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Medical Device News Magazine

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.

Wednesday, October 16, 2019

Three Questions Medical Product Business Owners Should Ask About Private Investments

By: John Geis, Principal of Cresset Partners

Owners of privately held medical product companies who either want to take their businesses to the next level or be rewarded for their years of hard work through a liquidity event often look to private investments to make that happen, since the money flowing into medical product companies is substantial. For example, in the medical technologies space, the average deal size in 2017 was $605 million.

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First Dual-Sensor Neuromuscular Patient Monitor Announced by Xavant Technology

The new Stimpod system and EMG sensor accessory will be exhibited at the American Society of Anesthesia Annual Meeting Oct. 19-21 in Orlando, Florida, alongside the company's entire Stimpod portfolio for anesthesia.
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BIOLASE Announces First-Ever U.S. & Canada Regulatory Clearance of Laser Crown and Veneer Removal

This new indication allows dentists to remove crowns and veneers in less than five minutes using laser technology. BIOLASE is the only dental laser company with this clearance.
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Apyx Medical Corporation Initiates Enrollment in Study Evaluating the Use of Renuvion® Technology in Skin Laxity Procedures in the Neck and Submental Region

The study is a prospective, multi-center, multi-phase, evaluator-blinded study designed to evaluate the safety and effectiveness of Renuvion technology when used to improve the appearance of lax tissue in the neck and submental region.
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PG-Seq™ Rapid Non-Invasive Preimplantation Genetic Testing Kit as Alternative to IVF Embryo Biopsies

The new kit shown to achieve over 90% correlation rate between biopsied embryos and testing spent culture media.
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Hyperfine and Yale School of Medicine Collaborate on World’s First Portable MRI Technology

Yale New Haven Hospital (YNHH) is the first hospital to use the Hyperfine POC MRI system on patients, as part of a 2-year study in conjunction with the American Heart Association. This study aims to overcome barriers that have prevented the routine use of MRI on unstable neurology intensive care unit patients who cannot be transported.
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First Patient Enrolled in Study of Aspiration for Thrombus Removal in Coronary Vessels

The CHEETAH study, a prospective, multi-center U.S. study to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. Introduced in 2018, as part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator™ 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. 
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Delpor to Tackle Opioid Use Disorder with $5.7 Million NIH HEAL Grant Award for the Development of a Once-Yearly Naltrexone Therapy to Prevent Relapses

The award comes through the NIH Helping to End Addiction Long-term Initiative, or the NIH HEAL Initiative, which aims to improve treatments for chronic pain, curb the rates of opioid use disorder and overdose, and achieve long-term recovery from opioid addiction.
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Injectsense Demonstrates Animal-to-Cloud IOP Sensing Pathway for Glaucoma Injectable Pressure Sensor Offers Platform for Multiple Medical Domains

Injectsense
The Injectsense IOP-Connect system creates an organ-to-cloud data connection that enables the clinician to assess glaucoma therapy effectiveness at any time.  The system is expected to provide unprecedented visibility into the IOP profile of the patient over time, and into previously unobserved changes that may affect glaucoma progression.
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National Institute for Health and Clinical Excellence Maintains Previous Recommendation for EXOGEN® Ultrasound Bone Healing System

Bioventus
EXOGEN uses natural bone healing process and promote fracture healing. It also has an 86% heal rate for fractures not healing on their own and provides 38% faster healing of fresh fractures.
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Medtronic Receives FDA Breakthrough Device Designation for Developing Stent Graft System to Treat Thoracoabdominal Aortic Aneurysm

Medtronic
The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Medtronic with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.
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Aethlon Medical Announces FDA Approval Of IDE For Oncology Indications

Aethlon Medical Inc.
An EFS for a medical device is similar to a phase 1 study for a drug or biologic and as such this trial will enroll a small number of patients with advanced head and neck cancer who cannot be treated with surgery or radiation.
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Turn Therapeutics™ Closes Series B Round

Turn Therapeutics™ Inc.
The capital raised will fund a large-scale, pre-launch, phase 4 trial for AtopX™ Eczema Emulsion, with enrollment scheduled to begin in Q1, 2020.
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Analytics Engine Receives FDA Clearance for Ambulatory Physiologic Monitoring

Biofourmis
This regulatory approval of the Biovitals™ Analytics Engine is part of FDA's growing recognition of machine-learning and AI in the Software as a Medical Device category.
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ControlRad™ Secures $15 Million Series B Financing

ControlRad Inc.
The Series B round, which was led by Questa Capital, will be used for fueling the commercial launch of the innovative ControlRad Trace system.
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Terumo BCT Launches First-of-its-Kind Device to Accelerate Cell Therapy Manufacturing

Terumo BCT
Finia is a fully automated, modular, functionally closed system that creates the final formulation of cell and gene therapies and divides them into user-defined doses for patients. The technology automates a process that is currently manual and labor-intensive with the added risk of error.
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SONOFLOW CO.56 Pro: The Evolution in Combined FlowBubble Measurement for Medical Products

