28 Dec

FDA permits marketing of device to treat diabetic foot ulcers

SILVER SPRING, Md., Dec. 28, 2017 /PRNewswire-USNewswire/ -- Today, the U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers. "Diabetes is the leading cause of lower limb amputations," said Binita Ashar, M.D., director of the division of surgical devices in FDA's Center for Devices and Radiological Health. "The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases. Additional options for successfully treating and healing ulcer wounds may help prevent lower limb amputations." An estimated 30.3 million people in the United States have been diagnosed with diabetes, according to the Centers for Disease Control and Prevention. Diabetes damages blood vessels and nerves, particularly in the feet, and can lead to severe infections that are difficult to treat. About 25 percent of people with diabetes will experience a foot ulcer in their lifetime. Amputation is sometimes necessary when circulation is so poor that a foot ulcer fails to heal or when treatment fails to stop the spread of an infection. The Dermapace System is intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2 (about the size of a soda can top) which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The Dermapace System is an external (extracorporeal) shock wave system that uses pulses of energy, similar to sound waves, to mechanically stimulate the wound. The device is intended for adult patients (22 years and older), presenting with diabetic foot ulcers lasting for more than 30 days, and should be used along with standard diabetic ulcer care. The FDA reviewed clinical data from two multi-center, randomized, double-blind studies with a total of 336 diabetic patients receiving either usual care, which includes wet-to-dry dressings or debridement (removal of damaged tissue) as needed, plus the Dermapace System shock wave therapy or usual care plus non-working (sham) shock wave therapy. Both patient groups included those with poorly controlled and well-controlled blood glucose levels. The patients who had between one and seven treatments with the Dermapace System showed an increase in wound healing at 24 weeks with a 44 percent wound closure rate. Those patients treated with the sham shock wave therapy showed a 30 percent wound closure rate during the same time period. The most common side effects observed were pain during application of the device, local bruising and numbness, migraines, nausea, fainting, wound infection, infection beyond the wound (cellulitis, osteomyelitis) and fever. The Dermapace System was reviewed through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices of a new type for which there is no legally marketed predicate device to which the device can claim substantial equivalence. This action also creates a new regulatory classification that would allow future devices to go through the FDA's 510(k) process, whereby devices can demonstrate substantial equivalence to this predicate device. The FDA permitted marketing of the Dermapace System to Sanuwave, Inc. More information: FDA: Recently Approved Devices FDA: De novo pathway FDA: Diabetes information for consumers CDC: Diabetes The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. Media Inquiries: Stephanie Caccomo, 301-348-1956, Stephanie.caccomo@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA SOURCE U.S. Food and Drug Administration Related Links http://www.fda.gov

Read More
28 Dec

The Global Shoulder Arthroplasty Market is expected to reach $ 1,866.3 million by 2023

NEW YORK, Dec. 28, 2017 /PRNewswire/ -- The Global Shoulder Arthroplasty Market was valued at $ 1,090.0 million in 2016, and is expected to reach $ 1,866.3 million by 2023, registering a CAGR of 8.1% during the forecast period. The growth of the global shoulder arthroplasty market is driven due to factors such as increasing incidences of arthritis-associated disorders such as osteoarthritis and rheumatoid arthritis, and growing geriatric population. Also, significant adoption of reverse shoulder arthroplasty by surgeons and growing sports-related injuries have further contributed to the growth of the market. Nevertheless, postoperative complications associated with shoulder arthroplasties and the cost associated with the shoulder arthroplasty devices is the factors that would limit the growth of the market. Read the full report: https://www.reportlinker.com/p05258049 The shoulder arthroplasty market is segmented based on procedures, devices, indications, end users, and regions. Based on procedures, the market is segmented into partial shoulder arthroplasty, total shoulder arthroplasty, and revision shoulder arthroplasty. Based on devices, the market is segmented into shoulder arthroplasty resurfacing implants, shoulder arthroplasty trauma devices, and shoulder arthroplasty platform systems. Based on indications, the market is segmented into arthritis, fracture/dislocation, rotator cuff tear arthropathy, Hill Sachs defect, and others. Based on end users, the market is segmented into hospitals & clinics and outpatient surgical centers. Based on geography, the market is segmented into North America, Europe, Asia-Pacific, and LAMEA. The market research report covers the analysis of key stake holders of the leading market participants are Integra LifeSciences Corporation, DJO Global, Zimmer Biomet, Wright Medical Group, Inc. /Tornier Inc., Johnson & Johnson (DePuy Synthes), Smith and Nephew Plc, Arthrex, Inc., Conmed Corporation, Evolutis, and Exactech, Inc. Read the full report: https://www.reportlinker.com/p05258049 About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. __________________________ Contact Clare: clare@reportlinker.com US: (339)-368-6001 Intl: +1 339-368-6001 SOURCE Reportlinker Related Links http://www.reportlinker.com

