BMOD @.17 - DD - Top 30 Reasons
1) Biomoda (OTCBB: BMOD), whose early cancer detection assay came from a spin-off of the Los Alamos National Labs, is on the verge of completing its Phase II studies for lung cancer patients.
2) Inexpensive $100 per test Non-Invasive Front End Cancer Screening Tool.
3)Patented Technology
4)Recent private placement up to $2M validates technology
5)Phase I has near 100% accuracy
6)State Governments funding clinical trials
7)Only 14% of Lung Cancer Patients Live 5 years Due to Late Diagnosis – Biomoda’s CyPath® Could Save Lives ®
8)Successful results of the Phase II pilot trial pave the way for the initiation of a pivotal Phase III by year-end.
9)There is currently no approved routine screening for lung cancer
10)Phase II results may be sufficient to receive a CE Mark in Europe by year-end with a European launch early next year.
11)Pending positive results from the pilot study, Biomoda plans to file an Investigational Device Exemption (IDE) with the FDA to review the pivotal Phase III study protocol.
12)Study sites, Principal investigator and a CRO have been identified for this proposed larger trial.
13)While currently TCPP and the CyPath® platform is being developed for the detection of Lung Cancer, the system of malignancy detection can easily be adapted to other types of cancers
14) The CyPath® platform can easily be adapted as a diagnostic tool for the detection of bladder cancer by testing the endothelial cells found in urine with TCPP in the same fashion as the lung cells are tested in from the sputum in lung cancer.
15)By changing the sample collection the technology can be applied to many different types of cancer.
16) Upon completion they plan to submit Phase II data to European regulators in hopes of being granted a CE Mark.
17)The Europe market potential for the assay is more than twice as large as it is in North America.
18)Plans to test and commercialize an entire portfolio of early cancer diagnostics tools, based on the same technology, for deadly breast, oral, prostate, bladder, colorectal, and cervical cancers.
19) When Phase II clinical trial results are complete, the Company intends to file a report with the FDA informing the agency of study findings and submit a pre-IDE (Investigational Device Exemption) filing.
20)(MOU) to establish a CLIA-certified Biomoda clinical laboratory in Ohio to support ongoing research and development on Biomoda's porphyrin-based assay for the detection of early-stage cancer.
21)Obio will help Biomoda launch a veterans screening program in Ohio, similar to ones completed in New Mexico and under consideration by the Nebraska Legislature.
22)Based on feedback from the FDA to date, we anticipate no delays in moving forward with Phase III.
23)Even in the earliest studies conducted, TCPP consistently identified pre-cancerous and cancer cells in patient samples.
24)In 1998, LungCheck conducted a study for Biomoda. The sensitivity, a measurement of accuracy, for this study was calculated at 96.2 percent.
25)Based on BMOD's reimbursement code study, there are reimbursement codes in place. So, Insurance companies will pay part an actual out of pocket costs could be lowered.
26)Leukemia could potentially be diagnosed with TCPP labeling solution, CyPath, using blood or bone marrow. There is also the potential to use CyPath for histological examination of biopsy samples for all cancers. There are three commonly used techniques for preparing slides for cytology examination. Biomoda has qualified CyPath with each of these techniques.
27) There is no screening protocol currently in place. Nothing in the market that does what BMOD's test is being designed to do, especially at a price point as low as what they expect their test to cost($100).
28) We have 90 million people in the United States and 215 million in Europe, that’s approximately 300 million people. If they can penetrate these markets to even 1%... 1% of which is 3 million. For BMOD to do 3 million assays, at $100 a piece, that’s $300 million in revenue.
29) Given the attractive cost/benefit profile of CyPath®, it is not unrealistic to plan it will become as accepted and prevalently used as PSA, colonoscopy, mammography and PAP tests are today.
30)Every FDA milestone BMOD reaches, the stock price has a big run higher.
