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

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