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Spinal Elements Promotes Jason Blain to President & Chief Operating Officer

Posted On July 11, 2017 By OrthoSpineNews In Spine /  

July 11, 2017

MARIETTA, Ga.–(BUSINESS WIRE)–Leading spinal solutions provider Spinal Elements today announced that Jason Blain has been appointed to the position of President and Chief Operating Officer (COO). In this new position, he will have responsibility for product development, quality, marketing, operations, and regulatory compliance. Mr. Blain will report to Spinal Elements CEO, Chris Fair and also will serve as a member of the board of directors.

Mr. Blain brings more than 20 years of experience in orthopedics, including hip replacements, knee replacements, trauma and spine products to his new role. He previously served as President of Spinal Elements and was a co-founder of that organization prior to Amendia’s acquisition of Spinal Elements in April of this year. The combined company was recently renamed Spinal Elements.

“Jason co-founded Spinal Elements in California and is chiefly responsible for their commitment to innovation of premium products and technologies for nearly 15 years. His track record of bringing best in class products to the marketplace will accelerate the combined company’s growth toward becoming the preferred spinal solutions provider to our clinicians and independent distributors,” said Chris Fair, CEO of Spinal Elements, “I look forward to working closely with Jason as we build a stronger connection with surgeons and the products we develop.”

Blain commented regarding his new role, “I look forward to taking on these expanded responsibilities as we continue to drive Spinal Elements toward being the preferred spine surgery solutions provider. We have a number of disruptive technologies that we will be bringing to the market in the coming months as we improve the operations of our recently-combined companies. This is an exciting time to be a part of the organization.”

Prior to founding Spinal Elements, Jason had roles of increasing responsibility in product development, manufacturing, regulatory affairs and quality assurance with Smith & Nephew, Alphatec, and Nuvasive. He has a bachelor’s degree in mechanical engineering from Christian Brothers University in Memphis, TN.

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 www.amendia.com or www.spinalelements.com.

Contacts

for Spinal Elements
Laura Charlton (formerly Johnson)
(760) 450-7749 cell
laurajohnsonpr@yahoo.com

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The ASC CerviKit by Xenco Medical Expands Nationwide with Disposable Spinal Systems for Ambulatory Surgery Centers

Posted On July 11, 2017 By OrthoSpineNews In Spine, Top Stories /  

July 11, 2017

SAN DIEGO–(BUSINESS WIRE)–Xenco Medical has announced the nationwide expansion of the ASC CerviKit, the compact delivery and storage platform for the company’s breakthrough, entirely disposable Anterior Cervical Discectomy and Fusion (ACDF) systems engineered from a highly durable composite polymer. The ASC CerviKit includes all of Xenco Medical’s single-use cervical implant families and is designed to be both lightweight and easily transportable. Designed to address the space constraints of ambulatory surgery centers, the systems in the ASC CerviKit offer a streamlined approach to the ACDF procedure as breakthrough single-use, composite polymer cervical implant systems. Comprising Xenco Medical’s pre-loaded Cervical interbodies and pre-loaded cervical plates as well as the supporting, single-use instruments, the ASC CerviKit is indicative of a larger movement in healthcare towards streamlined, efficient care.

With the single-use, composite polymer instrument and implants locked together in the sterile package, the Xenco Medical systems are designed to both increase efficiency in the OR as well as eliminate the internal logistics associated with the autoclave process. Existing at the intersection of materials science and biomechanical engineering, Xenco Medical’s single-use spinal systems are the first polymer-based devices of their kind. In addition to Xenco Medical’s cervical interbodies, The ASC CerviKit stores Xenco Medical’s newly launched Merge Cervical Plate system, a single-use platform using the company’s Snap-Align technology. The Merge Cervical Plate allows the surgeon to choose whether to attach the plate to the interbody prior to implantation or to connect in situ.

“Eliminating the costs, labor, and time associated with the autoclave process, the single-use systems in the ASC CerviKit have had extraordinary success in reducing logistical inefficiencies at outpatient surgery centers,” said Xenco Medical Founder and CEO Jason Haider.