Read More
28 Dec

Middle East Medical Device Market – Expected to Reach $31.6 Billion by 2025

DUBLIN, Dec. 28, 2017 /PRNewswire/ -- The "Middle East Medical Device Market by Product (In Vitro Diagnostics (IVD), Cardiology, Orthopedics), by FDA classification (Class I, II, III), by End-user, by Region and Segment Forecasts, 2014 - 2025" report has been added to Research and Markets' offering. The Middle East medical devices market is expected to reach USD 31.6 billion by 2025. This growth is anticipated to be a result of increasing geriatric population, and increasing incidences of conventional diseases such as diabetes and obesity. Other major drivers include technological innovations and increasing demand and acceptance of such technologies in Middle Eastern countries majorly in UAE, Saudi Arabia and Qatar. Furthermore, rising competitive pressure is witnessed in the Middle East medical device market as a result of high demand and low supply ratio. Hence, it can be predicted that the Middle East medical device market may witness lucrative growth over the forecast period. Another factor responsible for this propelling growth is the supportive reimbursement pathways adapted by the Middle Eastern countries majorly to ensure quality healthcare provisions for every civilian. Major developments are witnessed in terms of regulatory structures as well, with an agenda to provide monetary benefits to the civilians and improve overall lifestyle of the people. Further Key Findings From The Study Suggest: Based on product type, In-Vitro Diagnostics(IVD) is expected to dominate the market as of 2016. Furthermore, neurology device segment is anticipated to grow at the fastest CAGR owing to the factors such as growing incidence of conventional diseases, augmenting research and technological advancement offered by key industry players to meet the current unmet needs. The medical devices are also analyzed depending upon the U.S. FDA classification, with Class II being the dominant as well as the fastest growing segment during the forecast period. The Class II device segment is anticipated to capture over 60.0% of the market share by 2025. Geographic expansion into Qatar, U.A.E. and Iraq by well-established players is anticipated to promote the fastest growth for the region. Few of the industry players for the Middle East medical devices market include Medtronic, Johnson & Johnson, Siemens, Roche, Becton Dickinson and Abbott Laboratories. Entry of various new players coupled with collaborative efforts by existing players is expected to be witnessed over the forecast period. Key Topics Covered: Chapter 1. Methodology and Scope Chapter 2. Executive Summary Chapter 3. Middle East Medical Device Market Variables, Trends & Scope Chapter 4. Middle East Medical Device Market: Product Estimates & Trend Analysis Chapter 5. Middle East Medical Device Market: FDA Classification Estimates & Trend Analysis Chapter 6. Middle East Medical Device Market: End-use Estimates & Trend Analysis Chapter 7. Middle East Medical Device Market: Regional Estimates & Trend Analysis Chapter 8. Competitive Landscape Medtronic Johnson & Johnson Siemens Roche Becton Dickinson Abbott Laboratories Novartis Olympus Corporation General Electric Biomerica Baxter International Smith and Nephew BioMrieux Philips Zimmer Biomet For more information about this report visit https://www.researchandmarkets.com/research/vh9c5x/middle_east Media Contact: 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 Related Links http://www.researchandmarkets.com

Read More
27 Dec

Global Artificial Joints Market 2017-2021: Driven by Increasing Demand for MI Surgeries – Research and Markets

