Regulatory Pathway

A Strategic, Step-by-step plan from
concept to market.

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Here’s a timeline with eight sections that clearly outlines our path to delivering LIOR™ quickly and safely.

January 1, 2026

1. Post-Funding Milestones

Finalize funding agreements, hire engineering and regulatory consultants, secure supplier partnerships

January 1, 2026

April 1, 2026

2. Pre-Prototype Validation

Bench Testing of PLR-3 Firmware, simulated eye models, early risk analysis

April 1, 2026

July 1, 2026

3. Prototype Development

Build and refine functional prototype. Complete usability testing. Lock down design specs for regulatory submission

July 1, 2026

May 1, 2027

4. Clinical Testing

Pilot Study: Small cohort, single site, feasibility study
Pivotal Study: Multi-site, head to head with Neuroptics NPi-300 150-200 patients

May 1, 2027

January 1, 2028

5.Regulatory Pathway Canada

Submit Class II Medical Device License Application.
Approval anticipated in 3 months

January 1, 2028

September 1, 2028

6. Regulatory Pathway FDA

Submit 510(k) application with FDA clearance anticipated in 3-5 months

September 1, 2028

7. Manufacturing and Quality Systems

In parallel with regulatory submissions, implement ISO 13485 QMS. Validate manufacturing line and scale up suppliers

September 1, 2028

8. Market Access and Next Steps

Canada Launch Q3 2028, US Launch Q2 2029
Post Market Surveillance ongoing
EU MDR /UKCA planning beginning in late 2029

September 1, 2028

Strategic Initiatives

This roadmap shows a 3 year pathway from initial funding to the Canadian and U.S. Market which is standard for a Class II medical device following clinical-validation strategy.

1. Post-Funding Milestones (Q1 2026)

Secure engineering, clinical, and regulatory partners.
Allocate funds to prototype development, testing, and regulatory submissions. (Initial Discussions and NDA’s signed with Brash Inc.)
Establish advisory board of physicians, paramedics, RN’s and industry experts.
Lock down suppliers for core components (camera, LEDs, MCU, housing).

2. Pre-Prototype Validation (Q2 2026)

Test PLR-3 firmware against simulated eye models and light conditions.
Validate accuracy thresholds against Monte Carlo simulation results.
Perform bench studies to confirm pupil size and constriction velocity, percent and absolute change
Conduct initial risk analysis using ISO 14971 framework.

3. Prototype Development (Q3 2026-Q1 2027)

Build first fully functional LIOR prototype.
Verify all device functions (search, baseline, light stimulus, analysis, output).
Conduct usability and human factors testing under IEC 62366.
Refine industrial design for pocket portability and clinical workflow.
Finalize prototype for clinical study readiness.

4. Clinical Testing (Q2 2027- Q4 2027)

Pilot Study (Q2 2027):
• 20–30 patients, single site, feasibility and usability outcomes.
Pivotal Study (Q3–Q4 2027):
• 150–200 patients, multi-site, head-to-head comparison with Neuroptics NPi-300.
• Primary endpoint: agreement on pupil reactivity classification (normal, sluggish, non-reactive).
• Secondary endpoint: usability and workflow efficiency.
Collect data to support Health Canada and FDA submissions.

5. Regulatory Pathway Health Canada (Q1-Q2 2028)

Class II medical device designation confirmed.
Prepare Medical Device License (MDL) submission package.
Demonstrate safety, effectiveness, and usability.
Target approval by Q2 2028.

6. Regulatory Pathway FDA (Q3-2028)

Pursue Class II device classification through 510(k).
Leverage predicate devices (e.g., Neuroptics NPi-300).
Submit clinical, usability, and bench data package.
Anticipate FDA clearance by Q1 2029.

7. Manufacturing and Quality Systems (Q3 2027-Q2 2028)

Implement ISO 13485-compliant Quality Management System.
Validate suppliers and establish Good Manufacturing Practice processes.
Perform design verification and validation testing.
Conduct pilot production runs to confirm device consistency.

8. Market Access and Next Steps (Q3 2028 onward)

Launch LIOR in Canada following Health Canada approval.
Launch in the U.S. following FDA clearance.
Begin post-market surveillance and user feedback studies.
Expand into EU MDR and UKCA submissions (late 2029).
Plan for LIOR software updates and future device versions.

Want to be a part of bringing LIOR™ to Life?

We are actively seeking team members and partnerships to support every stage of the regulatory process. We encourage you to complete the “Explore Collaboration Form”, so we can keep you informed about future opportunities. Join us and be part of something extraordinary.

Explore Collaboration

What do Clinicians Have to Say?

We asked everyday clinicians what they thought about Quantitative Pupillometry and LIOR™…Here is what they said:

Pupillary assessments are completely subjective. Having a reliable device to measure size and reactivity accurately would greatly improve my ability to make better decisions in caring for the most critically ill patients.

Greg Pryde Critical Care Paramedic (ON)
Field Training Officer

“Paramedics need access to timely and accurate pupillary assessments. The penlight is not good enough when minutes matter. LIOR™ is simple to use and affordable making it accessible to all health care providers, not just the ICU.”

Chris Barclay Critical Care Paramedic, Flight
CBRNE certified

“Cost has been the main barrier to wider adoption of pupillometry. A practical, low-cost solution finally removes that barrier.”

Jason BenaimCritical Care Paramedic
Field Training Officer

“Making pupillometry affordable is as important as making it accurate. LIOR is positioned to do both without compromising usability.”

Alvin Yuhalogarasan CBRNE and Critical Care Resident Paramedic
Health and Safety Specialist

“Every clinician knows the value of pupil assessment in emergency care. A reliable, pocket-ready, quantitative tool would be a breakthrough we all need.”

Chris RotoloTactical Paramedic, Superintendant
TCCC Educator

“If every paramedic had access to this tool, assessment for head injury, CVA’s and Toxicology cases would be more reliable. That level of consistency would change emergency care.”

Rachel JanerAdvanced Care Paramedic, Deputy Commander
Masters in Business Admin.

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Regulatory Pathway

A Strategic, Step-by-step plan from concept to market.

1. Post-Funding Milestones

2. Pre-Prototype Validation

3. Prototype Development

4. Clinical Testing

5.Regulatory Pathway Canada

6. Regulatory Pathway FDA

7. Manufacturing and Quality Systems

8. Market Access and Next Steps

Strategic Initiatives​

Want to be a part of bringing LIOR™ to Life?

What do Clinicians Have to Say?​

A Strategic, Step-by-step plan from
concept to market.

Strategic Initiatives

What do Clinicians Have to Say?