-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, ALo4+1Lmo3MeX/j7TG9rpyNkr8tkeo/hVTsmSPhWUzfy/y3ZYOPy8+Mz99c+6hGU Nj+OWRhgJFzbprjjdojubA== 0000893220-08-000695.txt : 20080313 0000893220-08-000695.hdr.sgml : 20080313 20080313102643 ACCESSION NUMBER: 0000893220-08-000695 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20080313 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080313 DATE AS OF CHANGE: 20080313 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Echo Therapeutics, Inc. CENTRAL INDEX KEY: 0001031927 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 411649949 STATE OF INCORPORATION: MN FISCAL YEAR END: 1007 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23017 FILM NUMBER: 08685151 BUSINESS ADDRESS: STREET 1: 10 FORGE PARKWAY CITY: FRANKLIN STATE: MA ZIP: 02038 BUSINESS PHONE: 508 553-8850 MAIL ADDRESS: STREET 1: 10 FORGE PARKWAY CITY: FRANKLIN STATE: MA ZIP: 02038 FORMER COMPANY: FORMER CONFORMED NAME: SONTRA MEDICAL CORP DATE OF NAME CHANGE: 20020702 FORMER COMPANY: FORMER CONFORMED NAME: CHOICETEL COMMUNICATIONS INC/MN/ DATE OF NAME CHANGE: 20020701 FORMER COMPANY: FORMER CONFORMED NAME: SONTRA MEDICAL CORP DATE OF NAME CHANGE: 20020701 8-K 1 w51436e8vk.htm FORM 8-K e8vk
 

 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): March 13, 2008
 
Echo Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
         
Minnesota   000-23017   41-1649949
(State or Other Jurisdiction   (Commission File Number)   (I.R.S. Employer
of Incorporation)       Identification No.)
         
10 Forge Parkway
  02038
Franklin, Massachusetts
   
(Address of Principal Executive Offices)
  (Zip Code)
Registrant’s telephone number, including area code: (508) 553-8850
(Former name or former address, if changed since last report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


 

Item 7.01 Regulation FD Disclosure.
     The Registrant is hosting a webinar at 10:30 am, eastern time, on March 13, 2008. Please see the press release and script attached as Exhibit 99.1 and Exhibit 99.2.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
     
Exhibit No.   Description
 
   
99.1
  Press Release dated March 13, 2008.
 
   
99.2
  Script for Webinar dated March 13, 2008.

 


 

SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         


Dated: March 13, 2008
ECHO THERAPEUTICS, INC.    
 
  By:   /s/ Harry G. Mitchell    
    Harry G. Mitchell   
    Chief Operating Officer and
Chief Financial Officer 
 
 

 


 

EXHIBIT INDEX
         
Exhibit No.   Description  
 
       
99.1
 
Press Release dated March 13, 2008.
 
       
99.2
  Script for Webinar dated March 13, 2008.

 

EX-99.1 2 w51436exv99w1.htm PRESS RELEASE exv99w1
 

Exhibit 99.1
     
(ECHO THERAPEUTICS LOGO)
  Investor Relations Contacts:

Patrick T. Mooney, M.D.
Chairman & CEO
Echo Therapeutics
508-530-0329

Lilian Stern
Stern Investor Relations
212-362-1200
Echo Therapeutics Announces Positive Results from Symphony™ Transdermal Continuous Glucose
Monitoring System Study at Tufts Medical Center
Franklin, MA — March 13, 2008 — Echo Therapeutics (OTCBB: ECTE) today announced positive results from its clinical study of the Symphony™ tCGM System, a novel, non-invasive, transdermal continuous glucose monitoring (tCGM) system, conducted at the Tufts Medical Center in Boston, Massachusetts (Tufts). Echo is developing the Symphony tCGM System to provide patients with diabetes and healthcare professionals with a reliable, needle-free, wireless, continuous monitoring system to better manage diabetes and control blood glucose levels in the home use and hospital critical care settings. Data from the pilot study demonstrate that Symphony safely and reliably monitored blood glucose levels in the challenging operative and surgical intensive care unit at Tufts. Echo is planning to present these data at a major medical conference later this year.
“We are proud to be the first company to report positive clinical data on a non-invasive, transdermal continuous glucose monitoring system in the hospital critical care setting,” stated Patrick Mooney, M.D., Echo’s Chairman and CEO. “We are excited about the potential for our program in this area and look forward to continued progress with tCGM in both the home and hospital settings, with further studies planned throughout 2008.”
“Critically ill patients need tighter glycemic control to minimize morbidity and mortality,” said Stanley Nasraway, M.D., Director of Surgical Intensive Care Units at Tufts and the Principal Investigator of the study. “These data serve as a strong signal that Symphony could advance the standard of care regarding tight glycemic control in the hospital critical care setting, much like continuous electrocardiographic monitoring and pulse oximetry changed standards of care in that setting. This approach could provide doctors and nurses with breakthrough continuous blood glucometry technology and significantly improve our ability to monitor glucose levels of seriously ill patients in the intense intra-operative and post-operative settings.”

