Echo Therapeutics Completes Clinical Trial for its Prelude SkinPrep System

Echo Therapeutics (OTCBB: ECTE), in highly anticipated news, has successfully completed a clinical study regarding its Prelude SkinPrep System.  The Prelude SkinPrep System is a needle-free platform technology which provides for enhanced skin permeation for the delivery of topical pharmaceuticals.  In this case, the clinical study focused on the application of OTC 4% lidocaine cream for faster acting local dermal anesthesia.  Without knowing details of the results, we are confident in the success of the clinical study simply by the fact that the Company intends to submit a 510(k) premarket notification to the United States Food and Drug Administration in anticipation of market clearance and product sales. 

An abridged version of the book entitled, Prelude SkinPrep System for Dummies, would read something like this.  Lidocaine cream is a topical anesthetic used in clinical procedures to control pain on the surface of the skin.  Upon application, it can take up to 60 minutes for lidocaine to permeate the skin.  Imagine that, you go to the doctor for a simple procedure and you spend the majority of the time waiting for the anesthetic, lidocaine, to take effect.  Pretty frustrating right, but not much you can do.  Until now.  Echo’s SkinPrep System painlessly removes dead skin, thereby allowing the lidocaine to permeate more quickly.  In conjunction with Echo Therapeutics’ Prelude SkinPrep System, lidocaine is able to penetrate the skin significantly faster.  We don’t have access to data from the clinical study, but it could be as quick as ten minutes or less.

So what’s next?  First, the submission of a 510(k) premarket notification to the FDA.  Second, market clearance by the FDA.  Third, FDA clearance would trigger a $750,000 milestone payment from the Company’s partner, Ferndale Pharma Group, Inc.  And fourth, revenue opportunities begin.  Pretty exciting time for Echo Therapeutics and there is still so much more to talk about. 

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Dr. Pat Mooney of Echo Therapeutics Addresses Investors at a Recent Luncheon

Echo Therapeutics (OTCBB: ECTE) is clearly on to something.  The Company is developing a platform technology, the basis of which seeks to change the standard of care for continuous glucose monitoring from needle-based to needle-free.  Imagine that, no more needles, and in addition to monitoring the Company also provides a unique drug delivery system.  Click on the picture below to watch an excerpt from Dr. Pat Mooney’s recent investor presentation.

Echo Therapeutics: CEO Meeting Highlights

Last week Boenning & Scattergood hosted a meeting with Echo Therapeutics’ CEO Patrick Mooney.  Overall, their short and long-term views on the company continue to be positive, as Echo’s two pipeline products, Prelude™SkinPrep/LMX4 and Symphony™ tCGM, remain on track.  Below is a summary of their meeting with Dr. Pat Mooney, Echo’s CEO.

Ferndale Pharma Group is in the process finishing its 60 patient trial utilizing the Prelude in conjunction with its FDA approved fast acting topical anesthetic, LMX4.  Ferndale’s LMX4 is applied to a hospital patient’s (typically pediatrics) inner arm or hand, prior to a venous access procedure, to manage pain.  Venous access procedures are among the most common procedures performed at a hospital, with more than 400 million such procedures performed each year in U.S. hospitals.  More than 60 million of these procedures take place in the emergency department, and another 27 million IV line placements are associated with pre-surgery procedures.  It is recommended that LMX4 be applied to the patient’s skin at least 30 to 40 minutes prior to a venipuncture.  Ferndale believes the onset of analgesia should decrease for a patient who is first “prepped” with the Prelude.  Our research leads us to believe Ferndale’s trial should lower the time to analgesia from 30 to 40 minutes to fewer than 10.  If Ferndale’s data are that good, we feel this hardware/pharmaceutical combination could create new markets for the product, like the $1 billion plastic surgery/dermal filler market.  We expect Echo Therapeutics will release LMX4 trial data in the first week of July, 2010, and Ferndale will then file its 510(k) application with the FDA in 3Q:10.

