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«Monash Vision Group 2013 Annual Report Australian Research Council Research in Bionic Vision Science and Technology Initiative Monash Vision Group ...»

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Monash Vision Group

2013 Annual Report

Australian Research Council

Research in Bionic Vision Science and Technology Initiative

Monash Vision Group

Monash Vision Group is an A R C-funded Special Initiative with collaborative

partners Monash University, Grey Innovation, MiniFAB and Alfred Health. This

unique cross-sector consortium has two key goals:

• to develop a commercially and clinically viable cortical vision prosthesis or "directto-brain" bionic eye;

• to build upon existing knowledge to create outstanding research capabilities in bionic vision science and technology in Australia.

www.monash.edu/bioniceye The Alfred Alfred Health is a leader in healthcare delivery and improvement, striving to achieve the best possible health outcomes for patients and the community by integrating clinical practice with research and education. Alfred Health is recognised as a pacesetter in the national healthcare arena, is consistently linked to progressive developments in healthcare and services, medical research and healthcare teaching.

Alfred Health is providing expertise in MVG's clinical program, including the recruitment, testing and after-care of patients.

www.alfred.org.au Grey Innovation Grey Innovation is a cutting edge engineering company with experience in complex software, hardware and mechanical architectures across a number of industries and markets. Grey Innovation provides a unique product development and commercialisation service from initial strategy through design, testing, technology innovation, manufacture and market penetration. Grey Innovation is providing expertise for the development of MVG's external electronics and processing components of the vision system.

www.greyinnovation.com MiniFAB MiniFAB is a privately-held Melbourne-based contract engineering firm providing custom development and manufacture of disposable polymer micro-engineered products. Established in 2002, MiniFAB's product development process covers the entire spectrum, from converting early stage product concepts into prototypes, through to full-scale, high throughput OEM & ODM manufacturing. MiniFAB is providing expertise in the design and manufacture of MVG's implantable devices and tooling.

www.minifab.com.au Monash University Monash University is one of Australia's leading universities with an enviable record for research and development leading to commercialisation. MVG has Chief Investigators from departments within the Faculties of Engineering, Science and Medicine, Nursing and Health Sciences, with key inputs into all aspects of the Monash Vision project.

www.monash.edu pp 2 Contents Introduction to the Monash Vision Group Message from the Chair Director's Report Governance & Management Product Development, Supporting Research and Testing 2013 Highlights Research Training and Skills Development Commercial Program Visitors, Events and Public Engagement MVG in the Media Journal Publications and Submissions Conference Proceedings Financial Statement Key Performance Indicators Acknowledgements Introduction to the Monash Vision Group Monash Vision Group (MVG) is a consortium of engineers, vision scientists, industrial designers and medical researchers from Monash University, clinicians from Alfred Health and industry partners Grey Innovation and MiniFAB, with the primary goal of realising and demonstrating in patients a cortical vision prosthesis - or "direct to brain" bionic eye. MVG was established in 2010 with funding for four years from the Australian Research Council (A R C) Research in Bionic Vision Science and Technology Initiative. In July 2013, the A R C announced a one year extension, taking the Initiative to the end of 2014.

MVG's bionic vision system "Gennaris" bypasses damage to the eye and optic nerve and may therefore address conditions that cause up to 85% of currently untreatable blindness including glaucoma, age-related macular degeneration, acquired retinal disease and traumatic injury.

Gennaris comprises a miniature camera worn externally by the user. High-resolution images from the camera are fed to a custom-designed vision processor, which applies a number of signal processing techniques to extract the most useful features from the camera images. This new signal is fed - via a wireless transmitter - to up to 11 tiles that have been surgically implanted in the primary visual cortex of the brain.

Each tile houses its own microchip or A S I C (Application Specific Integrated Circuit), wireless receiver and 43 hair-thin microelectrodes that stimulate the neurons in the primary visual cortex.

This stimulation evokes brief flashes of light known as "phosphenes" in the visual field of the user, which the brain learns to interpret as vision. The number of phosphenes depends upon the number of implanted electrodes, in our case this will be up to 473.

MVG aims to implant Gennaris in first patients in 2015; this 2013 Annual Report presents progress by MVG over the past twelve months towards this key goal.

pp 3 Message from the Chair Professor David De Kretser AC 2013 was always going to be a critical year for the Monash Vision Group. With funding from the Special Research Initiative (S R I) due to finish, it was imperative for MVG to demonstrate successes in its technical and commercial programs and to secure funding for beyond 2013.

We enjoyed an excellent start to the year with the A R C Mid-Term Review site visit to Monash University in February. The panel spoke with many members of the MVG team, including board members, management, technical staff, students and also Monash University Executive. Panel members also enjoyed a tour of the MVG engineering and physiology laboratories. MVG received positive and encouraging feedback, with the panel highlighting the excellent progress that has been made since project launch in 2010 and a recommendation for this first phase of the S R I to continue.

In MVG's 2012 Annual Report, I commented on the importance of fundraising and my close interactions with Professor David Penington, former Chair of Bionic Vision Australia (BVA), towards attracting funding for both groups. During 2013, David and I continued with our approaches to Federal and State Governments, the Australian Research Council and National Health and Medical Research Council to highlight the benefits of continuing the S R I beyond the first phase. The discussions culminated in the S R I being extended for a further year, providing MVG and BVA with funding until the end of 2014. My thanks go to the A R C for allocating $1.9M to MVG on top of the $8M already awarded, which has enabled us to retain our team and continue on our path to producing a commercially attractive device to restore some sight to many people with profound vision impairment. My sincere thanks also go to David for his dedication and proactive approach to fundraising and I wish him all the very best in his future endeavours.

