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NightBalance obtains reimbursement in the Netherlands for its innovative sleep apnea therapy

22 december 2017 – The Hague, the Netherlands – NightBalance, a leader in innovative obstructive sleep apnea therapies, today announced that the Dutch National Health Care Institute (ZIN) issued a positive recommendation to include its sleep apnea therapy for reimbursement. The Sleep Position Trainer…

Gerelateerd aan: NightBalance

Sanifit appoints Alexander M. Gold, M.D., F.A.C.C. as Chief Medical Officer and President of its US subsidiary

14 december 2017 – Former SVP and Head of Clinical Development at Portola Pharmaceuticals appointed as Chief Medical Officer Palma, Spain and San Diego, USA – Laboratoris Sanifit S.L., a clinical-stage biopharmaceutical company focused on treatments for calcification disorders, today announces the…

Gerelateerd aan: Sanifit

Axonics® Granted Seven New U.S. Patents Related to its Implantable Sacral Neuromodulation Technology

4 december 2017 – Irvine, CA – Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of bladder and bowel dysfunction, announced today that the United States Patent and Trademark Office has granted Axonics seven new U.S.…

Gerelateerd aan: Axonics Modulation Technologies

Breath Therapeutics appoints Renu Gupta as Executive Director

28 november 2017 – Top-tier drug development executive joins Board of Directors Important reinforcement for development of lead program in Bronchiolitis Obliterans Munich, Frankfurt, Boston - Breath Therapeutics B.V. (Breath), a company developing advanced drug-aerosol therapeutics in pulmonary…

Gerelateerd aan: Breath Therapeutics

ProQR Prices Approximately $20 Million Underwritten Public Offering and Concurrent Registered Direct Offering of Ordinary Shares

14 november 2017 – LEIDEN, The Netherlands (GLOBE NEWSWIRE) -- ProQR Therapeutics N.V. (Nasdaq:PRQR), a biopharmaceutical company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases, today announced the pricing of its previously…

Gerelateerd aan: ProQR Therapeutics

ProQR Doses First LCA 10 Patient in Clinical Trial of QR-110, ProQR’s Lead Program for Genetic Blindness

13 november 2017 – Key Updates The first patient has received the first dose of QR-110 in the Phase 1/2 safety & efficacy clinical trial (PQ-110-001: NCT03140969) in children and adults with Leber’s congenital amaurosis 10 (LCA 10). LCA 10 is one of the most prevalent forms of gene-related blindness…

Gerelateerd aan: ProQR Therapeutics

Axonics® Receives IDE Clearance from U.S. FDA to Conduct a Pivotal Study with its Sacral Neuromodulation System for the Treatment of Urinary Dysfunction

7 november 2017 – Irvine, CA – Axonics Modulation Technologies, Inc., developer of the first rechargeable sacral neuromodulation (r-SNM™) system for the treatment of overactive bladder (OAB) and bowel dysfunction, today announced the U.S. Food & Drug Administration (FDA) has granted an Investigational…

Gerelateerd aan: Axonics Modulation Technologies

Lumeon Provides Real-Time Health System Orchestration to Cedars-Sinai Accelerator Powered by Techstars

24 oktober 2017 – Leading Care Pathway Management Platform to Dynamically Personalize and Streamline Surgery Experience for Patients BOSTON – Lumeon, the leader in Care Pathway Management, today announced its participation in the Cedars-Sinai Accelerator Powered by Techstars. Through the Accelerator,…

Gerelateerd aan: Lumeon

uniQure Strengthens Intellectual Property Portfolio with Acquisition of Patent Family Providing Broad Protection of the Hyperactive Padua Variant of Factor IX (FIX-Padua)

19 oktober 2017 – Issued Patent in the U.S. Covers Use of FIX-Padua in Gene Therapy Divisional patent applications filed to further strengthen Padua intellectual property position LEXINGTON, Mass. and AMSTERDAM, the Netherlands (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy…

