HENDERSON, Nev., July 11, 2007 (PRIME NEWSWIRE) -- BodyTel Scientific Inc. (OTCBB:BDYT), a company focused on the development of innovative wireless healthcare products, announces that the company has begun the U.S. Food & Drug Administration (FDA) clearance process for its blood glucose monitoring device, GlucoTel. The company has chosen MDC Associates, LLC (www.mdcassoc.com), FDA consultants, to assist BodyTel with the applications and tests required in the approval process.
Currently, the GlucoTel system is in the pre-IDE (investigation of device evaluation) phase of the FDA review process. The FDA has reviewed and confirmed that BodyTel's clinical study design is acceptable. Clinical studies are being planned and are scheduled to begin within the next 30-60 days. BodyTel anticipates submitting the necessary 510(k) application to the FDA in fall, receiving clearance to market the GlucoTel system in the U.S. before the end of the year.
"Now that we have completed the manufacturing of the first conforming samples of the GlucoTel meter, we are excited to begin the clinical trials. We are confident we will successfully reach the end points of the trial and demonstrate the user-friendliness of our meter. With the FDA clearance, we will be ready to market GlucoTel in the United States and all countries requesting this certificate," stated Stefan Schraps, CEO of BodyTel Scientific.
The GlucoTel monitoring device is a part of the GlucoTel self-managed telemedical diabetes system. It supports patients and doctors with the treatment of diabetes and its resulting illnesses. The blood sugar measuring instrument determines the sugar level electronically and transmits it automatically via Bluetooth to the patient's mobile phone. The data is then sent per text message (SMS) or data package (GPRS) directly to an internet database and stored long-term. The system enables the inclusion of the patient in their own treatment and improves the information basis and communication between doctor and patient.
About BodyTel Scientific
BodyTel Scientific Inc. is a company focused on the development of innovative wireless health monitoring products. Please visit www.bodytel.com for more company information.
Forward-Looking Statements
Statements regarding the Company's business which are not historical facts are "forward-looking statements" that involve risks and uncertainties that could cause actual results to differ materially from the potential results discussed in the forward-looking statements. Forward-looking statements in this press release include that Clinical studies are being planned and are scheduled to begin within the next 30-60 days, that BodyTel anticipates submitting the necessary 510(k) application to the FDA in fall, receiving clearance to market the GlucoTel system in the U.S. before the end of the year, that we are confident we will successfully reach the end points of the trial and demonstrate the user-friendliness of our meter, and that with the submission of a 510(k) application to the FDA and subsequent approval, we will begin to market GlucoTel within the United States. Actual results may differ materially from those currently anticipated due to a number of factors as we may find that our products must compete with cheaper or better products; we may not be able to retain key employees; a bigger market may not develop for our products and we may not be able to continue to attract new customers; we may face litigation if our technology fails to work when required; our intellectual property may be attacked and defeated in court proceedings; our patent and FDA/CE filings may be rejected by the patent offices and regulators; other companies may discover and develop better or cheaper technologies that would render our products obsolete and we may not have sufficient funding to further develop and/or market our technology. Readers are directed to BodyTel Scientific, Inc.'s reports as filed with the U.S. Securities and Exchange Commission from time to time, including but not limited to its 8-K filed December 14, 2006 under our prior name Sellcell.net which outlined the company's current business, for further information and factors that may affect BodyTel Scientific Inc.'s business and results of operations as well as the Company's form 10-KSB filed on December 15, 2006 and the Company's form 10-QSB filed on January 16, 2007. BodyTel Scientific Inc. undertakes no obligations to publicly update any forward-looking statements to reflect future events or circumstances.