INTRODUCTION
Noctura 400 Presentation
The Innovation Pathway Workshop
NE&NC AHSN Stakeholder Event
23rd June 2015
POLYPHOTONIX
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.
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.
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.
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NOCTURA 400
Noctura 400 Sleep Mask for
Diabetic Retinopathy and Diabetic Macular Oedema
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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
MECHANISM
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
How it works
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
Versus
Mesopic Response
Comparison of Scotopic and Photopic Responses to Noctura 400 treatment
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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
Wavelength
Wavelength
Photopic and Scotopic response curves
Response of the retina to Noctura treatment
CURRENT TREATMENTS
Retinopathy Development and Treatments
Noctura 400®
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Prevents dark
adaptation of the rods
Breaks hypoxia cycle
Low cost and non
invasive
Intra-Ocular Injection
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Pan-retinal Photocoagulation
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Highly invasive and expensive.
Permanently damages photoreceptors.
Continued treatment causes limited
vision
VEGF inhibitor
High Cost to NHS
Uncomfortable for patient
The Pod and Compliance monitoring technology.
COMPONENTS
OLED Emitters
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.
COMPLIANCE
Patient Compliance Data 12 Weeks
CLINICAL VALIDATION
Noctura 400 validation & evaluation process
Completed
2015
2016/2017
Phase I
40 participants
KTP & KTN Cell
Biology - Safety
INSIGHT - Phase II
60 participants
>>
>
CZ Trial, 40
participants
CANDLE – Current Care Pathway - NICE MTEP
CLEOPATRA - Phase III, 15 Centers, 300 participants. Early stage DME
PILOT – In Optometry DR/DME patients, within current care pathway
CCG - Business Case – Service Improvement
AHSN SUPPORT
Support from AHSN and Partners
NHS
Innovations
North
Special
interest GPs,
Clinicians and
CCG contacts,
coding issues
South Tees
NHS FT
CANDLE
Trial site
NIHR
Clinical
Research
Network
Links for
other biophotonics
projects
NE &NC
AHSN
Newcastle
Hospitals
NHS FT
City
Hospitals
Sunderland
NHS FT
CLEOPATRA
Trial, AMD
project,
procurement
process
Finance
and
recharging
landscape,
access to
clinicians
BUSINESS CASE
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
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
THANK YOU
Thank you
www.noctura.com
www.polyhotonix.com