 


 

Study Design
The pilot study was designed to evaluate the performance of Echo’s current generation Symphony tCGM System, including the use of its ultrasound-based skin permeation system and newly-improved biosensor technology incorporating proprietary hydrogel chemistry. The study was performed at Tufts and enrolled twenty-five (25) adult patients scheduled for elective cardiac surgery. The study included both intra-operative and post-operative continuous monitoring of blood glucose (BG) levels. Two biosensors were applied to each subject, one prior to surgery and one after surgery. Both Symphony sensors remained on the patient for 24 hours. BG levels were monitored per the established protocol of Tufts. The participating subjects and the Tufts medical staff were blinded to data collected by the Symphony monitor.
Analytical Methods
In this trial, the continuous data were compared to reference measurements from blood analyzers, glucometers and lab results based on the Tufts glucose monitoring protocols. Those reference measurements were paired with the Symphony results through a data analysis algorithm.. The primary statistical tools used to evaluate the performance of Symphony were Clarke Error Grid analysis and Mean Absolute Relative Difference (MARD). The Clarke Error Grid analysis was designed to evaluate the performance of glucometers and is used as an analytical tool to assess performance of continuous glucose monitors. The Clarke Error Grid is a plot of all data pairs categorized into five discrete areas: A, B, C, D and E. The A and B areas are the most clinically desirable zones and D and E are the least clinically desirable zones. Devices with a higher combined A and B percentage (closer to 100%) and lower combined D and E percentage (closer to 0) are considered to have better performance. Monitor performance is generally considered acceptable if at least ninety-five percent (95%) of the data points fall within the A/B region, along with negligible or no D/E points. MARD is an error calculation tool that measures the average relative difference between Symphony and the reference measurements, on a percentage basis. A low MARD error, below 20%, is consistent with an accurate device.
Results
Using approximately 1200 hours of continuous data from Symphony and 482 reference BG measurements from the 25 subjects, Clarke Error Grid analysis of the study data showed that Echo’s Symphony had over 97% of the data in the combined A and B percentages with approximately 70% in the “A” region, 27% in the “B” region, and less than 3% in the “D” region. The MARD for the study was approximately 16%. A total of forty-nine (49) Symphony sensors were used during the study. There were no Symphony failures and no adverse events, indicating strong reliability of the Symphony for applications in the hospital critical care setting.
Conference Call and Webcast Information
The Company will host a conference call at 10:30 AM ET to discuss the data and an update of its pipeline. To access the conference call, please dial 866-467-0407 (domestic) or 706-902-0164 (international) and reference the conference ID 39282879. A replay of the call will be available from 10:30 a.m. EST on March 13, until March 15, 2008, at midnight. To access the replay, please dial 800-642-1687 (domestic) or 706-645-9291 (international) and reference the conference ID 39282879. A live audio webcast of the call and the archived webcast will be available in the Investors section of the Echo Therapeutics website www.echotx.com.