Unlike the traditional metal instruments that are reused in hundreds of patients until a mechanical failure, Xenco Medical’s single-use systems are perfectly calibrated and sterile-packaged for patient-specific use. Made from a highly reinforced composite polymer, Xenco Medical’s patient-specific spinal systems have previously made news for outperforming aluminum metal in maintaining structural integrity.

About Xenco Medical

Xenco Medical is an American medical technology company committed to disruptive innovation for the purposes of creating a safer surgical environment. Through Xenco Medical’s line of disposable, sterile-packaged spinal systems, Xenco Medical seeks to ensure that the outcome of spine surgeries reflect the ability of the surgeons rather than the limitations of their instruments. For more information on Xenco Medical, visit www.xencomedical.com.

Contacts

Xenco Medical, LLC
Maicy Lunes
858-202-1505
mlunes@xencomedical.com

 

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    Medicrea Reports First Half 2017 Sales

    Posted On July 11, 2017 By OrthoSpineNews In Financial /  

    July 11, 2017

    LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today sales for the first half of 2017.

    2017 First Half Sales
    € millions H1 2016 H1 2017 Variation
    Sales 14.8 14.7 -1%

    Movements in exchange rates had no significant impact on the evolution of sales over the period

    Group sales remained steady over the first half of 2017 compared to the previous year despite solid performance during the month of June, notably in the U.S. where sales increased 10% over the prior year period. The global breakdown of the Group’s revenue demonstrates an ongoing growth trend in France, the Company’s domestic direct sales market, where sales increased by 8% compared to the first half of 2016. In Brazil, the Company’s historic leading export distribution market, the Company continued to face challenges related to local economic and regulatory factors leading to a 63% decrease in sales in the period compared to H1 2016. In April 2017, the Brazilian regulatory body, ANVISA, performed a long-awaited mandatory inspection of the Company’s recently-opened combined headquarters and manufacturing facilities in France. Following the successful ANVISA inspection, activity with Brazil is expected to resume in early 2018.

    Revenue generated by Medicrea’s UNiD™ ASI systems technology for personalized spine continued to accelerate throughout the first half of 2017, particularly in the U.S. where a growth of 41% was seen compared to the first half of 2016. Since the Company FDA-cleared the first-ever personalized approach to spine surgery with patient-specific implants in November of 2014, the number of cases performed in the U.S. has now surpassed the total internationally and reached more than $15 million in cumulative sales at the end of the first half of 2017 for UNiD™ TEK and associated Medicrea implants, particularly the patient-specific UNiD Rod used in conjunction with the Company’s portfolio of PASS® spinal systems for degenerative and complex spinal indications.

    As of the end of the first half of 2017, more than 1,500 UNiD™ ASI surgeries have been performed worldwide with a record number of UNiD™ TEK, patient-specific implants, manufactured and used in surgery during the month of June. The Company also performed the world’s first personalized minimally-invasive spine surgery in the U.S. by developing and launching patient-specific UNiD™ MIS Rod for minimally-invasive spine surgery.

    Denys Sournac, President and CEO of Medicrea, stated, “The significant FDA clearances obtained in the first half of 2017 evidence the Company’s focus of placing UNiD™ ASI technology for Adaptive Spine Intelligence into the hands of surgeons. We are creating easy-to-use compatible implant hardware and IT software systems that surgeons know and trust. The addition of PASS® TULIP will open new doors for Medicrea to gain market share for our patient-specific UNiD™ Rod, by lowering the barrier to entry for the large number of surgeons trained on top-loading instrumentation.”

    Recently, the Company announced FDA clearance of the UNiD™ HUB, a data-driven digital portal with surgical strategy and predictive modeling functionality, as well as the FDA clearance for and first U.S. surgery with the PASS® TULIP top-loading fixation, presenting an elegant solution to surgeons trained on this system – the global standard for posterior fixation.

    Next financial publication: Results for the 1st half of 2017: September 28, 2017, after market.

