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