Echo Therapeutics, Inc. engages in the development of transdermal skin permeation and diagnostic medical devices and specialty pharmaceutical drugs. Products Continuous Glucose Monitoring (CGM) The company’s major product is a non-invasive (needle-free), wireless, CGM system designed to provide real-time glucose data continuously. The CGM System includes a skin preparation device, transdermal glucose sensor and wireless transmitter. The transdermal skin preparation component of the system has been developed to be a device to improve access to the interstitial fluids and improve the flow of molecules across the protective membrane of the stratum corneum. The skin preparation device incorporates the company’s patented micro-abrasion technology into a hand-held device used to prepare a small area of the skin. The non-invasive sensor is applied to this prepared area to measure the interstitial glucose levels. The key feature of the company’s skin preparation device is its patented feedback mechanism, which allows the company to achieve optimal skin preparation for its transdermal sensing technologies. The device’s proprietary, patented feedback control mechanism consists of software, a microprocessor controlled circuit and measuring electrodes. After the skin is prepared, the electro-chemical glucose sensor is placed on the prepared site. The glucose sensor uses glucose oxidase to generate a continuous current that is proportional to the concentration of blood glucose in the vessels beneath the epidermis. Glucose data is then wirelessly transmitted in numerical and/or graphical form every minute to any remote device. Drug Delivery The company’s skin preparation device might also have application in the transdermal drug delivery market in addition to markets for other treatments. The localized removal of the stratum corneum created by the device might potentially provide a skin permeation process for the delivery of various topical pharmaceuticals and to facilitate other applications. Specialty Pharmaceutical Products The company’s transdermal drug reformulation platform, AzoneTS, is a penetration improver at low concentration levels. AzoneTS has the potential to expand the number of drugs that could be delivered transdermally in various therapeutic categories. The company’s most advanced drug candidate is Durhalieve, an AzoneTS formulation of triamcinolone acetonide, a medium potency corticosteroid approved by the United States Food and Drug Administration (FDA) for treatment of corticosteroid-responsive dermatoses. Durhalieve has completed Phase 3 clinical trials, and to obtain FDA approval, the company must satisfy certain clinical and manufacturing development requirements outlined by the FDA when they last reviewed the Durhalieve New Drug Application. Additionally, the company has modestly advanced the development programs for early stage AzoneTS reformulation drug candidates, including methotrexate-AzoneTS (MAZ). The company holds Investigational New Drug Applications for MAZ formulations for the treatment of psoriasis and mycoses fungoides, and has completed Phase 2 clinical studies of MAZ for the treatment of early-stage mycoses fungoides. In addition, the company has made annual and other applicable regulatory filings necessary to maintain the active status of the Azone Drug Master File, the Durhalieve and MAZ Investigational New Drug applications and the MAZ Orphan Drug application with the FDA. Partnerships Ferndale Pharma Group, Inc. (Ferndale) The company has a licensing agreement with Ferndale, a group of companies that specialize in the development, manufacture, distribution and marketing of various dermatologic products. Under the terms of the agreement, the company granted Ferndale the right to develop, market, sell and distribute the company’s skin preparation device for skin preparation prior to the application of topical anesthetics or analgesics prior to a range of needle-based medical procedures. In addition to the original territory of North America and the United Kingdom, the license agreement was amended in 2012 to cover South America, Australia, New Zealand, Switzerland and portion of the European Community. This partnership allows the company’s skin permeation technology platform to be combined with Ferndale’s leadership in the topical anesthetic market. Handok, Inc. The company has a license agreement with Handok Inc., a pharmaceutical/healthcare company in Korea with a core business focus in diabetes, cardiovascular, oncology, human vaccines, medical devices, diagnostics and consumer health. Under the terms of the agreement, the company granted Handok, Inc. the right to develop, market, sell and distribute the company’s CGM to medical facilities and individuals in South Korea. Medical Technologies Innovation Asia, Ltd. (MTIA) The company has a license, development and commercialization agreement (the ‘MTIA License’) with MTIA. Pursuant to the MTIA License, the company granted MTIA rights to exclusively research, develop, manufacture, and use the company’s CGM in connection with the development activities needed for regulatory approval in the People’s Republic of China, Hong Kong, Macau, and Taiwan; and exclusively make, have made, use, sell, have sold, offer for sale and import the company’s CGM in the Territory once regulatory approval has been received. Intellectual Property The company owns or has rights to various copyrights, trademarks and trade names used in its business, including Symphony CGM System, Symphony and Prelude SkinPrep System, Azone, AzoneTS, and Durhalieve. As of April 2, 2015, the company had 9 issued U.S. patents and approximately 70 issued foreign patents, and had approximately 25 patent applications pending worldwide. The company’s pharmaceutical patents begin expiring in 2019 and medical device patents begin expiring in 2025. Research and Development The company’s R&D expenses were approximately $4,962,000 for the year ended December 31, 2014. History Echo Therapeutics, Inc. was founded in 1989.
echo therapeutics inc (ECTE:OTC US)
99 Wood Avenue South
Iselin, NJ 08830
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