SDS Optic

Marcin Staniszewski

SDS Optic S.A. creates globally groundbreaking medical technologies, combining optical fiber optoelectronics (photonics), molecular biology, immunochemistry and modern medical bioengineering techniques. Thanks to its technologies and innovative approach, the company can completely revolutionize many diagnostic areas, on a scale comparable to the glucometer, ultrasound machine or magnetic resonance imaging.

The Company’s strategy is based on the creation of globally unique technologies for diagnostic devices and monitoring life processes in their natural state and in real time, with a primary focus on cancer, infectious, viral, bacterial and fungal diseases.

The Company’s vision is to help increase survival rates in cancer and other chronic diseases by 30% by 2030 and to co-create the future with disruptive technologies. The Company’s motto is: “Lifesaving Innovations”.

The company combines the results of its work in a unique technology platform, inPROBE®, which enables rapid oncological diagnostics performed in real time and without tissue biopsy, primarily for HER2-positive breast cancer. Currently, the key step in cancer diagnosis is tissue biopsy (a section of a cancerous tumor) and its histopathological examination to answer questions such as whether tumor markers are present in the tissues taken from the patient, particularly HER2 – the most malignant of breast cancers. The gold standard in histopathology today is immunohistochemical staining for hormone receptors, and the result of the test is, in a nutshell, a color stain. Based on the intensity of the tissue staining, one can tell if the patient has cancer of a particular type and at what stage of development it is. So the result is not numerical, but a relative visual assessment. Additionally, the waiting time for a histopathological result is often several weeks, and the diagnostic method itself generates a relatively high rate (about 25%) of false positives or false negatives. The technology invented and developed by SDS Optic enables doctors to give an accurate mathematical result and reduces the waiting time from several weeks to about 20 minutes.

SDS Optic has been founded by a team of recognized experts in medicine, molecular biology, photonics, bioengineering and related sciences. The company was established in 2013 as a project by Marcin Staniszewski, a graduate of the University of Akron (Akron, OH, USA) and a long-time collaborator at NASA Laboratory, and Magdalena Staniszewska, MD, PhD (Professor at the Catholic University of Lublin, Poland), a long-time researcher at Harvard Medical School (Boston, MA, USA), Case Western University (Cleveland, OH, USA), and the Polish Academy of Sciences (Wroclaw, PL).

In 2013, the company became a member of the Lublin Medicine Cluster and attracted the first investors (the investment fund of the Polish Entrepreneurship Foundation in Szczecin, and several individual investors), which funded the developement of the key technology of fiber optic encapsulation.

In 2015, the company (with the support of the National Center for Research and Development) started the development of a prototype fiber optic biosensor for the diagnosis of cancer biomarkers HER2 and CCL5 in breast cancer and for the determination of the concentration of the targeted anti-HER2 drug Trastuzumab (Herceptin). The project was carried out from 2015 to 2018 as part of a scientific consortium including the Medical University of Lublin, the Medical University of Wrocław and the University of Life Sciences in Lublin.

In 2017, the company received a prestigious grant from the European Commission under the SME Horizon 2020 program. The grant amount was close to EUR 4 million, which was a record-breaking sum in the history of SME companies in Poland. The grant has been used to fund development work, clinical trials of a diagnostic microprobe in HER2-positive breast cancer and commercialization and certification processes. In the same year, the company also obtained support of almost PLN 1 million under the Go To Brand program from the Polish Agency for Enterprise Development (PARP), the aim of which was to promote and build first contacts in the field of technology commercialization.

In 2017, INNOventure invested in SDS Optic. The capital was used to develop the company’s laboratory and prepare the device for clinical trials, including conducting preclinical studies on animals.

Between 2017 and 2020, the company has received several awards, including the best innovation in Europe created and led by a woman (the Women-led Innovation 2020 award from the European Commission’s Innovation Radar Prize). The company has filed a number of patent applications and registered its trademarks globally.

In 2019, SDS Optic was converted into a public limited company, which was the first step in the process leading the company to go public. It was also to encourage private capital market investors to invest in the development and commercialization of these breakthrough technologies.

Between 2019 and 2021, SDS Optic has conducted a number of development activities in the areas of next-phase animal testing, electrical safety testing, and has established partnerships with experts in the areas of medical device certification. SDS Optic also started its contact with the U.S. Food & Drug Administration (FDA). The Company also obtained all regulatory approvals necessary to commence clinical trials of inPROBE technology (in its first application: HER2-positive breast cancer), and signed an agreement with a Clinical Research Organization (CRO) which will conduct and supervise clinical trials scheduled for 2022.

In 2021, the Company successfully raised PLN 11 million through a pre-IPO private placement of shares. Under the offering, all the offered shares of the new issue were subscribed, and the maximum price per share was reached. Investment funds that participated in the offering are managed by leading domestic financial institutions, private investors and one of the largest nad most prestigious investment funds in the world. The capital raised will be used, among other things, to invest in building a pilot production of fiber optic biosensors, to support the implementation of the project under the received record-breaking Horizon 2020 grant on a European market, and to scale the proprietary inPROBE technology for further applications.

In November 2021 the company submitted to the Warsaw Stock Exchange S.A. the documents necessary for admission of the company’s shares to trading on the ASO NewConnect market, and the debut is planned for February 2022.

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