13 January 2020 – San Fransisco, California, USA

Bionic Vision Technologies Announces Interim Pilot Study Results of the BVT Bionic Eye System Designed to Help the Blind Achieve Greater Mobility and Independence.

Up to 44-Week Data Shows Significant Improvement in Both Obstacle Awareness and Object Detection

Bionic Vision Technologies today announced the interim results of a pilot study involving four patients with late-stage Retinitis Pigmentosa (RP) implanted with a visual prosthesis designed to improve awareness of external objects and patient surroundings. Results presented during the 38th Annual JP Morgan Conference in San Francisco demonstrated improved combined performance of all six functional vision tests at 44 weeks of active use of the device.

“These outcomes represent a significant milestone for Bionic Vision Technologies and give hope to many patients who have lost their sight due to late-stage RP,” said Ash Attia, CEO. “Based on these positive results, BVT intends to initiate a worldwide clinical trial for the commercialization of our Gen3 device which will offer improved performance and usability as well as a streamlined external design, similar to the appearance of traditional eyeglasses.”

This current two-year pilot study, being conducted at the Centre for Eye Research Australia (CERA) and the Bionics Institute in Melbourne, Australia, involves four adult participants with near total blindness caused by the inherited retinal disease, Retinitis Pigmentosa. Each study participant was unilaterally implanted with the BVT Gen2 suprachoroidal visual prosthesis in the eye with the least remaining vision. Mobility testing was initiated after a two-month surgical healing period followed by a 16-week period of vision rehabilitation training. Participants were asked to complete a series of six tests at 17 weeks following training and then at three monthly intervals from week 20 with the device turned both “on” and “off” to assess performance. Data has been collected up to 44 weeks for all patients and will continue to be collected for up to 104 weeks.

Of all mobility tests conducted, the most significant improvement in this cohort was observed with the Primary Obstacle Avoidance Task, which relies on participants identifying obstacles in their pathway. At 44 weeks, patients detected 74.3% of obstacles when the device was turned on, compared to only up to 4% of obstacles when the device was turned off. Considerable improvement was also recorded for the Location Task which relies on study participants identifying and touching an object similar to the shape of a window on a wall. At 44 weeks, subjects were able to locate and touch the window 70.3% of the time when the device was turned on, compared to only up to 24.4% of the time when the device was turned off.

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22 July 2019 – Melbourne, Victoria, Australia

Ash Attia joins BVT as CEO Bionic Vision Technologies Pty Ltd (BVT) today announced that Ash Attia has joined the company as its Chief Executive Officer (CEO).

Ash Attia has over 30 years of senior executive management experience in implantable devices and biotechnology. Most recently, Ash held the position of Vice President Asia Pacific, the Middle East and Israel, at TransMedics Inc. Prior to this, Ash held Vice President and Managing Director roles within several other major Australian and International medtech organizations such as Thoratec, St Jude Medical, Micromed, Syncardia, Ventracor, Biotronik, SulzerMedica and Telectronics. Ash has extensive experience in medical technology commercialization, general management, research and development, marketing, market entry strategies, regulatory and reimbursement across multiple geographies (USA, Asia Pacific and Europe). He is also a Fellow of the Australian Institute of Company Directors and has extensive governance experience being a Non-Executive Director on the board of ASX-listed Company DorsaVi for over 10 years.Ash holds a Masters of Science in Biomedical and Electronics Engineering from the New Jersey Institute of Technology in conjunction with the University of Medicine and Dentistry, New Jersey, USA. Ash also holds postgraduate qualifications in business and general management.

About Bionic Vision Technologies Pty Ltd (BVT)

Bionic Vision Technologies Pty Ltd (BVT) is an Australian medical device company that aims to preserve and restore a sense of vision by developing a range of best in class technologies to address degenerative retinal conditions. BVT is commercializing the technologies developed by Bionic Vision Australia (BVA), a consortium of leading universities and research institutes funded by the Australian Research Council from 2010 to 31 December 2016. In April 2017, BVT received $23.6 million from Hong Kong-based State Path Capital and China Huarong International Holdings. The funds enabled BVT to accelerate development and clinical studies. Consortium members collaborating on the trial include the Bionics Institute, Centre for Eye Research Australia, CSIRO’s Data 61, the University of Melbourne, and The Royal Victorian Eye and Ear Hospital. BVT will seek further capital to complete regulatory trials and technology development.

