Avisa Diagnostics Inc. (CSE:AVBT) (Avisa), a clinical-stage medical device company developing an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of bacterial load in post-COVID-19 long haulers and for ventilator-associated pneumonia, is pleased to announce that the Company has hired Barbara Bunger, PhD as Vice President, Clinical Development. In this newly created position, Dr. Bunger will be responsible for designing and executing the clinical development plan to achieve FDA premarket approval (PMA).
Barbara Bunger has over 30 years of industry experience and a highly successful track record in the development of clinical and regulatory strategy, global clinical research trial operations and overall evidence generation planning required to support reimbursement and market adoption.
Prior to joining Avisa, Dr. Bunger was Vice President of Clinical Research and Regulatory Strategy at Clinical Development and Regulatory Services, LTD., a company providing scientific, clinical research and regulatory services to the biopharmaceutical and medical device industry. She previously was World Wide Director, Clinical Research, Corporate Clinical Development at Beckton Dickinson, where she was responsible for executing trials around the globe for six business units. Prior to that, she led clinical research and regulatory functions while at several clinical and regulatory consulting firms as well as at medtech companies, including Medtronic Spine & Biologics, SI-Bone, Philips Healthcare's emerging business unit and Triangle Research and Regulatory Services. Dr. Bunger holds a PhD in health science – health administration & health economics, an MS in biology and a BS in nursing.
David S. Joseph, President and Chief Executive Officer of Avisa, said: "We are delighted to welcome Barbara to Avisa. She brings a vast wealth of experience in clinical development and regulatory affairs that will be invaluable as we ramp up our activities in these areas, including preparations for two pivotal trials for our Avisa BreathTest™, slated to start next year. Barbara has successfully designed and implemented clinical trials resulting in regulatory approvals and also understands what is needed post-approval to help gain market acceptance and reimbursement. I look forward to working with her as we enter this growth stage for the Company."
Barbara Bunger, PhD, Vice President, Clinical Development, added: "I am excited to join the Avisa team and to lead development of the Avisa BreathTest as it advances to the final stage of clinical testing. There is a major need for a point-of-care test that is fast, accurate and easy to administer for measuring bacterial load in suspected respiratory infections in order to guide and monitor patient treatment. I look forward to contributing to advancing this important diagnostic to help doctors and their patients."
About Avisa Diagnostics Inc.
Avisa (CSE-AVBT) is a clinical-stage medical device company developing the Avisa BreathTest™, a novel drug/device biomarker technology platform that enables the ultra-rapid detection of virulent bacterial pathogens, detecting and monitoring bacterial load after the patient inhales or ingests its proprietary drug substrates. The Company has established clinical proof-of-concept through trials in cystic fibrosis, tuberculosis and community-acquired pneumonia, which demonstrated positive safety and clinical efficacy results. Avisa is planning pivotal trials in Post-COVID-19 bronchiectasis and ventilator-associated pneumonia and plans to submit Investigational Device Exemption applications to the U.S. FDA for these trials next year. For further information, visit http://avisadx.com/ and follow us on LinkedIn and Twitter .
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