Biomoda Prepares for Phase III Clinical Trials

ALBUQUERQUE, N.M.--(Business Wire)--
Medical diagnostics company Biomoda, Inc. (OTCBB: BMOD) is taking preliminary
steps to launch multisite Phase III clinical trials of its in-vitro diagnostic
for early-stage lung cancer, trademarked under the name CyPath.

"As the Phase II trial wraps up, we are making sure that all the pieces are in
place to move immediately to a nationwide Phase III," Biomoda President John
Cousins said. "Most significantly, Dr. Thomas Bauer, the Principal Investigator
(PI) overseeing Phase II, has agreed to continue in the same role for our Phase
III trials. Dr. Bauer is widely recognized as one of the top lung cancer
researchers in the field, and we are privileged to be working with him."

Bauer, chief of thoracic surgery at the Helen F. Graham Cancer Center,
Christiana Care Health System, and head of Christiana`s participation in the
International Early Lung Cancer Action Program (I-ELCAP), is coordinating site
selection for the final phase of testing on the CyPath assay. Bauer`s work with
Biomoda follows the I-ELCAP Enrollment and Screening Protocol, and all sites
selected for the Phase III trials will be I-ELCAP approved.

Cousins said that Biomoda is finalizing the protocol for its Phase III trials
for submission to an Institutional Review Board (IRB) in early 2010. IRB review
protects research subjects by making sure the study protocol adheres to U.S.
Food and Drug Administration (FDA) and U.S. Department of Health and Human
Services regulations, that risks to participants are minimized and acceptable in
light of the possible benefits, that the informed consent document is accurate,
and that the research is conducted in an ethical manner.

Biomoda is seeking FDA approval of its cytology-based screening technology as a
Class III medical device under the Pre-Market Approval (PMA) process. "When
Phase II results are complete, probably by the end of January 2010, we will
report them immediately to the FDA along with the pre-IDE (Investigational
Device Exemption) filing," Cousins said. "Based on feedback from the FDA to
date, we anticipate no delays in moving forward with Phase III."

Biomoda (www.biomoda.com) is a cancer diagnostics company focused on the
development of accurate, inexpensive and noninvasive tests for the early
detection of cancer. The CyPath assay is based on a patented porphyrin-based
compound that binds to cancer cells and fluoresces red under ultraviolet light.

Biomoda, Inc.
John Cousins, 505-821-0875

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