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MediWound Ltd. (Nasdaq: MDWD) is an integrated biopharmaceutical company focused on developing, manufacturing, and commercializing novel therapeutic products. The company's mission is to address unmet medical needs in the fields of severe burns, chronic and other hard-to-heal wounds, connective tissue disorders, and other medical conditions. MediWound leverages its patented proteolytic enzyme technology to create innovative and effective treatments.
NexoBrid®, MediWound's flagship product, has received marketing authorization from multiple health agencies, including the European Medicines Agency, as well as health ministries in Israel and Argentina. This innovative biopharmaceutical product is designed for the non-surgical removal of dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns. Clinical trials have demonstrated NexoBrid's capability to rapidly and effectively debride eschar without harming viable tissue.
MediWound's pipeline includes several promising products. EscharEx®, another key product, is a topical biological drug being developed for debridement of chronic wounds. This product has shown significant potential in clinical trials, suggesting it can outperform traditional enzymatic debridement methods and improve patient outcomes. Additionally, MW005 is under development for the treatment of non-melanoma skin cancers, offering a new hope for patients with basal cell carcinoma.
The company has established valuable partnerships and research collaborations with industry leaders such as 3M, Mölnlycke, and MIMEDX. These collaborations aim to further validate and enhance MediWound's product pipeline. Recent achievements include substantial governmental grants, expanded indications for NexoBrid, and successful market entries in new regions.
Financially, MediWound is on solid ground. As of December 31, 2023, the company reported a cash, restricted cash, and investments balance of $42.1 million, compared to $34.1 million at the end of 2022. In the first quarter of 2023, MediWound raised $27.5 million through a registered direct offering, using $17.1 million to support its activities. The company expects its existing financial resources to be sufficient to reach profitability.
MediWound's commitment to improving patient care through innovative enzymatic therapeutics positions it as a significant player in the biopharmaceutical industry. With a strong pipeline and robust financial health, the company aims to continue delivering life-saving treatments and expanding its market presence.
For more information, visit www.mediwound.com and follow the company on LinkedIn and X.
MediWound Ltd. (Nasdaq: MDWD) announced positive results from its Phase I/II study of MW005 for treating low-risk Basal Cell Carcinoma (BCC), showing it to be safe, well-tolerated, and effective. Patients achieved complete clinical and histological clearance of target lesions. The study involved 11 patients receiving seven topical applications of MW005, with follow-ups confirming clearance. MediWound plans to continue patient enrollment and optimize dosing regimens. CEO Ofer Gonen highlighted MW005's potential as a non-surgical solution for BCC amidst rising cases, estimated at 4.3 million annually in the U.S.
MediWound Ltd. (NASDAQ: MDWD) has announced the marketing approval of NexoBrid in India, following an exclusive agreement with Bharat Serums and Vaccines Limited (BSV) to distribute the product for treating severe burns. NexoBrid, which enzymatically removes burn tissue, is expected to be marketed by BSV in the first half of 2023. This approval responds to a significant medical need, as India reports around seven million burn injuries annually, with high mortality rates. NexoBrid is already approved in 42 countries and has pending registration with the FDA.
MediWound Ltd. (Nasdaq: MDWD) announced a 1-for-7 reverse share split, effective December 20, 2022, after receiving shareholder approval on November 28, 2022. The split aims to enhance shareholder value and attract institutional investors by increasing the share price. Following the split, every seven shares will convert into one, with no fractional shares issued. The authorized share count will decrease from 90 million to approximately 12.86 million, while the par value will rise from NIS 0.01 to NIS 0.07. The company continues to develop its therapeutic solutions for tissue repair and regeneration.
MediWound Ltd. (NASDAQ: MDWD) announced significant financial developments, raising $30.5 million in gross proceeds to extend cash runway through 2025. The FDA's review of NexoBrid is progressing with a PDUFA date set for January 1, 2023, anticipated to generate substantial revenues upon approval. The company is also gearing up for a Phase 3 clinical study of EscharEx targeting a billion-dollar market opportunity. Despite a decrease in revenues to $5.8 million in Q3 2022 from $6.4 million in Q3 2021, MediWound holds a strong cash position of $17.6 million.
MediWound Ltd. (NASDAQ: MDWD) announced the publication of a paper in the November 2022 issue of Podiatry Management, detailing the efficacy of its product EscharEx® for debridement of Diabetic Foot Ulcers (DFUs). The findings indicate that over 50% of patients achieve complete debridement within a week. EscharEx outperformed hydrogel treatments and may represent a shift in wound care management. A meeting with the FDA is planned for Q4 2022 to discuss Phase 3 study design, highlighting the product's potential significance for chronic wound care.
MediWound Ltd. (Nasdaq: MDWD) announced a conference call and webcast on November 15, 2022, at 8:30 am Eastern Time to discuss its Q3 2022 financial results. The call will provide corporate updates and answer investor questions. MediWound focuses on biotherapeutic solutions for tissue repair, with products like NexoBrid for burn care and EscharEx for chronic wounds. The company is also developing MW005 for non-melanoma skin cancers, with results from a Phase I/II study indicating safety and efficacy.
MediWound Ltd. (NASDAQ: MDWD) has established a Strategic Advisory Board (SAB) comprised of industry leaders to guide its strategic initiatives. The board includes professionals such as John C. Lantis, Samuel Moed, and Eric Shem-Tov, who will bring extensive expertise to the company's efforts, particularly as EscharEx moves into Phase 3 studies and NexoBrid prepares for U.S. approval. This assembly aims to optimize MediWound’s product potential, reflecting the company’s commitment to advancing biotherapeutic solutions for tissue regeneration.
MediWound Ltd. (Nasdaq: MDWD) announced positive clinical outcomes from its EscharEx Phase 2 trials, presented at the SAWC Fall 2022 Conference. The data showed that EscharEx outperformed standard treatments for Venous Leg Ulcers, demonstrating significant improvements in debridement and tissue formation. Presentations highlighted its safety and efficacy, with no adverse effects on wound closure. The company plans to meet with the FDA to discuss the Phase 3 study design by year-end 2022, aiming to capture a share of the lucrative wound care market.
MediWound Ltd. (NASDAQ: MDWD) has successfully closed its registered direct and PIPE offerings, raising $30.5 million in gross proceeds. These funds will primarily support the development of EscharEx®, facility scaling, and general corporate purposes. CEO Ofer Gonen expressed satisfaction with attracting strong new investors and indicated the net proceeds enhance the company's balance sheet and provide an operational runway through 2025. The offerings were facilitated by H.C. Wainwright & Co. and include various warrants that will not be registered under the Securities Act of 1933.
MediWound Ltd. (NASDAQ: MDWD) has entered into a definitive securities purchase agreement for a registered direct offering, selling 7,575,513 ordinary shares at $1.75 each, expecting gross proceeds of approximately $13.26 million. Concurrently, the company will conduct a PIPE offering, selling 9,853,058 pre-funded and ordinary share warrants for expected gross proceeds of about $17.24 million. The total anticipated gross proceeds from both offerings stand at $30.5 million, which will primarily fund the development of EscharEx and general corporate purposes.
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