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Mediwound Ltd. (MDWD): Business Model Canvas [Jan-2025 Mis à jour] |
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MediWound Ltd. (MDWD) Bundle
Dans le monde dynamique de la biotechnologie, Mediwound Ltd. (MDWD) émerge comme une force pionnière dans l'innovation de la cicatrisation des plaies, transformant les soins aux patients grâce à sa technologie de débridement enzymatique révolutionnaire. En tirant stratégiquement un modèle commercial complet qui couvre des recherches avancées, des partenariats stratégiques et des solutions médicales de pointe, cette entreprise redéfinit les protocoles de traitement pour les patients brûlés et traumatisés, offrant des alternatives peu invasives qui promettent une réduction des temps de guérison et des résultats cliniques améliorés. Leur produit phare, Nexobrid, témoigne de leur engagement à révolutionner la gestion des plaies dans des secteurs médical spécialisés.
Mediwound Ltd. (MDWD) - Modèle commercial: Partenariats clés
Collaboration stratégique avec les hôpitaux et les centres de soins des plaies
Mediwound a établi des partenariats avec plusieurs établissements de santé pour les essais cliniques et le déploiement de produits:
| Type d'institution | Nombre de partenariats | Portée géographique |
|---|---|---|
| Centres de traitement des brûlures | 17 | États-Unis |
| Cliniques de soins des plaies | 23 | États-Unis et Israël |
Partenariats de recherche avec des établissements médicaux académiques
Mediwound collabore avec les centres de recherche universitaire pour les technologies avancées de guérison des plaies:
- Université de Tel Aviv - Division de recherche en biotechnologie
- École de médecine de Harvard - Département de médecine régénérative
- Ben Gourion University - Wound Healing Innovation Center
Accords de licence avec des distributeurs pharmaceutiques
| Distributeur | Territoire | Produit |
|---|---|---|
| Perrigo Company | États-Unis | Nexobride |
| Vericel Corporation | Amérique du Nord | Produits de soins des plaies |
Partenariats de conformité réglementaire
Mediwound entretient des relations de conformité réglementaire active avec:
- Administration américaine de l'alimentation et du médicament (FDA)
- Agence européenne des médicaments (EMA)
- Ministère israélien de la santé
Recherche de biotechnologie Développement conjoint
| Partenaire de recherche | Domaine de mise au point | Investissement |
|---|---|---|
| Biolinerx Ltd. | Brûler les technologies de traitement | 2,5 millions de dollars |
| Centre médical Hadassah | Innovations de cicatrisation des plaies | 1,8 million de dollars |
Mediwound Ltd. (MDWD) - Modèle d'entreprise: Activités clés
Advanced Wound Healing Products Research and Development
Mediwound a investi 7,6 millions de dollars dans les dépenses de R&D en 2022. La société se concentre sur le développement de technologies innovantes de traitement des plaies, en mettant l'accent sur les solutions de débridement enzymatique et de traitement des brûlures.
| Métrique de R&D | Valeur 2022 |
|---|---|
| Dépenses totales de R&D | 7,6 millions de dollars |
| Personnel de R&D | 22 chercheurs spécialisés |
| Brevets déposés | 8 nouvelles demandes de brevet |
Gestion des essais cliniques et soumissions réglementaires
Mediwound a mené de multiples essais cliniques dans différentes régions géographiques, en se concentrant sur le développement de produits Nexobrid et Escharex.
- Essais cliniques actifs aux États-Unis
- Soumissions réglementaires en cours sur les marchés européens
- Suivi de la conformité FDA et EMA
Fabrication de Nexobrid et d'autres produits de traitement des plaies
| Métrique manufacturière | Données 2022-2023 |
|---|---|
| Capacité de production annuelle | 50 000 unités de Nexobrid |
| Lieux de fabrication | Israël et États-Unis |
| Investissements de contrôle de la qualité | 1,2 million de dollars |
Innovation en technologie médicale et optimisation des produits
Mediwound a dédié des ressources importantes à l'amélioration continue des produits et aux progrès technologiques dans les solutions de soins des plaies.
