{"id":923045,"date":"2025-12-30T16:11:13","date_gmt":"2025-12-30T21:11:13","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic\/"},"modified":"2025-12-30T16:11:13","modified_gmt":"2025-12-30T21:11:13","slug":"koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic\/","title":{"rendered":"KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE\u00ae System with a Commercialized Oncology Biologic"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwlistdecimal { list-style-type: decimal }\n.bwlistdisc { list-style-type: disc }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE\u00ae System with a Commercialized Oncology Biologic<\/b><\/p>\n<p>MAHWAH, N.J.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<b>KORU Medical Systems, Inc. (NASDAQ: KRMD) (\u201cKORU Medical\u201d or the \u201cCompany\u201d),<\/b> a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for the use of KORU Medical\u2019s FreedomEDGE\u00ae infusion system to subcutaneously administer PHESGO\u00ae (pertuzumab\/trastuzumab\/hyaluronidase-zzxf), a co-formulated therapy for HER2+ breast cancer.<sup>1<\/sup><\/p>\n<p>\nThe submission represents a key milestone in KORU Medical\u2019s strategy to expand the use of the FreedomEDGE\u00ae system beyond its current immunoglobulin (Ig) indications and into the broader oncology infusion center market. The increasing shift from intravenous (IV) to subcutaneous (SC) drug delivery for cancer therapies allows for faster drug administration, reduced patient chair time, and aligns with a movement towards a more efficient care model.<sup>2<\/sup><\/p>\n<p>\nHowever, despite these advances, infusion centers continue to face unmet needs related to nursing satisfaction with drug administration, including workflow complexity associated with treatment protocol, time constraints for set up and physical discomfort for both patients and nurses during infusions.<sup> 3<\/sup> The FreedomEDGE\u00ae system is designed to address these challenges by enabling consistent, controlled large-volume SC delivery while supporting more streamlined clinical workflows.<\/p>\n<p>\n\u201cThe submission of our 510(k) for clearance of the FreedomEDGE\u00ae with a subcutaneous oncology biologic is a pivotal milestone for KORU. It sets the foundation for future growth and underscores our strategy to expand KORU\u2019s leadership into the growing drug delivery device market for oncology therapies,\u201d said Linda Tharby, KORU Medical\u2019s President and CEO. \u201cThis regulatory filing and expected clearance represents an exciting opportunity to enter a new point of care where we believe our technology can address a meaningful unmet need by improving the administration experience for nurses while supporting greater efficiency in oncology infusion centers.\u201d<\/p>\n<p>\nKORU Medical anticipates a market entry upon FDA 510(k) clearance.<\/p>\n<p>\nKORU Medical\u2019s Freedom Infusion System enables, simplifies, and enhances the delivery of large-volume subcutaneous drugs. Supporting drug products with various requirements for viscosity, flow rate, and delivered drug volume, the Freedom System is market proven with:<\/p>\n<ul class=\"bwlistdisc\">\n<li>\n15+ years on the market<\/p>\n<\/li>\n<li>\n45,000+ patients and over 2M infusions annually<sup>4<\/sup><\/li>\n<li>\n97% adherence rate and 8 on-label Subcutaneous drugs across 30+ countries<sup>5<\/sup><\/li>\n<\/ul>\n<p><b>Forward-looking Statements<\/b><\/p>\n<p>\nThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. All statements that are not historical fact are forward-looking statements, including, but not limited to, anticipated 510(k) clearance. Actual results may differ materially from the results predicted. The potential risks and uncertainties that could cause actual results to differ from the results predicted include those risks and uncertainties included under the captions \u201cRisk Factors\u201d in our Annual Report on Form 10-K for the year ended December 31, 2024 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, which are on file with the SEC and available on our website at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.korumedical.com%2Finvestors&amp;esheet=54386157&amp;newsitemid=20251230163792&amp;lan=en-US&amp;anchor=www.korumedical.com%2Finvestors&amp;index=1&amp;md5=cf290426587d0e47493a46d81f01b139\">www.korumedical.com\/investors<\/a> and on the SEC website at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.sec.gov&amp;esheet=54386157&amp;newsitemid=20251230163792&amp;lan=en-US&amp;anchor=www.sec.gov&amp;index=2&amp;md5=4e881ab3005a29588ff193e050b760a7\">www.sec.gov<\/a>. All information provided in this release and in the attachments is as of December 30, 2025. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. We undertake no duty to update this information unless required by law.<\/p>\n<p><b>About KORU Medical Systems<\/b><\/p>\n<p>\nKORU Medical develops, manufactures, and commercializes innovative and patient-centric subcutaneous infusion solutions that improve quality of life for patients around the world. The Freedom Syringe Infusion System (the \u201cFreedom System\u201d) currently includes the Freedom60<sup>\u00ae<\/sup> and FreedomEDGE<sup>\u00ae<\/sup> Syringe Infusion Drivers, Precision Flow Rate Tubing<sup>\u2122 <\/sup>and High-Flo Subcutaneous Safety Needle Sets<sup>\u2122<\/sup>. The Freedom System, which received its first FDA clearance in 1994, is used for self-administration in the home by the patient and\/or delivery in a clinical setting by a healthcare professional. Through its Pharma Services and Clinical Trials business, KORU Medical provides products for use by biopharmaceutical companies in feasibility\/clinical trials during the drug development process and, as needed, is capable of customizing the Freedom System for clinical and commercial use across multiple drug categories. For more information, please visit<b \/><a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.korumedical.com%2F&amp;esheet=54386157&amp;newsitemid=20251230163792&amp;lan=en-US&amp;anchor=www.korumedical.com&amp;index=3&amp;md5=36230909ce09eb9eff083f61f9bad2bd\"><b>www.korumedical.com<\/b><\/a><b>.<\/b><\/p>\n<p><b>References<\/b><\/p>\n<ol class=\"bwlistdecimal\">\n<li><a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.phesgo.com%2F&amp;esheet=54386157&amp;newsitemid=20251230163792&amp;lan=en-US&amp;anchor=PHESGO%26%23174%3B+%28pertuzumab+%2F+trastuzumab+%2F+hyaluronidase-zzfx%29+%7C+A+Treatment+for+HER2-Positive+Breast+Cancer&amp;index=4&amp;md5=1a28dc7d87ad1ac3c26695a2aab45dcd\">PHESGO\u00ae (pertuzumab \/ trastuzumab \/ hyaluronidase-zzfx) | A Treatment for HER2-Positive Breast Cancer<\/a><\/li>\n<li>\nWu A, Rutland B, Southworth C. et al. (2025) The Transformative Potential of Large-Volume Subcutaneous Drug Delivery: A Discussion of Current Capabilities and Future Prospects for Pharmaceutical Manufacturers. Discover Pharmaceutical Sciences 1:11. <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fdoi.org%2F10.1007%2Fs44395-025-00012-6&amp;esheet=54386157&amp;newsitemid=20251230163792&amp;lan=en-US&amp;anchor=https%3A%2F%2Fdoi.org%2F10.1007%2Fs44395-025-00012-6&amp;index=5&amp;md5=1f939b9dd479c78a353edf26208d58de\">https:\/\/doi.org\/10.1007\/s44395-025-00012-6<\/a><\/li>\n<li>\nMajapuro-Hirvonen A, Wilkinson M, Bosshard J, Rutland B. Comparing Mechanical Pump and Manual Push for Short-Duration Subcutaneous Infusions: A Nursing Preference Survey Study. Poster presented at ESID EHA SIOPE Focused Symposium 2025; November 18-20, 2025; Vienna, Austria.<\/p>\n<\/li>\n<li>\nKORU Medical Estimates and Third-Party Data on File<\/p>\n<\/li>\n<li>\nRutland B, Bosshard J, Southworth C. Enhancing Drug Adherence and Patient Outcomes: The Role of SCIG Pump Selection in Subcutaneous Immunoglobulin Therapy for Primary Immunodeficiency Disease. Poster presented at: National Home Infusion Association Annual Conference; March 23-27, 2024; Austin TX.<\/p>\n<\/li>\n<\/ol>\n<p>\n\u00a0<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20251230163792r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20251230163792\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20251230163792\/en\/<\/a><\/span><\/p>\n<p>\nInvestor Contact:<br \/>\n<br \/>Louisa Smith<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:investor@korumedical.com\">investor@korumedical.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> New Jersey United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Biotechnology Pharmaceutical Nursing Oncology Health FDA Medical Devices Health Technology<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20251230163792\/en\/2267831\/3\/KORU_Logo.