{"id":13894,"date":"2021-11-02T19:31:58","date_gmt":"2021-11-02T14:01:58","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=13894"},"modified":"2021-11-02T19:32:00","modified_gmt":"2021-11-02T14:02:00","slug":"recent-pharma-news-for-prolacta-renovia-magnus-hinge-health","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/recent-pharma-news-for-prolacta-renovia-magnus-hinge-health","title":{"rendered":"Magnus Medical\u2019s tech gets breakthrough status; Prolacta develops tests for pathogens detection; Renovia gets breakthrough designation for leva system; Hinge Health secures $600M funding"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a0d692bd0392\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a0d692bd0392\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/recent-pharma-news-for-prolacta-renovia-magnus-hinge-health\/#Magnus_Medicals_neurostimulation_technology_gets_FDA_breakthrough_status_to_treat_MDD\" >Magnus Medical\u2019s neurostimulation technology gets FDA breakthrough status to treat MDD<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/recent-pharma-news-for-prolacta-renovia-magnus-hinge-health\/#Prolacta_develops_test_for_pathogens_detection_in_donor_breast_milk\" >Prolacta develops test for pathogens detection in donor breast milk<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/recent-pharma-news-for-prolacta-renovia-magnus-hinge-health\/#Renovia_gets_FDA_breakthrough_designation_for_leva_system_for_chronic_faecal_incontinence_treatment_in_women\" >Renovia gets FDA breakthrough designation for leva system for chronic faecal incontinence treatment in women<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/recent-pharma-news-for-prolacta-renovia-magnus-hinge-health\/#Hinge_Health_secures_USD_600_Million_funding_to_boost_digital_health_capabilities\" >Hinge Health secures USD 600 Million funding to boost digital health capabilities<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-magnus-medical-s-neurostimulation-technology-gets-fda-breakthrough-status-to-treat-mdd\"><span class=\"ez-toc-section\" id=\"Magnus_Medicals_neurostimulation_technology_gets_FDA_breakthrough_status_to_treat_MDD\"><\/span><strong>Magnus Medical\u2019s neurostimulation technology gets FDA breakthrough status to treat MDD<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Magnus Medical has secured a breakthrough device designation from the US Food and Drug Administration (FDA) for its <strong><a href=\"https:\/\/www.delveinsight.com\/blog\/deep-brain-stimulation-devices-market\">neurostimulation technology for major depressive disorder (MDD) treatment<\/a><\/strong>.<\/p>\n\n\n\n<p>The individualised, rapid-acting, and non-invasive neurostimulation technology has been designed for <strong><a href=\"https:\/\/www.delveinsight.com\/blog\/major-depressive-disorder\">MDD treatment<\/a><\/strong> in people who have not improved sufficiently from antidepressant medication or other treatments.<\/p>\n\n\n\n<p>Magnus Medical has also secured USD 25 Million under the Series A financing round co-led by JAZZ Venture Partners and Red Tree Venture Capital.<\/p>\n\n\n\n<p>The Magnus system is developed using SAINT technology, which Magnus Medical exclusively licences from Stanford University for commercialisation.<\/p>\n\n\n\n<p>The investigational double-blinded randomised controlled trial (RCT) that evaluated SAINT technology displayed that it holds the potential to offer quick and better treatment for severe, refractory depression in a broader clinical setting.<\/p>\n\n\n\n<p>Fourteen study participants got active treatment, and another 15 received sham (placebo) treatment as part of the trials.<\/p>\n\n\n\n<p>The clinical study results showed that 79% of people in the active treatment arm entered remission compared to only 13% of people entering into emission in the sham treatment arm.<\/p>\n\n\n\n<p>In an earlier pilot study evaluating SAINT, 19 of 21 study participants (90%) entered remission, informed by the company.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Prolacta_develops_test_for_pathogens_detection_in_donor_breast_milk\"><\/span><strong>Prolacta develops test for pathogens detection in donor breast milk<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Prolacta Bioscience has developed a nucleic acid amplification test (NAAT) for detecting disease-causing pathogens in donated breast milk, including <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/covid-19-novel-coronavirus-19-therapeutic-pipeline-vaccines-diagnostics-competitive-landscape\">SARS-CoV-2<\/a><\/strong>.<\/p>\n\n\n\n<p>The company offers human milk-based nutritional products and applies NAAT to all donor milk received through its milk banks.<\/p>\n\n\n\n<p>Its NAAT protocol is designed to directly screen all the donated breast milk, substituting periodic donor blood tests or bulk testing of milk for viral DNA markers.<\/p>\n\n\n\n<p>The advanced test is made to address the concerns over milk donor\u2019s contract with a pathogen that could be transferred through the breast milk undetected, as the company said.<\/p>\n\n\n\n<p>Prolacta said that the human milk-banking industry currently tests milk donors for pathogens and infectious diseases in their blood at various intervals. As donors are not tested each time they donate milk, they could contact a virulent pathogen after initial or subsequent blood tests.<\/p>\n\n\n\n<p>Unaware of their infection, the donor may donate the milk, which could contain pathogens.<\/p>\n\n\n\n<p>Prolacta\u2019s NAAT directly tests the milk to ensure that both the donor and the donated milk are tested for infectious disease-causing pathogens. The testing will also decrease the risk of contaminated breast milk reaching the neonatal intensive care unit (NICU).