Core Insights - MediWound Ltd. provided a corporate and financial update ahead of the J.P. Morgan Healthcare Conference, highlighting progress in its clinical pipeline and operational capabilities [1][2] Corporate Updates - The EscharEx VALUE Phase III trial for venous leg ulcers (VLUs) is ongoing, with an interim assessment and enrollment completion expected by year-end 2026 [1][6] - Plans to expand the EscharEx program to diabetic foot ulcers (DFUs) and pressure ulcers (PUs) are anticipated in 2026 [1][6] - The NexoBrid manufacturing facility has been expanded and is now fully operational, increasing production capacity sixfold [1][6] Financial Outlook - Revenue for the full year 2025 totaled $17 million [5] - Updated financial guidance projects revenues of $24–26 million for 2026, $32–35 million for 2027, and $50–55 million for 2028 [1][12] - The company reported a cash position of $54 million as of December 31, 2025, with no debt [12]

Vericel Corporation (NASDAQ:VCEL) is one of the best small cap stocks to buy with huge upside potential. Truist analyst Richard Newitter slashed the price target on Vericel Corporation (NASDAQ:VCEL) to $45 from $50 on December 18, reaffirming a Buy rating on the stock as part of a broader research note previewing the coming year for the MedTech sector. Similarly, on December 16, Canaccord Genuity reaffirmed a Buy rating on Vericel Corporation (NASDAQ:VCEL) and set a $58 price target. Vericel Corporation ( ...

Market Trends - The market rotation trend is shifting from mega-cap tech stocks towards small caps, cyclicals, and financials, with expectations for this trend to continue due to easy monetary policy from the Fed and upcoming rate cuts [2][3] - Small caps are viewed as undervalued and are expected to outperform as the Fed enters a rate-cutting cycle, supported by fiscal policies and a new tax bill that benefits R&D intensive small caps [2][3] Investment Methodology - A list of small cap stocks was created using stock screeners, focusing on those with high analyst upside potential and hedge fund interest, with data sourced from Insider Monkey's database [6][7] - The methodology aims to identify stocks that hedge funds are investing in, as this strategy has historically outperformed the market [7] Company Highlights UP Fintech Holding Ltd. (NASDAQ:TIGR) - UP Fintech Holding Ltd. has a market cap of $1.54 billion and an analyst upside of 72.79%, with 18 hedge fund holders [8][9] - The company reported a fiscal Q3 revenue of $175.2 million, reflecting a 73.3% year-over-year growth, and a net income of $53.8 million, up 29.9% quarter-over-quarter [12] - Despite strong fiscal results, analysts maintain a cautious outlook due to anticipated rate cuts, slowing client acquisition, and market volatility [10][11] Vericel Corporation (NASDAQ:VCEL) - Vericel Corporation has a market cap of $1.84 billion and an analyst upside of 53.33%, also with 18 hedge fund holders [14] - The company reported fiscal Q3 revenue of $67.5 million, an increase from $57.9 million in the prior year, with net product revenue driven by MACI and Epicel products [15] - Vericel reaffirmed its full-year revenue guidance of $272 to $276 million, with a projected growth rate for MACI in the low 20% range [17]

Core Insights - MediWound Ltd. announced new clinical data demonstrating that NexoBrid effectively reduces embedded particles in traumatic tattoos caused by abrasion and blast injuries, achieving over 90% reduction in pigmented wound surface [1][4] Clinical Study Findings - The study published in the Journal of Burn Care & Research involved 15 patients with traumatic tattoos, showing a mean pigmented wound area decrease from 37.5% to 2.1% after NexoBrid application, indicating a 92.5% reduction [3][4] - In abrasive injuries, an average of 96% of visible pigments were removed, while in explosive injuries, pigment load was reduced by 84% [4] - The treatment was well tolerated, performed at bedside, with no treatment-related adverse events reported [4] Mechanism and Application - NexoBrid utilizes selective enzymatic action to remove non-viable tissue while preserving viable tissue, providing precision in treating irregular wound depths from blast injuries [5][9] - The application involves a 1–3 mm layer of NexoBrid under occlusion for four hours, followed by gentle scrubbing to reveal a clean wound bed [6] Limitations and Future Research - The study acknowledges limitations such as small sample size and short follow-up, suggesting the need for larger controlled studies to confirm long-term cosmetic outcomes [8] Company Overview - MediWound is a biotechnology company specializing in enzymatic, non-surgical therapies for tissue repair, with NexoBrid approved in over 40 countries for the treatment of thermal burns [11]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $5.4 million, a 23% increase year-over-year from $4.4 million in Q3 2024, primarily driven by higher development services revenue [11] - Gross profit for the quarter was $0.9 million, or 16.5% of revenue, compared to $0.7 million, or 15.5% in the prior year [11] - Net loss was $2.7 million, or $0.24 per share, an improvement from a net loss of $10.3 million, or $0.98 per share in the prior year [13] - Cash position as of September 30, 