Wednesday, November 13, 2019
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Breaking Medical Device Industry News
Wednesday, November 13, 2019

Welcome! Medical Device News Magazine reports the latest medical device industry 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 Medical Device News Magazine daily.

10/31/19: Oped: Sherif A.H. Sultan, MD, PhD, FRCS, EBQS-VASC Perfect AAA EVAR Stent Has Not Been Designed or Produced: All Current AAA EVAR Devices are Obsolete. Read Sultan’s Views Here.

XACT Robotics Announces Latest Financing Round Totaling $36M

The company intends to use the proceeds to support the commercialization and continued development activities in support of the recent U.S. market cleared XACT Robotic System, which also has CE Mark.
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AVITA Medical Announces Institutional Placement of A$120.0 Million

The Institutional Placement was managed by Bell Potter as sole lead manager.
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Sera Prognostics Raises $36 Million Series D Financing

Sera’s products focus on the early prediction of a woman’s individualized risk of preterm birth and other pregnancy complications.
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ELT Sight Acquires Assets and IP of MLase AG Excimer Ophthalmic Laser System for Glaucoma Surgery

MLase manufactures and markets innovative laser systems, including the ExTra ELT Laser and disposable applicator used to perform implant-free microinvasive glaucoma surgery.
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W. L. Gore & Associates To Reveal New Gender Insights From Real-world Aortic Data At 2019 VEITHsymposium

W. L. Gore & Associates Inc.
The presentations will be facilitated by lead investigators of the Global Registry for Endovascular Aortic Treatment (GREAT).
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Gyros Protein Technologies Acquired by Mesa Labs

Mesa Laboratories is a diversified supplier of quality control instruments and consumables to highly regulated markets.
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Hallura Ltd. Closes Its $7M Financing Round

Hallura Ltd.
The round was led by a group of US, Europe and Israel-based investors; Proceeds will be used to complete its clinical trials and register its breakthrough proprietary Hyaluronic Acid Dermal Fillers in Europe.
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EXPEDITE Study Initiated by Boston Medical Center to Evaluate Clinical Effectiveness of Pure-Vu® System for Improving Bowel Preparation Rates

Motus GI® Holdings, Inc.
The investigator-initiated study will assess the ability of the Pure-Vu System to accelerate time to a successful colonoscopy in a real-world setting. Study to enroll up to 100 hospital inpatient and outpatient participants in need of a diagnostic colonoscopy.
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Gyros Protein Technologies Acquired by Mesa Labs

Mesa Laboratories is a diversified supplier of quality control instruments and consumables to highly regulated markets.
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Multi-Center Clinical Study Demonstrates HeartTrends® Improves Early Detection for Heart Disease in Healthy Individuals

Lev El Diagnostics of Heart Diseases Ltd.
The collaborative Mayo Clinic – Sheba study demonstrated that HeartTrends' HRV analysis improves early myocardial ischemia detection compared to both traditional cardiovascular risk factors and commonly used treadmill stress testing. Additionally, the study results validate a new and independent cardiac risk factor, enhancing current factors, which include: smoking, obesity, high blood pressure and/or cholesterol.
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Netech Corporation Launches a New Line of Improved Gas Flow Meters

With an introductory price of $1795, the company reports their Netech's Digiflow 2000 is an unparalleled device providing its users with remarkable value.
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Hallura Ltd. Closes Its $7M Financing Round

Hallura Ltd.
The round was led by a group of US, Europe and Israel-based investors; Proceeds will be used to complete its clinical trials and register its breakthrough proprietary Hyaluronic Acid Dermal Fillers in Europe.
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New Study Shows Promise in Treating More Patients with World’s Smallest Pacemaker

Medtronic
The results from the MARVEL 2 study will be presented Nov. 16 during a Featured Science session at American Heart Association 2019, the AHA Scientific Sessions and were published today in JACC: Clinical Electrophysiology.
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CorTechs Labs Enters Phase 2 of $1.15 Million NIH Grant

CorTechs Labs
This project, funded by a $1.15 million, multi-year grant from the National Institutes of Health (NIH), was awarded to CorTechs Labs in December of 2018.
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Owlstone Medical Partners with Thermo Fisher Scientific

