MediWound’s NexoBrid® Highlighted in 45 Posters and Presentations at the 19th European Burns Association Congress
MediWound (Nasdaq: MDWD) recently showcased its product NexoBrid at the European Burns Association Congress 2022 in Turin, Italy. The conference featured 45 presentations highlighting the efficacy of NexoBrid in various burn scenarios, with over 11,000 patients treated. The company's CEO expressed satisfaction with the product's visibility and anticipates a significant regulatory milestone with a target PDUFA date of January 1, 2023, for potential FDA approval. NexoBrid is already approved in the EU and designated as an orphan biologic in the U.S., setting a solid foundation for its commercial prospects.
- NexoBrid featured in 45 presentations at the EBA Congress, indicating strong clinical interest.
- Over 11,000 patients treated with NexoBrid, showcasing extensive real-world application.
- Positive feedback from burn specialists enhances the product's credibility and market potential.
- Anticipated PDUFA date for NexoBrid on January 1, 2023, indicating potential FDA approval.
- None.
YAVNE, Israel, Sept. 12, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD) (“MediWound”), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced its successful and meaningful presence at the recently concluded 19th European Burns Association (EBA) Congress held in Turin, Italy on September 7-10, 2022.
NexoBrid was included in 45 scientific posters and presentations by leaders in the field of burn care over the Congress' four days. They demonstrated their experiences and patient outcomes with NexoBrid in a wide range of settings.
“We were honored to see NexoBrid highlighted by leading European burn specialists who shared data and experiences with their peers at this prestigious event. The burn specialists presented their use of NexoBrid in routine and mass casualty events, in adults and in children, in the treatment of large burns, and in the treatment of burns on sensitive and important areas such as the face, hands and feet. With more than eleven thousand patients treated to date with NexoBrid, we continue to be committed to bringing this new, minimally invasive modality paradigm to severe burn patients, improving their course of care and their quality of life,” said Professor Lior Rosenberg, M.D., Chief Medical Officer of MediWound.
Ofer Gonen, MediWound’s Chief Executive Officer, added, “We are very pleased to see NexoBrid’s impressive and enthusiastic participation at this year’s EBA Congress. This premier conference draws thought leaders and burn care specialists from around the world and it is the ideal setting for us to showcase NexoBrid and leverage the strength of the clinical data from our recent studies. We look forward to our target PDUFA date of January 1, 2023.”
Detailed information about each presentation may be accessed online at https://www.eba2022.org/
About the European Burns Association
The European Burns Association (EBA) was founded in 1981 by leading burn specialists in Europe to encourage co-operation in the field of burn care throughout the continent. The EBA serves as the umbrella organization to all the national burn organizations. It is the forum through which medical specialists, researchers, professionals allied to medicine (PAM) and other workers come in contact to discuss aspects of burn treatment and research. In this way, expertise and knowledge are spread throughout the countries of Europe. The EBA hosts a Congress every other year with the aim to provide a forum for the exchange and exploration of new ideas, current outcomes and future perspectives. This year’s Congress focused on burn care from every perspective: from the patient’s journey to the interaction of all team members to preparedness to Burn Mass Casualties Incidents (BMCI), with an emphasis on current evidence-based delivery of care, quality of care, and outcome measurement.
About NexoBrid
NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union and other international markets. Vericel holds an exclusive license for North American commercial rights to NexoBrid. The pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-and full-thickness thermal burns up to
About MediWound
MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn care, wound care and tissue repair.
NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep-partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage with the Food and Drug Administration (FDA). NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).
EscharEx is our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. EscharEx is well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds within a few daily applications in several Phase 2 trials. A meeting with the FDA to discuss the pivotal study design is targeted for the second half of 2022.
MW005, our topical biological drug for the treatment of non-melanoma actinic (solar) skin cancers, is a clinical-stage product candidate under development. The initial data from a Phase I/II study showed MW005 to be safe and well-tolerated, with a majority of the patients who completed the study with MW005 achieving complete histological clearance of their target lesions. The Company anticipates announcing the final data in the second half of 2022.
Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.
Cautionary Note Regarding Forward-Looking Statements
MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.
Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives, anticipated timelines, expectations and commercial potential of our products and product candidates, including NexoBrid. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the European Medicines Agency or by any other regulatory authority; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and product candidates; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to “shelter at home” or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.
These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 17, 2022, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.
| Contacts: | Monique Kosse |
| Boaz Gur-Lavie | Managing Director |
| Chief Financial Officer | LifeSci Advisors |
| MediWound Ltd. | 212-915-3820 |
| ir@mediwound.com | monique@lifesciadvisors.com |
FAQ
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