Goals and development strategy
We have clear and well-defined goals.
Our vision is to increase the survival rates for cancer and other chronic diseases to 30% by 2030, and co-create the future of breakthrough healthcare technologies. Become acquainted with our development strategies and follow how we wish to achieve these.
SDS Optic S.A. conduct clinical studies using the inPROBE® technology in HER2-positive breast cancers, in two stages:
- Part 1 (safety) – a study group of 18 patients at a clinical centre, duration: ca. 3-5 months;
- Part 2 (effectiveness / knowledge of tumour biology / algorithm calibration) – a multicentre study group of 192 patients, scheduled for the second half of 2022, duration: ca. 6-8 months.
Within the clinical studies, the Company poses a series of questions to gather necessary information. The Company wishes to be the first in the world to detect and measure concentrations of HER2 cancer biomarkers, without the acquisition of diseased tumour tissue. This knowledge is of great importance in the future development of the inPROBE® technology and an accurate calibration to traditional histopathology results (IHC and FISH).
Positive and satisfying answers to the majority of the questions will facilitate CE certification, the marketing authorisation procedure for the application of inPROBE® in diagnosing concentrations of HER2 biomarkers in breast cancers, and in the commercialisation process.
The Company also intends to develop new applications with the inPROBE® technology:
Infectious Diseases – conducted as part of a special purpose company FiBioMed, which in December 2020 received more than PLN 10 million from the National Research and Development Centre (NCBiR) funder of the “Coronaviruses” Fast Track program. www.fibiomed.com
Retina – the detection of biomarkers responsible for serious macular degeneration. The Company plans to open a branch in the United States and build a dedicated team supervised by people with extensive experience in eye diseases.
Pharmaceutical Microprobe – a device for detecting concentrations of biologically active substances in tumours. This is a very interesting research area for big pharmaceutical companies (big pharma) working on innovative cancer therapies.
HER2 in the Stomach – detection based on antibodies owned by the Company – measurement of concentrations of biomarkers in body fluids using an endoscope or laparoscope. The Company also intends to use the inPROBE® technology as an additional component of endoscopic examinations.
Diagnostic Microprobe in prostate cancers – application assumptions (including the process and safety) are going to be discussed with urologists on a working basis.
In compliance with this adopted strategy, the Company will simultaneously commercialise applications of the key inPROBE® microprobe technology in two models:
- Direct Commercialisation:
The Company as a manufacturer of a dedicated diagnostic device consisting of a detector and single-use sterilised optical diagnostic microprobe;
- Indirect Commercialisation:
Corporate partnership with global companies (cancer diagnostics, in vitro diagnostics) and global pharmaceutical companies (using the inPROBE® technology in their R&D).
The diagnostic device in HER2-positive breast cancers will be targeted mainly toward oncology clinics and clinical hospitals, and to a lesser extent diagnostic laboratories, pharmaceutical companies and the cancer diagnostics private sector. Distribution models will depend on the particular market characteristics. Aside from the Polish market, we are taking into consideration cooperation with specialised medical device distributors and corporate partnerships.
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