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Sunday, April 21, 2019

In the Spotlight

BREAKING MEDICAL DEVICE NEWS

Welcome! Medical Device News Magazine reports breaking device news, clinical trials and updates, product launches, profiles of device companies, acquisitions, executives on the move, non-profit and medical society news and more. Read by practicing medical specialists, industry executives, investors and other allied health professional. We invite you to visit the magazine daily! More here.

Video: Vascular Surgeons Chat about Impact of TransCarotid Artery Revascularization on Carotid Treatment

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Huawei Launch Track AI to Help Detect Early Signs of Visual Impairment in Children Across the World

Huawei
4/18/19: Huawei AI and smartphone technology to be used in eye hospitals around the world in partnership with leading eye institute.
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New EndoSuture Aneurysm Repair (ESAR) and Valiant Navion(TM) Data Presented at Charing Cross Demonstrate Safety and Efficacy in Patients with Complex Anatomies

Medtronic
4/17/19: Two-Year Endosuture Aneurysm Repair (ESAR) Data: Medtronic shared preliminary two-year data supporting the safety, durability, and effectiveness of Endurant to treat AAA patients with short aortic necks when used in combination with the Heli-FX(TM) EndoAnchor(TM) system.
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ViewRay Partners with Device Technologies Australia Pty Ltd.

ViewRay Inc.
4/17/19: ViewRay, Inc. will partner with the largest independent distributor in Australasia, who will market, sell, and support ViewRay's MRIdian MRI-guided radiation therapy system.
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TytoHome is Now Available at Best Buy

Tyto Care
4/17/19: TytoHome is a handheld examination device with attachments that can examine the heart, lungs, skin, ears, throat and abdomen, as well as measure body temperature, to enable remote diagnosis of acute care situations like ear infections, sore throats, fever, cold and flu, allergies, stomach aches, upper respiratory infections, coughs, rashes and more.
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Publication in the International Journal of Cardiology Demonstrates Neovasc Reducer Improves Diastolic Function in Patients Suffering from Severe Angina

Neovasc Inc
4/17/19: The Journal of Cardiology peer reviewed article demonstrates that coronary sinus ("CS") narrowing through the use of the Neovasc Reducer (the "Reducer") improves diastolic function and relaxation of the heart. The article title is: "The impact of coronary sinus narrowing on diastolic function in patients with refractory angina."
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AngioDynamics Reported: DIRECT Clinical Study Receives Institutional Review Board Approval for the Treatment of Stage III Pancreatic Cancer

AngioDynamics
4/17/19: Today’s approval enables AngioDynamics to accelerate its engagement with local IRBs and marks a significant milestone in the process of making Irreversible Electroporation (IRE) available to patients through the DIRECT clinical study. The Western IRB (WIRB) will serve as AngioDynamics’ IRB of record for the DIRECT clinical study.
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TherapeuticsMD Signs Binding Commitment Letter for $300 Million Non-Dilutive Term Loan Financing Facility with TPG Sixth Street Partners

TherapeuticsMD Inc.
4/17/19: TherapeuticsMD will host a conference call today (April 17, 2019) to discuss the financing transaction and the launch of BIJUVA.
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Zimmer Biomet and RTI Surgical® Partner with AAID Foundation to Expand Access to Dental Care for Veterans

Zimmer Biomet Holdings
4/16/19: The AAIDF is the charitable arm of the American Academy of Implant Dentistry, a Chicago-based professional organization that advances the science and practice of implant dentistry through education and research support and serves as the credentialing standard for implant dentistry.
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In2Bones Commercial Launch of the ClearGuard LE™ Endoscopic Soft Tissue Release System

In2Bones Global Inc.
4/16/19: Delivered pre-sterilized and fully disposable for single use, the ClearGuard LE™ Endoscopic Soft Tissue Release System is designed for a variety of soft tissue releases of the lower extremity, including the plantar fascia, gastrocnemius, tarsal tunnel, and Morton’s neuroma.
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Vizient Announces Membership Agreement with The Johns Hopkins Health System Corporation

Vizient Inc.
4/16/19: As part of this new agreement, Vizient reports The Johns Hopkins Health System Corporation will join Vizient’s group purchasing organization with the expectation of a decrease in its current supply costs.
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Surfacer Inside-Out Access Catheter System to be Featured at London Vascular Meeting