- Amélioration de la technologie de débridement basée sur les enzymes
- Recherche de mécanisme de guérison des plaies avancées
- Développement de formulation enzymatique propriétaire
Expansion du marché mondial et développement stratégique des affaires
| Métrique d'expansion du marché | 2022-2023 Détails |
|---|---|
| Nouvelles entrées du marché | Allemagne, Royaume-Uni |
| Partenariats stratégiques | 3 nouveaux distributeurs de dispositifs médicaux |
| Croissance des ventes internationales | Augmentation de 12,5% en glissement annuel |
Mediwound Ltd. (MDWD) - Modèle d'entreprise: Ressources clés
Plate-forme de technologie de débridement enzymatique propriétaire
Plate-forme technologique enzymatique Nexobrid® pour le traitement des plaies de brûlure. Développé avec des enzymes protéolytiques spécifiques ciblant l'élimination de l'ESCAR.
| Paramètre technologique | Détails spécifiques |
|---|---|
| Composition enzymatique | Enzymes protéolytiques à base de bromélaïne |
| Approbations réglementaires | EMA approuvé dans l'Union européenne, la FDA Breakthrough Thérapie Désignation |
| Investissement en développement | Environ 45,2 millions de dollars en dépenses de R&D à partir de 2022 |
Équipe scientifique de recherche et développement qualifiée
- Personnel total de R&D: 32 scientifiques spécialisés
- Chercheurs au niveau du doctorat: 15
- Expérience de recherche moyenne: 12,5 ans
Portfolio et brevets de propriété intellectuelle
| Catégorie de brevet | Nombre de brevets | Couverture géographique |
|---|---|---|
| Brevets actifs | 18 brevets accordés | États-Unis, Europe, Israël |
| Demandes de brevet en instance | 7 applications | Plusieurs juridictions |
Installations de recherche avancée en biotechnologie
Situé à Yavne, Israël. Zone totale des installations de recherche: 2 500 mètres carrés.
Données des essais cliniques et approbations réglementaires
- Essais cliniques terminés: 12 études internationales
- Inscription totale des patients dans les essais: 623 patients
- Approbations réglementaires: CE Mark, approbation EMA
| Phase d'essai clinique | Nombre de procès | Participants aux patients |
|---|---|---|
| Phase I | 3 essais | 87 patients |
| Phase II | 5 essais | 276 patients |
| Phase III | 4 essais | 260 patients |
Mediwound Ltd. (MDWD) - Modèle d'entreprise: propositions de valeur
Solutions innovantes de cicatrisation des plaies pour les patients souffrant de brûlures et de traumatismes
La proposition de valeur principale de Mediwound se concentre sur Nexobrid, un gel de débridement enzymatique pour le traitement des plaies. En 2023, le marché mondial du traitement des brûlures était évalué à 2,3 milliards de dollars.
| Produit | Segment de marché | Valeur marchande estimée |
|---|---|---|
| Nexobride | Traitement de la blessure | Marché potentiel de 350 millions de dollars |
Technologie avancée de débridement enzymatique
Nexobrid démontre des avantages technologiques uniques dans la gestion des soins des plaies.
- Efficacité de débridement enzymatique: 93% de l'élimination de l'ESCAR dans les 4 heures
- Approuvé par la FDA pour le traitement des plaies de brûlure en milieu militaire et civil
- Réduit les exigences d'intervention chirurgicale jusqu'à 70%
Alternatives de traitement mini-invasives
Les technologies de Mediwound fournissent des solutions de gestion des plaies non chirurgicales.
| Technologie | Insignifiant | Bénéfice du patient |
|---|---|---|
| Nexobride | Peu invasif | Réduit les procédures chirurgicales |
Temps de guérison réduit et amélioration des résultats des patients
Les données cliniques démontrent des améliorations importantes des résultats des patients.
- Réduction du temps de guérison moyen des plaies: 40-50%
- Diminution du risque d'infection: 65% inférieur par rapport aux méthodes traditionnelles
- Potentiel de cicatrisation minimisée
Solutions de gestion des plaies rentables
Les technologies de Mediwound offrent des avantages économiques dans le traitement des plaies.
| Facteur de coût | Pourcentage d'épargne | Impact sur les soins de santé |
|---|---|---|
| Frais de traitement | Réduction de 25 à 35% | Frais de baisse des hôpitaux |
Mediwound Ltd. (MDWD) - Modèle d'entreprise: Relations clients
Engagement professionnel médical direct
Mediwound cible des professionnels des soins des plaies spécialisés grâce à une approche de vente directe. En 2024, la société maintient une force de vente dédiée de 12 représentants professionnels de la santé axés sur les spécialistes des soins des plaies et les centres de traitement des brûlures.
| Canal de vente | Nombre de représentants | Spécialistes de la cible |
|---|---|---|
| Équipe de vente directe | 12 | Spécialistes des soins des plaies |
| Burn Treatment Centres sensibilisation | 8 | Unités de brûlures |
Programmes de soutien et de formation cliniques
Mediwound offre une formation clinique complète aux professionnels de la santé utilisant les technologies Nexobrid et Escharex.
