Agilis Robotics Targeting its Pre-B Round Fund-raising to be Completed by 2022

Successful In Vivo Testing Clears the Way for First Human Trial in Near Future

HONG KONG, Sept. 22, 2022 /PRNewswire/ -- 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.

About Agilis Robotics Limited

Agilis Robotics is a start-up company that develops highly miniaturised and flexible robotic instruments for endoluminal surgery. The robotic system is able to seamlessly integrate into current clinical workflows and drastically reduce the learning curve associated with endoscopic surgery. Ultimately, Agilis Robotics' goal is to provide clinicians with the next-generation of minimally invasive instruments so more patients can receive effective and efficient early stage care.

About Co-Founders of Agilis Robotics Limited

Dr. Ka-Wai Kwok obtained the Ph.D. degree from the Hamlyn Centre for Robotic Surgery, Department of Computing, Imperial College London. He was awarded the Croucher Foundation Fellowship, which supported his research jointly supervised by advisors in The University of Georgia, and Brigham and Women's Hospital, Harvard Medical School. Dr. Kwok has co-authored over 135 peer-viewed articles and is the principal investigator of group for Interventional Robotic and Imaging Systems (IRIS) at The University of Hong Kong (HKU) with over 5 inventions licensed. Dr. Kwok was awarded the Early Career Awards 2015/16 offered by Research Grants Council (RGC) of Hong Kong, IROS Toshio Fukuda Young Professional Award in 2020, HKU 2019-2020 Outstanding Young Researcher Award and HKU Young Innovator Award 2020.

Dr. Jason Chan graduated from Guy's, King's and St Thomas' School of Medicine in London, followed by specialist training in Otolaryngology, Head and Neck surgery at the Johns Hopkins Medical Institutions with advanced training in Head and Neck surgery, microvascular reconstruction and robotics. He is currently an Associate Professor in the Department of Otorhinolaryngology, Head and Neck Surgery at The Chinese University of Hong Kong with research interests the application of robotics in Head and Neck Surgery having recently led the Transoral Robotic Surgery component of the world's first application of the da Vinci SP in Transoral head and neck surgery.

[1] GLOBALCAN 2020, International Agency for Research on Cancer

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SOURCE Agilis Robotics