Gerelateerd aan: uniQure

uniQure Announces Hemophilia B Gene Therapy Program To Enter Pivotal Study With FIX-Padua Variant in 2018

19 oktober 2017 – AMT-060 with the FIX-Padua Modification (AMT-061) Demonstrates Substantial Increase in FIX Activity in Non-human Primates Plans to Initiate Pivotal Study with Enhanced AMT-061 in 2018 Achieves Alignment with FDA on Streamlined Clinical and Regulatory Strategy for AMT-061, Which…

Gerelateerd aan: uniQure

NightBalance's Sleep Position Trainer compares favorably to standard therapy in long term study on treating positional sleep apnea

28 september 2017 – NightBalance announced the publication of a study comparing its innovative "Sleep Position Trainer" (SPT) to the historic standard of care oral appliance therapy (OAT) in mild to moderate positional obstructive sleep apnea (POSA) over a 12-month period.

Gerelateerd aan: NightBalance

ProQR Announces Positive Top-Line Results from a Phase 1b Study of QR-010 in Subjects with Cystic Fibrosis

25 september 2017 – ProQR Therapeutics today announced positive preliminary top-line results from a Phase 1b safety and tolerability clinical trial of QR-010, a novel investigational RNA therapeutic in subjects with cystic fibrosis (CF).

Gerelateerd aan: ProQR Therapeutics

Levicept Starts First-in-Human Phase I Trial of LEVI-04, A Novel Fusion Protein Therapy for Chronic Pain

14 september 2017 – Sandwich, UK -- Levicept Ltd., an asset-centric biotechnology company focused on the development of LEVI-04, a first-in-class treatment for chronic pain indications, today announces that it has commenced its Phase I trial of LEVI-04 in healthy volunteers and osteoarthritis patients…

Gerelateerd aan: Levicept

Positive Results for the Axonics® RELAX-OAB Clinical Study Presented at the International Continence Society Congress

13 september 2017 – Irvine, CA and Florence, Italy – Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and bowel dysfunction, today announced the presentation of positive results from its prospective, multicenter…

Gerelateerd aan: Axonics Modulation Technologies

Symphogen presents detailed results for randomized Phase 2 study with Sym004 in refractory metastatic colorectal cancer at ESMO 2017 Congress

11 september 2017 – Data show clinically meaningful improvement in overall survival in a biomarker-defined patient population with late-stage metastatic colorectal cancer COPENHAGEN, Denmark - Symphogen, an advanced clinical-stage antibody company focused on oncology, today announced detailed results…

Gerelateerd aan: Symphogen

Axonics(r) Appoints Dr. Karen L. Noblett as Chief Medical Officer

6 september 2017 – IRVINE, Calif. - Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM(tm)) system for the treatment of urinary and bowel dysfunction, today announced the appointment of Karen L. Noblett, M.D., M.A.S., a urogynecologist and prolific…

Gerelateerd aan: Axonics Modulation Technologies

ProQR Completes Dosing of Cystic Fibrosis Patients in QR-010 Phase 1b Trial

29 augustus 2017 – Key Updates Last patient received their final dose in the PQ-010-001 Phase 1b clinical trial of QR-010 in CF patients with the F508del mutation. Top-line trial data are expected to be issued in a press release post-market close on Monday, September 25, 2017, followed by a conference…

Gerelateerd aan: ProQR Therapeutics

Gilde Healthcare verkoopt Viroclinics Biosciences

29 augustus 2017 – UTRECHT – Gilde Healthcare kondigt vandaag aan dat het haar meerderheidsbelang in Viroclinics Biosciences (Viroclinics), een contract research organisatie (CRO) die farmaceutische bedrijven ondersteunt bij de ontwikkeling van nieuwe geneesmiddelen voor virale infecties, heeft verkocht…

Gerelateerd aan: Viroclinics Biosciences

Gilde Healthcare invests in Mercachem and Syncom to build the Premier European Drug Discovery Contract Research Organization

28 augustus 2017 – Utrecht, the Netherlands — Gilde Healthcare, the European specialist investor in healthcare, together with Dutch pension service provider PGGM, as co-investor, have invested in Mercachem and Syncom, two of the leading European drug discovery Contract Research Organizations (CRO).…

Gerelateerd aan: Symeres

Private Equity Looking for Interns

3 augustus 2017 – Gilde Healthcare Services, a lower mid-market buy-out fund focused on Benelux and Germany, is looking for a student intern that is able to support the investment team with its activities.

