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University of New Mexico Technology for Diagnosing Tularemia Infection Receives Issued Patent

Albuquerque, NM, December 9, 2015—A new technology for detecting pneumonic tularemia     infection developed at the University of New Mexico (UNM) has received an issued patent (Patent No. 9,074,237, issued on July 7, 2015). The inventors are Drs. Seong Won Choi, Graham Timmins and Terry Wu at UNM’s Health Sciences Center. Dr. Timmins is a faculty member in the Department of Pharmaceutical Sciences at UNM’s College of Pharmacy and Chief Science Advisor to Avisa Pharma Inc., located in Santa Fe, New Mexico. Avisa is commercializing his patent portfolio of rapid, point-of-care, diagnostic breath tests for this and other bacterial diseases including tuberculosis, cystic fibrosis, ventilator-assisted and healthcare-acquired pneumonias, and chronic obstructive pulmonary disease.

Tularemia is a disease in animals and humans caused by the highly infectious bacterium Francisella tularensis. People can become infected from the bites of infected ticks and deer flies, handling infected animals, eating and drinking contaminated food and water, or inhaling the airborne bacteria. No human-to-human transmission has been report. As with other lung infections, diagnosis is done through blood or sputum culture and can take more than 48 hours to confirm.

Pneumonic tularemia, caused by inhaling the bacteria, is a severe form of the disease. Its Type A strain, if left untreated, can be fatal for more than 50 percent of those infected. F. tularensis is so infectious that it has been identified by the Centers for Disease Control as a potential biological warfare agent. Early detection and treatment of the bacterium would lead to improved recovery rates and better outcomes for patients.

The breath test platform technology rapidly measures an increase in isotopically labeled carbon dioxide and ammonia gasses in exhaled breath that are the result of enzymatic activity between inhaled isotopically labeled citrulline and the bacterium. The exhaled gasses serve as biomarkers for the presence of the infection. The test can selectively detect and type (A and B strain) F. tularensis in those with the infection, and can determine whether prescribed antibiotic treatment is working. The detection method can also be used with urine, whole blood, plasma, and serum samples.

Breath tests are recognized as the next innovation in non-invasive medical testing and the breath tests being developed by Avisa have the potential to be an enabling technology for detection and therapeutic monitoring of respiratory infections and diseases. An enabling technology is an invention that can spur radical change and is often characterized by the number of related technologies and diverse applications it generates. Currently, there are no non-sputum, point-of-care technologies that can rapidly detect if a patient has a respiratory infection for follow-up with immediate treatment and monitoring of therapy.

Avisa CEO David Joseph, an experienced life science entrepreneur, co-founded Avisa with Dr. Timmins in 2010. The company is developing a portable detection device, a laser spectrometer called the AVISAR SPEC™, that will be used with the 10-minute breath test in rural health clinics and modern medical clinics and hospitals. “This newly issued patent that utilizes the citrulline biomarker when coupled with the AVISAR SPEC™ can provide government agencies with a point-of-care product for the early detection of a bioterror agent such as tularemia anywhere in the world.”

STC CEO Lisa Kuuttila is pleased to see the tularemia technology receive a patent. “Dr. Timmins has received patents for the other breath test technologies in his patent portfolio. Adding the tularemia patent is a valuable asset for Avisa and validates the strength of the science behind the innovation. It is exciting to see an inventor and the company commercializing his technologies collaborating so productively. Dr. Timmins is very passionate about improving the diagnosis and treatment of bacterial lung diseases that affect the young, the elderly, and poor populations around the world.”

See Avisa’s latest press release on its breath test results for active tuberculosis in a South African pilot study, reprinted below.

Avisa’s Biomarker Breath Test Detects Tuberculosis in South Africa Pilot Study
A ten minute breath test for rapid screening and detection of active tuberculosis.

Santa Fe, NM, December 18, 2015: Avisa Pharma Inc. announced today that it successfully detected
active TB in a pilot study in Durban, South Africa. The study had three cohorts, suspected TB subjects who
were HIV negative, suspected TB subjects who were HIV positive and controls. The AV-BreathTest™
detected TB in both HIV+ and HIV- cohorts confirmed by PCR and standard TB culture. The AV-BreathTest™
measures the whole lung, in-vivo, does not require sputum, and is point-of-care. The time from test initiation
to result is less than 10 minutes, and the breath test has the potential to monitor antibiotic therapy. There
are 9.5 million active TB cases worldwide of which 1 million are children who have difficulty producing
sputum requiring traditional test procedures that are more invasive.

According to David S. Joseph, Avisa’s President and CEO, “This pilot study allows us to plan our pivotal
clinical trials to be held in 2017 on multiple continents for regulatory approvals. Early screening triage and
detection by our breath test biomarker can substantially reduce the spread of this terrible disease, reduce
the need for time consuming, low-sensitivity smear microscopy and identify active TB in those patients with
symptoms that have difficulty in producing sputum for culture or PCR detection. Moreover, since the test is
less than 10 minutes, monitoring efficacy of antibiotic therapy is another potential benefit of our technology
given the major concern of multi-drug resistance.”

Avisa is a clinical stage company that is developing an exciting, next-generation technology that enables the rapid detection of a variety of respiratory pathogens within minutes after the patient inhales its proprietary drug substrate, AV-U13. The AV-BreathTest™ is a rapid 10-minute test that screens and detects respiratory infections with the speed and sensitivity that can also facilitate the monitoring of antibiotic therapy using a simple breath test. The AVISAR SPEC™ laser spectrometer, under development by Avisa, incorporates major design advancements that have resulted in a highly portable, battery-operated detection device that will have enormous utility in point-of-care settings—from rural health clinics in the developing world to modern medical clinics and hospitals. Visit the website at http://avisapharma.com/.

As the technology-transfer and economic-development organization for the University of New Mexico (UNM), STC.UNM (STC) protects and commercializes technologies developed at UNM by filing patents and copyrights and transferring them to the marketplace. We connect the business community (companies, entrepreneurs and investors) to these UNM technologies for licensing opportunities and the creation of start-up companies. STC’s vision is to play a vital role in New Mexico’s economic development and to be a leader in technology commercialization. Under the leadership of CEO Lisa Kuuttila, STC is substantially growing its program using the Rainforest model to develop an innovation economy in New Mexico. In 2013, STC was tasked by UNM with implementing its economic-development initiatives. For additional information, contact Jovan Heusser, STC Senior Innovation Manager & Innovation Team Lead, at (505) 272-7908 or jheusser@stc.unm.edu. To learn more about us, visit our website at http://www.stc.unm.edu.