2025, was $60 million, up from $44 million at year-end 2024 [15] Business Line Data and Key Metrics Changes - EscharEx's VALUE phase III trial for venous leg ulcers is progressing with a target enrollment of 216 patients across approximately 40 sites [4] - NexoBrid's manufacturing facility expansion has increased production capacity sixfold, with expectations to reach full operational capacity by year-end 2025 [8] - NexoBrid reported record quarterly revenue growth of 38% year-over-year and 26% sequentially in the U.S. [8] Market Data and Key Metrics Changes - Medicare's recent reduction in reimbursement rates for skin substitute products is expected to pressure that category, making EscharEx more attractive as it is regulated under the BLA pathway [7] - An updated market assessment estimates annual peak sales for EscharEx at about $831 million, reflecting robust clinical data and health economic benefits [7] Company Strategy and Development Direction - The company is focused on three strategic priorities: advancing the EscharEx trial, expanding NexoBrid manufacturing, and securing funding for its strategy [4] - The company aims to leverage market changes to position EscharEx as a leading product in the enzymatic debridement segment [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strategic progress and operational readiness, positioning MediWound for growth in 2026 [16] - The company is actively monitoring enrollment trends in clinical trials and will update guidance as visibility improves [5] Other Important Information - The company completed a $30 million equity financing, enhancing its financial flexibility to execute long-term growth strategies [10] - The collaboration with BARDA on stockpiling and development activities is expected to resume following the end of a government shutdown [9] Q&A Session Summary Question: Changes in peak sales assumptions for SCAR-EX - Management clarified that the increase in peak sales estimate to $831 million is primarily due to updated pricing assumptions based on market access analysis, with no changes in patient volume or adoption rates [23][25] Question: Breakdown of revenue sources - Management indicated that detailed revenue breakdowns are not provided in quarterly calls, but gross margin improvements reflect a favorable revenue mix [44] Question: Update on BARDA contract status - The BARDA contract has not yet been awarded, but a proposal has been submitted, and the company is awaiting contract signing [46] Question: Impact of CPT code on adoption - Management noted that while a temporary CPT code is in place, a permanent code would enhance legitimacy and drive physician adoption and institutional acceptance [39]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $5.4 million, a 23% increase year-over-year from $4.4 million in Q3 2024 [11] - Gross profit for the quarter was $0.9 million, or 16.5% of revenue, compared to $0.7 million, or 15.5% in the prior year [11] - Net loss was $2.7 million, or $0.24 per share, compared to a net loss of $10.3 million, or $0.98 per share in the prior year [13] - Cash position as of September 30, 2025, was $60 million, up from $44 million at year-end 2024 [15] Business Line Data and Key Metrics Changes - EscharEx's VALUE Phase III trial for venous leg ulcers is progressing with a target of 216 patients across approximately 40 sites [4] - NexoBrid's manufacturing facility expansion has increased production capacity sixfold, with full operational capacity expected by year-end 2025 [8] - NexoBrid reported record quarterly revenue growth of 38% year-over-year and 26% sequentially [8] Market Data and Key Metrics Changes - Medicare's recent reduction in reimbursement rates for skin substitute products is expected to pressure that category, making EscharEx more attractive as it is regulated under the BLA pathway [7] - The updated U.S. market access assessment estimates annual peak sales for EscharEx at about $831 million, reflecting robust clinical data and health economic benefits [7] Company Strategy and Development Direction - The company is focused on three strategic priorities: advancing the EscharEx trial, expanding NexoBrid manufacturing, and securing funding for its strategy [4] - The company aims to leverage market changes to position EscharEx as a leading product in the enzymatic debridement segment [7] - The collaboration with BARDA is expected to resume following the government shutdown, which will support the development of NexoBrid [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's positioning for growth in 2026, citing consistent execution and strategic progress [16] - The company is actively monitoring enrollment trends in clinical trials and will update guidance as visibility improves [5] Other Important Information - The company completed a $30 million equity financing, enhancing its financial flexibility to execute long-term growth strategies [10] - The TGA in Australia approved NexoBrid for use in both adult and pediatric patients, expanding its global presence [9] Q&A Session Summary Question: Changes in peak sales assumptions for EscharEx - Management clarified that the increase in peak sales estimate to $831 million is primarily due to updated pricing assumptions based on market access