    About Medicrea (www.Medicrea.com)

    Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 100,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

    Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

    For further information, please visit: Medicrea.com.

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

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

    Contacts

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

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    DePuy Synthes Launches Single Use Kits For Wrist Fracture Surgery

    Posted On July 11, 2017 By OrthoSpineNews In Extremities /  

    WEST CHESTER, Pa., July 11, 2017 /PRNewswire/ — DePuy Synthes* has introduced the Distal Radius Sterile Kit, a pre-sterilized, single-use kit of instruments and implants to treat wrist fractures. The streamlined kits provide customers with the company’s market-leading plate and screw implants with instrumentation designed to help optimize operating room efficiency and eliminate procedural sterilization costs.

    An estimated 640,000 wrist fractures occur annually in men and women of all ages in the United States and are one of the most frequently seen fractures in the emergency room in people under 65.1 With such a high volume of procedures, surgeon and provider customers want a solution that enables high-quality treatment for patients while improving efficiency, reducing costs and minimizing delays associated with instrumentation and sterilization problems. One Canadian study demonstrated that surgical delays as brief as 10 minutes may cost a hospital more than $130,000 in staffing costs alone per year.2

    The Distal Radius Sterile Kit consists of one Variable Angle LCP® Two-Column Volar Distal Radius Plate, a distribution of screws, and the required fixation instrumentation—commonly what is needed for up to 80 percent of distal radius fracture cases currently treated with plates and screws. The simplified composition of the kit is designed to drive repeatable, more consistent procedures.

    “It’s important in trauma cases for the instrumentation to be arranged in a way that the surgeon can focus on the patient without distraction from the back table,” said Marc Richard**, M.D., Associate Professor, Hand, Upper Extremity and Microvascular Surgery, Department of Orthopaedic Surgery, Duke University Medical Center. “In my experience with these sterile kits, they have helped assure availability of the distal radius plates during unscheduled trauma cases.  Additionally, I have found that the simplified set and instrumentation can help the scrub team preserve operating room efficiency.”

    The Distal Radius Sterile kit brings value to healthcare systems by eliminating costs and time for sterilization. A UK industry report cites that single-use kits may save approximately $285 per procedure for sterilization, transport, and handling.3  To learn more about the Distal Radius Sterile Kits, visit www.DePuySynthes.com/DRSK.

    “The Distal Radius Sterile Kit is an example of how we are responding to customer needs by providing value beyond the implant,” said I.V. Hall, Global Franchise Leader, DePuy Synthes Trauma. “By combining our market-leading plate and screw solution with single-use instrumentation, we are supporting our customers ranging from academic medical centers to community hospitals in providing high-quality care in an efficient, cost-effective way.”

    About DePuy Synthes Companies
    DePuy Synthes Companies, part of the Johnson & Johnson Medical Devices Companies***, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

    *DePuy Synthes represents the products and services of DePuy Synthes Products, Inc. and its subsidiaries.
    **Consultant to DePuy Synthes Trauma
    ***The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

    ©DePuy Synthes 2017. All rights reserved
    DSUS/TRM/0617/1491

    1 Nellans, Kate W., et al. The Epidemiology of Distal Radius Fractures. Hand Clin. 2012 May; 28(2): 113–125.
    2 Wong J, Khu KJ, Kaderali Z, Bernstein M. Delays in the operating room: signs of an imperfect system. Canadian Journal of Surgery. 2010;53(3):189-195.
    3 Goldrein T, Locsei T, Craigwood, A. DYQ06 – Costs of Orthopaedic Surgery. Innovia Technology Report. 2010. Note: costs were converted from GBP to USD using 2010 conversion rates.

