EXOS-GFC™
Autologous Exosome-Enriched Growth Factor Concentrate System
EXOS-GFC™ represents a breakthrough in autologous regenerative medicine technology. This advanced medical device system enables the preparation of exosome-enriched plasma with concentrated growth factors derived exclusively from the patient's own blood. The system integrates proprietary ExoPure™ Bi-Phase Filtration Technology to deliver a high-purity, low-contaminant regenerative concentrate optimized for physician-led procedures in dermatology, trichology, and aesthetic medicine.
For use by trained medical professionals only. Prescription device (Rx Only).
Why EXOS-GFC™
EXOS-GFC™ is engineered to meet the stringent requirements of clinical regenerative medicine protocols. The system addresses critical challenges in autologous plasma preparation including contamination control, exosome yield optimization, and procedural sterility.
This advanced preparation system provides clinicians with a reliable, reproducible method for generating high-quality exosome-enriched plasma fractions suitable for therapeutic applications in hair restoration, aesthetic dermatology, and regenerative procedures.
Autologous & Patient-Derived
Eliminates immunogenic risk through exclusive use of patient's own biological material
Exosome-Enriched Preparation
Optimized for high-density extracellular vesicle concentration
Low Contamination Profile
Minimal RBC and WBC contamination through precision filtration
Closed Sterile System
Single-use design prevents cross-contamination and maintains sterility
Clinical Versatility
Designed for dermatology, trichology, and aesthetic procedures
Advanced Exosome Yield
2.5T
Extracellular Vesicles
Up to ~2.5 trillion extracellular vesicles per mL of prepared concentrate
30-150
Nanometer Range
Target exosome size distribution optimized for cellular signaling
High-Density Regenerative Concentrate
EXOS-GFC™ delivers exceptionally high concentrations of extracellular vesicles per milliliter of processed plasma. This high-density preparation ensures that each treatment session provides a therapeutically relevant dose of regenerative signaling molecules.
The concentrate is rich in bioactive exosomes that serve as intercellular communication vehicles, carrying genetic material and signaling proteins critical to tissue regeneration and cellular activation pathways.
Clinical Significance
The elevated exosome concentration differentiates EXOS-GFC™ from conventional platelet-rich plasma preparations. Exosomes function as paracrine mediators of tissue repair, capable of modulating cellular behavior in target tissues.
*Based on internal analytical evaluation using nanoparticle tracking analysis. Vesicle yield may vary between individuals based on age, health status, and blood quality.
Bioactive Composition
The EXOS-GFC fraction represents a complex biological preparation enriched with multiple classes of regenerative biomolecules. This autologous concentrate contains exosomes, growth factors, and genetic signaling cargo that collectively support tissue regeneration through paracrine and autocrine mechanisms.
Exosomes (30–150 nm)
Nano-sized extracellular vesicles containing:
  • Surface membrane proteins
  • Lipid bilayer structures
  • Encapsulated genetic material
  • Signaling molecules
Growth Factor Panel
Key regenerative proteins include:
  • PDGF – Platelet-Derived Growth Factor
  • VEGF – Vascular Endothelial Growth Factor
  • TGF-β – Transforming Growth Factor Beta
  • EGF – Epidermal Growth Factor
  • IGF-1 – Insulin-like Growth Factor
  • FGF – Fibroblast Growth Factor
Genetic Signaling Cargo
Exosomal nucleic acid content:
  • mRNA – Messenger RNA for protein synthesis
  • miRNA – MicroRNA for gene regulation
  • Other regulatory RNA species
These biomolecules function as intercellular messengers, supporting tissue regeneration, follicular signaling, angiogenesis, and cellular communication pathways essential for therapeutic outcomes.
ExoPure™ Bi-Phase Filtration Technology
Proprietary Technology
Nano-Precision Plasma Purification
At the core of EXOS-GFC™ lies ExoPure™, a proprietary bi-phase filtration technology engineered for nano-precision plasma purification. This dual-stage system ensures optimal removal of contaminating cellular elements while preserving critical exosomal and growth factor content.
Stage 1: Pre-Filtration
Coarse Debris Removal
  • Removes larger cellular debris and particulates
  • Eliminates platelet aggregates
  • Clears micro-clots and fibrin strands
  • Protects downstream nano-filtration membrane integrity
This initial phase prevents membrane fouling and ensures consistent performance of the precision filtration stage.
Stage 2: Nano-Precision Filtration
Final Sterile Filtration
  • Utilizes 0.2 µm membrane specification
  • Removes residual particulate contaminants
  • Permits passage of plasma proteins
  • Allows soluble growth factors transit
  • Enables exosome passage (30–150 nm)
The precisely calibrated pore size ensures retention of larger cells while allowing therapeutic nano-particles through.

