears, we are pleased that the majority of patients in this study said they were satisfied with the results of their rotator cuff surgeries,” said Martha Shadan, president and CEO of Rotation Medical. “As health systems transition to value-based care, data like these are becoming increasingly necessary to demonstrate the effectiveness of medical devices on indicators such as patient satisfaction, in addition to key health economic drivers that we are measuring in our REBUILD Registry Study.” The study, “Radiologic and clinical evaluation of a bioabsorbable collagen implant to treat partial-thickness tears: a prospective multi-center study,” adds to the growing body of literature supporting the use of the Rotation Medical Bioinductive Implant as a novel treatment for rotator cuff injury. Additional publications and information about the Rotation Medical rotator cuff system are available on the company’s website. About Rotator Cuff Tears Rotator cuff damage is the most common source of shoulder pain, affecting more than 4 million people annually in the U.S. Traditional approaches to treating degenerate or torn rotator cuffs often do not address the poor quality of the underlying tendon tissue, and a significant number of these tendons, after standard treatment, either degenerate further and/or re-tear. About the Rotation Medical Bioinductive Implant Cleared by the U.S. Food and Drug Administration in March 2014, the Rotation Medical Bioinductive Implant is designed to address both the biomechanics and biology required to heal a rotator cuff tendon tear by inducing new tissue growth at the site of implantation, resulting in increased tendon thickness and healing of tendon defects with new tissue growth. The collagen-based implant is about the size of a postage stamp and it is part of the Rotation Medical rotator cuff system, which also includes disposable instruments that allow the arthroscopic procedure to be performed easily and quickly. For important safety information, visit http://rotationmedical.com/our-solution/risks/. About Rotation Medical Rotation Medical Inc. was founded in 2009 and is committed to improving the treatment of rotator cuff disease with the Rotation Medical rotator cuff system, a breakthrough technology that has the potential to prevent rotator cuff disease progression and reduce re-tears by inducing the growth of new tendinous tissue. The company is privately held and funded by New Enterprise Associates (NEA), Life Sciences Partners (LSP) and Pappas Ventures. For more information, visit http://www.rotationmedical.com/.

Contacts

Merryman Communications Joni Ramirez, 323-532-0746 joni@merrymancommunications.com

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30 Nov

PAVmed Files 510(k) Submission with FDA for CarpX™ Device to Treat Carpal Tunnel Syndrome

