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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 |
