TIDMAVO
RNS Number : 1600L
Advanced Oncotherapy PLC
11 January 2021
11 January 2021
ADVANCED ONCOTHERAPY PLC
("Advanced Oncotherapy" or the "Company")
Technical update
Advanced Oncotherapy (AIM: AVO), the developer of
next-generation proton therapy systems for cancer treatment,
releases the following update on recent developments and
accomplishments regarding its LIGHT system.
Highlights since previous technical update released in September
2020:
-- Infrastructure in place to support assembly and testing
activities --> ongoing conditioning of high-power
radio-frequency (RF) accelerating units.
-- Optimal RF phase and amplitude stability reached -->
system now capable of supporting the delivery of a proton pulse
every 5 milliseconds.
-- Maximum intensity of the proton beam achieved during the
initial conditioning phase --> now ready to support more
efficient treatment plans and delivery.
-- Integration of the full medical software suite -->
previously a key roadblock for clinical users, now overcome.
-- Further studies presented at the American Society for
Radiation Oncology (ASTRO) --> demonstrating the superiority of
the proton beam generated by LIGHT.
-- Successful re-certification of ISO 13485 --> supporting
the operational activities at the installation and integration site
in Daresbury.
The Company remains on track to have a fully operational LIGHT
system with a 230MeV beam, which is the beam energy needed to treat
patients, during 2021 and the Board currently expects this to be in
the second half of 2021. Actual treatment of patients, which is
anticipated shortly after the LIGHT machine is fully operational,
remains dependent on the Company's clinical partner, University
Hospital Birmingham NHS Trust.
The following table summarises the key deliverables for
2021:
Deliverables Status
Medical software suite integrated Integration completed, installation
in standalone operation in Daresbury during H1 2021
------------------------------------
Financing partnership(s) to support Please refer to announcement
the delivery of the pipeline dated 6 January 2021
------------------------------------
Patient positioning system installed Delivered to Daresbury
------------------------------------
All accelerating structures conditioned Delivered to Daresbury
------------------------------------
All accelerating structures aligned Delivered to Daresbury
------------------------------------
Machine operational with a full Targeted for H2 2021
energy 230MeV beam
------------------------------------
Further commercial partnerships Strong pipeline of opportunities
and purchase orders for 2021
------------------------------------
While the Company continually monitors the potential impact of
the ongoing COVID-19 pandemic lockdown enforced by the UK
Government, it remains confident on the completion of its key
deliverables set out for 2021 with work currently continuing as
planned and the team deemed as "essential workers" and allowed to
continue working on site at Daresbury.
Nicolas Serandour, CEO of Advanced Oncotherapy, commented:
"We have continued to make good progress with the set-up of our
assembly site in Daresbury, a stepping stone in our plan for the
commercial roll-out of LIGHT, and remain committed to our
operational plan and key deliverables set out for 2021 despite
COVID-19. We are on track to have a fully operational LIGHT system
in 2021. As part of the integration and conditioning of our first
commercial LIGHT system, we have achieved excellent results which
support the differentiated and versatile profile of our LIGHT
offering."
Infrastructure in place to support assembly and testing
activities --> ongoing conditioning of high-power
radio-frequency (RF) accelerating units
The purpose of the site located at Daresbury, Cheshire, UK is to
assemble and test the various units of the LIGHT system so that the
proton beam meets the relevant medical, health and safety
requirements and standards. All the relevant infrastructure is now
in place; this required the seamless integration of various
disciplines and specialties, most notably Environmental Health and
Safety, radiation safety, electromagnetic compatibility and
electromagnetic interference, beam dynamics, electrical
engineering, electronics, mechanical engineering, vacuum
technology, magnet technology, RF technology, power converters, IT,
radiation protection, cooling and ventilation, survey and
alignment, electrical networks, and civil and structural
engineering.
Critical parts completed since September 2020 regarding the
infrastructure needed for the assembly and testing of future LIGHT
systems comprise, amongst others:
-- Successful set-up of three test stands used for high-power RF
conditioning : As part of the certification process, data related
to the testing, commissioning and maintainability of the
radio-frequency equipment of LIGHT must be recorded. In order to
test the accelerating structures that have various sizes and
specifications, three test stands have been successfully installed
with the ability to perform parallel tests and characterise the
LIGHT system. The conditioning of the accelerating units is ongoing
and has already allowed the Company to optimise key parameters
which will be integrated into the medical software and used to
prepare the relevant treatment plan for patients.
