Biosymtec's technology provides early detection of infections and other health state changes before symptoms are experienced and before clinical signs of illness are apparent. This provides the earliest possible medical intervention, and the technology is consistent with current trends towards the incorporation of wireless technology, and remote monitoring of health status & telemedicine.
Biosymtec Medical, Inc. is developing, in the final phase of design engineering, a new and unique product and system for personal health monitoring, never before available.
Biosymtec technology correlates, with a proprietary algorithm, certain sublingual and pulmonary data acquired from an individual upon waking, and within seconds can identify the onset of an illness, usually days before symptoms are present, such as fever.
Our patient-population market (target market) includes COPD, asthma, heart failure and cystic fibrosis patients representing more than 45 million people in the U.S. alone who should/must detect infections early.
A third market will include governments concerned about pandemics and/or bioterrorism attacks. The Biosymtec Initiative will provide an earlier warning than any system presently in place or planned. Millions of Biosymtec Monitors will be required.
The Biosymtec Monitor at the heart of the Biosymtec System was created as a broad-use platform to monitor patients for many pre-symptomatic signs of respiratory and non-respiratory infections which will result in many models addressing even more markets.
The Biosymtec System is being designed to receive biometrics from the Biosymtec Monitor and to forward proprietary-template graphs of the results to subscribing caretakers, physicians, hospitals and corporate health clinics.
Biosymtec System subscription revenues will exceed revenues from the sales and distribution of the Biosymtec Monitors.
The Biosymtec System is being developed with the individual patient in mind while being capable of monitoring entire populations of organizations, communities, counties, states and even countries.
The path to Biosymtec Medical’s profitability with sustainable revenues has been laid out in incremental phases beginning with the sales to the key specialists in the target market.
Revenue Paradigm: Sales of Biosymtec Monitors will place devices in the hands of patients to monitor themselves daily. Purchased Biosymtec Apps will permit patients to view the proprietary-template graphs of the results directly on their smartphones. The patients’ smartphones will automatically forward the graph data to the Biosymtec System where caretakers, physicians, hospitals and corporate health clinics, who have purchased subscriptions to the Biosymtec System, can view the graphs of the patients, and in the case of medical personnel, get paid by the insurance carrier to review the graphs.
Competition: No competitor currently has the equivalent of the Biosymtec Monitor or the Biosymtec System. One competitor is planning on offering a device to acquire certain data from a patient’s mouth, but they have no means of detecting infections early, in the incubation stage, as does the Biosymtec Monitor.
Pre-Clinical Trial Research Studies: Using discrete devices to acquire just two of the identified pre-symptomatic signs, three Research Studies were conducted in Hong Kong, Tianjin and Pennsylvania. The data from these studies, plus the data from over 400 women who used the Biosymtec System to record their reproductive cycles, produced over 23,000 data points from which the Algorithm was developed.
Regarding FDA: The Biosymtec Monitor is designed to be used exclusively in the home (never in the hospital or doctor’s office) by the purchaser. The onboard software provides the purchaser with a graphic report of the likelihood of 1. a developing infection, 2. respiratory condition and 3. respiratory infection, but the device itself does not diagnose. We are told, the FDA will not regulate such a device. The Biosymtec System graph is not expected to require 510K clearance, but FDA 510K clearance is likely to be obtained to validate the technology.
Biosymtec Medical, Inc. has assembled a team of seasoned medical-product professionals to operate the company, with Advisory Board members that have been identifying pre-symptomatic signs for over 12 years. Further, we have put in place mechanical, electrical, electronic and software engineers experienced in developing medical devices. We will complete our pilot run for clinical trials in just 35 weeks from funding.