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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 https://avisadx.com/ and follow us on LinkedIn and Twitter .
Contact
Avisa Diagnostics Inc.
David S. Joseph
President and Chief Executive Officer
Phone: +1 610 947 0360
E-mail: info@avisadx.com
www.avisadx.com
Investors and Media Contacts
MC Services AG
Laurie Doyle, Raimund Gabriel
E-mail: avisa@mc-services.eu
Europe: +49 89-210 2280
U.S.: +1-339-832-0752
Forward-looking Statements
This press release contains statements which constitute "forward-looking information" within the meaning of applicable securities laws, including statements regarding the plans, intentions, beliefs and current expectations of the Company with respect to future business activities and operating performance. Forward-looking information is often identified by the words "may", "would", "could", "should", "will", "intend", "plan", "anticipate", "believe", "estimate", "expect" or similar expressions and includes, but is not limited to, statements about the business plans and expectations of the Company and expectations for other economic, business, and/or competitive factors. Investors are cautioned that forward- looking information is not based on historical facts but instead reflects the Company's management's expectations, estimates or projections concerning future results or events based on the opinions, assumptions and estimates of management considered reasonable at the date the statements are made. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements of the Resulting Issuer. Among the key factors that could cause actual results to differ materially from those projected in the forward-looking information are the following: (i) changes in general economic, business and political conditions, including changes in the financial markets, changes in applicable laws and regulations both locally and in foreign jurisdictions; (ii) compliance with extensive government regulation and the costs associated with compliance; (iii) the risks and uncertainties associated with foreign markets; and (iv) risks associated with the COVID-19 pandemic. This forward-looking information may be affected by risks and uncertainties in the business of the Resulting Issuer and market conditions. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated or expected. Although the Company has attempted to identify important risks, uncertainties and factors which could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended and such changes could be material. The Company does not intend, nor assume any obligation, to update this forward-looking information except as otherwise required by applicable law.
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