analysis, with no changes in patient volume or adoption rates [25] Question: Breakdown of revenue sources - Management indicated that detailed revenue breakdowns are not provided in quarterly reports, but gross margin improvements reflect a favorable revenue mix [44] Question: Status of BARDA contract - The BARDA contract has not yet been awarded, but the company is awaiting the signing of the proposal submitted for a 10-year contract [46] Question: Impact of CPT code on adoption - Management noted that while a temporary CPT code is in place, a permanent code would enhance legitimacy and drive physician and institutional adoption of NexoBrid [39]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $5.4 million, a 23% increase year-over-year from $4.4 million in Q3 2024, primarily driven by higher development services revenue [11] - Gross profit for the quarter was $0.9 million, or 16.5% of revenue, compared to $0.7 million, or 15.5% in the prior year [11] - Net loss for Q3 2025 was $2.7 million, or $0.24 per share, an improvement from a net loss of $10.3 million, or $0.98 per share in Q3 2024 [12] - Adjusted EBITDA loss was $5.4 million, compared to a loss of $3.7 million in Q3 2024 [12] - As of September 30, 2025, cash and cash equivalents were $60 million, up from $44 million at year-end 2024 [15] Business Line Data and Key Metrics Changes - The EscharEx VALUE phase III trial for venous leg ulcers (VLU) is progressing with a target enrollment of 216 patients across approximately 40 sites [4] - NexoBrid manufacturing capacity has expanded sixfold, with full operational capacity expected by year-end 2025 [8] - NexoBrid reported record quarterly revenue growth of 38% year-over-year and 26% sequentially in the U.S. [8] Market Data and Key Metrics Changes - Medicare's recent reduction in reimbursement rates for skin substitute products is expected to pressure that category, while EscharEx aims to enter a market with a single legacy product generating approximately $370 million annually [6] - Updated U.S. market access and pricing assessment estimates annual peak sales for EscharEx at about $831 million, reflecting robust clinical data and health economic benefits [7] Company Strategy and Development Direction - The company is focused on three strategic priorities: advancing the EscharEx trial, expanding NexoBrid manufacturing, and securing funding for its strategy [4] - The company aims to leverage market changes to position EscharEx as an attractive option for strategic partners [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of clinical trials and the potential for EscharEx to drive growth [4] - The company is actively monitoring enrollment trends in the VALUE trial and will update guidance as visibility improves [5] - The recent $30 million equity financing strengthens the balance sheet and provides resources for long-term growth [10] Other Important Information - The company has received positive FDA feedback for its diabetic foot ulcer program and plans to initiate the study in the second half of 2026 [5] - The collaboration with BARDA on stockpiling and development activities is expected to resume following the end of the government shutdown [10] Q&A Session Summary Question: Can you provide details on the new peak sales assumption for SCAR-EX? - The updated U.S. peak sales estimate of $831 million reflects a focus on pricing rather than changes in patient volume or adoption rates [22][24] Question: What is the breakdown between DFU and VLU opportunities in the sales projection? - There are more diabetic foot ulcers than venous leg ulcers, but the company is prioritizing VLU due to pain issues associated with surgical debridement [30][32] Question: What is the status of the BARDA contract? - The BARDA RFP for a 10-year contract is pending, and the company is awaiting the contract to be signed [44] Question: How does the lack of a permanent CPT code impact adoption? - A permanent CPT code would enhance legitimacy and drive physician and institutional acceptance, facilitating wider adoption of NexoBrid [36][39]

Core Insights - MediWound Ltd. reported a third quarter 2025 revenue of $5.4 million, representing a 23% increase year-over-year from $4.4 million in Q3 2024 [6][25] - The company completed the commissioning of its expanded NexoBrid manufacturing facility, which is expected to reach full operational capacity by the end of 2025, increasing production capacity sixfold [2][7] - Enrollment in the VALUE Phase III trial of EscharEx for venous leg ulcers is ongoing, targeting 216 patients across approximately 40 sites in the U.S. and Europe [7] Financial Performance - The gross profit for Q3 2025 was $0.9 million, or 16.5% of total revenue, compared to $0.7 million, or 15.5% of total revenue in Q3 2024 [13][25] - Research and development expenses increased to $3.5 million in Q3 2025 from $2.5 million in Q3 2024, driven by investments in the EscharEx VALUE Phase III trial [13] - The net loss for Q3 2025 was $2.7 million, or $0.24 per share, a significant reduction from a net loss of $10.3 million, or $0.98 per share, in Q3 2024 [13][25] Corporate Developments - The company raised $30 million in equity financing to strengthen its balance sheet and support development programs and commercialization initiatives [5][9] - An independent global consulting firm estimated a peak sales opportunity of approximately $831 million for EscharEx, reflecting updated clinical data and health-economic considerations [7] - NexoBrid received approval for use in Australia, expanding its market presence to 45 countries worldwide [7] Upcoming Milestones - A pre-specified interim sample-size assessment for the VALUE Phase III trial is planned after 65% of patients complete treatment [7] - The company expects to initiate its clinical trial in diabetic foot ulcers in the second half of 2026 following positive FDA feedback [7]

