{"id":25054,"date":"2024-02-12T08:40:00","date_gmt":"2024-02-12T08:40:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4334381_AE34381_0"},"modified":"2024-02-12T08:40:00","modified_gmt":"2024-02-12T08:40:00","slug":"dignicap-delta-receives-market-approval-in-japan","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=25054","title":{"rendered":"DigniCap Delta receives market approval in Japan"},"content":{"rendered":"\n

LUND, Sweden<\/span>, Feb. 12, 2024<\/span> \/PRNewswire\/ — Dignitana announces that DigniCap Delta received market approval in Japan<\/span> from the Ministry of Health, Labor and Welfare (MHLW). In Japan, Dignitana will provide DigniCap Delta to Konica Minolta as a medical device manufacturer, and Konica Minolta<\/a> will proceed as a market authorization holder (MAH) to expand into the Japanese market.<\/b><\/p>\n

Regulatory approval for medical devices in Japan<\/span> is similar to the FDA clearance process for medical devices in the United States<\/span>, it is a pathway in which quality, efficacy, and safety are examined and approved according to the classifications established by law.<\/p>\n

Based on Dignitana’s distribution agreement with Konica Minolta, an initial order was placed in February and a second order for several devices will be placed in early spring 2024 to prepare for launch.<\/p>\n

"Introducing DigniCap Delta to the Japanese market is an important milestone for Dignitana as we continue to advance our strategic objectives. Konica Minolta has a long history of innovation as a technology leader in Asia<\/span> and around the globe and we are honored to have Konica Minolta as a partner to introduce DigniCap Delta’s next generation scalp cooling technology to patients in Japan<\/span>. Their strong market presence and team of experienced professionals bring tremendous value to our company and to oncology providers in Japan<\/span>," said Catarina Löwenadler, Dignitana CEO.<\/p>\n

"Interest in scalp cooling in Japan<\/span> is very strong, and we are excited to now be able to move forward with sales to customers who have been waiting for this advanced technology," said Toshikazu Imai<\/span>, General Manager Business development division, Konica Minolta.<\/p>\n

Over one million new incidences of cancer are diagnosed annually in Japan<\/span>. Breast cancer is the most common type of cancer for women in Japan<\/span>, with over 94 thousand women diagnosed with breast cancer in 2022 (ganjoho.jp)<\/a>.<\/p>\n

In order to demonstrate the effectiveness of DigniCap Delta, Konica Minolta initiated a clinical trial targeting breast cancer patients in May 2023<\/span> at St. Marianna University Breast & Imaging Center.<\/p>\n

With a primary market in the US, the FDA-cleared DigniCap Delta device uses industry-leading thermoelectric cooling to minimize hair loss that is a side effect of chemotherapy prescribed to treat solid tumors such as those from breast cancer, ovarian cancer and prostate cancer. Recognized internationally as a standard of care and quality of life advancement for cancer patients, scalp cooling is a treatment recommendation in the clinical practice guidelines published by National Comprehensive Cancer Network<\/a>® (NCCN), European Society for Medical Oncology<\/a> (ESMO), and Cancer Australia<\/span><\/a>. It is available in cancer centers around the globe.<\/p>\n

For More Information Contact<\/b>
Melissa Bourestom<\/span>, Chief Communications Officer, melissa.bourestom@dignitana.com<\/a>  +1 469-518-5031<\/p>\n

The following files are available for download:<\/p>\n

\n\n\n\n\n
\n

https:\/\/mb.cision.com\/Main\/2116\/3926589\/2596557.pdf<\/a><\/span><\/p>\n<\/td>\n

\n

Release<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

https:\/\/news.cision.com\/dignitana-ab\/i\/dignicap-delta-on-patient,c3266256<\/a><\/span><\/p>\n<\/td>\n

