{"id":1623,"date":"2022-11-08T07:00:00","date_gmt":"2022-11-08T06:00:00","guid":{"rendered":"https:\/\/avextra.com\/?p=1623"},"modified":"2023-03-02T12:53:25","modified_gmt":"2023-03-02T11:53:25","slug":"press-release","status":"publish","type":"post","link":"https:\/\/avextra.com\/en\/2022\/11\/press-release\/","title":{"rendered":"Medical Device Submission for a Cannabis Extract Inhaler"},"content":{"rendered":"

Avextra has commissioned the Leading Medical Device Specialists Activoris and Actarmo to prepare the EU Medical Device Submission for a Cannabis Extract Inhaler <\/h2>\n\n\n\n

Together these three partners will develop a pathway for the first cannabis inhalers to comply with European Medical Device Regulations<\/strong><\/h4>\n\n\n\n

Bensheim, Gem\u00fcnden (Wohra) and Gauting, 09. November 2022 \u2013<\/strong><\/em> German Avextra Pharma GmbH, one of the leading European manufacturers of cannabis-based medicines, today announced a partnership with two of the most experienced and respected medical device developers for inhalation worldwide, Activoris Medizintechnik GmbH and Actarmo Medical GmbH. Together this consortium will develop a clear regulatory pathway for an inhalation device in full compliance with EU Medical Device Regulations by the end of 2023. The future device will deliver fast onset of cannabis-based medicines combined with precise dosage thereby addressing a significant unmet patient need.<\/p>\n\n\n\n

By applying established pharmaceutical development and manufacturing processes to cannabis-based medicines, these companies will lay the foundation for the next generation of cannabinoid therapy and provide a new and innovative dosage option.<\/p>\n\n\n\n

Avextra will develop the cannabis extracts for inhalation. Activoris will lead the medical device development and certification process. Actarmo will assume responsibility for the combination product development and testing.<\/p>\n\n\n\n

Dr. Bernhard Babel, Co-CEO of Avextra comments: \u201cThis partnership is a significant milestone in Avextra\u2019s inhalation development strategy. It will provide patients and physicians the next generation in cannabinoid treatment.\u201d He continues: \u201cWe are very proud to partner with experienced Actarmo and Activoris. We are also working together with remarkable device suppliers and will disclose more soon.“<\/p>\n\n\n\n

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About Avextra Pharma GmbH<\/strong><\/strong><\/h4>\n\n\n\n

Avextra is the leading independent European medical Cannabis company in Europe mastering the full value chain, with cultivation of selected cannabis varieties in Portugal, manufacturing in a purpose-built GMP facility in Hessen and extensive R&D investment. Avextra entered the medical cannabis space to work with physicians, pharmacists and researchers to expand the clinical evidence for cannabis therapy and develop regulatory approved product that address patients\u2019 needs. Press contact: Lisa Schwede, +49 (0) 151 289 963 54, <\/a>press@avextra.com<\/a><\/p>\n<\/div>\n<\/div>\n\n\n\n

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About Activoris<\/strong><\/strong><\/strong><\/h4>\n\n\n\n

The Activoris group serves the Medtech, Pharma and Food industry with contract development, manufacturing and packaging. Activoris operates locations in Gem\u00fcnden (Wohra), Munich and Schwalmstadt. In its Life Science business units, Activoris supports clients with device development, strategic and regulatory consulting. Clients are established companies as well as innovative startups. Activoris‘ outsourcing services enable them to achieve greater flexibility, cost efficiency and faster market access. Axel Fischer, +49 (0) 6453.58535.10, <\/a><\/a>axel.fischer@activoris.com<\/a>.<\/a><\/p>\n<\/div>\n<\/div>\n\n\n\n

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About Actarmo Medical GmbH<\/strong><\/strong><\/strong><\/strong><\/h4>\n\n\n\n

Actarmo Medical is the experienced service provider for your respiratory product developments. Although a young enterprise, Actarmo was founded around life science and respiratory experts with a proven track record in aerosol science, inhaler development and regulatory approvals. Contact: Thomas Weuthen, + +49 (0) 89 614233 00, <\/a>thomas.weuthen@actarmo.com<\/a>  <\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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Deutsch:<\/h2>\n\n\n\n

Avextra beauftragt Activoris und Actarmo, um gemeinsam die Medical Device Submission f\u00fcr ein Inhalationsdevice zur Verabreichung von standardisierten Cannabisextrakten voranzubringen<\/h2>\n\n\n\n

Die Unternehmen haben es sich zum Ziel gesetzt, das erste Inhalationsdevice zur Verabreichung von standardisierten Cannabisextrakten vorzubereiten, das den neuen europ\u00e4ischen Richtlinien f\u00fcr Medizinprodukte entspricht.<\/strong><\/h4>\n\n\n\n

Bensheim, Gem\u00fcnden (Wohra) and Gauting, 09. November 2022 \u2013<\/strong><\/em> Avextra Pharma GmbH, einer der f\u00fchrenden europ\u00e4ischen Hersteller von Arzneimitteln auf Cannabisbasis und die renommierten Entwickler von Medizinprodukten zur Inhalation, Activoris Medizintechnik GmbH und Actarmo Medical GmbH, geben ihre Partnerschaft bekannt: Bis Ende 2023 wollen Activoris und Actarmo in Auftrag von Avextra die Parameter f\u00fcr ein Inhalationsger\u00e4t festlegen, das Patient:innen und \u00c4rzt:innen eine exakte Dosierung zur Inhalation von standardisierten Cannabisextrakten bietet. Das k\u00fcnftige Ger\u00e4t muss den neuen europ\u00e4ischen Richtlinien f\u00fcr Medizinprodukte entsprechen.<\/p>\n\n\n\n