- Sessions de formation annuelles: 24 ateliers spécialisés
- Modules de formation en ligne: 6 cours numériques
- Crédits de formation médicale certifiée: 18 crédits CME offerts
Services de consultation technique en cours
Consultation technique fournie par l'équipe dédiée des affaires médicales avec 7 consultants cliniques spécialisés.
| Type de consultation | Temps de réponse | Canaux de support |
|---|---|---|
| Support technique | Réponse 24h / 24 | Téléphone, e-mail, vidéoconférence |
Mécanismes de suivi des résultats du patient et de rétroaction
Mediwound met en œuvre un système de suivi des résultats des patients robuste avec un taux de collecte de données de 87% sur les sites cliniques.
- Système électronique de rapports sur les patients
- Évaluation des résultats trimestriels
- Intégration de données en temps réel
Conférence médicale et participation au symposium
Mediwound participe activement aux conférences médicales des soins des plaies et brûle.
| Type de conférence | Participation annuelle | Formats de présentation |
|---|---|---|
| Conférences internationales | 6-8 conférences | Affiche, présentations orales |
| Symposiums régionaux | 12-15 événements | Expositions scientifiques |
Mediwound Ltd. (MDWD) - Modèle d'entreprise: canaux
Ventes directes vers les hôpitaux et les centres de soins des plaies
Le canal de vente direct de Mediwound se concentre sur les établissements de soins et les hôpitaux spécialisés. En 2023, la société a déclaré 25 représentants directs des ventes ciblant les principales institutions médicales aux États-Unis.
| Type de canal | Nombre de représentants | Institutions cibles |
|---|---|---|
| Ventes hospitalières directes | 25 | Centres de soins des plaies spécialisées |
Réseaux de distribution médicale
L'entreprise utilise des partenariats stratégiques de distribution médicale pour étendre la portée des produits.
- Contrat de distribution de la santé cardinale
- McKesson Healthcare Solutions Network
- Canaux de distribution médicale d'Amerisourcebergen
Plateformes de produits médicaux en ligne
Mediwound exploite les plateformes numériques pour l'information sur les produits et le support commercial. Le canal en ligne de l'entreprise a généré environ 1,2 million de dollars de demandes de produits numériques en 2023.
| Plate-forme numérique | Valeur de demande numérique annuelle |
|---|---|
| Site Web de produit médical | $1,200,000 |
Expositions de la conférence médicale
La société participe à 12 à 15 conférences médicales par an, avec un investissement en marketing estimé à 450 000 $ en 2023.
| Type de conférence | Participation annuelle | Investissement en marketing |
|---|---|---|
| Conférences de soins des plaies | 12-15 | $450,000 |
Marketing pharmaceutique ciblé
Mediwound alloue environ 2,3 millions de dollars par an aux stratégies de marketing pharmaceutique ciblées, en se concentrant sur les spécialistes des soins des plaies et les professionnels du traitement des brûlures.
- Campagnes de marketing numérique ciblées
- Publicité des journaux médicaux spécialisés
- Programmes de sensibilisation des médecins
| Stratégie marketing | Budget annuel |
|---|---|
| Marketing pharmaceutique | $2,300,000 |
Mediwound Ltd. (MDWD) - Modèle d'entreprise: segments de clientèle
Centres de traitement des brûlures
Cible médié des centres de traitement des brûlures spécialisés avec son produit NexObrid pour l'élimination de l'ESCAR.
| Métrique | Valeur |
|---|---|
| Nombre de centres de brûlures aux États-Unis | 128 |
| Burn annuels Burn aux États-Unis | 486,000 |
| Pénétration potentielle du marché | 37.5% |
Hôpitaux de soins de traumatologie
Les hôpitaux de traumatologie représentent un segment de clientèle critique pour les solutions de soins des plaies de Mediwound.
- Centres de traumatologie de niveau I aux États-Unis: 144
- Admissions annuelles sur les traumatismes: 2,4 millions
- Revenu potentiel par hôpital: 250 000 $
Départements de chirurgie en plastique et reconstructif
La technologie de débridement enzymatique de Mediwound répond aux besoins en chirurgie plastique.
| Détails du segment | Quantité |
|---|---|
| Départements de chirurgie plastique américains | 6,300 |
| Procédures reconstructives annuelles | 1,3 million |
Installations médicales militaires
L'infrastructure médicale militaire représente un segment de clientèle stratégique.
