– 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…
– 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.…
– 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…
– 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…
– Breath Therapeutics Appoints Noreen Roth Henig, M.D. as Chief Medical Officer - Dr. Henig adds leadership and development expertise in pulmonary disease, inhaled therapies, and orphan disease to the executive management team - Breath Therapeutics is targeting Bronchiolitis Obliterans…
– Cambridge, UK and Indianapolis, US - Acacia Pharma (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialisation of new nausea & vomiting treatments for surgical and cancer patients, has secured a credit facility of up to $30 million with Hercules…
– The trial, called WINGS, will evaluate the safety and efficacy of QR-313 in subjects with recessive dystrophic epidermolysis bullosa due to mutations in exon 73 of the COL7A1 gene. QR-313 is a first-in-class potential therapeutic RNA molecule designed to improve the healing and integrity…
– LEXINGTON, Mass. and AMSTERDAM, the Netherlands (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe unmet medical needs, today announced that it has enrolled its first patient in the Phase III HOPE-B…
– Gilde Healthcare has announced that they have transferred their shares in the physiotherapy chain Fysius Back Clinics to AAC Capital. With the support of Gilde Healthcare, Fysius has grown into a national chain with 29 locations specialized in back care. Fysius is a chain of treatment…
– 's-Hertogenbosch, The Netherlands - Lava Therapeutics ("LAVA") today announced it has raised EUR 16 million in its first major institutional financing round from an investor syndicate led by Gilde Healthcare. The funding will support development of LAVA's proprietary pipeline of bispecific…