1. The Innovation Pathway Workshop NE&NC AHSN Stakeholder Event
INTRODUCTION
Noctura 400 Presentation
The Innovation Pathway Workshop
NE&NC AHSN Stakeholder Event
23rd June 2015

2. PolyPhotonix was established in 2009
Bio-Photonic Research and Development Company
Expertise in Organic Chemistry, OLED and Printed Electronics
Based at the National Centre for Printed Electronics at Sedgefield, County Durham
we have used the CPI facilities as a incubation facility.
POLYPHOTONIX

3. NOCTURA PRODUCTS
Diabetic Retinopathy:- Caused by changes in the blood vessels of the retina. New fragile blood vessels start to grow and often leak blood and fluid. Clinical trials complete and in progress, PILOT study in Primary Care, NICE MTEP pending.
Wet Age Related Macular Degeneration:- Abnormal blood vessels behind the retina start to grow under the macula. These new blood vessels are very fragile and leak blood and fluid. Blindness can occur very quickly. Phase I/II in progress, further trials in planning.
The three products on their way. Noctura 400 is closest to market. The others are a couple of years behind.
Dry Age Related Macular Degeneration:- Light-sensitive cells in the macula slowly break down, gradually blurring central vision and leading to blindness. There is no current treatment. Animal study completed, clinical trials planned.

4. Diabetic Retinopathy and Diabetic Macular Oedema
NOCTURA 400
Noctura 400 Sleep Mask for
Diabetic Retinopathy and Diabetic Macular Oedema
Class IIa medical device with CE accreditation
low cost, non invasive monitored ophthalmic therapy
worn at night during normal hours of sleep
3 month disposable mask

5. Structure of the Human Eye and Retinopathy Mechanism
Rod & Cone Photoreceptors
120 million rods
7 million cones
Cones are used in good light conditions: Rods are used in low light conditions
15 times as many Rods than Cones
During dark adaptation the oxygen requirement in the retina nearly doubles
Retina borders on hypoxia: Severe hypoxia if circulation is compromised.
For a patient with diabetes:-
Over production of VEGF chemicals which stimulate neo-vascular growth
Proliferation of blood vessels which physically obstruct vision
New blood vessels are weak and leak fluid - Macular Oedema

6. Noctura 400: Low intensity light of specific wavelength
Rods are prevented from dark adapting
Oxygen demand of the retina remains at normal day time levels (60%)
Hypoxic responses avoided
Reduced retinopathy and macular oedema
How it works
Versus

7. Comparison of Scotopic and Photopic Responses to Noctura 400 treatment
Photopic Response Curve outlines the general Light Adjusted (Cone) response to different wavelengths of light
Scotopic Response Curve outlines the Dark Adjusted (Rod) response to different wavelengths
As Diabetic Retinopathy is the primarily the result of rod metabolism, the Spectrum of the OLEDs should be appropriately tuned
Mesopic Response
Wavelength
Wavelength
Photopic and Scotopic response curves
Response of the retina to Noctura treatment

8. Retinopathy Development and Treatments
Noctura 400®
Prevents dark adaptation of the rods
Breaks hypoxia cycle
Low cost and non invasive
CURRENT TREATMENTS
Intra-Ocular Injection
VEGF inhibitor
High Cost to NHS
Uncomfortable for patient
Pan-retinal Photocoagulation
Highly invasive and expensive.
Permanently damages photoreceptors.
Continued treatment causes limited vision

9. The Pod and Compliance monitoring technology.
OLED Emitters
COMPONENTS
Capacitive Sensor – ‘On’
Capacitive Sensors – Detect Face & Dose Delivered
The mask works for 12 weeks. After which time it must be returned for data analysis. A replacement mask will be issued.
Capacitive Sensors – Detect Face & Dose Delivered

10. Patient Compliance Data 12 Weeks

11. Noctura 400 validation & evaluation process
CLINICAL VALIDATION
Phase I
40 participants
KTP & KTN Cell Biology - Safety
INSIGHT - Phase II
60 participants
CLEOPATRA - Phase III, 15 Centers, 300 participants. Early stage DME
Completed
CZ Trial, 40 participants
2015
CANDLE – Current Care Pathway - NICE MTEP
>>>
2016/2017
PILOT – In Optometry DR/DME patients, within current care pathway
CCG - Business Case – Service Improvement
Tirals underway at present.
Whilst we do have a phase 3 trial underway (for ealier stage patients) the Government were so keen for this treatment to become available that it made money available for a quick study that could put the health and economic arguments of the treatment beyond doubt and pave the way for rapid NHS adoption. The result was CANDLE.

12. Support from AHSN and Partners
NHS Innovations North
Links for other bio-photonics projects
AHSN SUPPORT
NIHR Clinical Research Network
Special interest GPs, Clinicians and CCG contacts, coding issues
NE &NC AHSN
Newcastle Hospitals NHS FT
South Tees NHS FT
Finance and recharging landscape, access to clinicians
City Hospitals Sunderland NHS FT
CANDLE Trial site
CLEOPATRA Trial, AMD project, procurement process

13. NHS opportunity for early adoption
Low risk medical device with CE mark
Cost savings compared with current treatments
70% savings compared with laser treatment
88% cheaper than intra-ocular injections
Step 1 - initial adoption opportunity
Prescribed and monitored in the Eye Hospital
Given in parallel with current treatments
Step 2 – future adoption to be considered earlier in care pathway
BUSINESS CASE
Unit cost per treatment
Unit cost with OPD follow up
Units required per patient per year
Cost per patient per year
Laser
£300
£420 6
£2,520
Injection
£750
£820 8
£6,560
Noctura 400 Sleep Mask
£125
£195 4
£780

14. www.noctura.com www.polyhotonix.com
Thank you
THANK YOU