Bluegrass Vascular Technologies
4/15/19: The Surfacer Inside-Out Access Catheter System is indicated for obtaining central venous access to facilitate catheter insertion in patients with diminished upper body access. Bluegrass Vascular is a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures.
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Intact Vascular Announces Tack Endovascular System (6F) Receives FDA Approval

Intact Vascular
4/15/19: Intact Vascular reported the U.S. Food and Drug Administration approval for the Tack Endovascular System (6F), a purpose-built dissection repair device implanted post-angioplasty in patients with peripheral arterial disease.
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Did NICE Lose its Marbles on the AAA Guidelines? Sultan Speaks Out April 12 in New York City

Interview
4/13/19: Professor Sherif Sultan, MB BCh MCh MD FRCSI DEVS FISVS FASA, DMD FRCS/Vasc EBQS/Vasc FAARM FACS FEVBS PhD presented the state of the NICE AAA Guideline and how it will impact the future of Vascular Surgery.
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Lung Cancer Study Uses the ANGLE Parsortix System

ANGLE plc
4/12/19: ANGLE reports the study is being conducted by the Hellenic Oncology Research Group (“Hellenic”) lead by the Principal Investigators, Associate Professor Athanasios Kotsakis and Professor Vassilis Georgoulias of the IASO General Hospital in Athens, Greece and is investigating both ctDNA (circulating tumor DNA, fragments of dead cancer cells) and CTCs.
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Reflow Medical Wing-IT IDE CTO Clinical Trial

Reflow Medical Inc.
4/10/19: ReFlow Medical reports eighty-five patients with advanced peripheral artery disease enrolled in the Wing-IT IDE CTO Clinical Trial. The Wingman Crossing Catheter uses an extendable beveled tip that creates a channel to help penetrate, or cross, the occlusion.
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Feasibility Study Underway to Assess Lumicell System

Lumicell Inc.
4/10/19: Lumicell states the study will determine the initial safety and efficacy of its Lumicell System for in vivo imaging of metastases to the peritoneum from primary ovarian cancer, appendiceal cancer, gastrointestinal cancer and mesothelioma.
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Atlantic Therapeutics To Launch INNOVO® – Novel Therapeutic Device For Stress Urinary Incontinence

Atlantic Therapeutics
4/9/19: INNOVO was approved by the United States Food and Drug Administration on November 13, 2018, and is the first ever transcutaneous electrical stimulator cleared by the FDA, offering U.S. women a safe, clinically effective and non-invasive choice to treat stress urinary incontinence
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Insera Therapeutics Earns CE Mark Approval for CLEAR Aspiration System

Insera Therapeutics Inc.
4/8/19: Insera Therapeutics reports this unique aspiration technology offers the ability to vary the vacuum suction pressures and intervals within the safe vacuum suction range up to -98.2 kPa (-29 inHg). A recent study using the CLEAR Aspiration System showed that complete clot ingestion with cyclical aspiration (namely varying the suction pressures) increases first-pass recanalization (namely ability to achieve full vessel re-opening using a single retrieval attempt) and reduces clot fragmentation compared to static aspiration (namely uniform suction pressure).
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New EndoSuture Aneurysm Repair (ESAR) and Valiant Navion(TM) Data Presented at Charing Cross Demonstrate Safety and Efficacy in Patients with Complex Anatomies

Medtronic
4/17/19: Two-Year Endosuture Aneurysm Repair (ESAR) Data: Medtronic shared preliminary two-year data supporting the safety, durability, and effectiveness of Endurant to treat AAA patients with short aortic necks when used in combination with the Heli-FX(TM) EndoAnchor(TM) system.
LEARN MORE

Fist Assist Devices Announces Approval of FACT by University of Chicago Medical Center

Fist Assist Devices LLC
4/9/19: The Fist Assist® device is the only wearable, patent-protected intermittent compression device that supports vein dilation for patients with ESRD. The non-invasive device applies intermittent pressure to a specific superficial arm vein to help dilate the vein prior to surgical or endovascular fistula placement. As extensively studied, larger veins before fistula creation can ensure that the fistula reaches optimal size without delays or extra procedures, ultimately reducing costs for both patients and dialysis providers.
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Soliton Reports Completion of Cellulite Clinical Trials

Soliton Inc.
4/9/19: Soliton reports the study, conducted by Dr. Michael Kaminer at SkinCare Physicians in Boston, MA, in collaboration with Dr. Elizabeth Tanzi of Capital Laser and Skin Care, concluded evaluation of safety and efficacy for all patients through the initial 12-week time point. The study is designed to evaluate results at both the 12-week and 26-week timepoints from initial treatment in order to assess both near-term and long-term effects.
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Perspectum Diagnostics: Multi-Parametric MRI Can Predict Clinical Outcomes According to New Data