    SOURCE DePuy Synthes

     

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    Back Pain Centers of America Announces Stryker’s Spine Division as a Finalist in the Awards of Excellence, “Technology Innovation” Category

    Posted On July 11, 2017 By OrthoSpineNews In Spine, Top Stories /  

    ATLANTA, GA (PRWEB) JULY 11, 2017

    Back Pain Centers of America (BPC), which connects people searching for solutions to their neck and back pain with a reputable physician in their area, announces that Stryker’s Spine division is a finalist in the 2017 Awards of Excellence for the Technology Innovation Award. This award is one of three categories of awards being presented in our 2017 series. The Technology Innovation Award recognizes the top innovations advancing the field of orthopedic medicine, and Stryker’s Spine Division is being honored for its LITe BIO Delivery System.

    The LITe BIO Delivery System is a uniquely designed hand-held device used to facilitate delivery of bone graft material to spinal surgery sites. The first-of-its-kind design of the LITe BIO Delivery System provides surgeons with a single-handed method to deliver any type of autograft, allograft, or synthetic bone graft material without obstructing visibility. The innovative delivery tool provides tactile, visual, and audible confirmation of bone graft delivery, and the mallet-free system eliminates the impaction of bone graft.

    “We are pleased to be recognized as a finalist in the Technology Innovation Award category,” said John Mayor, Vice President, Global Marketing for Stryker’s Spine division. “The new LITe BIO Delivery System combines three key features—a low-profile design, the versatility to accommodate any graft material, and direct visualization to aid in the precise placement of the graft. The LITe BIO Delivery System’s design offers a combination of features that no other bone graft delivery system on the market possesses.”

    “We created this award category to recognize innovation and advances in medicine and technology,” said Brent Wheeler, president of Back Pain Centers of America. “We applaud Stryker’s Spine division for its innovation in addressing existing challenges in spinal fusion procedures.”

    More information about the LITe BIO Delivery System can be found here.

    About Stryker 
    Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at http://www.stryker.com.

    About Back Pain Centers of America 
    Back Pain Centers of America (BPC) has helped people find safe, reliable relief for chronic pain since 2009. The call centers match patients searching for relief for neck and back pain to reputable, board-certified healthcare practices in their geographic area. BPC has the largest network of minimally-invasive spine centers in America. This service is free to patients. For more information, please visit http://www.backpaincenters.com. Also follow BPC on LinkedIn, Facebook, or Twitter.

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    InVivo Therapeutics Appoints Richard Toselli, M.D. as Chief Medical Officer

    Posted On July 10, 2017 By OrthoSpineNews In Biologics, Neuro, Top Stories /  

    July 10, 2017

    CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced the appointment of Richard Toselli, M.D., as Chief Medical Officer, effective July 5, 2017. Dr. Toselli, a fellowship-trained spinal neurosurgeon, will assume all responsibilities related to the company’s clinical and regulatory strategy.

    Prior to joining InVivo, Dr. Toselli served as Chief Medical Officer for Cochlear Limited. In that role, he was responsible for global clinical, regulatory, and medical affairs teams reporting to the CEO. Prior to that, Dr. Toselli served five years at Sanofi in various levels of increasing responsibility, including Vice President of Global Medical Affairs – Immunology and Inflammation, Biologics Division; Vice President of Global Medical Affairs and Head of the Biosurgery Discovery Performance Unit; and Vice President of Global Medical Affairs, Biosurgery. Before his time at Sanofi, he served as Chief Medical/Technology Officer for Covidien Surgical, and earlier held various roles at DePuy Spine including Director of Medical Affairs, Worldwide Vice President of Research and Development, and Worldwide Vice President of Clinical Evidence and External Relations. He subsequently held the position of Vice President of Evidence-Based Medicine at Johnson & Johnson for the device sector.

    Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “We are pleased to welcome Rich to the InVivo team during this pivotal moment in the company’s history. His deep industry experience paired with his medical training as a spine trauma neurosurgeon make him an invaluable asset as we look to finish enrollment of our pivotal probable benefit study and file for marketing approval.”

    Dr. Toselli’s previous academic positions include Assistant Professor at Brown University, Associate Professor, Director of Spine Center, and Associate Chief of Staff at the University of North Carolina (UNC), and Associate Professor at the University of Vermont. He holds a bachelor of arts from Providence College, his medical degree from Brown University, and a masters of business administration from the UNC’s Kenan-Flagler Business School. Dr. Toselli is a board-certified neurological surgeon.