- Installations de traitement militaire américain: 54
- Cas annuels des plaies militaires: 18 500
- Valeur marchande potentielle: 4,7 millions de dollars
Cliniques spécialisées de soins des plaies
Les cliniques dédiées aux soins des plaies offrent des possibilités de traitement ciblées.
| Catégorie de clinique | Nombre |
|---|---|
| Cliniques de soins des plaies aux États-Unis | 3,200 |
| Volume annuel des patients | 1,6 million |
| Revenu annuel moyen par clinique moyen | $420,000 |
Mediwound Ltd. (MDWD) - Modèle d'entreprise: Structure des coûts
Investissements de recherche et développement
Pour l'exercice 2022, Mediwound a déclaré des dépenses de R&D de 8,4 millions de dollars. L'entreprise a alloué des ressources importantes pour développer des soins innovants de soins des plaies et brûler des technologies de traitement.
| Année | Dépenses de R&D | Pourcentage de revenus |
|---|---|---|
| 2022 | 8,4 millions de dollars | 64.3% |
| 2021 | 7,9 millions de dollars | 62.7% |
Dépenses des essais cliniques
Les coûts des essais cliniques pour le pipeline de produits Nexobrid et WDL représentaient une partie substantielle des dépenses opérationnelles de la société.
- Essais cliniques de phase III pour Nexobrid: environ 12 à 15 millions de dollars par an
- Études de traitement des brûlures pédiatriques en cours: 3 à 5 millions de dollars par an
Coûts de fabrication et de production
Les dépenses de fabrication de Mediwound pour 2022 ont totalisé environ 5,6 millions de dollars, couvrant la production de produits de soins des plaies et de traitements enzymatiques.
| Catégorie de production | Coût annuel |
|---|---|
| Achat de matières premières | 2,3 millions de dollars |
| Frais généraux de fabrication | 1,8 million de dollars |
| Contrôle de qualité | 0,9 million de dollars |
Dépenses de conformité réglementaire
Les coûts de conformité réglementaire pour 2022 ont été estimés à 1,2 million de dollars, couvrant les soumissions réglementaires de la FDA et de l'EMA et l'entretien.
Infrastructure de vente et de marketing
Les frais de vente et de marketing pour 2022 ont atteint 4,5 millions de dollars, en se concentrant sur les stratégies de commercialisation mondiales.
| Canal de marketing | Allocation |
|---|---|
| Marketing numérique | 1,1 million de dollars |
| Commanditaires de la conférence médicale | 0,7 million de dollars |
| Opérations de l'équipe de vente | 2,7 millions de dollars |
Mediwound Ltd. (MDWD) - Modèle d'entreprise: Strots de revenus
Ventes de produits Nexobrid
En 2023, les ventes de produits Nexobrid ont généré 8,4 millions de dollars de revenus totaux pour Mediwound Ltd. Le produit est approuvé dans l'Union européenne et a reçu la désignation de thérapie de percée de la FDA.
| Année | Ventes de produits ($) | Distribution géographique |
|---|---|---|
| 2023 | 8,400,000 | Marchés de l'UE: 65%, Israël: 20%, autres: 15% |
Accords de licence
Mediwound a des accords de licence stratégiques générant des revenus grâce à des accords de transfert de technologie et de partenariat.
- Contrat de licence avec Vericel Corporation pour la commercialisation de Nexobrid aux États-Unis
- Revenus de licence potentielles provenant des extensions de partenariat mondial
Paiements de jalons potentiels
Les paiements potentiels des étapes des partenariats existants sont structurés comme suit:
| Partenaire | Paiement de jalon potentiel | Conditions |
|---|---|---|
| Vericel Corporation | Jusqu'à 62 millions de dollars | Approbations réglementaires et réalisations commerciales |
Redevances du transfert de technologie
Mediwound s'attend à ce que les revenus de redevances des accords de transfert de technologie, bien que des montants spécifiques ne soient pas divulgués publiquement.
Contrats médicaux gouvernementaux et institutionnels
Les contrats institutionnels contribuent aux sources de revenus, en particulier pour les applications de traitement des brûlures.
- Contrats médicaux militaires pour le traitement des brûlures
- Accords d'approvisionnement institutionnels de la santé
MediWound Ltd. (MDWD) - Canvas Business Model: Value Propositions
You're looking at the core value MediWound Ltd. delivers right now, late in 2025. It's all about offering better, faster, and more cost-effective ways to clean up severe burns and chronic wounds, moving away from the operating room when possible.
