Noctura 400 Presentation The Innovation Pathway Workshop NE&NC AHSN Stakeholder Event 23 rd June...
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Transcript of Noctura 400 Presentation The Innovation Pathway Workshop NE&NC AHSN Stakeholder Event 23 rd June...
Noctura 400 PresentationThe Innovation Pathway Workshop
NE&NC AHSN Stakeholder Event 23rd June 2015
INTR
OD
UCT
ION
POLY
PHO
TON
IX
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.
3
NO
CTU
RA P
ROD
UCT
S
NO
CTU
RA 4
00
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
ISM
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
opic
Res
pons
e
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
PON
ENTS
Patient Compliance Data 12 WeeksCO
MPL
IAN
CE
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
SN S
UPP
ORT
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
NES
S CA
SE
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
U
Thank you
www.noctura.com www.polyhotonix.com