Echo’s second pipeline product, the Symphony™ tCGM, is progressing well.  Echo is currently finishing the design work on its final glucose sensor, and we believe the company will start and complete a pilot CGM pilot study in 4Q:10.  If the results are positive, which we believe they will, Echo will conduct a full 300 patient clinical trial in 1Q:11.

We continue to rate ECTE an Outperform with a target price of $3.00.

Echo Therapeutics Morning Notes – Competitor DexCom Gets FDA Warning Letter on Sensor Wires

LifeTech Research released a “Morning Notes” update for Echo Therapeutics today highlighting a situation with competitor DexCom, which received an FDA Warning Letter for their Seven PLUS Continuous Glucose Monitoring System due to complaints involving sensor wire fractures underneath the patient’s skin. Since Echo Thera’s Symphony™ tCGM system does not utilize a needle that goes into the patient’s skin (Echo employs a transdermal patch), this could prove to be a significant differentiator between the two monitoring systems and make Echo’s solution a preferred product by diabetes patients once clinical trials are completed.

This report lists a number of actual patient complaints reported in the Warning Letter, most of which included a visit to their physician to remove the thin wire system broken off under the skin (ouch!). We have included a link below for more information that contrasts several other problems with the Dexcom Glucose monitoring system and how those problems are solved with Echo’s Symphony™ system.   

World renowned engineer, Dr. Robert Langer at Massachusetts Institute of Technology (MIT) who also serves as Chairman of the Scientific Advisory Board for Echo Therapeutics recently discussed the Symphony™ trandermal continuous glucose monitoring (tCGM) system – to listen to this interview go to:  http://www.lifetechcapital.com/echo.htm

More here.

Echo Therapeutics Analyst Update Report

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.

World Renowned Engineer Dr. Robert Langer Discusses Echo Therapeutics’ Prelude SkinPrep and Symphony Transdermal Continuous Glucose Monitoring Technologies

Dr. Robert Langer discusses Echo Therapeutics’ (OTCBB: ECTE) Prelude SkinPrep device and its Symphony trandermal continuous glucose monitoring (tCGM) system.

Investors can listen to Dr. Langer’s comments on Echo Therapeutics at: http://www.lifetechcapital.com/echo.htm

For those of you who don’t know Dr. Langer, is the David H. Koch Institute Professor (there are 14 Institute Professors at MIT; being an Institute Professor is the highest honor that can be awarded to a faculty member).  Dr. Langer has written approximately 1,050 articles.  He also has approximately 750 issued and pending patents worldwide.  Dr. Langer’s patents have been licensed or sublicensed to over 220 pharmaceutical, chemical, biotechnology and medical device companies.  He is the most cited engineer in history. 

Echo Therapeutics: No More Pricking Your Finger to Check Glucose Levels

Have you ever had to monitor your glucose levels?  If so, then you already know that having to prick your finger to provide a blood sample is no day at the beach.  And you are also likely aware that while the glucose level reading may be accurate at the specific point in time, it doesn’t measure glucose levels in between finger pricks.  What happens to your glucose level during those 60 minutes, does it go way up, way down, or do nothing.  No one knows because it is not being monitored. 

Let’s say you were to have glucose levels measured each hour, you would have your finger pricked 24 times a day.  Again, the question is what  happens during those 60 minutes between finger pricks.  To see what happens during that hour, what if we took readings every 15 minutes, that would be 96 times a day.  Ouch!!

At this point, you’re probably thinking “there has to be a better way.”  And you are not alone in thinkng that.  Those are exact same thoughts as the doctors and scientists from Echo Therapeutics (OTCBB: ECTE).  But Echo Therapeutics is doing something about it.  The Company is is developing a wireless and needle-free continuous glucose monitoring system.  Key points from the previous sentence include “needle-free,” no pricking of the finger and “continuous,” real time readings at any and all points in time.  Can you say paradigm shift?

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