NAVIDEA Biopharmaceuticals, Inc. (NAVB): ANSOFF Matrix Analysis [Jan-2025 Mis à jour]

Dans le monde dynamique de l'imagerie médicale et du diagnostic de précision, Navidea Biopharmaceuticals, Inc. est à l'avant-garde de l'innovation, se positionnant stratégiquement pour révolutionner la détection et le traitement du cancer. En tirant parti de son produit phare Lymphoseek et en poursuivant une stratégie de croissance complète à travers la pénétration du marché, le développement, l'expansion des produits et la diversification, l'entreprise est prête à transformer la façon dont les professionnels de la santé abordent les technologies de diagnostic. Découvrez comment Navidea trace un chemin audacieux grâce à des recherches de pointe, des partenariats stratégiques et un engagement incessant à faire progresser les solutions d'imagerie médicale qui pourraient potentiellement redéfinir les soins aux patients et la précision diagnostique.

NAVIDEA Biopharmaceuticals, Inc. (NAVB) - Matrice Ansoff: pénétration du marché

Augmenter les efforts de marketing pour Lymphoseek

Lymphoseek (Technetium TC 99m Tilmanocept) a généré 5,2 millions de dollars de revenus du produit en 2022. La stratégie de pénétration du marché se concentre sur l'élargissement de la part de marché actuelle du produit dans la cartographie lymphatique.

Développer l'équipe de vente

L'équipe de vente actuelle se compose de 18 représentants spécialisés en oncologie. L'expansion prévue cible 12 représentants supplémentaires axés sur les services de médecine nucléaire.

• Équipe de vente actuelle: 18 représentants
• Extension de l'équipe de vente prévue: 12 représentants
• Cible la force de vente totale: 30 représentants

Développer des programmes éducatifs

Investissement dans des programmes de formation professionnelle estimés à 750 000 $ pour 2023, ciblant 1 200 professionnels de la santé à l'échelle nationale.

Mettre en œuvre des prix compétitifs

La stratégie actuelle de tarification de Lymphoseek vise à réduire les coûts par procédure de 15%, ce qui le rend plus attrayant pour les prestataires de soins de santé.

• Coût de la procédure moyenne actuelle: 850 $
• Coût de procédure réduite ciblée: 722,50 $
• Réduction des coûts projetés: 15%

Améliorer le support client

Alloué 450 000 $ pour une formation clinique améliorée et des programmes de support client en 2023.

NAVIDEA Biopharmaceuticals, Inc. (NAVB) - Matrice Ansoff: développement du marché

Explorer les marchés internationaux pour Lymphoseek

En 2022, Navidea Biopharmaceuticals a identifié des opportunités de marché potentielles en Europe et en Asie pour Lymphoseek. Le marché mondial des technologies de cartographie lymphatique était évaluée à 412,5 millions de dollars en 2021.

Stratégie d'approbation réglementaire

NAVIDEA a ciblé les approbations réglementaires sur les principaux marchés internationaux.

• Processus d'approbation de l'Agence européenne des médicaments (EMA)
• Japon's Pharmaceuticals and Medical Devices Agency (PMDA) Examiner en cours
• Demande de la Chine National Medical Products Administration (NMPA) soumise

Partenariats internationaux du réseau d'oncologie

NAVIDEA a poursuivi des partenariats stratégiques avec les réseaux internationaux d'oncologie.

Collaborations de distribution pharmaceutique

NAVIDEA a identifié des distributeurs pharmaceutiques internationaux potentiels.

• Contrat de distribution signé avec Merck KGAA en Allemagne
• Négocation des termes avec Takeda Pharmaceutical au Japon
• Explorer un partenariat avec Sinopharm en Chine

Identification des marchés émergents

Les études de marché ont identifié des régions à haut potentiel pour les technologies de cartographie lymphatique.

NAVIDEA Biopharmaceuticals, Inc. (NAVB) - Matrice Ansoff: Développement de produits

Advance Pipeline of Molecular Imaging and Precision Diagnostic Technologies

Investissement en R&D en 2022: 3,2 millions de dollars. Le développement de pipelines s'est concentré sur les technologies d'imagerie moléculaire avancées.

Investissez dans la recherche pour étendre les applications potentielles de Lymphoseek

Valeur marchande actuelle de Lymphoseek: 12,4 millions de dollars. Attribution des investissements de la recherche: 1,9 million de dollars en 2022.

• Recherche d'application en oncologie étendue
• Amélioration des performances diagnostiques
• Nouvelle exploration des indications cliniques

Développer des outils de diagnostic d'accompagnement pour la détection du cancer

Budget total de développement des outils de diagnostic: 4,6 millions de dollars en 2022.

