The decision is yours. It is absolutely worth becoming familiar with our business activities. The inPROBE fibre optic microprobe for diagnosing HER2-positive biomarkers is innovative and unique on a global scale. We are a modern company, and our interdisciplinary team of scientists and specialists every day proves that the inPROBE technology has a future ahead.

On our website and in social media channels we focus on transparent communication to allow each visitor to form their own opinion about us.

Follow our social media to stay up to date with the current events:

1) Twitter: www.twitter.com/SDS_Optic (@SDS_Optic)
2) Linkedin: www.linkedin.com/company/sds-optic/ (@SDS Optic Inc.)
3) Facebook: www.facebook.com/sdsoptic/ (@sdsoptic)
4) YouTube SDS Optic: https://www.youtube.com/@sdsoptic

5) Twitter inPROBE: https://twitter.com/inPROBE_ (@OncoMicroprobe)
6) Facebook inPROBE: https://www.facebook.com/inprobemedtech (@inprobemedtech)

The pandemic, rising inflation and events beyond our eastern border are unquestionably leaving their mark on the economic situation and share prices worldwide.

In Poland, the biotechnological sector is constantly on the rise, closely combining innovative fields of science with business. Med-Tech and Bio-Tech projects require patience, but offer attractive profits in the long run. Our observations show that Polish investors are aware of this fact and are more willing to invest in biotechnological companies.

We do not comment on the movements in share prices of SDS Optic S.A. Regardless of the stock market situation, our priority is to implement our strategy and achieve new milestones in order to ultimately deliver a validated and safe product. In this way, we fulfil the promises given to patients, doctors and shareholders.

To this day, we had invested over PLN 54 M and raised almost PLN 60 M. These funds come from private investors (e.g. seed funding and venture capital) and public subsidies (e.g. the highest subsidy in the history of Polish companies from the SME sector of nearly EUR 4 million from the European Commission under the Horizon 2020 program).

Project development is also possible thanks to our shareholders. In June 2021, as part of the D series share issue, at the pre-IPO stage we had received PLN 11 M from private investors, e.g. renowned global investment funds. At the beginning of 2023 we conduct another public offering round and 

The last issue was in February 2023.

We do not exclude new issues as this is a natural stage in the development of all biotechnological companies. We already talked about this openly at our meetings and presentations at the pre-IPO round. Now we have secured funds for several months of business operations. We also have new tranches from the EU subsidies, which gives the prism of autonomic operations for a long time and ensures the achievement of our milestones.

The exact date of the next issue has not been arranged yet. We are now focusing primarily on the consistent achievement of our milestones and on building the Company value. Any changes in this respect will be announced in our current reports.

inPROBE is currently being developed for detecting HER2-positive biomarkers in breast cancer. The project is at the stage of clinical studies, which will take several months. At the same time, we are implementing the inPROBE commercialisation process.

The completion of R&D works is scheduled for the end of 2023/beginning of 2024, and consists of clinical studies and a comprehensive process of ISO 13485 certification and EU-MDR compliance for the European Union markets. The value of the remaining part of the investment is about PLN 5 million, and we have already secured funds for this.

The development of biotechnological projects and advanced technologies combines a plethora of components, stages and risks. The factors influencing the pace of actions are the operations of our multidisciplinary team, external institutions that supervise and regulate the process of the clinical studies, and target users of our solution (doctors and scientists).

Our priority is to deliver a safe, effective and validated product, adjusted to users’ needs. For this reason, at each stage of the project we consider all feedback and adjust our solutions on a current basis.

One example are the clinical studies interrupted by the coronavirus pandemic in 2020, when large clinical hospitals were transformed into dedicated hospitals, which totally suspended our works.

In addition, in May 2021, we adjusted the entire medical documentation to the updated Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Mandatory Disclosure Rules). This delays the commencement of the studies, yet guarantees that the commercialised technology meets the applicable requirements of the certification and validation, which significantly increases its value in the commercialisation process.

After easing the restrictions, our team was ready for action as early as the beginning of 2022. In the course of the initial pre-clinical training sessions (January-February 2022) we received valuable medical feedback, associated with additional improvements to the study. We decided to implement part of these in the manual section of the procedure, which took several additional weeks. In order to fully comply with all the regulatory requirements, we decided to submit an update form to the Office for Registration of Medicinal Products, Medical Devices and Biocides (URPL). At the end of June 2022, we received final approvals for the implementation of significant changes to our clinical study. Ultimately, the product quality, safety and functionality are of utmost importance. This step improves the technology attractiveness in the medical environment, which will translate into its value in the commercialisation process.

Thanks to the flexible form of the project development, which allows for responding to changes, we will ultimately deliver a significantly higher value, important for end users and our Shareholders.

