Dariusz Stencel MD, PhD, MBA

Nearly 20 years of experience working in R&D teams and in the field of clinical research, development, and launching medicinal products and medical devices into the market. Has collaborated with brands such as Novo Nordisk, Baxalta, Roche, AstraZeneca, and Bayer. Has 150 publications and presentations at major international scientific conferences.

Promising perspectives for the application of inPROBE® technology platform for protein expression determination

An inherent feature of modern oncology is personalization, manifested in conversion from the fit-to-all strategy based on applying the same chemotherapy regimens to all patients with a specific type of cancer to therapy tailored to the individual patient’s situation.
An integral part of personalization is the development of molecularly targeted therapies, acting on specific molecular targets related to the cancer cell, which are very often proteins expressed on the cell surface.

One of the earliest identified proteins is the human epidermal growth factor receptor 2 (HER2), a protein from the epidermal growth factor receptor (EGFR) family. Overexpression of the HER2 protein has been found on breast cancer cells, but also on stomach cancer cells and some rare subtypes of lung cancer [1].

In breast cancer, HER2 overexpression is associated with more aggressive tumor growth and poor prognosis (unfavorable prognostic factor), while enabling the use of targeted therapy with monoclonal antibody directed against this protein (favorable predictive factor).

Currently, HER2 expression on breast cancer cells is determined using immunohistochemistry (IHC) and – in doubtful cases – in situ hybridization (FISH) in tumor tissue samples collected during biopsy or surgery. The IHC method uses a chemical dye and evaluates the reaction result in the range of 0-3+. In the case of 0-1, HER2 expression is considered negative, a result of 2+ means that HER2 status of the tumor is not clear and is called “equivocal” and the HER2 status needs to be tested with FISH to clarify the result (a positive FISH result qualifies the tumor as HER2 positive), and a value of 3+ means positive HER2 expression.

Recently, the concept of HER2-low expression has been proposed, indicating low expression of the HER2 protein, undetectable by standard methods, but still being a positive predictive factor, and therefore justifying the use of targeted therapy. The change in the classification of HER2 protein expression is shown in the figure below [2].

Grafika paradygmatu oceny nadekspresji HER2  na graficznej prezentacji próbek tkanki z różnym stopniem nadekspresji białka.Fig. 1 Aktualny paradygmat oceny nadekspresji HER2 [2]

The recently made (April 5, 2024) decision of the US Food and Drug Administration (FDA) to register the medicinal product fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) in an accelerated mode “for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have previously received systemic therapy and have no satisfactory alternative therapeutic options” further emphasizes the need to use reliable methods for determining HER2 expression [3].

It should be also emphasized that regardless of HER expression classification, the result obtained is subjective, which obviously increases the risk of obtaining imprecise results, which in turn may lead to either insufficient/suboptimal treatment of patients with false negative results, or unnecessary overtreatment in the case of a false positive result.

Urządzenie diagnostyczne inPROBE: analizator i mikrosonda światłowodowaSDS Optic Inc. from Lublin has developed the inPROBE® technological platform designed to determine protein expression in a way different from the standard one. Firstly, the determination is performed in vivo, i.e. directly in the patient’s body, without the need to collect tissue, secondly, the determination is possible both in the tumor itself and in its immediate surroundings, thirdly, the result is obtained in real time, i.e. after about 30 minutes and finally, fourthly, the result is quantitative, so it is an objective result, expressed in numbers.

The technological platform developed by SDS Optic Inc. is based on fiber optic technology using sensors functionalized with proteins recognizing a specific diagnostic marker, e.g. HER2 protein. The optical signal caused by the interaction of the protein with the sensor surface, after conversion using a mathematical algorithm, is translated into a numerical value of protein expression level.

The first protein for which an appropriate inPROBE® probe was developed was HER2. In order to confirm the possibility of using inPROBE® in clinical practice and to determine the safety of this new technology, an “An open-label, multicenter, single-arm, safety and efficacy clinical investigation of diagnostic microprobe (inPROBE) for the assessment of HER2 receptor expression in population of women at high risk of breast cancer” was conducted ( SDS-HER-01-2018), the first part of which was recently completed.

