{"id":79814,"date":"2026-04-21T12:05:10","date_gmt":"2026-04-21T12:05:10","guid":{"rendered":"https:\/\/english.saigonbiz.com\/vn\/humacyte-announces-israeli-ministry-of-health-acceptance-of-marketing-authorization-application-for-symvess-for-vascular-trauma-repair\/"},"modified":"2026-04-21T12:05:10","modified_gmt":"2026-04-21T12:05:10","slug":"humacyte-announces-israeli-ministry-of-health-acceptance-of-marketing-authorization-application-for-symvess-for-vascular-trauma-repair","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/humacyte-announces-israeli-ministry-of-health-acceptance-of-marketing-authorization-application-for-symvess-for-vascular-trauma-repair\/","title":{"rendered":"Humacyte Announces Israeli Ministry of Health Acceptance of Marketing Authorization Application for Symvess\u00ae for Vascular Trauma Repair"},"content":{"rendered":"<div>\n<p align=\"center\"><em>&#8211; The Ministry of Health has set a 180-working-day review period for the MAA &#8211;\u00a0<\/em><\/p>\n<p align=\"center\"><em>&#8211; MAA process is one step in <\/em>planned expansion of<em> Symvess <\/em>into multiple countries outside of the U.S<em> &#8211; <\/em><\/p>\n<p>DURHAM, N.C., April  21, 2026  (GLOBE NEWSWIRE) &#8212; Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that its Marketing Authorization Application (MAA) seeking approval of the acellular tissue engineered vessel (ATEV, or Symvess) for arterial trauma repair has been accepted by the Israel Ministry of Health. The Ministry of Health has set a 180-working-day review period for the MAA due to the existing Food and Drug Administration (FDA) approval of Symvess in extremity vascular trauma.<\/p>\n<p>\u201cWe are very pleased that the Ministry of Health has accepted our MAA filing and has granted a 180-day review period,\u201d said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. \u201cThe MAA acceptance us another step in our planned global expansion of Symvess as we seek to provide this innovative regenerative medicine product to patients throughout the world. Many patients with severe vascular injuries are underserved by the current standard of care, and we are proud of the results that have been seen in our clinical trials and real-world humanitarian efforts.\u201d.<\/p>\n<p><strong>About Humacyte<\/strong><\/p>\n<p>Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte\u2019s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte\u2019s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA\u2019s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte\u2019s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=3cvfmXxWZ0lPkZALxk2VSQynOb4JTTzyrZysRnHZxihbj3LD4gTp7qyFW9eYC-YDsnkevZGMoSlKLG4odrPP6DY9k4UdZYxXcVdKYrUXdog=\" rel=\"nofollow\" target=\"_blank\" title=\"\"><u>www.Humacyte.com<\/u><\/a>.<\/p>\n<p><strong>Forward-Looking Statements<\/strong><\/p>\n<p>This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: \u201cmay,\u201d \u201cwill,\u201d \u201ccould,\u201d \u201cwould,\u201d \u201cshould,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cplan,\u201d \u201canticipate,\u201d \u201cbelieve,\u201d \u201cestimate,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201cpotential,\u201d \u201ccontinue,\u201d \u201congoing\u201d or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials; the anticipated characteristics and performance of our ATEVs; the implementation of our business model and strategic plans for our business; our ability to execute and achieve the expected benefits of our cost-saving measures and whether our efforts will result in further actions or additional asset impairment charges that adversely affect our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, competitive and\/or reputational factors, and other risks and uncertainties, including those described under the header \u201cRisk Factors\u201d in our Annual Report on Form 10-K for the year ended December 31, 2025 filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte\u2019s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.<\/p>\n<p><strong>Humacyte Investor Contact:<\/strong><br \/>Joyce Allaire<br \/>LifeSci Advisors LLC<br \/>+1-617-435-6602<br \/><u><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=GTlqByW4656FmNfmnTA9OQdLA3FVSJXAyJ2rjRboDGuyFAdMdHwWngJJiezICfCe1uQGS7dne_Fg5ma9lhwoaBiPeXPvCuZ0_R2_WxfKO4P5e_ndHMFIJoLftmbfzhAr\" rel=\"nofollow\" target=\"_blank\" title=\"jallaire@lifesciadvisors.com\">jallaire@lifesciadvisors.com<\/a><\/u><br \/><u><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=zdn34bDLiU4-l6sEggkyXpASEDrPgbw7lRl6xOTBgAmbDwIPU9LQnomY5bWhE3ZyNbufgnbrDR869CWwxTsSlCd_4Ay75-_V9ltVCaS6vtU=\" rel=\"nofollow\" target=\"_blank\" title=\"investors@humacyte.com\">investors@humacyte.com<\/a><\/u><\/p>\n<p><strong>Humacyte