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Biomoda, Inc. is a developmental stage company engaged in
the business of developing biopharmaceutical technology to
diagnose and treat human diseases. The Company currently
licenses two patents in the U.S. On November 10, 1992,
the Company licensed a patent for the detection of cancers
of the lung. A second patent, dealing with treatment
of cancers of the lung, was licensed on February 21, 1995.
A third patent, which deals with detecting pre-cancerous
conditions in human tissue, is currently pending.
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We also
currently have patents in these countries: Australia, Brazil,
Canada, Japan, Korea and Russia, and through the European Patent
Office, with the following countries: Belgium, Switzerland,
Germany, Denmark, Spain, France, Great Britain, Italy,
Netherlands. For the expanded development phase no
manufacturing facilities will be needed. For the
production phase Biomoda plans to initially contract out
production at comparable, competitive costs.
Biomoda’s
business opportunities are in developing products for the early
detection and targeted treatment of cancers. The initial
products relate to lung cancer and are based on commercializing
our core patent protected technology exploiting the physical and
chemical properties of a compound called Tetrakis Carboxy Phenyl
Porphine (“TCPP”). TCPP is a porphyrin with unique properties.
Porphyrins are compounds related to blood (such as heme in
hemoglobin) and having biological activity. TCPP has an
affinity to bind molecularly with cancer cells. This allows the
cancer cells to be identified because TCPP will fluoresce or
glow under certain light conditions. The next stage toward
product development is the refinement of our protocol and
process and proof of concept in clinical trials. This will
include:
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The
development of staining protocols: staining protocols are the
standardized operating procedures used to stain samples.
These include procedures for dissolving TCPP in different
solvents, attaching cells to microscope slides or suspending
them in solutions, and then rinsing out the stain and
preparing the sample for evaluation.
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The
creation of standard reference materials: standard reference
materials are cell samples that have a consistent level of
staining with TCPP. These bench-marking sets will be added to
the patient’s samples as an internal control to insure the
valid functioning of the staining procedure.
Clinical
trials will apply these techniques to registry sputum samples,
which are samples of tissues from cancer patients, along with
their relevant histories. Some tissue registries follow
patients who are at high risk of cancer, but do not yet have the
disease. These registry samples are the most valuable for
proving efficacy of a new screening test. The results of the
clinical trials will provide the proof of performance data
required to move into product commercialization and joint
venture and strategic alliance opportunities.
Markets
Our
business plan is to focus on developing our proprietary,
patented technology for the early detection of cancer cells into
products that are tailored for government, regulatory, medical
and public acceptance on a worldwide basis. The market for our
early detection of lung cancer products can be considered, in a
general sense, the entire world population since this is a
preliminary disease screening tool and the test is administered
outside the body. Everyone would benefit from this screening
test. More specifically, we are targeting high-risk and
at-risk populations in countries with relatively developed
medical care infrastructure systems. In addition to our
diagnostic product concepts, we intend to develop and market
therapeutic and cancer treatment products.
The market for these products are people that
have been diagnosed with lung cancer and are being treated.
We plan to
contract with manufacturing facilities to produce commercial
quantities of our products. The first products to be developed
will be used for early diagnosis of cancer, followed by products
that will aid in the imaging and treatment of cancer. The
Company will develop markets in response to the Company’s
products by focusing on hospitals, laboratories, and other
health care providers who typically will buy products based on
our technology for providing care to their patients. We also
plan to develop an international presence through licensing
agreements and possibly joint ventures with international
partners. |
