In an analyst update report, LifeTech Capital maintained its Strong Speculative Buy rating on Echo Therapeutics (OTCBB: ECTE) with a 12-18 month price target of $4.50. Below please find highlights from the report, a complete copy of which is available here.
- Echo’s Prelue SkinPrep system (a component of the Symphony system) began clinical trials on April 27, 2010 by partner Ferndale Pharma Group, which licensed Prelue for use with topical lidocaine. A 510(k) clearance with a U.S. launch is possible by Q4 2010. Ferndale has guaranteed a minimum royalty of $12.6 million to Echo.
- Echo’s Symphony transdermal continuous glucose monitor (tCGM) system is a unique needle-free, wireless system and is set to begin a pivotal clinical trial in ICU/Critical Care patients in Q4 2010 (following a final pilot trial). We believe this puts Echo ahead of the curve with respect to toughter FDA standards for hospital use.
- On August 13, 2009, the FDA issued a new warning that hospitals should not use GDH-PQQ glucose testing strips and monitors as they cannot distinguish between glucose and non-glucose sugars resulting in potentially fatal hypoglycemia due to falsely elevated glucose readings. The glucose test strips covered by the FDA public health warning are manufactured by Roche Diagnostics, Abbot Diabetes Care, and Home Diagnostics.
- FDA Commissioner, Dr. Margaret Hamburg’s letter on June 24, 2009, with CDRH analysis, to the American Association of Clinical Endocrinologists (and published by The New York Times on July 19th) signaled a new FDA stance to set tougher accuracy goals for glucose meters used in the hospital settiong. The CDRH analysis suggests that home-use glucose monitors, with up to 20% allowable error rates, are not suitable for ICU/critical care patient monitoring. The unusual results in the NICE-SUGAR trial have triggered the FDA to require development of glucose monitors more suitable for professional in-hospital use.
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