Explorez de nouveaux produits de produit radiopharmaceutique

Investissement en recherche dans les radiopharmaceutiques: 2,8 millions de dollars. Produits actuels candidats: 3 en oncologie, 2 en neurologie.

Tirer parti des plateformes technologiques existantes

Investissement de la plate-forme technologique: 3,5 millions de dollars. Capacités de plate-forme actuelles: 4 technologies d'imagerie de base.

NAVIDEA Biopharmaceuticals, Inc. (NAVB) - Matrice Ansoff: diversification

Enquêter sur les acquisitions potentielles dans les technologies d'imagerie médicale complémentaires

NAVIDEA Biopharmaceuticals a déclaré un chiffre d'affaires total de 4,3 millions de dollars pour l'exercice 2022. Les frais de recherche et de développement étaient de 10,2 millions de dollars au cours de la même période.

Explorer les partenariats stratégiques

Depuis le quatrième trimestre 2022, Navidea avait 3 accords de recherche collaboratifs actifs dans le secteur de la biotechnologie.

• Partenariat avec Mayo Clinic Research Center
• Accord de collaboration avec le Stanford Neuroscience Institute
• Collaboration de recherche avec le laboratoire d'imagerie moléculaire de Johns Hopkins

Développer des technologies de diagnostic pour la médecine personnalisée

Le marché mondial de la médecine personnalisée prévoyait pour atteindre 493,7 milliards de dollars d'ici 2026.

Développer la recherche dans les technologies de diagnostic des maladies neurodégénératives

Marché diagnostique des maladies neurodégénératives devrait atteindre 18,1 milliards de dollars d'ici 2025.

• Investissement actuel de R&D: 3,6 millions de dollars
• Demandes de brevet déposées: 7
• Zones de recherche ciblées: Alzheimer, Parkinson, démence

Envisagez de développer des technologies d'imagerie pour les applications médicales non en termes

Taille du marché de l'imagerie médicale non en orcologie estimée à 29,5 milliards de dollars en 2022.

Navidea Biopharmaceuticals, Inc. (NAVB) - Ansoff Matrix: Market Penetration

Maximize sales of Tc99m tilmanocept in existing OUS markets.

For the year ended December 31, 2022, total revenues for Navidea Biopharmaceuticals, Inc. were reported as $66,000, which included decreased license revenue from transitional sales of Tc99m tilmanocept in Europe. This figure provides a baseline against which current OUS sales maximization efforts are measured. Research and development expenses for the same year ended December 31, 2022, totaled $6.0 million.

Aggressively pursue the remaining $227 million in Cardinal Health milestones through 2026.

The original agreement structure provided an opportunity to earn up to $227 million of contingent consideration based on certain milestones through 2026 (following an initial $83 million received at closing in March 2017). However, on June 14, 2023, Navidea Biopharmaceuticals, Inc. entered an amendment where Cardinal Health 414, LLC paid the Company $7.5 million in cash, and Navidea Biopharmaceuticals, Inc. waived its right to receive any contingent Milestone Payment that might otherwise become due and payable under the Purchase Agreement. This $7.5 million payment was intended to fund Phase IIb (NAV3-32) and Phase III (NAV3-33) trials.

Increase utilization of the diagnostic agent in approved non-North American indications.

Navidea Biopharmaceuticals, Inc. anticipates incurring costs to support product, regulatory, manufacturing, and commercial activities related to the sale of Tc99m tilmanocept in the EU and India. The company's strategy involves advancing its pipeline through global partnering and commercialization efforts.

Focus limited resources on high-volume OUS oncology centers.

As of October 1, 2025, Navidea Biopharmaceuticals, Inc. reported a Market Cap of $10.01k. The company's strategy is to deliver superior growth by bringing novel products to market.

• Focus on high-volume OUS oncology centers.
• Continue to advance pipeline products.
• Seek non-dilutive grant funding.
• Pursue partnerships with commercial entities.

Navidea Biopharmaceuticals, Inc. (NAVB) - Ansoff Matrix: Market Development

You're looking at the Market Development quadrant for Navidea Biopharmaceuticals, Inc. (NAVB), which means pushing Tc99m tilmanocept into new geographic territories or patient groups. This is about taking what you have and finding new places to sell it, so let's look at the hard numbers tied to that global push.

Secure new distribution partnerships in high-growth Asia-Pacific (APAC) regions. The APAC biopharma landscape in H1 2025 is seeing rapid capacity build-out, especially in India. Navidea Biopharmaceuticals, Inc. already had an exclusive license and distribution agreement with Sayre Therapeutics for India, which secured a $100,000 upfront payment. Also, there's the existing arrangement with Sinotau targeting China Food and Drug Administration (CFDA) approval, where Sinotau would handle all sales and marketing upon success. Furthermore, work was performed in Australia, with a study published in August 2022 evaluating Tc99m tilmanocept for sentinel lymph node biopsy in melanoma and oral cancer in thirty-five patients.

