Periodic Reporting for period 1 - Navari (Pre-clinical study, continued technology development & health economic analysis for Navari Surgical AB)
Reporting period: 2023-07-01 to 2024-01-31
Cancer is the second-leading global health threat, causing around 10 million deaths annually and leading to nearly 20 million new cancer diagnoses each year. About 60% of cancer patients undergo surgery. However, despite the clear benefits (e.g. shorter hospital stay and less complications) and pressing demand for minimally invasive surgery (MIS) in various medical fields, especially in treating soft tissue organs, its slow integration into cancer treatment (20% MIS) raises concerns. The main barrier to adopting MIS for soft tissue cancers lies in the procedure's complexity, including challenges such as limited visualization, lack of depth perception, difficulty in navigating complicated anatomies, absence of tactile feedback, and the risks of not fully removing tumours or harming surrounding healthy tissues. Addressing these issues is crucial to facilitate a shift from traditional open surgeries to MIS, ultimately reducing the strain on patients, surgeons, and the global healthcare system.
Navari has developed ARVIS (Augmented Reality Visualization- & Imaging System), the world’s first technology enabling intraoperative augmented reality (AR)-guidance in real-time during MIS, for soft tissue cancers. ARVIS serves as the catalyst needed to facilitate the transition from open surgery to MIS. ARVIS integrates augmented reality (AR) with imaging from x-ray or ultrasound to precisely identify and render a 3D model of tumours & anatomical structures in real time. This is superimposed onto the surgeon's minimally invasive camera feed, enhancing surgical navigation and precision. ARVIS is a key enabling technology to convert open surgeries to MIS. With ARVIS, surgeons can perform MIS with higher precision and less damage to healthy tissue , thereby enabling patients to gain from less invasive procedures, shortening hospital stays (4 days MIS vs 7 days open- surgery), lowering the risk of complications and reducing post-operative pain (50% more likely to feel fully recovered after 12 months vs. open surgery) and facilitating a quicker return to normal life. Furthermore, by enhancing visualization for surgeons in MIS, ARVIS helps shortening the learning curve for new surgeons or those transitioning from open surgery, making MIS the obvious first choice of surgery. By making MIS more accessible and reducing the need for open surgeries, ARVIS helps in cutting down the length of hospital stays, minimizing post-surgical complications and shortens surgery time, resulting in significant cost savings. ARVIS has demonstrated its potential to increase the adoption rate of MIS, currently underutilized despite its advantages.
Navari has developed ARVIS (Augmented Reality Visualization- & Imaging System), the world’s first technology enabling intraoperative augmented reality (AR)-guidance in real-time during MIS, for soft tissue cancers. ARVIS serves as the catalyst needed to facilitate the transition from open surgery to MIS. ARVIS integrates augmented reality (AR) with imaging from x-ray or ultrasound to precisely identify and render a 3D model of tumours & anatomical structures in real time. This is superimposed onto the surgeon's minimally invasive camera feed, enhancing surgical navigation and precision. ARVIS is a key enabling technology to convert open surgeries to MIS. With ARVIS, surgeons can perform MIS with higher precision and less damage to healthy tissue , thereby enabling patients to gain from less invasive procedures, shortening hospital stays (4 days MIS vs 7 days open- surgery), lowering the risk of complications and reducing post-operative pain (50% more likely to feel fully recovered after 12 months vs. open surgery) and facilitating a quicker return to normal life. Furthermore, by enhancing visualization for surgeons in MIS, ARVIS helps shortening the learning curve for new surgeons or those transitioning from open surgery, making MIS the obvious first choice of surgery. By making MIS more accessible and reducing the need for open surgeries, ARVIS helps in cutting down the length of hospital stays, minimizing post-surgical complications and shortens surgery time, resulting in significant cost savings. ARVIS has demonstrated its potential to increase the adoption rate of MIS, currently underutilized despite its advantages.
This project has enabled us to design, document and perform a pre-clinical study, giving us a first proof-of-concept in vivo (TRL 5). Furthermore, with the data given from the pre-clinical study, a first health economic analysis has been performed, enabling us to gain a better understanding for both business case and pricing model.
The outcomes from the pre-clinical study was great, validating ARVIS huge potential. In total, 6 liver surgeries could be performed where a simulated tumor was identified and resected, only by guidance provided from ARVIS. Both the accuracy in the AR-overlay, as well as impact from organ deformation, was measured to be well within acceptance criteria, proving ARVIS suitability for clinical use. With learnings from the pre-clinical study in mind, a development roadmap has been formalized for product optimization with the overall ambition of initiating a clinical study during 2025.
With the data from the pre-clinical study, a first health economic analysis has been performed. Hypothesizes around the data received has been formulated, taking aspects such as potential time savings eg. into consideration. The health economic analysis has given us a better understating of our pricing model and ARVIS potential to increase efficiency, and thereby saving overall costs, for its customers (hospitals) on a yearly basis.
The outcomes from the pre-clinical study was great, validating ARVIS huge potential. In total, 6 liver surgeries could be performed where a simulated tumor was identified and resected, only by guidance provided from ARVIS. Both the accuracy in the AR-overlay, as well as impact from organ deformation, was measured to be well within acceptance criteria, proving ARVIS suitability for clinical use. With learnings from the pre-clinical study in mind, a development roadmap has been formalized for product optimization with the overall ambition of initiating a clinical study during 2025.
With the data from the pre-clinical study, a first health economic analysis has been performed. Hypothesizes around the data received has been formulated, taking aspects such as potential time savings eg. into consideration. The health economic analysis has given us a better understating of our pricing model and ARVIS potential to increase efficiency, and thereby saving overall costs, for its customers (hospitals) on a yearly basis.
The successful pre-clinical study did not only validated ARVIS huge potential in clinical settings, it also contributed to the scientific society where a novel and fully unique method to simulated liver cancer surgery has been developed. Learnings and the methodology for this is to be made available to the public in the form of a scientific publication currently being drafted.
Reaching a first proof-of-concept in vivo puts ARVIS one step closer towards commercialization. With the data generated, we have been able to risk-mitigate the technical- and clinical performance of ARVIS, putting Navari in a better position to attract the invested capital needed to reach to a stage where revenues can be generated. Ongoing work includes strengthening of IP portfolio where one additional patent is being filed, broadening our clinical network within Europe and the US market as well as developing an integrating various software functions for product optimization. Future challenges includes navigating the regulatory landscape, designing and conducting a clinical trial for CE-mark and to successfully installing ARVIS at first customer sites.
Reaching a first proof-of-concept in vivo puts ARVIS one step closer towards commercialization. With the data generated, we have been able to risk-mitigate the technical- and clinical performance of ARVIS, putting Navari in a better position to attract the invested capital needed to reach to a stage where revenues can be generated. Ongoing work includes strengthening of IP portfolio where one additional patent is being filed, broadening our clinical network within Europe and the US market as well as developing an integrating various software functions for product optimization. Future challenges includes navigating the regulatory landscape, designing and conducting a clinical trial for CE-mark and to successfully installing ARVIS at first customer sites.