Perspectum Diagnostics
4/8/19: Donna Cryer, President and CEO of the Global Liver Institute commented on the research: “As chronic liver diseases are increasingly recognized as prevalent across the globe, it is more important than ever to invest in methods that support its diagnosis, monitoring and treatment. Perspectum’s studies provide important evidence that non-invasive, so-called disruptive medical imaging technology, like LiverMultiScan, are key to these advances.”
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Novacyt Expands Development Partnership with Immunexpress

Novacyt SA
4/8/19: Immunexpress, a U.S.-based molecular diagnostic company with the first FDA cleared host response test for suspected sepsis patients, to further support the development of rapid diagnostic assays for the detection of sepsis.
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Innoblative Designs Gets FDA Clearance for SIRA™ RFA Electrosurgical Device

Innoblative Designs Inc.
4/9/19: "Receiving FDA clearance is a significant milestone for Innoblative, and we look forward to commercializing the SIRA device in the US market," said Tyler R. Wanke, CEO and Co-founder of Innoblative Designs. "With our initial indication in hand, we continue working towards obtaining additional indications where our novel technology can significantly impact patient care."
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Glytec Receives Another Patent Allowance for Therapy Advisor®

Glytec
4/9/19: The United States Patent and Trademark Office has granted Glytec another patent allowance for systems and methods related to a product registered under the brand name, Therapy Advisor®
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ReViral Announces Grant of Key US Composition of Matter Patent for their Respiratory Syncytial Virus Inhibitor Program

ReViral Ltd
4/8/19: This composition of matter patent claims certain inhibitors of the fusion protein of the respiratory syncytial virus (RSV), including RV521, the Company’s lead pipeline asset. The counterpart to this patent, EP3204375, has also been issued in Europe.
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Silk Road Medical Traded its First Shares this Morning on Nasdaq: (SILK)

Silk Road Medical Inc.
4/4/19: The medical device company is focused on reducing the risk of stroke by treating carotid artery disease – a condition that affects more than 4 million people in the U.S. and is estimated to be the primary cause of up to one-third of strokes.
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Sheaumann Laser New Family of High-Power Single-Mode Diode Lasers

Sheaumann Laser, Inc.
4/4/19: The new high-power single-mode laser diodes are the result of an internal innovation initiative. Sheaumann’s technical team designed and qualified a new growth structure capable of producing reliable, high-power single-mode lasers, which can be bonded to compact and versatile submounts.
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Tioga Medical, Transcatheter Valve Replacement, A Shifamed Portfolio Company, Gets $15M In Series A Financing

Tioga Medical
4/4/19: Company is developing a novel transcatheter valve replacement technology for mitral and tricuspid applications
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CSA Medical, Inc. Receives FDA Breakthrough Device Designation and IDE Approval for its RejuvenAir System for COPD Patients with Chronic Bronchitis

CSA Medical
4/3/19: CSA Medical plans to initiate the pivotal study designed as a prospective, multi-center, blinded randomized (2:1) sham controlled trial using the RejuvenAir System across 30 sites in the U.S., Europe and Canada with up to 330 subjects.
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Innovative Inogen One G5™ Portable Oxygen Concentrator Released into the Market

Inogen Inc.
4/3/19: At only 4.7 pounds and 6 flow settings, the Inogen One G5 portable oxygen concentrator is the most balanced portable oxygen concentrator Inogen has ever created to meet the needs of oxygen therapy patients and home medical equipment providers – for use at home, away, and for travel.
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InstruSafe New XL Transport Container Protects da Vinci SP, Xi and EndoWrist Laparoscopic Instruments from O.R. to Sterile Processing

InstruSafe
4/3/19: InstruSafe’s products are designed to protect delicate surgical instruments from unnecessary damage.  A recent study conducted at Altru Hospital in Grand Forks, ND, found that using custom InstruSafe Instrument Protection Trays for cataract surgery resulted in a 34% savings in instrument repair and replacement costs.
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New Study Shows LINX Treatment Lowers Overall Medical Expenses for GERD and Other Health Issues

ETHICON
4/3/19: The research for the LINX Reflux Management System was partially funded by Ethicon, part of Johnson & Johnson Medical Devices Companies, in collaboration with Highmark Health’s VITAL Innovation Platform, a test-and-learn environment for health innovations. 
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ClearGuard HD Antimicrobial Barrier Caps Receive CE Mark Approval

