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Medical Devices

Artio Medical Welcomes Clinical, Regulatory, and Quality Executives

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Company expands leadership team ahead of first US product launch

PRAIRIE VILLAGE, Kan., July 14, 2021 /PRNewswire/ — Artio Medical, Inc., a medical device company developing innovative products for the peripheral vascular, neurovascular, and structural heart markets, today announced the hiring of Erdie De Peralta as Vice President of Clinical and Regulatory Affairs and Delane Dale as Senior Director of Quality Assurance. De Peralta and Dale have joined Artio as the company prepares for the planned US market release of its first anticipated commercial product, the Solus Gold Embolization Device, and begins planning for a pivotal US clinical trial for the Amplifi Vein Dilation System.

De Peralta brings over 20 years of clinical and regulatory experience in the medical device industry. He is a skilled professional with expertise developing and executing successful regulatory and clinical strategies for peripheral vascular and neurovascular products. De Peralta comes to Artio from ExThera Medical Corporation where he served as the Vice President for Regulatory and Clinical Affairs. Prior to ExThera, he held regulatory leadership roles of increasing responsibility at Optiscan Biomedical, Abbott, St. Jude Medical, and Boston Scientific. De Peralta has a Master of Arts degree in Nursing from New York University.

Dale joins Artio with over 30 years of quality assurance experience for medical device companies. She has a proven track record of quality leadership, including managing process development, ensuring compliance, and implementing quality control measures for peripheral vascular and neurovascular products. Most recently, Dale served as the Quality Assurance and Quality Engineering Director for Confluent Medical Technologies, where she was instrumental in establishing compliance systems. Prior to Confluent Medical, Dale held quality leadership roles with BioInspire Technologies, Cordis, Covidien, LifeScan, Inc, and Varian Medical Systems. Dale has a Bachelor of Science degree in Industrial Engineering from Californial Polytechnic State University – San Luis Obispo.

“We are excited to welcome Erdie and Delane to the Artio team”, said Dr. F. Nicholas Franano, President and CEO of Artio Medical. “Their accomplished backgrounds and proven clinical, regulatory, and quality expertise will be critical to Artio’s success as we execute on our strategic plan and develop our broad portfolio of medical device products.”

About Artio Medical

Artio Medical is a medical device company committed to developing innovative products for the treatment of peripheral vascular, neurovascular, and structural heart diseases. For more information, please visit www.artiomedical.com.

About the Amplifi Vein Dilation System

An estimated 2.3 million end-stage renal disease patients require life-sustaining hemodialysis treatment worldwide. Creating and maintaining a suitable vascular access site is one of the most difficult and expensive aspects of hemodialysis. The National Kidney Foundation and Centers for Medicare and Medicaid Services agree that an arteriovenous fistula (AVF) is the preferred form of vascular access, however an estimated 35% of U.S. patients are ineligible for AVF surgery and more than 50% of AVFs fail to mature.1,2 The Amplifi Vein Dilation System is a wearable, external blood pump system designed to stimulate arm vein enlargement in hemodialysis patients prior to AVF surgery through a 7 – 10 day treatment of the arm with rapid, non-pulsatile blood flow. Amplifi aims to make more patients eligible for AVF surgery, reduce the time required for AVF maturation, and increase successful maturation after AVF creation.

About the Solus Gold Embolization Device

Continued blood flow through damaged or diseased blood vessels can result in life-threatening bleeding and other serious medical conditions. Peripheral vascular embolization is a minimally invasive procedure that blocks or reduces flow in blood vessels. The Solus Gold Embolization Device combines a low-profile, flexible catheter assembly and a non-porous, gold balloon-like implant for easy delivery, precise placement, and immediate vessel occlusion.

  1. Hemodialysis National Institute of Diabetes and Digestive and Kidney Disease, https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/hemodialysis
  2. United States Renal Data System (USRDS) End Stage Renal Disease Annual Report. 2018. https://www.usrds.org/.

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SOURCE Artio Medical, Inc.

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Source: https://www.biospace.com/article/releases/artio-medical-welcomes-clinical-regulatory-and-quality-executives/?s=93

Medical Devices

ViewMind announces developer agreement with HP to help revolutionise the diagnosis and treatment of cognitive disorders

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The medical device, digital health and artificial intelligence company ViewMind, today announces a new development agreement with HP Inc [HPQ].
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Source: https://www.biospace.com/article/releases/viewmind-announces-developer-agreement-with-hp-to-help-revolutionise-the-diagnosis-and-treatment-of-cognitive-disorders/?s=93

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Medical Devices

BIOLASE, Inc. To Report Second Quarter 2021 Results On August 12, 2021

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BIOLASE, Inc., the global leader in dental lasers, announced that it will release second quarter 2021 financial and operating results on Thursday, August 12, 2021 after the close of the U.S.
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Source: https://www.biospace.com/article/releases/biolase-inc-to-report-second-quarter-2021-results-on-august-12-2021/?s=93

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Medical Devices

Dentsply Sirona Reports Second Quarter 2021 Results

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Second quarter net sales of $1,067 million increased 117.3%, compared to $491 million in the second quarter of 2020.
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Source: https://www.biospace.com/article/releases/dentsply-sirona-reports-second-quarter-2021-results/?s=93

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Medical Devices

BD Announces Third Fiscal Quarter Results; Strong Base Growth Drives Better Performance In Quarter And Higher Guidance For Fiscal 2021

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BD, a leading global medical technology company, reported quarterly revenues of $4.9 billion for the third fiscal quarter ended June 30, 2021.
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Source: https://www.biospace.com/article/releases/bd-announces-third-fiscal-quarter-results-strong-base-growth-drives-better-performance-in-quarter-and-higher-guidance-for-fiscal-2021/?s=93

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