SDS Optic #news: inPROBE as a Polish Product of the Future and the launch of the Clean Room

July 13, 2022

The year 2022 has been extremely intense at SDS Optic. Six months have already passed, and we have accomplished a great deal of work and preparations for clinical trials, launched Clean Room facilities and equipment for in-house production of inPROBE biosensor fiber-optic components, and participated in international conferences and industry events. SDS Optic has also received a special recognition: the title of Polish Product of the Future. We have got a solid dose of news for you from the first half of 2022.

The inPROBE Microsensor as a Polish Product of the Future

In July 2022, a ceremonial gala for the 24th edition of the Polish Product of the Future competition was held in Warsaw, where SDS Optic S.A. received a Special Award, and the inPROBE microsensor was honored with the title of Polish Product of the Future. The company's CEO, Marcin Staniszewski, accepted the award in person from Mr. Wojciech Murdzek, former Minister of Science and Higher Education and current Secretary of State in ministries responsible for science.

Polish Product of the Future is an annual competition organized by the Polish Agency for Enterprise Development under the honorary patronage of the Ministry of Development and the Minister of Science and Higher Education. Since 2018, the competition has been co-organized by the National Centre for Research and Development. Each year, the competition identifies the most original and innovative solutions, products, and technologies. These include projects aimed at improving daily life, enhancing quality of life and health, as well as those that contribute to changes in production methods, increase automation, improve production efficiency, or support environmental protection. This year, the competition was particularly fierce, with 163 innovative projects submitted. The projects were evaluated by industry experts and the Competition Jury, which includes representatives from the Chancellery of the President of the Republic of Poland, the Chancellery of the Prime Minister, the Ministry of Development and Technology, the Ministry of Education and Science, the Patent Office of the Republic of Poland, the Polish Development Fund, the Industrial Development Agency, the Federation of Scientific and Technical Associations – Chief Technical Organization, the Warsaw University of Technology, the University of Warsaw, as well as the National Centre for Research and Development and PARP.

The award for our inPROBE technology is the achievement of the entire SDS Optic S.A. team.

Disclaimer: The special award in the Poland Product of the Future competition was granted from the funds of sub-action 2.4.1 PO IR.

Completion of stage two of pilot fiber optic biosensor production: Clean Room setup

In March 2022, in a current report, we announced the completion of the first stage of a milestone — the implementation of a pilot production line for optoelectronic biosensor components, which are part of the inPROBE technology. At the beginning of July this year, we had the pleasure of announcing the completion of the next stage — the launch of a new cleanroom facility with an exceptionally high cleanliness class, essential for the production of fiber-optic microsensor components.

The clean room at the headquarters of SDS Optic S.A. covers an area of approximately 72 square meters and consists of five high-cleanliness rooms connected by special airlocks. Three of these rooms meet the ISO 8 standard, while the remaining two meet the ISO 7 standard. This means they maintain a very low concentration of particles that could pose potential contamination risks, which is crucial for ensuring high product quality and future commercialization. The technological and production facilities have successfully passed testing and are already operational. We are currently awaiting the delivery of the final equipment and expect our pilot production line to be fully operational by the end of the year.

SDS Optic S.A. among the most innovative medical startups in Poland

In recent months, the report Top Disruptors in Healthcare 2022, highlighting the most innovative Polish startups, was published. SDS Optic S.A. was featured in this ranking. We are the only company in the report that combines biotechnology with optoelectronics (photonics). Our solution, inPROBE – a fiber-optic microsensor for real-time cancer diagnostics – is a revolutionary development in the global cancer diagnostics market, which is projected to grow at a CAGR of 12% in the coming years, with a total market value expected to reach USD 8.5 billion by 2024.

Approval to begin clinical trials and registration in the clinicaltrials.gov system

In the first quarter of 2022, we conducted training sessions for oncological surgeons at two medical centers selected to participate in Phase I of the clinical trials (safety study) of the inPROBE microsensor for the diagnosis of HER2-positive breast cancer. During the training, we received suggestions for improving the testing process. We determined that the feedback from the physicians was valuable from the perspective of the eventual commercialization of our solution. These suggestions were incorporated into the clinical trial documentation. With accuracy and thoroughness in mind, on April 7, 2022, we informed the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) about these important changes. Based on the submitted application, the President of URPL decided to issue an updated authorization, thereby approving all significant changes to the clinical trial proposed by the Company, including the new version of the clinical trial protocol along with the required attachments. Receiving this approval allows us to promptly proceed with the planned initiation visits at the two contracted clinical centers in Lublin and Kraków, with the aim of beginning Phase I of the clinical trial on patients as soon as possible, depending on the schedule of planned surgeries at the aforementioned centers.

At the same time, information about the inPROBE clinical trials was officially published in the renowned ClinicalTrials.gov database. ClinicalTrials.gov (CT.gov) is a public registry of clinical studies, with data provided by the U.S. National Library of Medicine—the world’s largest medical library, operated by the U.S. federal government. The database offers easy access to information on publicly and privately funded clinical trials covering a wide range of diseases and conditions. It includes all major clinical studies from around the world.