Developing A Thermometer for the Lungs
This Avisa Diagnostics profile is part of a paid investor education campaign.*
The global healthcare industry continues to experience rapid growth. With an average annual growth rate of 7.3 percent since 2014, healthcare spending is expected to exceed $10 trillion by 2022. Healthcare spending in the US accounted for 17.7 percent of the entire GDP in 2019, with that figure expected to rise to nearly 20percent by 2028.
Segmentation is an important consideration when it comes to investing in healthcare companies. Respiratory diagnostics is one segment within the healthcare industry to keep on the watchlist, especially in the wake of the COVID-19 pandemic. Before COVID-19, a child dies of pneumonia every 39 seconds and the United Nations Children’s Fund (UNICEF) projected around 18 million more health workers are needed by 2030. Amid the pandemic, pneumonia and other respiratory diseases become an even larger health concern. The respiratory disease diagnostics market alone is expected to be worth $6.7 billion by 2025.
Avisa Diagnostics (CSE:AVBT) is an innovative healthcare company specializing in respiratory disease diagnostics through its rapid, point-of-care Avisa BreathTest solution™. This simple, ultra-rapid breath test was designed to save time, money and lives, and has been dubbed a “thermometer for the lungs.”
The compelling new technology measures bacterial load in the lungs enabling better diagnoses, monitor therapy, and helping to mitigate the overuse of broad-spectrum antibiotics.
UN reports show that bacterial resistance is responsible for over 700,000 deaths worldwide and millions in healthcare costs. More targeted technologies, like the Avisa breath test, allow for specific diagnosis and prevent the unnecessary use of broad-spectrum antibiotics.
The technology also aids doctors in monitoring patients on ventilators. An estimated 1.7 million people are on ventilators in the US alone, and nearly half of all individuals on a ventilator get ventilator-associated pneumonia which can potentially be fatal. The Avisa breath test allows for unprecedented monitoring and has the potential to save thousands of lives.
In terms of early detection and the ability to allow physicians to rule in or out specific diagnoses, there is no comparable technology on the market today. Avisa BreathTest™ has the ability to quickly detect urease pathogens anywhere in the lung within 10 minutes, with AVISAR™, a point-of-care medical device that provides analysis in seconds.
Avisa is currently in the process of putting together their investigational new device exemption for the FDA. Pending approval, they will then be able to move into commercialization.
Any new technology is only as profitable as the team managing its release, and Avisa has put together a team with proven experience in key areas of diagnostics, clinical regulation and strategy, medical device design, as well as medical technology. This positions them well in the testing and commercialization of new medical technology.
As the Avisa breath test approaches clinical trials, it will be essential to have leaders experienced in developing strategic research trial operations and gathering the necessary evidence to take the device to market.
CEO David Joseph has over 40 years of experience in the commercialization of medtech and pharmaceuticals, co-founding four companies in the industry, which were successfully exited through IPOs and M&As.
VP of Clinical Development Barbara Bunger, Ph.D. has over 30 years of experience navigating clinical trials. He currently serves as the vice president at Clinical Development and Regulatory Services, LTD, a company providing scientific, clinical research and regulatory services to the biopharmaceutical and medical device industry.
Avisa Diagnostics’ Company Highlights
- Avisa Diagnostics 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 drug substrates via proprietary delivery systems.
- The respiratory disease diagnostics market alone is expected to be worth $6.7 billion by 2025, and the Avisa BreathTest™ is a unique technology addressing a prevalent issue within this growing market.
- 1.7 million people are on ventilators in the US alone, and nearly half of all individuals on a ventilator get ventilator-associated pneumonia, a potentially fatal condition. The Avisa breath test allows for unprecedented monitoring and has the potential to save thousands of lives.
- Avisa is currently in the process of putting together their investigational new device exemption for the FDA. Pending approval, they will then be able to move into commercialization.
- Avisa’s management team has decades of combined experience in the development and commercialization of medical technology, diagnostics and clinical regulation and strategy. Experience in these key industries put them in a strong position to move the Avisa BreathTest™ through clinical trials and into commercialization.
Avisa Diagnostics’ Breakthrough Technology
The Avisa BreathTest™ is a novel drug/device biomarker technology platform that enables the ultra-rapid detection of virulent bacterial pathogens. It works by detecting and monitoring bacterial load after the patient inhales or ingests its drug substrates via proprietary delivery systems.
Avisa has established clinical proof-of-concept through trials in cystic fibrosis, tuberculosis and community-acquired pneumonia, which demonstrated positive safety and clinical efficacy results.
Pivotal trials are also planned 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.
The breath test is a novel use of existing technology with a clinical proof-of-concept, which mitigates the risk when moving through clinical trials.
Avisa has sufficient funding to reach key value inflection points through product launch, as well as a smart business model developed by experienced leaders which will enable accelerated market entry.
Avisa Diagnostics’ Management Team
David S. Joseph — President & CEO
David S. Joseph has over 40 years of experience commercializing medtech/pharma, including co-founding four companies with successful exits either through IPOs or M&As.
Joseph was the Co‐founder, President, CEO and Chairman of SITE Microsurgical Systems, which was acquired by Johnson & Johnson Corporation (NYSE:JNJ) in 1983. He was also co-founder, President, CEO and Chairman of Surgical Laser Technologies, which reached IPO in 1989 and was acquired by Photo Medix in 1992.
Joseph then moved on to Orthovita, an orthobiologics company which reached IPO in 2006 and was acquired by Stryker (NYSE:SYK) in 2012 for US $350 million.
Prior to his entrepreneurial career, Joseph accrued over 15 years of executive healthcare management experience.
David Karshmer — SVP, Product Development
David Karshmer has over 25 years of experience in medical device design, providing a solid foundation for heading up the design of Avisa’s new breath test device.
Karshmer is also a successful serial entrepreneur, Avisa being his 6th start-up. He also founded IDEO Healthcare practice.
Matt Kuller — CFO
Matt Kuller is an experienced chief financial officer with over 15 years of experience in investment and financial management.
Kuller has been the CFO at multiple venture-backed startups, so he understands the unique challenges of determining financial strategy for a startup company.
He also has experience in the venture capital industry himself, as well as investment banking, rounding out his comprehensive understanding of business finance.
Barbara Bunger, Ph.D. — VP, Clinical Development
Barbara Bunger has over 30 years of industry experience, boasting a highly successful track record in the development of clinical and regulatory strategy, global clinical research trial operations and the overall evidence generation planning required to support reimbursement and market adoption.
She is the Vice President of Clinical Development and Regulatory Services at Clinical Development and Regulatory Services, LTD., a company providing scientific, clinical research and regulatory services to the biopharmaceutical and medical device industry. She is also Worldwide Director for the Clinical Research and Corporate Clinical Development at Becton Dickinson.
Bunger has led clinical research and regulatory functions 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.
Graham Timmins, Ph.D. — Chief Science Advisor
Graham Timmins, associate professor of medical chemistry at the University of New Mexico, is the chief scientific advisor on the Avisa BreathTest™ project.
Timmins is the author or co-author of over 50 scientific publications during the course of his academic career, and has been awarded multiple federal grants.
He is also the co-inventor of the Company’s patent portfolio.
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The information contained here is for information purposes only and is not to be construed as an offer or solicitation for the sale or purchase of securities. Readers should conduct their own research for all information publicly available concerning the company. Prior to making any investment decision, it is recommended that readers consult directly with Avisa Diagnostics and seek advice from a qualified investment advisor.