Executive Summary
Avisa is a clinical stage company that is developing an exciting, next-generationtechnology that
enables the rapid detection of tuberculosis (TB) using a simple breath test.
Global Unmet Need for Diagnosing Pulmonary Infections
There is enormous unmet need worldwide for better technologies for diagnosing serious pulmonary infections.
In the developing world, TB remains by far the top infectious diseases problem, with millions of individuals
infected every year leading to countless deaths around the globe. According to the World Health Organization
(WHO), about one-third of the world’s population has latent tuberculosis. In view of the serious threat posed by
HIV and TB co-infection, public health agencies around the globe have recommended that all HIV positive
patients receive routine TB testing. In the US and Europe, numerous patients suffering from a variety of
pulmonary diseases are at high risks for contracting life-threatening bacterial infections. The universal
challenge that limits the successful treatment of these diverse patient groups is the lack of non-sputum pointof-care technologies that can rapidly detect when a patient has a respiratory infection and the ability to monitor
therapy use. Diagnosis of respiratory TB infection using state-of-the-art technologies in a modern hospital
takes hours to days and may require patient isolation.Such capabilities are lacking entirely in many other areas
around the globe, leaving physicians with no options other than smear microscopy, remote molecular
diagnostics or symptom-based empirical treatment that is often inaccurate.
Avisa has just initiated the first clinical trials of its AVISAR™ system thatcan
detect a variety of respiratory pathogens withinminutes after the patient inhales
itsproprietary drug substrate,AV-U13. The AV-BreathTest™is a rapid 10minutetest that screens and detects respiratory infections with the speed and
sensitivity that can alsofacilitatethe monitoring of antibiotic therapy. 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.
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AVISAR SPEC 8”x 11”x 3.5” laser spectrometer
shown with nebulizer attachment
AVISARTM System
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TheAVISAR System incorporates a platform technology, stable non radioactive isotopic ratio of C and C,
representing a quantum leap in extending the utility of this proven approach for screening and early detecting
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of respiratory infections and other metabolic diseases. The AV-BreathTest is based on the presence of the
enzyme, urease, which is found in many bacterial urease based species including lung infections such as
Mycobacterium tuberculosis. The primary differentiator of this system is its inherent ability to quickly detect live
organisms anywhere in the lung. It is thus far superior to conventional culture-based detection techniques that
only sample limited regions of the respiratory tract. Live urease-containing bacteria can readily be detected
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using nebulized C-urea(AV-U13) that is converted to labeled carbon dioxide then exhaled and captured for
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immediate analysis by the AVISAR SPEC .
This proprietary point-of-care device replaces much larger laboratory based instrumentation typically used for
this purpose.This system represents a major step forward in terms of speed, sensitivity and portability—making
it suitable for use even in the most primitive point-of-care settings.Urea-based detection methods have been
previously approved, thus validating this useful approach for diagnostic purposes.Avisa has robust patent
protection for the use of its technology.
© AvisaPharma Inc. | 1660A Old Pecos Trail Suite A, Santa Fe, NM 87505| 490 Lapp Road, Malvern, PA 19355
Contact: David S. Joseph, Co-Founder, President & CEO | Work: (505) 820-1400 | Cell: (484) 459-5076
Fax: (505) 226-1500| Email: dsj@avisapharma.com | Website: www.avisapharma.com
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Addressing the TB Challenge with the AVISAR TMSystem
Seventy seven million TB smear microscopy tests using sputum samples are run every year worldwide. These
initial TB screens require days to run and require a confirmatory test if TB infection is suspected. In addition,
several high-risk patient groups, including children and HIV-infected patients are typically unable to generate
adequate sputum samples for testing. The result is that many cases of this deadly communicable disease go
undetected and untreated, with grave public health consequences. Challenges remain for those TB patients
that do receive treatment since there is currently no easy way of confirming the efficacy of drug regimens that
may extend for 2 years.
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The AVISAR System provides a solution to all of these problems:
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It allows immediate triaging of suspected TB infections.
Health care providers know within minutes whether a respiratory infection is present and whether to
direct the patient for confirmatory testing.
In addition, since no sputum sample is required, all patient groups can be quickly tested reliably and
efficiently for immediate follow up.
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Because of its portability, the AVISAR System can be efficiently deployed in even the most basic of
health care settings where it is desperately needed.
Trial Underway
Avisa is currently conducting a pilot TB clinical trial in South Africa in cohorts of TB HIV-positive and TB HIVnegative patients and control subjects.Based on compelling early results, a pivotal 6 to 9 month TB clinical trial
involving 700 patients is planned for 2017 at 15 trial sites across the US, EU and high TB burden countries.
Reimbursement – CPT Code for Breath Tests exists.
Avisa Business Strategy
Avisa is aggressively pursuing TB as its initial indication. This represents the fastest path forward to approval.
Effective penetration of the smear test market and follow-on approvals of the high-margin AV-BreathTest kit for
additional indications with has significant potential to generate a recurring per test revenue and a rapid path to
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profitability. Approval of other indications will drive new markets for the AVISAR System in the US and EU in
hospitals, ED departments, CCU units, skilled nursing units, urgent care centers and retail clinics.
Future Indications
Many life-threatening bacterial infections can accompany chronic pulmonary diseases.The AVISARPlatform
can be adapted for detecting many types of respiratory infections.Multiple indications will follow the first PMA
TB approval of the AVISA Platform:Healthcare Acquired Infections, Infectious Ventilator Associated
Complications,Cystic Fibrosis, and COPD.
Avisa is focusing initially on TB detection, where a rapid, portable point-of-care breath test would have a major
impact on addressing this highly communicable disease around the globe. Approval for use of the
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AVISAR System for TB will be followed by trials supporting its use for other respiratory indications and
market expansion. Positive results have already been seen using Avisa’s proprietary labeled urea drug
substrate reagent in a small cohort of CF patients known to be infected with Pseudomonas aeruginosa.
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Avisa is well positioned to advance the AVISAR System. Its management teamhas a combined 100 years of
direct experience in medical devices and pharmaceuticals,with extensive entrepreneurial experience and
proven track record of success.Management is supported by a strong Scientific Advisory Boardcomprised of
KOLs from respiratory, critical care and infectious disease specialties.
© AvisaPharma Inc. | 1660A Old Pecos Trail Suite A, Santa Fe, NM 87505| 490 Lapp Road, Malvern, PA 19355
Contact: David S. Joseph, Co-Founder, President & CEO | Work: (505) 820-1400 | Cell: (484) 459-5076
Fax: (505) 226-1500| Email: dsj@avisapharma.com | Website: www.avisapharma.com
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