-- Implementation of an ultra-high vacuum environment : Protons
must be accelerated throughout the LIGHT accelerating units at
ultra-high vacuum. The vacuum pumps have now been installed and
integrated with cables, cooling pipes and gauges and are supported
by position adjustment systems, which are required to satisfy the
stringent alignment tolerances that are necessary for the optimal
performance of the LIGHT accelerator.
-- Implementation of the cooling system: The chillers, pumps,
gages and flow control devices are installed and integrated to the
control system to support optimal operation of the LIGHT
accelerator.
-- Building of fixed and temporary shielding walls : These
shielding walls have been built based on the radiation protection
standards and can be removed, in such a way that parallel
operations can be undertaken, both at the accelerator and in the
treatment room areas.
-- Installation of instruments needed for the testing phase :
These instruments, which are key for a smooth integration process,
are now part of the fully functioning repositionable test benches
and include quadrupole magnets which are used to measure the beam
emittance, spectrometers which measure the beam energy and phase
probes which measure the arrival time of the beam bunches.
Optimal RF phase and amplitude stability reached --> system
now capable of supporting the delivery of a proton pulse every 5
milliseconds
The LIGHT accelerator has the capability of varying the proton
beam energy continuously from 70 MeV to 230 MeV in only five
milliseconds which the Board believes is a significant breakthrough
in the Company delivering a superior medical treatment compared to
other systems on the market which have a significantly slower
energy modulation. This is done by acting on both the power
provided to the accelerating units of the LIGHT accelerator and the
phase of the radio-frequency signal that is used to accelerate
protons. Consequently, achieving the right phase stability and
radio-frequency amplitude of the proton beam are critical
parameters in the commissioning of the LIGHT system. After a series
of tests performed in cooperation with Advanced Oncotherapy's
previously announced partner, ScandiNova, these have been achieved,
which provides the Company with continued confidence for the future
successful commercial deployment of LIGHT.
Maximum intensity of the proton beam achieved during the initial
conditioning phase --> now ready to support more efficient
treatment plans and delivery
In the current clinical routine, the goal is to deliver a
homogeneous, curative dose to the target whilst minimising the dose
delivered to the surrounding tissues. This is why an important
algorithm in the treatment plan in proton therapy is the ability to
change the number of protons per pulse, a parameter also called
intensity. During the initial conditioning process, the full
intensity of 300 uA as per the design has been reached. This is a
key step forward in the integration process and provides the basis
for an optimised treatment plan as the higher the intensity, the
more versatile the LIGHT system can be, and the wider the spectrum
of efficient treatment plans and delivery which can become
available for clinical users.
Integration of the full medical software suite --> previously
a key roadblock for clinical users, now overcome
One of the significant challenges faced by users of proton
therapy systems to date has been the lack of an integrated control
software suite. The Company has been working in partnership with
RaySearch Laboratories AB to develop a seamless software suite
customised for the LIGHT system which will support personalised
precision proton therapy.
The software suite provides users with a single interface for
patient preparation, treatment and follow-up processes, which
limits potential risks and facilitates a better user experience for
clinicians and healthcare workers. The Company has been using the
new integrated software suite at its R&D facility in Geneva,
Switzerland and expects to install the software in its clinical
system in Daresbury during H1 2021.
The Notes to Editors section below provides further details on
the various medical software packages.
After its successful factory acceptance testing, the patient
positioning system has been delivered to the assembly site in
Daresbury and is ready for installation. The patient positioning
system includes the diagnostic quality CT scanner used to scan
patients in a seated position; the real-time X-ray verification
system which enables continuous imaging of moving tumours; and the
robotic chair which can move and rotate the patient with high
accuracy and precision.
Further studies presented at ASTRO --> demonstrating the
superiority of the proton beam generated by LIGHT
The Company recently presented two posters at the ASTRO
conference further demonstrating the potential treatment advantages
of the proton beam generated by the LIGHT system:
-- Smaller proton spot sizes have been shown to improve
conformity to treatment targets. Due to its small constant spot
size, the LIGHT beam demonstrated in a modelling study ([1]) to be
more conformal to clinical targets than the cyclotron beam while at
the same time sparing more healthy tissues. Significantly, the
study showed that the LIGHT scanning beam spot size is constant
across the 150-230 MeV energy range, which is advantageous for all
clinical cases evaluated and in particular for the brain and
prostate tumour cases.
