BodyTel Scientific provides update on GlucoTel regulatory status

Henderson 29 October 2007BodyTel Scientific Inc. has achieved significant progress with respect to securing both CE and FDA regulatory approvals for its GlucoTel System. Management now expects to be granted CE approval no later than December, 2007 with FDA approval anticipated in the second quarter of 2008. BodyTel Scientific Inc. has appointed experienced suppliers and partners who have all previously undergone successful approval processes. Individual suppliers have been certified and BodyTel has already conducted a detailed risk analysis of the entire process and subsequent clinical trials as necessary in the approval process.

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"Upon receipt of CE approval, BodyTel will commence marketing and distributing its flagship product, GlucoTel, in Western Europe and the Middle East", stated Stefan Schraps, CEO of BodyTel. FDA clinical studies are anticipated to begin shortly in the United States.

GlucoTel is a telemedical blood glucose monitoring and diabetes management system consisting of several components used together in an integrated process. The GlucoTel measurement device is a wireless blood glucose meter that electronically captures the blood sugar level and sends it via Bluetooth to the patient's mobile phone. The data is then sent automatically via text message or internet connection to the company's web database "BodyTel Center", where it is stored long-term.

The GlucoTel system strives to close the gap between the patient and caregiver, allowing the user as is usual to measure the level of glucose in the blood. Users have unique access to their profile on the central internet database where they can review their blood glucose history as well as take advantage of additional on-line functionalities like electronic diary, automatic test strip re-ordering programmes and many more.

Critically, the patient can grant database access to health care professionals or caregivers to enable them to remotely monitor their patient's blood glucose levels and spot any deficiencies in their patient's self-treatment at an earlier stage. On request, an automatic alarm by any electronic media - e-mail, text message, fax, etc. - can be sent to a caregiver if a measurement falls below or rises above any pre-defined thresholds.

BodyTel Scientific Inc. is a German-American telehealth company that specializes in telemedical monitoring and management systems for chronic illnesses. The company combines their know-how in telecommunications, internet and medical technology to create new products and services for the changing needs of global health. BodyTel products are designed not only to simplify home monitoring by patients, but also to ease the communication of "measured body values" to health care professionals or other caregivers by bridging the gap between the patient and the caregivers instantaneously.

BodyTel's products - GlucoTel, PressureTel and WeightTel - are each at different stages of development and approval processes. More company news is available in the VMW July 2007 article BodyTel Scientific announces the formation of BodyTel Europe GmbH.


Leslie Versweyveld

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