Overall, 22 patients with diagnosed breast cancer and known HER2 expression status, determined using standard methods, i.e. immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) were included in the study, and ultimately 18 adult patients, were included in the statistical analysis. The study group included 6 patients with HER2-positive and 12 patients with HER2-negative breast cancer according to IHC/FISH assessment.

The primary endpoint was the initial determination of the range of HER2 receptor concentrations measured with inPROBE® which would correspond to the HER2 receptor status determined by a standard diagnostic method (IHC and FISH).

The ranges of HER2 receptor concentrations determined using the inPROBE® (for which the median, mean, minimum and maximum values were calculated) were compared with the HER2-positive and HER2-negative status determined using standard methods. There was a clear numerical trend towards higher values in the HER2-positive group compared to the HER2-negative group, despite the small size of the entire study population (which is typical for early-phase studies) and the larger number of patients with HER2-negative cancer. For the minimum values of the concentration ranges determined using the inPROBE®, statistical significance was obtained (Wilcoxon rank sum test; p=0.041). These observations were confirmed in an analysis using linear mixed models for repeated measures.

When analyzing the obtained results, the influence of small overall sample size and individual subgroups should be highlighted. Moreover, according the state of the art, it could be expected, that the group of HER2-negative patients probably accounted for a heterogeneous population, which also included patients with HER2-low expression. It can therefore be assumed that the inPROBE® technology enabled the detection of a certain biological feature of breast cancer, which was subsequently confirmed in large, international studies [2, 4]. For this reason, in the second part of the study, appropriate modifications will be introduced to the protocol, enabling a more precise assessment of IHC staining and adapting HER2 expression determinations using inPROBE® probe to the current HER2 expression classification.

The secondary endpoint was to compare the correlation of HER2 concentrations detected with one inPROBE® microprobe located in the tumor and a second one in the immediate tumor vicinity in HER2-positive patients. Although this endpoint was not achieved, probably due to the small number of patients with HER2-positive tumors (n=6), a statistically significant correlation was demonstrated in the concentrations of HER2 receptors detected using inPROBE® in the tumor and in the immediate tumor vicinity for the entire study population (HER2-positive and HER2-negative patients) (p=0.046).

In part I of the clinical trial the safety of the procedure was also assessed. During the diagnostic examination, no defects, damages, failures or cracks of inPROBE® were found. There were also no safety events related to the device itself and no adverse events was reported in study patients.
The results of I part of this study in breast cancer patients justify the initiation of further research projects. These will include other cancers expressing HER2, assessing levels of proteins associated with viral infections, and examining other types of biological material such as tissues sampled during biopsy (ex vivo) and body fluids.

The data collected so far indicate that inPROBE® technological platform is a multipotent, effective and safe method for quantitative determination of various proteins in biological material. It also seems that it may find wider application not only in medicine, where it can also be used to develop drugs and determine their pharmacokinetics, but also in other areas of science benefiting from the progress of molecular biology and genetics, such as agriculture, veterinary medicine, forensics or food and chemical industry.

1. Iqbal Ni, Iqbal Na. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int 2014; 2014: 852748.
2. Zhang H, Peng Y. Current Biological, Pathological and Clinical Landscape of HER2-Low Breast Cancer. Cancers 2023, 15, 126.
3. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2 [access: 07/04/2024]
4. Tarantino P, Hamilton E, Tolaney SM, et al. HER2-Low Breast Cancer: Pathological and Clinical Landscape. J Clin Oncol 2020; 38(17): 1951.


EIB to support SDS Optic with EUR 10 million funding for inPROBE®

EIB to support SDS Optic with EUR 10 million funding for inPROBE® novel biosensing platform technology scale-up research and development.

October 2, 2023. Lublin-based Polish company SDS Optic Inc., publicly listed at Warsaw Stock Exchange (NC:SDS), concluded EUR 10 million venture debt finance agreement with the European Investment Bank (EIB) under the InvestEU Fund for R&D project related to development and commercialization of its diagnostic and monitoring cutting-edge photonic biosensing inPROBE® platform technology.