December 27, 2017

DUBLIN--(BUSINESS WIRE)--The "Global Artificial Joints Market 2017-2021" report has been added to Research and Markets'offering. The global artificial joints market is expected to grow at a CAGR of 5.53% during the period 2017-2021. The report, Global Artificial Joints Market 2017-2021, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market. One trend in the market is increasing demand for MI surgeries. The demand for MI surgeries has been increasing across the world. MI surgeries reduce physical trauma and the risk of infections. This enables patients to recover faster. MI surgeries involve short hospital stay, improve comfort, and enable the early return to work. According to the report, one driver in the market is increasing incidence of age-related musculoskeletal disorders. Musculoskeletal disorders have been the most common disorder that affects the aging population. The most frequent musculoskeletal disorders among the aging population have been osteoporosis, osteoarthritis, fractures, and infections. With aging, musculoskeletal tissues become fragile, loose cartilage resilience, have reduced ligament elasticity, and loose of muscular strength, which reduce the ability of tissues to perform normal functions. Key vendors
  • DePuy Synthes
  • Smith & Nephew
  • Stryker
  • Zimmer Biomet
Other prominent vendors
  • Arthrex
  • Acumed
  • Aesculap Implant Systems
  • AK Medical
  • BioPro
  • DJO Surgical
  • Extremity Medical
  • Others
Key Topics Covered: Part 01: Executive Summary Part 02: Scope Of The Report Part 03: Research Methodology Part 04: Introduction Part 05: Market Landscape Part 06: Segmentation By Application Part 07: Segmentation By Product Type Part 08: Segmentation By End-User Part 09: Segmentation By Geography Part 10: Decision Framework Part 11: Drivers And Challenges Part 12: Market Trends Part 13: Vendor Landscape Part 14: Vendor Analysis For more information about this report visit https://www.researchandmarkets.com/research/qjthg7/global_artificial

Contacts

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 Related Topics: Orthopedic Devices

Read More
27 Dec

Anika Announces FDA 510(k) Clearance for Its Injectable HA-Based Bone Repair Treatment

December 27, 2017

BEDFORD, Mass.--(BUSINESS WIRE)--Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid ("HA") technology, today announced that its HA-based bone void filler received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is indicated for filling bone voids or defects of the skeletal system (i.e. extremities and pelvis), which are not intrinsic to the stability of the bone, created during surgery or resulting from traumatic injury. The bone void filler, which is composed of a synthetic, biocompatible bone graft substitute material, is injected into a void, hardens at body temperature, and is then resorbed and replaced by the growth of new bone during the healing process. Over one million musculoskeletal procedures performed in the U.S. involve bone void filling, also known as bone grafting,, and such procedures are most commonly required for spinal fusion, trauma, and revision total joint replacement procedures. We estimate the current market size for treating tibial plateau fractures, stress fractures around joints, and decompression of necrosed bone to be around $300 million. “We’re proud to announce the U.S. regulatory clearance of our innovative injectable HA-based bone void filler, which represents the U.S. commercial debut of our robust regenerative medicine portfolio,” said Charles H. Sherwood, Ph.D., Chief Executive Officer of Anika Therapeutics. “The rapid 510(k) clearance is a testament to Anika’s operational and strategic expertise. In addition, this new treatment represents a promising revenue growth opportunity, and advances our mission to provide innovative treatments to patients that address the full continuum of orthopedic care.” While the use of autologous bone or autograft has been the gold standard of treatment for bone grafting, the increased risk of procedural complications has prompted a shift towards alternate treatments1, such as synthetic, resorbable bone graft substitute materials. According to Dr. John Tierney, D.O., an orthopedic surgeon affiliated with New England Baptist Hospital, who has worked with our bone repair treatment: “Anika’s 510(k) clearance allows for the marketing of one of only a handful of bone graft substitutes that can be administered in a minimally invasive manner. It offers physicians an additional option for treating bone defects or injuries, without the need for expensive and high risk surgeries, while also reducing the operating room time spent on each case.” This positive physician feedback enhances our excitement about bringing this much-needed treatment to patients in the U.S. About Bone Repair Treatment Anika’s bone repair treatment is an injectable, HA-based, settable osteoconductive calcium phosphate bone graft substitute material, and is indicated for filling bone voids or defects of the skeletal system (i.e., extremities and pelvis) that are not intrinsic to the stability of bone structure. It is provided in a kit with two components (an aqueous solution in a pre-loaded syringe and a dry powder) that must be mixed, intra-operatively using the supplied mixing system, to form a cohesive paste, prior to administration. Anika’s bone void filler is provided sterile for single use in volumes ranging from 1.5cc to 4cc. About Anika Therapeutics, Inc. Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika's orthopedic medicine portfolio includes ORTHOVISC®MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com. Forward-Looking Statements The statements made in the last sentence of the second paragraph and the last sentence of the third paragraph of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the potential market for, and revenue growth opportunity for the Company associated with, this product. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties, and other factors. The Company's actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company's ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company's ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company's research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company's clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company's ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company's ability to provide an adequate and timely supply of its products to its customers; and (x) the Company's ability to achieve its growth targets. Additional factors and risks are described in the Company's periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC's website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release. 1 Marc Bohner, Resorbable biomaterials as bone graft substitutes, In Materials Today, Volume 13, Issues 1–2, 2010, Pages 24-30, ISSN 1369-7021, https://doi.org/10.1016/S1369-7021(10)70014-6. (http://www.sciencedirect.com/science/article/pii/S1369702110700146)

