Author: 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.

SDS Optic Inc., a company developing the proprietary inPROBE technology platform for real-time medical diagnosis of cancer, infectious, viral, bacterial and fungal diseases, has published its annual report for 2021. The past months have been accompanied by many milestone events for the development of the company and its product.

Summary of 2021 at SDS Optic Inc.

In 2021, the Company carried out toxicological tests on animals, registered a patent for its technology, and successfully acquired PLN 11 million in the pre-IPO offer and began the process of entering the NewConnect market. The debut of the Company took place in March this year. At the same time, SDS Optic has been intensively preparing for the start of clinical trials of its HER2 positive breast cancer device and has completed the first milestone on the way to launching its own pilot production of inPROBE fibre optic biosensors.

– In 2021, we implemented many milestones that were of importance for the further development of our Company and we are very satisfied with the pace we have achieved. In order to point out the most important events for us, it is necessary to mention the commencement of preparations for clinical trials despite the ongoing COVID-19 pandemic, including the selection of the first two clinical centres that will participate in the first stage of the research. The last round of financing marked a very important event for the Company, as we were able to attract renowned investors, and this was followed by the beginning of preparations for the debut on the NewConnect market. Finally, I would like to mention the conduct and positive completion of toxicological tests of inPROBE microprobe in a certified animal testing centre – says Marcin Staniszewski, Chief Executive Officer, Chief Technology Officer of SDS Optic Inc.

– Download the 2021 annual report of SDS Optic Inc. –

Further inPROBE applications

Last year SDS Optic also worked on new applications of inPROBE technology. Our subsidiary FiBioMed LTD acquired PLN 10 million from the National Centre for Research and Development for the purposes of R&D in the field of diagnostics of infectious, viral, bacterial and fungal diseases. One of the first new research areas will be the diagnosis of the SARS-CoV-2 virus. Adaptation of biosensor will allow for simultaneous analysis of 96 samples (a panel of optical fibre microprobes), which in turn will allow the creation of a mobile, high-pass diagnostic device opening the possibility of safe testing of samples in real time and in large clusters of people, including in large cities, office buildings, workplaces or schools. There will also be the option of adapting the device to the analysis of other pathogens and diagnostic markers, including in the field of sepsis markers.

– The FiBioMed team actively works on new fields of application for our inPROBE biosensor. Till now we managed to adjust the design of the probe in technological dimension, manufacture its crucial components, and also the biological components that are indispensable in the diagnostic process. We have the first prototypes of sensors ready. We designed and built a 3D model of the analyzer head for simultaneous handling of samples of 96 patients. We are currently working on the control software, we want the entire diagnostic process to be as automated as possible – says the President of the Company.

Promotion of the Company on the international scene

The company was also very active in the field of promotion of its technology, participating in several major industry events such as MEDICA2021 in Dusseldorf, Life Science Open Space 2021 or the European Innovation Council Summit 21. Participation in such events allows us not only to present the product and technology to the broader market, but above all, it supports building business relations and reaching potential end customers. The potential of inPROBE technology was also noticed in Poland, where SDS Optic was included in the publication summarizing 115 of the most innovative medical entities: Top Disruptors in Healthcare 2021. It is worth noting that the partners of the report were: Google for Startups, AstraZeneca, EIT Health and PZU Zdrowie.

Financial results

SDS Optic is at the stage of confirming the effectiveness of the developed biosensor for the diagnosis of HER2-positive breast cancer, which is reflected by its 2021 financial results. Throughout 2021, The Company achieved over PLN 451 thousand in sales revenue. Other operating revenues of the Company amounted to PLN 2.66 million (compared to PLN 3.36 million in 2020) and were based mainly on subsidies acquired by the Company in previous periods. The operating costs amounted to PLN 3.97 million (PLN 3.49 million in 2020) and resulted mainly from the research and development works carried out. At the end of 2021 The Company had over PLN 8.3 million in cash, which contributed to maintaining financial stability and was related to the issues of series C and D shares carried out in the first half of the year, from which a total of PLN 11.3 million was raised. Importantly, the Company does not have any outstanding loans and credits, or debt in the form of bonds. The total fixed assets of SDS Optic at the end of 2022 amounted to about PLN 1.2 million, compared to PLN 206 thousand in the previous year.