SDS Optic Inc. discovers, develops, produces, and commercializes unique diagnostics and monitoring devices, with focus on assisting healthcare with faster, less painful diagnostics and supports targeted treatment procedures. The company merges molecular biology, advanced photonic technologies, immunochemistry, and biomedical engineering, creating first ever single cell resolution immunoassay for breast cancer real-time diagnostics, the inPROBE® HER2 breast cancer detection device.

Our vision is to develop innovative cancer diagnostics & monitoring technologies that will help increase the cancer survival rate by 30% by 2030. We strive to achieve that by creating and implementing real-time, in vivo and numerically based photonic technologies. There is no doubt, that the European Investment Bank financial support will significantly accelerate our development and allow us to new scale-up applications to the market much faster than we assumed. This is another proof of trust we are getting from the global, renowned Institution, after very restrict verification and acceptance of our scientific data and solutions” – said Marcin Staniszewski, SDS Optic CEO

Thus, SDS Optic joined the elite group of innovative Polish companies, that cooperate with the European Institution, boosting the development and commercialization processes of unique and groundbreaking products in the field of biotechnology and medical innovation.

Vice-President of the EIB, prof. Teresa Czerwińska said: „Supporting research and innovation is one of the priorities of the European Investment Bank and we are pleased to start co-operation with SDS Optic, an ambitious Polish company specializing in the development of innovative medical diagnostic devices. EIB financing will enable the company to continue its dynamic growth and develop new technologies that will speed up diagnostic processes for the wider social benefit.

EIB will providee the SDS Optic with venture debt financing in the amount of up to EUR 10 million (over PLN 45 million). Financing will be paid out in three tranches, after accomplishment of the well-defined milestones. One of the additional conditions for each tranche will be the issuance by the SDS Optic to EIB of subscription warrants covering up to 8.5% of the fully issued current share and conditional capital, registered on a day of signing the finance contract.

European Investment Bank supports only to the most trustworthy and groundbreaking companies from Europe. The selection, negotiations, due diligence, and closing processes were very challenging. That proves our abilities to undertake on challenging negotiations with leading global leading institutions, conduct demanding legal and tech due diligence and bring a transaction to a successful close. That also proves our technology, business model, financials and commercials were vetted by one of the most demanding institutions. We are very proud of becoming one of the companies with EIB trust and support. On behalf of our team, I am more than happy to announce this news, especially because this is another example of SDS Optic’s ability to develop its projects while diversifying of different funding sources. SDS Optic is ready to move forward and start the implementation of our execution plan we have set for the upcoming years” – said Mateusz Sagan, SDS Optic SVP and COO

The additional guarantee agreement was signed by the European Investment Bank and SDS Optic’s daughter company FiBioMed as the original guarantor. Hence, SDS Optic will maintain all financial flows between the company and the related entity FiBioMed, ensuring stable development of a new application area from SDS Optic pipeline. FiBioMed was established to use the results of studies on the diagnostic possibilities of inPROBE® platform technology in the area of infectious diseases diagnostics.

Under the Agreement, the EIB will support SDS Optic’s investment objectives such as:
– R&D personnel and market access activities,
– further research and development of the SDS Optic’s related entities, incl. ongoing HER2 breast cancer diagnostics application clinical trials,
– new applications scale-up and development,
– covering the costs related to pre-clinical studies of new inPROBE® applications,
– clinical trials of new inPROBE® applications,
– expenses related to regulatory approvals,
– internal research and development of new applications,
– expenses related to the intellectual property protection,
– development of the SDS Optic’s infrastructure and purchase of modern research equipment for the R&D center, including machines and devices for the new semi-industrial pilot production of photonic parts of inPROBE® biosensors.

SDS Optic has already accomplished several milestones for the first payment. The company has received ISO 13485 certification by notified body TÜV NORD, gathered EUR 1 million found from equity injection and completed 1 part of clinical trials for HER2 Breast Cancer microprobes.

This cooperation will not only be beneficial for SDS Optic or the EIB but, what’s more important, it will remarkably affect the future Patients’ diagnostics pathway and will increase treatment efficiency. The Project has great potential to improve the quality of life of Patients around the world, providing them with faster, less painful, and less false test results, and thus a better chances of “increasing cancer survival rate by 30% by 2023”.

