New CapnoPen® CP-001k receives CE certification (MDR)

May 30, 2023


Capnopharm is proud to announce that its new CapnoPen® CP-001k received CE certification (MDR) for aerosolizing chemotherapy, DNA, RNA, nanomolecules, viruses, and immunotherapy into body cavities. As the only nebulizer with such certification, the new CapnoPen® is setting a new regulatory standard in Intraperitoneal Chemotherapy.

Stéphane Rohan Laurent, Capnopharm’s VP Sales & Business Development, comments: “Receiving CE certification constitutes a landmark achievement for our new CapnoPen® technology. It also responds to the growing demand from the oncology community for durable, harmonized standards in Intraperitoneal Chemotherapy.”

Capnopharm’s new CapnoPen® is the first PIPAC® nebulizer to obtain CE marking under the new MDR regulation 2017/745. Prof. Marc Reymond, Capnopharm’s CEO, sees here a benefit for the patients and their physicians: “Capnopharm’s new Capnopen® is approved for its effective intended use, namely aerosolizing chemotherapy, DNA, RNA, nanomolecules, viruses, and immunotherapy into body cavities. This is in contrast to other nebulizers on the market which are only approved for aerosolizing aqueous solutions or for irrigating the abdominal cavity: in clinical practice, these nebulizers are used “off-label”. The new Capnopen® is now classified into the appropriate risk category. Its regulatory approval meets the most current MDR standards and is the result of a thorough technical, biological, and clinical evaluation. This evaluation and the resulting approval protect the interests of patients and healthcare practitioners alike”.

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Capnopharm is a global medical technology company focusing on the development of innovative processes involving medical aerosols. Our science relies on a growing body of evidence around PIPAC® (Pressurized Intraperitoneal Aerosol Chemotherapy), an intraoperative aerosol drug delivery system. PIPAC® provides numerous avenues for research and development in oncology – from the reformulation of approved chemotherapy drugs to next-generation drugs involving nanoparticles, siDNA, mRNA, oncolytic viruses, immunotherapeutics, and cellular therapies. Together with our pharmaceutical clients, we explore the drug-device synergies which could shape the future of cancer care. In doing so, we are devoted to our mission of improving the health and well-being of cancer patients around the world, for the best possible quality of life.

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