BioMendics

What BioMendics does

BioMendics is a clinical-stage biopharmaceutical company developing small-molecule topical therapeutics for rare genetic dermatologic disorders. Its lead product, TolaSure Gel (BM-3103), is a 5% w/w proprietary topical gel formulation currently in a Phase II clinical trial (TAMES-02) for Epidermolysis Bullosa Simplex (EBS), with FDA Fast Track Designation received in 2026. The company's pipeline also targets epidermolytic ichthyosis, pachyonychia congenita, and scleroderma.

The company's core technology is its proprietary MTORX™ Small Molecule Liquid Crystal Technology, a platform that removes mutant keratins and degrades/recycles keratin aggregates without the antiproliferative or immunosuppressant side effects of conventional autophagy inducers. The adjunct Clearizome™ Technology platform extends this mechanism to additional keratin mutations (KRT1/10, KRT6/16/17) and to collagen aggregate removal for scleroderma. In a Phase I/IIa TAMES-01 study of 6 severe EBS adults, TolaSure Gel achieved 93% and 96% blister surface area reduction at Weeks 3 and 4 respectively (versus 52% and 45% for vehicle), with molecular disease correction confirmed by transmission electron microscopy showing loss of keratin aggregates and restoration of keratin filaments, and no treatment-related serious adverse events.

BioMendics operates a clinical trial recruitment-driven go-to-market model, running TAMES-02 at two Tier-1 academic sites (Stanford University School of Medicine with PI Dr. Joyce Teng and Northwestern Medicine with PI Dr. Amy Paller), with translational collaborations at University of Miami and UC Davis and community engagement through patient advocacy groups including debra of America, EB Research Partnership, and PC Project. As a privately held, angel-investor-backed LLC domiciled in Ohio and headquartered at the NEOMED REDIzone incubator, BioMendics is pre-revenue; future revenue is expected to derive from post-approval product sales and/or licensing agreements, with no commercial product yet approved and pricing not publicly disclosed.

Name

BioMendics

Legal name

BioMendics, LLC

Website

https://biomendics.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

1–10 employees

Short description

BioMendics is a clinical-stage biopharmaceutical company developing small-molecule topical therapeutics (MTORX™ platform) for rare genetic skin disorders, with lead candidate TolaSure Gel (BM-3103) in a Phase II trial for Epidermolysis Bullosa Simplex under FDA Fast Track Designation.

Ownership category

akta.pro rank

Product category

Rare Dermatologic Disorder Therapeutics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Dermatology Specialty Pharmaceuticals (HLAIACAL)

Keywords

• Rare dermatologic therapeutics
• Epidermolysis bullosa treatment
• Topical small molecule drugs
• Clinical-stage biopharmaceuticals
• Keratin aggregate therapies

Headquarters

HQ city

Rootstown

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Pharmaceutical Development and Licensing: BioMendics is a clinical-stage biopharmaceutical company developing small molecule therapeutics for rare dermatologic disorders. As a pre-revenue company in active clinical development, the company does not yet generate commercial revenue. Future revenue will likely derive from product sales and/or licensing agreements upon regulatory approval of its drug candidates.

Distribution channels1 record

Marketing channels5 records

Core offering

BioMendics is a clinical-stage biopharmaceutical company developing proprietary small molecule liquid crystal medications for rare dermatologic disorders. Its lead asset, BM-3103 (TolaSure Gel), is a patented 5% w/w topical gel based on MTORX™ Technology that targets mutant keratin aggregates to treat epidermolysis bullosa simplex (EBS). The pipeline also leverages the MTORX™ and Clearizome™ platforms to address epidermolytic ichthyosis, pachyonychia congenita, scleroderma, acute wound healing, and burns.

Product overview

BioMendics is a pharmaceutical company developing a portfolio of small molecule liquid crystal medications for rare dermatologic disorders. The core technology platform is MTORX™ Technology, which underlies the lead product BM-3103 (TolaSure Gel), a topical gel formulation for epidermolysis bullosa simplex. The company is also developing Clearizome™ Technology for additional conditions including epidermolytic ichthyosis, pachyonychia congenita, and scleroderma. The pipeline spans preclinical through Phase II clinical stages, with an active TAMES-02 Phase II clinical trial recruiting patients.

Differentiator

Problem solved

Functional benefit

Brands

• TolaSure Gel: Topical gel (BM-3103) being studied in Phase II clinical trials for epidermolysis bullosa simplex.
• MTORX Technology
• Clearizome Technology

Products and services

• BM-3103 (TolaSure Gel) Patented 5% w/w topical gel formulation of MTORX™ small molecule liquid crystal medication, manufactured under cGMP standards. Applied to wounded, healing, or intact skin to target and remove aggregated mutant keratins, restoring keratin filaments in patients with Epidermolysis Bullosa Simplex. Currently in Phase II (TAMES-02) clinical development with FDA Fast Track Designation.
• MTORX™ Technology Platform Proprietary investigational small molecule liquid crystal platform technology that removes mutant keratins and degrades/recycles keratin aggregates by regulating autophagy and inflammatory signaling, without antiproliferative or immunosuppressant side effects. Targeted applications include epidermolysis bullosa simplex, epidermolytic ichthyosis, pachyonychia congenita, scleroderma, acute wound healing, and burns.
• Clearizome™ Technology Investigational technology platform built on the MTORX™ approach, being evaluated for epidermolytic ichthyosis (removing mutated keratin 1 and 10), pachyonychia congenita (removing mutated keratin 6, 16, and 17), and scleroderma (removing excess collagen deposits to reduce skin thickening).