How the Bionic Vision Technologies (BVT) Pty Ltd bionic eye works

The BVT developed bionic eye consists of implanted and body worn components. The patient wears glasses with a small video camera mounted on the side. The live feed from the camera is processed and transmitted via an implanted microchip to an electrode array placed in a naturally occurring pocket behind the retina, called the suprachoroidal space. The electrodes stimulate remaining cells in the retina, to generate spots of light that give a patient a sense of vision.

4 March 2019 – Melbourne, Victoria, Australia

Quality expert Dr Adrian Oates joins BVT as Chief Operating Officer

Bionic Vision Technologies Pty Ltd (BVT) today announced that Dr Adrian Oates has joined the company as its Chief Operating Officer (COO).This appointment helps to build a highly experienced executive team at BVT and complements Brian Gordon’s recent commencement as BVT’s Chief Scientific Officer.With the excellent progress being achieved in its current clinical trial, BVT is increasingly focused on planning for future pivotal trials, regulatory approval and commercial release of its bionic eye technology. Adrian has more than 20 years of senior executive experience in the medical device, in-vitro diagnostic, biological and pharmaceutical health care industries at major companies including Cochlear and CSL.His early career was spent as a research scientist that later expanded to encompass strategic planning, global quality and safety best practices, clinicalstudy & regulatory strategy execution, as well as oversight of operational compliance and third party vendors.Key achievements include playing a leading role at Cochlear as Vice President of Quality & Regulatory in the development of a new sterile implantable medical device; leading the FDA accreditation project for influenza vaccine as Quality Director at CSL Behring; and, building processes and systems required for a start-up company as Vice President Quality, Regulatory and Clinical at Universal Biosensors resulting in the development and commercialization of point-of-care diagnostic test systems for global multinational companies. As Chief Operating Officer, Adrian will oversee BVT’s quality, product safety, operational, reimbursement and risk management practices.

About Bionic Vision Technologies Pty Ltd (BVT)

Bionic Vision Technologies Pty Ltd (BVT) is an Australian medical device company that aims to preserve and restore a sense of vision by developing a range of best in class technologies to address degenerative retinal conditions. BVT is commercializing the technologies developed by Bionic Vision Australia (BVA), a consortium of leading universities and research institutes funded by the Australian Research Council from 2010 to 31 December 2016. In April 2017, BVT received $23.6 million from Hong Kong-based State Path Capital and China Huarong International Holdings. The funds enabled BVT to accelerate development and clinical studies. Consortium members collaborating on the trial include the Bionics Institute, Centre for Eye Research Australia, CSIRO’s Data 61, the University of Melbourne, and The Royal Victorian Eye and Ear Hospital. BVT will seek further capital to complete regulatory trials and technology development.

How the Bionic Vision Technologies (BVT) Pty Ltd bionic eye works

The BVT developed bionic eye consists of implanted and body worn components. The patient wears glasses with a small video camera mounted on the side. The live feed from the camera is processed and transmitted via an implanted microchip to an electrode array placed in a naturally occurring pocket behind the retina, called the suprachoroidal space. The electrodes stimulate remaining cells in the retina, to generate spots of light that give a patient a sense of vision.

29 January 2019 – Melbourne, Victoria, Australia

BVT welcomes Brian Gordon as our new Chief Scientific Officer

Bionic Vision Technologies Pty Ltd (BVT) is delighted to announce that Brian Gordon will be joining the company as its CSO.Brian joins BVT from Cochlear Ltd where he has held various senior engineering roles including most recently the position of Senior Portfolio Manager, Implants. Brian was responsible for delivery of Cochlear’s new implant projects to market. As CSO, Brian will oversee BVT’s future product development, clinical trials and regulatory approval initiatives required for the commercialisation of BVT’s retinal implant. From his time at Cochlear and RØDE, Brian will bring his strong leadership and deep experience in program management and the full development and commercialization cycle of implantable devices. To date, BVT’s “bionic eye” has been implanted in 7 patients including 4 currently enrolled in the first trial of a completely portable device.

