MediWound Reports Third Quarter 2016 Financial Results

YAVNE, Israel, Nov. 14, 2016 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, reports financial results for the three and nine months ended September 30, 2016.

Highlights of the third quarter of 2016 include:
  • Third quarter 2016 Revenue of $518,000 compared with $102,000 in the prior year's third quarter, underscoring the Company's progress growing NexoBrid ® sales;
  • U.S. Phase 3 clinical trial protocol for NexoBrid to debride severe burns amended to increase the Total Body Surface Area (TBSA) of burn patients eligible for the study from 15% to 30%; and 
  • Multiple oral and poster presentations highlighting EscharEx ® and NexoBrid's innovative, effective and fast enzymatic debriding of severe burns and chronic wounds presented at the 18 th Congress of the International Society for Burn Injuries (ISBI).  

Management Commentary

"Our third quarter financial performance demonstrates progress in converting NexoBrid use into revenues.  The presentation of positive data at major burn meetings such as the ISBI continues to enhance interest as we work to transition NexoBrid to the standard-of-care for the debridement of severe burns," stated Gal Cohen, President and Chief Executive Officer of MediWound.  "Following discussions with U.S. Food and Drug Administration (FDA), we amended the protocol for our U.S. Phase 3 study of NexoBrid, to increase the TBSA of patients eligible for inclusion from 15% to 30%.  This amendment will allow for the inclusion of patients with larger TBSA and should support a broader marketing label. With the expansion of TBSA, we are required to collect additional data on this cohort of patients, which will require implementation of certain study adjustments.  As a result, we now expect to have the acute top-line data in the first half of 2018. 

"Earlier this year we were delighted to report compelling clinical efficacy and safety data from our Phase 2 study of EscharEx for the debridement of chronic and hard-to-heal wounds, particularly in diabetic foot ulcers and venous leg ulcers. We plan to submit our data package to the FDA by year-end, and expect to meet with the Agency in early 2017 to discuss a pivotal program for EscharEx in the U.S. We are excited to be advancing our clinical plan forward with the goal of making EscharEx available for the treatment of these indications.

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