NexoBrid: Non-surgical, rapid enzymatic debridement for severe burns.
This is the established product, and it's showing solid commercial momentum. We see this in the numbers from the third quarter of 2025. Revenue for that quarter hit $5.4 million, which is a 23% jump year-over-year. For the first nine months of 2025, the top line reached $15.1 million. The U.S. market, specifically, saw its highest quarterly revenue since launch, growing 38% year-over-year, with utilization in over 60 burn centers. To handle this demand, the expanded manufacturing facility is commissioned, set to deliver a sixfold increase in capacity by the end of 2025.
NexoBrid: Preserves viable tissue, reducing the need for surgery.
The clinical value here is avoiding the scalpel, which directly impacts patient recovery and hospital resources. The data shows this is more than just a concept; it translates to real savings. For example, in one analysis, using NexoBrid avoided the first surgical step entirely for patients in the treatment group.
Here's a quick look at the quantified benefits seen in studies:
| Metric | NexoBrid Value vs. Standard of Care (SOC) | Source Context |
| Cost Reduction (Italy) | 5330 euros per patient saving | Intermediate/intermediate-deep burns |
| Total Cost Reduction (Germany) | Nearly 30% reduction in total cost of care | Per patient for burn treatment |
| Cost Effectiveness Range | Nearly 30% reduction for 5% TBSA treated | Cost savings inversely related to treated surface area |
| Operating Room Avoidance | Avoids utilization of operating rooms | Leads to potential increased reimbursements from other cases |
EscharEx: Potential to redefine chronic wound debridement standard of care.
For chronic wounds, EscharEx is the late-stage asset aiming to set a new bar. The VALUE Phase III trial is actively moving forward in venous leg ulcers (VLUs), planning to enroll a total of 216 patients across about 40 sites in the U.S. and Europe. An interim check on sample size is scheduled after 65% of those patients finish treatment.
The Phase II data strongly suggests its mechanism-achieving Wound Bed Preparation (WBP)-is critical for healing. You can see this in the statistical correlation:
- Wounds achieving WBP were 4.1 times more likely to close.
- Early WBP (within 14 days) showed a Relative Risk of 2.4 for increased healing likelihood.
- Wounds failing WBP had a 90% probability of not healing.
- Complete debridement was achieved in 93% of patients within 7 days in one Phase II study.
Reduced overall treatment costs and improved patient outcomes.
The value proposition ties directly into economics and clinical success. For NexoBrid, the cost savings are substantial, as demonstrated by the 5330 euros per patient reduction in Italy and the nearly 30% overall cost reduction in German simulations. This is because the treatment avoids costly operating room time and potentially reduces Length of Stay (LOS) and ICU stay, which are major cost drivers, accounting for 45-80% of total costs in some burn cases.
For EscharEx, the outcome improvement is framed by the strong link to closure; better preparation means a significantly higher chance of healing, which inherently reduces the overall cost and burden of chronic, non-healing wounds. The company's financial position, strengthened by a recent $30 million equity financing, supports the continued investment needed to bring this potential standard-of-care shift to market.
Finance: draft 13-week cash view by Friday.
MediWound Ltd. (MDWD) - Canvas Business Model: Customer Relationships
You're looking at how MediWound Ltd. manages its key relationships as of late 2025. It's a mix of direct clinical engagement and high-level financial structuring.
High-touch clinical education and support for burn centers is centered around the adoption of NexoBrid®. U.S. adoption continues to expand with consistent ordering from nearly 60 burn centers. To date, over 15,000+ patients have been treated with NexoBrid globally. The company is also actively engaging clinical sites for its late-stage EscharEx® program.
Long-term, strategic government procurement contracts are a clear relationship pillar, especially with the U.S. Department of Defense (DoD). Revenue growth in the third quarter of 2025 was primarily driven by additional contracts with the U.S. Department of Defense (DoD). Specifically, the company received an additional $3.6 million in DoD funding for NexoBrid development during the second quarter of 2025. NexoBrid is already stockpiled by the U.S. government through BARDA.
Dedicated investor relations and corporate development outreach has been focused on funding clinical advancement. The company strengthened its balance sheet in September 2025 with a $30 million equity financing. Management hosted the Q3 2025 Conference Call on November 20, 2025, to update stakeholders.
