To: DanielleC who wrote (3746 ) 11/23/1999 11:19:00 AM From: chirodoc Read Replies (1) | Respond to of 6039
November 23, 1999 Company Statement Dear Shareholders; In this era of instantaneous email and the Internet it sometimes seems difficult to keep accurate information before the public. A few items of information and clarification would be appropriate at this time. There has been some concern that our recent improvements in software might somehow invalidate data collected in our clinical trials or delay our final module submission to the FDA. Our clinical sites have the data acquisition part of the system only and not the data analysis software. We have taken advantage of the time needed to collect trial data to continue to refine the data analysis software. By the time the data collection is competed, the analysis software will also be baselined. It will then be used to analyze all of the data collected during the trial. This will be the information that goes to the FDA in module 5. I have been asked to clarify our ongoing relationship with TSET considering our new relationships in Mexico. TSET?s contract is non-exclusive in Mexico. They continue, however, to be a very valuable part of the CTI team. They will continue to represent CTI in many areas, including ongoing activities in the Middle East and Africa. In Mexico the activities of TSET and the new Mexican consortium are complimentary. TSET is focused on standing up independent acute care cancer treatment centers, which will use CTI technology. Our new partners are involved in institutional and government sales, interconnections and the establishment of a central database. The commitments announced yesterday represent 100 systems valued in the neighborhood of $50,000,000. We are working to definitize initial deployment sites, delivery dates and payment schedules. The consortium has already set aside $10,000,000 for the project and will fund the remainder as needed. This project is on a fast track; otherwise we could not meet the very ambitious deployment schedule that has been agreed to. I want all concerned to know that our partners in Mexico have the resources to execute the project. Pegaso alone is a multi-billion dollar company. I will keep you advised as the project moves forward. There should be no concern with deploying our systems in Mexico before U.S. FDA approval. There are sections of the Federal Food, Drug and Cosmetics Act that apply to the exportation of unapproved medical devices. These include sections 801 and 802 of the act. CTI has already begun the coordination process to ensure that our foreign activities don?t disturb our primary objective of obtaining US FDA Pre Market Approval. CTI and our international consortium partners are also already coordinating the import process with the necessary Mexican officials. This process is aided by the fact that our system is totally non-invasive and falls into the FDA category of Non-Significant Risk (NSR). The Mexican consortium understands our status with the FDA, knows we are in the home stretch, and wants to get a head start?very understandable. I will continue to answer important questions, as I am able. However, I am sure that you know that this could become a full time task if allowed to become a cause unto itself. Our most important task is to focus on the now increased effort associated with foreign deployments. To that end we have just added two more employees to the CTI team. Although our business plan is to continue to subcontract most activities, these employees represent critical skills required to supervise subcontracts and ensure a top quality product.