More about SDS Optic: www.sdsoptic.com
More about inPROBE® technology: www.inprobe.com
Everything about the European Investment Bank: https://www.eib.org/en/

EIB press release: https://www.eib.org/en/press/all/2023-358-investeu-poland-eib-supports-sds-optic-in-scaling-up-its-cancer-detection-technology


Background information

The EIB Group is the EU’s long-term financing institution, owned by its member states. It comprises of the European Investment Bank (EIB) and the European Investment Fund (EIF). The EIB Group finances investments that contribute to EU policy goals, including social and territorial cohesion, and the just transition to climate neutrality.

The InvestEU programme provides the European Union with crucial long-term funding by leveraging substantial private and public funds in support of a sustainable recovery. It also helps mobilise private investments for the European Union’s policy priorities, such as the European Green Deal and the digital transition. The InvestEU programme brings together under one roof the multitude of EU financial instruments currently available to support investment in the European Union, making funding for investment projects in Europe simpler, more efficient and more flexible. The programme consists of three components: the InvestEU Fund, the InvestEU Advisory Hub and the InvestEU Portal. The InvestEU Fund is implemented through financial partners that will invest in projects using the EU budget guarantee of €26.2 billion. The entire budget guarantee will back the investment projects of the implementing partners, increase their risk-bearing capacity and thus mobilise at least €372 billion in additional investment.

SDS Optic Inc. discover, develop, produce and commercialize unique diagnostics and monitoring tools on a global scale. The company merges vast medical knowledge with technical skills to create disruptive technologies that can revolutionize global healthcare. They are developing life-saving innovations which can help medical staff in real-time diagnosis. Company concentrates on assisting healthcare with faster, less painful diagnostics and supports targeted, effective treatment procedures.

inPROBE®, invented and developed by SDS Optic, is a device designed specifically to reduce cancer diagnostic time (from months to minutes), and increase precision and effects of advanced cancer treatments. Optical fiber tip, with an only 6-micron wide diameter, covered with a specific antibodies is the prime basis for InProbe technology. It can be used both in cancer diagnostics and therapies, and also in real-time drug delivery monitoring, in a natural state (in vivo), thus giving professionals a fast and efficient method they need.

Milestone: Launch of the inPROBE production line

The inaugural launch of the inPROBE production line is already behind us! SDS Optic S.A. will celebrate the first anniversary of their premiere on NewConnect. Right before this event we will be pleased to announce the next milestone on the way to implementing a pilot production of optoelectronic components for the optical biosensors used in inPROBE® microprobes.

Our Company has received, installed, set up and inspected the efficiency of the devices and machines for the pilot production line, and then carried out a complete commissioning with the help of specialised services provided by the manufacturers, in compliance with the established design and structural specifications.

SDS Optic clean room window4 SDS Optic clean room window3 SDS Optic clean room window2













Marcin Staniszewski - Prezes Zarządu– The next process will involve calibration, setting up and optimising production processes, aimed at a complete transfer of the technology from the laboratory to a semi-industrial production level. At the same time, we will be working on the technical documentation and certification of the complete production process of optoelectronic (photonic) components for the optical biosensors used on our inPROBE® technological platform. We also plan further development of the R&D team in the photonic area. We are going to undertake these tasks by the end of the third quarter of 2023. We have already secured the possibility of independent production of biological, chemical and bioengineering components, and the milestone we have just reached is the next step towards production independence on a semi-industrial scale, which we believe will bring added value to the technology commercialisation process, and when searching for business partners – says Marcin Staniszewski, CEO at SDS Optic S.A. and Chief Technology Officer coordinating the pilot production line.


Since the premiere on NewConnect in March 2022, SDS Optic have achieved a series of milestones. We will keep the market updated on the plethora of operations connected with the development of the inPROBE® technology.