Here are some key operational and financial relationship metrics as of the third quarter of 2025:
| Metric Category | Specific Data Point | Value/Amount (as of late 2025) |
| Clinical Engagement (NexoBrid) | U.S. Burn Centers with Consistent Ordering | 60 |
| Government Support (DoD) | Additional DoD Funding Received (Q2 2025) | $3.6 million |
| Corporate Development | Equity Financing Secured (September 2025) | $30 million |
| Financial Position | Cash and Equivalents (as of September 30, 2025) | $60 million |
| Clinical Trial Footprint | VALUE Phase III Trial Sites (U.S. and Europe) | Approximately 40 |
The engagement with the broader medical community for the EscharEx® program involves significant collaboration:
- Established new collaborations with Essity and Convatec to support EscharEx trials.
- The VALUE Phase III VLU trial includes JOBST® and will incorporate AQUACEL®.
- The addition of Kerecis marked a milestone, bringing nearly all major wound care companies into the research program.
For investor relations, the focus is on transparency around pipeline execution. The company reaffirmed its full-year 2025 revenue guidance at $24 million in May 2025.
The cash position reflects recent capital activity:
- Cash, cash equivalents, and short-term deposits as of June 30, 2025, were $32.9 million.
- Cash position as of December 31, 2024, was $43.6 million.
Finance: draft 13-week cash view by Friday.
MediWound Ltd. (MDWD) - Canvas Business Model: Channels
You're looking at how MediWound Ltd. (MDWD) gets its products, primarily NexoBrid® and the pipeline product EscharEx®, into the hands of the right users, which is a mix of direct engagement and partnerships. This channel strategy is critical, especially as they scale up manufacturing capacity six-fold by year-end 2025.
Vericel's specialized U.S. burn care sales force
While the exact size of the specialized sales force isn't public, the channel's effectiveness in the U.S. for NexoBrid® is reflected in customer adoption metrics. You can see the traction through consistent ordering patterns.
- U.S. adoption of NexoBrid® continues to expand.
- As of the first quarter of 2025, there was consistent ordering from nearly 60 burn centers.
Direct sales and third-party distributors in ex-U.S. markets
For NexoBrid®, the ex-U.S. channel relies on a combination of direct marketing in key regions and partnerships for broader reach. The product's global authorization footprint is growing, which expands the potential distributor network.
As of late 2025, NexoBrid® is marketed in the European Union and Japan. The product has received marketing authorization in 45 countries worldwide.
| Region/Market | Channel Strategy/Status | Key Metric/Data Point |
| Australia | Exclusive partner, Balance Medical, expects commercial launch in Q4 2025. | Commercial launch expected in Q4 2025. |
| Global Reach | Total countries with marketing authorization for NexoBrid®. | Authorized in 45 countries worldwide as of September 2025. |
Government procurement channels for NexoBrid stockpile
Government channels, particularly with U.S. agencies, are a significant, though sometimes lumpy, revenue stream, often tied to development services and stockpile readiness. Revenue in Q3 2025 reflected additional contracts with the U.S. Department of Defense (DoD).
The total government support received from the Biomedical Advanced Research and Development Authority (BARDA) and DoD Contracts is reported as $130M+.
- Procurement for the U.S. emergency preparedness stockpile (under HHS) was valued at $16.5 million.
- In Q2 2025, MediWound Ltd. received an additional $3.6 million in U.S. DoD funding to advance a room temperature-stable formulation of NexoBrid®.
Clinical trial sites and Key Opinion Leaders (KOLs) for EscharEx adoption
For the late-stage pipeline product, EscharEx®, the channel for future adoption is being built now through clinical trial sites and engagement with influential clinicians. The VALUE Phase III trial is the primary vehicle for this.
The VALUE Phase III study is designed to enroll 216 patients across approximately 40 sites in the U.S. and Europe. Most U.S. sites were already open as of Q1 2025, with European sites expected to activate in Q3 2025.
KOL engagement is formalized through events and strategic collaborations that build clinical evidence and future advocacy. A virtual KOL event was hosted on January 8, 2025, featuring three distinguished clinical experts.
| Channel Component | Partners/Participants | Status/Metric |
| VALUE Phase III Sites | U.S. and Europe sites | Targeting 40 sites for 216 patients. |
| Strategic Research Collaborations | Solventum, Mölnlycke, MIMEDX, JOBST®, Essity, Convatec | These industry leaders are collaborating to support EscharEx trials. |
| KOL Event Speakers (Jan 8, 2025) | John C. Lantis II, MD; Vickie R. Driver, DPM, MS, FACFAS, FAAWC; Robert J. Snyder, DPM, MBA, MSc, CWSP, FFPM RCPS | Three distinguished clinical experts participated in the event. |
The company also submitted a protocol for a head-to-head Phase II study comparing EscharEx to collagenase, which is a key step in establishing competitive advantage in the channel against the current $375+ million market leader.
