Pipeline

June 25, 2018

Company	Drug/Device	Medical Condition	Status
bluebird bio, Inc.	LentiGlobin	anemia	Phase I trial
Kiyatec, Inc.	Ex Vivo 3D (EV3D)	cancer patients with both newly diagnosed and recurrent epithelial ovarian cancer and recurrent high-grade gliomas, which include glioblastomas (GBM)	Phase I trial initiated enrolling 640 subjects
Arrowhead Pharmaceuticals, Inc.	ARO-AAT subcutaneously administered RNA Interference (RNAi) therapeutic	are genetic liver disease associated with alpha-1 antitrypsin deficiency	Phase I trial initiated enrolling 44 subjects
Cambium Medical Technologies	Elate Ocular topical fibrinogen-depleted human platelet lysate biologic	dry eye secondary to graft-versus-host disease	Phase I/II trial initiated
Cefaly Technology	Cefaly ACUTE medical device	acute treatment of migraine	Phase III trial initiated enrolling 309 subjects in the U.S.
Avedro, Inc.	epithelium-on (epi-on) corneal collage cross-linking procedure	progressive keratoconus	Phase III trial initiated enrolling 275 subjects with progressive keratoconus across approximately 20 sites in the U.S.
TransMed7, LLC	SpeedBird platform of soft tissue biopsy devices	soft tissue samples	510(k) Clearance granted by the FDA
Bay Labs	EchoMD AutoEF software	fully automated clip selection and calculation of left ventricular ejection fraction (EF)	510(k) Clearance granted by the FDA
LivaNova PLC	MEMO 4D semi-rigid mitral annuloplasty ring	mitral regurgitation (MR)	510(k) Clearance granted by the FDA
PerkinElmer, Inc.	EUROIMMUN Crithidia luciliae	systemic lupus erythematosus (SLE)	510(k) clearance granted by the FDA
BlueWind Medical	RENOVA iStim implantable Tibial Nerve Neuromodulation System	overactive bladder (OAB)	Approval granted by the FDA
Grifols	Procleix Ultrio Elite	blood screening assay	Approval granted by the FDA
Grifols	Procleix WNV	blood screening assay	Approval granted by the FDA
Caladrius Biosciences, Inc.	CD34+ cell therapy program	refractory angina	RMAT designation granted by the FDA
ImmunoGen, Inc.	mirvetuximab soravtansine	medium-to-high folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer	Fast Track Designation granted by the FDA