Company Product Description Indication Status
Acarix AB, of Malmö, Sweden Cadscor system Records the heart sounds to analyze the myocardial movement and blood flow in the coronary arteries; results are shown as a calculated coronary artery disease (CAD)-score from 0-99, categorizing patients into 3 risk groups Differentiates patients referred with suspicion of heart failure Positive, long-term data from the Dan-NICAD I study was published in European Heart Journal – Digital Health; study assessed the prognostic value of heart sound analysis in patients referred to coronary computed tomography angiography (CTA) due to symptoms suggestive of obstructive CAD; of 1,675 enrolled patients, 1,464 were included in this substudy with a median follow-up time of 3 years; of patients with primary endpoints (all-cause mortality and myocardial infarction), the Acoustic score was >20 in 25 (96%) and the CAD-score was >20 in 22 (85%); the CAD-score contained prognostic information even after adjusting for lipid-lowering therapy initiation, stenosis at CTA, and early revascularization
Akili Interactive, of Boston AKL-T01 Digital therapeutic Treatment for patients with cognitive dysfunction following COVID-19 Entered a collaboration with Weill Cornell Medicine and New York-Presbyterian Hospital to conduct a randomized, controlled study in approximately 100 patients who previously had COVID-19 over 10 weeks, with 6 weeks of treatment and 4 weeks of follow-up; half of the study participants will receive the digital treatment and half will serve as a control group; the primary endpoint is mean change in cognitive function, as assessed by a measure of attention and processing speed
Akili Interactive, of Boston AKL-T01 Digital therapeutic Treatment for patients with cognitive dysfunction following COVID-19 Entered a collaboration with Vanderbilt University Medical Center to conduct a randomized, controlled study in approximately 100 patients who previously had COVID-19; half of the study participants will receive the digital treatment for 4 weeks and half will serve as a control group; the primary endpoint is mean change in cognitive function, as measured by CNS Vital Signs (composite score of cognitive function, especially attention and processing speed)
Boston Scientific Corp., of Marlborough, Mass. Watchman Flx Left atrial appendage closure (LAAC) device For stroke prevention in patients with non-valvular atrial fibrillation Circulation published 12-month results from the PINNACLE FLX trial assessing the safety and efficacy of the Watchman Flx device as an alternative to oral anticoagulation therapy in 400 patients; the study met its primary safety endpoint – defined as occurrence of a major procedure-related complication within 7 days following the procedure – with a low adverse event rate of 0.5%; also met its primary effectiveness endpoint, with data demonstrating a 100% rate of effective LAAC at 12 months post-procedure with peri-device flow < 5 mm; demonstrated an implant success rate of 98.8%; no patients experienced peri-procedural death, device embolization or pericardial effusion requiring cardiac surgery; 96.2% of patients were able to discontinue oral anticoagulation following their 45-day follow up
Cardiac Dimensions Inc., of Kirkland, Wash. Carillon Mitral Contour system Right heart approach to transcatheter mitral valve repair; uses distal and proximal anchors connected by a shaping ribbon Treatment for functional mitral regurgitation Published a second individual patient data meta-analysis in the ESC Heart Failure Journal; showed significant improvement in 6-minute walk test distance and Kansas City Cardio-myopathy Questionnaire (KCCQ) score at 1 and 12 months from baseline; more than 50% of the patients had improvements in KCCQ score of greater than 5 points at 12 months and a greater than 1 class improvement in New York Heart Association classification out to 12 months
Lumithera Inc., of Poulsbo, Wash. Valeda Light Delivery system Provides photobiomodulation (PBM) treatment Treatment of dry age-related macular degeneration (AMD) patient Reported positive results from LIGHTSITE II, the prospective, double-masked, randomized, multicenter, EU post-marketing clinical trial with a duration of 10 months; the analysis included 32 eyes in the PBM group and 19 eyes in the sham-treatment group in the modified intent to treat group with at least 1 post-treatment visit and disease consistent with intermediate dry AMD; demonstrated a statistically significant improvement in the primary endpoint of best corrected visual acuity at 9 months from baseline (p < 0.02) in PBM-treated subjects; no safety issues were identified following 3 rounds of PBM treatment given at 4-month intervals
Medcura Inc., of Riverdale, Md. R³ device Topical hm-P impregnated patch integrated into a wristband For radial closure after routine angiography 50 consecutive subjects undergoing a diagnostic catheter-based cardiac procedure were enrolled in a study at the University of Chicago; the R³ device facilitated hemostasis, on average, in 41 minutes while causing no adverse events defined as clinically arterial occlusions, re-bleeding, re-admission, cutaneous discomfort or inflammation, or meaningful hematomas either on the day of the procedure or after follow-ups at 7 and 30 days; used post-procedural ultrasound to confirm that 100% of the enrolled subjects had full radial artery patency prior to a same-day discharge; results were published in Cardiovascular Catheterization and Interventions
Pixium Vision SA, of Paris Prima system Sub-retinal miniature photovoltaic wireless implant Improves vision in patients with atrophic dry age-related macular degeneration Reported successful implantation of first patient in the PRIMAvera pivotal trial; 38 patients will be enrolled in the open label, baseline-controlled, nonrandomized, multicenter, prospective, single-arm confirmatory trial; primary efficacy endpoint is the proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more from baseline to 12 month; study will include 3 years of follow up
Protokinetix Inc., of Marietta, Ohio Anti-aging glycopeptide (AAGP) Therapeutic molecule Enhances stem cells for use in vision restoration after retina degeneration Study examined the benefit provided by AAGP to enable human induced pluripotent stem cell-derived retinal precursor cells transplanted to restore vision in an experimental model of blindness due to retina degeneration; cells transplanted without AAGP offered no benefits in electroretinography (ERG) or optokinetic tracking (OKT); AAGP treated cells showed 3-fold greater improvement in both ERG & OKT, with more transplanted cells surviving long-term in the retina; findings were published in the Journal of Tissue Engineering and Regenerative Medicine

Notes

For more information about individual companies and/or products, see Cortellis.