SDS Optic #news: inPROBE as the Polish Product of the Future and launching of the Clean Room Posted on 13 July 202210 August 2022 by Karol Maryniowski Here, at SDS Optic the year 2022 is extremely intense. It has been 6 months, and we have already done a lot of work and preparations for clinical trials, launching Clean Room rooms and equipment for own production of inPROBE biosensor fibre optic elements, and we also took part in international conferences and industry events. SDS Optic also received a unique distinction: the title of the Polish Product of the Future. We have a fair dose of news for you from the first half of 2022. The inPROBE micro probe as the Polish Product of the Future In July 2022, the ceremonial gala of the XXIV edition of the Polish Product of the Future competition took place in Warsaw, in which SDS Optic S.A. won the Special Prize, and the inPROBE microprobe was awarded the title of the Polish Product of the Future. The President of the Company, Marcin Staniszewski, personally received it from Mr. Wojciech Murdzek, the former Minister of Science and Higher Education, and current Secretary of State in the 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-organised by the National Centre for Research and Development. Every single year the competition identifies the most original and modern solutions, products and technologies, which, on the one hand, are aimed at facilitating people’s daily functioning, improving the quality of life, improving health, and, on the other hand, those that contribute to changing production methods, increase process automation, production efficiency or contribute to environmental protection. This year the competition was really fierce. There were 163 innovative projects submitted. The projects submitted for competition were evaluated by industry experts and the Competition Jury, which includes representatives of the Chancellery of the President of the Republic of Poland, the Chancellery of the President of the Council of Ministers, 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 – the Supreme 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 merit of the entire SDS Optic S.A. team. Completion of the second phase of implementation of the pilot production of optical fibre biosensors: preparation of the Clean Room In the March 2022 current report, we informed about the completion of the first stage of the implementation milestone, that is the implementation of the pilot production line of optoelectronic parts of biosensors, which constitute part of inPROBE technology. At the beginning of July this year, we were proud to announce the completion of the next stage, which is the launch of a new clean room with an exceptionally high class of cleanliness, required for the production of optical microprobe elements. The clean room at the SDS Optic S.A. headquarters has an area of approx. 72 sq m and consists of 5 rooms with a higher class of cleanliness, connected by special airlocks. Three of these rooms meet the requirements of the ISO8 standard, while the other two meet the ISO7 standard. This means that there is a very low concentration of particles constituting potential contaminants, which is significant for obtaining high quality products and their future commercialization. Technological and production facilities have passed their trials and have already been launched. We are waiting for the delivery of the last devices and we expect that by the end of the year our line for pilot production will already be complete. See the full current report: https://sdsoptic.pl/raporty-biezace-spolki-sds-optic-s-a-espi/ SDS Optic S.A. among the most innovative medical startups in Poland The “Top Distruptors in Healthcare 2022” report on the most innovative Polish startups was published last month. SDS Optic S.A. was included in this report. We are the sole company in the report to combine biotechnology with optoelectronics (photonics). Our inPROBE solution – a real-time fiber-optic microprobe for cancer diagnostics – is a revolution in the global cancer diagnostics market, with an estimated CAGR of 12% in the coming years, and its total value may increase to USD 8.5 billion by 2024. Check out the full report: https://aiwzdrowiu.pl/wp-content/uploads/2022/06/Raport-Top-Disruptors-in-Healthcare.pdf Consent to start clinical trials and registration with the clinicaltrials.gov system In the first quarter of 2022, we have already conducted training courses for oncology surgeons in two medical centres selected to participate in Phase I clinical trials (safety study) of the inPROBE microprobe in the diagnosis of HER2-positive breast cancer. In the course of the training, we received feedback in form of proposals for improving the research process. We decided that the feedback received from doctors is valuable from the point of view of the target commercialization of our solution. We included these suggestions in the clinical documentation for the trial. With reliability and accuracy of reporting in mind on 7 April 2022, we notified the URPL about these significant changes. On the basis of the submitted application, the President of URPL decided to issue an updated authorisation, thus accepting all significant changes in the clinical trial requested by the Company, including a new version of the clinical trial protocol with the required attachments. Receiving the above consent allows us to immediately proceed to the planned initiating visits in the two contracted clinical centres in Lublin and Krakow in order to commence Phase I clinical trials on patients as soon as possible, which will depend on the schedule of planned surgeries in the above-mentioned centres. inPROBE Fiber Microprobe – Clinical Trials At the same time, information about inPROBE clinical trials was officially published in the renowned ClinicalTrials.gov database. ClinicalTrials.gov (CT.gov) is a public clinical trial registry for which data is provided by the United States National Medical Library, the world’s largest medical library run by the United States federal government. The database shall provide easy access to information on publicly and privately supported clinical trials covering a wide range of diseases and conditions. It contains all the most important clinical trials from around the world. Our record can be found at: https://www.clinicaltrials.gov/ct2/show/NCT05415943 inPROBE at international industry events: BIO2022 in San Diego, ASCO in Chicago and others SDS Optic S.A. is well aware of the significance of appropriate promotion of such an innovative solution already at this stage of project development. Our objective is to reach the largest possible group of recipients interested in our technology. That is why we are continuously active in the international biotechnology arena. We are constantly expanding our network of business and scientific contacts. After the international Arab Health Fair, that we took part in at the beginning of the year, it is now the turn for the next events that we want to mention. BIO International Convention 2022 in San Diego (USA)The European Innovation Council (a body of the European Commission) selected SDS Optic S.A. as one of the most technologically advanced companies to represented the European Union, as part of the OTF 2.0 program, during the International BIO International Convention 2022. From 13 to 16 June, we presented our inPROBE technology in SanDiego (USA). The BIO International Convention is one of the largest events in the United States, grouping together the pharmaceutical and biotechnology industries in one place. The unique stand of SDS Optic S.A., that was prepared especially for this event, attracted many people. Our presence under the banner of the European Innovation Council and the European Commission has created many opportunities to present inPROBE to representatives of renowned institutions from around the world. We conducted dozens of B2B talks with representatives of global companies, scientific institutions, clinics and medical units. We have considerably expanded our network of contacts. The event also gave us an opportunity to promote our inPROBE technology in the United States and we used this opportunity to 100%. ASCO in Chicago (USA)SDS Optic S.A. also participated in the ASCO 2022 event at the beginning of June. The event brought together more than 30,000 oncologists, scientists and other health professionals. More than 200 sessions and 2,500 posters presented within 5 days of the conference presented the results of the latest research focused on diagnosing, treating and caring for cancer patients. In addition to a number of new and potentially changing therapeutic options, this year’s conference highlighted the need to further develop the tools used to identify patients who can benefit from modern therapies in particular way: – Breast cancer patients with low levels of HER2 (HER2-low) expression are a separate population that can now be effectively treated with drug complexes and HER2-targeted antibodies.– Newly identified biomarkers can be used to predict the response to therapy for bladder, colorectal, breast and other types of cancers. Participation in the ASCO2022, an exciting forum of innovative achievements, has confirmed our belief that in the near future, advanced diagnostic and monitoring solutions, such as the inPROBE fibre optic micro probe, will become one of the crucial elements of the cancer treatment process. Other industry events: BIO2022 and ASCO 2022 in the United States were not the only events we participated in. Spring and summer at SDS Optic were also associated with our presence at: ESMO 2022 in Berlin 8’th LSX World Congress in London EU-Startups Summit 2022 in Barcelona WallStreet26 Conference The first half of 2022 is behind us, but there are still many exceptional events and successes ahead. If you want to know what is currently happening in our Company, you need to follow our social media channels.