7 Jun 2024 – Melbourne, Victoria, Australia

Bionic eye trial reveals substantial vision improvements over two and a half years

Results of the first clinical trial of Australia’s ‘second generation’ bionic eye have demonstrated ‘substantial improvement’ in four participants’ functional vision, daily activities and quality of life over a period of more than two and a half years.

Detailed outcomes from the trial, led by the Centre for Eye Research Australia, Bionics Institute, University of Melbourne and Royal Victorian Eye and Ear Hospital, are published today in Ophthalmology Science.

The findings add to interim results which showed that the second-generation bionic eye developed by Australian company Bionic Vision Technologies provided rapid improvements for four patients with blindness caused the genetic eye condition retinitis pigmentosa.

The new study tracked the patients from the time they received the implant surgery in 2018 to 2021.

Its findings demonstrate the device is stable and durable over the longer term– staying in place behind the retina without complication and still having 97 per cent of electrodes functioning 2.7 years after first implant.

Dr Ash Attia, CEO of Bionic Vision Technologies said “ We are encouraged by the excellent results of the generation 2 Bionic eye trial. We are looking forward to finalize the development of the Generation 3 bionic eye and enter the worldwide pivotal trial and ultimately gain regulatory approval”. “Regulatory approval will allow us to make this important technology available to RP patients which will positively impact their lives” Dr Attia said.

Download the full media release

2 Dec 2022 – Melbourne, Victoria, Australia

Australia’s ABC present 7:30 Report Story on the Bionic Eye

Australian Broadcasting Corporation (ABC)’s Nadia Daly presents an amazing story on the 7:30 Report of two individuals who have adapted to using bionic technology to get the most out of life. Watch as Bionic Eye recipient Scott Nixon shares how the Bionic Eye has helped improve his everyday life, and Bionic Vision Technologies CEO Dr Ash Attia explains how the system works.

Watch online here or you can read more information here

Delivering life-changing technology like this takes years and requires an incredible team behind it. Bionic Vision Technologies is proud to be partnering with Centre for Eye Research Australia (CERA), CSIRO’s Data61, Bionics Institute, University of Melbourne, Tricycle Developments, and Tekt Industries on the development and commercialisation to bring this technology to thousands of people who could benefit.

27 Oct 2022 – Melbourne, Victoria, Australia

Dept. Home Affairs (Global Australia) Interview Dr Ash Attia in “Aussie Inventors” Series

BVT CEO Dr Ash Attia talks about BVT’s Bionic Eye as part of Dept. Home Affairs’ (Global Australia) “Aussie Inventors” series, and the life-changing opportunity to bring this technology to the millions of people who could benefit.

31 Jan 2022 – Melbourne, Victoria, Australia

Global Boost to Australia’s Revolutionary Bionic Eye Technology

Australia’s world-first Bionic Eye System has been granted designation as a Breakthrough Device by the Food and Drug Administration (FDA) in the United States.

Created by Bionic Vision Technologies (BVT), the Centre for Eye Research Australia, the Bionics Institute, CSIRO’s Data61 and the University of Melbourne, this groundbreaking technology aims to give functional vision to millions of people who have lost their sight due to the genetic condition, Retinitis Pigmentosa (RP).

The FDA’s Breakthrough Devices Program speeds up the review and assessment of medical devices which provide “more effective treatment” than any alternatives currently available.

“This is a significant achievement and a key milestone for BVT,” CEO Dr Ash Attia said. “The life-changing bionic eye can be brought more quickly to the people who need it the most.”
Tiny cameras, embedded within a pair of glasses, send electrical signals to a wearable proces- sor. The processor transmits to an implant behind the retina, delivering visual information to the blind person, giving them functional vision.

A recently published peer-reviewed two-year study focused on four Australians using the bi- onic eye. They reported being able to recognise their loved ones in a cafe, identify vacant chairs, sort their washing, and identify surroundings such as traffic lights, cars, people, trees, and street poles.

Download the full media release

6 September 2021 – Melbourne, Victoria, Australia

Australia’s Bionic Eye advances due to US partnership

Bionic Vision Technologies (BVT) has formed a strategic partnership with leading US MedTech company, Cirtec Medical.

Under the partnership, Cirtec has taken a strategic stake in BVT and will assist the Australian compa-ny to develop and manufacture its next generation bionic eye.

BVT has created the world’s first suprachoroidal retinal implant to restore functional vision to the blind. The BVT team includes several experts who worked on the renowned Cochlear implants and several cardiac implantable devices. BVT partners with leading Australian research institutions includ-ing CSIRO, the Bionics Institute, and the Centre for Eye Research Australia.

“We highly value this partnership with Cirtec Medical, in order to take the 3rd generation bionic eye to everyone who needs it around the world,” CEO of BVT, Ash Attia, says.

