31 Aug

MiMedx Reports MultiCenter randomized Controlled VLU Clinical Study Accepted for Publication in The International Wound Journal

MARIETTA, Ga.Aug. 31, 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 that their latest peer-reviewed clinical study of the MiMedx dehydrated human amnion/chorion membrane ("dHACM") allografts was accepted for publication in the International Wound Journal.
The paper entitled "A Multicenter Randomized Controlled Trial Evaluating the Efficacy of Dehydrated Human Amnion/Chorion Membrane (EpiFix) Allograft for the Treatment of Venous Leg Ulcers," was authored by Christian Bianchi, MD, FACS; Shawn Cazzell, DPM, FACFAS; Dean Vayser, DPM, FACFAS; Alexander M. Reyzelman, DPM, FACFAS; Hasan Doslouglu, MD, FACS; Gregory Tovmassian, DPM; and the EpiFix VLU Study Group of Delores Farrer, DPM, MBA, CWS; Elisa Taffe, MD; Lacey Loveland, DPM; David O'Connor, MD; Marc D. Baer, DPM, FACFAS; and Sara Dahle, DPM, MPH. The electronic publication of the article in the International Wound Journal is expected to be made in the next few weeks. At that time, MiMedx expects to issue a follow-up press release with the detailed study results and link to the article. Parker H. Petit, Chairman and CEO, stated, "This is the first large scale successful Venous Leg Ulcer (VLU) study to be completed in nearly 20 years, and the first large randomized controlled trial (RCT) of this quality on a biological allograft. No other organization has completed such a VLU study and achieved such compelling results. Our EpiFix bilayer allograft is the first and only biologic with these confirmed clinical results. This study is evidence that MiMedx continues to distance itself from our competitors." Bill Taylor, President and COO, said, "The 16 week randomized, fifteen-center, clinical trial evaluated the efficacy of MiMedx EpiFix® as an adjunct to moist wound dressings and multilayer compression bandages for the treatment of non-healing full-thickness VLUs. The 109 subjects were randomized to receive EpiFix in addition to moist dressings and compression or moist dressings and compression alone. The primary endpoint was time to complete healing. Secondary endpoints were the proportion of subjects with complete healing by 12 and 16 weeks." Taylor continued, "The study results for the patients treated with EpiFix showed VLU healing rates of 60% within 12 weeks and 71% within 16 weeks. Healing rate in this context means the percentage of patients that achieved complete healing. These results are vastly superior to VLU healing rates reported in studies of other advanced wound care products. In the 1998 randomized study of VLU healing rates with Apligraf® conducted by Falanga, et al., a healing rate of 63% was reported at 24 weeks, which, while a separate study, nevertheless corresponds to the week 12 healing rate of 60% with EpiFix reported in this study. The healing results observed with EpiFix within 12 weeks are even more remarkable given that Falanga, et al. reported a mean wound size of 1.33 ± 2.69 cmfor Apligraf treated subjects, and excluded patients with uncontrolled diabetes and other clinically significant medical conditions that could impair wound healing. In this EpiFix study, patients with these types of comorbidities were included and mean wound size was considerably larger at 7.6 ± 6.1 cm2." "While we have achieved Medicare reimbursement coverage for both VLU's and Diabetic Foot Ulcers (DFUs), our breadth of reimbursement coverage with commercial payers is primarily for DFUs. Commercial health insurance plans are heavily influenced by the results of published clinical studies, and numerous clinical studies have been conducted and published that confirm the healing effects of EpiFix on DFUs. With the publication of this study and its compelling results in VLU healing rates, we expect a significant revenue opportunity will develop for MiMedx as commercial payers see this body of evidence demonstrating the clinical efficacy of EpiFix in the treatment of VLUs. We have used very conservative parameters to calculate the impact of gaining additional VLU coverage with payers. We estimate with the impact of this study, MiMedx can obtain VLU coverage for approximately 133 million additional commercial lives," noted Petit. Taylor added, "Published data indicates that the prevalence rate of VLUs in the commercial population is 0.183 percent. Assuming three to four EpiFix applications for a VLU, which is a very moderate assumption, and assuming an extremely conservative market penetration rate of 10 to 15 percent, we believe our incremental annual revenue opportunity based on patients presenting with VLUs not currently covered by our commercial insurance will be between approximately $75 million and $150 million." Chris Cashman, EVP and Chief Commercialization Officer, commented, "We are extremely confident in our ability to achieve and exceed our VLU market penetration estimates if additional commercial insurance coverage is gained. Currently, only about 30% of the commercial plans that cover EpiFix for DFUs also cover EpiFix for VLUs as well. This study should dramatically increase that ratio. We now have approximately 350 sales professionals focused on the commercial wound care market, and we anticipate that number to grow to approximately 375 sales professionals by year-end. Given the VLU market opportunity, without even considering the approximate one million acute pressure ulcers that could also benefit from EpiFix applications, we are very excited about the revenue opportunities that this landmark clinical study can facilitate for MiMedx." "We are looking forward to soon reporting the full details of this study when the article is electronically published," concluded Petit. About MiMedx MiMedx® is a biopharmaceutical company developing and marketing regenerative 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 1,000,000 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 the timing, results, and publication of clinical studies; the potential safety and efficacy, and additional approved uses and markets for our products; our expectations of how insurers will respond to this data and the size and timing of additional revenue opportunities; the estimated number of sales professionals by year-end; and the advantage over competitors that will be conferred by this result. 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 unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; insurance coverage decisions may not occur as anticipated or coverage requirements may change; that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated; and we may be unable to hire sufficient qualified sales persons in a timely manner. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, 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.