<\/p>\n\n\n\n<p>Prolacta has started using NAAT on all its incoming donor milk in 2017 and has extended the platform to test for ten different disease-causing pathogens. It has added the real-time feature to detect <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/covid-19-therapeutic-pipeline-vaccines\">SARS-CoV-2<\/a><\/strong>, Mycobacterium tuberculosis, <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/zika-virus-infection-pipeline-insight\">Zika virus<\/a><\/strong>,T. pallidum, <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/human-immunodeficiency-virus-type-1-hiv-1-market\">HIV-1<\/a><\/strong> and HIV-2, HTLV-I and HTLV-II, <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/hepatitis-b-market\">hepatitis B<\/a><\/strong> and <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/hepatitis-c-market\">hepatitis C<\/a><\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Renovia_gets_FDA_breakthrough_designation_for_leva_system_for_chronic_faecal_incontinence_treatment_in_women\"><\/span><strong>Renovia gets FDA breakthrough designation for leva system for chronic faecal incontinence treatment in women<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Renovia has secured the US Food and Drug Administration (FDA) Breakthrough Device Designation (BDD) for its leva <strong><a href=\"https:\/\/www.delveinsight.com\/blog\/digital-therapeutics-for-depression\">Digital Therapeutic System<\/a><\/strong> for <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/fecal-incontinence-pipeline-insight\">chronic faecal incontinence treatment<\/a><\/strong> in women.<\/p>\n\n\n\n<p>The company is engaged in creating digital therapeutics for female pelvic floor disorders, and leva <strong><a href=\"https:\/\/www.delveinsight.com\/blog\/digital-therapeutics-in-medtech\">Digital Therapeutic<\/a><\/strong> is the company\u2019s lead product.<\/p>\n\n\n\n<p>The leva Digital Therapeutic system is already approved in the US for treating stress, mixed and mild to moderate urgency urinary incontinence (UI) and pelvic floor strengthening.<\/p>\n\n\n\n<p>Available by prescription, the device combines a small FDA-approved vaginal wand with a smartphone app to proffer real-time visualisation of pelvic movement.<\/p>\n\n\n\n<p>Faecal incontinence, which is commonly referred to as accidental bowel leakage, is a progressive condition.<\/p>\n\n\n\n<p>The involuntary loss of stool is embarrassing and places women at increased risk for depression, shame, guilt, social isolation, and nursing home placement.<\/p>\n\n\n\n<p>As per the company, first-line treatments for bowel leaks comprise antidiarrheal medications and rectal biofeedback devices.<\/p>\n\n\n\n<p>The medications and rectal biofeedback devices are challenging to maintain, and the evidence supporting the effectiveness of current <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/fecal-incontinence-market\">devices in Faecal incontinence treatment<\/a><\/strong> is limited.<\/p>\n\n\n\n<p>The leva System offers a non-invasive, surgery- and a drug-free way for women to train and strengthen their pelvic floor muscles at home and in just five minutes a day, as per Renovia.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Hinge_Health_secures_USD_600_Million_funding_to_boost_digital_health_capabilities\"><\/span><strong>Hinge Health secures USD 600 Million funding to boost digital health capabilities<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Hinge Health, a digital musculoskeletal clinic, has secured USD 600 Million in funding to expand its digital health capabilities.<\/p>\n\n\n\n<p>The company has closed a USD 400 Million series E financing, led by Tiger Global and Coatue Management, to fulfil the growing demand from Americans anticipating accessible care for back and joint pain.<\/p>\n\n\n\n<p>In addition, Alkeon and Whale Rock acquired ownership as part of a USD 200 Million secondary investment.<\/p>\n\n\n\n<p>With the latest funding, the company has achieved a USD 6.2 Billion valuation and turned into one of the most valuable <strong><a href=\"https:\/\/www.delveinsight.com\/blog\/potential-dangers-of-ai-in-healthcare\">companies in digital health<\/a><\/strong>.<\/p>\n\n\n\n<p>Hinge Health, which has doubled its customer base year over year, has one of the most extensive clinical, data science, and R&amp;D teams in digital health.<\/p>\n\n\n\n<p>Employers and health plans collaborated with Hinge Health to proffer members access to a clinical care team and an advanced technology portfolio.<\/p>\n\n\n\n<p>The portfolio comprises computer vision and motion sensors for exercise therapy and motion assessments and Hinge Health Enso <strong><a href=\"https:\/\/www.delveinsight.com\/blog\/covid-19-and-wearable-technology\">wearable technology<\/a><\/strong> for noninvasive and nonaddictive pain relief.<\/p>\n\n\n\n<p>The company also delivers HingeConnect to bridge the gap between in-person and digital MSK care and facilitate near-real-time interventions by integrating health data with more than 750,000 providers.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Magnus Medical\u2019s neurostimulation technology gets FDA breakthrough status to treat MDD Magnus Medical has secured a breakthrough device designation from the US Food and Drug Administration (FDA) for its neurostimulation technology for major depressive disorder (MDD) treatment. The individualised, rapid-acting, and non-invasive neurostimulation technology has been designed for MDD treatment in people who have not [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":13898,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[420,639],"industry":[17225],"therapeutic_areas":[17239,17233,17245],"class_list":["post-13894","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-news","tag-pharma-news","industry-pharmaceutical","therapeutic_areas-gastroenterology","therapeutic_areas-hematological-disorders","therapeutic_areas-neurology"],"acf":[],"yoast_head":"<!-- This site is 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