Respiratory company Vapotherm provides business update in response to COVID-19 pandemic
– New Hampshire (United States) – Vapotherm, Inc. (NYSE: VAPO), the Gilde Healthcare company focused on the commercialization of its proprietary Hi-VNI Technology products that are used to treat patients suffering from respiratory distress, today announced an update on their business…
Acacia Pharma announces year and results and outlook 2020
– Cambridge (United Kingdom) and Indianapolis (United States) – Acacia Pharma (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery,…
Acacia Pharma announces US FDA approval of BARHEMSYS® to treat PONV
– Cambridge (United Kingdom) and Indianapolis (United States) – Gilde Healthcare company Acacia Pharma (EURONEXT: ACPH), a hospital pharmaceutical company focused on therapeutic solutions improving the care of patients undergoing significant treatments such as surgery, other invasive…
Ablative Solutions Announces Publication of Data from the Peregrine Post-Market Study in the Journal of the American College of Cardiology: Cardiovascular Interventions
– Data Provide Preliminary Evidence of Efficacy of the Investigational Peregrine System Kit SAN JOSE, Calif. — Ablative Solutions, Inc., a company pioneering new approaches for the treatment of hypertension, today announced that positive six-month results from the Peregrine Post-Market…
First patient dosed in pivotal phase 3 trial of SNF472 in calciphylaxis
– First patient dosed in phase 3 trial of SNF472 for the treatment of calcific uremic arteriolopathy (CUA) or calciphylaxis Palma, Spain and San Diego, USA – Sanifit, a clinical-stage biopharmaceutical company focused on developing treatments for calcification disorders, today announced…
Axonics® receives reimbursement approval in Germany for its Sacral Neuromodulation
– Irvine, CA (United States) – Gilde Healthcare portfolio company Axonics Modulation Technologies, Inc. (NASDAQ:AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable Sacral Neuromodulation (“SNM”) devices for the treatment of bladder…
Acacia Pharma wins BEL Small Company of the Year Award 2019
– Cambridge (United Kingdom) and Indianapolis (United States) – Gilde Healthcare portfolio company Acacia Pharma Group plc (EURONEXT: ACPH), a pharmaceutical company developing and commercialising hospital products for US and international markets, has been awarded BEL Small Company…
Acacia Pharma signs strategic in-licensing and finance agreement with Cosmo Pharmaceuticals N.V.
– Acacia Pharma has in-licensed exclusive US rights to ultra-short-acting sedative, ByFavo™ (remimazolam) from Cosmo adding to its portfolio of near-market products Cosmo will make a €10 million equity investment in Acacia Pharma and provide a new €35 million loan facility to support…
MercachemSyncom acquires the European operations of Alcami
– Utrecht (the Netherlands) – Gilde Healthcare portfolio company MercachemSyncom, the leading mid-sized European drug-discovery contract research organization, has announced that it has acquired Alcami’s European cGMP CMC drug substance development site, based in Weert, the Netherlands. The…
Lava Therapeutics appoints immuno-oncology experts James Allison, Ph.D. and Padmanee Sharma, M.D., Ph.D. to advisory board
– Utrecht (the Netherlands) and Philadelphia (United States) – Gilde Healthcare company Lava Therapeutics (“LAVA”) announced that James P. Allison, Ph.D., a 2018 Nobel Prize recipient in Physiology or Medicine for his discovery of cancer therapy by inhibition of negative immune regulation,…
Gilde Healthcare exits occupational health provider BlijWerkt to Mentha Capital
– Utrecht (the Netherlands) – Gilde Healthcare today announced it has sold its majority stake in occupational health provider BlijWerkt to Mentha Capital, subject to approval by the Dutch Healthcare Authority. Led by Gilde, BlijWerkt has become a national player and challenger to the…
Lumeon partners with Medtronic on value-based care
– Utrecht (the Netherlands) and London, (UK) – Lumeon, the leader in Care Pathway Management (CPM), today announced that it has entered a strategic partnership with Medtronic, a global leader in medical technology, services, and solutions, that will support Medtronic’s European healthcare…
Axonics® raises $110 million via Public Offering of Common Stock
– Irvine, CA (US) – Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) (“Axonics”), a medical technology company that has developed and is commercializing novel implantable rechargeable sacral neuromodulation (“SNM”) devices for the treatment of bladder and bowel dysfunction, today…
Axonics® announces U.S. FDA approval for its sacral neuromodulation system for urinary clinical indications
– Irvine, CA (US) – Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable sacral neuromodulation (“SNM”) devices for the treatment of bladder and bowel dysfunction, today announced…
Sanifit announces positive Phase 2b data in cardiovascular calcification
– Utrecht (The Netherlands), Palma (Spain) and San Diego (US) – Sanifit, a clinical-stage biopharmaceutical company focused on treatments for progressive vascular calcification disorders, today announced that the international Phase 2b CaLIPSO study of SNF472 in patients with end stage…
Nyxoah publishes positive clinical data
– Utrecht (The Netherlands) and Mont-Saint-Guibert (Belgium) – Nyxoah S.A., a healthtech company focused on the development of innovative solutions and services for sleep related disorders, announced today the publication of data from the BLAST OSA (BiLAteral Hypoglossal Nerve Stimulation…
Axonics® Provides Full One-Year Results from ARTISAN-SNM Pivotal Study at AUGS/IUGA Joint Scientific Meeting
– Durable Outcomes Highlighted in Plenary Session Presentation; Expanding on Positive Topline Data Released in August More than 350 Physicians Attended a Symposium Highlighting Hands-on Physician Experience with the Recently FDA-Approved Axonics r-SNM® System1 IRVINE, Calif.— Axonics…
Acacia Pharma announces new BARHEMSYS® PDUFA date of 26 february 2020
– Utrecht (The Netherlands) and Cambridge (Massachusetts) – Gilde Healthcare company Acacia Pharma (BRU:ACPH), a pharmaceutical company developing and commercializing hospital products for US and international markets, announces that the US Food and Drug Administration (FDA) has accepted…
Axonics receives FDA approval for neurostimulator to treat fecal incontinence
– 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…
Ablative Solutions Announces Positive 12-Month Results from Study Evaluating Company’s Novel Therapy for Uncontrolled Hypertension
– 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…
CVRx obtains FDA approval for heart failure neuromodulation device
– 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.…
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…