Contacts

For Investor Inquiries: Anika Therapeutics, Inc. Sylvia Cheung, 781-457-9000 Chief Financial Officer or For Media Inquiries: Pure Communications Sonal Vasudev, 917-523-1418 sonal@purecommunicationsinc.com

Read More
26 Dec

Zimmer Biomet Announces Positive Results from PROGRESS II Trial of Autologous Protein Solution Prepared with nSTRIDE® APS Kit

WARSAW, Ind.Dec. 22, 2017 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the publication of positive results from a pilot study demonstrating the safety and promising efficacy of the nSTRIDE® Autologous Protein Solution (APS) Kit for the treatment of knee osteoarthritis (OA). In the trial, known as PROGRESS II, investigators prepared APS by using Zimmer Biomet's nSTRIDE APS Kit, which concentrates anti-inflammatory cytokines and growth factors from a sample of the patient's own blood, for delivery via a single intra-articular injection into the knee joint. The results, which appeared in The American Journal of Sports Medicine1, show significant improvement in the percentage change from baseline in pain scores measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), as well as comparable safety to saline. OA, the most common type of arthritis, is a progressive disease of the joints. Often referred to as "wear and tear" arthritis, OA occurs when the top layer of cartilage, the slippery tissue that covers the ends of bones in a joint and helps absorb the shock of movement, breaks down and wears away. The bones under the cartilage then rub together, causing pain, swelling and loss of motion in that joint. Eventually, the joint may lose its normal shape and/or develop bone spurs around its edges. "Inflammation is a critical factor in the pain and cartilage breakdown associated with knee osteoarthritis, and research has established that APS derived from the patient's whole blood contains a host of powerful anti-inflammatory and anabolic proteins," said Elizaveta Kon, MD, Associate Professor, Humanitas University, Milan, Italy, and lead investigator of the PROGRESS II trial. "After nearly a decade of preclinical and clinical research into the use of autologous anti-inflammatory cytokines and growth factors to treat osteoarthritis pain, we were pleased to demonstrate that APS, prepared with the nSTRIDE APS Kit, may be a promising, safe and viable new treatment for patients living with osteoarthritis of the knee." The PROGRESS II trial was a prospective, randomized, double-blind, saline-controlled pilot study that enrolled 46 patients with unilateral, mild-to-moderate, symptomatic knee OA pain from the four trial sites across Europe. Patients were randomized to receive either a single injection of APS prepared by the nSTRIDE APS Kit (n=31), or a single saline injection (n=15). Patient-reported outcomes and adverse events were assessed at two weeks, and at one, three, six and 12 months post-injection. Clinical effectiveness was measured using the Visual Analog Scale (VAS), the WOMAC, and the Knee Injury and Osteoarthritis Outcome Score (KOOS). X-ray and magnetic resonance imaging (MRI) evaluations were taken at baseline, as well as three and 12 months following treatment. Top-line results showed that patients treated with APS demonstrated:

  • A 65 percent change in WOMAC pain score from baseline to 12 months compared to a 41 percent change in the saline group (p = 0.02).
  • A 49 percent improvement in VAS pain scores compared to a 13 percent improvement in the saline group (p = 0.06).
  • No procedure- or device-related serious adverse events, and comparable frequency, severity and relatedness of adverse events as compared to the saline group.
The nSTRIDE APS Kit is not commercially available in the United States but is currently marketed in Europe, via CE Mark, and in Japan, where it is marketed as the APS Kit. Results from the PROGRESS II study formed the basis for two additional confirmatory trials: the PROGRESS IV trial (NCT02905240), which received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) in July 2016 and is currently enrolling patients, and the PROGRESS V trial (NCT03182374), which is underway in Europe to support global reimbursement efforts. "As a global leader in musculoskeletal healthcare, Zimmer Biomet is committed to addressing the needs of patients along the entire continuum of care, from the management of symptoms like pain and stiffness with safe, non-invasive intra-articular injections like APS and Gel-One®, to restoring joint function and mobility with our extensive portfolio of implant systems to treat advanced orthopaedic disease," said David Nolan, Group President, Biologics, Extremities, Sports Medicine, Surgical, Trauma, Foot and Ankle, Office Based Technologies and Zimmer Biomet Signature Solutions. "The positive results of the PROGRESS II trial not only reinforce the safety and clinical value of the autologous anti-inflammatory protein solution prepared with the nSTRIDE APS Kit, but also lay the groundwork to advance our regulatory efforts in the United States and accelerate our commercial adoption and expansion in Europe and Asia-Pacific." About nSTRIDE APS The nSTRIDE APS Kit is currently under clinical evaluation in the United States. It holds a CE Mark in Europe and is approved in Japan as the APS Kit. The device produces an anti-inflammatory-rich cellular solution from a patient's own blood. The output of the nSTRIDE APS Kit contains white blood cells and their corresponding anti-inflammatory cytokines in concentrations much higher than that of whole blood, in addition to anabolic cytokines that may promote cartilage health.2 These anti-inflammatory cytokines target and inhibit the pro-inflammatory and catabolic cytokines Interleukin-1 (IL-1) and Tumor Necrosis Factor Alpha (TNFα). Zimmer Biomet currently licenses the nSTRIDE APS technology to Owl Manor Veterinary, a privately held medical device company dedicated to joint preservation, tendon and ligament treatment, and advanced wound care treatment of equine and canine companion animals, under the brand name Pro-Stride Injection™.  For more information, please visit http://www.omveterinary.com/. References:
  1. Kon E, Engebretsen L, Verdonk P, Nehrer S, Filardo G Clinical outcomes of an autologous protein solution injection for knee osteoarthritis: a 1-year pilot double-blinded randomized controlled trial. Published in The American Journal of Sports Medicine, October 2017 [Epub ahead of print].
  2. O'Shaughnessey K, Matuska A, Hoeppner J, et al. Autologous protein solution prepared from the blood of osteoarthritic patients contains an enhanced profile of anti-inflammatory cytokines and anabolic growth factors. J Orthop Res 2014;32(10):1349-55.
About Zimmer Biomet Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products. We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives. We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet. Cautionary Statement Regarding Forward-Looking Statements This release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet's expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see Zimmer Biomet's periodic reports filed with the U.S. Securities and Exchange Commission (SEC).  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet's filings with the SEC.  Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Readers of this release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this release. ZBH-Corp   SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmer.com