The key events that are worth noting are:
– launch of specialised clean rooms in the company’s registered office at the ECOTECH-Complex in Lublin, ESPI Report 1/2022
– commencement of the first phase of clinical trials (safety studies) on the optical microprobe to confirm its use in diagnosing patients with HER2-positive and HER2-negative breast cancer, ESPI Report 13/2022
– appointing a Scientific Advisory Board composed of outstanding specialists with international experience, ESPI Report 17/2022
– end of the investment stage of the pilot production of optoelectronic components for the optical biosensors used in inPROBE® microprobes, ESPI Report 25/2022
– registration of a subsidiary company in the USA, as an official step towards reaching the next milestone of opening of an R&D centre in that market, ESPI Report 28/202
signing a contract for advising in finding a strategic partner interested in the commercialisation of the inPROBE® technological platform with the renown Clairfield International from New York, ESPI Report 1/2023

SDS Optic #news: Clairfield International as a transaction advisor for SDS Optic S.A. in the commercialisation of inPROBE®

SDS Optic S.A. is a company listed on NewConnect that develops their own technological platform inPROBE® for diagnosing cancers and infectious diseases in real time, and for monitoring health status. On 3 January 2023 the company signed a contract for advising in finding a strategic partner interested in commercialisation of the platform with the renown Clairfield International from New York, who will be responsible for identifying and selecting potential purchasers and for attracting their attention to the platform.

The partner’s operations will involve market research of and contact with global companies from the healthcare sector, with a particular focus on big pharma and big medtech. At a later stage, Clairfield will support the Company in the organisation of the due diligence process, shaping the negotiation strategy and final talks associated with drawing up a contract for the commercialisation of inPROBE®. The contract provides for the option to scale into other applications, license and purchases of selected applications of the technology.

Crosby OHare Założyciel i Partner Zarządzający w Clairfield International– We are very glad that we have the opportunity to advise SDS Optic, the award-winning company developing inPROBE®, a breakthrough diagnostic technology used in oncology and medicine. SDS Optic have achieved a plethora of milestones towards commercialisation, and their technology has breakthrough potential both in oncological diagnostics and in innovative medication, thanks mainly to their significantly higher sensitivity and effectiveness. We are very happy that we will be able to support the SDS Optic team in attracting the interest of potential partners and in building the commercial success of inPROBE® – says Crosby O’Hare, Founder and Managing Partner at Clairfield International.

The co-operation is scheduled to commence on 1 February 2023, in 3 stages:

  • development of a detailed strategy and action plan
  • preparation of presentation materials, a list potential partners, and a contact strategy
  • marketing and promotion of the project among potential commercial partners.

Mateusz Sagan Dyrektor Operacyjny i ds Rozwoju BiznesuClairfield International is a leading global transaction advisor. Thanks to their experience in medical technologies and biotechnology, they bring to our commercialisation process of inPROBE® extensive expertise and relationship with the leading companies in the world. We have been working extensively with the Clairfield International team for over 3 years now, so we are familiar with each other. We have had many productive meetings, both at the Company’s registered office and in New York, which have allowed Clairfield to get to know our breakthrough technology and choose the best time to start a large-scale cooperation. We are extremely happy that we have got to a place where we can clearly say that this is the right moment, and to begin active endeavours in finding partners for commercialisation. Clairfield brings contacts, knowledge and experience in transactions in medical and pharmaceutical technologies, and their recent partnership contract with Yamada Consulting Group, a leading company providing transaction advisory services in Japan and Southeast Asia, accelerates our targets of finding a partner across potentially many markets. It should be emphasised that the best global concerns dealing with endoscopic technologies have their registered offices in Asia. We declare our full readiness and openness to facilitate making this process as smooth as possible, and achieve common success in the commercialisation of inPROBE® – says Mateusz Sagan, CEO at SDS Optic S.A.

Edward Grey Dyrektor Zarządzający w ClairfieldWe can be sure that we have acquired extensive knowledge and understanding of inPROBE®, its stage of development, and can provide timely support for the most attractive transactions for SDS Optic and its shareholders. We appreciate the regular contact and communication we have maintained with SDS Optic over the past 3 years. We are confident that Clairfield is going to be a great advisor and advocate of all these years of hard work achieved by SDS Optic in getting to this important moment. We are proud that we have become a part of this team – says Edward Grey, Managing Director at Clairfield.


