One of the most important events of the past weeks at SDS Optic S.A. was the official launch of clinical trials. 1st Stage began with a study carried out at the SPSK 1 Oncologic Surgery Clinic in Lublin on 25 August 2022. The research was preceded by initial training, where medical personnel was acquainted with the instructions for use and the principles of inPROBE technology operation.PHASE I safety study – 18 patients with HER2+ and HER2- breast cancer
FAZA I – badanie bezpieczeństwa – 18 pacjentek z rakiem piersi HER2+ i HER2-
The planned completion of the first phase is December 2022. At the end of this stage and the preparation of the appropriate final test report, Phase II will be initiated.
As part of 2nd Stage, the researchers focus on confirming the safety and correlation of the status of the HER2 receptor determined with use of the probe with the diagnostic standard that already exists on the market. This will constitute a confirmation of the effectiveness of our probe.
5 medical institutions will participate in the second part of clinical trials. The planned duration of this stage is from 6 to 8 months. Much will depend on the schedule of patient examinations in individual institutions.
Clinical centres have already been verified and the training for medical personnel participating in the research was already scheduled. The conduct of clinical trials is supervised by an external CRO partner.
PHASE II – Effectiveness Study – 192 breast cancer patients
The clinical trials we are conducting are an open-label, multicentre safety and efficacy study of the inPROBE microprobe designed to determine the expression of HER2 in a population of women at high risk of breast cancer. Shall the results confirm the initial assumptions and results of pre-clinical studies, the Company will be able to carry out further work related to the commercialization of the technology. The results obtained within the framework of clinical trials will constitute an extremely valuable element of the Company’s know-how. They will also enrich the existing knowledge base on the in vivo applications of photonics and molecular biology for real-time health diagnostics and monitoring.
Production independence is one of the main objectives that we strive for, which aims not only to generate revenue, but also to develop ready-made procedures and know-how in the field of mass production of the inPROBE microprobe. This will constitute an invaluable advantage in the commercialization of the solution.
On 14 November 2022, we reached another milestone in the form of the completion of the investment phase regarding the implementation of pilot production of optoelectronic parts of fibre optic biosensors for use in the inPROBE® microprobes.The company received the last and at the same time crucial specialized device customized for the planned production of optoelectronic parts of fibre optic biosensors from the USA. Thus, the investment phase, including the order, purchase, delivery and start-up of production equipment and machines of a total value of PLN 2.4 million, was completed. To finance this milestone, the Company raised funds from the issue of series D shares carried out in 2021.
– Our clean room has been equipped with the necessary devices for the planned part of the production of optoelectronic parts of fibre optic biosensors, which we use in the inPROBE microprobes. This is one of the key steps towards achieving production independence on a semi-industrial scale – the planned production capacity of the clean room is approx. 50 000 biosensors per annum. Earlier, we have secured the possibility of independent production of biological, chemical and bioengineering elements, while, at least so far, the fibre optic biosensors have been produced so far by our external partners. We will soon start work on calibration and optimization of production processes using purchased machines and devices. At the same time, we will also conduct the process of recruiting new members of our R&D team. The next step will be to carry out the process of validation and certification of the planned production – we expect it to complete it in Q4 2023. As a result, a complete certified process and production documentation will be created. Our potential business partners will thus be assured that the production of inPROBE microprobe is possible on a mass scale. We believe that this will be a key value at the stage of its commercialization – says Marcin Staniszewski, President of the Management Board of SDS Optic S.A.
RThe development of innovative medical technologies is a complex process that poses many challenges on the borderline of science, management, law and business. For years SDS Optic has successfully combined the work of scientists from diverse fields of science, as well as business professionals. This year, the Management Board decided to take another step towards combining science and business.
In addition to the daily involvement of our specialists and clinical and business partners, SDS Optic S.A. now receives support and valuable opinions from experienced scientists, doctors and entrepreneurs.
On 6 October 2022 we established the Scientific Advisory Council. Its first members, including the Chairman of the SAB, were appointed.
The board-appointed panel of the Scientific Advisory Council includes:
Go to the Scientific Council’s website, find out more about its tasks and get to know its members more closely https://sdsoptic.pl/en/scientific-advisory-board/
The company has received positive decisions on granting patents for applications filed for the essential elements of our inPROBE biosensor.