November 28, 2017

NEW YORK--(BUSINESS WIRE)--PAVmed Inc. (Nasdaq: PAVM, PAVMW), a highly differentiated, multiproduct medical device company, today announced that it has filed a 510(k) premarket notification submission with the U.S. Food and Drug Administration (FDA) for its CarpX™ minimally invasive device designed to treat carpal tunnel syndrome. “We are very excited to have reached this most important milestone in PAVmed’s corporate history,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “CarpX has become the most commercially promising and clinically exciting product in our pipeline and we believe it will revolutionize the treatment of carpal tunnel syndrome, a widely prevalent condition that exacts a significant clinical and economic burden on society in the U.S. and worldwide. Based on epidemiological and market research data we estimate CarpX's addressable market opportunity to exceed $1 billion." David A. Kelly, M.D., Co-Director of Plastic Surgery at the Center for Dermatology and Plastic Surgery in Gilbert, Arizona, concurred. “I have had the opportunity to use PAVmed’s highly innovative CarpX device in pre-submission testing and am very impressed with its performance. As a busy hand surgeon, I strongly believe that CarpX will be a game-changer in the treatment of carpal tunnel syndrome, providing patients with a much less invasive option and significantly shorter recovery times than traditional open carpal tunnel surgery.” Carpal tunnel syndrome is the most common cumulative trauma disorder. It accounts for over half of all occupational injuries in the U.S. and over $20 billion in annual workers’ compensation costs. The carpal tunnel is an anatomic space in the wrist through which tendons and the median nerve pass. Cumulative trauma from repetitive motion (e.g., typing) leads to inflammation, scarring and compression of the nerve, resulting in a syndrome of debilitating symptoms in the hands. It is estimated to affect 2.5% of U.S. adults with 600,000 undergoing invasive carpal tunnel surgery each year and many more choosing to defer surgery and suffer in silence. Traditional carpal tunnel surgery involves making incisions at the base on the hand through which the scarred ligament is cut to relieve compression of the nerve. Recovery times vary but can last many months. “We designed CarpX to closely mimic the anatomic results of traditional invasive carpal tunnel surgery but to do so much less invasively, using catheters, balloons, radiofrequency energy and other established tools that have contributed to the percutaneous and minimally invasive revolutions in the treatment of other conditions,” said Brian J. deGuzman, M.D., PAVmed’s Chief Medical Officer. “Our balloon catheter device is designed to be inserted under the scarred ligament in a minimally invasive fashion, while pushing the nerve and tendons away. When activated, bipolar radiofrequency electrodes precisely cut the ligament from the inside out in a matter of seconds. The device design provides physicians with ongoing feedback to optimize the safety and completeness of the procedure,” he added. “As with all of our products, CarpX’s development and regulatory testing were performed using our unique business model focused on speed to market and capital efficiency. We are proud to have achieved this milestone within a timeframe and with capital expenditures to date that beat our model’s benchmarks,” added Dr. Aklog. “We believe we have assembled a strong submission and are targeting clearance in the first half of 2018. Upon successful regulatory clearance, we anticipate an aggressive commercialization strategy using well-established independent sales channels targeting the appropriate physician specialties.” “I eagerly await CarpX’s regulatory clearance and the opportunity to offer this ground-breaking innovation to my patients suffering from carpal tunnel syndrome,” said Dr. Kelly. About PAVmed PAVmed Inc. is a highly differentiated, multiproduct medical device company employing a unique business model designed to advance products from concept to commercialization much more rapidly and with significantly less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation. PAVmed’s diversified pipeline of products address unmet clinical needs, have attractive regulatory pathways and market opportunities and encompass a broad spectrum of clinical areas including carpal tunnel syndrome (CarpX™), interventional radiology (PortIO™ and NextCath™), pediatric ear infections (DisappEAR™) medical infusions (NextFlo™ and NextCath™), and tissue ablation and cardiovascular intervention (Caldus™). The Company intends to further expand its pipeline through engagements with clinician innovators and leading academic medical centers. For further information, please visit www.pavmed.com. Forward-Looking Statements This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of the Company’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, the uncertainties inherent in research and development, including the cost and time required advance our products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from our preclinical studies; whether and when our products are cleared by regulatory authorities; market acceptance of our products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market any of its products. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item IA, “Risk Factors,” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Reports on Form 10-Q filed by us after our most recent Annual Report. We disclaim any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.

Contacts

Investors LHA Investor Relations Kim Sutton Golodetz, (212) 838-3777 kgolodetz@lhai.com or Media RooneyPartners Marion Janic, (212) 223-4017 mjanic@rooneyco.com

