Healthcare Industry News: venous insufficiency
News Release - May 30, 2007
Derma Sciences Receives FDA Clearance for MOBILITY-1(TM) Treatment of Vascular Diseases
PRINCETON, N.J.--(HSMN NewsFeed)--Derma Sciences, Inc. (OTCBB: DSCI ), a manufacturer and full line supplier of advanced wound care products, today announced that it has obtained FDA clearance to market and sell its MOBILITY-1(TM) boot and compressor device for the treatment of Chronic venous insufficiency (CVI), Deep Vein Thrombosis (DVT) prevention, venous ulcers, lymphedema, and other conditions that require compression therapy, including the enhancement of blood circulation during recovery from coronary artery bypass graft surgery and orthopedic hip and knee replacements.Previously, the company had obtained clearance for the sale of the compression boot. The additional clearance to sell the compressor will allow MOBILITY-1(TM) to more effectively compete with other standard intermittent compression (IPC) therapy devices that require an electronic compressor, currently a $40 million dollar market in the US. The fact that MOBILITY-1(TM) provides patients the ability to take their therapy outside the home allows it to additionally compete in the $80 million static compression dressings market. Derma Sciences believes that receipt of FDA clearance will also expedite its receipt of Medicare reimbursement codes.
"MOBILITY-1(TM), used as a system (the boot in conjunction with the electronic compressor), will provide significant benefits over competitive devices for patients who are ambulatory and do not want to be confined to their homes for therapy," said Barry J. Wolfenson, VP of Marketing & Business Development. "Patients will be able to take the system to their places of work, as well as on vacation and anywhere else it would be convenient for them to receive optimal therapy. We believe this added flexibility will not only improve patient's quality of life, but will also provide the economic benefit of not missing as many days of work. We will shortly be initiating a trial to demonstrate this economic benefit, which we hope will make MOBILITY-1(TM) the standard of care within managed care organizations when IPC therapy is initially prescribed."
A study conducted by Frost & Sullivan estimates that the market for compression devices to treat venous ulcers alone reached $156 million in 2006. That market becomes significantly larger when accounting for patients with lymphedema and other chronic venous insufficiencies. The Company believes MOBILITY-1(TM) will become the standard treatment for ambulatory patients with vascular diseases who do not benefit from static compression modalities.
MOBILITY-1(TM) includes a lightweight wearable dynamic compression device that periodically inflates and deflates thereby producing segmented and therapeutically significant compression, generated either by the walking motion of the patient or through a small electronic compressor. The device incorporates several patented design mechanisms, including the mechanism which allows the compression to be driven by the walking motion of the patient, as well as the check valves within the internal flow system which allow the device to control airflow and pressure internally, instead of by a larger external compressor. This, in turn, allows for the device's unique design and subsequent ability to have airflow provided by a very small and portable compressor. It is the only device of its kind that is cleared for the treatment of chronic venous insufficiency, venous leg ulcers, lymphedema and deep vein thrombosis.
About Derma Sciences, Inc.
Derma Sciences, Inc. provides a full range of skin care; wound management and specialty securement devices that are used primarily in the professional markets, specifically hospitals, nursing homes and home care settings. For more information about Derma Sciences, Inc., visit its home page on the Internet at http://www.dermasciences.com.
Forward-looking Statements
Statements contained in this release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward-looking statements. Readers are cautioned, that certain important factors may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements which may be made in this release or which are otherwise made by or on behalf of the Company. Factors which may affect the Company's results include, but are not limited to, product demand, market acceptance, impact of competitive products and prices, product development, completion of an acquisition, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks. Additional factors that could cause or contribute to differences between the Company's actual results and forward-looking statements Include but are not limited to, those discussed in the Company's filings with the Securities and Exchange Commission.
Source: Derma Sciences
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