– Utrecht (The Netherlands), Cambridge (United States) – Gilde Healthcare company Axonics, a medical technology company that commercializes a novel implantable rechargeable sacral neuromodulation (“SNM”) device for the treatment of urinary and bowel dysfunction, today announced the…
– Data Provide Preliminary Evidence of Efficacy of the Investigational Peregrine System Kit SAN JOSE, Calif. and PARIS – Ablative Solutions, Inc., a company pioneering new approaches for the treatment of hypertension, today announced 12-month results from the Peregrine Post-Market…
– Utrecht (The Netherlands), Cambridge (United States) – Gilde Healthcare company CVRx, Inc., announces today that it received Premarket Approval (PMA) from the United States Food and Drug Administration (FDA) to market its BAROSTIM NEO device for heart failure in the United States.…
– Financing co-led by new investors LSP and Andera Partners, with participation of existing investors Forbion, Ysios Capital, Kurma Partners, ID Invest Partners, BB Pureos Bioventures and Gilde Healthcare Proceeds to be used for the 1,400-patient international pivotal Phase III trial…
– Veteran Leader Brings Extensive Experience from Both Pharma and Device Industries San Jose, Calif., US - Ablative Solutions, Inc., a company pioneering new approaches to the treatment of hypertension, today announced that Kate Rumrill has been appointed as the new President and…
– Cambridge, UK and Indianapolis, US - Acacia Pharma, a pharmaceutical company developing and commercialising hospital products for US and international markets, announces receipt of the official Type A meeting minutes from the US Food and Drug Administration (“FDA”) relating to the…
– IRVINE, Calif., /PRNewswire/ -- Inari Medical, Inc. announced today that the company has appointed Thomas M. Tu, M.D. as Chief Medical Officer. Dr. Tu is a pioneer in definitive catheter-based treatment of pulmonary embolism (PE). He was the lead author in the publication of the…
– Proceeds to enable progression of orphan designated lead candidate SNF472 into pivotal phase 3 trial for treatment of calciphylaxis Round led by Spanish investor Caixa Capital Risc Deal supported by new investors Columbus Venture Partners and Alta Life Sciences in addition to…
– Utrecht (The Netherlands), Cambridge (United States) - Gilde Healthcare today announces its investment in Vesper Medical, Inc. (Wayne, PA), a developer of medical devices for minimally invasive peripheral vascular procedures. Gilde Healthcare led the $37 million financing together…
– Utrecht, The Netherlands - QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced 510(k) clearance of its QIAstat-Dx syndromic testing system by the U.S. Food and Drug Administration. The regulatory approval will trigger a milestone payment to Gilde Healthcare which…
– Phase 3 BOSTON clinical studies will evaluate Liposomal Cyclosporine A for Inhalation (L CsA i), the first potential therapy for Bronchiolitis Obliterans Syndrome (BOS) BOS is a devastating lung disease with high mortality affecting over 30,000 people worldwide following lung or…
– Utrecht, The Netherlands and Mont-Saint-Guibert, Belgium – Nyxoah S.A., a healthtech company focusing on the development of innovative solutions and services for sleep related disorders, today announced that the company has received CE Mark approval for the Genio™ system in Europe.…
– Gilde Healthcare’s investment allows Eetgemak to realize new growth plans, including expansion into Belgium Utrecht and Frankfurt - Gilde Healthcare, the European specialist investor in healthcare, acquires a majority stake in Eetgemak from stock listed investment firm Value8.…
– IRVINE, CA – Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, reported today financial…
– Utrecht, The Netherlands and Boston, US - Calypso Biotech (Amsterdam, The Netherlands), an emerging leader in the development of therapeutic antibodies for autoimmune diseases, announces today the closing of a €20M Series A financing led by Gilde Healthcare and Inkef Capital. They…
– Irvine, CA – Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, today announced the submission…
– Cambridge, UK and Indianapolis, US - Acacia Pharma (EURONEXT: ACPH) announces results from its latest study of BARHEMSYS™, its anti-emetic currently under FDA review for the management of post-operative nausea & vomiting (PONV). The study did not find a significant risk for heart…
– Cambridge, UK and Indianapolis, US - Acacia Pharma Group plc ("Acacia Pharma", the "Company") (EURONEXT: ACPH) announces that data and analyses from its positive Phase 2 clinical trial of APD403 (intravenous and oral amisulpride) in chemotherapy induced nausea and vomiting (CINV)…
– IRVINE, CALIFORNIA – Inari Medical, Inc. announced today the enrollment of the first patient in the FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (“FLASH”) using the FlowTriever® System for the treatment of pulmonary embolism (PE”). FLASH is a 500-patient…
– Utrecht (The Netherlands), Boston (United States) – Lumeon, the digital health scale-up in Care Pathway Management (CPM), today announced the closure of a $28M investment. The financing allows Lumeon to expand its U.S. team and Boston headquarters, scale commercial operations and…
– All Patients Achieved and Sustained Therapeutic Factor IX Activity with a Mean FIX Level of 31% of Normal at Six Weeks After Administration None of the Patients Received Factor Infusions, Experienced Any Reported Bleeding Events or Required Immunosuppression Over a Combined 24 Weeks…
– Utrecht (The Netherlands) - Nyxoah S.A., a medical device company focused on the development and commercialization of a best-in-class hypoglossal nerve stimulation (HGNS) therapy for the treatment of Obstructive Sleep Apnea (OSA), announced today that it successfully raised an additional…