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31 Aug

joimax®, Inc. Opens Its First Education & Training Center in Irvine, California, Posts Record Sales in the US and Continues to Make Gains with Endoscopic Reimbursement

August 31, 2017

IRVINE, Calif.--(BUSINESS WIRE)--joimax® announces the grand opening of its new state-of-the-art Training    and Education Center in Irvine, California. The company will be holding its first workshop at the Center on       September 8-9th. As the market leader in endoscopic spine surgery, joimax® is fully dedicated to outstanding physician education, training and services worldwide. Due to the newly released US CPT reimbursement code, valid since January 1st, 2017, the demand for joimax® endoscopic procedures are growing monthly in the USA among patients as well as the physician community. This fast growing demand creates major needs which joimax®, Inc. is addressing with fast expansion of its US organization. “This new wet lab facility provides a major base for supporting our fast growing education needs for both our new sales and clinical associates, but moreover it’s a place for physicians to be trained,” states Bob Wolownik, National Director of Sales for joimax® Inc. joimax® also announced that they are taking the lead in supporting this years’ workshops and educational sessions at: SMISS Sept 14-16, 2017 - Las Vegas, NV Sole Supporter of the Endoscopic Lab Session ISASS Sept 22-23, 2017 - Long Beach, CA Endoscopic Lab Supporter NASS Oct. 25-28, 2017 - Orlando, FL Endoscopic Spine Surgery Session Sponsor and Endoscopic Lab Supporter joimax® has also made significant strides in reimbursement support for endoscopic spine procedures via a new external coding support hotline that it manages along with a payor correspondence package. joimax’s Vice President of Operations & Reimbursement, Brian Schneider, recently stated, “We have seen a significant rise in interest from both payors and physicians asking to receive information and streamline communication regarding the new endoscopic spine code.” “As we received a first CPT reimbursement code for endoscopic spine surgery earlier this year and now invest wisely for future growth, joimax® will continue to write a major success story in the US, similar to what it has accomplished in Europe and Asia,” states Maximilian Ries, General Manager for joimax®, Inc. He announced that the company is continuing to post record sales by nearly doubling its year to date US revenues, which is in line with the company’s budget plan. Overall joimax® is very pleased with the great strides achieved in the US market and sees continued sustainable growth globally. “All this is an important step towards the full acceptance of endoscopic minimally invasive spine surgery techniques and their benefits to both the physician and their patients in the US now as well,” echoes Wolfgang Ries, Founder and CEO of joimax®. The company’s European and Asian sales also show record numbers. Earlier this year, joimax® also received multiple new product registrations in Asia and recently in Brazil to fully access this new market. About joimax® Founded in Karlsruhe, Germany, in 2001, joimax® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS® (transforaminal), iLESSYS® (interlaminar) and CESSYS® (cervical) for decompression procedures, MultiZYTE® (for facet and sacroiliac joint therapy) or with EndoLIF® and Percusys® for minimally-invasive endoscopic assisted stabilizations, proven endoscopic systems are provided that, together, cover a variety of indications. In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax® technologies to operate through small incisions - under local or full anesthetic - via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”).

