BMOD: All the pieces are now in place!
We are currently concluding our pilot clinical study.
Biomoda has closed patient enrollment and sample collection for the pilot study.
The study team is completing data analysis and preparing its report for release.
Results will be published at the end of the study period after data has been analyzed.
The Company anticipates results sufficient to provide the foundation for a pivotal clinical study leading to submission to the FDA for approval of the commercial sale of Biomoda’s technology.
Dr. Thomas L. Bauer, Chief Thoracic Surgeon and cancer researcher with the Christiana Care Health System in Delaware, is the national Principal Investigator (PI) overseeing the pilot clinical study currently underway. Dr. Bauer has led several lung and esophageal cancer studies.
We are also developing strategies to enter the European market, including filing for approval of a CE mark.
Biomoda has taken preliminary steps necessary to conduct the multi-site pivotal clinical study of our diagnostic for early-stage lung cancer, trademarked under the name CyPath®.
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 pilot 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.
==================================================================
US PATENTS AND TRADEMARKS
In January 2005, the U.S. Patent Office awarded a Patent to Biomoda entitled "Compositions and Methods for Detecting Precancerous Conditions in Cells and Tissue Samples using 5, 10, 15, 20 Tetrakis (Carboxyphenyl) Porphine." This Patent represented a significant addition to our patent portfolio and expanded our intellectual property to include cancer screening as a compliment to the existing technology. We filed for a continuation of this Patent based on research currently underway by researchers at Biomoda.
In April 2008, the U.S. Patent Office awarded a Divisional Patent to Biomoda entitled “Method of Prognosing Response to Cancer Therapy with 5, 10, 15, 20 - Tetrakis (Carboxyphenyl) Porphine,” patent number 7,382,764.
On October 22, 2009, Biomoda received a Notice of Allowance from the U.S. Patent and Trademark Office for the patent “Method for Making 5, 10, 15, 20- Tetrakis (Carboxyphenyl) Porphine (TCPP) Solution and Composition Comprising TCPP.” The new patent is number 7,670,799.
Subsequent to June 30, 2010, Biomoda filed an additional patent application, “System and Method for Analyzing Samples Labeled with 5, 10, 15, 20 Tetrakis (4-Carboxyphenyl) Porphine (TCPP)” which provides a quantitative method for reading tissue samples for signs of malignant cells based on flow cytometry and dark-field microscopy.
On July 27, 2010, Biomoda received a Notice of Allowance from the Canadian Intellectual Property Office for "Compositions and Methods for Detecting Precancerous Conditions in Cells and Tissue Samples using 5, 10, 15, 20 Tetrakis (Carboxyphenyl) Porphine." The new Canadian patent number is 2,429,526.
The U.S. Patent and Trademark Office has registered the marks CyPath® and CyDx®.
==================================================================
Most recent PR: Biomoda Signs Research Agreement with Saccomanno Research Institute
Cancer diagnostics company Biomoda, Inc. (OTCBB: BMOD) (www.biomoda.com) is working with the Saccomanno Research Institute to advance Biomoda’s patented system for measuring the photon emission rate of CyPath®-stained cells to detect early-stage lung cancer.
Biomoda’s CyPath® labeling solution for the early detection of cancers is based on meso-tetra (4 carboxyphenyl) porphine or TCPP, a porphyrin compound that binds to cancer cells and fluoresces under specific frequencies of light. Participants in Biomoda’s pilot clinical study, which is nearing completion, provided deep-lung sputum samples to be labeled with the CyPath® solution and viewed under fluorescent microscopy. The samples are also screened for cancer with Pap stain analysis and CT scans. Pending FDA approval, CyPath® is for investigational use only.
“It is especially appropriate that Biomoda is working with the Saccomanno Research Institute since its namesake, the late Dr. Geno Saccomanno, pioneered the development of sputum cytology for the early detection of lung cancer,” said John Cousins, President of Biomoda. Working at St. Mary’s Hospital and Medical Center in Grand Junction, Colorado, Saccomanno originally focused on the prevalence of lung cancer in the uranium miners who lived in the area. He conducted nearly 50 years of research on the diagnostic applications of sputum cytology.
“Under the direction of Dr. Marty Jacobson, the Saccomanno Institute will provide expertise needed for the pivotal clinical study, which is the next step toward commercializing the CyPath® technology as a cancer screening tool appropriate for large populations,” Cousins said. “We are delighted that Dr. Jacobson’s laboratory has joined our pivotal study team.”
About Biomoda
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. In addition to its first product for lung cancer, diagnostic assays for cervical, breast, colorectal, bladder, and oral cancers are targeted for development.
About the Saccomanno Research Institute
Building on the work begun by Dr. Geno Saccomanno, Ph.D., M.D., the Saccomanno Research Institute focuses on genetic, environmental and occupational diseases affecting the population served by the St. Mary’s Hospital medical community. As a result of its history with the health risks of uranium mining, the Institute has conducted epidemiological and clinical studies of the genetics of disease susceptibility, early detection of disease and disease outcomes.
*All info from BMOD's most recent filing and PR
News 
Market Data 
Discover 