Read More
22 Dec

Hartford HealthCare Pioneers Robotic-Assisted Spine Surgery

HARTFORD, Conn.Dec. 22, 2017 /PRNewswire/ -- Hartford HealthCare (HHC) has pioneered a new, advanced technology at The Hospital of Central Connecticut, which is the first hospital in all of New England to use the new Globus ExcelsiusGPS™, a sophisticated surgical guidance system for spine procedures. The new technology also will soon be available at Backus Hospital.
The ExcelsiusGPS™ brings an even greater level of precision to surgeons performing spine surgery and the patients they serve. The ExcelsiusGPS™ system is the first robotic assisted navigation system that is used by surgeons during the procedure, in real time. It is designed specifically to make surgery safer, and help surgeons ensure implants and hardware placement is even more precise. The technology also enables minimally invasive spine procedures which are often linked to less blood loss, less muscle damage, and a faster recovery. "We are innovators at Hartford HealthCare, and we have a long history of bringing the latest and most valuable technology to the patients and communities we serve," said Jeffrey Flaks, Hartford HealthCare President and Chief Operating Officer. "We believe technology is a true partner in care — enabling our talented experts to improve outcomes, enhance quality and deliver an exceptional experience for our patients. This is a fitting next step as we continue to pioneer guidance technology in healthcare." Hartford HealthCare is a leader in robotic-assisted surgery, with an extensive surgical robotics program, which is aimed at improving patient outcomes and improving the quality of care. Hartford HealthCare has been using the da Vinci® Surgical System for several years, combining the latest in minimally invasive surgical and robotics technologies to perform successful complex as well as routine surgeries. In March, Hartford HealthCare became the first healthcare system in the state of Connecticut and throughout the Northeast to debut Mazor X robotic-assisted surgical guidance system. About Hartford HealthCare. Hartford HealthCare is Connecticut's most comprehensive health care network. Our fully integrated health system includes a tertiary-care teaching hospital, an acute-care community teaching hospital, an acute-care hospital and trauma center, two community hospitals, the state's most extensive behavioral health services network, a large primary care physician practice group, a regional home care system, an array of senior care services, a coordinated cancer institute with five cancer centers, and a large physical therapy rehabilitation network. Visit us at www.hartfordhealthcare.org. SOURCE Hartford HealthCare

Related Links

https://hartfordhealthcare.org

Read More
22 Dec

Centinel Spine Completes Acquisition of Prodisc Assets

NEW YORKDec. 22, 2017 /PRNewswire/ -- Centinel Spine, LLC (CS) is pleased to announce the acquisition of the worldwide assets of the prodisc® Total Disc Replacement portfolio from DePuy Synthes Products, Inc.  The prodisc line of products are total disc replacement (TDR) products with the longest history of use globally.  The prodisc® portfolio includes prodisc® C and prodisc® L in the United States and prodisc® VIVO, prodisc® NOVA, prodisc® C, prodisc® L, and prodisc® O, along with DISCOVER™ Cervical outside the United States. This acquisition complements Centinel Spine's existing spinal implant portfolio of leading technologies for anterior column support of the spine from cervical to lumbar.  This includes the company's standalone portfolio of STALIF C®, STALIF C-Ti™, MIDLINE II™, MIDLINE II-Ti™, and STALIF L™, as well as additional products ACTILIF™ Cervical Cage TRANSOM™ Plate, and ALTOS® PCT. Centinel Spine, the pioneer of the No-Profile®, Integrated Interbody™ has a 30 year history of developing integrated interbody devices into a standard treatment for patients with degenerated disc disease. Centinel Spine will utilize the same clinical, regulatory, and development expertise to broaden acceptance and to increase carrier coverage and surgeon adoption of total discs worldwide. "This transaction is the next step in the evolution of Centinel Spine executing on its mission to become the worldwide leading company addressing spinal disease through anterior access to the spine with the widest breadth and depth of technology platforms," said John J. Viscogliosi, Centinel Spine Chairman & CEO. For background in understanding the acquisition, Viscogliosi Brothers, LLC, a lead investor in Centinel Spine, was the founder of Spine Solutions, Inc., the company that led the original IDE study to bring prodisc to the United States. The company also completed debt and equity financing to close on the transaction and provide working capital.  Piper Jaffray & Co. served as the sole placement agent for Centinel Spine. About Centinel Spine, LLC. Centinel Spine, LLC. is a privately-held spinal device company leading the development and commercialization of the No- Profile, Integrated Interbody fusion technologies. For more information on Centinel Spine products and technologies, please visit the Company's web site at www.CentinelSpine.com. The company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica LLC and Surgicraft LTD. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies and continues its corporate mission of becoming the leading anterior column support spine franchise, providing elegantly simple implants and instruments that are tissue-sparing and generate superior clinical outcomes. Centinel Spine derived its name from the "Sentinel Sign" – the radiographic confirmation of a successful fusion anterior to the interbody device.