Contacts

Press contact USA: joimax® Inc. Melissa Brumley, +1 949 859 3472 Melissa.brumley@joimaxusa.com or Press contact Int.: joimax® GmbH Sabine Jarosch, +49 721 25514, ext.213 sabine.jarosch@joimax.com

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31 Aug

Bone Therapeutics appoints Jean-Luc Vandebroek as Chief Financial Officer

Gosselies, Belgium, 31 August 2017, 7am CEST - BONE THERAPEUTICS (Euronext Brussels and Paris:BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedic and bone diseases, today announces the appointment of Jean-Luc Vandebroek as Chief Financial Officer, effective 1 September 2017. Jean-Luc will replace Wim Goemaere, who is leaving the Company to take up a senior position within a not-for-profit organisation. Wim will continue to support the Company as a Non-Executive Director, and will lead a managed succession during the transition period.

Jean-Luc Vandebroek is a seasoned finance executive with extensive international finance experience at major public and privately-owned companies. Jean-Luc has built a successful career spanning 15 years at the Belgian-US retailer, Delhaize Group (now Ahold Delhaize). During this period, he held various senior financial positions with increasing responsibility, including roles as Corporate Director Finance Europe and US and Vice President Finance BeLux. He later became Group Chief Financial Officer at Fluxys, a listed, pan-European gas infrastructure group, where he was responsible for the financing of large infrastructure investments using diverse forms of funding on capital markets. Prior to joining Bone Therapeutics, Jean-Luc served as Director and Chief Financial Officer of Moteo Two Wheels and Bihr Europe, the motorcycle division of Alcopa Group, a Belgian family holding with an annual revenue of around EUR 1.7 billion.

Steve Swinson, Chairman of Bone Therapeutics, commented: "We are pleased to welcome Jean-Luc Vandebroek to Bone Therapeutics. With his strong financial acumen, experience leading commercial-stage companies and understanding of corporate finance, Jean-Luc is well equipped to oversee Bone Therapeutics' financial planning needs in its increasingly mature phase of development. The Board wishes to express its gratitude to Wim Goemaere for his significant contribution to the development of Bone Therapeutics, including stewarding the Company through a successful initial public offering in 2015 which raised EUR 37 million. We are glad that he will continue to support the Board of Bone Therapeutics as a Non-Executive Director and wish him well in his new role."

Commenting on his appointment, Jean-Luc Vandebroek said: "I am delighted to be joining Bone Therapeutics at this exciting time in its development. I look forward to working with the Board and management team to help deliver value to shareholders and bring Bone Therapeutics' innovative cell therapy products closer to the market and to patients."

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into "osteoblastic", or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

Our primary clinical focus is ALLOB®, an allogeneic "off-the-shelf" cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB®, obtained from patient`s own bone marrow and currently in Phase III development for osteonecrosis and non-union fractures.

Bone Therapeutics` cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

Contacts

Bone Therapeutics SA

Thomas Lienard, Chief Executive Officer Wim Goemaere, Chief Financial Officer Tel: +32 (0)2 529 59 90 investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:

Consilium Strategic Communications Amber Fennell, Jessica Hodgson and Hendrik Thys Tel: +44 (0) 20 3709 5701 bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:

NewCap Investor Relations & Financial Communications Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau Tel: + 33 (0)1 44 71 94 94 bone@newcap.eu

For US Media and Investor Enquiries

Westwicke Partners John Woolford Tel: + 1 443 213 0506 john.woolford@westwicke.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients. The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Bone Therapeutics SA via Globenewswire  
This article appears in: News Headlines Referenced Stocks: BOTHE

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31 Aug

Seven of Colorado’s Top Private Orthopedic Practices Come Together to Form Orthopedic Centers of Colorado, Now the State’s Largest Practice

