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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 |
