EIC-backed SDS Optic lists on Warsaw’s NewConnect to fund scale-up of inPROBE in vivo HER2 diagnostic

SDS Optic S.A., a Polish biotech and medtech developer supported by the European Innovation Council, made its market debut on NewConnect, the Warsaw Stock Exchange alternative trading system, on 15 March 2022. The company said shares opened about 15 percent higher at the bell. The listing follows a pre-IPO placement of €2.5 million that brought institutional investors and high net worth individuals onto the cap table representing 20.7 percent of share capital.

What SDS Optic says it will finance with the new capital

According to company statements, proceeds from the pre-IPO round and the public debut will be used to scale the core inPROBE technology, invest in capital expenditure to build a semi-industrial production facility for photonics biosensors, strengthen commercialization efforts and corporate partnerships, and cover future operating expenses. Those uses align with typical deep tech scale-up needs but also carry familiar execution risks for device makers, especially in precision photonics and medical device manufacturing.

Funding history and EIC support

SDS Optic reports nearly €13 million raised to date through a mix of non-dilutive and equity funding. The company has been supported by the European Innovation Council for around five years. EIC backing began as a Phase I SME Instrument award and continued with a Phase II SME Instrument grant, the predecessor of the current EIC Accelerator, amounting to nearly €4 million in public funding linked to the SDS-OMIPROBE project. That project is described as running until the end of 2022 and focuses on an in vivo, real-time, numerically based diagnostics platform for HER2 breast cancer.

What inPROBE is and how SDS Optic positions it

SDS Optic describes inPROBE as a photonics-based microprobe platform that combines molecular biology, immunochemistry, photonics and biomedical engineering. The company claims inPROBE can detect cancer biomarkers such as HER2 in vivo and in real time, without the need for tissue biopsy, and produce numerical outputs intended to help clinicians assess biomarker expression and monitor therapy delivery in situ. SDS Optic positions the technology as potentially scalable to other cancer markers and additional clinical areas including infectious diseases, ophthalmology, endoscopy and sepsis monitoring. The company also highlights services such as antibody development and optical coatings as part of its operational footprint.

Development and clinical status

SDS Optic reports completion of in vitro and preclinical animal testing stages and says clinical trials have been initiated, involving more than 200 patients across five oncology centres in Poland. The specific endpoints, trial design, control arms and regulatory strategy have not been disclosed in company summaries. The SDS-OMIPROBE project, funded under the EIC instrument, is described as focusing on real-time in vivo HER2 diagnostics and numerical analysis through the end of 2022.

Company profile and operational capacity

SDS Optic employs almost 40 people and operates an R&D centre of almost 700 square metres in Lublin, Poland. Public-facing materials indicate capabilities in custom antibody development and small scale production in BSL2 laboratories and an offering of advanced optical coatings using nanolayer technology. These capabilities align with the combined molecular and photonics focus of inPROBE, but scaling from prototype to clinical-grade manufacture remains a material step.

Market, regulatory and commercial context

The company listed on NewConnect, which is an alternative trading platform aimed at smaller companies seeking earlier stage public capital and visibility. NewConnect listings are typically subject to higher volatility and lower liquidity than main exchanges. The reported 15 percent opening gain on 15 March 2022 should be read in that context and may reflect a combination of thin float, investor appetite for EIC-backed deep tech, and market dynamics influenced at that time by regional geopolitical uncertainty such as the war in Ukraine.

From a regulatory perspective, any in vivo diagnostic or monitoring device in the European market must follow the EU medical device regulation pathway applicable to its classification. That typically requires robust clinical evidence demonstrating safety and performance and an established quality management system for manufacturing and post-market surveillance. For adoption in clinical practice, additional barriers include reimbursement, integration with existing diagnostic workflows, clinician training and competition from established laboratory-based diagnostics such as immunohistochemistry and in situ hybridization or emerging approaches such as liquid biopsies and digital pathology.

Role of EIC funding and wider EU innovation ecosystem context

SDS Optic is one example of a company that has used European public deep tech support to bridge early development risks. The European Innovation Council provides grants and business acceleration services and the EIC Fund can co-invest alongside private investors. Public grants can de-risk technology development, accelerate clinical activities and boost investor confidence, but they do not remove the technical, regulatory or commercial risks that determine whether a medtech device reaches scale. The EIC often aims to leverage private co-investment; recent EIC communications point to significant leverage ratios in its portfolio overall, though leverage varies by sector and stage.

Risks, open questions and what to watch next

Key uncertainties remain. The clinical evidence base is the most important variable for a device that claims to replace or complement tissue biopsy. Public descriptions note trials with more than 200 patients but do not disclose trial endpoints, comparator methods, statistical results or regulatory timelines. Manufacturing photonics biosensors at semi-industrial scale introduces new quality and yield risks and may require additional capital beyond the amounts reported. Commercial adoption will depend on convincing clinicians and payers the method is accurate, repeatable and cost effective compared with established diagnostics and emerging alternatives. Finally, market signals on NewConnect should be interpreted cautiously given that small-cap listings often show pronounced early price moves.

Bottom line

SDS Optic presents an intriguing technical approach at the intersection of photonics and molecular diagnostics and benefits from multi-year EIC support and early capital. The company has moved from laboratory and preclinical work into patient studies and has now taken the step of listing on NewConnect to finance scale-up. The crucial next milestones for investors, clinicians and partners are transparent clinical data, regulatory progress, demonstration of reproducible manufacturing at scale and early adoption evidence. Public funding and a listing help with capital and visibility but do not guarantee that a novel in vivo diagnostic will clear the scientific, regulatory and market hurdles ahead.