Company Product Description Indication Status
Brainstorm Cell Therapeutics Inc., of New York Nurown Glial- and brain cell line-derived neurotrophic factor-producing stem cells Amyotrophic lateral sclerosis Presented clinical outcomes from its phase II trial, which evaluated MRI features of 48 participants in the SysteMS substudy of the CLIMB study; 17 patients had improved 9-hole peg test (9HPT) scores from baseline to 12-24 months later vs. 29 with worsened or stable 9HPT scores over that same period; whole brain volume at baseline (improved 9HPT: 1505±51 vs. stable-worse 9HPT: 1471±62; p=0.069; t-test) and follow-up (improved: 1501.555±52.039 vs. stable-worse: 1461.304±63.562; p=0.03; t-test) differed between the two 9HPT groups, as did gray matter volume at follow-up (improved 1505.059 ±50.961 vs. stable-worse 865.57±41.352; p=0.063: t-test); 18 patients had an improved timed-25-foot-walk (T25FW) score vs. 27 whose score worsened or remained stable over the 12-month period; deep white matter FLAIR/T2 lesion volume at baseline (improved: 0.43±0.507 vs. stable-worse: 0.827±0.561; p=0.03; t-test) and follow-up (improved: 0.429±0.503 vs. stable-worse: 0.864±0.603; p=0.02) differed between the two T25FW groups; the investigators did not observe any association between mean upper cervical cord analysis and functional improvement measures
Viveve Medical Inc., of Englewood, Colo. Viveve system Cryogen-cooled, monopolar radiofrequency (CMRF) based device Improvement of stress urinary incontinence (SUI) in women Reported positive primary efficacy data from its 3-arm, 5-month feasibility study to compare Viveve's CMRF treatment and a cryogen-only sham treatment to an inert sham treatment for mild to moderate SUI in women; the primary efficacy endpoint – change from baseline in the standardized 1-hour pad weight test at 5 months post treatment – was positively achieved; the median change from baseline in the active CMRF treatment group and the cryogen-only sham treatment group was -9.5 grams and -6.8 grams, respectively, vs. -4.4 grams in the inert sham treatment group; the study also assessed several secondary endpoints but showed no differentiation between groups; no device-related safety issues were reported

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