SONOTEC
As a leading sensor technology specialist in medical technology SONOTEC easily meets the latest EMC product standard IEC 60601-1-2 (Edition 4) for the SONOFLOW CO.56 Pro FlowBubble Sensor. In addition to Edition 4, the sensors meet IEC 60601-1 (Edition 3) and IEC 61157, the standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment, and RoH's 2011/65/EU to guarantee CE compliance.
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First Patient in the U.S. Multi-Center Enrolled in LIGHTSITE III Clinical Study to Treat Dry Age-Related Macular Degeneration

LumiThera Inc.
The randomized, multi-center study called LIGHTSITE III enrolled and treated the first patient at Cumberland Valley Retina in Hagerstown, Maryland. The United States study is being conducted in leading retinal centers throughout the United States. The study will enroll approximately 100 patients suffering from dry AMD and treat them over the course of two years. In addition to demonstrating safety, key efficacy endpoints include visual acuity, contrast sensitivity and reduction of drusen deposits.
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Endotronix Closes Expanded Series D Financing Round of $70 Million for Heart Failure Solution

Endotronix Inc.
The funds will be used to support the landmark PROACTIVE-HF IDE clinical trial of the Cordella® Pulmonary Artery Sensor System (Cordella Sensor) and commercialization of the Cordella® Heart Failure System (Cordella System).
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Cook Medical’s Unique Biodesign® Anal Fistula Plug Se Recommended by NICE

COOK Medical
This is the highest level of recommendation from the NICE committee and means that there is enough evidence for surgeons experienced in managing anal fistulas to consider this procedure as a treatment option.
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VITROS® XT 7600 Integrated System from Ortho Clinical Diagnostics Receives CE Mark

Ortho Clinical Diagnostics
By combining Ortho's proprietary dry slide technology with sophisticated digital imaging capabilities and the potential to perform two separate lab tests simultaneously, Ortho is introducing digital chemistry to clinical lab management.
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AltaValve™, 4C Medical’s Novel Transcatheter Mitral Regurgitation Device Highlighted at TCT 2019

4C Medical Technologies Inc
The AltaValve is a Transcatheter Mitral Valve Replacement (TMVR) device designed to broaden the treatable patient population: the device's supra-annular fit and atrial-only fixation bypass the concerns of anchoring and fixation difficulties present in current TMVR technologies.
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Ribometrix Announces $7.8 Million in New Funding to Advance RNA-Targeting Drug Discovery Platform

Ribometrix
Ribometrix is a biotechnology company that develops small molecule therapeutics that directly target RNA to treat human diseases, today announced $7.8 million in additional...
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Cerveau Technologies Inc. Signs Research Agreement with Takeda to Provide Novel Tau Imaging Agent

Cerveau Technologies Inc.
The collaboration is focused on using [F-18]MK-6240 as a biomarker in Takeda’s neurodegenerative disease research. The companies will evaluate Takeda’s investigational therapeutics for potential treatment of neurodegenerative diseases in humans.
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Access Vascular Secures $6M in New Funding

Access Vascular Inc
The new funding will also support product development as the company seeks to expand its portfolio of reduced thrombosis intravenous devices.
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Hensler Surgical Technologies Announces Two New Applications for the Hensler Bone Press™ – Orthopedic Edition

Hensler Surgical Technologies
The two new techniques will initially focus on Intramedullary (IM) post-reaming and tibial condyle harvesting methodology.
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DePuy Synthes Expands Comprehensive Offering to Treat Degenerative Spine Disease with Launch of 3D Printed Implant Portfolio for Spine Surgery

Johnson & Johnson
The innovative portfolio, which includes 3D printed titanium interbody implants for spinal fusion surgery is designed to mimic natural bone and help facilitate spinal fusion.
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Tepha Inc. Announces the Presentation of Pre-Clinical and Clinical Data on the Use of P4HB™ Regenerative Scaffolds In Urogynecology

Tepha Inc
Fully resorbable scaffolds manufactured from Tepha's P4HB polymer were first introduced in 2012 and have now been safely used in more than 200,000 surgical procedures around the world in both complex abdominal wall reconstruction as well as plastic and reconstructive surgery applications.
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Penlon Ltd. Launches Sigma EVA Vaporizer for Desflurane

Penlon Ltd
Sigma EVA, is an advanced electronic vaporizer specifically designed to provide a better way to deliver of Desflurane. Penlon will be one of a very small number of companies to have developed and launched a Vaporizer for Desflurane.
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Abbott’s High Sensitivity Troponin-I Blood Test Receives FDA Approval

Abbott
As one of the most researched troponin diagnostic tests, doctors in the U.S. can now utilize this proven technology to help detect heart attacks faster and more accurately than contemporary troponin tests.
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NuVasive to Highlight Its Enabling Technologies at NASS

NuVasive Inc.
Company also to unveil its robotic application designed to support the future of spine care.
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Device Company Generates Funding to Expand Its Peripheral Nerve Repair Technologies

Renerva, LLC
The NIH support will enable the company to expand the applications of its first product, Renerva Peripheral Nerve Matrix (PNM), an injectable gel derived from porcine tissue that promotes and supports repair and regeneration in injured peripheral nerves.
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LENS 4K Surgical Imaging System Launched

