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Diagnostics Firm Readies for Pivotal FDA Study of Device That Detects Bacterial Lung Infections

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Promising early results and a new line of equity support Avisa Diagnostic’s drive for IDE approval of its rapid-response breath test for pneumonia, TB, CF, and other lung ailments.

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.



1) Diane Fraser compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor/employee. He/she or members of his/her household own securities of the following companies mentioned in the article: None. He/she or members of his/her household are paid by the following companies mentioned in this article: None. His/her company has a financial relationship with the following companies referred to in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees. As of the date of this article, an affiliate of Streetwise Reports has a consulting relationship with Avisa Diagnostics Inc. Please click here for more information. An affiliate of Streetwise Reports is conducting a digital media marketing campaign for this article on behalf of Avisa Diagnostics Inc. Please click here for more information. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

3) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.

4) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Avisa Diagnostics Inc., a company mentioned in this article.

5) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.



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