{"id":14685,"date":"2026-06-02T18:05:00","date_gmt":"2026-06-02T16:05:00","guid":{"rendered":"http:\/\/stocks-future.com\/?guid=27f1df3aab98c97e0db19991301375ed"},"modified":"2026-06-02T18:05:00","modified_gmt":"2026-06-02T16:05:00","slug":"nephrodites-holly-implantable-continuous-dialysis-system-awarded-selection-into-fdas-tap-to-accelerate-development-and-patient-access","status":"publish","type":"post","link":"https:\/\/stocks-future.com\/?p=14685","title":{"rendered":"Nephrodite\u2019s Holly\u2122 Implantable Continuous Dialysis System Awarded Selection into FDA\u2019s TAP to Accelerate Development and Patient Access"},"content":{"rendered":"<ul class=\"bwlistdisc\">\n<li>\nNephrodite is among a select group of companies to hold both FDA Breakthrough Device Designation and TAP acceptance<\/li>\n<li>\nThe FDA\u2019s Total Product Life Cycle Advisory Program (TAP) provides Nephrodite with deeper solution-focused engagement from FDA experts and other stakeholders<\/li>\n<\/ul><p>ATLANTA--(BUSINESS WIRE)--<a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fnephrodite.com%2F&amp;esheet=54544333&amp;newsitemid=20260602635977&amp;lan=en-US&amp;anchor=Nephrodite%2C+Inc.&amp;index=1&amp;md5=9dc5b8fc971caa4ca76e4b29ac5fddbc\" rel=\"nofollow\" shape=\"rect\">Nephrodite, Inc.<\/a>, a medical device company developing an implantable, continuous renal replacement system, today announced that its Holly\u2122 system has been selected to participate in TAP by the U.S. Food and Drug Administration (FDA).<\/p><br\/><a href=\"https:\/\/mms.businesswire.com\/media\/20260602635977\/en\/2818902\/5\/Logo%3DDark_%284%29.jpg\"><img src=\"https:\/\/mms.businesswire.com\/media\/20260602635977\/en\/2818902\/22\/Logo%3DDark_%284%29.jpg\" \/><\/a><br\/><a href=\"https:\/\/mms.businesswire.com\/media\/20260602635977\/en\/2818902\/5\/Logo%3DDark_%284%29.jpg\"><img src=\"https:\/\/mms.businesswire.com\/media\/20260602635977\/en\/2818902\/21\/Logo%3DDark_%284%29.jpg\" \/><\/a><p>\n\u201cWe are dedicated to moving our technology as quickly and safely as possible into healthcare systems for eligible patients with end-stage kidney disease to stop the burden of three-times-weekly, clinic-based dialysis and improve their physical and mental health, mobility and quality of life. This recognition from the FDA demonstrates our shared goals and the structured framework will support Nephrodite through clinical development,\u201d said Nikhil Shah, DO, MPH, Co-Founder and CEO of Nephrodite. \u201cWe\u2019re actively preparing for Good Laboratory Practice studies and compiling the necessary regulatory submissions to clear the path for early feasibility trials of our investigational device.\u201d<\/p><p>\nTAP is designed to accelerate development and patient access for medical devices addressing critical unmet healthcare needs by enabling early and frequent engagement with FDA advisors to inform clinical, regulatory and commercialization planning.<\/p><p>\nNephrodite\u2019s participation in TAP builds on its Breakthrough Device Designation received in late 2025 and is intended to support regulatory alignment around the company\u2019s upcoming Good Laboratory Practice (GLP) studies, a key step toward first-in-human evaluation. This early alignment with the FDA is expected to reduce regulatory uncertainty, improve development efficiency and establish a more predictable path to FDA authorization and Medicare coverage through the recently announced RAPID program.<\/p><p>\n\u201cDialysis is a life-saving, but burdensome and incomplete analog for kidney function, requiring patients to adhere to rigid treatment schedules that significantly impact quality of life,\u201d said Hiep Nguyen, MD, Co-Founder and Senior Vice President of Science and Technology at Nephrodite. \u201cIn patients with end-stage kidney disease, I see a clear and urgent need for our Holly device every day. It\u2019s a solution that I believe will deliver continuous, mechanical renal replacement therapy that supports independence in their daily lives. We are hearing from patients all over the United States, and universally they are eager for change that gives them more independence.\u201d<\/p><p>\nHolly is an implantable, continuous dialysis system designed to provide sustained toxin clearance and fluid balance without the burden of intermittent, clinic-based dialysis. The system is being developed as an alternative renal replacement solution for patients with end-stage kidney disease.<\/p><p>\nFollow Nephrodite on <a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fnephrodite-inc%2F&amp;esheet=54544333&amp;newsitemid=20260602635977&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=2&amp;md5=3d87a0d4dfdaeb161256eefb2f6f4316\" rel=\"nofollow\" shape=\"rect\">LinkedIn<\/a> and visit <a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fnephrodite.com&amp;esheet=54544333&amp;newsitemid=20260602635977&amp;lan=en-US&amp;anchor=nephrodite.com&amp;index=3&amp;md5=206b03bf62b304a637d81a1e00b19a8a\" rel=\"nofollow\" shape=\"rect\">nephrodite.com<\/a> for ongoing updates.<\/p><p>\n<i>Holly\u2122 is an investigational device and is not yet approved for commercial use.<\/i><\/p><p>\n<b>About Nephrodite<\/b><\/p><p>\nNephrodite is a medical device company dedicated to creating a better alternative to dialysis by developing Holly, an implantable, continuous renal replacement device designed to restore freedom, function and independence in people living with end-stage kidney disease. Founded by board-certified urologists Nikhil L. Shah, DO, MPH, and Hiep T. Nguyen, MD, the company combines deep clinical expertise with engineering innovation to deliver a true renal replacement platform. Headquartered in Atlanta, Georgia, Nephrodite is backed by leading investors and supported by a robust intellectual property portfolio.<\/p><br\/> <b>Contacts<\/b> <br\/><p>\nMedia Contact:\n<br\/>Eric Schudiske\n<br\/><a  href=\"mailto:eric@bioscribe.com\" rel=\"nofollow\" shape=\"rect\">eric@bioscribe.com<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Nephrodite is among a select group of companies to hold both FDA Breakthrough Device Designation and TAP acceptance<\/p>\n<p>The FDA\u2019s Total Product Life Cycle Advisory Program (TAP) provides Nephrodite with deeper solution-focused engagement from FDA expert&#8230;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-14685","post","type-post","status-publish","format-standard","hentry","category-infos-businesswire"],"_links":{"self":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/14685","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=14685"}],"version-history":[{"count":1,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/14685\/revisions"}],"predecessor-version":[{"id":14686,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/14685\/revisions\/14686"}],"wp:attachment":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=14685"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=14685"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=14685"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}