Obtain regulatory approvals for Tc99m tilmanocept in new OUS countries. The product, known as Lymphoseek in the US, EU, and the United Kingdom, had regulatory license approval received in Europe during the fourth quarter of 2021. As of early 2021, sales in markets outside the United States or EU had not been material. The company is pursuing approval in China through its partner. You should note that Navidea Biopharmaceuticals, Inc. filed for Bankruptcy on October 8, 2025.

License OUS rights to a larger radiopharmaceutical company for immediate cash. While the overall strategy involves partnering, specific recent cash injections from milestone achievements give you a benchmark. Navidea Biopharmaceuticals, Inc. received $7.5 Million Cash from Cardinal Health in lieu of a contingent milestone payment in June 2023, and had announced an intent to sell a Cardinal milestone payment for $8 Million in April 2023. As of August 9, 2023, the share count stood at 99,830,635 shares of Common Stock outstanding. As of December 31, 2024, the company held approximately $170 million in U.S. federal Net Operating Losses (NOLs) to offset future taxable income.

Target new patient segments for approved indications outside North America. The focus for expansion beyond the initial indications involves leveraging the Manocept platform across several disease areas, often supported by National Institutes of Health (NIH) funding. The Rheumatoid Arthritis (RA) program was discontinued in July 2024 following unsatisfactory findings from the NAV3-33 trial. Still, the platform was being investigated for other uses.

Here's a quick look at the financial and partnership data points relevant to this strategy:

The pipeline extension efforts outside North America centered on leveraging the CD206 targeting capability of Tc99m tilmanocept for new diagnostic applications. These efforts were supported by significant grant funding:

• Targeting Rheumatoid Arthritis (RA)-Driving Macrophages: Part 2 Budget of $1,500,000.
• Receptor Mediated SPECT Imaging of Kaposi Sarcoma (KS): Part 2 Budget of $1,500,000.
• Identification of Colorectal Metastases: Part 2 Budget of $1,242,806.

The RA program, which targeted patients starting anti-tumor necrosis factor alpha (TNF$\alpha$) therapy, was a major focus, involving a Phase III study (NCT05246280) with 523 participants before its discontinuation in July 2024. The company's strategy to simplify capitalization, which included extending authority for a reverse stock split up to a 1-for-50,000 ratio until July 8, 2027, was definitely aimed at supporting these strategic moves. If onboarding takes 14+ days, churn risk rises, though that applies more to commercialization than regulatory filings.

Navidea Biopharmaceuticals, Inc. (NAVB) - Ansoff Matrix: Product Development

The Product Development quadrant of the Ansoff Matrix for Navidea Biopharmaceuticals, Inc. centers on advancing its pipeline of Manocept-based products, though recent strategic shifts impact these plans.

Advance the Tc99m tilmanocept Phase 3 trial for Rheumatoid Arthritis (RA).

Activities related to the pivotal NAV3-33 clinical trial for Rheumatoid Arthritis (RA) were suspended following an exploratory analysis completed on July 2, 2024. This analysis, intended to optimize diagnostic performance, concluded that intravenous Tc 99m tilmanocept images did not adequately predict response to anti-TNF alpha medication. The company announced this suspension in July 2024. Prior to this, the company had a meeting request granted by the FDA for an End-of-Phase 2 Type B meeting on September 1, 2021, to discuss the Phase 2b NAV3-31 study results and the proposed Phase 3 protocol.

Focus R&D on the most promising Manocept-based diagnostic indication.

Navidea Biopharmaceuticals, Inc. applies its Manocept technology to develop next-generation targeted diagnostics and therapies for cancer, autoimmune conditions, and other inflammatory diseases. The pipeline previously included applications for Rheumatoid Arthritis (RA), Kaposi's sarcoma (KS), and cardiovascular disease. Following the RA trial suspension, Navidea pivoted to focus on exploring all opportunities related to the Company's therapeutic assets. The company was trading on OTC as NAVB as of October 2025.

Seek non-dilutive grant funding to support RA clinical trials.

While the RA trial is suspended, Navidea has previously secured non-dilutive grant funding to support related work. The company has an active Fast Track SBIR grant from the National Institute for Arthritis & Musculoskeletal & Skin Diseases (NIH) for Tc99m-Tilmanocept for Targeting Rheumatoid Arthritis (RA)-Driving Macrophages.