-- The delivery of an ultra-high level of radiation in a very
short time, a technique known as FLASH, could change cancer
treatment by treating patients in possibly one single visit to the
hospital. Calculations have shown[2], that the LIGHT system will be
able to deliver variable high doses of protons within 0.5 second
pulses[3] and that the spot size can be varied from one to six
millimetres, which are both essential in delivering a highly
differentiated, faster and optimised FLASH treatment with improved
conformality.
Successful re-certification of ISO 13485 --> supporting the
operational activities at the installation and integration site in
Daresbury
In January 2019, the Company obtained ISO 13485:2016
certification, the internationally recognised quality standard to
ensure the consistent design, development, production, installation
and sale of medical devices that are safe for their intended
purposes.
A subsequent external audit was performed in December 2020 by
Lloyd's Register which was focused on installation, integration and
product safety management operations. The review confirmed that the
design and development and the manufacturing control activities
were in compliance with the highest standards for safety and
product performance. This result provides a strong platform for the
continued integration of the LIGHT system. It further highlights
the importance placed on the quality of the LIGHT system and the
need to have robust processes in accordance with the stringent
requirements associated with medical devices.
- ENDS -
Advanced Oncotherapy plc www.avoplc.com
Dr. Michael Sinclair, Executive Chairman Tel: +44 (0) 20 3617 8728
Nicolas Serandour, CEO
Allenby Capital Limited (Nomad and Joint Broker)
Nick Athanas / Liz Kirchner (Corporate Finance) Tel: +44 (0) 20 3328 5656
Amrit Nahal / Matt Butlin (Sales & Corporate Broking)
SI Capital Ltd (Joint Broker)
Nick Emerson Tel: +44 (0) 1483 413 500
Jon Levinson Tel: +44 (0) 20 3871 4066
FTI Consulting (Financial PR & IR) advancedoncotherapy@fticonsulting.com
Simon Conway / Rob Winder Tel: +44 (0) 20 3727 1000
Notes to Editors
The software suite includes the following components:
-- Machine parameter verification : Software that compares
intended settings with actual machine settings to ensure proper
proton treatment delivery.
-- Oncology information system : Software integrated with the
treatment planning system that offers managed workflows and enables
patient treatment to be modified daily.
-- Treatment planning system : Software used by clinicians to
prepare a proton therapy treatment for each patient.
-- Treatment session manager : Software that prepares the daily
proton treatment for patient delivery.
-- Spot map visualisation : Software that shows a graphic
display to the staff of the scanning proton spots during
operation.
About Advanced Oncotherapy Plc www.avoplc.com
Advanced Oncotherapy, a UK headquartered company with offices in
London, Geneva, The Netherlands and in the USA, is a provider of
particle therapy with protons that harnesses the best in modern
technology. Advanced Oncotherapy's team "ADAM," based in Geneva,
focuses on the development of a proprietary proton accelerator
called, Linac Image Guided Hadron Technology (LIGHT). LIGHT's
compact configuration delivers proton beams in a way that
facilitates greater precision and electronic control.
Advanced Oncotherapy will offer healthcare providers affordable
systems that will enable them to treat cancer with innovative
technology as well as expected lower treatment-related side
effects.
Advanced Oncotherapy continually monitors the market for any
emerging improvements in delivering proton therapy and actively
seeks working relationships with providers of these innovative
technologies. Through these relationships, the Company will remain
the prime provider of an innovative and cost-effective system for
particle therapy with protons.
[1] Farr JB, Kolano AM, Aumon S, Degiovanni A, Caldara M,
Valloni A. Proton LINAC Transverse Beam Scanning Performance
Implications for Therapeutic Quality Improvement. International
Journal of Radiation Oncology*Biology*Physics. 2020;108(3,
Supplement):e351. https://doi.org/10.1016/j.ijrobp.2020.07.2334
[2] Kolano AM, Degiovanni A, Farr JB. Investigation on the PBS
FLASH Beam Delivery Technique Using a Proton Linac. International
Journal of Radiation Oncology*Biology*Physics. 2020;108(3,
Supplement):e331. https://doi.org/10.1016/j.ijrobp.2020.07.791
[3] Mean dose rates required for the FLASH effect are of the
order of 40-200 Gy/s in less than 0.5 s, delivered in 5-10 ms
pulses. Conventional radiotherapy dose rates are significantly
lower with 0.03 Gy/s rates delivered within several minutes
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