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MEDICAL DEVICE NEWS MAGAZINE

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Biotechnology News Magazine

Fluidx Medical Technology Announces Series A Led by Multinational Strategic Investor

Novel Oncology Embolic Device financing supports prospective, clinical trials and market entry

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Fluidx Medical Technology, a privately held medical device company founded to develop GPX, an innovative embolic material, and other technologies today announced the oversubscribed closing of the first tranche of its Series A financing round.

The Series A was led by a large multinational strategic investor, and joined by its existing investor base as well as several new investors.  The funding will be used to support prospective clinical trials, including the pivotal trial, as well as preparation for market entry.

“GPX has been quite simple to prepare, deliver and control,” said Dr. Andrew Holden, M.D., MBChB, FRANZCR, EBIR, ONZM, Director of Interventional Radiology, Auckland City Hospital, Auckland, New Zealand.  “The material is very radiopaque during delivery and has demonstrated excellent distal penetration, particularly important in our tumor embolization cases.”

Embolic devices are widely used to stop blood flow for targeted treatment of hypervascular tumors, vessel malformations, internal bleeds, and other cancer-related uses.  Challenges with embolic devices today can include complicated preparation processes, issues with visibility during device delivery, reliance on the body’s coagulation situation, and lack of complete penetration of vessel beds and tumor feeding vessels.

The GPX Embolic Device is an innovative embolic designed for simple preparation and quick material delivery.  GPX technology is a low viscosity, aqueous-based solution in a syringe that solidifies into a durable embolus upon delivery without polymerization or dimethyl-sulfoxide (DMSO) precipitation.  GPX is designed to occlude blood vessels independent of a patient’s coagulation situation.  Unlike competitive technologies that require special preparation materials and time, the GPX device is packaged ready-to-use in a syringe, requires less than 30 seconds of tableside preparation by the clinician, and may be delivered through standard catheters or small microcatheters (no complex mixing systems or special delivery catheters are necessary). *

“The GPX team achieved a great deal with seed funding including first patient use of the device.  We have been very pleased with the overwhelming investor support for our Series A raise,” said Libble Ginster, CEO of Fluidx Medical Technology.  “Our company’s mission is to elevate patient care through innovation, and we look forward to bringing the GPX technology to the clinical community.”

Fluidx Medical Technology is a Salt Lake City, Utah based company focused on developing the GPX Embolic Device and other innovative medical technologies.  The GPX Embolic Device is under development and does not have marketing clearance or approval in any market at this time. For investigational use (in New Zealand) only.

Executives

Intelligent Implants Taps Leading Medical Device Entrepreneur, Benjamin A. Hertzog, PhD, as CEO

Dr. Hertzog will lead the progression of product development, clinical, and commercial activities for the company’s novel and proprietary smart orthopedic implant platform.

US Med-Equip Appoints 4 New Chief Executives

"We sought out superstars and brought in the best executives in their fields to join our burgeoning team. They will be instrumental in building on the growth of our company and our community of employees and healthcare partners we support," Salario said. Read who they are.

Perineologic Appoints Jim Fortune as President and Promotes Matthew Allaway, DO, to Chief Executive Officer

Mr. Fortune served as chief operating officer at Ocular Therapeutix, Inc. Dr. Allaway is the founder of Perineologic and has been a practicing urologist and managing partner at Urology Associates in Cumberland, Maryland.

FDA Updates

Medtronic Reports FDA Approval of Spinal Cord Stimulation Therapy for Treating Chronic Pain Resulting from Diabetic Peripheral Neuropathy

This new indication enables us to apply Medtronic's more than 40 years of proven SCS experience, as well as the company's deep diabetes expertise, to deliver better care to even greater numbers of diabetes patients.

Cardiovascular Systems, Inc. and OrbusNeich Announce FDA PMA Approval of Scoreflex® Scoring Balloon

Scott Ward, CSI’s Chairman, President and Chief Executive Officer, said, “We remain committed to expanding our portfolio of differentiated products that help physicians deliver improved outcomes for patients with complex coronary artery disease.

Nevro Reports FDA Approval for Expanded Labeling for Senza® Spinal Cord Stimulation System

This approval is specific to Nevro's proprietary 10 kHz Therapy and differentiates Nevro's Senza System as the only SCS system with specific labeling to treat NSRBP patients.
Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.
Tags

Diagnostic Imaging

Carestream Continues Drive to Improve Image Quality and Workflow With 45 Patents in 2021

“Carestream continuously strives to deliver cutting-edge technologies worldwide, and these patents demonstrate our commitment to meet the evolving needs of providers and patients alike,” said Eugene Shkurko, Intellectual Property Counsel at Carestream.

Aidoc Partners with Novant Health

By incorporating Aidoc's AI platform, which includes seven FDA-cleared solutions for triage and notification of patients with acute medical conditions, Novant Health is taking proactive steps to improve patient outcomes and reduce emergency department (ED) length of stay amid resource constraints inflicted by the Omicron variant.

Trials

NEJM: New Data on COVID-19 Lung Transplants

The analysis of more than 3,000 lung transplants in the U.S. between Aug. 1, 2020, and Sept. 30, 2021, showed that during the pandemic, 7% of the nation’s lung transplants were performed to treat severe, irreversible lung damage caused by COVID-19. More than half of these patients needed ventilators or extracorporeal membrane oxygenation, or ECMO, before their transplant.

Preclinical Study Provides Guidance for Optimizing Safety and Efficacy of Endovascular Hepatic Denervation Devices to Treat Diabetes

“This study leveraged our deep experience in preclinical evaluation of denervation therapies and could not have been performed in a timely manner without the digital morphometry techniques we developed in-house. We remain excited about the potential of neuromodulation technologies and are committed to supporting further innovation in this space,” explained Rami Tzafriri, PhD, lead author and Director of Research and Innovation at CBSET.

Other News

NEJM: New Data on COVID-19 Lung Transplants

The analysis of more than 3,000 lung transplants in the U.S. between Aug. 1, 2020, and Sept. 30, 2021, showed that during the pandemic, 7% of the nation’s lung transplants were performed to treat severe, irreversible lung damage caused by COVID-19. More than half of these patients needed ventilators or extracorporeal membrane oxygenation, or ECMO, before their transplant.

University of Colorado School of Medicine Will Work with DreaMed Diabetes to Deploy Its Advisor System as a New Resource for Diabetes Device Initiation

“We are truly honored to be part of this project,” said Ryan Hovey, general manager for North America at DreaMed. “We have been able to demonstrate the ability to support endocrinology practices by centralizing patient device data as well as providing evaluation reports and FDA cleared treatment recommendations.

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