Frequently asked questions

The decision in this matter is up to you. It is certainly worth taking an interest in our activities and the technology we are developing, which is innovative and unique on a global scale. We are building a modern company, and our interdisciplinary team of scientists and specialists works every day to ensure the success of the inPROBE^® technology.

The situation on the capital markets and investor sentiment toward individual sectors have a significant impact on stock prices of companies worldwide.

In Poland, the biotechnology sector is still developing. It is a unique area that combines innovative fields of science with business. Med-Tech and Bio-Tech projects require patience and involve significant risk, but in the long term, they can yield attractive profits.

We do not comment on the share price movements of SDS Optic S.A. Regardless of the current stock market situation, our priority is to execute an optimized strategy that is continuously adjusted to the development of our product and market changes.

We do not rule out raising additional capital, as it is a natural stage in the development of any biotechnology company at a stage like ours. The company has communicated the possibility of capital raises since it first entered the stock exchange.

No decisions have been made regarding the specific date of the next capital raise. Any changes in this regard will be communicated by the Company through official information channels for listed companies, in the form of ESPI and EBI reports.

The development of technology that combines biotechnology, optoelectronics, and advanced medical technologies involves multiple stages and risks associated with the outcomes of this work. One of the factors influencing the timeline is the work of our multidisciplinary team. Other important factors include regulations and oversight by external institutions responsible for clinical trials, as well as the market situation, which we continuously monitor.

The company analyzes feedback at every stage of the project, adjusting its solutions and development strategy accordingly. Thanks to a flexible operating model, we can respond quickly to changes and deliver high-value solutions for end users, potential buyers, and our shareholders.

The inPROBE^® device consists of a detector, proprietary software, and a disposable probe in the form of a fiber-optic biosensor. Ultimately, the technology is intended to enable measurements both in vivo (within the patient's body) and in vitro (outside the patient's body).

The inPROBE^® technology is a new approach to assessing the expression of biomarkers such as the HER2 receptor. From the very beginning, our goal has been to develop a safe and validated technology that meets both clinical and market needs.

The technology is based on a patented method of fiber optic hermetization, combining photonics with immunochemistry. The detector sends a beam of light into the optical fiber, and an algorithm compares the wavelength before and after the biomarker molecules are "captured." Based on this comparison, the system assesses the expression level of the target molecule and converts the data into a medical result.

The goal of the developed technology is to support precision medicine and provide diagnostic results in real time. inPROBE^® has the potential to complement traditional biopsy and immunohistochemistry by enabling rapid determination of diagnostic biomarker levels.

We are currently focusing on HER2 diagnostics in breast cancer, but inPROBE^® potentially has a broader range of applications.

Our goal is to develop inPROBE^® toward scalable technology applicable to other diagnostic and therapeutic areas. Laboratory and preclinical study results indicate the potential for detecting other molecular targets, including infectious diseases and monitoring drug delivery.

Creating medical devices requires regular optimization of internal processes and compliance with regulatory standards. SDS Optic S.A. holds the ISO EN 13485 certification, which is dedicated to medical device manufacturers. As part of the development of inPROBE^®, we are also carrying out the necessary steps for final MDR certification and obtaining the CE mark.

The list of scientific publications by the SDS Optic team is available for download below.

Biopsy and immunohistochemistry will remain the fundamental diagnostic methods for a long time. The inPROBE^® technology is not intended to replace them, but rather to complement the diagnostic pathway with a new tool that will allow determination of cancer biomarker expression levels in a shorter time.

The inPROBE^® fiber optic micrometric probe is a globally unique technology that combines photonics with molecular biology and medical engineering. Currently, there is no commercial solution on the market that enables real-time determination of cancer biomarker concentrations in a patient's body.

The main market of the Warsaw Stock Exchange is a natural direction of development for SDS Optic S.A. Currently, we are listed on the ASO NewConnect, which allows for gradual preparation of organizational structures. We are also considering a "dual-listing" on one of the foreign stock exchanges to increase the availability of shares for investors.

More information about the Company can be found on our website and on the following platforms: LinkedIn, Facebook and YouTube.

Acting in the best interests of the Company, the Management Board granted warrants to key employees, including Professor Magdalena Staniszewska, pursuant to Section 5(2) of the Incentive Program Rules. This provision states that: "The Management Board, and with respect to members of the Management Board and the Supervisory Board, the Supervisory Board, following the procedure set out in Section 5(3) below, may, where justified by the Company's interests, grant an Eligible Person the right to acquire Warrants even if the relevant Performance Targets have not been achieved or the Eligible Person has not satisfied the criteria specified in these Rules.".

Given the limited availability of qualified specialists, these measures were essential to maintaining the Company's competitiveness as an employer and encouraging employees to continue their employment with the Company. They also helped reduce the risk of employees leaving for organizations offering more attractive benefits, including higher financial compensation.

The Company has developed the key components of its regulatory strategy, forming the foundation for a planned Pre-Submission (Pre-Sub) request to the FDA. The submission timeline is dependent on the successful completion of discussions with a potential partner, whose participation may impact the scope and design of the planned clinical development program. Following the fulfillment of this condition, the Company intends to submit a Pre-Sub request to the FDA to seek the Agency’s feedback and guidance on the proposed regulatory strategy.

The agreements entered into on July 24 and September 16, 2025, have been completed and settled at 100%. As a result, the implementation and settlement of the long-term agreement with the diagnostic partner from November 25, 2025, have reached a level of 70%. The settlement of the collaboration with the bio pharmaceutical partner is currently at its final stage.

The "Corporate Presentation – June 2026" was prepared to support ongoing discussions with prospective strategic partners, including organizations in the United States and the European Union. The information contained in the presentation will be updated as needed. The Company intends to organize an investor meeting or webinar. The preferred timing for this event would be after the potential execution of a partnership agreement. Once the date, format, and other details have been finalized, the Company will provide further information.

The Company continuously evaluates available financing options, including raising capital from financial investors and securing an additional tranche of financing from the European Investment Bank (EIB). As part of these discussions, the Company also takes into account the varying preferences of potential investors regarding the structure of the financing.