DENVERAug. 31, 2017 /PRNewswire/ -- Fifty-six of Colorado's top orthopedic physicians, across seven practices, have united under a common vision of improving outcomes, efficiency, cost, and quality to form Orthopedic Centers of Colorado, LLC (OCC). With 19 offices across the Denver metro area, the combined practice is the largest provider of orthopedic and musculoskeletal care in the state. The seven practices coming together as Orthopedic Centers of Colorado, LLC are:
  • Advanced Orthopedic & Sports Medicine Specialists P.C.
  • Colorado Orthopedic Consultants, P.C.
  • Denver Spine Surgeons, LLC
  • Denver-Vail Orthopedics, P.C.
  • Hand Surgery Associates, P.C.
  • Orthopedic Associates, LLC
  • Peak Orthopedics & Spine, PLLC
In a market where just 33 percent of physicians work in independent practice, down from 48 percent in 2012, this formation represents a physician-driven commitment to the private-practice model of medicine. "The private-practice model has proven to deliver a higher level of quality at a more competitive price," said Davis Hurley, MD, president of Orthopedic Centers of Colorado. "Patients will continue to benefit from the more personalized approach that private practice delivers to accommodate each patient's needs." As a physician-driven organization, OCC will remain nimble enough to adapt to the ever-changing healthcare landscape, and emerge as pioneers in improved patient outcomes and reduced costs, while maintaining strong personal relationships with the patients from the communities we serve. The seven practices will begin operating as Orthopedic Centers of Colorado on September 1, 2017. Patients of the practices will see no interruption in their care and services and will begin to see the OCC name on patient communications. About Orthopedic Centers of Colorado, LLC The number one choice for orthopedic, hand and spine health in Colorado and the Rocky Mountains, Orthopedic Centers of Colorado is an independent group of 56 physicians focused on patient specific care, quality outcomes, value and continuous improvement. We've assembled the best doctors across nearly 30 areas of expertise including Colorado's best sports medicine and orthopedic physicians. Patients can visit any of our 19 convenient locations for care from doctors who believe quality patient care starts with a great patient experience. Learn more at orthocentersco.com   SOURCE Orthopedic Centers of Colorado, LLC

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31 Aug

Global Cartilage Repair Market 2017-2021 with Acelity, DePuy Synthes, Stryker & Smith & Nephew Dominating

DUBLINAugust 31, 2017 /PRNewswire/ -- The "Global Cartilage Repair Market 2017-2021" report has been added to Research and Markets' offering.
The global cartilage repair market to grow at a CAGR of 11.59 % during the period 2017-2021. The treatment of articular cartilage has evolved tremendously in the past decade. Reparative and restorative methods have been developed to address the significant source of morbidity in the young and active patients. Articular cartilage injury can be focal, which is localized or systemic. Procedures are being developed not only to alleviate the symptoms associated with articular cartilage defects but also to limit the progression of cartilage damages into degenerative diseases. According to the report, one of the major drivers for this market is Rising incidence of accidental injuries. Globally, the road traffic injuries are increasing, with post complicated symptoms such as weakening of tendons, cartilage tear, and orthopedic issues. The latest trend gaining momentum in the market is Gene therapy and stem cell therapy. Gene therapy is one of the promising fields in the cartilage repair. Many clinical studies have been performed for cartilage repair. The researchers are trying to develop gene therapy for cartilage repair and currently been investigated for clinical application. Further, the report states that one of the major factors hindering the growth of this market is Product side effects. Surgeons use cartilage repair products such as tissue scaffold to improve the recovery. These products once grafted in the body may cause serious complications, resulting in their increased scrutiny for safety and efficacy. In many autologous chondrocyte implantation, there were common complications such as graft rejection, symptomatic hypertrophy, disturbed fusion and delamination. Key vendors
  • Acelity
  • DePuy Synthes
  • Stryker
  • Smith & Nephew
Other prominent vendors
  • AlloSource
  • Bio-Tissue
  • CellGenix
  • Collagen Solutions
  • Geistlich Pharma
  • Orteq
  • RTI Surgical
  • TORNIER
  • Vericel
  • XTANT MEDICAL
Key Topics Covered:
  1. Executive Summary
  2. Scope Of The Report
  3. Research Methodology
  4. Introduction
  5. Market Landscape
  6. Market Segmentation By Product
  7. Market Segmentation By End-User
  8. Geographical Segmentation
  9. Drivers And Challenges
  10. Market Trends
  11. Vendor Landscape
  12. Key Vendor Analysis
  13. Appendix
For more information about this report visit https://www.researchandmarkets.com/research/sng3nx/global_cartilage Media Contact: Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 SOURCE Research and Markets

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30 Aug

Tiny cameras to help AHN doctors evaluate damaged knees

Aug. 29, 2017 - 

Highmark Health and Allegheny Health Network are exploring handheld diagnostic technology that could one day reduce the need for MRI in diagnosing some knee injuries, such as meniscal tears.

The health care networks on Tuesday announced a collaboration with medical device company Trice Medical to evaluate a new imaging tool called mi-eye, which allows doctors to view knee joints from their offices.

The arthroscopic device provides the ability to look inside joints for signs of wear.

“I think in the select patient, this definitely has a role to play, and it will save not only time but money to the system,” said Dr. Sam Akhavan, an AHN orthopedic surgeon who is participating in the study. “Traditionally, with joint injuries, the diagnostic process can span several weeks, often including an in-office physical exam, followed by an MRI, and then a follow-up consultation and surgery if needed.”