Clinical Outcome: A highly purified, exosome-enriched autologous plasma fraction with minimal cellular contamination, optimized protein concentration, and maximal extracellular vesicle content suitable for therapeutic applications.
Clinical Applications
EXOS-GFC™ is utilized under physician supervision across multiple regenerative medicine specialties. The autologous nature of the preparation eliminates concerns regarding immunological rejection or disease transmission.
Clinical applications span aesthetic medicine, dermatological therapeutics, and regenerative procedures where growth factor and exosome delivery may benefit tissue repair and cellular activation.
Hair & Scalp Procedures
Autologous concentrate for follicular stimulation protocols and scalp rejuvenation procedures
Trichology Protocols
Specialized applications in hair loss management and follicular health optimization
Aesthetic Medicine
Skin rejuvenation, textural improvement, and aesthetic enhancement procedures
Regenerative Dermatology
Autologous regenerative applications for various dermatological indications
The final EXOS-GFC product is administered strictly according to the treating physician's clinical protocol. Injection technique, volume, anatomical site, and treatment frequency remain at the discretion of the qualified medical professional based on patient-specific factors and clinical objectives.
System Features
EXOS-GFC™ is engineered with comprehensive safety features and quality controls to ensure consistent performance, procedural sterility, and regulatory compliance. Every component meets stringent medical device manufacturing standards.
Closed System Design
Minimizes environmental exposure and contamination risk throughout the preparation process from blood collection through final concentrate delivery
Sterile & Non-Pyrogenic
All blood-contact components manufactured and sterilized to ensure absence of endotoxins and microbial contamination
Single-Use Only
Designed for single-patient use to eliminate cross-contamination risk and ensure optimal performance for each procedure
Irradiation Sterilized
Terminal sterilization using validated gamma irradiation protocols ensuring complete sterility assurance
ISO 13485:2016 Compliant
Manufactured under internationally recognized quality management system for medical devices
Kit Contents
Each EXOS-GFC™ Kit provides all necessary components for a complete autologous exosome-enriched plasma preparation procedure. The integrated system design eliminates the need for auxiliary equipment procurement while ensuring component compatibility.
Primary Collection Tubes
5 mL Sterile EXOS-GFC Tubes with Platelet Activator
Quantity: 4 tubes
Pre-loaded with proprietary platelet activation and separation medium optimized for exosome preservation
Secondary Processing Tube
Centrifugation Tube (Sterile)
Quantity: 1 tube
For intermediate plasma processing and concentrate pooling
Final Collection Vessel
Collection Tube (Sterile)
Quantity: 1 tube
For final purified concentrate collection post-filtration
Filtration Assembly
ExoPure™ Bi-Phase Filtration Membrane Cup (Sterile)
Quantity: 1 unit
Proprietary dual-stage filtration system with precision 0.2 µm membrane
Transfer Syringe
10 mL Sterile Syringe
Quantity: 1 syringe
For aseptic plasma transfer and filtration procedures

Total Blood Volume Processed: Approximately 20 mL of whole blood (4 tubes × 5 mL per tube) yields sufficient exosome-enriched concentrate for typical clinical procedures.
Intended Use
Clinical Scope & Indications
EXOS-GFC™ is intended for use by trained medical professionals as a single-use sterile system for the preparation of autologous exosome-enriched growth factor concentrate from peripheral venous blood.
The device facilitates the isolation and concentration of the patient's own plasma-derived regenerative components including extracellular vesicles (exosomes), growth factors, and associated bioactive molecules.
Operator Qualification
Must be operated exclusively by licensed physicians, dermatologists, trichologists, or aesthetic surgeons with appropriate training in autologous blood component preparation and therapeutic administration techniques.
Preparation Objective
To generate a sterile, purified, exosome-enriched plasma fraction suitable for autologous therapeutic applications as determined by the treating physician's clinical protocol.
Clinical Context
The prepared concentrate is intended for use within regenerative medicine procedures where autologous growth factors and exosomal content may provide therapeutic benefit. Specific indications remain at physician discretion.
Important: EXOS-GFC™ does not diagnose, treat, cure, or prevent any disease. It is a medical device system for autologous blood component preparation. Clinical outcomes depend on physician technique, patient factors, and treatment protocols.
Safety & Regulatory Information
Prescription Device
Professional Use Only
EXOS-GFC™ is classified as a prescription medical device requiring physician oversight. Adherence to safety guidelines and contraindications is mandatory to ensure patient safety and optimal clinical outcomes.
Prescription Status
Rx Only – Prescription Device
Available only through licensed medical professionals. Not for over-the-counter sale or self-administration by patients.
Contraindications & Limitations
Not Established For:
  • Pediatric patients (under 18 years)
  • Pregnant women
  • Nursing mothers
  • Patients with active systemic infections
  • Patients with blood-borne pathogen exposure
Blood Collection Requirements
Critical Procedural Mandate:
Blood collection must be performed using evacuated tube systems only. Use of syringes or other collection methods may compromise sample quality, introduce contamination, or damage cellular components.
Single-Use Mandate
Do Not Reuse
All components are designed for single patient use. Reprocessing, resterilization, or reuse is strictly prohibited and may result in infection transmission or device failure.
Package Integrity
Pre-Use Inspection Required
Do not use if sterile packaging is damaged, opened, or compromised. Inspect all seals and packaging integrity before initiating procedure.
Storage & Handling
Environmental Requirements
Proper storage and handling of EXOS-GFC™ kits is essential to maintain product sterility, component integrity, and functional performance throughout shelf life.
All storage conditions must be monitored and maintained within specified parameters to ensure device reliability and patient safety.
Temperature Control
Store between 5°C – 30°C (41°F – 86°F)
Maintain consistent ambient conditions. Avoid temperature fluctuations that may compromise component materials or separation media. Standard room temperature or climate-controlled storage is appropriate.
Light & Moisture Protection
Protect from direct light exposure and moisture
Store in original packaging until use. Prolonged light exposure may degrade separation media. Moisture ingress may compromise sterile barriers. Keep in dry environment away from windows or humid areas.
Freeze Prevention
Do not freeze
Freezing may damage tube materials, disrupt separation media, and compromise sterile seals. Frozen units must be discarded and cannot be used even if subsequently thawed.