The granted patents relate to a device for detecting and/or determining the concentration of an analyte present in tissue and a method utilizing this device. This means that the Company has received protection for the crucial elements of the optical sensor technology (inPROBE fibre optic microprobe), which allow the measurement to be performed both in vivo and in isolated tissue, including solid tissue, without the need for any preparation thereof. The measurement method we use is fast and sensitive, and does not require the use of fluorescent or chemiluminescent markers, which is an additional advantage in terms of its safety for doctors and patients.
Both the patent of the US Patent and Trademark Office and the patent protection granted by the European Patent Office are valid for 20 years from the date of filing, i.e. from 26 May 2017.
The patent covers the United States and 38 countries under EPO jurisdiction.
On 27 September 2022, at 10:00 a.m., an investor webinar of SDS optics S.A., entitled “ACTIVITIES and PLANS” took place. During the live broadcast, the Company’s Management Team summarized its current activities and also presented development plans.
As part of the webinar, the participants could learn more about the progress in the implementation of the milestones adopted by the Company. We also presented the course of inPROBE clinical trials started in August. The Management Board presented the development of inPROBE technology and the subsequent stages of work on the diagnostic microprobe for HER-2-positive breast cancers.
Our management team also summarized the work related to the construction of its own pilot production line of photonic biosensors. An important item of the webinar’s agenda was to discuss plans related to the scaling of the inPROBE technology platform up to the area of infectious disease diagnostics (FiBioMed), as well as to the monitoring of drug delivery (pharmaceutical probe).
The recorded webinar is available on the Company’s YouTube channel: https://www.youtube.com/watch?v=5bzfsk7oEgk
On September 28th this year, Mateusz Sagan, as part of the online live event Connect&ScaleUp, talked about how inPROBE technology will support medicine and healthcare. The Connect&ScaleUp event is a series of regular interviews organized by the Polish Agency for Enterprise Development (PARP) to promote the achievements of companies in the Polish medtech sector, as well as cooperation between science and business. In addition to the presentation of SDS Optic S.A., Mateusz Sagan presented the Company in a panel discussing the sources of development of the industry, the most important trends in the medical innovation markets, as well as the opportunities and threats associated with the development of medical technologies.
Photo: Chief Operations and Business Development Officer Mateusz Sagan during a live broadcast
In October, SDS Optic S.A. also received a unique award for the best debut in the category of the report on the activities of companies listed on the NewConnect market. The statuette was received on behalf of the Management Board by Karol Maryniowski, responsible for investor relations, marketing and communication. The Best Annual Report is a competition organized annually by the Institute of Accounting and Taxation, which is famous for its reliability in the analysis of submitted reports and the high specialization of its evaluation chapter. The award confirms the quality of the reports delivered to the market and the direction of the Issuer’s development in the broader context of its communication with the market.
Photo: In the middle: Karol Maryniowski with the Best Annual Report 2021 award for SDS Optic S.A.
Representatives of the Company have recently had the opportunity to develop the company’s network of international contacts and establish cross-border relations with potential partners of the Company. At the turn of August and September, the 27th International Conference of Optical Fiber Sensors was held in Washington, D.C. (USA).
And in September. In October the company also had the opportunity to participate in the Advamed MedTech Conference in Boston (USA), which is an incubator for ideas, developing cooperation and innovation for a healthier world. We held meetings there with representatives of the global medical technology market.
Photo: Mateusz Sagan at the Advamed MedTech conference
The active participation of international industry events allows SDS Optic S.A. to gradually develop the network of contacts and promote the inPROBE technology abroad. This is important in the context of the future development of the company and the commercialization of our solution.
BioTechX in Basel (Switzerland) – Europe’s largest congress on diagnostics, precision medicine and digital transformation in the pharmaceutical and medical industries. Karol Maryniowski, our Marketing, Communication and IR Manager and Mateusz Sagan, Chief Operating and Business Development Officer represented SDS Optic in the start-up zone with our own stand. It was a great opportunity to confront the unusual combination of molecular biology with fibre optics in inPROBE with increasingly fashionable NLP solutions, data analysis and other technologies related to data processing.
MEDICA 2022 in Dusseldorf – this year the largest European event in the world of health and technology gathered many interesting professionals from the world of biotechnology, medicine, medical devices or pharmacology. The event confirmed the deep need to build business and scientific relations in traditional ways. Following the pandemic, companies return to personal contacts, even despite the benefits of using asynchronous communication technologies and tools. MEDICA 2022 meant 4 amazing days, filled with constant conversations with representatives of companies from all over the world.