Quantifiable outcome

• Blister surface area reduction of 93% at Week 3 (BM-3103) vs. 52% (Vehicle), p<0.05
• +3 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Five partnerships are on record, tiered core and secondary.

• Stanford University School of MedicinecoreStrategic or Co-development PartnerCollaboration with Stanford University Department of Dermatology for clinical trial conduct. Principal Investigators include Dr. Albert Chiou (Clinical Associate Professor), Dr. Jean Tang (Professor, led 6 investigator-initiated clinical trials in EB), and Dr. Joyce Teng (Professor, LPCH at Stanford). Dr. Teng serves as Principal Investigator for TAMES-02 clinical trial at Stanford site.
• Northwestern Medicine Department of DermatologycoreStrategic or Co-development PartnerCollaboration with Northwestern Medicine for TAMES-02 clinical trial conduct. Dr. Amy Paller serves as Principal Investigator at Northwestern site. Clinical trial coordination through Dr. Lydia Rabbaa Khabbaz.
• University of Miami Miller School of MedicinesecondaryStrategic or Co-development PartnerPartnership with Dr. Robert Kirsner (Chairman and Tenured Professor, Department of Dermatology and Cutaneous Surgery) and Dr. Stephen Davis (Research Professor with 30+ years wound healing expertise using porcine models). Collaboration on wound healing research and development.
• University of California DavissecondaryStrategic or Co-development PartnerPartnership with Dr. Min Zhao (Professor of Dermatology and Ophthalmology) and Dr. Brian Reid (PhD) focusing on wound healing and tissue regeneration research, including electric field therapies and stem cell migration targeting.
• Northeast Ohio Medical University (NEOMED)secondaryStrategic or Co-development PartnerBioMendics is located in the REDIzone® incubator on the NEOMED campus. Dr. Chun-Che Tsai, Co-Founder, is Emeritus Professor of Chemistry and Biochemistry at Kent State University with over 40 years liquid crystal biologics research experience.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Amryt Pharma (a Chiesi company): Amryt Pharma, now part of Chiesi, was a specialty rare disease company with dermatology assets (e.g., Filsuvez/Oleogel-S10 for EB). Highly comparable in rare dermatology positioning, topical wound healing EB indication, and orphan drug commercial model.
• Dermavant Sciences: Dermavant develops novel topical therapeutics in dermatology (e.g., VTAMA). Comparable to BioMendics on specialty dermatology topical drug development, though at a broader commercial scale.
• BridgeBio Pharma: BridgeBio is a larger rare disease biotech with dermatology-adjacent programs (e.g., topical and systemic therapies for genetic conditions). Relevant as a benchmark for rare disease biotech clinical and financing models.
• Arcutis Biotherapeutics: Arcutis is a commercial-stage specialty dermatology company with multiple FDA-approved topical dermatology products (e.g., ZORYVE). It is a broader incumbent in medical-grade dermatology that informs comparison on topical dermatology pricing, distribution, and regulatory strategy.
• Sol-Gel Technologies: Sol-Gel develops branded and generic topical dermatology products with proprietary delivery technology. Comparable as a specialty/topical dermatology drug developer, though more focused on acne and generic opportunities than rare disease.

Direct peers

• Palvella Therapeutics: Palvella is a clinical-stage rare dermatology company developing topical and localized therapies for serious genetic skin diseases (e.g., QTORIN platform for pachyonychia congenita and microcystic lymphatic malformations). Highly comparable given rare skin disease focus and topical formulation strategy.
• Abeona Therapeutics: Abeona has historically developed gene therapies and cell-based approaches for recessive and simplex EB (e.g., EB-101). It is a direct competitor in rare genetic skin disorders, operating in the same EB clinical landscape as BioMendics.
• Krystal Biotech: Krystal Biotech developed and gained FDA approval for VYJUVEK, the first approved therapy for recessive dystrophic epidermolysis bullosa. It is the most relevant direct peer for BioMendics given shared rare dermatology focus, EB target overlap, and late-stage clinical development model.
• Phoenix Tissue Repair (sub. of Shreiber) / Pachyonychia Congenita Project competitors: Researchers and small biotechs developing therapeutics for pachyonychia congenita (PC) directly overlap BioMendics' PC indication target, and PC Project connects patient advocacy similar to BioMendics' partner model.
• Castle Creek Biosciences: Castle Creek Biosciences develops gene therapies for dystrophic epidermolysis bullosa (FCX-007). It is a direct rare EB peer with autologous cell therapy approach, comparable in clinical-stage positioning and orphan disease focus.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/biomendics-llc

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 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 BioMendics