FDA approves Abreu BTT 700 System for temperature monitoring

Brain Tunnelgenix Technologies Corp. (BTT Corp.) announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance to market its Abreu BTT™ 700 System for continuous temperature monitoring. The Abreu BTT 700 System sensor is approved for placement on the skin and to be used during surgical procedures, recovery room, intensive care and general patient monitoring.

“FDA approval of our Abreu BTT 700 System marks a successful milestone for BTT Corp., and we are excited that medical professionals and researchers will now have access to the first product in history that enables temperature to be continuously monitored on the only truly thermoconductive skin in the body”

The Abreu BTT 700 System is the world's first continuous and noninvasive device that measures temperature on the skin surface of the body with the highest thermoconductivity, the fat-free skin which overlies the Brain Temperature Tunnel™ (BTT™). Located between the eye and eyebrow, the BTT's skin site lacks insulation tissue and the internal portion is in direct communication with the brain, thereby enabling temperature to be accurately and continuously monitored for the first time in history with the unimpeded transfer of internal thermal energy through the skin.

The Abreu BTT 700 System conquers the last frontier for monitoring vital signs -- the continuous noninvasive monitoring of body temperature. Unlike blood pressure, heart rate, respiration and oxygen saturation, up to now temperature was the only vital sign that could not be noninvasively monitored in a continuous fashion; temperature needed to be measured and recorded manually by nurses or invasively by doctors using catheters during surgery. The Abreu BTT 700 System now allows for the first time in history full automation of patient monitoring with both wired and wireless signal transmission.

The Abreu BTT 700 System, which is protected by patents in the U.S. and abroad, will be available next month and will make its world debut at the Annual Meeting of the American Society of Anesthesiologists (ASA) in San Diego, CA.

"FDA approval of our Abreu BTT 700 System marks a successful milestone for BTT Corp., and we are excited that medical professionals and researchers will now have access to the first product in history that enables temperature to be continuously monitored on the only truly thermoconductive skin in the body," said Rick Foreman, Chief Executive Officer of BTT Corp. "BTT Corp. uniquely harnessed the best of biology to create the best of technology for safely and effectively monitoring temperature during surgical procedures and for recovery room, intensive care and general patient monitoring. This breakthrough will enable clinicians to escape their dependence on invasive thermometry and surface measurements across thermal barriers. With the exception of putting a sensor directly inside the brain, studies have shown that the BTT is the only sensor capable of detecting brain hypothermia and harmful cerebral hyperthermia."

Benefits of the Abreu BTT 700 System

Precise temperature readings are vital to making the right medical decisions. A report by the U.S. Army Medical Center (Hermstad E., Adams B. J Emerg Trauma Shock. 2010 Jan;3(1):66-9), for example, shows the lack of and the need for unobtrusive continuous temperature monitoring that can be used from the combat field to the hospital. The report states "the patient's hyperthermia went undetected and untreated" and that this may be a frequent situation; in this case, the patient died. The report also states that with the "…current conflict in Iraq and common traumatic brain injury, this is likely to be more common than has been reported." Early hyperthermia detection may prevent fatal outcomes, and the Abreu BTT 700 System uniquely fulfills this critical need in the military, in hospitals and ambulances as well as in the field of sports.

In addition, the recent SCIP (Surgical Care Improvement Program) protocol mandates warming treatment to be initiated to maintain a patient's intra- and postoperative temperature above 36° C, which is critical both for patient care and for hospitals in light of pay for performance reimbursement. The Abreu BTT 700 System uniquely enables patient temperature to be continuously monitored with one sensor throughout the intraoperative and perioperative period to ensure that the SCIP protocol is met.

The Abreu BTT 700 System also uniquely enables any patient's temperature to be remotely monitored from the nurse's station including mobile technology, ideally reducing the estimated 2 billion times each year that U.S. hospital nursing staff check patients' temperature. Continuous, automated and labor-free monitoring can eliminate middle-of-the-night temperature checks.

Also, by detecting spikes in infections earlier, the cost of treatment can be reduced and the performance of drug therapies can be improved (the earlier the treatment, the more effective it is) -- and with better, earlier treatment, the length of hospital stays can be reduced. It has been estimated that the U.S. alone wastes $40 billion a year because of inaccurate temperature measurements that lead to both "false negatives" and "false positives" due to under- or overestimation of patient temperature.

The Abreu BTT 700 System will also usher in a new medical era -- the era of Thermal Signatures™ -- from detecting ovulation for natural contraception or conception, for example, to delineating the brain thermal signature for Alzheimer's disease and Parkinson's disease. This will allow early diagnosis and early implementation of therapy to preserve brain function, while expediting and reducing the cost of clinical trials for those much-needed drugs for treating these devastating conditions.

A Groundbreaking Scientific Discovery

The Abreu BTT 700 System is based on the groundbreaking discovery by Yale researcher Dr. Marc Abreu of the BTT, a new thermal organ in the body. The body's own natural temperature indicator, this thermal and radiant path provides a direct and undisturbed connection between the thermal storage area in the brain and a unique area of skin between the eye and nose. BTT Corp. is harnessing the power of this tunnel to the brain, the organ most sensitive to -- and most responsible for -- body temperature.

Since the invention of the thermometer 300 years ago, humans have invaded multiple orifices and penetrated multiple sites in an attempt to overcome the body's thermal barriers to monitor temperature. Because the body's layer of fat provides insulation and prevents adequate thermal emission, the skin surface, such as the forehead and axila, cannot provide accurate thermal measurement. Forehead thermometers are therefore forced to rely on artificial calculations, which can lead to overestimation and underestimation. Ear canal thermometry also relies on artificial estimations, and numerous reports, including reports by the British Government, show the limitations and dangers of the errors caused by ear thermometers.

In addition, rapid digital oral and rectal thermometers also frequently rely on estimation techniques, leading to further inaccuracies. Furthermore, oral thermometry requires at least a 30-minute wait after food or liquid is consumed, otherwise the measurements will provide an erroneous reading. The BTT site's unique physiology is not affected by fluid/food intake.

A study from a research group at Yale University ("Infrared Thermographic Analysis of Temperature on the Face, Forehead, Neck and Supero-medial Orbit," presented at the 2009 Annual Meeting of the ASA), proved the reliability of temperature measurements from the BTT. In addition, three previous studies by the Department of Anesthesiology of Yale School of Medicine that showed BTT's ability to noninvasively and continuously monitor core (internal) and intracranial temperature were also presented at the ASA. Another study by the Department of Anesthesiology of the University of Connecticut School of Medicine that showed that BTT enabled noninvasive monitoring of core temperature of patients undergoing surgery was presented at the World Congress of Anesthesiology in Paris, France. An unprecedented seven more studies on the BTT will be presented at this year's ASA meeting.