Avisa Diagnostics Inc. (AVBT:CSE), a clinical-stage medical device company, aims to replace the standard of care for diagnosing and monitoring bacterial lung infections, ranging from tuberculosis and cystic fibrosis to pneumonia and the bronchiectasis now common among long Covid-19 patients.
Likening its Avisa BreathTestTM to a “thermometer for the lungs, the only test that detects live organisms,” the company’s proprietary platform uses a breath biomarker to detect and monitor pulmonary infections with a noninvasive test that delivers results in 10 minutes.
“It can take up to three days to get results using a sputum test, which is the current standard of care,” said David S. Joseph, cofounder and CEO of Avisa. “During that three days, physicians often prescribe broad-spectrum antibiotics, out of an abundance of caution, for patients suspected with community acquired pneumonia, although studies show those drugs are not needed in 85% of cases. Our test has the potential to mitigate the overuse of those powerful drugs, which comes with both a financial and a societal cost.”
Avisa has established the safety and efficacy of its device in three clinical proof-of-concept trials. The first demonstrated the device’s ability to detect dangerous lung bacteria in cystic fibrosis patients. The second confirmed its speed and safety in diagnosing tuberculosis. The third proved its value in detecting community-acquired pneumonia in an emergency-room setting.
Those studies were precursors for the company’s upcoming application to the U.S. FDA for a pivotal trial in detecting post-Covid-19 bronchiectasis and ventilator-assisted pneumonia. The company also will apply for an Investigational Device Exemption in early 2022.
The Avisa BreathTest assesses a patients’ lungs for the presence of urease-positive pathogens, which are expressed by the most virulent bacterial lung infections. The patient inhales a diagnostic drug (13C-urea AV-U13) for several minutes. If pathogens are present, the AV-U13 is converted into labeled CO2. A spectrometer analyzes the exhalation for the presence of the urease pathogen.
In addition to the speed of diagnosis, the Avisa technology is simple to use and portable. The device and spectrometer can be used in clinics, emergency rooms, in the ICU/CCu, urgent care centers, and skilled nursing facilities.
Joseph also foresees the opportunity to address the “potential epidemic within a pandemic.” This includes the 25% to 30% of post-acute Covid-19 survivors at increased risk of bacterial or fungal infection and the increasing rates of ventilator-associated pneumonia (VAP). “Even before Covid-19, one-quarter of the 1.7 million ICU patients on ventilators in the U.S. developed VAP annually, with half of them experiencing extended hospital stays ” Joseph said.
“We believe this represents a $3.3 billion market opportunity in the U.S. alone, plus opportunity in other respiratory diseases, such as COPD.” In the case of VAP, the Avisa technology offers the advantage of being able to capture and analyze a patient’s breath without interrupting the ventilation cycle. This makes it easier and safer to monitor a patient’s bacteria load and assess whether the therapy is working.
The pharma-economic benefits of the Avisa BreathTest include eliminating or shortening hospital stays and reducing use of broad-spectrum antibiotics. The latter not only delivers quantifiable financial benefits to providers and payors, it also may slow down the development of antibiotic-resistant strains of bacteria. The company plans to measure these pharma-economic benefits alongside safety and efficacy in its pivotal study planned for 2022.
Another catalyst for Avisa is its recent $40-million share subscription facility from GEM (Global Emerging Markets). The money, linked to trading volume in Avisa shares, will be available to Avisa for drawdown over the next three years. Joseph noted that this will give the company stability as it expands operations and moves forward with FDA reviews and approvals. Avisa’s listing on an exchange such as the Canadian Securities Exchange in May 2021 was part of the GEM agreement requirement.
Avisa’s platform was developed by researchers at the University of New Mexico. The company’s management team offers decades of experience in the business of medical devices, including design, clinical development, and the technology of medical devices.
Senior leadership includes several serial entrepreneurs who have led and successfully exited several start-ups. They are supported by a Science Advisory Board of pulmonology and infectious disease experts. Avisa's patent portfolio includes the Avisa BreathTest and AVISAR spectrometer, as well as the 13C-urease and other biomarkers used in their drug/device combination products.
As of August 18, 2021, the company’s market capitalization was $CA11.87 million, and the share price stood at US$0.16.
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