Name

Medosome Biotec

Legal name

Medosome Biotec, LLC

Website

https://mdbiotec.com

Company type

Private

Operating status

Operating

Ownership category

akta.pro rank

Product category

Pediatric Biopharmaceuticals

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414), Medical Laboratories (621511), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836), Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Personalized Therapeutic Design (neoantigen vaccines, individualized cell/gene therapies) (HLAAANAK)

akta.pro secondary industries

Genetic & Genomic Rare Disease Therapeutics (HLAIAIAA), Translational Medicine & Biomarkers (HLAIALAF), Engineered Protein Therapeutics (de novo/AI-designed proteins, novel scaffolds) (HLAAAAAJ), Genomics & Molecular Diagnostics (Trial Support) (HLAGAEAD)

Keywords

• Pediatric biotechnology
• Rare disease therapeutics
• Precision medicine diagnostics
• Probiotic drug delivery
• Companion diagnostics

Headquarters

HQ city

Alachua

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Others

Revenue model

1. Drug Development and Commercialization: Developing early-stage technologies from preclinical through IND/Phase I, with strategic partnerships for FDA marketing approval and commercialization of pharmaceutical products.
2. Genetic Testing Services: CLIA certified genetic testing laboratory providing companion diagnostics including GSTZ1 haplotyping and HIV/HCV subpopulation testing for personalized dosing.
3. SBIR/STTR Grant Funding: Pursuing Small Business Innovation Research and Small Business Technology Transfer grants from government agencies including HHS/NIH, NSF, DOD, DOE, USDA.
4. Spin-off Companies: Formation of subsidiary companies like Nuteric Natural Health Products for commercializing product lines, with faculty collaborators benefiting from spin-off entities.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Medosome Biotec develops and commercializes early-stage biotechnologies for pediatric rare and tropical diseases, including small molecule drugs (DCA, MyeGen-0298), a Lactobacillus-based oral peptide delivery platform, biological therapeutics (Ang-(1-7)), and CLIA-certified genetic testing services (GSTZ1 haplotyping, HIV/HCV subpopulation assays) for personalized pharmaceutical dosing. The company operates from late discovery through IND/Phase I, leveraging precision medicine to pair companion diagnostics with its therapeutic pipeline.

Product overview

Medosome Biotec is a pediatric biotechnology company developing a portfolio of therapeutic drugs and genetic diagnostic tests. The therapeutic pipeline includes: Dichloroacetate (DCA) for Pyruvate Dehydrogenase Complex Deficiency; MyeGen-0298 for demyelinating diseases; Nuteric anti-diarrheal beverage; a Lactobacillus-based oral delivery platform for peptide/protein drugs including GLP-1; and Ang-(1-7) for diabetic retinopathy. The genetic testing portfolio includes GSTZ1 haplotyping for personalized DCA dosing and NextGen sequencing assays for HIV/HCV subpopulation detection. The company operates a CLIA-certified, CAP-accredited clinical genetic testing laboratory supporting its precision medicine focus.

Differentiator

Problem solved

Functional benefit

Brands

• Nuteric: Anti-diarrheal beverage for pediatric diarrhea with pro-absorptive and anti-secretory properties, currently in clinical trial in Bangladesh
• MyeGen-0298
• LBP (Lactobacillus Based Platform)
• GSTZ1 Haplotyping Test
• HIV/HCV Subpopulation Assay

Products and services

• Dichloroacetate (DCA) Small molecule drug for the treatment of Pyruvate Dehydrogenase Complex Deficiency (PDCD) and other indications including pulmonary arterial hypertension, diabetes, heart disease, cancer, and sepsis.
• MyeGen-0298 Small molecule drug that stimulates myelinating cells (oligodendrocytes) and myelin formation for the treatment of demyelinating diseases including periventricular leukomalacia (PL) and multiple sclerosis (MS).
• Nuteric Anti-diarrheal beverage with pro-absorptive and anti-secretory properties for the treatment of pediatric diarrhea.
• Lactobacillus Based Platform (LBP) Probiotics-based oral delivery system for peptide and protein drugs including GLP-1, using Lactobacillus bacteria for robust, scalable, and cost-effective oral delivery of therapeutics.
• Ang-(1-7) Biological Drug Biological drug for the treatment of diabetic retinopathy and other vascular disorders, delivered orally via probiotic-produced Angiotensin-(1-7) using Lactobacillus bacteria.
• GSTZ1 Haplotyping Test Genetic test for determining GSTZ1 haplotype variations that influence dichloroacetate (DCA) metabolism kinetics, distinguishing 'fast' and 'slow' drug metabolizers for personalized DCA dosing.
• NextGen Sequencing Assay for HIV/HCV Highly sensitive next-generation sequencing assay for detecting HIV and HCV subpopulations, including minor drug-resistant variants not detectable in standard commercial assays, for personalized antiretroviral drug dosing.
• Companion Diagnostics and Laboratory Developed Tests Genetic tests for rare disease diagnosis and personalized pharmaceutical drug dosing, forming the company's precision medicine initiative.