Smith+Nephew
The LENS 4K System features a Camera Control Unit with an integrated light source, Camera Head, image management options and Tablet Application in a single solution. The latest native 4K 3CMOS Ultra High Definition technology combined with Smith+Nephew's proprietary image and light processing is intended to create impressive color reproduction, image clarity, and depth of field.
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Industry’s First Powered Circular Stapler Launched by Ethicon

ETHICON
The new ECHELON CIRCULAR Powered Stapler combines two innovative Ethicon technologies, 3D Stapling Technology that evenly distributes compression and Gripping Surface Technology, which provides gentler handling to reduce compressive forces on tissues.
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Medical Specialists Report Updates with CivaSheet® Directional Brachytherapy in the Treatment of Sarcoma

CivaTech Oncology Inc
Demonstrates up to three year local control in recurrent retroperitoneal sarcomas when implanted during surgical resection.
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Coronary ViperWire Advance® With Flex Tip Receives FDA Approval

Cardiovascular Systems
ViperWire Advance with Flex Tip is the latest advancement to CSI’s coronary Diamondback 360® orbital atherectomy system. Diamondback is the only atherectomy device to treat calcific coronary artery disease by both safely reducing superficial lesions and creating fractures of deep calcium, facilitating stent delivery, expansion and wall apposition for low restenosis rates.
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The iBox Validation Study from the Paris Transplant Group Published in the British Medical Journal

CareDx Inc.
“Our BMJ publication shows the algorithm we created can provide standardization across centers worldwide,” said Alexandre Loupy, MD, Director of the Paris Transplant Group. “The iBox risk prediction score may help guide patient monitoring and further improve the design and the development of a valid and early surrogate endpoint for clinical trials.”
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Study Design for REVIVE-HF: RCT in Europe

BioVentrix
To demonstrate that treatment with the Revivent TC™ System is more effective than Guideline Directed Medical Therapy (GDMT) for the treatment of ischemic heart failure.
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Terumo BCT Launches First-of-its-Kind Device to Accelerate Cell Therapy Manufacturing

Terumo BCT
Finia is a fully automated, modular, functionally closed system that creates the final formulation of cell and gene therapies and divides them into user-defined doses for patients. The technology automates a process that is currently manual and labor-intensive with the added risk of error.
LEARN MORE

ControlRad™ Secures $15 Million Series B Financing

The Series B round, which was led by Questa Capital, will be used for fueling the commercial launch of the innovative ControlRad Trace system.
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MARKET REPORTS

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

Dr. Douglas Drachman Named Next Annual Scientific Session Vice Chair of the American College of Cardiology’s Annual Scientific Session

NON PROFIT
Drachman will serve as vice-chair for ACC.21 and ACC.22 and transition to chair for ACC.23 and ACC.24.
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American College of Cardiology Issues Principles for Overcoming Compensation, Opportunity Inequity

NON PROFIT
The document is the first in a new series of ACC workforce health policy documents and will serve as guidance for clinicians and administrators to advance the profession toward the goals of fairness, including minimizing and reducing disparities, and improved patient care.
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Updates to the 2019 Standards of Medical Care in Diabetes

NON PROFIT
Revisions include updated treatment information for adults and youth with type 2 diabetes and new guidelines for people with diabetes who use continuous glucose monitoring.
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EXECUTIVES

Brian Armijo Appointed Vice President of Operations at Imperative Care

Executives
Armijo brings significant relevant expertise in scaling operations to support the commercialization of products used in life-saving medical interventions. The company also announced it has expanded its sales force to include five new team members with deep neurovascular experience.
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Michael J. McNulty Names VP Sales and Marketing

Executives
McNulty will lead Miach’s commercialization and sales efforts for the Bridge-Enhanced® ACL Repair (BEAR®) Implant, an investigational device designed for anterior cruciate ligament (ACL) repair.
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Dr. Ali Tinazli Joins Fluxergy as Chief Commercial Officer

Executives
Dr. Tinazli will oversee all commercial operations, strategic planning, business development, sales, and strategic partnerships for the point-of-care (POC) diagnostics company.
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Dave Reed Receives Chuck Lauer Award

Executives
Chuck Lauer was the publisher of Modern Healthcare and a networking expert among healthcare suppliers and providers. He was known for his mentorship to others in his profession, as well as his incisive yet supportive critiques of the ways current healthcare systems were serving patients. He passed away in 2017.
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World Renowned Lung Cancer Expert Named CMO of Biodesix

Executives
Dr. Jett joins Steven Springmeyer, M.D. as co-CMO to support all aspects of the Company’s research, development and commercialization efforts. Today’s news comes as Biodesix continues to drive adoption of the recently launched Nodify XL2™ proteomic nodule classifier.
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LaVerne Council and Barbara Schwarzentraub Added to CONMED Corporation BOD

Executives
Ms. Schwarzentraub will join the Board effective immediately, with Ms. Council joining the Board effective as of December 1, 2019.
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