Company Product Description Indication Status
Baylis Medical Co. Inc., of Mississauga, Ontario Versacross RF Transseptal Solution Features a single radiofrequency (RF)-tipped wire Used to introduce the transseptal sheath into the superior vena cava (SVC), gain transseptal access and act as an exchange wire in the left atrium to facilitate Mitraclip Guide delivery Published study in Catheterization and Cardiovascular Interventions on procedural efficiency for Mitraclip transcatheter mitral valve repair (TMVR) with use of the Versacross; demonstrated guide delivery from femoral access in under 7.5 minutes; reported 3.3 minutes to gain transseptal access and a subsequent 3.8 minutes to achieve Mitraclip Guide delivery, with a 100% success rate
Biocardia Inc., of San Carlos, Calif. Helix biotherapeutic delivery system Percutaneous catheter delivery system with helical needle Enables local delivery of cell and gene based therapies to treat heart failure, myocardial infarction, ischemia, and cardiac conduction disorders Helix system demonstrated the best safety profile among clinical transendocardial catheter injection systems used for cardiac cell therapy delivery in study published in Cardiovascular Revascularization Medicine; analyzed clinical trials encompassing 1,789 patients that underwent transendocardial injections using either a helical needle (Helix system), or 1 of 3 other clinical use designs: an electro-anatomically tracked straight needle, a straight needle without tracking elements, or a curved needle; reported the combined transendocardial injection-associated serious adverse event (SAE) rate was 3.4% across all 4 catheters, with the Helix system demonstrating the lowest SAE rate of 1.1%; the next-closest delivery system had 3 times as many reported adverse events as the Helix system, with 1 system having 8.3 times as many adverse events as the Helix system
Biodesix Inc., of Boulder, Colo. Nodify XL2 lung nodule test Blood-based proteomic test Helps identify patients who have a suspicious lung nodule that is likely benign or at a reduced risk of being cancerous Published extended analysis from PANOPTIC trial in CHEST; reported findings that all nodules in the study group that were established as benign after 1 year remained benign after 2 years of follow-up
Bioskryb Inc., of Durham, N.C. ResolveDNA kits Uses primary template-directed amplification (PTA) For whole genome amplification from single cells or ultra-low DNA inputs Study demonstrated ability of PTA to accurately and uniformly amplify the genomes of single cells; data showed that PTA can overcome the limitations of whole genome amplification and provide high-quality, scalable analysis of single-cell genomic heterogeneity to enable new insights into human disease at the cellular level
Caredx Inc., of South San Francisco Allosure Noninvasive donor-derived cell-free DNA (dd-cfDNA) test Identifies allograft rejection in pediatric kidney transplant patients Published study in Pediatric Transplantation demonstrating the utility of Allosure for identifying allograft rejection; included 67 pediatric patients tested between October of 2017 and October of 2019 who underwent initial testing with Allosure as part of routine monitoring or in response to clinical suspicion for rejection; neither donor‐specific HLA antibodies nor AT1R positivity was statistically associated with biopsy‐proven rejection; however, dd‐cfDNA >1% was diagnostic of rejection with sensitivity of 86% and specificity of 100% (AUC: 0.996, 0.98‐1.00; P = .002)
Hancock Jaffe Laboratories Inc., of Irvine, Calif. Venovalve Porcine based valve implant Surgically implanted in the deep venous system of the leg to treat reflux associated with chronic venous insufficiency (CVI) Reported that the 10th patient in its first-in-human clinical study has successfully reached the 1-year milestone; CVI dramatically improved when compared to pre-surgery levels, with reflux (the backwards flow of blood) improving 71%; disease manifestations, as measured by a venous clinical severity scores improved 33%; pain as measured on a visual analog scale improved 100%
Ihealthscreen Inc., of Richmond Hill, N.Y. Ipredict Artificial intelligence (AI)-based tool For early diagnosis of age-related macular degeneration (AMD) Presented a prospective study demonstrating 88.7% accuracy, compared to ophthalmologist gradings, on detecting referable AMD
Multi Radiance Medical Inc., of Solon, Ohio Super pulsed laser therapy technology Noninvasive device that preserves and improves the thickness of the diaphragm Improves respiratory function in critically ill COVID-19 patients Trial results showed that super pulsed laser therapy decreased invasive intubation time/need by 18% overall, and decreased mechanical ventilation time/need overall by 23%
Quotient Ltd., of Eysins, Switzerland Mosaiq Expanded Immunohematology Microarray Automated, consolidated testing platform, allowing for multiple tests across different modalities For performing blood grouping and transfusion-transmitted infection screening of donated blood Reported preliminary EU field trial performance data; over 4,000 randomly selected human blood donor samples have been tested; data suggest that tests performed with Quotient's microarray are highly accurate
Sensus Healthcare Inc., of Boca Raton, Fla. Superficial radiation therapy (SRT) Low-energy X-ray technology Treats nonmelanoma skin cancers and keloids Published a prospective clinical study showing that a single low dose of SRT following excision of 14 keloids had an approximate 6.25% recurrence rate at 6 months; for the 10 patients available for follow-up at 24 months, none of the keloids had recurred; study was published in the Journal of the American Academy of Dermatology


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