Pursuit Vascular Inc.
4/3/19: ClearGuard HD Antimicrobial Barrier Caps meets the requirements of the European Medical Devices Directive, which now allows Pursuit Vascular to commercialize ClearGuard HD caps in the European Union and other CE Mark geographies. 
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Gordian™ Surgical Surpasses 2,000 Surgeries with Its FDA-Cleared and CE-Marked TroClose 1200 Access-Closure System for Laparoscopic Surgery

Gordian Surgical
4/3/19: “TroClose 1200 is a simple, effective device to close laparoscopic incisions. No longer do I have to point a sharp instrument toward the intestine or major blood vessels in the abdomen to close a 10-millimeter port. Besides saving time in the OR, TroClose will reduce inadvertent injury,” said Barry Salky, MD, Professor Emeritus of Surgery and Founder of the Division of Laparoscopic Surgery at Mount Sinai Hospital, New York, New York, one of the largest and most respected hospitals in the United States and acclaimed internationally for its clinical care leadership.
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Atlantic Therapeutics To Launch INNOVO® – Novel Therapeutic Device For Stress Urinary Incontinence

Atlantic Therapeutics
4/9/19: INNOVO was approved by the United States Food and Drug Administration on November 13, 2018, and is the first ever transcutaneous electrical stimulator cleared by the FDA, offering U.S. women a safe, clinically effective and non-invasive choice to treat stress urinary incontinence
LEARN MORE

Market Reports

Global Trocars Market by Product Type, Type of Tip, Application, End-user, and Region

Market Analysis
3/29/19: Global trocars market is expected to reach $968.5 million by 2024, at a CAGR of 6.8% during the forecast period of 2019 to 2024.
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Global Tuberculosis Diagnostics Market Outlook to 2024 – Nucleic Acid Testing is Expected to Hold the Highest Market Share

Market Analysis
3/19/19: Factors propelling the growth of the market include the increasing burden of tuberculosis and multidrug-resistant tuberculosis, increasing R&D investments, intensive product pipelines, and increasing government initiatives in the emerging markets.
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China Orthopedic Large Joint Device Market Report Suite 2018

Market Analysis
3/19/19: Demand for primary hip replacement will remain strong over the forecast period. Following Western trends, the Chinese hip replacement market is slowly shifting towards an increasing acceptance of ceramic implant balls, HCPE liners and cementless hips implants. The market includes knee replacement devices, hip replacement devices and bone cement and will exhibit rapid growth, despite steady price declines caused by both market competition and pressure from the government.
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Non Profit News

New ACP Guidelines Would Result in Thousands of Unnecessary Breast Cancer Deaths

NON PROFIT
4/8/19: That approach would also likely result in thousands more women enduring extensive surgery, mastectomies and chemotherapy for advanced cancers - and do little to nothing to address overdiagnosis or the harms of screening named in the ACP guidelines.
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New Bill Would Help Address Racial and Ethnic Disparities in Colorectal Cancer Care

NON PROFIT
4/2/19: The bipartisan bill introduced in the U.S. House of Representatives today by Reps. Danny Davis (D-IL) and Brad Wenstrup (R-OH) would provide Medicare coverage for CT Colonography (CTC) screening — also known as virtual colonoscopy.
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ADA’s William T. Cefalu, MD, to Testify on the Rising Cost of Insulin Before the Oversight and Investigations Subcommittee of the U.S. House of...

NON PROFIT
4/1/19: Dr. Cefalu will address the rising costs of insulin, which impact millions of Americans with diabetes who rely on this life-sustaining medication.
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Executives

SynCardia Systems Announces Major Promotions

Executives
4/3/19: Don Webber and Peter Spadaro offer over 60 years of medical device leadership and management experience to SynCardia Systems.
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Timothy Stonesifer Appointed CFO of Alcon

Executives
4/2/19: Timothy Stonesifer is a seasoned executive who joins Alcon with over 29 years of global financial and operational experience. He was most recently with Hewlett Packard Enterprises (HPE), where he served as Executive Vice President and CFO.
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GT Biopharma Completes Management Restructuring

Executives
3/26/19: Anthony J Cataldo has been named Chairman and Chief Executive Officer of GT Biopharma. Mr. Cataldo founded and served as Chairman and Chief Executive Officer at Iovance Biotherapeutics, Inc. He created Iovance with assets purchased from the National Cancer Institute (NCI).
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