The study will look at the effectiveness of using the device to diagnose meniscal tears on a patient's initial visit, possibly saving time and money.

Akhavan has enrolled six patients and expects to work with 100 before issuing a final analysis.

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30 Aug

Mazor Robotics and Medtronic Enter Next Phase of Strategic Partnership; Medtronic to Make a $40 million Third Tranche Investment in Mazor

CAESAREA, Israel--(BUSINESS WIRE)-- Mazor Robotics Ltd. (MZOR), a pioneer and a leader in the field of surgical guidance systems, today announced that it has entered the next phase of its strategic partnership with Medtronic earlier than planned and their existing agreements have been amended accordingly. The agreements provide for the conversion of the commercial relationship between the parties, with Medtronic assuming exclusive worldwide distribution of the Mazor X system, and Medtronic making a $40 million third tranche investment in Mazor. These developments are a result of the early achievement of certain sales and marketing milestones by both companies, as well as higher than expected global market acceptance and demand for the Mazor X system. Medtronic and Mazor originally entered into a strategic agreement in May 2016. Key Highlights Include:

  • Medtronic assumes exclusive global spine market commercial responsibility for the Mazor X Surgical Assurance Platform and its accessories.
  • The implementation of annual minimums for purchase of Mazor X systems by Medtronic with a cumulative potential of hundreds of Mazor X systems over a four and a half-year period.
  • Approximately 30 members of the current Mazor sales organization are expected to join Medtronic to assure continuation of the current momentum.
  • Co-development of future products for the spine market that combine Mazor Robotics’ core expertise in surgical planning and precision-guided surgical systems with Medtronic’s navigation capabilities and implant systems. The first results of this combined and synergistic effort are expected to be demonstrated this fall.
  • Mazor will continue to provide service to the global installed base of the Mazor X.
  • A shared economic incentive to continue developing products and services that maintain innovation leadership and utilization of Mazor Robotics clinical solutions.
  • Medtronic will invest $40 million in Mazor Robotics’ American Depository Shares (ADS) at a price of $38.46 per ADS, which represents the weighted average of the closing price of Mazor’s ADS on Nasdaq over the past 20 trading days. This third tranche of investment in Mazor by Medtronic will bring Medtronic’s total investment in Mazor to $72 million, representing approximately 11.9% of the outstanding shares post investment and 10.6% of the fully diluted shares outstanding post investment. Mazor will also issue to Medtronic warrants to purchase an additional 1.21 million Mazor ADSs at an exercise price of $44.23 per ADS. The exercise price represents a 15% premium over the per share price for the $40 million equity investment. Medtronic has the right to exercise the warrants immediately in whole or in part, for cash, and they expire after 18 months. Assuming the full exercise of the warrants, Medtronic’s investment in Mazor will reach $125 million and its ownership could increase to 4.2 million ADSs, or 14.2%, based on the current number of ADSs outstanding on a fully diluted basis. Closing of the $40 million equity investment is expected to take place on or around September 12, 2017.
“Medtronic is our valued strategic partner and together we have achieved the desired outcome for Phase I well ahead of our original plan,” commented Ori Hadomi, Chief Executive Officer. “I believe that the move to this next phase reinforces our significant leadership position in the growing market for surgical guidance systems for spine procedures. Our strategic partnership will allow hospitals in new markets around the world to have access to the Mazor X and gain the clinical benefits that this technology offers. “The strategic partnership between Mazor and Medtronic has already resulted in 59 Mazor X system orders since the October 2016 launch and reflects an accelerated sales cycle due to customers’ eagerness to adopt our solutions for the spine market,” added Mr. Hadomi. “Now, as commercial responsibility for the Mazor X in the spine market shifts to Medtronic, the annual minimums for sale of Mazor X systems agreed to by the two companies are expected to drive substantial improvement in Mazor’s financial results during the next several years. Together we will be able to further advance our robust jointly-developed product pipeline for the spine market, to make a difference for patients while Mazor also pursues new opportunities to apply our innovative technologies to other medical needs.” “Moving to the next phase of our strategic partnership demonstrates our shared passion for transforming how spine surgery is done,” said Doug King, senior vice president & president of the Medtronic Spine division, which is part of Medtronic's Restorative Therapies Group. “Mazor Robotics’ technology and Medtronic’s navigation capabilities and implant systems provide spine surgeons with complete procedural solutions that advance the standard of care and will help surgeons maximize predictability and efficiency.” Mazor will continue to manufacture and recognize revenues for Mazor X system sales, disposable kits and service fees all of which will be sold at contractual pricing agreed with Medtronic. The contracted pricing is at a lower rate than Mazor realized through its direct sales