Equipping Surgeons with New Tools to Improve Accuracy and Patient Outcomes

Canada-Israel Industrial Research & Development FoundationEquipping Surgeons with New Tools to Improve Accuracy and Patient Outcomes

CIIRDF Enables the Development of Novel Surgical Navigation and Implant Technologies

Canadian Company: Claron

Israeli Company: BrainsGate

Sector: Life sciences; Information and Communication Technologies

Opportunity

Across North America and Europe, physicians increasingly perform image-guided surgery (IGS) on the brain, cancer tumors, and spinal cord injuries. During this computer-assisted surgery, the IGS system tracks the movement of the surgical instrument, and the surrounding patient anatomy. At the beginning of the procedure, the system captures and registers 3D images of the patient’s body. During the surgery, the IGS system displays the position of the surgical instruments within this imagery, which serves as a map for the surgeon. It is an innovation that improves surgical accuracy, and helps to prevent navigation errors that can impede treatment outcomes, or damage patient anatomy. A Canada-Israel R&D team aims to broaden the use of IGS to include stroke treatment and in-office sinus surgery.

Objective

This CIIRDF-supported R&D project brought together:

  • BrainsGate, an Israeli medical device company that develop innovative therapies for Central Nervous System diseases; and
  • Claron, a Canadian firm dedicated to the development of medical image processing solutions.

BrainsGate has developed the Ischemic Stroke System (ISS) to help those who suffer from ischemic stroke, a condition that prompts a loss of blood flow in the brain, impairing neurological function. The ISS features an electrode that is implanted in the roof of the patient’s mouth. It delivers electrical stimulation to a nervous centre, prompting the dilation of blood vessels and increasing blood flow in the brain. While existing treatments must be initiated within a few hours of a stroke, the ISS extends the patient treatment window up to 24 hours. To facilitate broad adoption of this technology, BrainsGate incorporated an IGS device into the system to further increase ease of use. With support from CIIRDF, the company is partnering with Claron to further simplify and improve the implantation process by incorporating innovative IGS technologies into this medical product.

Claron has acquired extensive expertise in 3D imaging and optical positioning technology for medical applications. Through its collaboration with BrainsGate, Claron has developed two new surgical IGS products including:

  • Navient which guides ears, nose and throat surgeons as they perform sinus surgery in their office or at small clinic; and
  • Navident which guides dental surgeons as they place dental implants in patients.

With support from CIIRDF, BrainsGate and Claron combined their technological expertise, and developed improved surgical navigation and implant delivery technologies. The companies are now integrating these technologies into the ISS, Navient and Navident products.

Outcomes

“CIIRDF enabled us to develop a new neurosimulator implant and delivery system that enhances the capabilities of our ISS. This represents a major milestone towards the development of many other novel applications that we are working on to treat central nervous

system disorders. Our company is devoting many resources to the conduct of a costly, large-scale ISS clinical trial. CIIRDF enabled us to undertake this R&D with Claron in parallel with the clinical trial, accelerating our technology development. We will apply the expertise acquired during this project for years to come.”

Srulik Dvorsky, Vice President, R&D and Operations, BrainsGate

“This CIIRDF project enabled us to develop and commercialize novel technology in collaboration with BrainsGate. We have recently completed patient trials, and acquired regulatory approval from Health Canada for Navident. We are now pursuing regulatory approval from the United States Food and Drug Administration (FDA), and the CE Mark in Europe to broaden our global marketing. We expect regulatory approvals for Navient to follow shortly. We have also established a new production facility, and expanded our navigation products team. We expect revenues from Navident and Navient to exceed $100 million within the next 10 years.”

Doron Dekel, Co-CEO and Director, Navigation, Claron