Owlstone Medical
The collaboration seeks to advance the application of non-invasive breath sampling to address the challenges of the early detection of disease and the precision medicine delivery of healthcare through the discovery and validation of novel biomarkers
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Post-Ablation Cavity Evaluation Clinical Study Published in the Journal of Minimally Invasive Gynecology

AEGEA Medical
The PACE study evaluated hysteroscopic access to the uterine cavity for women who previously underwent endometrial ablation for heavy menstrual bleeding as part of a pivotal trial of the company’s Mara™ Water Vapor Ablation System.
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OsteoRemedies® Announces the Full Commercial Launch of the First Preformed Knee Spacer with Modular Stems

"Our vision is to continue to provide simple but comprehensive solutions to the growing clinical challenges surrounding infected total joints.  By providing surgeons with the only modular knee stems cleared by the FDA, we believe our portfolio remains the most robust which allows us to bolster our leadership position," stated Chris Hughes, President and CEO, OsteoRemedies®.
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Positive Six-Month Data from TOBA II BTK Clinical Trial

Intact Vascular
Results of its Tack Optimized Balloon Angioplasty (TOBA) II BTK clinical trial, successfully achieving all primary (P < 0.0001) and secondary endpoints with very low rates of major amputation and all-cause death.
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Indigo® Aspiration System IDE Trial for Acute Pulmonary Embolism Meets Primary Safety and Efficacy Endpoints

Penumbra Inc.
“The positive results of the EXTRACT-PE trial, the first prospective safety and efficacy study of the Indigo Aspiration System, are a step forward in building needed clinical evidence around catheter-based embolectomy in patients with acute pulmonary embolism,” said Akhilesh Sista, MD, FSIR, FAHA, EXTRACT-PE national principal investigator, chief of Vascular and Interventional Radiology at NYU-Langone School of Medicine, and vice chair of the recently published Interventional Therapies for Acute Pulmonary Embolism guidelines from the American Heart Association.
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CATHETRIX Foley Catheter Securement Device to be Distributed in Three Markets

CATHETRIX
The company reports FoleySafe is the world's first catheter stabilizer which actively prevents possible damage to the bladder and urethra from accidental urinary catheter extraction.
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bellavista™ 1000e Ventilator System Receives FDA Clearance

Vyaire Medical Inc.
The company reports it is the newest addition to Vyaire's high-end ventilation portfolio offering a comprehensive solution for hospitals with the integration of high flow oxygen therapy and advanced synchrony support for neonatal to adult patients in a single device.
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Hospitech Respiration Announces Article Published by Physicians from Mayo Clinic, FL, USA

Hospitech Respiration Ltd.
This published data suggests that the AnapnoGuard system holds the potential to assist the care team in attenuating complications related to excessive cuff pressure, aspiration of subglottic secretions and endobronchial intubation. The data demonstrates quantitative removal of secretions and effective airway cuff pressure management.
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Senza® Omnia™ Spinal Cord Stimulation System Launhced in the U.S.

Nevro Corp
The Omnia system is the first and only SCS system designed to deliver Nevro's proprietary HF10® therapy in addition to all other available SCS frequencies. 
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MR Solutions’ Preclinical Imaging Systems

MR Solutions
The introduction of liquid helium free, high-end MRI systems by MR Solutions substantially reduces the environmental impact when compared to competitor units.
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Olympus Now the Exclusive Distributor of the RocaFlow Pump and Tubing Sets

Olympus Medical Systems Group
Olympus will distribute the RocaFlow Double Chamber Pump System and Tubing Sets for use in urology procedures including ureteroscopy for kidney stones and trans-urethral resection of the prostate.
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Itamar Medical Announces Blue Shield of CA and Blue Cross Blue Shield Federal Employee Plan to Include WatchPAT™ in Their Policies

Itamar Medical Ltd.
The Company also announced the release of the U.S. Centers for Medicare & Medicaid Services (CMS) 2020 Fee Schedule which is the second year of a 3-year proposed plan by CMS to reevaluate reimbursement in-home sleep apnea diagnostic codes.
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Avanos Medical Announces Third Quarter 2019 Results

Avanos Medical Inc.
"Our COOLIEF business delivered another quarter of double-digit growth; nevertheless, we were disappointed that our overall third-quarter performance fell short of our expectations" stated Joe Woody, Avanos' chief executive officer.
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TTP Ventures Introduces New High-Performance Micropumps for Medical and Life Science Markets

