Echo Therapeutics Inc., developer of non-invasive, wireless, transdermal glucose monitoring systems, today announced positive results of a clinical study of its new and improved biosensor, the Symphony tCGM System, for patients with type 1 and type 2 Diabetes.
The Symphony tCGM System consists of the company’s wireless transmission and transdermal biosensor technologies, as well as its Prelude SkinPrep System, which incorporates needle-free, controlled skin ablation.
The study tested the performance of the system in glucose readings in ten patients with type 1 or type 2 Diabetes; results showed a 97 percent accuracy in the readings.
“This study represents another major step forward in our Symphony development program,” Patrick Mooney, M.D., Echo chairman and CEO stated in the press release. “We believe that we have successfully developed a new cost-effective, one-piece biosensor and, with this study, we have demonstrated improvement in the accuracy of our Symphony system glucose readings. Data from this study demonstrates that Symphony, using the new, improved, cost-effective biosensor, is safe, accurate and reliable at monitoring glucose levels. We look forward to continued progress with our Symphony development program throughout this year and next as we move toward our goal of making Symphony available to patients.”
The news sent shares of ECTE soaring nearly 15 percent to $3.15 in today’s early trade.
For more information visit www.echotx.com
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Yesterday, Echo Therapeutics, Inc. announced that it has received the key components of its next generation Symphony tCGM System design. This newly-engineered design is currently undergoing its final functionality testing. Echo is in the process of developing the Symphony™ tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system. It is also focused on developing its Prelude™ SkinPrep System for transdermal drug delivery.
The updated Symphony System will be ready for demonstration very soon. It will be further tested in a final series of clinical trials shortly thereafter, replacing the prototype used in earlier clinical trials. The new design incorporates numerous technological advances that will enable the product to meet market expectations for system accuracy, manufacturability and product cost. Echo believes that upon completion of the final development work, no significant changes will be made to the Symphony tCGM System, and that the newly-engineered device will be used for sale. The addressable market for needle-free, continuous wireless glucose monitoring in the hospital critical care setting exceeds $1 billion annually and the global glucose monitoring market exceeds $12 billion annually.
“We are excited to commence what we hope are the final series of modifications and testing as we move closer to our goal of a pivotal study which would form the basis of our application to the FDA for marketing clearance of the product-candidate,” said Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics. “We look forward to an exciting year of development progress and validating the improvements that we have made in clinical testing.”
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Echo Therapeutics, Inc. (OTC BB: ECTE) has their focus on thelate-stage development of transdermal diagnostic devices as well as specialty pharmaceuticals. The company is currently developing a needle-free, transdermal continuous glucose monitoring system in conjunction with novel transdermal reformulations of existing FDA-approved products. Echo Therapeutics hopes to change the paradigm of invasive, episodic glucose testing in diabetes home use and hospital critical care markets. For further information, visit the Company’s web site at www.echotx.com.
Echo Therapeutics is a medical device and specialty pharmaceutical company based out of Franklin, Massachusetts. The company is focused on developing a trans-dermal continuous glucose monitoring (tCGM) system and developing reformulations of a variety of FDA-approved specialty pharmaceutical products.
Echo is applying its patented AzoneTS™ trans-dermal drug formulation technology to create a suite of topical reformulations on FDA-approved products that are on the market today. The company plans to create the reformulations in accordance with the FDA’s Section 505(b)(2) guidelines. Echo intends to capitalize on its long-term relationship with Cato Research, a global contract research and development organization (CRO), and work in tandem with Cato to develop its suite of improved topical products.
Echo’s lead drug candidate, Durhalieve™, is an AzoneTS topical reformulation of triamcinolone acetonide. The company has submitted a new Drug Application (NDA) with the FDA classifying Durhalieve™ as a new, proprietary treatment for corticosteroid responsive dermatoses. By late-2008, Echo hopes to submit an Investigational New Drug (IND) application with the FDA that will allow Phase 2 clinical development of Durhalieve for treatment of keloid scarring and hypertrophic scarring.
The company is currently developing the next-generation glucose monitoring system for home or hospital use for diabetic patients. Echo’s Symphony™ System is slated to change the invasive and periodic glucose testing diabetic patients currently perform. Symphony™ combines Echo’s patented feedback mechanism for optimal skin permeation control with a non-invasive trans-dermal biosensor to provide continuous data on a patient’s glucose level. With the increasing number of individuals being diagnosed with Type-2 diabetes each year, the Symphony™ system will potentially improve patient compliance with better glucose control throughout the day, providing an improved quality of life for patients.
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Regulatory approval marks a major milestone for investors exploring the business environment for exceptional stock opportunities in the healthcare sector. Individuals and teams get brilliant ideas all the time, but only a tiny fraction of them make it past the eagle eyes of the US Food and Drug Administration (FDA). Here is a loss-making company with a novel technology that has passed all the stringent and exhaustive steps towards FDA approval.
The FDA does not consider economics, so investors must normally contend with the risk of infeasible selling prices or inadequate margins when buying stock on the basis of regulatory clearances alone. However, this is not a significant investment hazard in the case of the company under review here. The reason lies in a universal phobia from which we all suffer: it is normal to joke about being injected, but the stark business truth is that even hardened medical professionals quail when syringes armed with needles are turned on their arms.
This company has FDA approval for substituting painful needles with ultra-sound waves to transmit drugs across skin barriers. It makes losses as it expands this technological platform, and applies it to a wide range of drugs in common use. However, investors have bright prospects of gains, whether the company brings its technology to market alone, or whether the stock is acquired by a larger peer from the sector. A therapeutic area such as diabetes, in which more than one injection may be required daily for life, is so large and relatively price insensitive that this company’s core strength is a bright indicator of high future stock value.
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