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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - Sinusway (Sinusway- a revolutionary single-use endoscope device for treatment of severe sinuses infection (Sinusitis))

Teaser

Summary

Endoscopy is a procedure that is performed using an endoscope that is introduced into the body to examine hollow organs of the body (e.g. the respiratory tract, the ear, the gastrointestinal tract, etc.). Current endoscopes used for ear, nose, and sinus surgery are not designed with focus on the specific needs of the ENT, resulting in providing limited visualization of the anatomy and poor ergonomics, affecting the quality and possibilities of surgery. 3NT Medical aims to bring to market revolutionary single-use endoscopes for ENT (ear, nose and throat) procedures that are carefully designed for the ENT physisi, providing superior visualization of the ear, nose and throat at optimal ergonomics. . The immediate next steps of 3NT Medical are to complete development of its Peregrine Drivable ENT Scope (for nose and sinus surgery) and Colibri Micro ENT Scope (for ear surgery), further develop the video console and imaging quality that serves both endoscopes, and carry out postmarketing activities as the products are introduced into the EU market.

Work performed

During the feasibility assessment, 3NT Medical completed a full analysis of the technical and business potential of Peregrine and Colibri. 3NT Medical produced a work plan, detailing the main steps to prepare for market entry. The business sustainability was evaluated by means of a detailed market analysis (size, barriers, customer segments, competitors) and preparing a commercialisation strategy and a detailed financial analysis.

Final results

Conventional endoscopes for treatment of sinusitis can be subdivided into multi-use flexible endoscopes and rigid angled endoscopes. However, each of these categories of endoscopes have problems associated with their use. Rigid angled endoscopes only see in straight lines and therefore cannot maneuver into the maxillary, frontal or sphenoid sinuses and cannot provide tissue-level intra-sinus visualization. Flexible endoscopes are rarely used for nasal and sinus examination because of poor ergonomics requiring two hands, and very limited bending and deflecting capabilities which are not suitable for the tight nasal cavity; the rare instances in which they can be applied, is when maximal surgery was previously done, and never during surgery itself, because of high risk for cross contamination. Peregrine solves overcomes these huge drawbacks because it can turn tightly and extend beyond the turn, practically \'crawling around the corner\'; coupled with a small, integrated irrigation channel and single-hand control, it makes the ideal endoscope for nasal and sinus procedures.

The operative microscope is the standard visualization means used for all ear surgeries. The main disadvantage of the microscope is the need to work within its \'line of sight\' â€“ meaning that although most of the middle ear is visible through the ear canal, many recesses are hidden by the walls of the ear canal. In recent years, endoscopes have become more popular for middle ear surgery since they provide visualization superior to that of the surgical microscopes allowing the surgeon to complete more complex tasks via the external ear canal (transcanal approach), reducing the need for soft tissue incisions and bone drilling. However, drawbacks of endoscopic surgery in the middle ear include extremely challenging one-handed operation technique, reliance on endoscope motion to assess depth perception, inability to observe the tip of angled endoscopes and heat generated by the light source projected in close proximity to sensitive structures such as the facial nerve. Colibri, unlike existing endoscopes and microscope was designed specifically for the otologist â€“ the ear surgeon, boasting classic otology tools ergonomics that ear surgeons have been familiar with for decades. This unique ergonomics facilitate bi-manual, dexterous, balanced otology procedures, alongside superior ability to visualize the delicate ear anatomy â€“ potentially better both microscopes and endsocopes. Moreover, since it is single-use and sterile ,it is always ready for use with no procedure down-time or breakage concerns.

These devices, which 3NT Medical has designed with complete attention to the ENT surgeon\'s specific needs, will lead to better less invasive surgery and better outcomes for patients.