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Overview

Bionic Vision Technologies has developed a Bionic Eye Visual Prosthesis System to restore functional vision to the blind suffering from inherited retinal diseases. The company has completed initial human testing in seven patients to demonstrate safety and initial efficacy with positive outcomes in patient mobility and device stability/durability.

This unique system offers several advantages to competitive products, including:
1) A safer and faster implantation procedure that can be completed in two to three hours;
2) The implant does not make direct contact with the retina, thereby expected to preserve remaining vision and;
3) The system’s software and hardware components can be safely and easily upgraded.

BVT has also created and acquired significant Intellectual Property covering surgical techniques and advanced vision processing algorithms. In addition, the company has recruited an experienced medical device management team with proven development, operational and commercialization successes.

The System improves patient navigation & object detection providing improved freedom of movement and real world engagement.
Market

The global incidence of Inherited Retinal Disease (IRD) is one-in-2,000 people. The incidence for Retinitis Pigmentosa (RP) is one-in-4,000, and as high as one-in 1000 in China and India (of which 80% are projected to become legally blind). Assuming a global population of approximately 7.8 billion, the market for RP-impacted patients is about 1.6 million of the estimated 3.9 million IRD patients. BVT has elected to pursue initial regulatory approval in the well-defined RP market, with subsequent expansion in its scope of treatment following US/EU approval.

The System

BVT’s Bionic Eye System consists of a wearable device and a visual implant similar in concept and design to that used by cochlear hearing implants. Eyeglass frames, embedded with cutting edge technology, translate images into electrical signals. Electrodes placed behind the patient’s eye use these signals to stimulate the retina and deliver visual information to the brain. Implanting the electrodes in the suprachoroidal space (between the choroid and the sclera), as opposed to sub-retinal or epi-retinal implantation, avoids damage to an already compromised retina. Because the implant is placed behind the retina and does not make contact with the retina, patients may still be able to participate in gene, stem cell or other future therapies.

Patients are able to regain functional vision once the Bionic Eye is turned on and begin training in the use of the system. With this system, a patient can both detect objects and avoid obstacles as well as recognize and perform tasks they were not able to do prior to implantation. Patient feedback has been extremely positive, and all components of the system have remained intact and durable over the course of the study and two plus years post the most recent study.

 

Regulatory

The Company’s regulatory strategy is aligned to that of a Class III implantable medical device with safety and efficacy data to be submitted to the regulatory authorities for approval. The company received FDA breakthrough category in December 2021.

Commercialization

The company is expected to gain commercial approval from regulatory authorities and to start generating revenues from the RP market. The company will also expand into other disease states such as additional IRD’s, Diabetic Retinopathy and Age-related Macular Degeneration-related vision loss as appropriate.

Capitalization & Funding Overview To Date

  • BVT is a privately held Australian company with offices in Sydney, Melbourne, and in California (In Progress)
  • Originally funded by a grant from the Australian government
  • Additional private funding (US$18M) followed in 2017
  • Awarded BioMedTech Horizons 3 research grant in 2020*

BVT Management Group

  • Ergad Gold PhD, Chairman
  • Ash Attia PhD, CEO
  • Brian Gordon, CTO
  • Adrian Oates PhD, COO
  • Sam Stefopoulos, Director (R&D) Hardware and Systems
  • Xerxes Battiwalla, Director (R&D) Software and Artificial Intelligence

Collaborators

 

* Delivered by MTPConnect, the Australian Government’s $45 million BioMedTech Horizons program, is an Medical Research Future Fund (MRFF) initiative to support innovative collaborative health technologies, drive discoveries towards proof-of-concept and commercialisation that address key health challenges as well as maximise entrepreneurship and idea potential.

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