Pipeline

February 11, 2019
Company Drug/Device Medical Condition Status
AtriCure, Inc. cryoICE Ablation System atrial fibrillation (Afib) Phase I trial initiated enrolling up to 150 subjects at up to 20 centers in the U.S. with persistent and long-standing persistent atrial fibrillation undergoing cardiac surgical procedure(s) for heart valve repair or replacement and/or coronary artery bypass procedures
Verseon VE-1902 coronary artery disease Phase I trial initiated enrolling 100-120 healthy volunteers
Actinium Pharmaceuticals, Inc. Actimab-A and venetoclax Acute Myeloid Leukemia (AML) Phase I/II trial initiated enrolling subjects with relapsed or refractory AML that have been previously treated with venetoclax and subjects that have never received venetoclax
Orphan Technologies OT-58 classical homocystinuria Phase II trial initiated enrolling up to 20 subjects
Neurana Pharmaceuticals tolperisone acute muscle spasms of the back Phase II trial initiated enrolling 400 subjects
BioLineRx Ltd. BL-8040 pancreatic cancer Orphan Drug Designation granted by the FDA
REGENXBIO, Inc. RGX-181 late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2)
disease		 Rare Pediatric Disease Designation granted
by the FDA
Pharnext SA PXT3003 Charcot-Marie-Tooth disease Type 1A (CMT1A) Fast Track Designation granted by the FDA
Teleflex Incorporated MANTA Vascular Closure Device large bore femoral arterial access site closure PMA granted by the FDA
Flowonix Medical, Inc. Flowonix Maestro Software for Clinician Programmers used to program Prometra Pump Systems intrathecal infusion
of drug therapy		 Approval granted by the FDA
Cook Medical Zenith Dissection Endovascular System Type B dissections of the descending thoracic aorta Approval granted by the FDA
Mylan N.V. generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder) twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) Approval granted by the FDA

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