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Augmented Reality Vision for Surgery

Periodic Reporting for period 1 - ARVisS (Augmented Reality Vision for Surgery)

Reporting period: 2015-11-01 to 2016-04-30

With the ARVisS product range, Trivisio will offer accessible, time-efficient and improved surgery for high, incidence, cancer tissue resections. Creating a more efficient experience and improved abilities for the physicians, in a first commercialization stage ARVisS will concentrate on bringing higher surgical precision and reduced procedure times for two major malignancies. The tumors located in the breast and prostate tissue alone account for over a quarter of the cancer incidences In Europe. Treated in over 6300 European hospitals in 2015, significant amounts of surgical interventions have lead to relatively high survival chances. But cancer recurrence, resulting side effects and the loss of large amounts of healthy tissue are strongly correlated with the completeness and accuracy of the resection, and account for the largest share of the social and economic burden.

With Trivisio’s latest technology an unprecedented technological approach integrates the prime functions of magnification, fluorescence detection and intraoperative guidance. Further improvement of the surgical precision by means of more efficient, yet financially more accessible technology is the main goal. Designed on the continuous requests and feedback of partner surgeons, a set of easy-to-use, fully see-through AR glasses, a small autonomous cube scanner and a powerful processing unit have been developed. They will offer the improved survival rates, significantly reduce the reoccurrences and the related psychological and economical weight, and increase the applicability and efficiency of the procedures.
Substantial communication and feedback gained from the cooperations with its current partner medical institutions and further analysis of Europe’s regional variations has allowed Trivisio to accurately understand and segment the European market. More substantiate conclusions on the choice of the prime targets, the potential market demand, the competitive positioning, the freedom to operate and the potential risks could be taken.

A notorious improvement in the market reach has been achieved by expanding its communication to, and involving surgeons from the private hospital domain. On European scale, both the public, mostly academic hospitals and the larger corporate-structured private hospital groups account for relatively equal shares of the treatments. Trivisio is now expanding its established network of partners in university hospitals with units from relevant large private hospital groups as the Ramsay Générale de Santé. Offering solutions, working together and receiving feedback from new partners within this substantial part of the market, allows Trivisio to expand its network and reach. With the company’s international mindset, it aims at having confirmed early adopters in both segments in over 10 different nations within the coming year. To subsequently aboard the overall medical market, the main communication and marketing channels will consist of medical exhibitions and conferences. This type of more direct contact and sales is already familiar to Trivisio and has proven successful in its other markets. It will also allow the sales to be more flexible towards the different forms of purchase channels and responsible entities in relatively hierarchical hospital organizations.

At the start of the commercialization of the ARVisS system, four different product levels will be offered categorized along data display, magnification, fluorescence detection and intraoperative guidance functions. Offering these advantages at every stage a specific market evaluation and competitive analysis could be made. High flexibility and extensive experience in development has allowed Trivisio to create a novel and different technological approach relative to its competitors at every level. Next to an unprecedented treatment efficiency and improved user experience, while remaining highly profitable a severe price reduction is now possible. Dependent on the aforementioned function level, 50 % down to 25 % of the current market standards will be achieved.

Next, an analysis of the freedom to operate in terms of Intellectual Property and the regulatory requirements has been made with the support of two major European research centers with extensive experience in the field, the Fraunhofer Society and the KU Leuven. It could be concluded that no relevant international patents hinder the implementation and commercialization of ARVisS and Trivisio is evaluating the options for the protection of several crucial elements in its technology.

In terms of regulatory requirements Trivisio is taking the appropriate measures in regards of the necessary European CE mark. As Trivisio will focus on sales on the European market and will offer a high warranty on quality and reliance, its devices will also be conform with the ISO 13485 regulation. Three agencies that have the necessary experience in specialized certifications for medical devices are considered once the final adaptations in user-comfort and cancer specificity have been made. Adjusted to the necessary clinical security and performance, the ARVisS systems will comply with the EU health, safety and environmental protection directives and regulations.

With a more detailed market evaluation and extensive feedback from experienced partner institutions Trivisio was able to refine the assessment of the economic and financial viability of the ARVisS product family. It has further on allowed to refine the risk analysis and define the relevant mitigation strategies. Aside of the personnel costs, the main expenses before the market launch lie in achieving the regulatory requirements, the marketing and commercial reach out, and slightly lower costs of goods for further test devices of the ARVisS system that are systematically distributed to the partner surgeons. After the market entry the main costs will lie in respectively cost of goods, personnel and marketing presence on conferences. Substantial investments in ARVisS were funded by Trivisio’s sales in parallel product synergies and prior related research projects on parts of its technology.

The most important change in Trivisio’s strategy for the final commercialization preparations however lies in an earlier launch of the medical AR data glasses of the ARVisS system as an independent unit. Due to successful development that has finished ahead of time and shorter medical regulation procedures, the marketing and commercialization of the subunit will start ahead in the coming year. The decision has been taken on demand and interest of large clients, and in order to strengthen the first-mover advantages and more efficiently prepare the commercialization channels for the final ARVisS system. The expected sales of 500 units in advance will guarantee a part of the funding for strong preparations to the final market launch of, and improve the acquisition of the necessary personnel for ARVisS.
Trivisio’s innovating capabilities in optical design and the production of near-the-eye technologies have been applauded with success. Its AR engineering team has for instance provided the optical hardware winning the German Innovation Award in IT in 2013. As the market entry and success of AR technology proposed by competition has been delayed or have resulted in lower performances than expected, Trivisio’s latest AR technology has gained interest of large corporations from various markets as SAP, Siemens and Thales. Having worked successfully in close collaboration with physicians, the design of ARVisS has continuously been improved to be the most efficient tool for the aforementioned cancers of the breast and prostate. As they form a substantial part of the overall cancer burden in Europe, that reaches over 125 billion, the lack of precision and completeness of the procedures form the main reasons for reoccurrences. This leads to lower survival, a severe psychological weight and insecurity for the patients, and a supplementary and important financial pressure on the national health care systems. For instance, with an incidence of 67.6 per 100.000 European inhabitants, according to Eurostat breast cancer alone has accounted for about 5.58 million of total mastectomies and 12.36 million of partial excisions of mammary glands in 2013. It is on the requests of the relevant physicians that Trivisio has systematically engaged itself to develop a completely new, commercially available approach that will simply, but radically enhance the current procedures.
The main benefits of the ARVisS system.
The 3 state-of-the-art tools are offered from a unique point-of-view.
The novel approach is based on Trivisio's unprecedented AR technology.
Europe's current status in high incidence cancer surgery.