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Advanced Intra-Operative Navigation in Arthroscopy Surgery

Periodic Reporting for period 2 - in.nav (Advanced Intra-Operative Navigation in Arthroscopy Surgery)

Reporting period: 2018-06-01 to 2019-12-31

The overall success of any kind of orthopedic surgery largely depends on the correct positioning and alignment of elements in the bone anatomy. In knee Anterior Cruciate Ligament (ACL), which is a well-established arthroscopic surgery with 700.000 cases being performed every year, the average success rate is only 85%, with 10% of patients having to undergo revision surgery. The challenging execution of arthroscopy creates a market opportunity for systems and technologies able to assist the surgeon. In Total Knee Arthroplasty (TKA), which is a widespread procedure with about two and a half million cases per year, poor implant alignment contributes to significant patient dissatisfaction (19%) and is directly responsible for 20% of the 300 000 revision procedures performed every year. Computer navigation was introduced 15 years ago, but despite the proven clinical benefits, current market penetration is less than 5%. The reasons are twofold: (i) ergonomics - systems are cumbersome to use, disrupt workflow and add surgery time; (ii) economics - upfront investment in capital equipment makes navigation financially viable only in large volume hospitals.

The objective of this project is, therefore, to develop and bring to market a video-based technology for surgical navigation, that will combine intelligent video processing for 3D mapping of the anatomy with Augmented Reality (AR) for overlaying meaningful guidance information in images. It is the first system of the kind that provides higher metric accuracy while solving the problems of ergonomics (intuitive to use thanks to AR, no lines of sight or bulky markers, minimum additional time) and economics (no capital equipment with software being deployed in a tablet PC). It is also the first effective solution for navigation in arthroscopy which uses the video acquired by the already existing arthroscopic camera.

P3D has successfully demonstrated the technology in ex-vivo experiments both in arthroscopy and open surgery, validating the applicability and potential of the technology for the orthopedic market.
With the conclusion of this project, the company now has a set of software systems that have been validated from a clinical feasibility standpoint and that can either be incorporated into a partner’s surgical navigation platform or can potentiate the future launch of a P3D product.
Throughout this reporting period, P3D has further developed the in.nav prototype software and hardware for the ACL and TKA procedures, to the point of performance and usability suitable for use in post-mortem experiments.
Three post-mortem experiments have been conducted, and a positive validation of the clinical benefits of the technology was observed.
P3D has also engaged KOL surgeons and established a licensing partnership in open surgery for the application of in.nav in implant positioning.
A final QMS-documentation pack was created and validated so the technology is able to support future regulatory global submissions
The in.nav system and its underlying technology is the target of multiple patents and scientific articles in reputed conference/journals in the area of computer vision.
With the introduction of a more ergonomic and affordable navigation solution into the orthopedic market, all stakeholder (patients, surgeons and healthcare systems) will benefit from gains in clinical results, time of surgery and equipment investment needed.
With this project P3D expects to be in condition to secure further licensing deals of its software applications to global manufacturers of medical devices and implants, leveraging the growth of the company in this sector.
Final demonstration event - Cadaver Trial