Experienced Executives Join Physeon Team on Heels of Commencement of US VIVA Trial.
SCHAFFHAUSEN, Switzerland, December 17, 2018 (GLOBE NEWSWIRE) -- Physeon GmbH (“Physeon” or the “Company”), a leading developer of medical technology products for venous access, today announced the addition of multiple accomplished executives to its management team. Today’s announcement follows the Company’s recent announcement of the first patient having been enrolled in its “VIVA” (Veinplicity for Improved Venous Access) Trial in the United States for the Veinplicity® Device.
“We are very pleased to welcome multiple new accomplished members to our management team on the heels of having recently enrolled our first patient in our US “VIVA” trial. The highest quality leaders available in their field have now joined our team. This is a strategic iniative in supporting our US clinical trial plans” says Alan Wilson, Executive Chairman, Novintum Medical Technology, GmbH, the owner of Physeon GmbH”.
Niall Behan has been named as the Company’s Director of Quality, Rachel Kennedy as its Director of Regulatory, Nancy Moureau as its Clinical Research Director, and Lori Segar as its Director of Clinical Affairs.
Niall Behan, the Company’s newly named Director of Quality brings to Physeon 20+ years of experience leading pharmaceutical and medical device companies. He was Co-founder of Vysera Biomedical. Held leadership positions with Boston Scientific and Merit Medical Systems Inc. where he was responsible for developing and launching a number of new products. Has over 30 patent applications, 15 granted patents and runs a consultancy business focused on streamlining regulatory and quality solutions for small medical device companies.
Rachel Kennedy, the Company’s newly named Director of Regulatory brings to Physeon a 30+ year career in the medical device industry. Her expertise is in research, manufacturing, product development, quality systems and regulatory affairs for devices in the areas of orthopedics including spine and extremities, general surgery and neurology. She has prepared reports evaluating the safety and performance of medical devices for therapeutic areas including blood processing, cardiovascular, diabetes, general surgery, orthopedics and wound care.
Nancy Moureau, the Company’s newly named Clinical Research Director comes to Physeon with a 30+ year career in clinical practice and research of vascular access practices. She is an internationally recognized speaker, author, researcher and expert in the field of vascular access practices. She uses her experience as 30+ years as a nurse to continue clinical work as an instructor, educator and research advisor. She was recipient of the Herbst Award for excellence and is heavily involved with research and literature analysis working in conjunction with Griffith University as an adjunct associate professor and the AVATAR group Alliance for Vascular Access Teaching and Research.
Lori Segar, the Company’s newly named Director of Clinical Affairs comes to Physeon having a 20+ year career in clinical research. She has been an independent clinical research consultant to a variety of startup and mid-size medical device companies. She possesses expertise in cardiovascular, neuromodulation, and other therapeutic areas. She also works closely with medical centers across the US, EU and Pacific Rim on studies ranging from feasibility to global pivotal trials.
Veinplicity is designed to alleviate one of the most common challenges in health care – Difficult Venous Access (DVA). Up to 80% of hospitalized patients need a peripheral IV cannula for the infusion of fluids and medications. Although it’s the most common invasive procedure performed in health care, first attempt failure rates can be high, costly, cause needlessly damage to veins and lead to increased stress for patients and staff. It can also be an administrative and financial burden for the hospital, outpatient centers.
Veinplicity is intended to address these challenges by significantly increasing the size, vessel wall rigidity and stability of targeted peripheral veins, making them easier to find and easier to cannulate for an IV at first attempt. It is the only technology available which has a positive and temporary physiological effect on targets veins for the placement of IVs by making the targeted vein temporary larger resulting in making it an easier target to hit on a first attempt to cannulate.
Veinplicity consists of a proprietary portable electronic stimulation device which passes a gentle electrical current between proprietary and dedicated electrodes placed on the palm of the hand and the bicep area of the patient.
In one of the Company’s initial clinical study the dilatory effect of Veinplicity was compared to the dilatory effect of heat pack treatment, which has long been considered the standard of care when veins cannot be palpated. As well as dilating veins 38% more, Veinplicity’s effect lasted twice as long as heat treatment, allowing clinicians’ crucial extra time to perform this important procedure.
The Veinplicity Device is CE Marked and is available in several countries in the EU. It is not yet approved by the FDA and is not for sale in the US.
Established in 2015 and located in Schaffhausen, Switzerland, Physeon is a boutique medical device company created to guide the development and commercialization of new innovations in healthcare. The Company embraces research and science to bring about innovative ideas and medical products that can advance the health and well-being of patients and simplify processes for healthcare professionals.
For more information, visit www.physeon.com
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