EQS-News: Marinomed Biotech AG / Key word(s): Miscellaneous
Marinomed Biotech AG: First Carragelose products receive new Medical Device Regulation (MDR) certification
11.09.2024 / 07:45 CET/CEST
The issuer is solely responsible for the content of this announcement.
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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)^(1)^,(2)(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
(3)https://www.carragelose.com/en/portfolio/launched-products, scientific publications on Carragelose® at (4)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: (5)https://www.marinomed.com.
For further inquiries contact:
Marinomed Biotech AG
PR & IR: Lucia Ziegler
T: +43 2262 90300 158
E-Mail: (6)pr@marinomed.com
E-Mail: (7)ir@marinomed.com
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.
(8)^(1) (9)https://www.dovepress.com/efficacy-of-a-nasal-spray-containing-iota-carrageenan-in-the-postexpos-peer-reviewed-fulltext-article-IJGM
(10)^(2)
(11)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
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11.09.2024 CET/CEST This Corporate News was distributed by EQS Group AG. www.eqs.com
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Language: English
Company: Marinomed Biotech AG
Hovengasse 25
2100 Korneuburg
Austria
Phone: +43 2262 90300
E-mail: office@marinomed.com
Internet: www.marinomed.com
ISIN: ATMARINOMED6
WKN: A2N9MM
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt,
Munich, Stuttgart, Tradegate Exchange; Vienna Stock Exchange
(Official Market)
EQS News ID: 1985507
End of News EQS News Service
1985507 11.09.2024 CET/CEST
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