Logo_ClairfieldClairfield International is a global company providing corporate finance services, mainly fusions and takeovers, for international corporations and financial investors. The advisors focus on the mid-market, executing transactions of up to EUR 500 million (enterprise value). The company is among the top twenty financial advisors in the world and ranks 7th in healthcare transactions, acc. to the Global Mid-Market M&A Review list prepared by Refinitiv. Clairfield employs about 300 specialists in 25 countries, and over the last 5 years has taken part in over 700 transactions with a total of EUR 25 billion. In November 2022, Clairfield signed a strategic contract with Yamada Consulting Group, one of the largest and most famous transaction advisory companies in Japan and Southeast Asia. As part of their transactions in the healthcare sector, Clairfield is developing their competencies around biotechnology, pharmacy, medical devices, supplies, hospitals, clinics, as well as laboratory services and equipment. As part of their biotechnological projects and medical devices, Clairfield has special experience in diagnostics and molecular therapeutics.

SDS Optic #news: clinical trials and pilot production run of the inPROBE microprobe

Since our last entry we witnessed several really intense months. Our team was working hard on the implementation of Phase I clinical trials, which was launched in summer. Engineers are taken up by the pilot production of the inPROBE microprobe. QA specialists ensure the correct implementation of the ISO system and MDR requirements. In parallel, the company also develops an international network of contacts and consistently cares about maintaining the interest in the inPROBE in Poland and worldwide. Read the complete article to find out what else was (and is) going on in our Company.

Clinical Trials

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-

  • observation of adverse events
  • determination of the feasibility of the inPROBE test
  • initial correlation of measurement result and receptor status

Badania Kliniczne - siv I faza

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.

Badania Kliniczne sondy inPROBE

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

  • confirmation of safety on a larger number of patients
  • determination of the effectiveness of the diagnostic method

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.

Pilot production

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.

Clean Room SDS Optic - pilotażowa produkcja mikrosondy

– 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.

Appointment of the Scientific Council

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:

  • Magdalena Staniszewska PhD, DSc
  • Prof. Wojciech Polkowski MD, PhD, DSc
  • Avi Dukler PhD
  • Prof. Andrius Kazlauskas PhD
  • Arun Balakumaran MD, PhD


Scientific Advisory Board

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/

Patents granted

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.

Investor webinar “ACTIVITIES and PLANS”

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

Presentation of the Company at the Connect&ScaleUp event

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.

Connect and Scale Up 2022Photo: Chief Operations and Business Development Officer Mateusz Sagan during a live broadcast

The Best Annual Report 2021 distinction at the NewConnect market

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.

The Best Annual Report GPW 2022Photo: In the middle: Karol Maryniowski with the Best Annual Report 2021 award for SDS Optic S.A.

Conferences and industry events

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 2022

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.

Karol Maryniowski i Mateusz sagan na targach MEDICA 2022 Karol Maryniowski i Marzena Strok-Sadło na targach MEDICA 2022 Mateusz Sagan na stoisku SDS Optic S.A. na targach MEDICA 2022

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

EIC Multi-Corporate Day

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.

EIC MultiCorporate Day Fresenius Medtronic

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.

Biotech industry investor conference

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

Presentation of scientific results at the EAW 2022 symposium in Barcelona

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.

SDS Optic at ENA BacelonaPhoto: 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/

SDS Optic S.A. will once again represent the European Union at the Dubai Arab Health Fair

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.

SDS Optic at Arab Health 2023 - OTF preparatory workshop

EIC OTF 2.0 Training Workshop SDS Optic

Our stand:

Building: Za’abeel Hall 6
Stand: Z6.C20
Date: 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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Media about SDS Optic

ISBnews [02.12.2022]

Forbes [24.11.2022]

Stowarzyszenie Inwestorów Indywidualnych [16.11.2022] Magazyn Akcjonariusz (3/2022)

evertiq.pl [15.11.2022]

tek.info.pl [15.11.2022]

Investing.com [14.11.2022]

Forbes [23.10.2022]

Navigator Capital Group [17.10.2022]

Parkiet [16.10.2022]

IRIP [13.10.2022]


My Company POLSKA [30.09.2022]

My Company POLSKA [22.09.2022]

Biznes Radar [25.08.2022]

Bankier [25.08.2022]

Forbes [28.07.2022]

Stockwatch [20.07.2022]

Nauka w Polsce [06.07.2022]