Company Overview - Vericel Corporation is a leader in advanced therapies for the sports medicine and severe burn care markets, combining innovations in biology with medical technologies to create a differentiated portfolio of cell therapies and specialty biologics [2] - The company markets three main products in the United States: MACI, Epicel, and holds an exclusive license for NexoBrid [2] Product Details - MACI is an autologous cellularized scaffold product for repairing symptomatic, full-thickness cartilage defects of the knee in adults [2] - Epicel is a permanent skin replacement for treating patients with deep dermal or full-thickness burns covering 30% or more of total body surface area [2] - NexoBrid is a biological orphan product indicated for eschar removal in patients with deep partial-thickness and/or full-thickness thermal burns [2] Upcoming Events - Vericel Corporation will participate in a fireside chat at the Stephens Annual Investment Conference on November 20, 2025, at 11:00 a.m. ET [1]

Financial Data and Key Metrics Changes - The company reported record total revenue of $67.5 million for Q3 2025, exceeding guidance, with MACI revenue growing 25% to $55.7 million [11][12] - GAAP net income was over $5 million, and adjusted EBITDA margin reached 25%, reflecting a nearly 800 basis points increase year-over-year [3][12] - Operating cash flow for the quarter was a record $22.1 million, contributing to a free cash flow of nearly $20 million [12] Business Line Data and Key Metrics Changes - MACI revenue growth was driven by strong biopsy growth, with record highs in both MACI biopsies and the number of surgeons taking biopsies [4][5] - Burn care revenue was $11.8 million, a 21% sequential increase, with EPICEL revenue at $10.4 million, marking its highest quarter of the year [11][12] - NexoBrid revenue reached $1.5 million, its highest since launch, growing 38% year-over-year [11] Market Data and Key Metrics Changes - The company has over 800 MACI Arthro-trained surgeons, with significant growth in biopsy and implant rates among trained surgeons compared to untrained ones [5][6] - The U.K. is targeted for MACI's international expansion, with plans to submit a marketing application in mid-2026 and a potential launch in the first half of 2027 [8][9] Company Strategy and Development Direction - The company is focused on expanding its MACI Salesforce and investing in sales operations, marketing, and medical functions to enhance operational excellence [10] - A phased approach to MACI's international expansion is being initiated, starting with the U.K. due to favorable market conditions [8][9] - The company plans to initiate a phase 3 MACI Ankle Clinical Study, representing a substantial growth opportunity [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining strong top-line growth and profitability, with expectations for continued revenue growth in 2026 and beyond [16][41] - The company anticipates a significant acceleration in MACI revenue growth from 18% in the first half of the year to approximately 23% in the second half [13][14] - Management highlighted the importance of maintaining a prudent approach to guidance, especially in light of potential variability in the burn care segment [45] Other Important Information - The company achieved a gross profit margin of 73.5%, with expectations for a gross margin of approximately 77% in Q4 [12][15] - The company is not assuming additional NexoBrid revenue related to the BARDA RFP process initiated in August, although there is potential for incremental revenue [14][15] Q&A Session Summary Question: Insights on MACI Arthro contributions in 2026 - Management indicated that they expect high contributions from MACI Arthro but will be prudent in guidance, starting with a baseline of around 20% growth for MACI [20][24] Question: MACI Arthro sales in Q3 and expectations for 2026 - Management clarified that they do not view MACI Arthro as cannibalizing legacy MACI but rather as expanding overall MACI utilization [47][49] Question: Trends in MACI biopsy growth and surgeon adoption - Management noted strong biopsy growth across all surgeon types, with a significant increase in trained surgeons leading to higher implant rates [70][71] Question: R&D spending and expectations for Q4 - Management confirmed total operating expenses of about $50 million for Q4, with increased investments in salesforce expansion and the ankle trial [75][78] Question: Post-surgical pain and recovery times with MACI Arthro - Management highlighted positive early indicators of reduced post-surgical pain and faster recovery times associated with MACI Arthro procedures [78][79]