YAVNE, Israel, Nov. 2, 2015 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq:MDWD), a fully integrated biopharmaceutical company specializing in innovative therapies to address unmet needs in severe burn and wound management, announced today that it has provided its flagship product, NexoBrid, a drug for the removal of dead or damaged tissue (eschar) in patients with severe burns, as humanitarian aid to treat patients who were severely burned during a massive fire that occurred at a nightclub in Bucharest, Romania on Friday, October 30, 2015. This mass casualty is one of the most serious disasters in Romania in recent years.
Immediately after learning about the disaster on Friday night, MediWound volunteered to send additional quantities of NexoBrid to Romanian hospitals as quickly as possible, as stock of NexoBrid in the region had been consumed by Romanian hospitals within hours of the event. In addition, MediWound sent two burn specialists from Israel and Europe, who are experts at administering NexoBrid, to help treat the many wounded patients hospitalized in burn centers in Romania.
MediWound's product, NexoBrid, was granted marketing authorization from the European Medicines Agency (EMA) and the Israeli and Argentinean Ministries of Health for the removal of eschar in adults with deep partial and full-thickness thermal burns. NexoBrid represents a new paradigm in burn care management having demonstrated in clinical studies, with statistical significance, its ability to non-surgically and rapidly remove in a single, four-hour application the eschar, earlier than other modalities, without harming viable tissue. In clinical studies NexoBrid has demonstrated a significant reduction in surgical burden with long-term outcomes that are comparable to the current surgical treatment.
"The disaster in Romania underscores the important role NexoBrid can have in treating severe burn patients, particularly in mass casualty incidents, where the capacity to carry out surgeries is limited and the need for diagnosis of the injury and for rapid medical intervention is critical," stated Gal Cohen, President and Chief Executive Officer of MediWound. "Unfortunately, mass casualty incidents are not limited to extensive terrorist attacks. There are civilian mass casualties as we have seen recently with the explosions at a Chinese chemical plant, and at an amusement park in Taiwan, each of which resulted in hundreds of burn victims. Even a multi-vehicle road accident could challenge burn treatment capacity and turn into a mass casualty incident.
"Recently, MediWound signed a contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA) for the advancement of the development and manufacturing, as well as the procurement of NexoBrid, as part of BARDA's preparedness for mass casualty events in the U.S. We look forward to working with various international agencies and governments to advance the use of NexoBrid for mass casualty and disaster preparedness.
"We want to thank Ambassador Zvi Heifetz and Dr. Zvi Herman Berkowitz, Honorary Consul of Romania in Israel and the personal doctor to the Israeli Prime Minister, for their quick coordination with the Romanian authorities as well as to Soroka Medical Center, for its willingness to send one of its top burn specialists to Romania to assist the medical teams on such short notice. MediWound is pleased to be able to help the disaster victims and wishes a full recovery to the injured patients," added Gal Cohen.
About MediWound Ltd.
MediWound is a fully integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, as well as chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid, received marketing authorization from the European Medicines Agency and from the Israeli and Argentinean Ministries of Health for removal of dead or damaged tissue, known as eschar, in adults with deep partial- and full-thickness thermal burns. NexoBrid represents a new paradigm in burn care management, and clinical trials have demonstrated, with statistical significance, its ability to non-surgically and rapidly remove the eschar earlier and, without harming viable tissues. For more information, please visit www.mediwound.com.
Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the US Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions and results related to financial results forecast, commercial results, clinical trials and the regulatory authorizations. In some cases, you can identify forward-looking statements by terminology such as "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," "predict," "potential," or the negative of these terms or other similar expressions. Forward-looking statements are based on MediWound's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors. In particular, you should consider the risks discussed under the heading "Risk Factors" in our annual report on Form 20-F for the year ended December 31, 2014 and information contained in other documents filed with or furnished to the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. The forward-looking statements made herein speak only as of the date of this announcement and MediWound undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
|Contacts:||Anne Marie Fields|
|Sharon Malka||Senior Vice President|
|Chief Financial & Operations Officer||LHA|