This year SDS Optic S.A. was able to present itself with its own stand in the Start-up Park zone. Our technology enjoyed exceptional interest, and the number of new and extremely valuable contacts significantly exceeded our expectations and the assumed communication objectives we set ourselves for this trip. Thank you very much for your interest.
In addition to its own stand, SDS Optic was invited to present its project on the stage of the “MEDICA Healthcare Forum”. Mateusz Sagan, Chief Operating and Business Development Officer had the opportunity to introduce the participants to the essence of inPROBE activities, and to present data that confirm the market demand for innovative diagnostic devices at the early stage of cancer, infectious and fungal diseases.
See the video summary with a presentation of SDS Optic S.A. at MEDICA 2022: https://youtu.be/uZTwZOMy8x4
At the same time, another important event took place near Frankfurt. The European Innovation Council, Fresenius Kabi and Medtronic invited SDS Optic to participate in the EIC Multi-Corporate Day on 14 and 15 November in Bad Homburg, Germany.
During this two-day event, we had the opportunity to refresh our contacts with other Council beneficiaries and with the EIC itself, as well as to establish new relationships with representatives of Fresenius Kabi and Medtronic. Our brand has also been invited to an individual business meeting with Medtronic representatives.
On 6 December 2022, Marcin Staniszewski, CEO of SDS Optic S.A. and Mateusz Sagan, the company’s Chief Operations and Business Development Officer took part in an extremely interesting event, bringing together outstanding representatives of the Polish biotechnology industry. In addition to participation in discussion panels and discussions behind the scenes, we had the opportunity to tell more about the financing of our development, the Company’s journey to the WSE and the future development of inPROBE technology.
Our brand maintains a stable and attractive position on the market and is already established as part of the landscape of Polish biotechnology industry and we are very pleased that we can share our experiences. See a short video summary of this event: https://www.youtube.com/watch?v=5VOPCze6xq0
Representatives of the Research & Development team of SDS Optic S.A.: Magdalena Staniszewska, Scientific Director and Co-founder of the company, and Agata Mitura, Research Team Leader – Biology, participated in the prestigious 34th EORTC NCI AACR Symposium in Barcelona held from 26 to 28 October 2022.The company presented the results of its proprietary scientific research indicating the accumulation of the soluble form of the HER2 receptor in the area of the HER2+ tumour, which confirms that it is the optimal location for diagnosis with use of the inPROBE probe. In addition to the poster presentation, it also offered us a unique opportunity to get acquainted with the latest trends in the development of anticancer drugs, the use of liquid biopsy procedures in the diagnosis and monitoring of therapy, and legal regulations of clinical trials. Participation in the meeting and presentation of research results gathered by specialists in various fields of oncology indicate new possibilities for applying the inPROBE technology and new directions of development for our technology.
Photo: Scientific Director of SDS Optic S.A. Prof. Magdalena Staniszewska at the EAW 2022 symposium in Barcelona
The poster presented as part of this event can be seen at https://sdsoptic.pl/en/poster-her2-distribution-in-tumor-and-blood-of-mice-with-xenograft-human-cancer/
The company has already participated in the first meetings inaugurating the event as part of the OTF program organized by the European Innovation Council (EIC) established by the European Commission. SDS Optic was again among the 20 most innovative companies from the European Union, which were invited to represent our region in a special pavilion at the 2023 Arab Health Fair.
This year, EIC asked SDS Optic S.A. to present its experience from previous editions and to present a set of best practices related to this event to other participants of the OTF 2.0 program.
Karol Maryniowski, our Marketing, Communications and Investor Relations Manager, talked about what to expect at the Dubai trade fair, what to keep in mind when establishing business relations in the United Arab Emirates. We shared tips on how to prepare for the fair to succeed and gain valuable leads and contacts. We also had the opportunity to present our Company and its achievements. It was a great honour and an extraordinary distinction for us.
Building: Za’abeel Hall 6Stand: Z6.C20Date: 20 January to 2 February 2023
One of the biggest events in the Middle East region is ahead of us. It offers a unique opportunity to gain new valuable contacts in the Arab Emirates region, as well in the rest of the world. If you’re going to Dubai during that time. We look forward to seeing you there!
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Stowarzyszenie Inwestorów Indywidualnych [16.11.2022] Magazyn Akcjonariusz (3/2022)https://www.sii.org.pl/15882/edukacja/akcjonariusz/nasza-technologia-moze-stac-sie-swiatowym-standardem-w-diagnostyce.html
Navigator Capital Group [17.10.2022]https://navigatorcapital.pl/sds-optic-s-a-the-best-annual-report-2021/
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