Medinice 2026: FDA for CoolCryo, CE MDR for PacePress, PLN 8.7m for AtriClamp – cardiology medtech at a regulatory breakthrough

Medinice wins FDA for CoolCryo, CE MDR for PacePress, and PLN 8.7m of EU funding for AtriClamp – a pre-commercial cardiology medtech at a regulatory breakthrough

Medinice S.A. – headquartered at ul. Hankiewicza 2 in Warsaw (postcode 02-103, Mazowieckie voivodeship), registered in the KRS under number 0000443282 – secured three structural regulatory catalysts in 2025: FDA certification for CoolCryo (a cryoapplicator for ablation in cardiac surgery), CE MDR certification for PacePress (a compression dressing applied after pacemaker implantation) and PLN 8.7 m of EU funding (European Funds for Mazovia) for the development of AtriClamp (a left-atrial-appendage closure clip).

The Q1 2025 results reflect the pre-commercial phase: parent revenue of PLN 56k (versus PLN 60k), a parent net loss of PLN 1.0 m (versus PLN 1.2 m a year earlier – a roughly 17% narrower loss) and a consolidated loss of PLN 1.1 m. Equity at end-March 2025 stood at PLN 38.4 m – a financial buffer for delivering the regulatory milestones and commercialisation. The company maintains a portfolio of five cardiac-surgery projects in different development phases.

The strongest structural signal is PacePress – a clinical trial closed early with a positive result. Early termination on the back of a positive interim analysis means the product is performing better than expected – which shortens the path to commercialisation. PacePress commercialisation is targeted for 2025, with first commercial revenue expected in H2 2025 or Q1 2026. The second breakthrough is CoolCryo with the FDA: a 510K filed in Q2 2025 and 14 patients recruited into the European clinical trial – preparation for parallel US and EU commercialisation.

Medinice

WARSZAWA · KRS 0000443282 · SPÓŁKA AKCYJNA

Revenue

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Hankiewicza 2 in Warsaw: Choudhary's single-member board, R&D in the subsidiary, 5 cardiac-surgery projects

The address at ul. Hankiewicza 2, 02-103 Warsaw places Medinice's seat in the office-and-residential part of Warsaw's Ochota district, west of the centre, in the biotech-medtech cluster. The company has operated in its current corporate form (Medinice S.A., KRS 0000443282) since 10 December 2012, listed on the Warsaw Stock Exchange under the ticker MDI (ISIN PLMDNCE00016) since 2018 – previously on NewConnect from 2014.

Governance rests with a single-member management board – CEO Sanjeev Choudhary (an interventional cardiologist with international, Polish-Indian experience). Representation rule: a sole board member represents the company alone; with a multi-member board, two members act jointly or one member acts with a registered proxy. The CFO is Piotr Łoziński. The shareholder base belongs largely to a founder-and-medical coalition alongside Polish OFE and TFI funds; the company is a rare example of such an early-stage Polish medtech listed on the WSE Main Market.

Under Polish PKD codes the principal activity is 74.90.Z (other professional, scientific and technical activities). Actual R&D activity concentrates in the subsidiary Medinice B+R Sp. z o.o., also based in Warsaw. E-delivery address: AE:PL-81250-95237-IJVSE-17; website medinice.pl.

Project portfolio (five devices):

• PacePress – a compression dressing applied after pacemaker implantation; CE MDR in Q1 2025, commercialisation targeted for 2025.
• CoolCryo – a cryoapplicator for ablation in cardiac surgery; FDA approval in 2025, 510K filed in Q2 2025.
• AtriClamp – a clip for left-atrial-appendage (LAA) closure; PLN 8.7 m of EU funding (European Funds for Mazovia).
• MiniMax – an ablation electrode.
• EP Bioptom – a heart-muscle biopsy electrode.

Polish pre-commercial cardiology medtech sector on the WSE: Medinice in the "five regulatory projects" niche

The Polish pre-commercial cardiology medtech sector listed on the Warsaw exchange has narrow representation in 2026 – Medinice is one of very few Polish issuers in a regulatory-breakthrough phase with a multi-project portfolio:

• Medinice (Warsaw, sWIG80) – five cardiac-surgery projects, FDA + CE MDR + EU funding in 2025.
• Medicalgorithmics (Warsaw, sWIG80) – cardiology AI (PocketECG, DRAI), FDA-certified, positive Q4 2025 EBITDA.
• Captor Therapeutics (Wrocław, mWIG40) – a TPD biotech, a phase neighbour (pre-commercial).
• Mabion (Konstantynów Łódzki) – biosimilars and contract manufacturing (CDMO), at a different point on the road to profitability.
• Selvita, Ryvu Therapeutics (Kraków) – oncology biotech.

