Alliqua Demonstrates Wound Healing Benefit of SilverSeal® Dressing on Foot and Ankle Post-Surgical Wounds
- Reduction in Scarring and Incidence of Infections Observed -
NEW YORK, Feb. 11, 2013 /PRNewswire/ -- Alliqua, Inc. (OTCQB:ALQA) ("Alliqua" or the "Company") today announced interim results from a post-marketing pilot study to investigate the reduction in scarring and incidence of infection conferred by Alliqua's SilverSeal® dressing compared to that of a standard petroleum-based dressing in patients who had undergone foot and ankle surgery. Preliminary results at four weeks show reduced incidence of infection as well as a greater reduction in scar length, width and height among patients using SilverSeal® compared to those who had the control dressing applied. Study results are being presented at the annual meeting of the American College of Foot and Ankle Surgeons ("ACFAS"), taking place February 11-14, 2013 in Las Vegas, NV.
"I was very impressed with the early results seen in this study compared to the traditional petroleum-based dressing," said Stephen A. Brigido, DPM, director of the foot and ankle fellowship at Coordinated Health and an investigator in the Alliqua study. "The importance of controlling bioburden in wounds cannot be over-emphasized. The trend we're noting in reduced infection rate in the SilverSeal® group and assumed reduction in bioburden may certainly be playing a role in the reduction in dehiscence and scarring. Reduced scarring, in turn, is associated with improvements in both appearance and movement, as scar tissue can impair joint articulation. I believe these characteristics have significant benefits for patients."
David Johnson, Alliqua's chief executive officer added, "These preliminary results are quite promising and we're looking forward to presentation of the complete data set. Based on what we're seeing, I believe that SilverSeal® may have the potential to be a cost-effective and easy-to-use solution to bring down infection-related healthcare costs and at the same time significantly improve patient care."
In this study 62 patients who had undergone ankle and foot (including forefoot, midfoot or hindfoot) surgery were randomized 1:1 to receive either Alliqua's silver-impregnated SilverSeal® dressing or a standard petroleum-based dressing. Following surgery, all patients were evaluated for three months following surgery to assess degree of scarring, the presence of superficial or deep infections, and dehiscence (the re-opening of surgical wounds).
At four weeks, 30 patients had been assessed for infection and dehiscence. In these preliminary results, there were no cases of post-operative infection reported in the 15 patients who received the SilverSeal® dressing and three infections in patients who received the petroleum-based dressing. Moreover, none of the SilverSeal® patients experienced dehiscence. At the time of the data submission, complete scar metrics were available for eight patients. Among these eight, those in the SilverSeal® group experienced greater reductions in average scar length, width and height compared to those patients with petroleum-based dressings. Complete results from the entire study population will be presented at a future medical meeting.
These results are summarized in a poster titled "Utilization of Silver Hydrogel Sheet Dressing on Post-Surgical Wounds: A Pilot Study in Foot & Ankle Surgery" that is being presented at the ACFAS meeting in a poster session that is open from February 11-13, 2013.
About Alliqua, Inc.
Alliqua, Inc. (ALQA) ("Alliqua") is a biopharmaceutical company focused on the development, manufacturing, and distribution of proprietary transdermal wound care and drug delivery technologies. Alliqua's leading technology platform produces hydrogels, a 3-dimensional cross-linked network of water soluble polymers capable of numerous chemical configurations.
Alliqua currently markets its new line of 510K FDA-approved hydrogel products for wound care under the SilverSeal® brand. Alliqua's electron beam production process, located at its 16,000 square foot GMP manufacturing facility in Langhorne PA, allows Alliqua to aggressively develop and custom manufacture a wide variety of hydrogels. Alliqua's hydrogels can be customized for various transdermal applications to address market opportunities in the treatment of wounds as well as the delivery of numerous drugs or other agents for pharmaceutical and cosmetic industries. Additionally, Alliqua's drug delivery platform, in combination with certain active pharmaceutical ingredients, can provide pharmaceutical companies with a transdermal technology to enhance patient compliance and potentially extend the patent life of valuable drug franchises. Additionally, our subsidiary, HepaLife Biosystems, Inc., focuses on the development of a cell-based bioartificial liver system, known as HepaMate™.
Any statements contained in this press release regarding our ongoing research and development and the results attained by us to-date have not been evaluated by the Food and Drug Administration.
Legal Notice Regarding Forward-Looking Statements
This release contains forward-looking statements. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties outside of the our control that can make such statements untrue, including, but not limited to, inadequate capital, adverse economic conditions, intense competition, lack of meaningful research results, entry of new competitors and products, adverse federal, state and local government regulation, termination of contracts or agreements, technological obsolescence of our products, technical problems with our research and products, price increases for supplies and components, inability to carry out research, development and commercialization plans, loss or retirement of key executives and research scientists and other specific risks. We currently have no commercial products intended to diagnose, treat, prevent or cure any disease. The statements contained in this press release regarding our ongoing research and development and the results attained by us to-date have not been evaluated by the Food and Drug Administration. There can be no assurance that further research and development, and/or whether clinical trial results, if any, will validate and support the results of our preliminary research and studies. Further, there can be no assurance that the necessary regulatory approvals will be obtained or that we will be able to develop new products on the basis of our technologies. In addition, other factors that could cause actual results to differ materially are discussed in our Annual Report on Form 10-K filed with the SEC on March 29, 2012 and our most recent Form 10-Q filings with the SEC. Investors and security holders are urged to read these documents free of charge on the SEC's web site at www.sec.gov. We undertake no obligation to publicly update or revise our forward- looking statements as a result of new information, future events or otherwise.
Contacts for Alliqua, Inc.
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SOURCE Alliqua, Inc.
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