For more than three decades, Cirtec Medical has been a leading provider of implantable medical device development and manufacturing services. The company has a long history of working with the world’s most innovative startups, creating breakthrough medical devices.

“Cirtec is excited to support BVT in the development and eventual commercialisation of this life -changing technology, and we look forward to continuing our long-term partnership” Brian Highley, CEO of Cirtec Medical, says.
A recent two-year study shows the BVT Bionic Eye System is safe, improving vision and wellbeing for people with near-total blindness.
The System consists of a tiny camera, mounted on a pair of glasses, which send electrical signals to a wearable processor – similar to Cochlear’s Bionic Ear. The processor transmits to an implant behind the retina, delivering visual information to the blind person, encouraging more independence, social interactions, and awareness of their environment.
BVT is planning a global pivotal study in 2022. The aim is to create an affordable implant for millions of people who suffer from a genetic condition called Retinitis Pigmentosa (RP) that robs them of their sight. The late-Stage RP market is estimated at US$3.5Bn+.

Download the full media release

26 March 2021 – Melbourne, Victoria, Australia

Australia’s bionic vision: restoring sight to millions

The Australian Financial Review:

An Australian medical technology company, Melbourne-based Bionic Vision Technologies (BVT), is poised to make major inroads into the retinitis pigmentosa treatment market with a breakthrough implantable device that aims to achieve for blind people what Cochlear achieved for the profoundly deaf.

BVT has developed a “bionic eye” prosthetic implant that can restore functional vision to blind people suffering from inherited retinal diseases such as retinitis pigmentosa.

Following a successful two-year feasibility study conducted on patients with retinitis pigmentosa, BVT is on track to complete clinical trials in early 2024 with plans for the device to become available commercially in the US and Europe in late 2024 subject to additional capital funding.

…

Clinical study data from patients implanted with the device show the prosthesis is safe and gives significant improvements to functional vision and quality of life. Users reported an improved awareness of external objects and surroundings.

“Our early studies have confirmed the safety and efficacy of our next-generation device. The next step is to initiate worldwide clinical trials ahead of seeking regulatory approval in key markets, starting in the US with Australia, Europe, China and India to follow,” says BVT chief executive Dr Ash Attia.

“We are on the cusp of something revolutionary with global market potential.

Read the full article (PDF)

28 February 2021 – Melbourne, Victoria, Australia

Australian bionic eye lets the blind ‘see’ again for the first time in a new trial

Sue Dunlevy, News Corp Australia Network:

Sefa Kuzu has never seen the faces of his twins. The 50-year-old Melbourne father lost his sight to a degenerative eye disease before his son and daughter were born in 2005. But with help from a bionic eye developed in Australia, he is seeing more of them for the first time.

“I can tell how tall they are and how wide they are,” he said.

The bionic eye, implanted in 2018, is also helping Mr Kuzu navigate everyday life, “when walking on the streets, not bump(ing) into cars parked on the driveways” and finding the tools he needs for his woodwork.

Mr Kuzu is one of four people currently trialling the bionic eye created in Melbourne that is now poised to enter global trials to gain marketing approval. It’s thought the revolutionary device could be a lifeline to the 8000 Australians robbed of their sight by the degenerative genetic condition Retinitis Pigmentosa, which affects 1.5 million people worldwide and is the most common cause of inherited blindness.

News Corp Australia interviewed the four people currently trialling the device who said they were able to recognise objects on table tops, navigate obstacle courses, find doorways and make out the outlines of people nearby.

Read the full article

15 February 2021 – Melbourne, Victoria, Australia

Bionic Vision Technologies Advances Clinical Program With AU$1 million Medical Research Future Fund Grant.

Bionic Vision Technologies (BVT) has started work on the next phase of development for its world-leading Australian bionic eye technology thanks to a recent Australian Government grant to refine its vision processing algorithms.

BVT’s bionic eye is designed for people with the inherited retinal disease retinitis pigmentosa for which there is no current cure.

Clinical study data from patients implanted with the device show the prosthesis is safe and gives significant improvements to functional vision and quality of life. Users reported an improved awareness of external objects and surroundings.
The Melbourne-based Australian medical technology start-up received A$1million from the Medical Research Future Fund’s BioMedTech Horizons 3.0 program in late 2020.

The funds will help finalise development of sophisticated vision processing software which turns images taken by a pair of smart glasses into signals that stimulate the brain to create information about what the user is ‘seeing’.

The new software is a key part of BVT’s next generation device set to be used in a global study aimed at gathering data to support regulatory submissions in major commercial markets. Early studies have confirmed safety and efficacy.

The Australian device has several technological advantages including a unique implant method that allows the device to be upgraded or replaced.

Download the full media release

13 January 2020 – San Francisco, 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.

Download the full media release

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.