Poster: HER2 distribution in tumor and blood of mice with xenograft human cancer

Aleksandra Antos1, Marta Świtalska2, Agnieszka Topolska-Woś1, Marcin Woś1, Agata Mitura1, Magdalena Staniszewska1, 3

1SDS Optic S.A., Głęboka 39, 20-612 Lublin 2Department of Experimental Oncology, Ludwik Hirszfeld Institute of Immunology and Experimental Therapy, Polish Academy of Sciences, Weigla 12, 53-114, Wrocław, Poland 3Faculty of Science and Health, The John Paul II Catholic University of Lublin, Konstantynów 1J, 20-708 Lublin, Poland

Correspondance: mstaniszewska@sdsoptic.pl

Presented at 34’th EORTC-NCI-AACR, Barcelona 2022
P. session PP02 – Animal Models, p no 36


Arun Balakumaran, MD PhD – SAB Member

Dr Arun Balakumaran - Członek Rady Naukowej

Arun Balakumaran, MD PhD

Oncologist, Scientist, SAB Members

Oncologist, Scientist, and Biotechnology Executive. He is an MD, Ph.D., Board Certified in Hematology and Medical Oncology with a Master’s degree in Health Care Management at Harvard University.

He has a long-standing interest in cell and gene therapy. His experience ranges from lab research, phase 1 -3 clinical development, including breakthrough designations and successful registration experiences, through medical affairs and business development. Arun began his biotech/pharma career at Amgen (NASDAQ: AMGN) where he was responsible for clinical development as Medical Director and North American Medical Led.

Prior to joining Amgen, he spent 6 years with the NIH, where he was the Medical Lead for Bone Marrow Stromal Cells (MSC) Transplant Center. He joined Allogene (NASDAQ: ALLO) in the fall of 2018 and is currently the Head of Clinical Development running clinical programs in allogeneic CAR-Ts targeting CD19, BCMA, and CD70.

Before Allogene, Arun was Executive Director and Product Development Lead, Hematological Malignancies at Merck (NYSE: MRK), driving the approval of Pembrolizumab in lymphomas. Additionally, he is on the scientific advisory board of diagnostic companies.

Prof. Andrius Kazlauskas, PhD – SAB Member

Dr Andrius Kazlauskas - Członek Rady Naukowej

Prof. Andrius Kazlauskas, PhD

Molecular Biologist, Chemist, SAB Member

Andrius Kazlauskas, PhD is a vascular biologist seeking to understand the pathogenesis of blinding eye diseases. He received his PhD in Chemistry from Cleveland State University and complete his postdoc at the Fred Hutchinson Cancer Research Center in Seattle, where he investigated signaling pathways by which receptor tyrosine kinase initiate cell proliferation in cases of cancer.

As a faculty member at the University of Colorado and then Harvard Medical School, Dr. Kazlauskas interrogated signaling events underlying pathogenesis of cancer and retinal disorders such as proliferative diabetic retinopathy (PDR), age-related macular degeneration, and proliferative vitreoretinopathy.

Dr. Kazlauskas obtained first-hand experience and insight into translational research while working in the Ophthalmology Department of F. Hoffman-La Roche in Basel, Switzerland (SMI: RO). He returned to academia to investigate the pathogenesis of diabetic retinopathy. Currently serves as Professor at University of Illinois Chicago.

Avi Dukler, PhD – SAB Member

Avi Dukler - SAB Member

Avi Dukler, PhD

Biotechnologist, Business Leader, SAB Member

Dr. Dukler is a healthcare business leader who focuses on new applications for digital health, personalized medicine, and molecular diagnostics. He received his PhD in biotechnology and B.Sc. in Life Sciences from the Tel Aviv University in Israel.

During his 23+ years in the diagnostics industry, Dr. Dukler co-founded Kepler Diagnostics, Inc, Fantestico Inc, and Glycominds Ltd., where he commercialized innovative digital health and clinical diagnostics products.

Dr. Dukler led Glycominds IPO in 2011 at TASE and structured a strategic deal with LabCorp (NYSE: LH). Dr. Dukler is an inventor and author of multiple patents and scientific publications, completed several transactions including M&A, asset sales, IP licenses, private and public fundraising.