\n

DigniCap Delta on patient<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

LUND, Sweden, Feb. 12, 2024 \/PRNewswire\/ — Dignitana announces that DigniCap Delta received market approval in Japan from the Ministry of Health, Labor and Welfare (MHLW). In Japan, Dignitana will provide DigniCap Delta to Konica Minolta as a medical device manufacturer, and Konica Minolta will proceed as a market authorization holder (MAH) to expand into the Japanese market. Regulatory […]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-25054","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"\nDigniCap Delta receives market approval in Japan - My Blog<\/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:\/\/transmediavictoria.net.au\/?p=25054\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"DigniCap Delta receives market approval in Japan - My Blog\" \/>\n<meta property=\"og:description\" content=\"LUND, Sweden, Feb. 12, 2024 \/PRNewswire\/ — Dignitana announces that DigniCap Delta received market approval in Japan from the Ministry of Health, Labor and Welfare (MHLW). In Japan, Dignitana will provide DigniCap Delta to Konica Minolta as a medical device manufacturer, and Konica Minolta will proceed as a market authorization holder (MAH) to expand into the Japanese market. Regulatory […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/transmediavictoria.net.au\/?p=25054\" \/>\n<meta property=\"og:site_name\" content=\"My Blog\" \/>\n<meta property=\"article:published_time\" content=\"2024-02-12T08:40:00+00:00\" \/>\n<meta name=\"author\" content=\"admin_tony\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin_tony\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=25054#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=25054\"},\"author\":{\"name\":\"admin_tony\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#\\\/schema\\\/person\\\/5b51d407d652c0aa802bea269ea5d7e7\"},\"headline\":\"DigniCap Delta receives market approval in Japan\",\"datePublished\":\"2024-02-12T08:40:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=25054\"},\"wordCount\":490,\"articleSection\":[\"Business News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=25054\",\"url\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=25054\",\"name\":\"DigniCap Delta receives market approval in Japan - My Blog\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#website\"},\"datePublished\":\"2024-02-12T08:40:00+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#\\\/schema\\\/person\\\/5b51d407d652c0aa802bea269ea5d7e7\"},\"breadcrumb\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=25054#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=25054\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=25054#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/transmediavictoria.net.au\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"DigniCap Delta receives market approval in Japan\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#website\",\"url\":\"https:\\\/\\\/transmediavictoria.net.au\\\/\",\"name\":\"My Blog\",\"description\":\"My WordPress Blog\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#\\\/schema\\\/person\\\/5b51d407d652c0aa802bea269ea5d7e7\",\"name\":\"admin_tony\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g\",\"caption\":\"admin_tony\"},\"url\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?author=8\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"DigniCap Delta receives market approval in Japan - My Blog","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/transmediavictoria.net.au\/?p=25054","og_locale":"en_US","og_type":"article","og_title":"DigniCap Delta receives market approval in Japan - My Blog","og_description":"LUND, Sweden, Feb. 12, 2024 \/PRNewswire\/ — Dignitana announces that DigniCap Delta received market approval in Japan from the Ministry of Health, Labor and Welfare (MHLW). In Japan, Dignitana will provide DigniCap Delta to Konica Minolta as a medical device manufacturer, and Konica Minolta will proceed as a market authorization holder (MAH) to expand into the Japanese market. Regulatory […]","og_url":"https:\/\/transmediavictoria.net.au\/?p=25054","og_site_name":"My Blog","article_published_time":"2024-02-12T08:40:00+00:00","author":"admin_tony","twitter_card":"summary_large_image","twitter_misc":{"Written by":"admin_tony","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/transmediavictoria.net.au\/?p=25054#article","isPartOf":{"@id":"https:\/\/transmediavictoria.net.au\/?p=25054"},"author":{"name":"admin_tony","@id":"https:\/\/transmediavictoria.net.au\/#\/schema\/person\/5b51d407d652c0aa802bea269ea5d7e7"},"headline":"DigniCap Delta receives market approval in Japan","datePublished":"2024-02-12T08:40:00+00:00","mainEntityOfPage":{"@id":"https:\/\/transmediavictoria.net.au\/?p=25054"},"wordCount":490,"articleSection":["Business News"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/transmediavictoria.net.au\/?p=25054","url":"https:\/\/transmediavictoria.net.au\/?p=25054","name":"DigniCap Delta receives market approval in Japan - My Blog","isPartOf":{"@id":"https:\/\/transmediavictoria.net.au\/#website"},"datePublished":"2024-02-12T08:40:00+00:00","author":{"@id":"https:\/\/transmediavictoria.net.au\/#\/schema\/person\/5b51d407d652c0aa802bea269ea5d7e7"},"breadcrumb":{"@id":"https:\/\/transmediavictoria.net.au\/?p=25054#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/transmediavictoria.net.au\/?p=25054"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/transmediavictoria.net.au\/?p=25054#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/transmediavictoria.net.au\/"},{"@type":"ListItem","position":2,"name":"DigniCap Delta receives market approval in Japan"}]},{"@type":"WebSite","@id":"https:\/\/transmediavictoria.net.au\/#website","url":"https:\/\/transmediavictoria.net.au\/","name":"My Blog","description":"My WordPress Blog","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/transmediavictoria.net.au\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/transmediavictoria.net.au\/#\/schema\/person\/5b51d407d652c0aa802bea269ea5d7e7","name":"admin_tony","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g","caption":"admin_tony"},"url":"https:\/\/transmediavictoria.net.au\/?author=8"}]}},"_links":{"self":[{"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=\/wp\/v2\/posts\/25054","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=25054"}],"version-history":[{"count":0,"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=\/wp\/v2\/posts\/25054\/revisions"}],"wp:attachment":[{"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=25054"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=25054"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=25054"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}