David S. Joseph, President and Chief Executive Officer of Avisa, said: "The CSE listing is a major milestone for our company that enables us to utilize the equity facility that we have in place. This funding is expected to be sufficient for us to complete the development and FDA regulatory approval process for the Avisa BreathTest in our two lead indications - in Post-COVID-19 long haulers and for ventilator-associated pneumonia – as well as to launch the ABT in the U.S."
Graham Timmins, Ph.D., Chief Science Advisor of Avisa, added: "There is an urgent need to detect severe respiratory infections quickly to guide treatment. The ABT measures bacterial load in suspected respiratory infections and may represent an effective alternative to sputum culture-based diagnostics. Importantly, the ABT can then monitor the efficacy of ongoing treatments and mitigate the over use of antibiotics and the growing rise of antimicrobial resistance."
Avisa provides an update on ABT development plans
Avisa is currently developing ABT for detection and patient monitoring of Post-COVID-19 bronchiectasis and VAP. The ABT may overcome the limitations of current tests in terms of speed, accuracy and ease of administration.
Bronchiectasis in Post-COVID-19 Long Haulers : Bronchiectasis is a condition whereby the bronchial tubes are permanently damaged, widened and thickened, allowing bacteria and mucus build up in the lungs. This results in frequent infections and airway blockage. Metadata studies cite 52% of Post-COVID-19 patients are diagnosed with "traction" bronchiectasis 1 . The ABT has a unique ability to address this emerging problem, prevent exacerbations and positively impact the healthcare system with better health outcomes. Leading pulmonologists are setting up Post-COVID-19 follow-up clinics in major medical centers, similar to exisiting clinics for patients with chronic obstructive pulmonary disorder (COPD). Avisa is planning to submit an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) in the first quarter of 2022 to initiate a pivotal trial in this indication. The trial, if successful, will serve as the basis for submitting a Premarket Approval Application (PMA).
Ventilator Associated Pneumonia (VAP): In the U.S. alone, there are approximately 400,000 cases of VAP annually 2 . Approximately 25% of the 1.7 million intensive care unit (ICU) patients who are on ventilators each year develop VAP. VAP results in extended hospital stays and high mortality; 30-50% of VAP patients die. The ABT provides a quantitative measurement of bacterial load to detect colonization and guide treatment before virulent VAP establishes itself. The ABT can also monitor VAP antibiotic therapy. Avisa plans to submit a supplemental IDE application to the FDA to initiate a pivotal trial in VAP in the third quarter of 2022.
About the Avisa BreathTest™
The Avisa BreathTest™ (ABT) is a biomarker, quantitative, point-of-care test for rapidly detecting pulmonary infections due to certain virulent pathogens without the need to collect and culture sputum or other biological samples. The ABT is based on the presence of the urease enzyme found in certain bacterial species that cause pneumonia, such as S. aureus , P. aeruginosa , Klebsiella and H. influenzae . Live urease-containing bacteria can be detected using inhaled 13 C-urea, which is converted by these bacteria to labeled carbon dioxide ( 13 CO 2 ) and ammonia. The non-radioactive, isotopic ratio of 13 CO 2 / 12 CO 2 in the exhaled breath of the patient is measured by the Avisa spectrometer. The spectrometer, together with the simple inhaled drug/device combination, measures the whole lung, live organisms in just 10 minutes, akin to a thermometer.
Additional 13 C-urea indications for potential future development include community- and hospital-acquired pneumonia as well as COPD.
About Avisa Diagnostics Inc.
Avisa 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 (505) 820 1400
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.
Neither the CSE nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.
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1 American Journal of Roentgenology (May 2020) " Relation Between Chest CT Findings and Clinical Conditions of Coronavirus Disease (COVID-19) Pneumonia: A Multicenter Study ", Zhao, W. et al.
2 Critical Care (March 2014) " Ventilator-associated pneumonia in the ICU ", Kalanuria A, A., Zai W. & Mirski M.
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