Periodic Reporting for period 1 - FLUAR (FLUAR - A novel solution for fluorescence-guided surgery based on augmented reality)
Periodo di rendicontazione: 2023-04-01 al 2024-03-31
Fluorescence-guided surgery (FGS) uses near-infrared (NIR) sensors to detect and display fluorescent biomarkers indicating the exact location of tumors. But the current cameras and monitors force surgeons to match the images to the body via subjective comparisons. This long, error-prone process reduces the accurracy, and increases operating times and cost. This is a critical problem in cancer surgery where complete tumor removal is key to prevent recurrence, e.g. a yearly incidence of <0.5 M breast cancer patients requires over 2.8 M surgeries.
FLUAR are novel augmented reality (AR) glasses with integrated high-end NIR sensors and computer vision algorithms. They detect and display the fluorescent biomarkers and thereby the tumor margins in the surgeons’ direct sight. FLUAR will increase the surgeons’ accuracy and reduce tumor removal times.
This EIC Horizon Europe project aims to finalize and validate FLUAR’s technical developments and clinical usability according to end-user requirements.
FLUAR are novel augmented reality (AR) glasses with integrated high-end NIR sensors and computer vision algorithms. They detect and display the fluorescent biomarkers and thereby the tumor margins in the surgeons’ direct sight. FLUAR will increase the surgeons’ accuracy and reduce tumor removal times.
This EIC Horizon Europe project aims to finalize and validate FLUAR’s technical developments and clinical usability according to end-user requirements.
The 1st phase of the FLUAR project has focused on technical fine-tuning and validation of the various hardware and software developments in order to achieve a final device version best tuned to the various performance, usability, and regulatory requirements.
In terms of hardware, a novel illumination and registration system has been developed in order to ensure wearable FGS capabilities for long procedures. The optical performance characteristics have been tuned to the specific application and target fluorophore. Electronics and mechanics are finalized into a final model ready for the upcoming electromagnetic and stability tests. Software developments have focused on improvements of the algorithms and codes for optimized visualization of the target signals in the direct field of view of the surgeons.
The first phase of the project has delivered a working prototype ready for regulatory testing and further clinical validation steps to be performed during the second phase of the project. Several specific design choices have led to potential acceleration in the development process aiming at early market approval for the US FDA market.
In terms of hardware, a novel illumination and registration system has been developed in order to ensure wearable FGS capabilities for long procedures. The optical performance characteristics have been tuned to the specific application and target fluorophore. Electronics and mechanics are finalized into a final model ready for the upcoming electromagnetic and stability tests. Software developments have focused on improvements of the algorithms and codes for optimized visualization of the target signals in the direct field of view of the surgeons.
The first phase of the project has delivered a working prototype ready for regulatory testing and further clinical validation steps to be performed during the second phase of the project. Several specific design choices have led to potential acceleration in the development process aiming at early market approval for the US FDA market.
Arspectra is moving on to the next phase of the project focused on clinical usability and later validation of the FLUAR technology as a Medical Device. Next to the various EMC and stability tests, further improvements will be implemented along the clinical end-user feedback received. For access to the US FDA market, the 510k approval process will be launched. Simultaneously, the next clinical evaluation steps will be taken to eventual market approval for the EU MDR markets.
In parallel, Arspectra’s commercial team is starting with the implementation of the outreach and commercial go-to-market strategy for both the European and American markets. All necessary contractual/legal, commercial, marketing, and outreach documentation is being prepared to ensure an efficient market launch as soon as regulatory approval is obtained.
In parallel, Arspectra’s commercial team is starting with the implementation of the outreach and commercial go-to-market strategy for both the European and American markets. All necessary contractual/legal, commercial, marketing, and outreach documentation is being prepared to ensure an efficient market launch as soon as regulatory approval is obtained.