Avenue Vine

Times Square, called The Crossroads of the World, in Midtown Manhattan is a vibrant shopping, restaurant and theatre district, famous for its annual New Year's Eve ball drop, where more than a million revelers crowd the area for the ball lowering. Its famous news ticker was first used in 1928 to announce Presidential election results, and it has announced the world's news ever since including the end of World War II, the assassination of President Kennedy, and man's landing on the moon.

"This is one of the most highly trafficked public places in the world and to use it to tell the Biomoda efforts to reduce the horrific toll cancer has on our society will have a dramatic impact," said John Cousins, President.

About Biomoda:
Biomoda is committed to the vision that the early detection of cancer is achievable in our lifetime. Through the developments of our technologies and an array of complimentary business models, Biomoda is creating diagnostic tools to assist clinicians in early detection, staged diagnosis and aid in determining therapy routes. Biomoda's prototype tests are inexpensive, simple and accurate. Our business plan is to focus on economically large markets where our proprietary, patented technology will significantly reduce overall costs in the healthcare system and improve patient outcomes. At Biomoda, our mission is to create and market new diagnostic solutions for the early detection and clinical management of cancer; solutions that provide compelling value to the healthcare system through cost savings and improved patient outcomes.

Biomoda, Inc., is a biopharmaceutical company focusing on very early cancer detection technology. Biomoda’s novel cell-targeting technology is globally patented for the detection of pre-cancerous and cancerous conditions in all human tissue. This technology, originally called Tetrakis Carboxy Phenyl Porphine (TCPP), was developed at Los Alamos National Laboratories. Biomoda obtained a worldwide exclusive license to the TCPP technology from the University of California in late 1995, and began new research broadening the scope of the original patent and technology. In November 2000, Biomoda filed a new U.S. provisional patent application defining the ability of Biomoda’s version of the TCPP to detect pre-cancerous and cancerous conditions in all human tissue.

Our diagnostic kit staining technique exploits the unique cell-targeting characteristics of porphyrins–extremely tiny, water-soluble biological pigments–that seek an intracellular binding site in abnormal cells. When exposed to certain wavelengths of fluorescent light, our diagnostic stain causes abnormal cells to literally light up red/orange with a degree of fluorescence proportional to the abnormality of the cell. Biomoda’s first product will be a non-invasive test for the extreme early detection of lung cancer.

Currently, there are no commercially available methods of detecting lung cancer at the pre-cancerous stage and there is no FDA approved screen for lung cancer. We are preparing for additional clinical trials and commercialization for extreme early lung cancer detection, thus putting Biomoda on the leading edge of the research curve.

Before marketing any of its products, the Company will need to complete one or more clinical investigations of each product. There can be no assurance that the results of such clinical investigations will be favorable to the Company. During each investigative study and prior to its completion, the results of the investigation will remain “blinded” to ensure the integrity of the study. The Company will not know the results of any study, favorable or unfavorable to the Company, until after the study has been completed. Such data must be submitted to the FDA as part of any regulatory filing seeking approval to market the product. Even if the results are favorable, the FDA may dispute the claims of safety, efficacy, or clinical utility and not allow the product to be marketed.

General:
The Company’s present strategy is to seek partners for commercializing its products in foreign markets. There can be no assurance that the company will be successful in finding suitable collaborative partners for any of its technology, nor can there be any assurance as to the timing or terms of any such collaborations. Such collaborative arrangements, if entered into, may provide for the company to receive a royalty for sales of its products by the licensee, as well as up-front licensing fees and payments for development work performed by the company. Royalties on sales, in any event, will depend in part upon the efforts required of the licensee, which may include the completion of product research and development, performance of clinical investigations, obtaining regulatory approvals, and manufacturing and marketing any products. The amount and timing of resources devoted to these activities may be controlled by the licensee. Should the licensee fail to perform any essential functions, the company’s business and results could be adversely affected. If the company is unable to enter into favorable collaborative arrangements, the company may not have sufficient resources to develop its products. In addition, there can be no assurance that any of the company’s collaborative partners would not pursue alternative technologies or develop alternative products on their own or in collaboration with others, including the company’s competitors.

Managed care organizations, hospitals, ob/gyn specialists, and lung cancer specialists in the region of Biomoda’s licensed cytopathology lab will be alerted by direct mailings about the availability of improved technology for detection of lung cancer in sputum samples and cervical cancer from pap smears. A price list will be included. A direct sales approach by telephone may be appropriate, particularly since sales to clinical labs around the country will have to be supported by Biomoda personnel with a knowledge base similar to that of the decision makers.

Biomoda executives will directly contact and negotiate national sales/operating agreements (a National Account Approach). To the extent that reagents are sold to small laboratories, these sales will be accomplished through one or more major reagent distributors. Sales support may be challenging, since the company anticipates that sputum sample preparation will be particularly difficult in inexperienced hands. Biomoda intends to support the customers with technical support provided via phone, fax, and internet and detailed procedural documentation.

Finalized plans for selling Biomoda products and services will be developed during the first eighteen months. The Marketing/Sales executive whom the Company plans to hire during the second year will actively participate in the consolidation and implementation of the selling program.

Manufacturing:
For the initial development phase, no manufacturing facilities will be needed. However, production and packaging facilities both for the cytopathology reagents and for clinical trials materials will be required. Since TCPP can be manufactured by total chemical synthesis, Biomoda plans initially to contract out production of TCPP as a fine chemical. Pharmaceutical companies may be particularly attractive contract manufacturers. It is likely that when the cytopatholgy product kits reach the market, Biomoda will invest in the capital equipment for production and packaging, although the decision may be made to continue to contract out these functions so long as costs are competitive. All formulations will be treated as confidential trade secrets, extending to all contract manufacturers. Patents on formulations will be pursued aggressively, minimizing the concerns attending contract manufacturing.

Biomoda will investigate contract manufacturing options with U.S., European and Asian companies.

Quality assurance and quality control will be maintained by an in-house QA/QC group, checking conformance to requirements of outside contractors. A Total Quality Management approach will be implemented, extending to the suppliers of raw and finished materials.

Product Research and Development:
Initial research will be conducted for the development of a method for early detection and diagnosing of lung cancer. The first phase will be conducted at a single site, with a control group known to have lung disease and at a high risk for having cancer. The goal of this additional clinical work will be to refine the preliminary laboratory and contract lab results on scoring relative to cellular anomalies. We intend to refine the protocol and further develop a systematic and reproducible approach to accurately defining sensitivity and specificity. The institution that will be our strategic partner in this study will have a large sputum bank with detailed information on the patients and samples. The Company is currently in the process of reviewing several candidates for use as strategic partners.

The second phase will be a multi-site pilot study to gain further insight into reproducibility and to evaluate the data with academic collaborators. It is intended that the results will be published in peer-review publications to further corroborate the data and disclose the potential of the technology.

"Safe Harbor" Statement:
This press release contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and are naturally subject to uncertainty and changes in circumstances. Actual results may vary materially from expectations contained herein. Biomoda is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise. This is a public press release privacy policy.

Biomoda Website: www.biomoda.com

Source: Biomoda, Inc.via PRNewswire, ALBUQUERQUE, N.M.--May 18, 2007