Three structural features of the Medinice model that explain the 2025–2026 situation:

• A five-project portfolio = structural regulatory-risk diversification – unlike a single-product biotech (where an FDA rejection can mean failure), Medinice has five independent regulatory paths. The FDA success for CoolCryo and CE MDR for PacePress confirm the validation process works; the other three projects (AtriClamp, MiniMax, EP Bioptom) are at various phases. Each subsequent regulatory milestone strengthens the valuation.
• Specialisation in cardiac surgery = a high-margin, high-price niche – cardiac-surgery devices carry high entry barriers (FDA Class III, CE MDR) and long purchasing cycles (hospital plus insurer), but also high margins (typically 60–80% gross margin post-commercialisation). PacePress and CoolCryo position Medinice in this premium segment.
• PLN 38.4 m of equity = a multi-year operating buffer – at an annual loss of around PLN 4–5 m, PLN 38.4 m of equity covers 7–10 years of operating development without another share issue. PacePress commercialisation in 2025 and CoolCryo in 2026 should start generating revenue, further shortening the path to break-even.

Implication for the investment profile: pre-commercial medtech with FDA + CE in the portfolio, road to break-even in 2026–2028

The interpretation is speculative – the conclusions below are scenarios, not certainties:

“Our goal is to file the 510K application this quarter. The CE certificate and the early closure of the clinical trial enable PacePress commercialisation in 2025. Three regulatory catalysts – FDA for CoolCryo, CE MDR for PacePress and PLN 8.7 m of EU funding for AtriClamp – are the foundation of the commercial phase.”

Three possible consequences of the 2025 results and regulatory breakthroughs for Medinice's investment profile in 2026:

• PacePress commercialisation in 2025 = first commercial revenue and the key proof of concept – the CE MDR-certified product should start generating revenue in H2 2025 or Q1 2026. Initial market expectations are PLN 5–15 m a year once scaled, depending on distribution in Poland and the EU and on US expansion. Any commercialisation delay would be a meaningful signal for the valuation.
• CoolCryo with parallel FDA + CE = a structurally valuable premium product – cryoapplicators for surgical ablation sit in a segment with an estimated global TAM of USD 1–2 bn. A Polish manufacturer with FDA clearance has a real shot at partnerships with US distributors (Boston Scientific, Medtronic, Abbott Vascular). Any such partnership would be a step-change catalyst.
• PLN 8.7 m of EU funding for AtriClamp = a longer runway without dilution – the EU grant allows AtriClamp development to continue (LAA closure is a segment growing dynamically with the rising atrial-fibrillation population) without a dilutive share issue. That is a structural benefit for current shareholders.

Main company-specific risks across the 2026–2027 cycle:

• Delivery of PacePress commercialisation – the first commercial product must prove itself in sales; any delay or slow hospital purchasing will affect the valuation.
• Competition from Boston Scientific, Medtronic, and Abbott – global cardiac-surgery players with R&D budgets many times larger than Medinice's; any competing product of theirs in the ablation / LAA-closure segment affects its position.
• The FDA and CE MDR cycle for the remaining projects – every FDA/EMA decision on AtriClamp, MiniMax, and EP Bioptom will be a key catalyst; delays are possible.
• Equity versus R&D costs – the PLN 38.4 m buffer covers roughly 7–10 years, but any acceleration of multi-project development could shorten that period.
• Small market cap and low liquidity – a typical small-cap medtech risk; single orders can move the share price sharply.

What you'll find in the Medinice S.A. profile

The Medinice S.A. profile in our database carries the full picture of the company: composition of the single-member management board (with CEO Sanjeev Choudhary), the KRS registration history from 10 December 2012, the registered address at ul. Hankiewicza 2 in Warsaw, e-delivery status (AE:PL-81250-95237-IJVSE-17), the website medinice.pl, and the assigned PKD code 74.90.Z (other professional activities). The profile is also available in English – relevant for international investors specialising in pre-commercial medtech, since Medinice is the only Polish stock-listed company developing five innovative cardiac-surgery devices (PacePress, CoolCryo, AtriClamp, MiniMax, EP Bioptom) with three regulatory catalysts in 2025 (FDA, CE MDR, EU funding).

This material is informational and does not constitute investment advice.

Data: Polish KRS Court Register (KRS 0000443282); Medinice S.A. – Q1 2025 results communication (May 2025); Strefa Inwestorów – Q1 2025 Medinice analysis (key regulatory progress); StockWatch – communication on the closure of the PacePress clinical trial (August 2025); ISB Zdrowie – communication on the positive PacePress clinical trial result; Bankier.pl – MEDINICE listing profile; PKD 74.90.Z classification (other professional activities); company history – registration as S.A. on 10 December 2012, NewConnect debut 2014, migration to the WSE Main Market 2018, as of 2026-05-02.