Media Contact:<\/strong><br \/>Rich Luchette<br \/>Precision Strategies<br \/>+1-202-845-3924<br \/><u><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=54_qaTTLZbQNDRY9_IqnmVD3KuaNZevBc_KrNE22olIqJax3bDbpgSigxvMbPak8gOCw2fGHJf5q3469P4BL6uh7SGEmsmdtnFEWdk4q5jwBrKSDYJZtpi9JLXyoAzav\" rel=\"nofollow\" target=\"_blank\" title=\"rich@precisionstrategies.com\">rich@precisionstrategies.com<\/a><\/u><br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=xqMVzM3kmbiWRs4sI1P-UyDgCF3OfNejEMnbeK8qFHXt-HwLumZNQhWlGwY8_OLp53lUOQo6x1JweFi8LyItx2_zxgN-kDCo-U40JtGe5MU=\" rel=\"nofollow\" target=\"_blank\" title=\"\"><u>media@humacyte.com<\/u><\/a><\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/ZTk2NThhNWQtZjYwMy00NzVhLWFkZjUtMGM0ODA0MGFjMjI2LTEyMjA5ODktMjAyNi0wNC0yMS1lbg==\/tiny\/Humacyte-Inc.png\" referrerpolicy=\"no-referrer-when-downgrade\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>&#8211; The Ministry of Health has set a 180-working-day review period for the MAA &#8211;\u00a0 &#8211; MAA process is one step in planned expansion of Symvess into multiple countries outside of the U.S &#8211; DURHAM, N.C., April 21, 2026 (GLOBE NEWSWIRE) &#8212; Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered [&#8230;]\n","protected":false},"author":1,"featured_media":79815,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-79814","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pr-newswire"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.6 (Yoast SEO v21.6) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Humacyte Announces Israeli Ministry of Health Acceptance of Marketing Authorization Application for Symvess\u00ae for Vascular Trauma Repair - Biz and Live in Saigon<\/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:\/\/english.saigonbiz.com\/vn\/humacyte-announces-israeli-ministry-of-health-acceptance-of-marketing-authorization-application-for-symvess-for-vascular-trauma-repair\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Humacyte Announces Israeli Ministry of Health Acceptance of Marketing Authorization Application for Symvess\u00ae for Vascular Trauma Repair\" \/>\n<meta property=\"og:description\" content=\"&#8211; The Ministry of Health has set a 180-working-day review period for the MAA &#8211;\u00a0 &#8211; MAA process is one step in planned expansion of S\" \/>\n<meta property=\"og:url\" content=\"https:\/\/english.saigonbiz.com\/vn\/humacyte-announces-israeli-ministry-of-health-acceptance-of-marketing-authorization-application-for-symvess-for-vascular-trauma-repair\/\" \/>\n<meta property=\"og:site_name\" content=\"Biz and Live in Saigon\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/SaigonbizGroup\" \/>\n<meta property=\"article:published_time\" content=\"2026-04-21T12:05:10+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/english.saigonbiz.com\/vn\/wp-content\/uploads\/2026\/04\/sgb-media-kit-2026.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1075\" \/>\n\t<meta property=\"og:image:height\" content=\"716\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"admin\" \/>\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\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/humacyte-announces-israeli-ministry-of-health-acceptance-of-marketing-authorization-application-for-symvess-for-vascular-trauma-repair\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/humacyte-announces-israeli-ministry-of-health-acceptance-of-marketing-authorization-application-for-symvess-for-vascular-trauma-repair\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/#\/schema\/person\/267b348e6cf32a66aab33637c2d399a6\"},\"headline\":\"Humacyte Announces Israeli Ministry of Health Acceptance of Marketing Authorization Application for Symvess\u00ae for Vascular Trauma Repair\",\"datePublished\":\"2026-04-21T12:05:10+00:00\",\"dateModified\":\"2026-04-21T12:05:10+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/humacyte-announces-israeli-ministry-of-health-acceptance-of-marketing-authorization-application-for-symvess-for-vascular-trauma-repair\/\"},\"wordCount\":1046,\"publisher\":{\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/#organization\"},\"articleSection\":[\"Pr Newswire\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/humacyte-announces-israeli-ministry-of-health-acceptance-of-marketing-authorization-application-for-symvess-for-vascular-trauma-repair\/\",\"url\":\"https:\/\/english.saigonbiz.com\/vn\/humacyte-announces-israeli-ministry-of-health-acceptance-of-marketing-authorization-application-for-symvess-for-vascular-trauma-repair\/\",\"name\":\"Humacyte Announces Israeli Ministry of Health Acceptance of Marketing Authorization Application for Symvess\u00ae for Vascular Trauma Repair - 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