Wednesday, November 13, 2019
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.

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.
The Institutional Placement was managed by Bell Potter as sole lead manager.
Sera’s products focus on the early prediction of a woman’s individualized risk of preterm birth and other pregnancy complications.
MLase manufactures and markets innovative laser systems, including the ExTra ELT Laser and disposable applicator used to perform implant-free microinvasive glaucoma surgery.
The presentations will be facilitated by lead investigators of the Global Registry for Endovascular Aortic Treatment (GREAT).
Mesa Laboratories is a diversified supplier of quality control instruments and consumables to highly regulated markets.
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.
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.
Mesa Laboratories is a diversified supplier of quality control instruments and consumables to highly regulated markets.
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.
With an introductory price of $1795, the company reports their Netech's Digiflow 2000 is an unparalleled device providing its users with remarkable value.
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.
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.
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.
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
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.
"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®.
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.
“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.
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.
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.
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.
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. 
The introduction of liquid helium free, high-end MRI systems by MR Solutions substantially reduces the environmental impact when compared to competitor units.
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.
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.
"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.
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.
"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.
ICU Medical entered into a definitive agreement to acquire Pursuit Vascular, Inc. for $75M with an additional earnout payment potentially due in 2021.

MARKET REPORTS

Global Arthroscopy Instruments Market Analysis, Trends & Forecasts

The Arthroscopy Instruments market worldwide is projected to grow by US$1.7 Billion, driven by a compounded growth of 5.9%.

North America Nephrostomy Devices Market 2019-2025 Report

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.

Global Medical Imaging Industry Quarterly Tracker Q1 2019

The medical imaging and informatics industry is evolving rapidly, and new products and solutions are launched every other day. As the reimbursement environment is...

Ampoules & Syringes Worldwide Market Forecast

The rising number of health issues owing to the unhealthy lifestyle is expected to drive the market for ampoules and syringes.

European $11.18 Bn Diabetes Care Devices Market to 2027

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.

ASSOCIATION NEWS

Revolutionary Lung Cancer Robot Is Unveiled

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...

ACS NSQIP® Recognizes 88 Participating Hospitals

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

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.
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.
Patel is the latest addition to Experic’s team.
Hutton currently serves as Chief Operating Officer with more than 20 years of experience in the medical device, medical technology, and diagnostics industries.
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.
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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