Publicerat: 2026-01-23 15:10:00

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Finwire om Monivent AB: Monivent receives the second tranche of the bridge loan after an updated launch plan with Dräger

The medical technology company Monivent announces that the company and Dräger have agreed on an updated commercial plan for the launch of Neo100. Thus, the condition for the second tranche of the bridge loan from September 2025 has been met, and a disbursement of 4 million SEK has been made. The bridge loan totals 8 million SEK.The company states that all outstanding questions to date in the MDR process have been answered in dialogue with the notified body BSI. Any additional questions are expected in the first quarter of 2026. Monivent's current assessment is that MDR approval can be obtained at the end of the second quarter of 2026. The updated plan means that Dräger will prepare for and begin the launch of Neo100 in Europe after receiving MDR approval. The 510(k) application to the FDA is planned to be submitted at the beginning of 2026, with a launch in the USA after approval. New minimum volumes will be negotiated separately for Europe and the USA after the respective market approvals.At the same time, the board and management are in dialogue with financial advisors to secure the company's long-term financing.

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