We have many successes to report but on a personal note, I would like to highlight the well-deserved achievements of two team members in particular. Our Director, Professor Arthur Lowery, was awarded a prestigious Australian Laureate Fellowship by the A R C in July, which is one of our nation's highest academic achievements. In June, Professor Jeffrey Rosenfeld was awarded an Officer of the Order of the British Empire for his services to neurosurgery and the University of Papua New Guinea's School of Medicine. Many congratulations to both Arthur and Jeffrey for these outstanding accomplishments.

I am delighted to report that each of our valued Advisory Board members has agreed to continue with MVG for the extension period. I would like to thank them for their important contributions, enthusiasm and insights and I look forward to working with them over the next year to provide guidance to MVG management and in securing resources for beyond 2014. My thanks also go to our industry and clinical partners MiniFAB, Grey Innovation and Alfred Health - and to Monash University. Their support is central to the success of MVG as we continue on our exciting journey towards first patient implantation and a commercial device.

Professor David De Kretser AC Advisory Board Chair, Monash Vision Group pp 4 Director's Report Professor Arthur Lowery This has been a team-building experience for all of us, and more importantly, a capability building endeavour.

Awarded $9.9M of Government funding.

Over $12M in-kind contributions from MVG partners.

Over $3M cash contributions from Monash University.

I am delighted to present the fourth report of the Monash Vision Group. We are in the final stages of manufacturing a complete bionic vision system prototype, which may benefit hundreds of thousands of people who are vision impaired. We are aiming to have full testing completed within the next 18 months, which will enable a First in Human (F I H) trial to be conducted.

The initial project funding was for 4 years, from 2010 to 2013 inclusive, under the Australian Research Council's "Research in Bionic Vision Science and Technology Initiative". We are thankful to the A R C for extending the funding for a further year, until the end of 2014, and to the NHMRC for awarding a $1.46M Development Grant to fund further human trials following the F I H. The extension followed a successful A R C review in February 2013 and presentations from Professors David de Kretser (MVG) and David Penington (Bionic Vision Australia) to senior figures in Australia. I would like to personally thank Senator Kim Carr for his passionate belief and support of scientific and engineering research over many years, without which we would not be equipped to take on challenges of a global scale.

Our system is designed to benefit the majority of people with untreatable blindness, as it stimulates the brain directly with several hundred electrodes, each potentially producing a "phosphene" or sensation of light.

This approach does not require a functional optic nerve or eye, so is the only solution for those who have lost their sight through trauma to these parts of the visual pathway.

The project has been extremely challenging. To elicit several hundred points of light, we are planning to implant up to 11 tiles onto the surface of the brain. Each tile is a miniaturised electronic system that converts radio waves into discrete stimulation pulses on 43 electrodes. The system includes a radio receiver, which also harvests power from the waves; decoding and error correcting circuits to ensure the integrity of the received data; 43 digital to analogue converters, to provide 32 different stimulation levels; 43 voltage to current converters, to provide stimulation pulses, and 43 micro-electrodes that conduct these pulses to the correct layer of the visual cortex of the brain. This complexity is designed into 500,000 transistors per tile, forming a complex "system on a chip". Importantly, the electronics is sealed within an hermetic package, to ensure no unwanted interaction with the tissue around it.

The materials engineering is complex, because we have only a limited pallet of FDAapproved materials with which to make the tile. The process of constructing the electronics and sealing into the tile is complex and requires over 70 assembly steps.

Thus, experience of our partner, MiniFAB, in certified manufacturing has been critical in the development and manufacture of the tiles.

On the outside of the head is a wireless transmitter, camera and another set pp 5 of complex electronics to convert the camera's complex images into a useful representation of the real world on a few hundred electrodes. In 2012, Monash Art, Design and Architecture joined our project to provide the industrial design of the packaging that contains these components. Based on consultations with Vision Australia and its clients, prototype headgear has been developed in conjunction with Grey Innovation and with help from the project workshop in Monash Electrical Engineering. This prototype was exhibited as part of the Melbourne Now exhibition over the summer of 2013/14. The vision processing software, developed by Monash's computer vision group and ported onto the processor in collaboration with Grey Innovation, has also been demonstrated at several conferences and events.

The challenge in 2014 is to bring the F I H prototype system together for extensive testing. In preparation, we have spent much of 2013 developing methods to test the implant tiles and external processor during its assembly, and as a full system after manufacture. This has involved the creation of a set of electronic test boards, into which the partially-assembled parts plug, and a suite of testing software. We have also developed bench-top test rigs for the insertion tool, which is somewhat like a pinball machine, and thermal test jigs for the tiles, to ensure that they can be cooled sufficiently by blood flow.

Our bench-top testing is backed by extensive computer simulations and library research. We have also developed a set of psychophysics tests, to explore the capabilities of our potential patients before and after bionic vision has been turned on. This is critical as regulatory approval is dependent upon showing an improvement in quality of life. We were pleased to host Doctor Bob Greenberg, CEO of Second Sight, to our laboratories in August 2013. He was very helpful in detailing their experiences with the FDA in obtaining humanitarian approval for their retinal implant device.

The remainder of this report will detail the technology and successes of 2013. This includes detailed technical reports, presented as sub-projects, which have been written by the scientists and engineers undertaking the work. I would like to commend all of our technical staff for their outstanding effort in the past year.

A key to our confidence in being able to deliver a F I H implant in 2015 has been the extremely detailed planning and reporting of the whole team on a weekly basis. The weekly Technical Architecture meetings and reporting have been driven by Peter Bettonvil, of MiniFAB, and attended by all groups across Monash and the partners.

This has been a team-building experience for all of us, and more importantly, a capability building endeavour. We are one of the few places in the world that is able to develop micro-miniaturised electronic systems to meet medical challenges. This capability could underpin a new industry sector in Australia with a large export potential.

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