FDA Plays

[biocqr]

pcrutch: "I really dont see how $ECTE will be able to compete."

Really?

LifeTech Capital report on ECTE and DXCM...

We believe the transdermal biosensor is a significant advantage
over the existing biosensors on the market. All existing FDAapproved continuous glucose monitoring (CGM) systems are
needle-based, requiring insertion of a glucose sensor into the
patient’s skin, which gives rise to risks of infection,
inflammation or bleeding at the insertion site. Symphony™ is a
non-invasive tCGM system that does not require insertion of its
glucose sensor and thus does not give rise to the risks associated
with needle-based CGM systems.

We also believe Echo Therapeutics clinical trials in the critical care setting provides a major marketing advantage over the
competition in the hospital market. The Symphony™ system would represent an answer to the new FDA demands for more accurate glucose monitors in the hospital. (see FDA to Require Hospitals to Use More Accurate Glucose Monitors)We further believe that the comparatively short 1-2 day biosensor life is not a drawback, but rather an advantage. In the at-home market, the weekly biosensors begin to lose adhesion after several showers, swimming and other physical activity and rubbing against clothing. It can cost a person $60 if they accidently dislodge or damage the biosensor whereas a cheaper 1-2 day biosensor reduces the economic risk of biosensor damage through daily activity.

Additionally, skin irritation from being in contact with the adhesive as well as the possibility of infection raises hygiene issues. The risk of infection becomes a significant issue in the critical care/ICU market. We believe a 1 or 2 day biosensor makes more sense in the same way daily disposable contact lenses are safer than extended wear contact lenses.

Finally, there are risks involving the competitor’s need for sensor wires resulting in sensor wire fractures underneath the
patients’ skin. The FDA issued a warning letter to DexCom concerning these sensor wire fractures in May 2010 and also
noted that the DexCom SEVEN and SEVEN PLUS Systems are not approved for use in children or adolescents, pregnant women or persons on dialysis and can only be used in the abdomen. (see FDA Warning Letter to DexCom on Sensor Wire Factures).

On May 21, 2010, Echo Therapeutics competitor DexCom (Nasdaq:DXCM) received an FDA Warning Letter for their Seven PLUS Continuous Glucose Monitoring System due to complaints involving sensor wire fractures underneath patient's skin as reported to the FDA. In addition, their sensors are not approved for use in children or adolescents, pregnant women or persons on dialysis and can only be used in the abdomen. Investors should note that Echo Therapeutics Symphony Transdermal Continuous Glucose Monitoring (tCGM) system eliminates the need for sensor wires and could be considered safer, especially for children and adolescents.

http://www.lifetechcapital.com/reports/ECTE%20Update%2004-01-11.pdf