First Carragelose products receive new Medical Device Regulation (MDR) certification

Marinomed Biotech AG: First Carragelose products receive new Medical Device Regulation (MDR) certification

• Two Carragelose nasal sprays have received declaration of conformity under the new medical device regulation - certificates for further products expected later in the year
• Extensive clinical data for Carragelose facilitates challenging demands for MDR transition
• MDR-compliance is a major asset for medical devices and adds significant value to Carragelose portfolio
• Evaluation process regarding strategic options for the Carragelose business ongoing; due diligence phase continuing but no agreements made to date

Korneuburg, Austria, 11. September 2024 – Marinomed Biotech AG (VSE:MARI) has received the certificates for the first two Carragelose products under the new medical device regulation (MDR). The European Union (EU) implemented the new medical device regulation in May 2021, replacing the previously valid medical device directive (MDD) and increasing scrutiny on medical device safety throughout the full product lifecycle. The MDR sets new EU-wide standards regarding the requirements for safety, performance, quality of clinical data and overall technical documentation for medical devices. Compliance with the new MDR is the prerequisite for the marketing of medical devices in the EU after the end of the transition period in 2028.

The declaration of conformity for the first Carragelose products represents a major milestone for the whole portfolio and creates a promising foundation for the certification of the other Carragelose products. Furthermore, successful MDR transition adds significant value to the Carragelose asset. As announced mid-December 2023, the Company commenced an evaluation process regarding strategic options for the Carragelose business area. Without any relevant interim step having occurred, the Company updates the market that potential buyers are still in the process of conducting due diligence. To date, no binding agreements have been concluded. In this process, Marinomed aims for a decision to be made and announced by the end of the year.

Eva Prieschl-Grassauer, CSO of Marinomed, comments: “MDR-transition and the associated necessary documentation is very demanding. However, thanks to the excellent work of our regulatory affairs team and the extensive clinical data that we have generated for Carragelose over the years, we are able to meet the new requirements. The issuing of these certificates is further confirmation of the quality, safety and appropriate technical documentation of our Carragelose products and increases the value of this asset, also for a potential strategic partner. We are proud to have received the first certificates well before the end of the transition period in 2028. We are confident that the other products will also be certified under the new MDR and will therefore continue to be approved for marketing and distribution in the EU.”

About Carragelose®

Carragelose® is a sulfated polymer from red seaweed and a unique, broadly active virus- and allergen-blocking compound. It is known as a gentle, effective, and safe prevention and treatment of various viral respiratory infections. Several clinical and preclinical studies have shown that Carragelose® forms a protective layer on the mucosa that prevents viruses from infecting cells. Laboratory and clinical data have demonstrated that Carragelose® can also inhibit the spreading of SARS-CoV-2.^[1],[2] Marinomed is the holder of the IP rights and has licensed Carragelose® for marketing in Europe, North America, Australia, and parts of Asia and Latin America. Marinomed’s portfolio of Carragelose®-containing nasal sprays and oral products can be accessed at https://www.carragelose.com/en/portfolio/launched-products, scientific publications on Carragelose® at https://www.carragelose.com/en/publications.

About Marinomed Biotech AG

Marinomed Biotech AG is an Austrian, science-based biotech company with a growing development pipeline and globally marketed therapeutics. The Company develops innovative patent-protected products in the therapeutic areas immunology and virology based on the platform Marinosolv® and the virus-blocking activity of Carragelose®. The Marinosolv® technology improves the solubility and bioavailability of hardly soluble compounds and is used to develop new therapeutics for autoreactive immune disorders. The virology segment includes Carragelose®-based over-the-counter (OTC) products to prevent and treat respiratory viral infections that are partnered in more than 40 countries. The Company is headquartered in Korneuburg, Austria, and is listed on the Vienna Stock Exchange (VSE:MARI). For further information, please visit: https://www.marinomed.com.

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Disclaimer

This press release contains forward-looking statements, which are based on current views, expectations and projections of the management of Marinomed Biotech AG about future events. These forward-looking statements are subject to risks, uncertainties and assumptions that could cause actual results, performance or events to differ materially from those described in, or expressed or implied by, such statements. The current views, expectations and projections of the management of Marinomed Biotech AG may be identified by the context of such statements or words such as “anticipate,” “believe”, “estimate”, “expect”, “intend”, “plan”, “project” and “target”. Forward-looking statements are only valid as of the date they are made and Marinomed Biotech AG does not assume any obligation to update, review or revise any forward-looking statements contained in this press release whether as a result of new information, future developments or otherwise. Marinomed, Marinosolv® and Carragelose® are registered trademarks of Marinomed Biotech AG. These trademarks may be owned or licensed in select locations only.

^[1]  https://www.dovepress.com/efficacy-of-a-nasal-spray-containing-iota-carrageenan-in-the-postexpos-peer-reviewed-fulltext-article-IJGM

^[2]  https://www.marinomed.com/en/news/marinomed-biotech-ag-shares-positive-clinical-trial-results-for-iota-carrageenan-nasal-spray-in-the-prevention-of-covid-19-1