HepaLife Technologies Announces 510(k) Submission to the FDA for Its Silver Based Antimicrobial Wound Dressing

Marketed under the Hydress +Plus™ Brand Name, the Silver Dressing Is Expected to Represent a Significant Driver for HepaLife’s Wound Care Portfolio

NEW YORK, N.Y.--(BUSINESS WIRE)--HepaLife Technologies, Inc. (OTCBB:HPLF) (FWB:HL1) (“HepaLife”), an advanced biomedical products company focused on the development and manufacturing of proprietary drug delivery and liver health technologies, today announced a 510(k) submission to the FDA by its AquaMed Technologies, Inc. (“AquaMed”) subsidiary seeking pre-market clearance for its silver based antimicrobial wound dressing.

“As the process for clearance takes place, we look forward to providing our shareholders with updates on this, as well as various other leading growth initiatives for our organization over the coming weeks and months.”

HepaLife intends for its silver based dressing, marketed under the Hydress +Plus™ brand name, to be an important addition to its existing wound care products. Silver, when moist, emits ions. Silver ions (Ag+) are bioactive and in sufficient concentration readily kill bacteria in both external wounds and in living tissue. Upon approval, the Hydress +Plus™ silver based dressings are expected to be manufactured by AquaMed, yet marketed and sold through HepaLife’s recently formed Alliqua BioMedical, Inc. (“Alliqua”) subsidiary, which will also be responsible for selling and marketing HepaLife’s various other hyrdrogel products going forward.

“We believe that this product represents an important step forward in the field of advanced wound care, and one which has the potential to drive our business opportunities in the near term,” said Matt Harriton, CEO of Alliqua. “The management team is committed to getting this product to market as quickly as possible while simultaneously developing strong distribution channels and marketing resources for its launch.”

Silver based wound dressings are becoming increasingly prevalent in wound care due to the recent increase of antibiotic-resistant bacteria such as methicillin-resistant Staphylococcus aureus, known as MRSA. The Company’s dressing is approximately 90% water based; hence, does not have the issues of requiring pre-wetting or absorption of transdermal water loss or wound exudate to become bioactive.

Mr. Harriton continued, “As the process for clearance takes place, we look forward to providing our shareholders with updates on this, as well as various other leading growth initiatives for our organization over the coming weeks and months.”

Management anticipates that the initial markets for the product will include diabetic ulcers, pressure sores, burns and post surgical applications. Management estimates that the number of diabetic ulcers in the U.S. is in excess of 2.5 million wounds and that there are over 30 million surgical procedures done in the US each year.

About HepaLife Technologies, Inc.

HepaLife Technologies, Inc. (OTCBB: HPLF) (FWB: HL1), is an advanced biomedical products company focused on the development and manufacturing of proprietary technologies in the fields of drug delivery, advanced wound care and liver health preservation. Through its recently formed subsidiary, Alliqua BioMedical, Inc., HepaLife intends to develop active ingredient and transdermal drug delivery products, primarily utilizing the proprietary hydrogel technology platform manufactured by HepaLife’s AquaMed Technologies, Inc. subsidiary.

AquaMed Technologies, Inc. (“AquaMed”), another wholly-owned subsidiary of HepaLife, manufactures custom hydrogels used for transdermal drug delivery, wound care, medical diagnostics, and cosmetics. These products use proprietary manufacturing technologies which enable AquaMed to produce what is known in the healthcare industry as high water content, electron beam cross-linked aqueous polymer sheet hydrogels. AquaMed believes that it is one of two known manufacturers in the world for these gels.

HepaLife Technologies, Inc. is also the developer of HepaMate™, an extracorporeal cell-based bioartificial liver system designed to combine blood detoxification with liver cell therapy to provide whole liver function in patients with the most severe forms of liver failure. HepaMate™ is comprised of a blood plasma separation cartridge, a hollow-fiber bioreactor filled with proprietary porcine liver cells, a charcoal column, an oxygenator, circuit tubing and a plasma reservoir. These components are assembled into a patented blood/plasma circulation system, which is placed on the HepaDrive™ perfusion platform.

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.

For additional information, please visit www.hepalife.com, and www.aquamedinc.com

To receive future press releases via email, please visit: http://www.hepalife.com/investor_alerts.php

Legal Notice Regarding Forward-Looking Statements

This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. 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, including but not limited to adverse economic conditions, intense competition, lack of meaningful research results, entry of new competitors and products, adverse federal, state and local government regulation, inadequate capital, 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 most recent Form 10-Q and Form 10-K filings with the Securities and Exchange Commission. 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.


TechConnect Wire™ press releases...

Annual Meeting

TechConnect World 2015