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30 Nov

Regentis Biomaterials Performs the First Cases in GelrinC Pivotal Study

PRINCETON, New Jersey and OR AKIVA, IsraelNovember 28, 2017 /PRNewswire/ -- Regentis Biomaterials announced today the start of its Phase III pivotal clinical trial of GelrinC for the treatment of focal knee cartilage defects with successful surgery on three patients in the U.S. and Denmark. These procedures are part of a Food and Drug Adminstration (FDA) approved Investigational Device Exemption (IDE) clinical study to compare GelrinC to microfracture, the current standard of care treatment. The clinical study will be used to support a Pre-market Approval Application (PMA) which will allow Regentis to market GelrinC in the U.S.
The US procedures were performed by Dr. Jason Scopp at the Peninsula Orthopaedic Clinic in Salisbury, Maryland and by Dr. Bryan Huber at Mansfield Orthopaedics at Copley Hospital in Morrisville, Vermont while the Denmark procedure was completed by Dr. Martin Lind in Aarhus University Hospital in Aarhus. "We are entering our next evolution in the field of joint preservation. While many current techniques involve transplanting cartilage from a donor, the GelrinC implant allows us to harness the benefits of our patient's own mesenchymal stem cells," said Dr. Jason Scopp from Peninsula Orthopaedic Clinic. "The  technique was extremely quick, adding a mere 10 minutes to a standard practice procedure. Product application to the lesion was easy with the assistance of Regentis's proprietery delivery device. It completely filled the defect and after a short exposure to UV light, an optimal implant was formed." "The success of these three clinical procedures is a significant milestone for Regentis and represents a big step to helping US and European patients recover from damaged articular knee cartilage," said Regentis President and CEO Alastair Clemow, Ph.D. "In our previous study in Europe, GelrinC demonstrated outstanding clinical outcomes, and we look forward to continue demonstrating the effectiveness of this novel treatment for US patients." The FDA trial will appraise the safety and efficacy of GelrinC compared to the raw level data of a historical microfracture control arm. This study design overcomes the limitation of randomized control studies in this field, and is expected to generate faster patient enrollment and significantly reduce the time for product approval. With an estimated market opportunity in excess of $1 billion, cartilage repair is the largest unmet need in orthopedic sports medicine today. Articular cartilage is the smooth, white tissue covering the ends of bones where they come together to form joints. Focal defects of the cartilage layer are extremely painful for patients and usually occur due to sudden trauma. Surgical intervention is often required because of the limited capacity for cartilage to repair itself. The current standard of care treatment is microfracture but this only provides short term relief and often requires surgical re-intervention. About Regentis Biomaterials With offices in Or Akiva, Israel and Princeton, NJ, Regentis Biomaterials is a privately held company focused on developing and commercializing proprietary hydrogels for tissue regeneration. The company's core technology is Gelrin™, a biodegradable hydrogel based on polyethylene glycol diacrylate and denatured human fibrinogen originally developed at the Technion - Israel Institute of Technology by Dr. Dror Seliktar. The Gelrin hydrogel platform combines the stability and versatility of a synthetic material with the bio-functionality of a natural substance for a range of clinical applications. For more information, please visit http://www.regentis.co.il. For media inquiries, please contact: Josh Turner Media Relations Phone: 011-972-54-949-6526 josh@jtpublicrelations.com USA Alastair Clemow, PhD President & CEO +1-508-930-8865 Israel Livnat Ben Zur General Manager 011-972-52-860-4735 SOURCE Regentis Biomaterials Ltd.

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30 Nov

curasan Inc. announces Orthopedic Private Label Distribution Agreement

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 ir@curasan.com 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 Xtant Medical: Xtant Medical Holdings, Inc. (NYSE American:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

02.11.2017 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de


 

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30 Nov

curasan signs new cooperation with Implantcast for the DACH-region

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

Contact: Andrea Weidner Investor Relations / Corporate Communications Tel. +49 6027 40900-51 Fax +49 6027 40900-39 andrea.weidner@curasan.com

30.11.2017 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de  

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30 Nov

Scientists Race To Regrow Lost Knee Cartilage

Nov. 27, 2017 - By Kathleen Doheny/WebMD Health News

 Bad knees sideline athletes and mere mortals alike.About 14 million Americans have osteoarthritis of the knees severe enough to cause pain and inflammation, according to the Arthritis Foundation, and more people are getting the condition -- also known as OA -- as they age. As the knee's natural cushioning -- the cartilage -- wanes, inflammation and pain rise, and people can't get around as well. Building knee cartilage has been a dream of researchers, and now several methods are under study. None has yet shown it can prevent or cure osteoarthritis, and all are in early phases, caution the scientists who presented their findings at the recent annual meeting of the American College of Rheumatology in San Diego, CA.

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.
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29 Nov

Spinal Elements Announces Headquarters And CEO Changes

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.

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