Bioluminate, Inc.


	What is BioLuminate? BioLuminate, Inc. is a private, development-stage, Silicon Valley start-up company. It is developing, in collaboration with NASA/Ames and Lawrence Livermore National Laboratory (LLNL), a "smart" probe that provides real-time breast cancer detection data to physicians, and may serve as a cancer therapy delivery device, when cancer is found. What evidence is there that a "smart" probe is needed for early detection of breast cancer? In the US every week, approximately 16,000 women needlessly undergo open surgical breast biopsies, that is no cancer is found. The annual cost to the U.S. healthcare system for these procedures is estimated to be approximately $2.3 billion. The toll on the emotions of these women and their families is immeasurable. In addition, about 4,600 cases of breast cancer are missed each week in the U.S. during physician review of mammograms and physical examinations. The fact is, initial breast cancer screening procedures do not provide specific information about known cancer indicators. A light spot on a mammogram x-ray can be many things besides cancer. How is BioLuminate collaborating with NASA/Ames and Lawrence Livermore Laboratory? Are any other public or private entities involved? BioLuminate has an exclusive license to NASA's "Smart Surgical Probe" technology for all cancer applications and has the exclusive rights to develop Lawrence Livermore National Laboratory's pro-prietary optical imaging and probing technology for all cancer detection applications. The BioLuminate project team includes LLNL scientists, Soquel Technology, Westar Design and ALARA Inc. How will the BioLuminate Smart Probe^TM be used? After a suspicious region of the breast has been identified by mammography and/or a physical exam, the surgeon or radiologist would administer a one-minute test using the BioLuminate Smart Probe^TM. The device, which is less invasive than a routine blood test, will provide an instant computer display of quantitative measurements of the following six known cancer indicators: Oxygen partial pressure Electrical impedance Temperature Light scattering and absorption properties Deoxygenated hemoglobin Vascularization Tissue density With these six measurements, the physician has specific information about the tissue that has been tested and can determine with greater accuracy the best way to care for the patient. The probe can be used in the physician's office or an institutional health care setting. Is it expected to replace current breast cancer screening methods and diagnostic tools? No, the probe is intended to provide additional information after initial screening has taken place. How does the software work? The software enables the physician to detect not just the absolute values of the six cancer indicators in a suspicious breast lesion, but the values relative to normal tissue in specific patients. As the probe passes through a patient's normal tissue, the physician signals the computer to record these measurements as "not cancer." Then he or she proceeds to the suspicious region and makes the same measurements, comparing the results with those previously obtained from normal tissue. How soon will it be on the market? We estimate it will take 18 months to design and fabricate the first commercial prototype and complete the first clinical study. The regulatory approval process could take another year. Our current estimates indicate that the BioLuminate Smart Probe^TM will be commercially available by the end of 2005. How will it save healthcare dollars? Breast cancer biopsies in the U.S. average approximately $2,620 per patient, given appropriate weighting factors for the number of surgical and core needle procedures performed. The net cost savings achieved by using the BioLuminate Smart Probe in the U.S. would be $2,095 per patient. An annual savings to the U.S. healthcare system of $2.335 billion is estimated. Similar savings would be expected in Europe. How much will the BioLuminate Smart Probe^TM cost? It is estimated that the BioLuminate Smart Probe procedure will cost $525 per test, which includes a $250 disposable needle. The entire instrument system, consisting of computer, optical components, conversion electronics and graphics display, is expected to cost less than $50,000. What is the size of the market for this product? The combined U.S. and European markets for breast cancer detection products includes up to 12.6 million women annually. In the U.S., about 975,000 open surgical breast biopsies are performed each year. European numbers are typically 80 percent of U.S. numbers. What other uses are foreseen for the Smart Probe? Based on our new platform technology, BioLuminate is developing a measurement device that will detect a significant number of the malignant breast lesions that are missed each year by current marginal screening procedures. We also expected to greatly improve breast cancer screening effectiveness, especially in younger women where mammograms are less effective because of denser breast tissue. Future applications of this technology are expected to include prostate, lung, colon, cervical and brain cancer. In addition, the technology has potential to serve as an aiming device for core needle biopsies; to deliver therapies such as laser heat, cryogenics, drugs, and radioactive seeds; and to monitor the effectiveness of cancer treatment. When will clinical trials begin? We expect to begin clinical trials before the end of 2001. The project team currently is designing and fabricating its first prototype.