YAVNE, Israel - MediWound Ltd. (NASDAQ:MDWD), a leader in enzymatic therapeutics for tissue repair, has released positive results from the NEXT Expanded Access Protocol, confirming the safety and efficacy of its product, NexoBrid, for eschar removal in burn patients. This program, which began in 2019, aimed to provide continuous access to NexoBrid at burn centers until its commercialization.
The NEXT protocol, an open-label, single-arm treatment study conducted at 29 U.S. burn centers, treated 239 patients, including 215 adults and 24 children, with deep partial and full-thickness thermal burns. The results showed that 94.9% of adults and 100% of children achieved complete debridement with NexoBrid. Notably, only 4.2% of adults required surgical excision post-treatment, with none in the pediatric group.
Patients treated with NexoBrid experienced a swift eschar removal process, typically completed in less than a day. The median time to wound closure was 22 days for adults and 28 days for children, with a median hospital stay of 10 days for both groups.
According to Jeremy Goverman, MD, FACS, Associate Professor of Surgery at Harvard Medical School, "The NEXT results reaffirm the significant benefits of NexoBrid in managing severe burns." He emphasized the reduction in the need for surgical interventions and the enhancement of patient outcomes.
The safety data from NEXT was consistent with the established safety profile of NexoBrid, and no new safety concerns were identified by the Data Safety and Monitoring Board (DSMB).
NexoBrid has been approved in over 40 countries, including the United States, European Union, and Japan, and has been designated as an orphan biologic drug in these territories. Its development has been supported by federal funds from the U.S.
The company, MediWound, is focused on developing, producing, and commercializing biologics that improve care standards, patient experiences, and reduce costs. Their first drug, NexoBrid, is approved for eschar removal in severe burns and is part of a product pipeline that includes EscharEx, a Phase III-ready biologic for chronic wound debridement.
MediWound Ltd. has made significant strides in various areas. The company has reported a rise in Q1 revenue to $5 million, up from $3.8 million in the same period last year, despite a net loss of $9.7 million, primarily due to financial expenses.
MediWound has also secured a $25 million investment in a private investment in public equity (PIPE) offering, headlined by a $15 million investment from Mölnlycke Health Care.
MediWound has entered into a collaboration agreement with Mölnlycke, which grants Mölnlycke certain rights, such as appointing a representative to MediWound's R&D Committee. These developments reflect the company's ongoing efforts to advance its strategic plans and improve patient experiences while reducing costs and unnecessary surgeries.
InvestingPro Insights
MediWound Ltd. (NASDAQ:MDWD) has recently shared promising results from their NEXT protocol, which may have a significant impact on the company's financial performance and stock valuation. As investors evaluate the company's potential, it is essential to consider the following InvestingPro data and tips.
InvestingPro Data:
- Market Cap: MediWound currently has a market capitalization of $162.28 million, reflecting investor valuation of the company.
- P/E Ratio: The price-to-earnings ratio stands at -12.79, indicating that the market currently does not expect earnings growth in the near term.
- Revenue Growth (Quarterly): Despite a decrease in revenue over the last twelve months, the company has seen a quarterly revenue growth of 30.67% in Q1 2023, which could signal a turnaround in its financial performance.
InvestingPro Tips:
- MediWound holds more cash than debt on its balance sheet, which is a positive sign for financial stability and may provide the company with the flexibility to invest in further research and development or marketing of NexoBrid.
- The stock has experienced a large price uptick over the last six months, with a 55.38% total return, reflecting increased investor confidence possibly due to the positive results from the NEXT protocol and the commercial potential of NexoBrid.
These insights could be particularly relevant for investors considering the company's recent achievements and future prospects. For a more comprehensive analysis, MediWound has an additional 8 InvestingPro Tips available at https://www.investing.com/pro/MDWD, which could further inform investment decisions.
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