Noctura 400 PresentationThe Innovation Pathway Workshop

NE&NC AHSN Stakeholder Event 23rd June 2015

INTR

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POLY

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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.

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.

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.

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.

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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

MEC

HAN

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Structure of the Human Eye and Retinopathy Mechanism

• 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

Rod & Cone Photoreceptors

120 million rods7 million cones

How

it w

orks

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

Mes

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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

Response of the retina to Noctura treatment

Wavelength

Photopic and Scotopic response curves

Wavelength

CURR

ENT

TREA

TMEN

TS Noctura 400®

• Prevents dark adaptation of the rods

• Breaks hypoxia cycle• Low cost and non

invasive

Pan-retinal Photocoagulation• Highly invasive and expensive.• Permanently damages photoreceptors.• Continued treatment causes limited

vision

Intra-Ocular Injection• VEGF inhibitor• High Cost to NHS• Uncomfortable for patient

and TreatmentsRetinopathy Development

The Pod and Compliance monitoring technology.

Capacitive Sensor – ‘On’

Capacitive Sensors – Detect Face & Dose Delivered

OLED Emitters

The mask works for 12 weeks. After which time it must be returned for data analysis. A replacement mask will be issued.

COM

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Patient Compliance Data 12 WeeksCO

MPL

IAN

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Noctura 400 validation & evaluation process

Phase I 40 participants

KTP & KTN Cell Biology - Safety

INSIGHT - Phase II60 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

CLIN

ICAL

VAL

IDAT

ION

NHS Innovations

North

Special interest GPs, Clinicians and CCG contacts, coding issues

Support from AHSN and PartnersAH

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UPP

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NE &NC AHSN

Newcastle Hospitals NHS FT

NIHR Clinical

Research Network

City Hospitals

Sunderland NHS FT

South Tees NHS FT

Links for other bio-photonics projects

CANDLE Trial site

CLEOPATRA Trial, AMD

project, procurement

process

Finance and recharging landscape, access to clinicians

BUSI

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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

THAN

K YO

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Thank you

www.noctura.com www.polyhotonix.com