Quantifiable outcome

• FDA Phase III clinical trial completed for DCA treatment of PDCD
• +2 more outcomes

Named customers1 record

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Six partnerships are on record, tiered core and minor.

• Saol TherapeuticscoreStrategic or Co-development PartnerStrategic partner that submitted New Drug Application (NDA) for marketing approval to the FDA in August 2024 for dichloroacetate (DCA) treatment of Pyruvate Dehydrogenase Complex Deficiency (PDCD). This partnership represents a key milestone in bringing their drug to market.
• ICDDR,B (International Centre for Diarrhoeal Disease Research, Bangladesh)coreStrategic or Co-development PartnerInternational research institution collaborating on clinical trial for Nuteric pediatric diarrhea treatment in Bangladesh. The collaboration focuses on evaluating safety and efficacy of the anti-diarrheal beverage.
• Academic Researchers and University Technology Transfer OfficescoreStrategic or Co-development PartnerPartnership with faculty members to prepare and submit SBIR/STTR grant proposals. Upon funding, Medosome works collaboratively toward submitting IND applications to FDA. Faculty collaborators benefit from spin-off company formations.
• Clinical-Stage Pharmaceutical CompaniescoreStrategic or Co-development PartnerStrategic alignment with clinical-stage pharmaceutical companies to advance promising drugs toward FDA marketing approval and commercialization. Medosome focuses on early-stage technologies while partners provide clinical development capabilities.
• Nuteric Natural Health Products, LLCminorOEM/ Whitelabel/ Licensing PartnerSpin-off subsidiary company formed to commercialize the line of products promoting GI health, including the Nuteric anti-diarrheal beverage.
• Gifting HealthminorOthersNon-profit organization formed to promote GI health in developing countries, complementing the commercial efforts of Nuteric Natural Health Products.

Scale indicators6 records

Recent moves8 records

Expansion highlights3 records

Direct peers

• Saol Therapeutics: Clinical-stage rare disease pharmaceutical company and Medosome's strategic partner for DCA commercialization. Directly comparable as a small rare-disease-focused drug developer handling FDA approval and launch for niche indications.
• Ultragenyx Pharmaceutical: Commercial-stage rare and ultra-rare disease biotech with multiple late-stage programs and approved products. Comparable in targeting genetically defined rare diseases with limited treatment options, though at meaningfully greater scale.
• Soleno Therapeutics: Small-cap rare disease biotech focused on pediatric disorders. Comparable in size and stage to Medosome, with a single lead rare-disease program advancing through late-stage development toward FDA approval.
• Provention Bio: Small-cap biotech focused on autoimmune and rare disease therapeutics with FDA-approved product. Comparable as a similarly sized rare-disease-focused company that advanced a niche therapy through FDA approval.

Broad incumbents

• BioMarin Pharmaceutical: Established rare disease biotech with a portfolio of approved therapies, particularly in pediatric metabolic and genetic conditions. Comparable as a rare-disease commercial-stage operator, though substantially larger and more diversified.
• Alexion (AstraZeneca Rare Disease): Major rare disease franchise within AstraZeneca with commercialized orphan therapies and companion diagnostics. Relevant comparator for Medosome's rare-disease + diagnostic positioning, though operating at pharma scale.
• Myriad Genetics: Established clinical genetic testing and companion diagnostics company. Comparable to Medosome's CLIA-certified genetic testing laboratory operations and companion diagnostic strategy, though broader in scope and public-market scale.
• Natera: Clinical genetic testing and molecular diagnostics company with CLIA-certified laboratory operations. Comparable as a CLIA-certified lab offering precision-medicine tests, particularly relevant to Medosome's companion diagnostic business.
• Recordati Rare Diseases: Established rare disease business unit of Recordati, commercializing treatments for orphan and rare conditions globally. Relevant comparator for the eventual commercialization phase of Medosome's rare disease assets, particularly in the metabolic disorder space.

Emerging players

• Vedanta Biosciences: Clinical-stage company developing defined bacterial consortia and live biotherapeutic products. Comparable to Medosome's Lactobacillus-based oral peptide/protein delivery platform approach to microbial therapeutics.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Medosome Biotec