TTP Ventus
The new HP Series has been designed for applications requiring high pressure, with the first model delivering in excess of 800 mBar, doubling what was available with previous models.
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Compugen Announces FDA Clearance of IND Application for COM902

Compugen Ltd.
"IND clearance for COM902 is an important milestone that marks the third program based on new drug targets we discovered to be evaluated in the clinic," said Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen.
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Pursuit Vascular to Be Acquired by ICU Medical

ICU Medical
ICU Medical entered into a definitive agreement to acquire Pursuit Vascular, Inc. for $75M with an additional earnout payment potentially due in 2021.
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MARKET REPORTS

Global Arthroscopy Instruments Market Analysis, Trends & Forecasts

Market Analysis
The Arthroscopy Instruments market worldwide is projected to grow by US$1.7 Billion, driven by a compounded growth of 5.9%.
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North America Nephrostomy Devices Market 2019-2025 Report

Market Analysis
Due to favorable reimbursement policies, increased product awareness, the accessibility of highly skilled physicians and the involvement of well-established healthcare facilities in the region, it is expected to see significant growth in the future as well.
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Global Medical Imaging Industry Quarterly Tracker Q1 2019

Market Analysis
The medical imaging and informatics industry is evolving rapidly, and new products and solutions are launched every other day. As the reimbursement environment is...
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Ampoules & Syringes Worldwide Market Forecast

Market Analysis
The rising number of health issues owing to the unhealthy lifestyle is expected to drive the market for ampoules and syringes.
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European $11.18 Bn Diabetes Care Devices Market to 2027

Market Analysis
The Europe diabetes care devices market is expected to reach US$ 11,184.6 Mn in 2027 from US$ 6,853.3 Mn in 2018. The market is estimated to grow with a CAGR of 5.7% from 2019-2027.
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ASSOCIATION NEWS

Quadriplegics May Benefit from Over-the-Skin Electrical Stimulation

NON PROFIT
Approximately 5.4 million people are living with paralysis in the United States, with stroke and spinal cord injury the two leading causes.
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Revolutionary Lung Cancer Robot Is Unveiled

NON PROFIT
A revolutionary robot can now detect lung cancer at an early stage allowing for more-accurate diagnosis, changing the prognosis for many now diagnosed with the #1...
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ACS NSQIP® Recognizes 88 Participating Hospitals

NON PROFIT
Recognized hospitals are deemed “Meritorious” for their composite quality scores in eight surgical care outcome areas.
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EXECUTIVES

Robert J. Rosenthal, Ph.D. Appointed to InVivo Therapeutics BOD

Executives
Dr. Rosenthal brings more than 25 years of experience to the InVivo Board as an accomplished executive and business leader in the biotechnology, therapeutics and medical device industries. With the addition of Dr. Rosenthal, InVivo’s Board has six members, five of whom are independent.
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Rob Germain Joins Aloe Care Advisory Board

Executives
Germain has held leadership positions with Aetna, the global health team at the Bill and Melinda Gates Foundation, and one of the largest owner/operators of senior living communities in the US. Germain has a BA in French, Philosophy and Political Science from Lynchburg College as well as an MBA and a Masters in International Economics from Sciences Po in Paris.
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Niyati Patel Appointed Director of Quality Assurance and Compliance of Experic

Executives
Patel is the latest addition to Experic’s team.
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Scott Hutton Appointed CEO of Biodesix

Executives
Hutton currently serves as Chief Operating Officer with more than 20 years of experience in the medical device, medical technology, and diagnostics industries.
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Bill Athenson Named New CEO of Third Pole Therapeutics

Executives
Athenson joins Third Pole building on the recent hires of Elizabeth Holmberg as Chief Financial Officer, formerly CFO of Ikaria, and Christopher Miles as Chief Technology Officer, formerly global head of consulting services at Altran.
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Peter Markham CEO of CBSET Honored as ‘2019 Biomedical Research Business Leader’ by Massachusetts Society for Medical Research

Executives
Prior to co-founding CBSET in 2006, Mr. Markham served as General Manager of the Worcester/Southbridge division of Charles River Laboratories where he had P&L responsibility for a multi-disciplinary preclinical business unit which serviced the Toxicology, Pharmacology, Surgery, Metabolism, Pharmacokinetics, and Bioanalytical Chemistry markets.
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