    About InVivo Therapeutics

    InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

    Safe Harbor Statement

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold, the progress of the clinical program and the timing of the completion of enrollment in the INSPIRE Study and of the filing of an application for marketing approval. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report of the three months ended March 31, 2017, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

    Contacts

    InVivo Therapeutics
    Heather Hamel, 617-863-5530
    Investor Relations
    Investor-relations@invivotherapeutics.com

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    Cartiva, Inc., Announces Multiple Presentations at American Orthopaedic Foot and Ankle Society Annual Meeting 2017

    Posted On July 10, 2017 By OrthoSpineNews In Extremities /  

    July 10, 2017

    ALPHARETTA, Ga.–(BUSINESS WIRE)–Cartiva, Inc. (Company), a developer of innovative products for treating cartilage damage and osteoarthritis, announced today that clinical data on its Cartiva Synthetic Implant (SCI) will be presented at the American Orthopaedic Foot and Ankle Society (AOFAS) Annual Meeting taking place July 12-15 at the Washington State Convention Center in Seattle, Washington. The AOFAS is a medical specialty society comprised of more than 2,200 orthopaedic surgeons from the US and abroad who specialize in the care of patients with injuries, diseases and other conditions of the foot and ankle. The presentations include:

    • Friday, July 14th 10:15 AM to 10:20 AM, podium presentation by Mark A. Glazebrook, MSc, MD, PhD, FRCSC, “Revision of Implant to Great Toe Fusion: Did We “Burn a Bridge” With a Synthetic Implant Hemiarthroplasty?”
    • Saturday, July 15th 8:20 AM to 8:25 AM, podium presentation by Judith F. Baumhauer, MD, MPH, “Correlation of Hallux Rigidus Coughlin Grade with First MTP Motion, Intra-operative Cartilage Loss and Treatment Success for 1st MTP Arthrodesis and Hemi-Arthroplasty.” This abstract was selected by the AOFAS Program Committee as one of three finalists for the prestigious Roger A. Mann Award. The Mann award is given in recognition of the best clinical paper accepted for presentation at the annual meeting. The winner of the award will be announced during the meeting on Friday, July 14th.
    • Saturday, July 15th 9:10 AM to 9:15 AM, podium presentation by Andrew J. Goldberg, OBE, MD, MBBS, FRCS, FRCS (Tr&Orth), “The Influence of Patient Factors on the Outcome of Synthetic Cartilage Implant Hemiarthroplasty versus First Metatarsophalangeal Joint Arthrodesis in Advanced Hallux Rigidus.”

    In addition, the Company will sponsor a symposium on Friday July 14th from 6:30 AM to 8:00 AM, Level 6, Rooms 611 & 612. Entitled “The Difference is DATA™ – Cartiva Synthetic Cartilage Implant for Hallux Rigidus”, the symposium’s faculty includes Judith F. Baumhauer, MD, MPH, Michael J. Coughlin, MD, Timothy R. Daniels, MD, FRCSC, Mark A. Glazebrook, MSc, MD, PhD, FRCSC, David B. Thordarson, MD and Keith L. Wapner, MD.

    The Company invites all conference attendees to visit Cartiva exhibitor Booth #1211 for ongoing demonstrations of its Cartiva SCI technology.

    About Cartiva, Inc.

    Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative solutions for patients with cartilage damage and osteoarthritis. Cartiva’s venture investors include New Enterprise Associates and Windham Venture Partners. Additional information is available on the company’s website at www.cartiva.net.

    Contacts

    Cartiva, Inc.
    Peter Pizzo, 770-754-3855
    Chief Financial Officer

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    Ortho Development Corporation signs exclusive distribution agreement with China Pioneer Pharma Holdings Limited

    Posted On July 10, 2017 By OrthoSpineNews In Recon, Top Stories /  

    DRAPER, Utah, July 5, 2017 – Ortho Development® Corporation (ODEV) is pleased to announce the signing of an agreement with China Pioneer Pharma Holdings Limited (CPP) as the exclusive distributor of ODEV’s Balanced Knee® System in the People’s Republic of China.