For more information, please contact:

Varun Gandhi

Wendy F. DiCicco

SVP, Corporate Finance & Strategic Planning

Chief Operating and Chief Financial Officer

Centinel Spine, LLC              

Centinel Spine, LLC

900 Airport Road, Suite 3B  

900 Airport Road, Suite 3B

West Chester, PA 19380    

West Chester, PA 19380

Phone: 484-887-8871

Phone: 484-887-8837

Email: v.gandhi@centinelspine.com

Email: w.dicicco@centinelspine.com

  SOURCE Centinel Spine, Inc.

Related Links

http://www.CentinelSpine.com

Read More
22 Dec

Paragon 28® launches the Gorilla® Lateral Column Plating System designed to address the cuboid and lateral column in cases of Charcot deformity

ENGLEWOOD, Colo.Dec. 22, 2017 /PRNewswire/ -- Since its inception, Paragon 28® has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28® has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefitting both the surgeon and patient. The Gorilla® Lateral Column Plating System was developed to offer surgeons a dedicated plating system designed to aid in the stabilization, fusion and fixation of the lateral column. This construct allows for strength, stability and compression throughout the lateral column which can help address certain cases of Charcot reconstruction where plantar subluxation of the cuboid may result in ulceration. This plate and screw construct consists of a dorsal plate placed on the 4th metatarsal, 5th metatarsal and cuboid that can accept a 5.5 mm Type II Anodized, non-locking, solid plate screw. This screw interfaces with the plate and is intended to span from the space between the 4th and 5th metatarsals, through the cuboid and into the posterior aspect of the calcaneus. The Gorilla® Lateral Column Plating System contains system specific instrumentation to help facilitate insertion of the 5.5 mm solid plate screw as well as a unique templating system. This templating system not only aids in determining the correct size and location of the plate, but more importantly aids in the creation of a reamed space in a specific location between the 4th and 5th metatarsals. A Joint Finding Paddle is included and is intended to center the template allowing for equal reaming of the 4th and 5th metatarsals to allow room for the 5.5 mm solid plate screw to be placed and achieve optimal screw trajectory. This addition to the Gorilla® R3CON Plating System family leverages all the benefits of the Gorilla System including the ability for all of the standard plate holes to accept either 2.7 mm, 3.5 mm or 4.2 mm locking and non-locking plate screws as well as a robust assortment of foot and ankle specific instrumentation. Paragon 28® is grateful for the significant contributions Dr. Douglas Blacklidge, DPM has made as the surgeon designer of this system. CONTACT: Jim Edson Director of Product Management and Marketing jedson@paragon28.com SOURCE Paragon 28

Read More
22 Dec

Histogenics Corporation and MEDINET Co., Ltd Enter Into Licensing Agreement for Development and Commercialization of NeoCart for the Japanese Market

WALTHAM, Mass., Dec. 21, 2017 (GLOBE NEWSWIRE) -- Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, announced that it has entered into an agreement with MEDINET Co., Ltd. (MEDINET), a pioneering leader in the development and commercialization of cancer immuno-cell therapy technologies, for the development and commercialization of NeoCart® for the Japanese market.

“This transformative collaboration for Histogenics is a clear validation of the value NeoCart potentially provides to the physicians and patients who suffer from painful cartilage defects and related loss of function.  MEDINET is one of the leaders of the burgeoning regenerative medicine sector in Japan, with strong capabilities in development and manufacturing of cell therapy products.  We believe their recent initiatives to further develop their therapeutic capabilities with the addition of innovative products such as NeoCart will provide a rapid entry into the Japanese market,” stated Adam Gridley, President and Chief Executive Officer of Histogenics.  “Our ability to leverage our long clinical and translational medicine history in the U.S. in markets such as Japan was a first step in bringing NeoCart to other regions, and we look forward to expanding our global presence more broadly in 2018 into other potential territories in Asia and Europe.”

