Evidence Base
Our evidence.
What it proves and what it doesn't.
We hold ourselves to a high standard of scientific integrity. This page presents our evidence base clearly — what has been independently verified, what is real-world observation, and what is the planned formal validation pathway.
Independent Laboratory Validation
NABL Accredited
performance testing.
The following data was independently generated by Cotecna India (NABL Accredited) India Pvt. Ltd., an NABL Accredited testing lab, across two separate test reports — physical/mechanical (Dec 2025, Report CPSGGHD2534833_Rev02) and chemical/skin safety (April 2026, Report CPSGGHD2607945_Rev01). laboratory, in December 2025. Report Reference: CPSGGHD2534833. These are not manufacturer claims — they are independently verified measurements.
Cotecna India (NABL Accredited) India (NABL) · NABL Accredited Laboratory · Dec 2025 & Apr 2026
Reports: CPSGGHD2534833 · ASTM F1446 Standard · Independent testing — not manufacturer conducted
88.1%
Multi-Layer Impact Attenuation (ASTM F1446)
483N
Chin Strap Retention Force (Tensile Load)
pH 6.5
Skin Safety pH — Neutral, Chronic Contact Safe
PASS
Azo Dyes · Disperse Dyes · Heavy Metals (EN/ISO)
PASS
pH 6.5–6.6 · Skin-safe (ISO 3071:2020)
BDL
Heavy Metals — All 9 tested Below Detection Limit
PASS
Carcinogenic Disperse Dyes — All Clear
PASS
Defects & Workmanship · Appearance After 3 Washes
Real-World Evidence Base
42+ verified outcomes.
Independently documented.
The following data is drawn from 42+ independently verifiable feedback entries across structured survey (n=8), verified public website reviews (n=6), and direct customer interactions (n=28). Geographic distribution: 15+ Indian cities.
Scientific note: The following real-world observations are from a non-interventional, pre-IEC evaluation phase. They have not been generated through a formal randomised controlled trial or IEC-approved clinical study. They represent early real-world behavioural signals that support the hypothesis of superior compliance performance. Formal clinical validation is being pursued through an IEC-approved observational study at leading neurology hospitals and clinics.
62.5%
Voluntary Wear Compliance
Patients wore DazzleSafe™ without any caregiver reminder — the primary metric for compliance-driven design. Structured survey n=8. Traditional helmet literature reports 15–25% voluntary compliance.
0
Head Injuries in Documented Fall Events
Zero head injuries across five independently reported fall and seizure events while wearing DazzleSafe™. Includes one patient with 3–4 daily tonic-clonic seizures over an extended observation period.
100%
Caregiver Recommendation Rate
Every verified user across 42+ independently documented feedback entries would recommend DazzleSafe™. No paid marketing used to generate any of these responses.
8.9
Average Comfort Score (out of 10)
Structured survey n=8. 87.5% of structured survey participants reported wearing DazzleSafe™ for 2+ hours daily. 25% reported sleeping in it.
2 yr
Continuous Use — Single Unit
One verified DazzleSafe™ unit documented in continuous daily use for over 2 years across multiple fall events — zero structural failure. No comparable Indian-manufactured seizure headgear has documented this durability.
15+
Indian Cities Represented
Organic market adoption across 15+ Indian states and cities without paid advertising — indicating genuine clinical demand and prescriber-driven word-of-mouth across geographies.
Clinical Validation Roadmap
The path to
IEC-approved evidence.
Our formal clinical validation pathway is structured to generate peer-reviewed, publishable evidence that will establish DazzleSafe™ as a clinically adopted standard of care — not just a commercially successful product.
Complete
Phase 1
NABL Lab Testing & CDSCO Registration
Independent performance validation. Regulatory registration. India's first in this category.
Complete
Phase 2
Pre-IEC Real-World Observation
42+ verified user outcomes. 0 head injuries in documented falls. Compliance signal confirmed.
In Progress
Phase 3
IEC-Approved Clinical Study at Leading Hospitals
30-patient prospective observational study. Primary endpoint: ≥70% daily wear compliance at 12 weeks.
Planned
Phase 4
PubMed-Indexed Publication
First peer-reviewed Indian clinical evidence on neurological protective headgear compliance. Manuscript target Q1 2027.