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News 2017

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

December 22, 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…

Related to: NightBalance

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

December 14, 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…

Related to: Sanifit

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

December 4, 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.…

Related to: Axonics Modulation Technologies

Breath Therapeutics appoints Renu Gupta as Executive Director

November 28, 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…

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

November 14, 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…

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

November 13, 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…

Related to: 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

November 7, 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…

Related to: Axonics Modulation Technologies

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

October 24, 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,…

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

October 19, 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…

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

October 19, 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…

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

September 28, 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.

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

September 25, 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).

Related to: ProQR Therapeutics

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

September 14, 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…

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

September 13, 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…

Related to: Axonics Modulation Technologies

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

September 11, 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…

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

September 6, 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…

Related to: Axonics Modulation Technologies

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

August 29, 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…

Related to: ProQR Therapeutics

Gilde Healthcare exits Viroclinics Biosciences

August 29, 2017 – UTRECHT, THE NETHERLANDS – Gilde Healthcare, the European specialist investor, today announces it has sold its majority share in Viroclinics Biosciences (Viroclinics), the contract research organization (CRO), to Parcom Capital. Gilde Healthcare invested in 2013 out of its Gilde…

Related to: Viroclinics Biosciences

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

August 28, 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).…

Related to: Symeres

Private Equity Looking for Interns

August 3, 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

July 10, 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…

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

July 6, 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…

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

July 6, 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…

Related to: Axonics Modulation Technologies

Lumeon wins MedTech Breakthrough Award

June 7, 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…

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

June 1, 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…

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

June 1, 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…

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

May 31, 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…

Related to: ProQR Therapeutics

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

May 22, 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,…

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

April 27, 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…

Related to: ProQR Therapeutics

Moximed Closes Oversubscribed $50MM Financing Round

March 16, 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),…

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Gilde Healthcare realizes trade sale of Bionx medical to Ottobock

March 15, 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…

Related to: BionX

Gilde Healthcare participates in EUR 43.5 million financing round of German respiratory disease company Breath Therapeutics

March 8, 2017 – Utrecht, the Netherlands — Gilde Healthcare today announces its investment in Breath Therapeutics, a company developing advanced drug-aerosol therapeutics in pulmonary orphan indications. Gilde Healthcare participated in a €43.5 million Series A financing round together with Sofinnova…

Related to: Breath Therapeutics

Digital Noema Telehealth and Lumeon Partner to Optimize Telemedicine Pathways

February 20, 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…

Related to: Lumeon

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

February 13, 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…

Related to: Acacia Pharma

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

January 24, 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…

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Gilde Healthcare

Gilde Healthcare

Gilde Healthcare is a specialized healthcare investor managing over €1.4 billion ($1.5 billion) across two fund strategies: venture & growth capital and private equity. Gilde Healthcare's venture & growth capital fund invests in health tech and therapeutics. The venture & growth companies are based in Europe and North America. Gilde Healthcare's private equity fund invests in profitable European lower mid-market healthcare companies with a focus on the Benelux and DACH region. The private equity fund targets healthcare providers, suppliers of medical products and service providers in the healthcare market.

Investment Philosophy

Gilde Healthcare invests in fast growing, innovative businesses delivering better care at lower cost.

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