 


 

About Echo Therapeutics
Echo Therapeutics is focused on specialty pharmaceuticals and medical devices. Echo is developing novel topical reformulations of FDA-approved products and non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) systems for people with diabetes and for use by healthcare professionals in hospital critical care units worldwide.
Cautionary Statement Regarding Forward Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks related to regulatory approvals and the success of Echo’s ongoing studies regarding the efficacy of Echo’s tCGM systems, the failure of future development and preliminary marketing efforts related to Echo’s tCGM systems, risks and uncertainties relating to Echo’s ability to develop, market and sell diagnostic products based on its skin permeation platform technologies, the availability of substantial additional equity capital to support robust research, development and product commercialization activities, and the success of research, development, and regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to Echo’s tCGM systems. Furthermore, Echo’s transdermal continuous glucose monitoring systems have not yet been approved for sale. The regulatory approval process for its tCGM systems involves, among other things, successfully completing clinical trials and obtaining a premarket approval, or PMA, from the FDA. The PMA process requires Echo to prove the safety and efficacy of its tCGM systems to the FDA’s satisfaction. This process can be expensive and uncertain, and there is no guarantee that Echo will be able to submit a PMA for its Symphony tCGM System or that its Symphony tCGM System will be approved by the FDA in any specific timeframe or at all. In addition, clinical testing of Echo’s products and eventual commercialization of its products are subject to all of the risks and uncertainties set forth in its periodic reports filed with the Securities and Exchange Commission.
These and other factors are identified and described in more detail in Echo’s filings with the Securities and Exchange Commission, including, without limitation, Echo’s respective annual reports on Form 10-KSB for the year ended December 31, 2006, Echo’s most recent quarterly reports on Form 10-QSB, and Echo’s current reports on Form 8-K. The foregoing list of factors is not exhaustive. Echo Therapeutics, Inc. undertakes no obligation to publicly update or revise any forward-looking statements.
(ECHO THERAPEUTICS LOGO)
10 Forge Parkway
Franklin, MA 02038, USA
Tel: 1+ 877-476-6878
Fax: 1+ 508-553-8760
www.echotx.com
     © 2002 — 2008 Echo Therapeutics, Inc. All rights reserved worldwide.

 

EX-99.2 3 w51436exv99w2.htm SCRIPT FOR WEBINAR exv99w2
 

Echo Therapeutics
Symphony Data Results Conference Call Script
March 13, 2008
Speaker Dial in Number:   866-467-0407
Confirmation Number:   “Speaker”
8:25 AM: Dial into the speaker line
8:29 AM: The operator will ask for a minute of silence before beginning the call.
8:30 AM: Operator begins speaking
Conference call operator:
Good morning ladies and gentlemen. Welcome to the Echo Therapeutics conference call. At this time all participants are in a listen-only mode. We will be facilitating a question and answer session at the end of today’s conference.
I would now like to turn the call over to the Echo team. Please proceed.

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 2 of 21
Melanie:
Thank you. My name is Melanie Friedman of Stern Investor Relations. I would like to welcome you to the Echo Therapeutics conference call and webcast to review the company’s Symphony data. With me today from Echo are Chairman and CEO, Dr. Patrick Mooney.
Before we begin the call, I would like to remind you that today’s discussion will contain forward-looking statements that involve risks and uncertainties. These risks and uncertainties are outlined in today’s press release and in our recent filings with the Securities and Exchange Commission. Our actual results may differ materially from what is discussed on today’s call.

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 3 of 21
I will now turn the call over to Echo’s CEO, Dr. Patrick Mooney.
Pat:
Thank you, Melanie and thanks to everyone taking the time to join the call this morning.
With me today from the Echo team are Dr. Han Chuang, director of R&D and Wayne Menzie, director of technology and clinical development. We are pleased to be here with you all today to discuss the positive results from our pilot clinical study of the Symphony™ tCGM System, a novel, non-invasive, needle-free, transdermal continuous glucose monitoring system, conducted at Tufts Medical Center in Boston. We are

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 4 of 21
developing the Symphony tCGM System to provide people with diabetes and healthcare professionals with a reliable, needle-free, wireless, continuous monitoring system to better manage glucose levels in patients with diabetes and to better control blood glucose levels in diabetic and non-diabetic patients in the hospital critical care setting. Data from this pilot study demonstrate that Symphony safely and reliably monitored blood glucose levels during open heart surgery and the challenging post-operative recovery period in the Tufts cardiac surgery intensive care unit.