Shelf Life: Refer to expiration date printed on individual kit packaging. Do not use beyond expiration date. Expired kits may not perform as specified and must be discarded.
Transportation: During shipping, protect from extreme temperatures, physical damage, and moisture exposure. Inspect package integrity upon receipt.
Manufacturing & Compliance
EXOS-GFC™ is manufactured under stringent quality management systems with full regulatory compliance and traceability protocols. Every production lot undergoes comprehensive testing and validation to ensure consistent performance and patient safety.
ISO 13485:2016 Quality System
Manufactured in facilities certified to international medical device quality management standards
Validated Sterilization
Terminal sterilization using validated gamma irradiation protocols with documented sterility assurance
CDSCO-Licensed Facility
Production performed in Central Drugs Standard Control Organisation licensed medical device manufacturing facility
Batch Traceability
Comprehensive lot-level documentation enabling full traceability from raw materials through finished device
Quality Testing
Each production batch undergoes sterility testing, endotoxin analysis, and functional performance validation
Documentation Control
Complete device history records maintained per regulatory requirements including component sourcing and process validation

Regulatory Status: EXOS-GFC™ is registered as a medical device with appropriate regulatory authorities. All marketing and distribution activities comply with applicable medical device regulations in jurisdictions of sale.
Important Disclaimer
Device Classification & Limitations
EXOS-GFC™ is classified as a medical device system for autologous blood component preparation. It is not a drug, biologic, pharmaceutical product, or therapeutic agent.
The device provides a means of preparing exosome-enriched plasma from patient blood but does not itself possess therapeutic properties or make specific health claims.
Clinical Variability: Clinical outcomes may vary significantly based on patient-specific factors including age, overall health status, underlying medical conditions, tissue quality, and individual biological response. Results cannot be guaranteed.
Technique Dependence: Outcomes are highly dependent on physician technique, procedural protocol, injection methodology, anatomical site selection, treatment frequency, and post-procedure care. Operator skill and experience significantly influence results.
Protocol Responsibility: All treatment protocols, dosing decisions, injection techniques, and patient selection criteria remain the exclusive responsibility of the qualified medical professional. The manufacturer provides the preparation device only.
Professional Requirement: All procedures utilizing EXOS-GFC™ must be performed by qualified, licensed medical professionals with appropriate training in autologous regenerative medicine techniques, blood component handling, and sterile procedural protocols.
This device has not been evaluated by regulatory authorities for specific disease treatment, diagnosis, cure, or prevention. Physicians utilizing EXOS-GFC™ are responsible for obtaining appropriate informed consent, discussing realistic expectations, and ensuring patients understand potential risks and limitations.
For Medical Professionals Only
EXOS-GFC™ represents advanced autologous regenerative medicine technology designed exclusively for trained clinical practitioners. Comprehensive technical documentation, clinical support resources, and training materials are available to qualified medical professionals.
Clinical Resources
Access detailed technical specifications, preparation protocols, and clinical application guidance designed for physician education and optimal device utilization.
Professional Support
Our clinical support team provides technical assistance, protocol consultation, and educational resources exclusively to licensed medical practitioners.

Verification Required: Access to detailed clinical information, technical specifications, and ordering systems requires verification of professional medical credentials. Contact our professional services team for access authorization.
Medical Professional Inquiries: For product information, technical support, training resources, or procurement inquiries, qualified medical professionals should contact our clinical support division through authorized channels.
Loading...