Company Product Description Indication Status
Becton, Dickinson and Co., of Franklin Lakes, N.J. BD Libertas Wearable Injector Subcutaneous drug delivery system Deliver drugs such as biologics with viscosities up to 50 cP in 2-5 mL and 5-10 mL configurations In a 52-subject clinical trial, BD Libertas delivered within an acceptable time period 5 mL of 8 cP injections to the abdomen and thigh regardless of age, gender or body mass index and with/without patient movement; removal of the device was found to be acceptable and 100% of patients were likely to use it if prescribed; no severe wheal, erythema or bleeding observed and no unacceptable pain at 24 hours post-injection; a detailed analysis of the independently sponsored and conducted study was published in Clinical and Translational Science
Cytosorbents Corp., of Monmouth Junction, N.J. Cytosorb Blood purification device To treat deadly inflammation in critically ill and cardiac surgery patients In a retrospective single center genetic matched analysis, Cytosorb was associated with rapid and significant (>50%) reduction in norepinephrine requirements in the first 24 hours vs no change in norepinephrine requirements in the control group; mortality rates were significantly lower in Cytosorb group vs matched controls (21/4% vs 47.6%, p=0.029 for 28-day mortality; 35.7% vs 61.9%, p=0.015 for in-hospital mortality; results were published in Biomedicines
Exact Sciences Corp., of Madison, Wis. Oncotype Dx Test Genomic test to inform cancer treatment Breast cancer Data from RxPONDER trial found the Oncotype Dx test successfully defined the benefit of chemotherapy in early-stage, node-positive breast cancer patients with Oncotype Dx Breast Recurrence Score results of 0-25; postmenopausal women with Recurrence Scores of 0-25 showed no benefit fromo chemotherapy and may avoid side effects of treatment, and no chemotherapy benefit observed regardless of number of affected nodes, tumor grade or size; results also demonstrated, after a median of 5 yrs of follow up, that premenopausal women with Recurrence Scores 0-25 had statistically significant chemotherapy benefit, with average improvement in distant recurrence rates at 5 yrs of 3%
Follica Inc., of Boston, Mass. Hair Follicle Neogenesis device Regenerative platform for hair growth Androgenetic alopecia, epithelial aging and other related conditions Pilot study in 11 women with mild to moderate female pattern hair loss who had been on stable existing treatments for 6 or more months underwent 6 treatments with the Hair Follicle Neogenesis device; results showed 10 of 11 patients had improvement in hair growth and all 11 improved on their physician-graded Sinclair scores, with an average improvement of 1 full stage; adverse events reported were mild and self-resolving and all women completed treatment; study was published in International Journal of Women's Dermatology
Lungpacer Medical Inc., of Exton, Pa. Lungpacer Diaphragm Pacing Therapy System Temporary, percutaneously placed, transvenous, phrenic nerve-stimulating device Treatment of patients on mechanical ventilation, including COVID-19 patients The 30-day, multicenter, randomized, controlled RESCUE 2 feasibility trial evaluated the Lungpacer System as a weaning therapy, comparing standard of care to Lungpacer plus SoC for patients on long-term mechanical ventilation; in data subset that included patients who received at least 50% of the protocol-required Lungpacer therapy, average improvement in inspiratory muscle strength, as measured by Maximal Inspiratory Pressure, in the Lungpacer arm was 308% greater than in the SoC group; Rapid Shallow Breathing Index improvement was 167% greater vs SoC; compared to baseline, diaphragm thickening fraction improved by 35% and 30% more for right and left hemidiaphragms, respectively; Lungpacer group also showed a strong positive trend in the proportion of patients weaned and reduction in average duration of mechanical ventilation by day 30, compared with the SoC group
Menarini Silicon Biosystems S.p.A., of Bologna, Italy Cellsearch CTC System Circulating tumor cell (CTC) test For determining the prognosis of patients with metastatic breast, colorectal or prostate cancer Results of a pooled analysis of 14 clinical trials on the relevance of CTC count to predict both disease prognosis and treatment efficacy in metastatic breast cancer, based on 4,079 cases across all advanced breast cancer subtypes; results showed patients whose CTC is negative at both baseline and follow-up had a median overall survival of 47.05 months, compared with 17.87 months for those with a positive CTC status at both check points (p-value <0.0001), an almost 2-fold increase in OS of patients whose CTC status remained positive
Nanostring Technologies Inc., of Seattle, Wash. Geomx Digital Spatial Profiler Platform for use in regional in-depth protein expression profiling Discovery and translational research Researchers analyzed formalin-fixed paraffin-embedded (FFPE) autopsy samples from patients with SARS-CoV-2 infection with the Geomx DSP, using the >1,800+ plex Geomx COVID-19 Immune Response Atlas and a 79-plex Geomx protein assay; Geomx DSP revealed high intra- and inter-patient heterogeneity in the abundance and localization of immune markers; immune cell types were classified in each region of interest, revealing relationships between virus location and immune cell abundance, which could have therapeutic implications; results were published in Nature Communications
Sengine Precision Medicine Inc., of Seattle, Wash. Paris Test CLIA-certified functional drug sensitivity assay For selection of personalized cancer treatments Data from a study on the predictive value of the Paris Test in breast cancer tumors showed a 70.5% success rate in delivering a report ranking targeted, endocrine and chemotherapy agents in a clinically relevant timeframe for a cohort of metastatic, heavily pretreated breast cancer patients; there was high genomic concordance between known actionable biomarkers such as PIK3CA and FGFR1/FGFR2, and Paris Test organoid drug sensitivity; test identified candidate therapies in most patients lacking known druggable biomarkers and guided oncologist treatment decisions in 50% of post-assay interventions
Visualdx, of Rochester, N.Y. Dermexpert Artificial intelligence-powered mobile app Diagnosis of skin conditions In a study published in Journal of Investigative Dermatology, primary care physicians accurately diagnosed skin conditions 68% of the time with use of the visual aid, vs 36% of the time without; moreover, when applied to a wide set of clinical settings, it achieved near equal efficacy in analyzing lighter (70%) and darker skin (68%)


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