    China has recently surpassed Japan as the second largest market for orthopedic medical devices in the world. With an aging population and improvement in health insurance policies, the demand for total knee replacement procedures in China has been increasing rapidly. “Our strategic vision includes expanding distribution beyond the U.S. and Japanese markets into high-growth, emerging markets like China,” said Brent Bartholomew, President of ODEV. “We have been seeking the right distribution partner in China for quite some time, and are delighted to be working with an established, reputable partner like CPP.”

    CPP is one of the largest comprehensive marketing, promotion and channel management service providers dedicated to importing pharmaceutical products and medical devices in China. Their portfolio includes ophthalmology, pain management, cardiovascular, respiratory, gastroenterology, immunology, orthopedics and other therapeutic areas, and a range of medical devices covering various medical specialties, including ophthalmology, odontology and wound care, etc. As of 31 December 2016, CPP sold products through its nationwide marketing, promotion and channel management service networks to approximately 30,000 hospitals and other medical institutions and over 108,000 pharmacies across all provinces, municipalities and autonomous regions in China.

    Ortho Development’s Balanced Knee® System (BKS) includes implants and instrumentation for primary and revision total knee replacement procedures. The design is based on proven technology with over 17 years of successful clinical results and more than 70,000 implanted worldwide. BKS implants are offered in a wide range of sizes and options to allow optimal anatomical fit for a variety of patients. The system has a patented locking mechanism specifically designed to minimize the micro-motion between the plastic tibial insert and the titanium tibial base plate implants. Simple and intuitive instrumentation facilitates reproducibility in the hands of every surgeon and aides in proper intraoperative balancing of the knee joint.

    The medical device registration in China for the BKS has already been completed, and CPP intends to begin marketing the product immediately. Following the tender and bidding process with specific hospitals, CPP expects the first knee replacement procedures in China with BKS will occur in early 2018.

    About Ortho Development Corporation

    Ortho Development Corporation was founded in 1994 and is a privately held company located in Draper, Utah, U.S.A. The company is passionate about designing and manufacturing the best, clinically proven, high-performance orthopedic devices in the world. The primary product focus is total knee and hip joint replacement; and also includes trauma fracture repair, and spine treatment. Ortho Development products are distributed through a growing network of independent sales reps and distributors and are used by hundreds of surgeons at world-renowned orthopaedic hospitals and teaching universities, as well as in a widespread number of regional and community hospitals. The company’s majority shareholder is Japan Medical Dynamic Marketing, Inc. (Japan MDM), a publicly-traded, Japanese medical device distribution company.

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    Implanet Announces Its Half-Yearly Report on the Liquidity Contract With ODDO Corporate Finance

    Posted On July 10, 2017 By OrthoSpineNews In Financial /  

    July 07, 2017

    BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

    Pursuant to the liquidity contract entrusted to ODDO Corporate Finance by IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible), on 30 June 2017 the following assets appeared on the liquidity account:

    • Number of shares: 134,950
    • Cash balance of the liquidity account: €46,060.29

    As a reminder, at the time of the last half-yearly report on 31 December 2016, the following resources were booked to the liquidity account:

    • Number of shares: 136,500
    • Cash balance of the liquidity account: €40,003.79

    As a reminder, at the time of the settlement of the contract, the following resources were booked to the liquidity account:

    • Number of shares: 0
    • Cash balance of the liquidity account: €400,000.00

    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 Compartment C of the Euronext™ regulated market in Paris.

    Contacts

    IMPLANET
    Ludovic Lastennet
    CEO
    Tel. : +33 (0)5 57 99 55 55
    investors@implanet.com
    or
    NewCap
    Investor Relations
    Florent Alba, Tel. : +33 (0)1 44 71 94 94
    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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    Providence Medical Technology Announces Publication of Two New Studies Supporting Tissue-Sparing Posterior Cervical Fusion

    Posted On July 10, 2017 By OrthoSpineNews In Spine /  

    WALNUT CREEK, Calif., July 10, 2017 /PRNewswire/ — Providence Medical Technology, Inc., a developer of innovative cervical spine technology, announced the publication of multiple independent studies demonstrating the results of its tissue-sparing posterior cervical fusion technology.