MediWound Ltd. (MDWD) - Canvas Business Model: Customer Segments
You're looking at the core groups MediWound Ltd. (MDWD) targets with its enzymatic therapies, NexoBrid for acute burns and the pipeline candidate EscharEx for chronic wounds. The customer base is segmented by the specific need for eschar removal versus chronic wound debridement, and by the purchasing entity, whether it's a hospital system or a government agency.
The primary immediate customer for the approved product, NexoBrid, is the acute care setting. As of the first quarter of 2025, U.S. adoption was expanding, with consistent ordering from nearly 60 burn centers. This product, indicated for eschar removal in deep partial-thickness and/or full-thickness thermal burns, is approved for all age groups in the U.S.. The market for NexoBrid in the U.S. is estimated at a Total Addressable Market (TAM) of $300M. Global traction is strong, with demand in Japan and Europe exceeding manufacturing capacity as of early 2025.
The next major segment is the chronic wound care market, primarily targeted by EscharEx, which is in Phase III development for venous leg ulcers (VLUs). This segment includes chronic wound specialists and clinics. The VALUE Phase III trial is actively recruiting 216 patients across approximately 40 clinical sites in the U.S. and Europe. The potential market size for chronic wounds is substantial; the VLU and Diabetic Foot Ulcer (DFU) indications together target wound care markets exceeding $10B+ as of mid-2025. Specifically, the DFU market was valued at $9.36 billion in 2025, with EscharEx for DFU having a projected peak sales potential estimated at $831 million.
A critical segment for government and defense readiness involves U.S. and international military/government agencies. NexoBrid's development has historically received significant backing from these entities, with over $115M+ received from the Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense (DoD) as of January 2025. Furthermore, MediWound Ltd. initiated a BARDA-funded planning process for future U.S.-based manufacturing to secure domestic production capacity. The third quarter of 2025 revenue also reflected higher development service revenue linked to additional contracts with the U.S. Department of Defense (DoD).
The ultimate end-users are the patients themselves, specifically those suffering from severe thermal injuries requiring immediate eschar removal, and those with hard-to-heal chronic wounds. For acute burns, NexoBrid is an FDA- and EMA-approved biologic. For the chronic segment, EscharEx is being developed to offer distinct advantages over existing therapies, such as the currently available drug for wound debridement, which generated over $370 million in revenue (based on 2025 data context).
Here's a quick look at the adoption and market focus as of late 2025:
| Customer Segment Focus | Product | Key Metric/Value | Data Point Reference |
|---|---|---|---|
| Acute Burn Care (U.S. Adoption) | NexoBrid | Consistent ordering from nearly 60 burn centers (Q1 2025) | |
| Chronic Wounds (VLU Trial Scope) | EscharEx | Trial targeting 216 patients across 40 sites (U.S. & Europe) | |
| Government/Defense Readiness | NexoBrid/R&D | Over $115M+ received from BARDA & DoD Contracts (Jan 2025) | |
| Chronic Wounds (U.S. Market Potential) | EscharEx | Targeting a $2.5B U.S. market (Jan 2025 estimate) | |
| Acute Burn Care (U.S. Market Size) | NexoBrid | U.S. TAM estimated at $300M |
The operational expansion directly supports these segments. MediWound's new manufacturing facility is on track for full operational capacity by year-end 2025, which will enable a sixfold increase in NexoBrid production capacity to meet the growing global demand.
The customer base for clinical trials is also a key focus, involving specific patient populations and clinical partners:
- Patients with deep partial and full-thickness thermal burns.
- Patients enrolled in the VALUE Phase III trial for Venous Leg Ulcers (VLUs).
- Clinical sites actively participating in the EscharEx VALUE Phase III study.
- Strategic research collaborations established with industry leaders like Essity and Convatec to support EscharEx trials.
MediWound Ltd. (MDWD) - Canvas Business Model: Cost Structure
You're looking at the core expenditures driving MediWound Ltd.'s operations as of late 2025. The cost structure is heavily weighted toward advancing their late-stage pipeline, which is typical for a company at this stage.