– Our model of financial activity at the current stage of the Company’s development was largely based on grants and funds acquired from capital investors. We raise funds for a specific stage of work or project and we reliably carry them out. Our vision has convinced many private and institutional investors so far, some of whom have invested in the development of SDS Optic at the earliest stages of our journey, which is already in 2013. It should be emphasized that our business model has been very well thought out and we are well prepared to achieve the subsequent milestones.

We have a very responsible cost policy, which allows us to maintain financial stability, we do not have any long-term liabilities and we receive further tranches of grant financing on an ongoing basis, which proves our ability to obtain further demanded funds. One of the objectives for the coming quarters is to build the value of the Company’s assets, including fixed assets, and to carry out further stages of R&D work. Our overarching goal is to commercialize the first use of inPROBE, which will allow the Company to generate the first significant amounts of revenue in the coming years – says Mateusz Sagan, Chief Business Officer, SVP at SDS Optic Inc.

On the eve of inPROBE clinical trials

Since the beginning of 2022, the SDS Optic team has been intensively preparing for the commencement of Phase I clinical trials of the inPROBE microprobe. In the first quarter, training was conducted in carefully selected and contracted clinical centres for physicians and medical staff, who will participate in the research. This gave them the opportunity to submit their proposals for testing procedures. The company openly accepted these reports and, in consultation with a professional CRO advisor, who coordinates the research process, decided to update the necessary documentation at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL). Organizational procedures were also been developed and tested to assist in the smooth implementation of the research.

– We will be the first in the world to detect and measure the concentration of the HER2 tumour biomarker in the tumour area without simultaneously acquiring the affected tissue from the tumour (biopsy). In clinical trials, we expect confirmation of information obtained in animal models, and the acquired knowledge will be of great importance for the further development of our inPROBE technology and the possibility of its accurate calibration against traditional methods of histopathological diagnosis – the IHC or FISH methods. We currently await the update of the consent to conduct the trial that we first received at the end of 2021. We decided to introduce and report changes to the research procedure to make it even more reliable and provide the greatest possible value in the process of development of the entire technology. We also have the final report in mind, which will be created after the end of this and the subsequent phase of research and which will be important evidence for the introduction of our solution to the wider market. We are also thinking about the process of its commercialization, we are already taking care that the commercial, clinical and regulatory values of our technological documentation are as high as possible – explains Magdalena Staniszewska PhD, DSc – co-author of the technology and Chief Science Officer of SDS Optic Inc.

The budget for both phases of the clinical trial was secured by the Company from the funds obtained under the SME Instrument Horizon2020 program. The value of the current financial expenditures related to the development of inPROBE technology amounted to approx. PLN 43 million, of which approx. PLN 7 million will be allocated to clinical trials on patients. These funds were acquired, among others, from the SME Instrument Horizon2020 programme run by the European Commission, the National Centre for Research and Development and from our capital investors.

SDS Optic Inc. has developed an innovative and globally unique inPROBE fibre optic micro-probe. It is a biosensor with a high level of sensitivity and specificity, allowing for biological measurement of the concentration of a specific biomarker or a dedicated compound in the patient’s body (in vivo test), eliminating the need to collect tissue (perform biopsy). The basic field of application, the development and commercialization of which the Company is currently focusing on, is diagnostics, as well as targeted treatment of HER2-positive breast cancer markers. SDS Optic technology could be an alternative or complementary diagnostic method for the more time-consuming and invasive traditional biopsy.

Market reports indicate that the average annual growth rate of the global market for HER2 molecular diagnostics in 2019-2025 will be 12%, increasing the value of this market to over USD 6.4 billion in 2025. In 2019, more than 7.5 million tests were performed in the area of HER2 molecular diagnostics of a total value of more than USD 4.1 billion.

Announcement of the implementation of the subsequent milestones of SDS Optic Inc.

The second half and the end of 2022 will keep our Company equally busy. SDS Optic is completing preparations for clinical trials divided into phase I (safety) and phase II (validation), and at the end of the year it intends to launch the upcoming pilot production line of its biosensors. At the same time, the Company initiated its search for a specialized advisor in the future process of commercializing the biosensor for diagnosis in HER2-positive breast cancer and is preparing to launch its branch together with a research and development centre in the United States.

Stay tuned!