channel. In addition, Mazor will be entitled to certain synergy fees associated with the use of Medtronic implants in Mazor Robotics' installed base. Moving from direct sales to a strategic distribution model is expected to immediately reduce Mazor’s annual operating expenses by approximately $13 million. Trailing 12-month operating expenses for Mazor totaled $52.7 million. The proceeds from the investment will further strengthen Mazor’s balance sheet and provide the resources to continue to collaborate with Medtronic to develop innovative solutions for the spine market, as well as develop innovative solutions for other potential markets. Mazor will continue to independently develop and market globally the Renaissance Surgical Guidance System, which was first launched in 2011. Efforts for Renaissance will be focused on certain market segments for which the Renaissance provides significant customer added value. CONFERENCE CALL INFORMATION The Company will host a conference call to discuss today’s announcement at 8:30 AM EDT (3:30 PM IDT). Investors within the United States interested in participating are invited to call 1-800-289-0498. Participants in Israel can use the toll-free dial-in number 1-80-925-8350. All other international participants can use the dial-in number 1-719-325-4818. For all callers, refer to Conference ID 1217133. A replay of the event will be available for two weeks following the conclusion of the call. To access the replay, callers in the United States can call 1-866-375-1919 and reference the Replay Access Code: 1217133. All international callers can dial 1-719-457-0820, using the same Replay Access Code. To access the webcast, please visit www.mazorrobotics.com and select ‘Investor Relations.’ About Mazor Mazor Robotics believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance System enables surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit www.MazorRobotics.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor's current expectations and projections about future events. There are important factors that could cause Mazor's actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. For example, Mazor is using forward-looking statements in this press release when it discusses the outcome of the Phase II agreements with Medtronic, when it states that the results of combined development efforts are expected to be launched this fall, when it states that sales minimums are expected to drive substantial improvement in Mazor’s financial results during the next several years, when it discusses that the strategic partnership will allow hospitals in new markets around the world to have access to the Mazor X and gain the clinical benefits that this technology offers, when benefits spine surgeons will get from the combination of Mazor's technology and Medtronic's navigation capabilities and implant systems are discussed, when it discusses advancing its robust, jointly-developed product pipeline for the spine market while pursuing exclusive efforts to apply its innovation to other medical needs, when it discusses that moving from direct sales to a strategic distribution model is expected to immediately reduce its annual operating expenses, when it discusses continuing to independently develop and market globally the Renaissance Surgical Guidance System and where it will focus its efforts with regard to this system, and when it discusses the timing of the closing of the Medtronic purchase of ADSs and the potential exercise of warrants as well as the use of proceeds from the sale of such securities. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor's filings with the Securities and Exchange Commission (SEC) including those discussed under the heading "Risk Factors" in Mazor’s annual report on Form 20-F filed with the SEC on May 1, 2017 and in subsequent filings with the SEC. For more details, refer to Mazor's SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law. http://cts.businesswire.com/ct/CT?id=bwnews&sty=20170829006252r1&sid=acqr7&distro=nx&lang=en View source version on businesswire.comhttp://www.businesswire.com/news/home/20170829006252/en/ EVC Group Michael Polyviou, 212-850-6020 mpolyviou@evcgroup.com or Doug Sherk, 646-445-4800 dsherk@evcgroup.com Source: Mazor Robotics Ltd.

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30 Aug

Globus Medical Appoints David M. Demski as CEO

AUDUBON, Penn., Aug. 29, 2017 (GLOBE NEWSWIRE) -- Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced that, the Board of Directors has named David M. Demski as the Company’s Chief Executive Officer, effective immediately.  Mr. Demski will report to David C. Paul, the Company’s founder, Chairman of the Board, and Chief Executive Officer since its inception in 2003.  Mr. Paul will remain in the role of Executive Chairman.

Mr. Demski has been a Globus Medical senior executive since 2003, serving initially as Chief Financial Officer from 2003 until 2008.  In 2008, he became President and Chief Operating Officer of the Company, responsible for all of its domestic and international commercial operations, including sales, marketing, manufacturing, and finance.  During Mr. Demski’s tenure as President and COO, Globus Medical consistently delivered above-category growth and profit margins, culminating in the Company’s successful initial public offering in 2012.  In 2015, Mr. Demski became President, Emerging Technologies, and assumed responsibility for overseeing the Company’s expansion into the areas of imaging, navigation, and robotics, as well as orthopedic trauma, both of which are expected to contribute to the Company’s growth over the next decade.

