Non-invasive glucose monitoring system



Labopharm Inc. has announced that its New Drug Application (NDA) for the Company’s novel once-daily formulation of trazodone (DDS-04A), a serotonin antagonist reuptake inhibitor (SARI), for the treatment of major depressive disorder, has been accepted for review and filed by the U.S. Food and Drug Administration (FDA). The action date under the Prescription Drug User

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Solianis has just finalised a test series in which patients with diabetes have worn the first configuration of the multisensor system for non-invasive Continuous Glucose Monitoring at home and at work.

Results show that the system tracks glucose in these settings and that it is sensitive to hyper- and hypoglycemic glucose excursions.

“This is the first study ever performed with any non-invasive glucose sensor in a home use environment. The data show clearly that the technology works and that we are on our way to the final product.” says Mario Stark, CEO of Solianis. The company expects to launch its first product in Europe in 2010 after CE approval, targeting this non-invasive device at the insulin dependent diabetes population. Later model variants will address patients with diabetes and impaired glucose tolerance.

To move forward with the implementation of the prototype and set up the market introduction, Solianis has strengthened its Board of Directors with two renowned industry experts:

Dr. Russ Potts holds a PhD in Biochemistry. He worked at Pfizer on transdermal drug delivery and at Cygnus as Vice President R&D until 2002. Cygnus developed the first FDA-approved, minimally-invasive, continuous glucose monitor “Glucowatch”. At Cygnus his responsibilities included FDA technical liaison & fund raising, with strategic as well as technical input. Today he is a consultant for drug delivery and glucose monitoring devices. His role at Solianis will include technical and patent support, recommendations for the approach to the FDA and strategic planning.

Dr. Anders Weber holds a Ph.D. in Immunology from the Royal Veterinary and Agricultural University of Copenhagen, and he has performed his post doctorate studies on optical immunosensors at the University of Michigan, Ann Arbor, and the Biotechnology Centre in Pittsburgh. He started his industrial career as Development Engineer at Radiometer A/S in Copenhagen as part of a team developing amperometric glucose and lactate sensors and subsequently headed the advanced Sensors Development Unit. In various capacities, he initiated and managed 12 start-up companies on behalf of Danish Development Finance Corporation and other investors.

http://www.solianis.com

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A study in the Dec. 15 issue of the Journal of Clinical Sleep Medicine suggests that screening type 2 diabetes patients for obstructive sleep apnea (OSA) and treating those who have OSA with continuous positive airway pressure (CPAP) therapy could improve the management of their hyperglycemia and might favorably influence their long-term prognosis. Results

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