New Non-Invasive Blood Glucose Measurement and Continuous Monitoring Device: the Glucoband(R)Main Category: Diabetes
Also Included In: Medical Devices / Diagnostics
Article Date: 10 Jun 2005
Calisto Medical, Inc today announced that it has positively concluded pre-clinical trial on the prototype of in-house developed personal glucose monitor - Glucoband(R). The new non-invasive glucose measurement and monitoring device is using company's proprietary, patent pending technology based on Bio-Electric Impedance Spectroscopy (BEIS). Calisto Medical has been developing its flagship product, the Glucoband(R) for almost two years. This is the first public announcement triggered by successful conclusion of a series of pre-clinical trials.
"We believe that with our new product - Glucoband(R), the true non-invasive blood glucose monitoring finally became a reality. BEIS, the core technology, was developed by Calisto Medical. It will open many venues for medical telemetry, health monitoring and express diagnostics. Our innovative and advanced micro-electronic system design capabilities will greatly contribute to the creation of a family of Calisto non-invasive health management products, constituting an outstanding opportunity to create unparalleled value for our customers and shareholders in the multi-billion-dollar diabetes monitoring and treatment market," said Dr. Vahram Mouradian, chairman and CEO of Calisto Medical, Inc.
"We plan to proceed with the manufacturing and worldwide distribution of Glucoband(R) as quickly as possible to maintain the unique situation for now being the only true non-invasive monitor vendor in the growing diabetes monitoring market. We also plan to seek technology, financial and distribution partners that already have experience with related products, technology and have established market shares. We have already had preliminary discussions with several interested parties."
Product Development Status
"Several prototypes of Glucoband(R) will undergo clinical studies and we are in the process of development of FDA-compliant clinical trial protocols. First results from standard-based clinical tests should be available by the end of 2005, early 2006" said Dr. Henry A. Punzi, F.C.P., Scientific Advisory Board Member of Calisto Medical, Inc. "Our near-term goals are to proceed with clinical trials on Glucoband(R) seeking FDA pre-marketing clearance and approval."
Currently Calisto Medical is working to improve the single measurement duration and reliability of Glucoband(R) by embedding new proprietary reagent imprints in the proprietary ASIC. Once this is accomplished, final product design, engineering, production, marketing activities and regulatory final approval would be needed before making the product available in the U.S. We plan to launch the product in international markets while it is awaiting U.S. FDA approval. Timing for these new development activities depends on sufficient funding and the availability of clinical trial feedback.
"Continuous glucose monitoring has become an important component of diabetes management for both children and adults. In this regard availability of Glucoband(R) for diabetic community promises for making a significant positive impact" said Mr. Zareh Baghdasarian, a Board Member of Calisto Medical, Inc.
Glucoband(R) worn on the wrist like regular wristwatch would allow people with diabetes to continuously and non-invasively monitor their blood glucose levels without the pain and inconvenience of multiple fingerstick blood tests or implanting a sensor. Prototypes of the device have shown the capability of providing readings once in 6 minutes.
Blood glucose levels are a measure of an individual's health status. Because people with diabetes cannot properly metabolize glucose, they typically monitor their glucose levels by frequently pricking their fingertips to draw the drop of blood necessary for conventional glucose monitoring. The estimated worldwide market for glucose testing is $5.5 billion with an annual growth rate of 15 to 18 percent.
Contact: Vahram Mouradian
Company Name: CALISTO MEDICAL, INC.
Original article posted on Medical News Today.
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