Successful In Vivo Testing Clears the Way for First Human Trial in Near Future
Agilis Robotics Limited (“Agilis Robotics” or the “Company“), the creator of the first surgical robotic instruments in Hong Kong to target endoscopic submucosal dissection (ESD) and en bloc resection of bladder tumour (ERBT) procedures, has announced its fund-raising status, as well as its latest technological achievements.
Agilis Robotics’ A Round fund-raising has been completed in 2022, with the Pre-B Round, which involves fund raising for respective applications with the Food and Drug Administration (FDA) and National Medical Products Administration (NMPA) set to commence. Such efforts will go towards improving the marketisation efficiency of the Company’s products in the Mainland China. The Pre-B Round fund raising activity is projected to conclude by the end of 2022, with a fund-raising target set at US$5 million. It is worth noting that Agilis Robotics’ has targeted its market value to meet the basic application requirement as stipulated in Chapter 18A pertaining to the listing of biotech companies on the Main Board of the Hong Kong Stock Exchange by 2025.
In the area of robotics, Agilis Robotics has made further progress in the areas of specification, compatibility and AI. On the specifications front, its long, flexible and miniature robotic arms – with five degrees of freedom, have enhanced tissue traction and instrument triangulation. Since the robotic arms also include a variety of end effectors, they can complete a wide range of intricate tasks. What is more, seamless compatibility is realised as each robotic arm is less than 2.8 mm in diameter, hence they can directly channel through or alongside conventional endoscopes that are currently used in clinical practice. In terms of surgeon usability, improvements have been made to the surgeon console, which is both compact and mobile, thus allowing for its placement within close proximity to the patient. Furthermore, with free-floating pen controllers, seamless transition from endoscope controls can be achieved. Mindful of the benefits and importance of AI-driven guidance and training, Agilis Robotics has set performance benchmarks to enhance user training and flatten the learning curve. This includes training on such topics as monocular depth estimation and instrument segmentation for conventional endoscopes.
It is worth noting that Agilis Robotics successfully completed in vivo testing, which involved the artificial bladder tumour resection in June 2022. The extremely narrow diameter of the robotic arms allowed their compatibility with traditional urology telescopes and sheaths, and the arms were able to clamp and cut tumour tissue. Most importantly, the entire tumour was successfully removed. The Company is now targeting its first-in-man (FIM) trial/test in 2024.
Agilis Robotics has maintained progress on the back of successive achievements, spanning concept development to successful patent application(s); cadaveric testing for machine prototyping; and most recently, completion of in vivo testing which will lead to FIM trials. Despite the long development journey and high financial and technological demands, Agilis Robotics has consistently met its objectives.
As the first and only company in Hong Kong to develop robotic instruments that target the ESD and ERBT segments, Agilis Robotics is well positioned to assist the medical community as demand for such procedures continue to rise. Already, manual procedures of the targeted market (gastrointestinal and bladder) in China in 2019 are 6 million per annum and global bladder cancer cases in 2020 are 573 thousand[1]. Projected cases suitable for robotics ESD and ERBT procedures number 5.5 million and 690 thousand, respectively, around the world each year. With the worldwide promotion of early colorectal cancer screening, the number of ESD procedures is increasing rapidly by 18.6% annually. Possessing the unique, small diameter flexible surgical robotic instruments that are compatible with both flexible and rigid endoscopes, the Company is in an advantageous position to address the unmet clinical demand for interventional endoscopy, and just as importantly, deliver benefits to patients in terms of shorter procedure time and lower rate of recurrence.
Kwok Ka-Wai, Ph.D. (Imp London), Co-Founder of Agilis Robotics said, “Under the watchful eye of a professional management team comprising experts in robotics, clinical trials and finance, with thorough understanding and experience in R&D, clinical workflows and fund management, we will be able to address different facets of surgical device development. This same team will also ensure that Agilis Robotics fully capitalises on burgeoning market segments and maintain its growth trajectory.”
Jason Y K Chan, Residency at Johns Hopkins Medicine (DABOto), Co- Founder of Agilis Robotics said, “With the increasing widespread uptake of endoscopy procedures, in particular colorectal screening, there is a rapidly increasing unmet need to address and minimally invasively remove lesions identified. In the bladder, there is a significant unmet need to perform en bloc resections to reduce recurrence of bladder cancer. Agilis matches these needs and enhances the surgeon’s ease and comfort in performing these procedures, aiming to improve patient care, reduce hospital length of stay and need for more invasive procedures.
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