Agendia's MammaPrint® Recommended by ASCO Breast Cancer Guideline in Focused Update Based on Landmark MINDACT Trial Data

10 juli 2017 – ASCO® recommends MammaPrint® for clinical high risk, hormone receptor-positive, HER2- negative breast cancer, to inform decisions on withholding chemotherapy ASCO recommends MammaPrint as currently the only genomic test to be used to guide treatment decisions for 1-3 lymph node positive…

Gerelateerd aan: Agendia

Agendia's MammaPrint® recommended by the 2017 St. Gallen International Breast Cancer Guidelines in significant update

6 juli 2017 – IRVINE, CA and AMSTERDAM – Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics announces that the 15th St. Gallen International Breast Cancer Guidelines recently published in Annals of Oncology1 have recommended the MammaPrint® 70-Gene Breast Cancer…

Gerelateerd aan: Agendia

Gilde Healthcare participates in EUR 31 million financing round of neuromodulation company Axonics

6 juli 2017 – Utrecht, the Netherlands — Gilde Healthcare today announces its investment in Axonics (Paris, France and Irvine, US), developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and bowel dysfunction. Gilde Healthcare participated in a EUR…

Gerelateerd aan: Axonics Modulation Technologies

Lumeon wins MedTech Breakthrough Award

7 juni 2017 – LONDON AND NEW YORK – Lumeon, a leading digital health company, has won the MedTech Breakthrough Award for Best Overall Health Administration Software. The awards recognize the top companies, people, platforms and products in the global health and medical technology market today. Lumeon’s…

Gerelateerd aan: Lumeon

STAT-Dx obtains a EUR 20 million EIB loan facility under the InnovFin programme

1 juni 2017 – Malta STAT-Dx EUR 20 million EIB loan facility under the InnovFin programme to support medical diagnostics innovation in Spain The EIB is providing STAT-Dx (STAT-Diagnostica & Innovation, S.L.), a Spanish company developing advanced molecular diagnostic systems to help combat…

Gerelateerd aan: STAT-Dx QIAGEN

Agendia's MammaPrint® Now Included in Blue Shield of California Coverage for Breast Cancer Patients

1 juni 2017 – IRVINE, CA and AMSTERDAM – Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, today announces that Blue Shield of California has updated its Medical Policy 2.04.36 Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis…

Gerelateerd aan: Agendia

ProQR Receives Fast Track Designation from the FDA for QR-110 for Leber's Congenital Amaurosis Type 10

31 mei 2017 – Key Updates ProQR receives Fast Track designation by the U.S. Food and Drug Administration (FDA). Closer interaction with FDA could potentially accelerate the development of QR-110 in patients with Leber's Congenital Amaurosis Type 10 (LCA 10). LCA 10 is one of the most prevalent…

Gerelateerd aan: ProQR Therapeutics

AM-Pharma completes patient recruitment of recombinant human Alkaline Phosphatase (recAP) Phase II trial in Acute Kidney Injury

22 mei 2017 – Recruitment of 301 patients in STOP-AKI adaptive Phase II trial marks largest ever therapeutic study in AKI Bunnik, The Netherlands — AM-Pharma B.V., a biopharmaceutical company focused on the development of recombinant human Alkaline Phosphatase (reCAP) for inflammatory diseases,…

Gerelateerd aan: AM Pharma

ProQR Announces Clearance of IND Application to Start Clinical Trial for QR-110 in Leber’s Congenital Amaurosis Type 10 Patients

