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. [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:
More about inPROBE® technology:
Everything about the European Investment Bank:

EIB press release:


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

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:

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:

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:

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

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) [15.11.2022] [15.11.2022] [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],sds-optic-rozpoczela-faze-bezpieczenstwa-badan-klinicznych-mikrosondy-inprobe

Bankier [25.08.2022]

Forbes [28.07.2022]

Stockwatch [20.07.2022],akcje,298818

Nauka w Polsce [06.07.2022]


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

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.

Marcin Staniszewski i Wojciech Murdzek - Polski Produkt Przyszlosci2 Marcin Staniszewski i Wojciech Murdzek - Polski Produkt Przyszlosci3

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.

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

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:

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:

Mikrosonda swiatlowodowa inPROBE - badania kliniczne

Consent to start clinical trials and registration with the 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 database. ( 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:

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.

inPROBE na targach BIO2022 w San Diego

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.

SDS Optic na ASCO2022_1

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.

Summary of 2021 at SDS Optic Inc.
and the announcement of the next milestones in 2022

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.

Marcin Staniszewski - zdjęcieIn 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 centresays 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.

Summary of 2021 at SDS Optic S.A. and the announcement of milestones for 2022

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.

Mateusz Sagan - zdjęcieOur 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 yearssays 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.

Magdalena Staniszewska_zdjecie do artykuluWe 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 possibleexplains 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!

SDS Optic #news: next milestones and inPROBE development

The first quarter of 2022 is already behind us. As we announced during our debut on the NewConnect market, this year is rich in many important events. We are consistently pursuing all of the Company’s objectives and are pleased to announce the achievement of the subsequent milestones of the inPROBE project – an optical fibre micoprobe for the diagnosis of HER2 positive breast cancer. What exactly happened in our Company?

Achieving the milestone in the field of implementation of the pilot production of fibre optic biosensors

Shortly after the debut of SDS Optic on the NewConnect market, in the ESPI system we published a current report on the completion of the first stage of milestone realisation in the field of implementation of pilot production of optoelectronic parts of optical fiber biosensors for use in inPROBE microprobes.

This stage consisted of: the design process, ordering and purchasing of dedicated personalized fixed assets (production equipment and machines) worth PLN 2.4 million in total. To achieve this goal, our Company obtained funds from the issue of D-series shares and the purchase of which is indicated in the Information Document, as one of the key objectives to be achieved after the Company’s shares were listed at the NewConnect market.

This constitutes a huge step towards achieving manufacturing independence in the production and preparation of the optoelectronic (photonic) parts of optical fibre biosensor (microprobe).

The creation of a professional production line together with the expansion of the R&D team in the area of photonics will enable us to manufacture up to 50 thousand proprietary biosensors per year.

As part of the implementation of the next stages, we plan to:
– start-up and calibrate production processes,
– hire new members for our R&D team,
– carry out the process of validation and certification of the planned production.
– elaborate certified process and production documentation.

Full ESPI report (PL):

SDS Optic Inc. as one of the 20 most innovative companies in the European Union will represent the European Pavilion at the BIO 2022 conference in San Diego, USA

At the end of March, we received information that our Company was included in the 20 most technologically advanced companies in the European Union. SDS Optic Inc. and the rest of the selected companies will represent the EU in a special pavilion at the BIO 2022, the largest event of this type in the USA. The conference brings together the most important players in the biotechnology and pharmaceutical industries.

SDS Optic na BIO2022 w San Diego

From 13 to 16 June, during the conference, we plan an intensive exchange of knowledge with specialists from the BioTech and Pharma industries. This time will definitely also be filled by networking with potential future partners. We believe that our technology can significantly improve the quality of services and products in many sectors related to medicine. We want to strongly promote our inPROBE technology in terms of drug delivery monitoring in real time. The BIO 2022 event is a great opportunity to do so. The conference abounds in numerous interesting lectures and lectures that not only allow us to keep track of the latest information from the world of medicine and pharmacology, but also significantly increase our levels of creativity.

The first investor chat at SDS Optic Inc.