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 5 of 21
As you all may know, diabetes is the sixth leading cause of death in the U.S. and is associated with several serious potential complications, including coronary and vascular disease, retinopathy, neuropathy, and nephropathy. These complications generally arise as a result of diabetic patients not keeping tight control of their glucose levels; in other words they do not keep glucose levels in a normal range. As a result, in diabetics, hyperglycemia, which is high levels of circulating blood glucose, leads to those long term, serious complications associated with the disease. Additionally, hypoglycemia is a potentially life threatening consequence of having blood glucose that is too low. Serious hypoglycemia can even lead to coma

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 6 of 21
and death. As a result, patients with diabetes and patients in the hospital setting need to check their glucose levels frequently.
It is estimated that the global glucose monitoring market is greater than $7 billion and is significantly under-penetrated.
In the Type 1 or Type 2 home use diabetes market, finger-stick capillary blood glucose monitoring is the standard-of-care for managing one’s glucose levels. For critically ill patients in the hospital setting, with or without diabetes, glucose levels are checked more frequently. In fact, in some hospitals, intensive care patients get their glucose levels check as frequently as every hour. Depending on the hospital, or the setting within a particular hospital, methods of evaluating glucose levels vary

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 7 of 21
from spot, finger-stick capillary testing to full laboratory analysis. However, all of these methods of testing, either in the home use or hospital based setting, have significant limitations and are, to varying degrees, inconvenient for the many diabetic or non-diabetic critically ill patients and healthcare practitioners that take care of these patients. In the hospital in particular, frequent glucose testing places significant additional stress on an already overburdened nursing staff. These are major problems that result in decreased frequency of glucose testing. It is estimated that a diabetic patient who checks their blood glucose levels 4 times daily, as recommended by the American Diabetes Association, may miss up to 80% of hypo- or hyperglycemic excursions. The reason for this is simple. Finger stick testing

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 8 of 21
only provides a snapshot of a patient’s glucose level at a particular point in time. That data point does not provide any visibility on what that patient’s glucose level is 10 minutes later, let alone 1 or 2 hours later. Also, and perhaps more importantly, the medical literature is clear that critical care patients need tighter glycemic control in order to minimize the morbidity and mortality that results from dangerous glycemic excursions and to improve patient outcomes in the critical care setting. More and more hospital intensive care units have adopted strict glucose monitoring protocols—as much as every hour. However, surgeons and critical care physicians who take care of these unit-based patients readily acknowledge that more frequent testing—that is, more frequent than every hour—would

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 9 of 21
clearly be better and likely lead to better patient outcomes in the critical care units. As a result of all of this, it is clear that having non-invasive, continuous glucose level data that is sent wirelessly to a small handheld monitor that is easy to read and could alarm if glucose levels were too high or too low, provides significant advantages.
So, best practices in both settings are clear: more frequent glucose testing. In the hospital the trend is to advance the monitoring of blood glucose from the current standard of once every 1- 2 hours to more frequent, and if possible, needle-free, continuous testing. We believe that when this happens, blood glucose measurements could become the 5th Vital Sign, and

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 10 of 21
tighter glycemic control, without serious hypoglycemia, will be the standard of care for all seriously ill hospitalized patients, worldwide.
Our Symphony System generates needle-free, continuous glucose level readings and trend information that lead to improved compliance and allow for tighter control of glucose levels.
It is estimated that the hospital critical care market for glucose monitoring will grow to $500 million by 2010. That estimate does not include the adoption of continuous glucose monitoring on a hospital-wide basis, which we believe would only be practical with a needle-free, continuous and wireless system.

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 11 of 21
We believe Symphony will represent an important option for both physicians and patients as it will provide a completely needle free, non-invasive way to continuously monitor glucose.
At this time I would now like to review the study design and data.
The pilot study was designed to evaluate the performance of our current generation Symphony System, including the use of our ultrasound-based skin permeation system and newly-improved biosensor technology incorporating proprietary hydrogel chemistry. The study was performed at Tufts and enrolled

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 12 of 21
twenty-five adult patients scheduled for elective cardiac surgery and included both intra-operative and post-operative continuous, non-invasive monitoring of blood glucose levels. Two Symphony System biosensors were applied to each patient, one prior to surgery and one after surgery, and these sensors remained on the patient for 24 hours while their blood glucose levels were monitored according to the established Tufts protocol. The participating subjects and the Tufts medical staff were blinded to data collected by the Symphony system.
I’d now like to take a few minutes to explain the measurements used to analyze the data from the study. The continuous data were compared to reference measurements of blood analyzers,

