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YAVNE, Israel, March 03, 2017 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announces that outcomes from an independent cost analysis review utilizing NexoBrid in severe burn management compared with standard-of-care (SOC) were published in the February edition of the journal, BioMedical Research International, in an article titled, “Cost Analysis of a Novel Enzymatic Debriding Agent for Management of Burn Wounds.” The full text of the article can be accessed here.
The study results showed that the 10 patients treated with NexoBrid demonstrated total net savings of €53,300 compared with the SOC. The confidence interval analysis confirmed the savings. These results showed significant savings are obtained with the use of NexoBrid.
NexoBrid is an easy-to-use, topically-applied pharmaceutical treatment for severe burns that removes dead or damaged tissue, known as “eschar”, in approximately four hours without harming the surrounding healthy tissue.
The study was conducted at the Burn Unit of the University Hospital Policlinio e Giovanni XXIII in Bari, Italy. The study assessed the cost of treatment with NexoBrid compared with the SOC cost in 20 adult patients with intermediate-deep thermal burns of 14–22% total body surface area (TBSA) in a 1:1 ratio. SOC was defined as surgical excision (first surgical step) followed by autografting surgery (second surgical step). In the 10 patients treated with NexoBrid, the first surgical step was not performed.
NexoBrid was applied in an ambulatory or bed-side setting 30 minutes after minor patient intravenous sedation and analgesia. One physician and one nurse were involved in the process. After four hours, the product was removed, and saline soaks were left in place for four to 10 hours before proceeding with standard dressing. In four patients treated by NexoBrid, all burns healed spontaneously without the need for additional skin grafting whereas all patients treated by SOC required skin grafting.
The cost analysis was performed in accordance with the weighted average Italian Health Ministry Diagnosis Related Groups (DRGs) and with Conferenza Stato/Regioni 2003 and the study by Tan et al. For each cost, 95% confidence intervals were evaluated.
“We are particularly pleased with the publication of this very favorable cost analysis review as it supports both the clinical and economic benefits of NexoBrid compared with the current standard-of-care in the routine management of severe burns. The results show that using NexoBrid significantly reduces costs due to fewer surgeries, less blood loss and less time in the Intensive Care Unit (ICU). We believe that the growing body of independent cost effectiveness data generated by various burn centers across Europe in routine burn management will provide the foundation from which to grow and expand reimbursement for NexoBrid as we transition it to become the new standard-of-care in the treatment of severe burns,” stated Gal Cohen, Chief Executive Officer of MediWound.
The review also concluded that:
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, chronic and other hard-to-heal wounds. MediWound’s first innovative biopharmaceutical product, NexoBrid®, received marketing authorization from the European Medicines Agency as well as the Israeli and Argentinian Ministries of Health, for removal of dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns and was launched in Europe, Israel and Argentina. 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 tissue.
MediWound's second innovative product, EscharEx®, is a topical biological drug being developed for debridement of chronic and other hard-to-heal wounds and is complementary to the large number of existing wound healing products, which require a clean wound bed in order to heal the wound. EscharEx contains the same proteolytic enzyme technology as NexoBrid, and benefits from the wealth of existing development data on NexoBrid. In two Phase 2 studies, EscharEx demonstrated safety and efficacy in the debridement of chronic and other hard-to-heal wounds, within a few daily applications.
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 the regulatory authorizations and launch dates. 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, 2016 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.
Chief Financial and Operations Officer
|Anne Marie Fields|
Senior Vice President
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