    In the first study published by Lenzi J, et al. in World Neurosurgery (2017), the authors report results from the first ever prospective, randomized, controlled trial comparing operative results using the DTRAX® Expandable Cage system versus conservative care for patients diagnosed with single-level cervical radiculopathy. The study presents data on 40 patients from each group. The paper reports significant improvements in VAS neck and arm pain relative to the control group at all time points out to one year. The paper also reports marked improvements from baseline in NDI and SF-36. This publication was completed independent of any conflict of interest from the authors and not sponsored in any way by the company. The table below summarizes the VAS results.

    Pre

    1 Month

    6 Months

    12 Months

    Surgery

    VAS neck

    5.725

    1.925

    0.75

    0.33

    VAS arm

    8.65

    0.575

    0.35

    0.25

    Conservative Care

    VAS neck

    5.475

    3.8

    1.5

    1.05

    VAS arm

    8.775

    5.35

    3.615

    1.77

    A complete copy of this study can be found at http://dx.doi.org/10.1016/j.wneu.2016.12.125

    In the second publication by William Smith, et al. in Operative Neurosurgery (2017), the authors report the results of bilateral posterior cervical fusion cages for the treatment of anterior cervical pseudarthrosis again through the use of the company’s flagship tissue-sparing DTRAX Spinal System and CAVUX® Cervical Cages. This study was not sponsored by Providence in any way; however, some of the investigators and authors of this publication maintain ownership and compensation relationships with Providence. This paper reports results of 25 patients at a mean follow-up of 18 months. The table below summarizes improvements in VAS neck, VAS arm, and NDI scores. This study also reports that fusion was confirmed radiographically in all 25 patients.

    Pre-Op

    Follow-up

    VAS neck

    7.9

    3.8

    VAS arm

    7.24

    3.12

    NDI

    65.1

    29.1

    A complete copy of this study can be found at http://doi.org/10.1093/ons/opx103

    “We were delighted to receive notification of these recent publications adding to the growing body of clinical evidence supporting our innovative tissue-sparing posterior cervical fusion technology,” said Jeff Smith, CEO of Providence. “We are grateful for the work of these authors and particularly thankful to the patients who volunteered to participate in a randomized controlled trial to study the impact of our novel surgical approach. These independent studies represent two of the more common applications of our cervical fusion technology, and it is encouraging that new clinical evidence continues to support these use cases. We are committed to clinical research and look forward to additional publications moving forward.”

    The DTRAX Expandable Cage System used in the first study is CE marked and indicated for posterior cervical treatment at C3-C7 (inclusive) spinal levels for the following: patient with single level radiculopathy due to degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets. The DTRAX Expandable Cage System used in the first study is not cleared or approved by the FDA and is not available for order or sale in the United States.

    The CAVUX Cervical Cage system used in the second study is CE marked and FDA cleared and indicated for use in skeletally mature patients, with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least size weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.

    About Providence Medical Technology, Inc.
    Providence Medical Technology, Inc. is a privately-held medical device company focused on innovative solutions for cervical spinal conditions. The company has pioneered a proprietary, tissue-sparing approach to posterior cervical fusion. Providence has developed surgical instrumentation and implants that offer unique benefits to the $2 billionworldwide cervical spine market. The Providence family of products includes the DTRAX® Spinal Instrumentation System, CAVUX® intervertebral implants, and the ALLY™ line of bone and facet screws. All products are shipped-sterile and single-use to maximize perioperative efficiency and ensure consistent quality and performance. For more information, visit www.providencemt.com

    For other clinical publications regarding this technology visit www.providencemt.com/clinical

    SOURCE Providence Medical Technology, Inc.

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