SDS Optic S.A. is launching a technology collaboration with Philips and the R&D institute CSEM

June 26, 2023

On July 1, 2023, SDS Optic S.A. — a company listed on NewConnect and developing the proprietary inPROBE^® technology platform for real-time medical diagnostics of cancer and infectious diseases, as well as health monitoring — will begin a technological collaboration with Philips (Philips Engineering Solutions division) based in Eindhoven, the Netherlands (“Philips”), and the research and development institute CSEM based in Neuchâtel, Switzerland (“CSEM”). This partnership, established within a newly formed consortium, marks another milestone aimed at developing a commercial prototype of the inPROBE^® detection device (analyzer) and launching contract-based large-scale production of its final version. The project will receive funding of up to EUR 244,090 (approx. PLN 1.1 million) under the MedPhab initiative, co-financed by the European Commission, which represents up to 72% of the project’s total estimated cost of EUR 339,120 (approx. PLN 1.5 million).

As part of the planned activities, the Company’s analyzer project (a detection device) will be scaled up from a clinical prototype to a commercial and industrial prototype. This analyzer is designed for analysis and measurement in studies using disposable inPROBE^® microsensors. The planned work will result in complete project, engineering, system, and regulatory documentation that meets the requirements of the quality management system for medical devices in accordance with the PN EN ISO 13485:2016 standard, which has been implemented by the Company and certified by the notified body TÜV NORD Polska. The documentation will also comply with the regulations of the European Medical Device Regulation (EU-MDR).

As a result of the work carried out by the Consortium, SDS Optic S.A. will become the owner of the complete process and production documentation, with full rights to manage the acquired industrial property. This will enable the Company to freely determine the industrial development of the product, the location of its production, and naturally, the areas in which the technology will be applied. The actions undertaken within the consortium aim to emphasize the independence of SDS Optic S.A. in the commercialization process of the inPROBE^® solution, particularly with regard to further licensing and sales. The developed documentation, along with the anticipated successful completion of the tasks planned under the MedPhab project, will enable the creation of a detection device (analyzer) ready for industrial commercialization. This analyzer will be one of the key components of the inPROBE^® system, which is based on groundbreaking photonic biosensors. Collaboration with Philips and the possibility of having inPROBE^® analyzers manufactured by such an experienced brand, under certified conditions with the highest quality standards, will be a significant asset in the commercialization process and a means of further developing the inPROBE^® technology for future applications.

“This project marks a breakthrough for us in the industrialization of our technology. Prototyping and semi-industrial production of our analyzer in collaboration with Philips, alongside the renowned Swiss research center CSEM, ensures the highest quality in processes, documentation, quality control, and compliance with all certification and regulatory requirements for medical devices. Philips is one of the world’s leading companies in the design and manufacturing of medical equipment, and the additional support from the Swiss CSEM Institute in the area of precision optoelectronic components only strengthens our foundations. As part of the MedPhab project, carried out by SDS Optic in cooperation with Philips and CSEM, a complete design documentation of our analyzer will be developed, adapted to industrial-scale production. This documentation will be owned by the Company, allowing us to maintain full control over the direction of our technology’s development and enabling us to manufacture our analyzers anywhere in the world, while offering potential corporate partners a guarantee of quality throughout the entire process,” says Mateusz Sagan, COO of SDS Optic S.A.

“In the MedPhab project, we support the development of innovative photonic technologies for medical applications and connect small and medium-sized enterprises with the right industrialization partners to enable effective implementation of certified device production. By working with us and our MedPhab partners – CSEM and Philips – SDS Optic is taking an important step toward the commercialization of its inPROBE^® technology platform, which will help improve the quality of life for many patients,” says Dr. Elena Beletkaia, Business Development Manager at Philips Engineering Solutions.

“CSEM is excited to support innovation in cancer treatment. Together with our Medphab partner Philips, we will take SDS Optic’s technology to the next level!” – Andreas (Charles) Voelker, Research and Business Development in Photonics, CSEM

Work on the MedPhab project will continue from July 2023 to July 2024.

MedPhab is a consortium composed of leading European research institutes and medical industry leaders, established and co-funded by the European Commission to develop devices based on photonic technologies for medical applications. The project's main focus is the creation and testing of pilot production lines for three application areas of the developed technologies: medical devices used in hospital settings, devices for home healthcare, and diagnostic equipment. All activities are carried out in compliance with ISO 13485 standards, and the medical products being developed aim to meet the regulatory requirements of the EU-MDR and EU-IVDR.

Philips Engineering Solutions (PES) is the engineering division of the Philips Group. Its role is to support, develop, and implement technological innovations into semi-industrial production environments and industrialization processes. PES works on both internal Philips projects and for external clients developing breakthrough medical technologies, with a primary focus on semiconductor, photonic, and micro-medical device technologies.PES also acts as a small-scale industrial contract manufacturer of medical devices, based on technical documentation provided by clients. The company complies with all required medical standards and makes its resources available for audits and quality inspections in accordance with EU-MDR and EU-IVDR regulations.

The CSEM Institute, headquartered in Switzerland, is a strong international public-private non-profit center employing over 550 people. It specializes in the development and support of breakthrough technologies in precision manufacturing processes, digitalization, ultra-low-power electronics, optoelectronic components, artificial intelligence, and renewable energy. CSEM primarily supports and collaborates with the medical, renewable energy, watchmaking, and space technology sectors.

SDS Optic S.A. has developed an innovative and globally unique fiber-optic microsensor called inPROBE^®. It is a biosensor with a high level of sensitivity and specificity, enabling the measurement of the concentration of a specific biomarker or dedicated compound directly in the patient’s body (in vivo), without the need for tissue collection (biopsy). The primary area of application that the company is currently focusing on for development and commercialization is the diagnosis of HER2-positive breast cancer and the monitoring of targeted therapy for this type of tumor. The technology being developed by SDS Optic S.A. may serve as a complement or alternative to the more time-consuming and invasive traditional biopsy.