For investors
Building the infrastructure for the future of global eye health.
A regulated medical device, a structural gap in a market of 200 million people, and a recurring-revenue model that scales with every patient treated.
- People with AMD worldwide
- 200MProjected to reach 288 million by 2040.
- Dry AMD share
- 85–90%The form with the fewest approved treatments.
- Annual US economic burden
- $49BDriven mostly by lost productivity and quality of life.
- Regulatory classification
- Class IIaCE-first under the EU MDR, then UKCA.
The thesis
The market does not need another hospital console.
Dry AMD is diagnosed and monitored in community optometry. Interventional technology has been designed for hospitals and specialist centres. That mismatch has left effective approaches locked in high-cost, low-access environments while the majority of patients are told to wait.
Revolux is built for where the patients are. A Class IIa binocular photobiomodulation platform, portable enough for a standard consulting room, rigorous enough for a regulated clinical pathway, and sold as a subscription so a practice can start with no upfront cost.
People living with AMD worldwide
Each figure is two million people. The dark centre of every head is the central vision that dry AMD takes.
196million people living with AMD
2020published
- Living with AMD in 2020
- Added by 2040: 92 million
The figures behind this chart
| Year | People with AMD |
|---|---|
| 2020 | 196 million |
| 2040 | 288 million |
Source: Wong et al., The Lancet Global Health, 2014. Years between the two published figures are a straight line between them.
Where the innovation has gone
Each square is one patient in a hundred.
- Dry AMD90%
- Most patients. Few options.
- Wet AMD10%
- Most of the therapeutic investment.
Business model
Recurring revenue that scales with patient volume.
Clinics subscribe to Revolux rather than buying capital equipment. Each treatment course is nine sessions over three weeks, and repeatable cycles mean revenue for the clinic, and for BioPhotonix, scales linearly with the number of patients treated.
- Subscription model with no upfront cost to the clinic
- One patient every three months covers a practice's subscription
- Integrated software for reporting, compliance and post-market data
- Designed for community optometry, the setting where dry AMD is actually managed
Regulatory strategy
CE-first, safety by design.
We are implementing a quality management system aligned with ISO 13485 and pursuing CE marking under the EU Medical Device Regulation, alongside UKCA for the UK. The pathway requires third-party testing against international standards for optical safety, electrical safety and biocompatibility.
- ISO 13485 quality management system
- ISO 15004-2 and ANSI Z80.36 optical safety
- IEC 60601-1 medical electrical safety
- ISO 10993 biocompatibility
- ISO 13485Quality management system
- EU MDRClass IIa, CE-first strategy
- UKCAUK market conformity
- ISO 15004-2Ophthalmic optical safety
- ANSI Z80.36Light hazard protection
- IEC 60601-1Medical electrical safety
- ISO 10993Biocompatibility
Development roadmap
From concept to clinic.
Medical device development is a disciplined journey of risk reduction. Each stage below locks something down before the next begins.
- TRL 1–3Complete
Research and problem definition
Confirmed that the science of photobiomodulation is sound, and that existing delivery methods fail community use: handheld devices lack consistency, hospital consoles lack accessibility.
- ArchitectureComplete
Binocular platform selected
A headset-based architecture chosen to guarantee precise source-to-eye geometry and repeatable dosimetry, so every patient receives the intended dose whichever clinic they visit.
- TRL 4Complete
Lab validation
Functional prototypes fabricated with Med Design validated the ergonomic assumptions for adults over 50. Thermal limits, output stability and software logic tested.
- TRL 5In progress
Design freeze
Locking the hardware configuration: optical arrays, power subsystems and safety interlocks, under ISO 13485 quality standards, with optical engineering input from Fraunhofer and WideBlue.
- NextPlanned
Pilot clinical evaluation
Revolux moves out of the lab and into the hands of clinicians: the final step before scaling for regulatory approval.
- RegulatoryPlanned
CE and UKCA marking
Class IIa conformity under the EU MDR, then UKCA for the UK market, with third-party testing against the optical, electrical and biocompatibility standards.
- LaunchPlanned
Community deployment
Subscription rollout to community optometry, with clinician training, integrated reporting and post-market surveillance.
Team and partners
A clinician founder, with the specialists a medical device needs.
Adail Islam
Founder and Director, BSc Optometry, BSc Orthoptics
Dr Nikola Krstajic
Scientific and clinical advisory. PhD, Lecturer in Medical Physics, University of Dundee.
Edwin Lindsay
Regulatory and compliance. Managing Director, Compliance Solutions Life Sciences.
Martin Pacitti
Engineering partner. Project Manager, WideBlue.
Next step
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This page is provided for information only. It is not an offer to sell or a solicitation of an offer to buy any securities, and nothing here constitutes investment advice. Figures are drawn from published sources and the company's own development records and may be updated.