AM-Pharma Raises Record Financing of €116m [$133m] for Phase III Trial in Acute Kidney Injury
– 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…
Ablative Solutions Announces Appointment of Kate Rumrill as President and Chief Executive Officer
– 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…
Acacia Pharma plans to resubmit the BARHEMSYS® NDA in Q3 2019
– 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…
Inari Medical Appoints Thomas M. Tu, M.D. as Chief Medical Officer
– 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…
Sanifit announces €72.2M ($80.9M) financing in Spain’s largest private biotech fundraise
– 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…
Gilde Healthcare co-leads $37M financing of Vesper Medical to complete development of its Duo Venous Stent System
– 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…
QIAstat-Dx gains 510(k) clearance by FDA, triggering milestone payment for Gilde Healthcare
– 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…
Breath Therapeutics Announces Initiation of Global Phase 3 Trials for the Treatment of Bronchiolitis Obliterans Syndrome
– 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…
Nyxoah receives European CE Mark approval for the Genio™ system to treat sleep apnea
– 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 acquires healthcare food supplier Eetgemak from Value8
– 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.…
Axonics® Announces Fourth Quarter and Full Year 2018 Financial Results and Operational Update
– 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…
Gilde Healthcare leads EUR 20M Series A financing round of Calypso Biotech
– 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…
Axonics® Submits Full Body MRI Data to U.S. Food & Drug Administration for its Sacral Neuromodulation System
– 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…
Acacia Pharma reports positive cardiac safety data for BARHEMSYS™
– 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…
Acacia Pharma announces positive clinical results for APD403 in chemotherapy induced nausea & vomiting published in Supportive Care in Cancer
– 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)…
Inari Medical Announces First Patient Enrolled in FLASH Registry Using the FlowTriever System for Pulmonary Embolism
– 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…
Lumeon secures $28M in funding to accelerate growth in the US market
– 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…
uniQure Announces Initial Topline Data from Study of AMT-061 in Patients with Hemophilia B
– 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…
Nyxoah raises €15 million in financing round led by Australian MedTech corporate Cochlear (ASX: COH)
– 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…
Vapotherm raises $56M via an IPO at NYSE
– Utrecht (The Netherlands), Cambridge (United States) – Respiratory device producer Vapotherm, Inc. announced its Initial Public Offering and listing on the NYSE exchange. Shares in the IPO are issued to institutional investors in the US and Europe, raising gross proceeds of $56 million.…
Axonics raises $120 million via an Initial Public Offering on NASDAQ
– Utrecht (The Netherlands), Cambridge (United States) - Axonics Modulation Technologies announced its Initial Public Offering and listing on the NASDAQ exchange. Shares in the IPO are issued to institutional investors in the US and Europe, raising gross proceeds of $120 million, representing…
Acacia Pharma Announces Positive Barhemsys Data Published in Leading Anaesthesia Journal
– Phase 3 Clinical Trial Data Show Efficacy of BARHEMSYS in Treatment of Post-Operative Nausea & Vomiting Cambridge, UK and Indianapolis, US - Acacia Pharma Group plc ("Acacia Pharma", the "Company") (EURONEXT: ACPH) announces that data and analyses from its positive Phase 3 clinical…