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE\u00ae System with a Commercialized Oncology Biologic MAHWAH, N.J.&#8211;(BUSINESS WIRE)&#8211;KORU Medical Systems, Inc. (NASDAQ: KRMD) (\u201cKORU Medical\u201d or the \u201cCompany\u201d), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for the use of KORU Medical\u2019s FreedomEDGE\u00ae infusion system to subcutaneously administer PHESGO\u00ae (pertuzumab\/trastuzumab\/hyaluronidase-zzxf), a co-formulated therapy for HER2+ breast cancer.1 The submission represents a key milestone in KORU Medical\u2019s strategy to expand the use of the FreedomEDGE\u00ae system beyond its current immunoglobulin (Ig) indications and into the broader oncology &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE\u00ae System with a Commercialized Oncology Biologic&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-923045","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE\u00ae System with a Commercialized Oncology Biologic - Market Newsdesk<\/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:\/\/www.marketnewsdesk.com\/index.php\/koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE\u00ae System with a Commercialized Oncology Biologic - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE\u00ae System with a Commercialized Oncology Biologic MAHWAH, N.J.&#8211;(BUSINESS WIRE)&#8211;KORU Medical Systems, Inc. (NASDAQ: KRMD) (\u201cKORU Medical\u201d or the \u201cCompany\u201d), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for the use of KORU Medical\u2019s FreedomEDGE\u00ae infusion system to subcutaneously administer PHESGO\u00ae (pertuzumab\/trastuzumab\/hyaluronidase-zzxf), a co-formulated therapy for HER2+ breast cancer.1 The submission represents a key milestone in KORU Medical\u2019s strategy to expand the use of the FreedomEDGE\u00ae system beyond its current immunoglobulin (Ig) indications and into the broader oncology &hellip; Continue reading &quot;KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE\u00ae System with a Commercialized Oncology Biologic&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-12-30T21:11:13+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20251230163792r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE\u00ae System with a Commercialized Oncology Biologic\",\"datePublished\":\"2025-12-30T21:11:13+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic\\\/\"},\"wordCount\":898,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20251230163792r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic\\\/\",\"name\":\"KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE\u00ae System with a Commercialized Oncology Biologic - 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(NASDAQ: KRMD) (\u201cKORU Medical\u201d or the \u201cCompany\u201d), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for the use of KORU Medical\u2019s FreedomEDGE\u00ae infusion system to subcutaneously administer PHESGO\u00ae (pertuzumab\/trastuzumab\/hyaluronidase-zzxf), a co-formulated therapy for HER2+ breast cancer.1 The submission represents a key milestone in KORU Medical\u2019s strategy to expand the use of the FreedomEDGE\u00ae system beyond its current immunoglobulin (Ig) indications and into the broader oncology &hellip; Continue reading \"KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE\u00ae System with a Commercialized Oncology Biologic\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic\/","og_site_name":"Market Newsdesk","article_published_time":"2025-12-30T21:11:13+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20251230163792r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE\u00ae System with a Commercialized Oncology Biologic","datePublished":"2025-12-30T21:11:13+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic\/"},"wordCount":898,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20251230163792r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/koru-medical-systems-announces-510k-submission-for-clearance-of-the-freedomedge-system-with-a-commercialized-oncology-biologic\/","name":"KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE\u00ae System with a Commercialized Oncology Biologic - 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