27 april 2017 – Key updates With the clearance of the investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA), ProQR can now start clinical development of QR-110 in Leber's congenital amaurosis Type 10 (LCA 10) patients LCA 10 is one of the most prevalent forms…

Gerelateerd aan: ProQR Therapeutics

Moximed Closes Oversubscribed $50MM Financing Round

16 maart 2017 – Funding Intended to Support FDA Approval and Early US Commercialization of Unicompartmental Load Absorber for Knee Osteoarthritis HAYWARD, California - Moximed®, Inc., developer of unicompartmental load absorber implants for active patients with painful knee osteoarthritis (OA),…

Gerelateerd aan: Moximed

Gilde Healthcare realizes trade sale of Bionx medical to Ottobock

15 maart 2017 – Bedford, Massachusetts — Otto Bock HealthCare GmbH, a global leader in prosthetics and orthotics, announced the acquisition of BionX Medical (BionX), a US-based portfolio company of Gilde Healthcare. BionX's flagship product is emPOWER, the world's only active prosthetic foot that…

Gerelateerd aan: BionX

Gilde Healthcare participeert in een EUR 43,5 miljoen financieringsronde van Duits farmacie bedrijf Breath Therapeutics

8 maart 2017 – Utrecht – Gilde Healthcare kondigt vandaag een investering aan in Breath Therapeutics, een Duits bedrijf dat zich bezighoudt met de ontwikkeling van geavanceerde drug-aerosol therapieën voor ernstige longziektes. De totale financieringsronde bedraagt EUR 43,5 miljoen. Gilde Healthcare…

Gerelateerd aan: Breath Therapeutics

Digital Noema Telehealth and Lumeon Partner to Optimize Telemedicine Pathways

20 februari 2017 – LONDON AND NEW YORK – Today at HIMSS, Lumeon, a leading digital health company, and Digital Noema Telehealth (DN Telehealth), a provider of telemedicine and remote patient monitoring, announce they are partnering to optimize care pathways for telemedicine reimbursements. DN Telehealth…

Gerelateerd aan: Lumeon

Acacia announces positive results from final pivotal Phase 3 trial of BAREMSIS™

13 februari 2017 – NDA to be submitted to the US FDA 1H 2017 Cambridge, UK – Acacia Pharma Group Ltd ("Acacia"), the supportive care company, announces positive results from its fourth and final pivotal Phase 3 study investigating its lead product BAREMSIS™ for the rescue treatment of patients who…

Gerelateerd aan: Acacia Pharma

Gilde Healthcare's buy & build platform RAD-x acquires medical imaging group to initiate European expansion

24 januari 2017 – RAD-x closes its first transaction: IRD SA, a leading Swiss Diagnostic Imaging Centre RAD-x announced that it has acquired Geneva-based IRD SA, a leading diagnostic imaging provider. The sellers of IRD SA will reinvest part of the proceeds in the RAD-x holding and join the Gilde…

Gerelateerd aan: RAD-x

Gilde Healthcare

Gilde Healthcare

Gilde Healthcare is een gespecialiseerde Europese investeringsmaatschappij met €1.4 miljard ($1.5 miljard) onder beheer in twee aparte fondsstrategieën: venture & groeikapitaal en private equity. Gilde Healthcare's venture & groeikapitaalfonds participeert in medische technologie en nieuwe geneesmiddelen. De venture & groeibedrijven zijn gevestigd in Europa en Noord Amerika. Gilde Healthcare’s private equity fonds neemt deel in winstgevende Europese bedrijven met een primaire focus op de middenmarkt in Benelux en Duitstalige landen. Het private equity fonds is gericht op zorgverleners, toeleveranciers en producenten van medische producten en overige dienstverleners actief in de zorgsector.

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Gilde Healthcare investeert in snelgroeiende, innovatieve bedrijven die betere zorg tegen lagere kosten mogelijk maken.

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