Avisa Reports on Progress with Biomarker AV BreathTest Platform

  • Ten-minute, point-of-care breath test rapidly detects virulent bacterial infections to mitigate overuse of antibiotics and save hospital costs
  • Proof-of-concept trial in Emergency Department pneumonia expected to be completed by year end; will pave the way for pivotal trial
  • New patents granted around portable laptop-size device to administer breath test and for new indication – detection of life-threatening infection, Clostridium difficile

Santa Fe, NM, September 18, 2018: Avisa Pharma Inc. (“Avisa”) today provided an update on recent progress with its novel rapid, point-of-care breath test – AV BreathTest. The AV BreathTest is a ten-minute test that can detect and monitor therapy for a wide range of severe respiratory infections with a high degree of sensitivity. By enabling this quick detection, the AV BreathTest guides appropriate use and selection of antibiotics (“antibiotic stewardship”) to combat their widespread overuse that has fueled the rise of antibiotic-resistant infections by differentiating virulent bacterial pathogens from viral infections and streptococcus pneumoniae in 10 minutes.

Advancing in clinical development

The AV BreathTest is currently being studied for the detection of pneumonia in the Emergency Department (PED) in an investigator-sponsored study at the University of New Mexico Medical Center and Henry Ford Hospital. Topline data from the ongoing trial in PED detection are expected to be available by year end. Assuming this trial is successful, Avisa plans to initiate a Pre-Submission meeting with the U.S. Food and Drug Administration (FDA) in early 2019 to discuss the design of a pivotal trial in the PED detection, with plans to then initiate this study in 2020.

New patents granted

Patents have been granted for the AVISAR laser spectrometer in the U.S., Europe, Japan and China. The AVISAR is a portable, laptop-size medical device used to analyze the results of the AV BreathTest. The AVISAR has a novel wavelength pair that can analyze exhaled breath for labeled carbon dioxide to indicate infection, quickly giving the results of the AV BreathTest in a point-of-care setting.

The Company also was recently issued a U.S. patent through a license with the University of New Mexico covering detection of Clostridium difficile (“C. diff”) infections as part of the AV BreathTest platform. Avisa plans to develop a new diagnostic breath test for C. diff to both predict relapse and determine antibiotic resistance/sensitivity by monitoring treatment response.

Next steps

Given Avisa’s strong recent progress, the Company is commencing a Series B financing round to advance the clinical development of the AV BreathTest in PED through a filing for regulatory approval, as well as explore new indications.

In addition to ongoing work in PED, Avisa plans to evaluate the AV BreathTest in ventilator-acquired pneumonia, as well as chronic obstructive pulmonary disease (COPD) exacerbations, cystic fibrosis exacerbations and C. diff infections, all potentially life-threatening issues where rapid detection and monitoring therapy could enable more effective treatment, faster – saving costs and saving lives.

“We are excited about the progress we are making with the AV BreathTest and look forward to reporting the results from the ongoing clinical trial in Emergency Department pneumonia,” said David S. Joseph, Avisa President and CEO. “The new patents we announced today significantly strengthen our IP around this novel point-of-care test. The portable AVISAR is an integral part of our technology platform that will enable its effective use in critical care and acute care hospital settings, emergency departments, urgent care clinics and home care settings.”

ABOUT AVISA AND THE AV BREATHTEST PLATFORM

Avisa is a clinical stage company that is developing a next-generation technology that enables the rapid detection of a variety of respiratory pathogens within minutes after the patient inhales or ingests its proprietary drug substrate, AV-U13. The AV BreathTest™ is a rapid 10-minute test that detects respiratory infections with the speed and sensitivity that can also facilitate the monitoring of antibiotic therapy. The lead indication for AV BreathTest is detection of pneumonia in the Emergency Department (PED), for which an investigator-sponsored study is ongoing with topline data expected by year end 2018. Additional potential indications include ventilator-acquired pneumonia, COPD, cystic fibrosis and Clostridium difficile. The AVISAR laser spectrometer incorporates major design advancements that have resulted in a highly portable, laptop-size detection device that should have enormous utility in point-of-care settings—from emergency departments, hospitals, ICU/CCU units, urgent care centers, long-term care facilities and home care settings.

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