Our business model is based on two pillars:

• our own production of the microprobe and sale of devices as part of our own semi-industrial infrastructure of the production of photonic biosensors;
• sale/licencing of selected parts of the technology (acc. to the area of interest).

We have already begun the implementation of the inPROBE commercialisation process.
We are currently developing our own production line with an annual production capacity of up to 50 thousand microprobes. The installation of the machines and the start-up of advanced production devices in dedicated rooms with controlled environment parameters (clean rooms) will have been completed by the end of 2022.

At the end of 2022/beginning of 2023, we will start development of the automated production processes. Then, we will go on to the process of certification and validation of these, which ultimately will make it easier for our potential partners to talk to us about commercialisation, and will facilitate future scaling of the technology.

The microprobe should be available immediately after receiving the certificate (following completion of the clinical studies). To the best of our current knowledge and according to our team’s estimates, the approximate date of the product launch is the end of 2023/beginning of 2024, which can change in case of unforeseen circumstances.

We are also fine-tuning technical issues connected with the second pillar of our business model, i.e. winning an M&A partner, opening a facility in the USA, and entering into relations with licensed partners within the scope of inPROBE production and international sale.

inPROBE consists of a detector and one-single probe in the form of a fibre optic biosensor. The apparatus serves for in vivo (in the patient body) measurement of concentrations of specific molecules, markers or bioactive elements, avoiding tissue collection and preparation. The test lasts several minutes and provides objective exact numeral real-time results.

This global revolution is comparable to the invention of magnetic resonance imaging.

The principles of operation of the technology are based on the patented method of optic fibre airtight sealing, which allows combining photonics with advanced molecular biology, medical engineering and immunochemistry. In this way, we are able to place a histopathological laboratory on the front face of the optical fibre.

The inPROBE technology is a breakthrough in the market of traditional in vitro diagnostics (in the laboratory). The results are rapid (within minutes). Numerical data is objective, accurate and free from “human errors”. inPROBE can supplement a traditional biopsy, giving a more exact and earlier diagnosis, as well as indicating effective treatment.

Currently, we are applying the technology in diagnosing HER2 in breast cancer, but it shows a significantly higher potential that we are going to use.

inPROBE is a scalable technological platform. In the future, it can serve for detecting other cancer biomarkers (e.g. in prostate, stomach, large intestine, lung and brain cancer), infectious diseases (e.g. coronavirus), eye diseases (e.g. wet age-related macular degeneration) and fungal diseases (e.g. sepsis – a contemporary challenge for medicine).

The inPROBE technology has a great potential in monitoring the effectiveness of medication delivery into a target place in the body, as well as in testing the efficacy of new medications and introducing these to the market.

In the future, inPROBE can deliver essential information on the distribution of medications in tissues. In this way, thoroughly examined medications can be developed and launched in a significantly more effective manner.

We are fine-tuning and implementing the production processes and internal management systems. By the end of 2022, we plan to introduce most of the certification processes and procedures, with those connected with ISO (e.g. ISO 13485). At the end of 2022/beginning of 2023, we are going to commence a test and audit by an independent external entity to evaluate the level of implementation of the necessary standards and requirements. The completion of the audit is scheduled for the second quarter of 2023.

In compliance with EU 201775 MDR, our fibre optic inPROBE microprobe has been classified as a medical device consisting of a sterile probe, and an active medical device with dedicated software.

In view of the new Regulation (EU-MDR) of May 2021, prior to the clinical studies, all necessary tests and studies confirming the safety of use of the medical device for the staff and patients were carried out.

After completing and summarising the clinical studies in 2023, the Company will assess the compliance with EU 2017/275 MDR. The audit will be carried out in cooperation with an authorised Notified Authority. The EU-MDR certificate allows CE marking on inPROBE, submitting the device and obtaining the permit for a launch from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Warsaw.

In order to obtain a certificate of compliance from the EU-MDR, a confirmation that the company has a well-functioning Quality Assurance System is required. SDS Optic S.A. is currently implementing procedures defined in the ISO EN 13485 standard dedicated for medical device manufacturers. This confirms that the manufacturer is able to deliver medical devices and related services in compliance with legal requirements, guaranteeing the declared quality and meeting customer expectations. The Company has defined the key and auxiliary corporate processes with essential system documentation.

We are conducting activities aimed at meeting the regulation of the US Food and Drug Association (FDA) under the “Pre-Submission” procedure and with support from our consultants in the United States.

SDS Optic S.A. has a defined policy for scientific publications that is inextricably linked to the Company’s industrial property rights and data privacy policy.

Below is a list of selected publications and patent rights:

The Company plans new scientific publications, coinciding with the inPROBE technology launch and following the implemented intellectual property management strategy (IP Strategy) defining the selected key components of the technology that constitute the exclusive know-how of the Company and are not subject to patent application restrictions. In our opinion, this approach increases the attractiveness of the commercialisation process for potential corporate partners.