Mr. Paul will continue to focus on strategic initiatives and will spend less time on day-to-day operational matters.  The Company reported that the timing of these management changes was designed to allow Mr. Paul to recover from a health condition. Mr. Paul is expected to make a full recovery over the next several months and plans to remain actively involved with the Company both during his recovery and thereafter.

“No one is or could be more well suited to be CEO of Globus Medical than Dave,” said David Paul.  “He has been with us since the very start of this Company, has led virtually every aspect of its operations, and has been a significant contributor to the Company’s success to date.  During the seven years when Dave served as President, among his many responsibilities were direct leadership of both our domestic and international sales forces.  During that time, and as he took over responsibility for our Emerging Technologies division, Dave honed a talent for optimizing sales team performance and developing and commercializing new products.  His skill set is precisely what we need to continue our focus on profitable growth.

“With Dave taking over day-to-day management of the Company, I can focus on the things I am most passionate about and the areas in which I can bring the most value to our shareholders: strategy and technology innovation.  Globus Medical was built on delivering groundbreaking solutions to surgeons and their patients, and we will not stray from our core mission.  We have built a strong company and will move forward with the same vision and passion for which we are known. I look forward to being part of the Company’s continued success.”

Conference Call Details: Globus Medical will hold a teleconference to discuss the press release with the investment community at 5:30 p.m. Eastern Time. Globus invites all interested parties to join the call by dialing:

1-855-533-7141 United States Participants 1-216-562-0337 International Participants

There is no passcode for the teleconference.

For interested parties who do not wish to ask questions, the teleconference will be webcast live and may be accessed through a link on the Globus Medical website at www.globusmedical.com/investors.

The call will be archived until Tuesday, September 5, 2017. The audio archive can be accessed by calling 1-855-859-2056 in the U.S. or 1-404-537-3406 from outside the U.S. The passcode for the audio replay is 7826-9364.

About Globus Medical, Inc.                                       Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA.  The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

Safe Harbor Statements All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms and specifically include statements regarding Mr. Paul’s medical prognosis. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, changes in Mr. Paul’s medical condition, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus Medical products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.
Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

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29 Aug

OrthoPediatrics and Mighty Oak Medical Team Up to Bring Pediatric-Friendly Spinal Navigation to Children’s Hospitals

WARSAW, Ind., Aug. 28, 2017 (GLOBE NEWSWIRE) -- OrthoPediatrics and Mighty Oak Medical are pleased to announce a navigation partnership that can provide unsurpassed screw placement accuracy in the pediatric population.  Mighty Oak Medical is the manufacturer of FIREFLY® Pedicle Screw Navigation Guides, which are 3D printed and patient-specific at each planned vertebral level. FIREFLY® Guides address the clear market need for a navigation solution that does not rely on intraoperative radiation, and is ideally suited for longer construct cases. OrthoPediatrics regards scoliosis surgeries as an excellent application of FIREFLY® Technology, and has been granted the exclusive distribution rights for FIREFLY® Pedicle Screw Navigation Guides in pediatric hospitals in the United States. The FIREFLY® Pedicle Screw Navigation Guides can be used with any Spinal Deformity Correction system, including the OrthoPediatrics RESPONSE Spinal Deformity System.

David Bailey, Executive Vice President of OrthoPediatrics, said, “Our partnership with Mighty Oak Medical is one more way OrthoPediatrics is advancing the field of pediatric orthopedics.  The FIREFLY® Technology will be a valuable addition to our spine portfolio, and we are pleased to partner with another company that is Leading Innovation in Pediatric Orthopedics!” "This distribution relationship is going to highlight the stark differences between robotic and optical navigation systems, which can cost up to a million dollars and are highly complex and radiation heavy, with the 3D printed patient-specific disposable solution of FIREFLY®.  In the capable hands of the OrthoPediatrics team, we believe the FIREFLY Guides’ validated 99.7% accuracy, combined with ease of use, should quickly bring a safe and reliable navigation tool to pediatric facilities across the United States”, stated Heidi Frey, President of Mighty Oak Medical. About OrthoPediatrics Corp.  Founded in 2006, OrthoPediatrics is the only orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 21 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma and deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products to 35 countries outside the United States. Investor Contacts: The Ruth Group, attn: Zack Kubow; (646) 536-7020  zkubow@theruthgroup.com. About Mighty Oak Medical Mighty Oak is a medical device incubator and a leader in patient-specific solutions for the spine. Our robust patent portfolio, both US and worldwide, and pipeline of patient-specific devices for the spine, is unparalleled. By combining the talents of experienced spine surgeons and biomedical engineers, spine surgeries can be made safer and more efficient. Our mission is to improve surgical outcomes in a manner that is both cost-effective and patient-centered. We have the freedom to focus on innovative solutions, and our team is developing many exciting and disruptive products that meet these objectives. For more information, please contact info@mightyoakmedical.com.