Histogenics’ formal consultations with the Office of Cellular and Tissue-based Products of the Japan Pharmaceuticals and Medical Devices Agency (the PMDA) concluded in the second quarter of 2017 and the positive conclusion of those consultations played an integral role in enabling this collaboration. Formal feedback from the PMDA regarding the development and approval pathway for NeoCart in Japan included:

  • A 30-patient, one-year confirmatory clinical trial in Japanese patients, comparing NeoCart to microfracture, would be sufficient for applying for full Marketing and Manufacturing Authorization in Japan in conjunction with data from Histogenics’ fully enrolled U.S. Phase 3 clinical trial.
  • NeoCart would be regulated as a Regenerative Medical Product, as covered by the recently enacted laws in Japan, and Histogenics can supply the confirmatory clinical trial from the U.S. using the current good manufacturing process (cGMP) for NeoCart.

“I am excited about the potential to bring this exciting therapy to Japanese patients and physicians through this new partnership,” stated Dr. Shuichi Mizuno, Ph.D., a scientific founder of NeoCart, Assistant Professor, Orthopedic Surgery, Brigham and Women’s Hospital, and Harvard Medical School, in whose laboratory the underlying technology for NeoCart was discovered.

Japanese Cartilage Repair Market

The Japanese cartilage repair market is estimated to be the second largest market in the world after the U.S. and it is estimated that there may be at least 10,000 NeoCart treatments per year.  If left untreated, cartilage defects may result in Osteoarthritis (OA) and ultimately, total knee replacements.  Market forecasts predict that the number of OA patients in Japan aged 40 and older amounts to more than 25 million and is expected to accelerate as the population ages.

In the first half of 2017, Histogenics conducted market research in Japan with approximately 80 leading surgeons with the findings summarized below:

  • Approximately 60% of patients with knee cartilage defects are either not treated, or treated solely for temporary pain relief.
  • Approximately 60-70% of patients with knee cartilage defects that are left untreated will likely progress to OA in the knee.
  • Cartilage defects are believed to have caused OA in 15-20% of patients suffering from knee OA.
  • More than 85% of orthopedic surgeons are not satisfied with the current options to treat knee cartilage defects.
  • Approximately 80% of orthopedic surgeons consider early improvement in pain and function to be important and more than half of the surgeons feel they would prescribe NeoCart based on published data.

“This licensing deal has been realized based on our longtime close relationship with Histogenics.  I am excited about and proud of, the big challenge to enter into the regenerative medical product market with NeoCart in collaboration with the excellent team of Histogenics,” stated Yoshiji Kimura, Chief Executive Officer of MEDINET.  “We believe this restorative cell therapy will contribute to better treatment by the physicians and quality life, of the patients with knee cartilage defects in Japan.”

Locust Walk served as transaction advisor to Histogenics.

Conference Call and Webcast Information

Histogenics’ management will host a conference call on Thursday, December 21, 2017 at 9:00 a.m. ET.  A question-and-answer session will follow Histogenics’ remarks.  To participate on the live call, please dial 877-930-8064 (domestic) or 253-336-8040 (international) and provide the conference ID: 5982636 five to ten minutes before the start of the call.

A live audio webcast of the presentation will be available via the “Investor Relations” page of the Histogenics website, www.histogenics.com, or by clicking here.  A replay of the webcast will be archived on Histogenics’ website for approximately 45 days following the presentation.

About Histogenics Corporation

Histogenics (Nasdaq:HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function.  Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis.  NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use.  Histogenics recently completed enrollment of its NeoCart Phase 3 clinical trial and expects to report top-line, one-year superiority data in the third quarter of 2018.  NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications.  For more information on Histogenics and NeoCart, please visit www.histogenics.com.

About MEDINET Co., Ltd.

MEDINET is a pioneering leader in the development and commercialization of cancer immuno-cell therapies.  MEDINET is also rigorously preparing to enter into the regenerative medical product market to leverage its long clinical and translational medicine history responding to the expected aging of the population.  MEDINET went public in October, 2003 on the MOTHERS, Tokyo Stock Exchange.  For more information, visit http://www.medinet-inc.co.jp/english/.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws.  Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements.  Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others:  the timing and success of Histogenics’ NeoCart Phase 3 clinical trial, including, without limitation, possible delays in generating the data from the clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; NeoCart’s regulation as a Regenerative Medical Product; the market size and potential patient population in Japan; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov.  In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics.  Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.  Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Read More