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 13 of 21
glucometers and lab results at various times based on the Tufts glucose monitoring protocols. Those paired measurements were then populated into data pairs through the computation of a data processing algorithm. The primary statistical tools used to evaluate the performance of Symphony were Clarke Error Grid analysis and Mean Absolute Relative Difference, or MARD.
The Clarke Error Grid analysis was designed to evaluate the performance of handheld glucometers and is one of several analytical tools used to assess performance of continuous glucose monitors. The Clarke Error Grid is a plot of all data pairs categorized into five discrete areas: A, B, C, D and E. The A and B areas are the most clinically desirable zones and D and

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 14 of 21
E are the least clinically desirable zones. Devices with a higher combined A and B percentage, closer to 100%, and lower combined D and E percentage, closer to 0, are considered to have better performance. Monitor performance is generally considered acceptable if at least 95% of the data points fall within the A/B region, along with negligible or no D/E points.
MARD is an error calculation tool that measures the average disparity between Symphony data and the reference measurements, on a percentage basis. A low MARD error, below 20%, is consistent with a device that has better performance.

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 15 of 21
So, in this study, Clarke Error Grid analysis of the data showed that Symphony had approximately 97% combined A and B percentages with approximately 70% in the “A” region, 27% in the “B” region, and less than 3% in the “D” region. The MARD for the study was approximately 16%.
Importantly, over 1200 hours of continuous data were collected from the 49 Symphony study sensors. Additionally, 482 study reference data points were successfully collected from the 25 patients. There were no “out-of-the-box” failures with the Symphony sensor—meaning that all 49 monitoring systems functioned well without any failure. This fact demonstrates that

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 16 of 21
Symphony is reliable. Finally there were no adverse events attributed to Symphony in the study.
As a result of these data we have concluded that this study has demonstrated that Symphony has performed very well during and after open heart surgery and is safe and reliable. We feel that these results, the first and only data announced from a completely needle-free transdermal, continuous glucose monitoring system tested in critically ill humans, are very compelling and that Symphony could provide doctors and nurses with breakthrough continuous, needle-free glucometry and significantly improve their ability to monitor glucose levels and glucose trends of seriously ill patients in the intense intra- and post-operative settings. We are very pleased with the results

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 17 of 21
from study and look forward to further progress with additional clinical trials throughout the year.
We plan to present these data and a more detailed analysis at a major medical conference later this year.
Finally, I would like to provide guidance on our 2008 goals for the Symphony program.
    We plan to obtain technical feasibility with our next generation, cost-effective and easier-to-use Prelude™ skin preparation system used with our current Symphony System, in the next month or so;

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 18 of 21
    In the second quarter of 2008, we will start another home use based pilot study in patients with Type 1 or Type 2 diabetes utilizing our Prelude skin preparation system;
 
    In the third quarter of 2008, we will start an additional hospital based critical care study at multiple sights with several thought leaders in tight glycemic control in the surgical and intensive care setting. Again, in this study we plan to use our Prelude skin prep system in combination with our current generation Symphony biosensor technology;

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 19 of 21
    We will also continue to improve the reliability and accuracy of our Symphony transdermal biosensor and will look to advance the next generation of that technology into additional clinical studies throughout the second half of this year and early part of next year;
 
    We expect to begin hospital critical care and possibly diabetes home use PMA-enabling pivotal studies in the first part of next year;
 
    And, finally, given that we have unencumbered ownership of our Prelude-based Symphony tCGM System we plan to be aggressive in our corporate partnering discussions throughout this year and next as we advance the product through clinical studies.

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 20 of 21
In conclusion, I’d like to reiterate that we are very excited about the Symphony program and this validation data, and we look forward to continued progress with the program. We look forward to updating you as we meet our milestones in the coming year. We will now be happy to take any questions.
Q&A
Pat:
Thank you for joining us today. We look forward to keeping you informed of our progress on future calls.

 


 

Echo Therapeutics
Symphony Results Conference Call
Page 21 of 21

 

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