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29 Aug

NuVasive Announces World-Class Innovation Center At San Diego Headquarters

SAN DIEGOAug. 29, 2017 /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the expansion of its San Diego global headquarters, including the creation of an innovation center of excellence where surgeons from around the world will be educated and trained on the latest NuVasive spine technology and procedures designed to drive clinical predictability and improve patients' lives. NuVasive, founded in 1997 as a local San Diego medical technology startup, pioneered minimally invasive, lateral spine surgery and earned its reputation as one of the most innovative spine companies in the industry. Today, the Company ranks third in the global spine market and anticipates surpassing the $1 billion revenue mark at the end of this year. As the Company continues to grow at an accelerated rate, it plans to renovate and further build out its world headquarters starting in January 2018. The Company's growth is reflected in several areas, including training more than 500 surgeons annually on its products and procedures at its San Diego campus, a commitment to increasing its R&D spend as a percent of revenue from 5 to 7 percent over the next several years, and creating jobs, locally and globally. NuVasive's San Diego campus, located at 7475 Lusk Boulevard in Sorrento Valley, will increase by more than 100,000 square feet, bringing the total space to approximately 250,000 square feet. Expansion plans include renovating the current two buildings on campus and adding a third building. The newly renovated campus will include an innovation center of excellence, showcasing the Company's state-of-the-art product and procedural offerings and highlighting its world renowned surgeon education. Additional features of the campus include:

  • an expanded surgeon education lab for onsite surgeon training and education;
  • a prototype design facility with 3D printing capabilities;
  • state-of-the art biomedical testing center; and
  • a new amenities building which will include an onsite café, fitness center and meeting space to accommodate up to 750 attendees.
"Our headquarters expansion reflects our commitment to the San Diego region where medical technology companies and the life sciences industry have significantly contributed to the growth for decades," said Gregory T. Lucier, NuVasive's chairman and chief executive officer. "Our new facility will offer NuVasive the unique opportunity to have our design facility, lab space and product development in one location where visiting surgeons and our product development teams can collaborate closely on our newest technologies. With the support of Mayor Faulconer and the San Diego Regional Chamber of Commerce, we are eager to continue our investment into the San Diego area with a facility that attracts, retains and grows the high-performing employee talent we have here at NuVasive." NuVasive worked closely with city and state officials to re-invest in the area and continue the commitment of bringing surgeons from around the world to train at the onsite cadaver lab. "It's an exciting day for NuVasive and a proud moment for San Diego," said San Diego Mayor Kevin Faulconer. "NuVasive is a homegrown company that's supporting our innovation economy, creating jobs for San Diegans and leading the world in transformative spinal surgeries. We will continue to create an environment in San Diego where companies like NuVasive can grow and thrive." Mayor Faulconer and other state and local officials visited the San Diego campus earlier this year. "San Diego's business community applauds the expansion of the NuVasive campus," said Jerry Sanders, San Diego Regional Chamber of Commerce's president and chief executive officer. "NuVasive is a major contributor to San Diego'svital medical technology industry and has demonstrated an admirable commitment not only to supporting our region but to totally revolutionizing spine surgery across the world. It's a major point of pride for San Diego to be home to such leading innovators who are growing, thriving, and hiring here." While San Diego serves as the Company's global headquarters, NuVasive remains committed to expanding its global footprint. The Company recently opened its new international headquarters in Amsterdam, and finished a new 180,000 square foot manufacturing center in West Carrollton, Ohio. NuVasive's footprint also includes a 100,000 square foot facility in Memphis, Tennessee, which serves at the Company's central distribution hub. About NuVasive NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company's portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com. Forward-Looking Statements NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive's results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company's surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive's products (including the iGA™ platform), the Company's ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive's news releases and periodic filings with the Securities and Exchange Commission. NuVasive's public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.   SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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