F\u00fcnf Jahre, nachdem die deutsche Bundesregierung schwerkranken Patient:innen Zugang zu Medikamenten auf Cannabisbasis gew\u00e4hrt hat, sind die Dosierungsm\u00f6glichkeiten f\u00fcr Patient:innen im Wesentlichen die Inhalation von getrockneten Bl\u00fcten sowie die orale Verabreichung von standardisierten Cannabisextrakten. Hier setzen Avextra, Activoris Medizintechnik und Actarmo Medical an \u2013 Gemeinsam arbeiten sie daran, neue Inhalationsoptionen f\u00fcr Medikamente auf Cannabisbasis zu entwickeln, die Patient:innen und \u00c4rzt:innen bis Ende 2023 eine exakte Dosierung von Cannabinoiden mithilfe eines Inhalationsger\u00e4tes erm\u00f6glichen.<\/p>\n\n\n\n

Im Rahmen des Projektes wird Avextra die Arzneimittelformulierung entwickeln, Activoris Medizintechnik ist f\u00fcr die Medizinprodukteentwicklung und -zertifizierung verantwortlich, Actarmo Medical f\u00fcr die Kombinationsproduktentwicklung und Testung.<\/p>\n\n\n\n

Dr. Bernhard Babel, Co-CEO von Avextra zeigt sich erfreut \u00fcber die Zusammenarbeit: \u201eDiese Partnerschaft ist ein wichtiger Meilenstein in der Entwicklungsstrategie von Avextra f\u00fcr Inhalation. Sie wird Patient:innen und \u00c4rzt:innen die n\u00e4chste Generation der Cannabinoid-Behandlung erm\u00f6glichen.“ Dr. Babel erg\u00e4nzt: \u201eWir sind sehr stolz darauf, mit Activoris Medizintechnik und Actarmo Medical als erfahrende Partner zusammenzuarbeiten. Wir arbeiten auch mit bemerkenswerten Herstellern der Ger\u00e4te zusammen und freuen uns, bald mehr bekannt geben zu k\u00f6nnen.“<\/p>\n\n\n\n

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\u00dcber Avextra Pharma GmbH<\/strong><\/h4>\n\n\n\n

Avextra mit Produktionsstandort im hessischen Bensheim ist einer der f\u00fchrenden vertikal- integrierten europ\u00e4ischen Anbieter f\u00fcr hochwertige cannabisbasierte Arzneimittel.  Das Unternehmen legt den Fokus auf die Herstellung von exakt eingestellten Cannabisextrakten. Hier liegt die gesamte Wertsch\u00f6pfungskette in einer Hand \u2013 vom Anbau der Pflanzen in Portugal bis hin zur pharmazeutischen Herstellung in Deutschland. Pressekontakt: Lisa Schwede, +49 151 289 963 54, <\/a>press@avextra.com<\/a><\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u00dcber Activoris<\/strong><\/strong><\/h4>\n\n\n\n

Die Activoris Medizintechnik GmbH in Gem\u00fcnden (Wohra) ist ein Dienstleistungsunternehmen f\u00fcr Auftragsproduktion, Medtech-Entwicklung und strategische Beratung f\u00fcr Unternehmen der Life-Science- und Pharma-Industrie. Die Kunden sind etablierte Unternehmen als auch innovative Startups aus der BioTech-, MedTech- und Pharmabranche. Durch die Outsourcing-Services der Activoris erreichen sie h\u00f6here Flexibilit\u00e4t, Kosteneffizienz und schnelleren Marktzugang. Activoris unterh\u00e4lt Standorte in Gem\u00fcnden (Wohra), M\u00fcnchen und Schwalmstadt. Kontakt: Axel Fischer, +49 (0) 6453 58535 10, axel.fischer@activoris.com<\/a><\/a><\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u00dcber Actarmo Medical GmbH<\/strong><\/strong><\/strong><\/h4>\n\n\n\n

Actarmo Medical ist ein erfahrener Dienstleister f\u00fcr Produktentwicklungen im Bereich Atemwegserkrankungen. Das junge Unternehmen wurde von Experten aus den Bereichen Biowissenschaften und Atemwegserkrankungen gegr\u00fcndet, die \u00fcber eine nachweisliche Erfolgsbilanz in den Bereichen Aerosolwissenschaft, Inhalatorentwicklung und beh\u00f6rdliche Zulassungen verf\u00fcgen. Kontakt: Thomas Weuthen, + 49 (0) 89 614233 00, thomas.weuthen@actarmo.com<\/a><\/a><\/p>\n<\/div>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"

Bensheim, Gem\u00fcnden (Wohra) and Gauting, 09. November 2022 \u2013 Together these three partners will develop a pathway for the first cannabis inhalers to comply with European Medical Device Regulations\u2026<\/p>","protected":false},"author":1,"featured_media":2670,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"einzelbeitrag-ohne-bild","format":"standard","meta":{"inline_featured_image":false,"advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[8,9],"tags":[],"yoast_head":"\nMedical Device Submission f\u00fcr ein Inhalationsdevice - Cannabisbasierte Arzneimittel von Avextra<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/avextra.com\/en\/2022\/11\/press-release\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Device Submission f\u00fcr ein Inhalationsdevice - Cannabisbasierte Arzneimittel von Avextra\" \/>\n<meta property=\"og:description\" content=\"Bensheim, Gem\u00fcnden (Wohra) and Gauting, 09. 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