SDS Optic S.A. has obtained positive results from the first part of the inPROBE clinical trial

SDS Optic S.A. has announced the results of Part I of an open, multi-center, single-arm clinical study on the effectiveness of the inPROBE^® microsensor in assessing HER2 receptor expression in a population of women at high risk of breast cancer, as well as its safety of use. The obtained results are consistent with SDS Optic's research hypothesis that the inPROBE^® examination procedure is safe and may be effective in complementing the breast cancer diagnostic process.

Prof Magdalena Staniszewska, KUL: "Eighteen adult patients diagnosed with breast cancer and with a known HER2 expression status, determined using standard methods—immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH)—were included in the statistical analysis. The study involved six patients with HER2-positive and twelve with HER2-negative breast cancer status. Today's positive findings are the result of excellent collaboration within an interdisciplinary research team comprising clinicians, scientists, engineers, and CRO specialists. Key factors included the team's expertise and experience in both the formal and technical preparation of the study, as well as the efficient execution of the research itself, using a new device in clinical conditions for the first time. Special thanks go to the patients, whose participation is essential for the development of breakthrough technologies."

The study conducted by SDS Optic S.A. has achieved the primary endpoint, which was the preliminary determination of HER2 receptor concentration ranges measured using inPROBE^® that correspond to the HER2 receptor status determined by traditional diagnostic standards (IHC and FISH tests). Tumor analysis using the inPROBE^® diagnostic microprobe included measuring HER2 concentration both within the tumor itself and in its immediate surroundings. SDS Optic is the first company in the world to successfully attempt to assess the molecular characteristics of a tumor (HER2 marker) directly within a patient’s body using fiber optic technology. Across the entire study population (both HER2-positive and HER2-negative patients), a statistically significant correlation was demonstrated between the average values of marker measurements obtained in the tumor and its surrounding area. A larger patient sample in the second phase of the clinical trial should allow for the confirmation of these observations with greater statistical power in the HER2-positive patient group.

Dr Dariusz Stencel, Medical Liaison at SDS Optic S.A.: "The obtained results indicate the effectiveness and safety of inPROBE^®. The microsensor could serve as an additional diagnostic tool for oncologists, enabling faster and more precise molecular diagnostics for patients with breast cancer, which remains the leading cause of cancer incidence and the second leading cause of cancer-related mortality among women in Poland. We are actively preparing for the second phase of the study, which will involve approximately 200 patients and is expected to provide new and interesting data."

Comparing the concentration ranges of the HER2 receptor measured using the inPROBE^® microsensor for HER2-positive and HER2-negative statuses revealed a clear numerical trend toward higher values in the HER2-positive group compared to the HER2-negative group. Statistical significance was achieved for the minimum values of this range using the exact Wilcoxon rank-sum test (p=0.041). These observations were confirmed through analysis using linear mixed models for repeated measurements. This validated the research hypothesis adopted by SDS Optic.

Mateusz Sagan, Chief Operating and Business Development Officer at SDS Optic S.A.: "We are pleased to inform the market about the positive results of the first part of our clinical trial. It was a time-consuming process, but as a result, the Company can officially present a complete statistical summary, which is of great value for the planned second part of the clinical trial and, in the longer term, for the commercialization of the technology and the ongoing M&A process conducted with Clairfield."

In Part I of the study, the safety of the procedure was also assessed. No defects, damage, malfunctions, or fractures of the inPROBE^® microsensor were observed during the diagnostic examination that could lead to adverse effects. Additionally, no safety-related incidents involving the device itself or any adverse effects in the patients participating in the study were reported.

Principal Investigator, Andrzej Kurylcio, MD, PhD, Professor at the Medical University of Lublin, Department of Oncological Surgery: "These are very interesting results despite the typical small sample size of the studied group in the first part of the study and the significant disproportion between the group of patients with HER2-positive and HER2-negative tumors. In light of current publications on so-called low HER2 expression, it seems that the group of patients with HER2-negative breast cancer may be heterogeneous, including patients with truly HER2-negative breast cancer, but also those with low HER2 expression, which could falsely elevate the expression level in this population. This will be one of the important aspects of the second part of the study."

The company plans to begin the second phase of the clinical trial, which will involve 192 female patients, allowing for significantly greater statistical power of the results. Based on the observations and results obtained, SDS Optic is preparing to introduce beneficial improvements to the research process and update the documentation and submissions to the relevant authorities and committees. The company also recently reported achieving a milestone in the pilot production of its inPROBE^® biosensor.

The CEO of SDS Optic S.A., Marcin Staniszewski: "In the second part of the clinical study, we plan to use sensors that are 100% self-produced. This requires updating certain documents in the Quality Management System and conducting the necessary notification process with the notified body TUV Nord. The aim of these actions is to ensure compliance with all regulatory requirements and to reduce the risk of receiving incorrect or incomplete final clinical study documentation, which could negatively impact the final certification process of the inPROBE^® technology."

The objective of Part II of the study will be to confirm the efficacy and safety of the inPROBE^® technology. The recruitment period for this part of the study (from the inclusion of the first patient to the inclusion of the last patient) is expected to last approximately 6 months. After the recruitment period for Part II concludes, the final steps of the clinical trial will follow (database closure and verification), followed by the preparation of the final statistical report. Based on the collected results, it will be possible to prepare a scientific publication to widely communicate the results in the scientific and medical communities and to enhance the commercial potential of the inPROBE^® technology. The Management also points out the possibility of changes to the planned schedule due to factors beyond the Company's control.