On 12 April, the first investor chat of SDS Optic Inc. took place. Our Leadership Team talked about the most important and interesting events in the life of the Company.

The Company was represented by:
🔹Marcin Staniszewski, Chairman of the Board, Founder and Shareholder
🔹Magdalena Staniszewska, Director of Research and Development, Founder and Shareholder
🔹Mateusz Sagan, Chief Operating and Business Development Officer and Shareholder.

Investors could first-hand receive up-to-date information about our inPROBE fibre microprobe for less-invasive diagnosis of cancer, infectious and fungal diseases, and real-time drug delivery monitoring.

The webinar present:
🔹What is our development strategy
🔹What is the process of cancer diagnosis today and…
🔹 how the inPROBE microprobe will change that process in the future
🔹What business model related to commercialization is implemented by the Company
🔹What targets and plans have been adopted at SDS Optic for the next 12 months

During the webinar we also:
🔹Present the principles of inPROBE technology
🔹Present our industrial property rights policy
🔹Present the Company’s current technical infrastructure
🔹Tell you how the development process of the production facilities will look like

Watch the webinar recording ⤵️

🖥️ Download the full version of the investor presentation!



Signing an annex to the grant agreement under the SME Instrument Horizon2020

Since our debut on the NewConnect market, we also signed an annex to the agreement with the European Commission regarding the Company’s acquisition of a grant in the amount of €3,985,000 from the SME Instrument Horizon2020 programme. As part of this co-financing, development works are carried out, as well as clinical research and certification of the HER2+ breast cancer diagnostic microprobe device, developed under the inPROBE brand, are financed.

The Commission thus confirmed the legitimacy of using the remaining part of the subsidy, originally granted in 2017. The remaining amount of €985,000 is still available to SDS Optic Inc. These resources will be used to carry out the clinical research undertaken, to finance the remuneration of the R&D team and the administration and management, as well as the work in the field of certification and communication and commercialisation of inPROBE technology.

The annex was concluded in order to coordinate the schedule of the project implemented under the SME Instrument Horizon2020 programme with the work schedule of SDS Optic Inc.

Full ESPI report (PL):

SDS Optic won the Innovation radar Prize 2020 for the best innovation created by Women.

SDS Optic has been granted “Women-led Innovation” award at Innovation Radar Prize 2020, a prestigious achievement announced yearly by the European Commission. The  competition recognizes the best European innovation and its founder.

The award has been granted for inPROBE – a photonics-based microprobe for a quick and precise breast cancer diagnostic.

Breast cancer is one of the most common form of cancers. Every year more than 1,7mln women are diagnosed globally, with more than half a million deaths. A clear opportunity and chance for these patients is fast and reliable diagnosis,  that today is fully based on tissue biopsy and the time consuming histopathology testing.

We can change this status quo with the innovation created by Magdalena Staniszewska, PhD DSc, Co-Founder & CSO of SDS Optic Inc. The inPROBE is a disruptive diagnostics device, offering quick and precise targeted tumor markers assessment.

SDS Optic has received almost €4mln European Commission funding from the SME Instrument Horizon2020 program to run clinical trials and certification of the inPROBE.

European Healthtech Investment Forum 2020

Great news for us that we’ve been selected to present inPROBE technology at the Tech Tour Healthtech 2020 in Helsinki. The fourth edition of the European Healthtech Investment Forum 2020 will take place on 10-11 March 2020 in Helsinki, bringing together leading investors from Europe and some of the most promising Healthtech entrepreneurs of Europe and Finland. The event will concentrate on the following subsectors: Digital Health, Medical Devices & Diagnostics, Personalized Health. 40 of the best European early stage Healthtech companies will be selected to present at the event by the investors from our selection committee. The applying companies will be assessed on the basis of their business potential, product and technology merit, competitive position, investment or partnering interest, team experience and project quality. The event will once again allow entrepreneurs to meet and present themselves to active international investors and corporations seeking investment and partnerships. SDS Optic will be represent by our Chief Business Officer Mateusz Sagan.