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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 and the incidence for Retinitis Pigmentosa (RP) is one-in-4,000 (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. The projected revenue from the first five years of sales could be as high as $1.3 billion. 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. It operates by translating images from a camera mounted on an eyeglass frame into electrical signals which stimulate the nerves via electrodes placed behind the patient’s eye to 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.

Two months after surgery, the BVT Bionic Eye is turned on and patients begin training in the use of the system. The BVT System enables the patient to see a series of white light dots and the combined image represents the surrounding objects. With this system, a patient can both detect objects and avoid obstacles. Patients feedback has been positive and all components of the system have remained intact and durable over the course of the 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.

Commercialization

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

Capitalization & Funding Overview

  • 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
  • Seeking to raise US $20 Million in equity funding to manufacture clinical units and conduct Australian, US and EU clinical trials.

BVT Management Group

  • Ergad Gold PhD, Chairman
  • Ash Attia, CEO
  • Brian Gordon, CTO
  • Adrian Oates PhD, COO

Collaborators

 

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