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Platform

Four asset classes, one unified thesis.

Melitrix operates an integrated platform spanning medical devices, pharmaceutical products, consulting services, and manufacturing investments, structured so each capability reinforces the others.

01 · ASSET CLASS

Medical Devices

Melitrix is a commercial-stage medical technology company specializing in advanced wound care solutions. Our flagship technology is FDA 510(k) cleared and currently available on the market, reflecting our commitment to clinical excellence and patient outcomes.

  • 1 product, 510(k) cleared, currently in commercialization, our first marketed medical device asset.
  • Diagnostic and therapeutic devices, designed for point-of-care and clinical settings with a focus on workflow integration.
  • Monitoring and connected-health, additional programs in evaluation for the platform roadmap.
510(k) Cleared CE Mark ISO 13485
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Medical device engineering
Capability
Class II & III device development across diagnostic, therapeutic, and monitoring domains.
02 · ASSET CLASS

Pharmaceutical Products

A dual-track pharmaceutical strategy combining bioequivalent generics with 505(b)(2) reformulation programs, leveraging deep regulatory expertise to deliver accessible, differentiated therapies with speed and scientific integrity.

Generics · ANDA 505(b)(2) · NDA Sterile Injectables
Sub-class A
Generics

Bioequivalence established across the portfolio. Multiple generic products, sterile injectables, topical solutions, cutaneous lacquers, and oral syrups, are manufactured through our European partner network and ready for ANDA filings in target markets.

Sub-class B
505(b)(2), MT-01

Our lead 505(b)(2) asset MT-01 is in stabilization studies and progressing through Phase 2 clinical trials, on track for NDA filing via the 505(b)(2) pathway.

We offer a wide range of Solutions for injectables, Oral solutions, Tablets, and Capsules across cardiology, diabetology, pain management, dermatology, ophthalmology, and neurology.

Explore pharma partnership
Sterile injectable development
Lead Program
MT-01, topical combination reformulation on the 505(b)(2) pathway.
03 · ASSET CLASS

Consulting Services

Strategic life science consulting grounded in regulatory intelligence, market access strategy, and commercial operations. We guide emerging and established companies through the complexities of the healthcare landscape.

  • Regulatory strategy, FDA engagement, pathway selection, submission planning, and response management.
  • Market access, payer strategy, pricing frameworks, and commercialization roadmaps.
  • Technical due diligence, clinical, regulatory, and commercial diligence for investors and acquirers.
Regulatory Market Access Diligence
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Strategic consulting
Focus
Regulatory, market access, and diligence support for life science operators and investors.
04 · ASSET CLASS

Investments & CDMO Services

A capital-deployment and manufacturing partnership model built for the modern biotech ecosystem. We invest in high-conviction life science opportunities and provide contract development and manufacturing services that accelerate client programs.

  • Life science capital, early-stage equity and strategic co-investment alongside operational support.
  • CDMO services, formulation development, analytical support, and contract manufacturing through our European partner network.
  • Co-development, risk-shared programs that align capital, science, and commercial execution.
CDMO Capital Co-development
Explore capital or CDMO
Pharmaceutical manufacturing
Network
European CDMO partners supporting sterile, solid-dose, and topical manufacturing.
Pipeline

Programs in development

A snapshot of our active programs across pharmaceutical and device asset classes. Details on select programs are available under NDA to qualified partners and investors.

Program
Asset Class
Pathway
Stage
MT-01
Combination reformulation
Pharma, 505(b)(2)
NDA, 505(b)(2)
DiscoveryPreclinicalStabilizationPhase 2NDA Submission
MT-G Portfolio
11+ generic products (inj., topical, oral)
Pharma, Generics
ANDA
FormulationBioequivalenceScale-upANDA prepSubmission
MT-D1
Lead medical device, commercialization
Medical Device
510(k) Cleared
ConceptEngineeringVerification510(k)Commercial

Program names are internal designations. Product and indication-specific details are shared under confidentiality with qualified counterparties.

Regulatory Pathways

Literate across every pathway we touch

Our platform is built to navigate the full range of FDA regulatory pathways relevant to our asset classes, without compromise on scientific or procedural rigor.

Device
510(k)

Premarket notification pathway for Class II devices substantially equivalent to a legally marketed predicate.

Device
PMA

Premarket approval for Class III devices, requiring clinical evidence of safety and effectiveness.

Pharma · Generic
ANDA

Abbreviated new drug application for bioequivalent generic therapies referencing an approved innovator product.

Pharma · NDA
505(b)(2)

Hybrid NDA pathway leveraging existing safety data for reformulated, repurposed, or combination drug products.

Want deeper details on a specific program?

Qualified partners and investors can request a confidential briefing on any asset class or program.

Request a Briefing Meet the Team