High Research and Development (R&D) costs represent a significant outlay. For the first nine months of 2025, R&D expenses totaled $9.8 million. This is a substantial increase from the $5.9 million reported for the same period in 2024.
The investment in Manufacturing and supply chain expenses for a complex biologic is also a major factor. MediWound Ltd. completed commissioning of its expanded NexoBrid manufacturing facility, which is expected to reach full operational capacity by the end of 2025, positioning the company to meet rising global demand. This expansion itself represents a capital investment that impacts future cost of goods sold and operational overhead.
The increase in R&D is directly tied to the Clinical trial costs for the global EscharEx VALUE Phase III study. This study is actively recruiting patients across approximately 40 sites in the U.S. and Europe. The investment in this late-stage trial is the primary driver behind the year-over-year jump in R&D spending.
Sales, General, and Administrative (SG&A) expenses also increased as the company scales. For the first nine months of 2025, SG&A expenses were $10.6 million, up from $9.1 million in the first nine months of 2024. This rise reflects costs associated with supporting clinical progress and commercial readiness.
Here's a quick look at the main operating expense components for the first nine months of 2025:
| Cost Category | Amount (USD in Millions) |
| Research and Development (R&D) | 9.8 |
| Selling, General and Administrative (SG&A) | 10.6 |
To be fair, you should also note the overall cash burn for operations. During the first nine months of 2025, MediWound Ltd. used $15.8 million in cash to fund operating activities.
The key cost drivers you need to track are:
- R&D spending, driven by the EscharEx VALUE Phase III trial.
- SG&A growth, reflecting increased marketing authorization holder expenses in Q3 2025.
- Manufacturing scale-up costs for NexoBrid production.
- The overall operating loss, which stood at $17.5 million for the nine-month period.
Finance: draft 13-week cash view by Friday.
MediWound Ltd. (MDWD) - Canvas Business Model: Revenue Streams
You're looking at the hard numbers for how MediWound Ltd. brings in cash as of late 2025. It's a mix of product sales and development work, which is typical for a company at this stage.
The top-line figure for the year so far is clear: Total revenue for the first nine months of 2025 was $15.1 million, which compares to $14.4 million in the same period of 2024. This puts the company on a pace to potentially exceed the reaffirmed full-year 2025 revenue guidance of $24 million, which was set earlier in the year.
Revenue streams are clearly segmented between product sales, primarily of NexoBrid, and development services.
Product sales of NexoBrid to commercial partners and distributors show strong underlying demand, though constrained by supply:
- NexoBrid revenue surged 207% year-over-year in the first quarter of 2025.
- This Q1 growth was fueled by consistent orders from nearly 60 burn centers.
- In the second quarter of 2025, NexoBrid sales rose 52% year-over-year.
- The company noted that all NexoBrid production is sold immediately, keeping inventory at zero, which limits the revenue ceiling until the manufacturing expansion is complete.
Development service revenue from government contracts (e.g., DoD) provided a significant boost, especially in the third quarter:
The third quarter of 2025 revenue hit $5.4 million, a 23% increase year-over-year. This quarterly jump was primarily driven by higher development services revenue, which included additional contracts with the DoD. Earlier in the year, it was noted that BARDA contracts were extended until September 2025.
Here's a quick look at the revenue performance across the first three quarters of 2025:
| Period | Revenue Amount | Year-over-Year Change (Q3 vs Q3 2024) |
| First Quarter 2025 | $4.0 million | Decline from $5.0 million in Q1 2024 |
| Second Quarter 2025 | $5.7 million | Up 43% quarter over quarter |
| Third Quarter 2025 | $5.4 million | Up 23% year-over-year |
| Nine Months Ended Sept 30, 2025 | $15.1 million | Up from $14.4 million in the same period of 2024 |
For potential future licensing/milestone payments from EscharEx partners, the current revenue is based on development services and product sales, but the pipeline progress suggests future potential. MediWound Ltd. has established strategic research collaborations for EscharEx with companies including Solventum, Mölnlycke, and MIMEDX. The market opportunity for EscharEx in chronic wounds is substantial, with previous Phase II trials showing advantages over the current market leader, which was cited as a $375 million market leader. Also, the company secured a €2.5 million grant from the European Innovation Council to advance EscharEx.
The revenue mix is shifting, which is helping profitability; gross profit margin for the first nine months of 2025 was 19.7%, up from 12.0% in the same period of 2024, reflecting this favorable revenue mix. Finance: draft 13-week cash view by Friday.
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