About Bionic Vision Technologies Pty Ltd (BVT)

Bionic Vision Technologies Pty Ltd (BVT) is an Australian medical device company that aims to preserve and restore a sense of vision by developing a range of best in class technologies to address degenerative retinal conditions. BVT is commercialising the technologies developed by Bionic Vision Australia (BVA), a consortium of leading universities and research institutes funded by the Australian Research Council from 2010 to 31 December 2016. In April 2017, BVT received A$23.6 million from Hong Kong-based State Path Capital and China Huarong International Holdings. The funds enabled BVT to accelerate development and clinical studies. Consortium members collaborating on the trial include the Bionics Institute, Centre for Eye Research Australia, CSIRO’s Data 61, the University of Melbourne, and The Royal Victorian Eye and Ear Hospital. BVT will seek further capital to complete regulatory trials and technology development.

How the Bionic Vision Technologies (BVT) Pty Ltd bionic eye works

The BVT developed bionic eye consists of implanted and body worn components. The patient wears glasses with a small video camera mounted on the side. The live feed from the camera is processed and transmitted via an implanted microchip to an electrode array placed in a naturally occurring pocket behind the retina, called the suprachoroidal space. The electrodes stimulate remaining cells in the retina, to generate spots of light that give a patient a sense of vision.

19 November 2018 – Melbourne, Victoria, Australia

Restoring sight: Clinical progress towards Australia’s bionic eye

Bionic Vision Technologies Pty Ltd (BVT) today announced medical researchers had successfully restored a sense of vision in four blind people with its bionic eye as part of a clinical trial in Melbourne. Researchers said they were “very pleased” with the progress of all four patients who have had a “sense of sight” restored. All four have a degenerative genetic condition called Retinitis Pigmentosa which causes loss of vision. Principal investigator Associate Professor Penny Allen made the announcement to the annual Royal Australian and New Zealand College of Ophthalmologists Scientific meeting in Adelaide.An earlier study of three patients established the safety of a prototype but restricted use to the lab. The new study uses a permanent device that can be used every day. Assoc Prof Penny Allen, of the Centre for Eye Research Australia and head of the Vitreoretinal Unit at The Royal Victorian Eye and Ear Hospital, said, “We have completed surgeries on four patients to implant the device and the team is very pleased with their progress. All four patients have had a sense of sight restored and are in the process of learning how to use the bionic eye for mobility and other activities.”

“Each of the patients has returned home after surgery and are working with the clinical and research team to learn to use the device and incorporate it into their everyday lives.“We believe the Australian bionic eye being tested has advantages over international competitors, including a superior surgical approach, stability of the device and unique vision processing software that aims to improve the patient’s experience. “At the moment, we are focused on patients who have vision loss due to Retinitis Pigmentosa, an inherited genetic condition. “Based on our results so far, we know that our approach is safer and less invasive, and the patients have all made impressive progress with mobility and activities of daily living,” Assoc Prof Allen said. Chairman of Retina Australia, Leighton Boyd said, “We welcome developments like this which potentially provide support and independence to the many people and families affected by this genetic condition. The ability to regain a sense of sight will make a positive difference to the lives of people diagnosed with Retinitis Pigmentosa.” Retinitis Pigmentosa is a debilitating genetic disorder that leads to loss of vision. It affects about one in every 4,000 people, affecting 1.5 million people worldwide. It is the leading cause of inherited blindness. There is currently no cure.

About Bionic Vision Technologies Pty Ltd (BVT)

Bionic Vision Technologies Pty Ltd (BVT) is an Australian medical device company that aims to preserve and restore a sense of vision by developing a range of best in class technologies to address degenerative retinal conditions. BVT is commercialising the technologies developed by Bionic Vision Australia (BVA), a consortium of leading universities and research institutes funded by the Australian Research Council from 2010 to 31 December 2016. In April 2017, BVT received A$23.6 million from Hong Kong-based State Path Capital and China Huarong International Holdings. The funds enabled BVT to accelerate development and clinical studies. Consortium members collaborating on the trial include the Bionics Institute, Centre for Eye Research Australia, CSIRO’s Data 61, the University of Melbourne, and The Royal Victorian Eye and Ear Hospital. BVT will seek further capital to complete regulatory trials and technology development.

How the Bionic Vision Technologies (BVT) Pty Ltd bionic eye works

The BVT developed bionic eye consists of implanted and body worn components. The patient wears glasses with a small video camera mounted on the side. The live feed from the camera is processed and transmitted via an implanted microchip to an electrode array placed in a naturally occurring pocket behind the retina, called the suprachoroidal space. The electrodes stimulate remaining cells in the retina, to generate spots of light that give a patient a sense of vision.