Five platforms. One translational pipeline.
From a single diagnostic biosensor to four distinct delivery technologies, each platform is documented with its mechanism, preclinical validation, and current development stage.
SPR Optical Biosensor
A label-free, portable optical biosensing system for the rapid, early detection of breast and brain cancer biomarkers from a liquid biopsy.
Real-time analysis
Instantaneous binding kinetics, without fluorescent labels.
Liquid biopsy
Non-invasive detection directly from serum or plasma.
High sensitivity
Detects low-abundance autoantibodies at pg/mL concentration.
Portable point-of-care
Integrated microfluidics designed for point-of-care testing.
Physics, biology, and device — in one workflow
The physics: the sensor detects changes in refractive index at a metal-dielectric interface; binding events alter the angle of minimum reflectivity.
The biology: disease-specific antigens are immobilized on the sensor chip; patient serum is introduced to detect autoantibodies.
The device: an automated microfluidic sample-handling system is integrated with the optical sensor for under-100µL samples and sub-30-minute results.
SPR vs. current standard-of-care diagnostics
| Parameter | MRI / PET-CT | ELISA / Serology | Miragen SPR |
|---|---|---|---|
| Cost per test (India) | ₹8,000 – ₹30,000+ | ₹2,000 – ₹5,000 | Target < ₹1,000 |
| Time to result | Hours – days | 4 – 24 hours | < 30 minutes |
| Sensitivity | Requires visible tumor mass | ng/mL – µg/mL | pg/mL (ultra-sensitive) |
| Accessibility | Centralized imaging center | Laboratory required | Point-of-care, field-deployable |
Comparison based on current clinical oncology guidelines (NCCN) and Miragen internal data.
Strategic roadmap — currently in Lab Validation
Proof of Concept
- Sensor fabrication
- Microfluidic design
- Initial buffer tests
Analytical Validation
- LoD / LoQ establishment
- Specificity studies
- Reproducibility tests
Clinical Validation
- Patient cohort study
- Comparison vs. standard
- Statistical analysis
Regulatory & Scale
- CDSCO device filing
- Manufacturing transfer
- Commercial pilot
What we're seeking from partners: access to patient cohorts (breast/brain), biobanking support, clinician feedback on protocol design, and blinded validation studies.
BBB-Penetrating Nanotubes
A nose-to-brain delivery system using self-assembled, transferrin-targeted nanotubes to bypass the blood-brain barrier for non-invasive glioblastoma treatment.
The blood-brain barrier excludes nearly all small-molecule drugs and 100% of large-molecule biologics, while active efflux pumps eject many therapeutic agents back into circulation — forcing the high systemic doses that cause severe side effects.
Intranasal RationaleMiragen's nanotubes travel the nose-to-brain pathway via the olfactory and trigeminal nerves — bypassing the BBB entirely, reaching the CNS within minutes, and avoiding first-pass metabolism.
Active targeting: transferrin functionalization targets overexpressed receptors on BBB endothelial cells and glioma cells, enabling receptor-mediated transcytosis.
Payload: Temozolomide (TMZ) with combination agents for tumor heterogeneity coverage, in a biodegradable PLGA/PLA core.
In vivo evidence across two cancer models
BBB Crossing Confirmed
Ex vivo fluorescence imaging 24 hours after intranasal administration confirmed brain accumulation and co-localization with glioblastoma cells, validating BBB penetration and tumor-specific targeting.
Tumor volume: 4.13 mm³ · Max radiance: 2.22×10⁵ p/sec/cm²/sr
Systemic Tumor Targeting
Whole-body and ex vivo imaging (Day 44) confirmed nanoparticle accumulation and retention specifically in breast tumor tissue, validating the EPR effect and active targeting mechanism.
Suggests potential for treating breast-to-brain metastases.
Therapeutic Impact
~78% tumor growth inhibition vs. free-drug control (p<0.001); median survival extended from 28 to over 60 days (p<0.01) with no significant weight loss or organ toxicity observed.
Model: orthotopic GBM (U87MG-Luc) in nude mice.
Formulation built for scale-up from day one
A Quality-by-Design approach defines Critical Process Parameters across nanoprecipitation, tangential flow filtration, and sterile filtration — currently validated at 10L per batch and GMP-ready, with release specifications including PDI < 0.2, encapsulation efficiency > 85%, and endotoxin < 0.5 EU/mL.
Injectable Self-Gelling Wafer
A patented in-situ gelling implant for post-surgical application, designed to prevent tumor recurrence through localized, sustained drug release.
In-situ gelation
Injectable liquid forms a gel depot at body temperature.
Sustained release
Controlled therapeutic delivery over several weeks.
Localized control
Targets residual cells at the surgical resection margin.
Image-guided
Compatible with MRI/CT monitoring post-implant.
From cavity injection to sustained release
Cavity Injection
- Liquid sol, injectable viscosity
- Customizable volume
- Following tumor resection
In-Situ Gelation
- Triggered at 37°C body temp
- Solidifies in < 2 minutes
- Conformal coverage
Depot Formation
- Fills irregular margins
- High tissue adhesion
- MRI / CT visible
Sustained Release
- Zero-order release kinetics
- 4–6 week duration
- Minimal systemic toxicity
Miragen Wafer vs. Gliadel®
| Feature | Gliadel® (Standard) | Miragen Wafer |
|---|---|---|
| Administration | Surgical implant | Injectable |
| Geometry | Rigid disc | Conformal gel |
| Duration | ~2–3 weeks | Tunable (months) |
TRL 4–5 · Preclinical Validated
Validated in orthotopic mouse models showing sustained release and tumor suppression, with a scale-up protocol established.
Next milestone: toxicology studies and formulation stability work ahead of IND filing.
Target partnership: neurosurgery departments for post-operative clinical trials.
Transdermal Nanoparticles
A patented lipid-based delivery system engineered to overcome stratum corneum barriers for deep dermal penetration of therapeutics and micronutrients.
Oleic acid acts as a permeation enhancer, disrupting the ordered lipid packing of the stratum corneum to create fluidized channels for nanoparticle entry — achieving deep dermal penetration where standard liposomes remain on the skin surface.
Draize scale evaluation on six human volunteers confirmed zero irritation, with the lipid-based nanoparticle platform passing the full safety protocol.
Irritation potential: 0.0 / 4.0
Draize scale protocol — passed.
GRAS-approved materials
Biocompatible, biodegradable lipids throughout.
Micronutrient fortification, built for cosmetic bases
Lip Salve
Nanoparticle-infused stick for daily micronutrient delivery.
Face Packs
Multani mitti base enriched with dermal-penetrating nutrients.
Transdermal Creams
Therapeutic bases for Vitamin B12 and other active ingredients.
Microneedle Patches
A self-applicable, pain-free transdermal system for non-invasive delivery of biomolecules, vitamins, and vaccines with improved patient compliance.
Microneedles penetrate the stratum corneum without reaching nerve endings, enabling a simple press-and-apply mechanism for home use — no bio-hazardous sharps waste, with dissolving formulations available.
Pain-free application
Minimal discomfort, no needle anxiety.
Self-administration
Patient-friendly, no clinic visit required.
Custom payloads
Vitamins, micronutrients, and small molecules.
Better compliance
Bypasses GI degradation and pill fatigue.
TRL · Prototype Optimization Phase
Lab Validation
Optimization
GMP Scale-Up
Commercialization
Seeking: GMP manufacturing partners, CDSCO regulatory consultants, and precision molding partners for tech transfer.