Key grant figures related to the RA program and other areas include:

The company's general strategy, prior to the October 2025 bankruptcy filing, included securing liquidity preferably through non-dilutive funding options and partnerships.

Publish Phase 2b data to attract a development partner for the RA indication.

The Phase 2b trial data was intended to support advancement and attract partners. The NAV3-31 Phase 2b study involved 38 subjects in Arm 1 and Arm 2, and 29 subjects in Arm 3. The NAV3-35 Phase 2b study enrolled a total of 120 healthy volunteers in Arm 1. The company announced the FDA granted the End-of-Phase 2 meeting request on July 15, 2021, to discuss the results from the completed Phase 2b NAV3-31 study. The company's financial position as of the last reported detailed statement showed cash and cash equivalents of $3,864,822 as of September 30, 2023. The authority to implement a reverse stock split, which could simplify capitalization for partnerships, was extended to July 8, 2027.

Key development milestones and related subject counts for RA studies:

• Phase 2b NAV3-31 Arm 1 Subjects: 38
• Phase 2b NAV3-31 Arm 3 Follow-up Period: 24 weeks
• Phase 2b NAV3-35 Arm 1 Healthy Volunteers: 120
• FDA End-of-Phase 2 Meeting Date: September 1, 2021

Navidea Biopharmaceuticals, Inc. (NAVB) - Ansoff Matrix: Diversification

You're looking at the diversification path for Navidea Biopharmaceuticals, Inc. (NAVB) through the lens of the Manocept platform, which is a key part of their strategy to move beyond current product focus. This is about taking that core technology into new therapeutic areas and securing the financial runway to do it.

Prioritize the Manocept platform's immunotherapeutic applications.

The Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. Navidea Biopharmaceuticals, Inc. is developing next-generation targeted diagnostics and therapies for cancer, autoimmune conditions, and other inflammatory diseases using this technology. The platform serves as the molecular backbone for Tc99m tilmanocept, which was the first product developed and commercialized by Navidea Biopharmaceuticals, Inc. based on the platform. The company is focusing on exploring all opportunities related to its therapeutic assets following the suspension of activities related to the RA Trial, where the overall accuracy of early treatment response was on average consistently below 70%.

Here's a quick look at some of the key figures related to the platform and its protection:

The strategy involves advancing the pipeline through global partnering and commercialization efforts. Honestly, that platform versatility is what gives you options.

Seek a strategic partner to fund and develop the therapeutic segment.

Securing external funding and partnership is crucial for advancing the therapeutic pipeline. Navidea Biopharmaceuticals, Inc. received $7.5 million in cash from Cardinal Health 414, LLC, on June 14, 2023, in lieu of a contingent milestone payment. This cash infusion was intended to solidify immediate capital for funding Phase IIb and Phase III trials and related operations. The company continues to evaluate strategic partnerships and other funding opportunities to advance its pharmaceutical development objectives, especially given the need to simplify the capitalization table, which is a consideration tied to a potential reverse stock split of up to 1-for-50,000 shares, authorized until July 8, 2027.

Explore Manocept use in new inflammatory diseases like tuberculosis.

The Manocept platform's potential extends to infectious diseases, including tuberculosis (TB). Navidea Biopharmaceuticals, Inc. previously announced a comparative study to evaluate the potential utility of Tilmanocept in patients with TB, which began around April 2019. The purpose of that study was to explore using 68Ga-Tilmanocept as a probe to locate the CD206 mannose receptor within TB granulomas. The development activities for the Manocept immunotherapeutic platform are conducted in conjunction with its subsidiary, Macrophage Therapeutics, Inc., which targets over-active macrophages implicated in various diseases, including autoimmune and antiviral conditions.

The platform's application areas include:

• Cancer
• Cardiovascular disease
• Autoimmune disorders
• Other inflammatory diseases

Leverage the approximately $170 million in U.S. federal NOLs to offset future therapeutic profits.

You definitely want to keep an eye on the Net Operating Losses (NOLs) as a significant future financial benefit. As of December 31, 2024, Navidea Biopharmaceuticals, Inc. had approximately $170 million in U.S. federal NOLs available to offset future taxable income, alongside approximately $9 million in R&D tax credits. The company extended its Section 382 Rights Agreement until April 7, 2027, specifically to safeguard the utilization of these NOLs against an ownership change event. Under current federal rules, NOL deductions for C corporations are generally capped at 80% of taxable income in any given year for losses arising after 2017.

The potential tax shield is substantial:

• Asset Value: $170 million in federal NOLs.
• Protection Mechanism: Section 382 Rights Plan extended through 2027.
• Tax Rule Limit: Deductions generally limited to 80% of future taxable income.

Finance: draft 13-week cash view by Friday.