Company Product Description Indication Status
Ava Science Inc., of San Francisco Ava Fertility Tracker Sensor bracelet wearable and accompanying app that uses machine learning Measures and displays physiological parameters for presymptomatic detection of COVID-19 Said it will launch the COVID-19: Rapid Early Detection (COVID-RED) clinical trial in order to test whether a wearable device can detect a COVID-19 infection in real-time and alert people to get tested or self-isolate prior to showing symptoms; more than 20,000 participants of all genders and across general and high-risk populations will be provided with an Ava bracelet in the study; participants will wear the Ava bracelet for up to 9 months nightly while they sleep; partnering with other consortium members like Roche and Sanquin, Ava will provide asymptomatic participants identified as potentially ill by the app with access to a diagnostic test
Dot Laboratories Inc. (dba Dotlab), of San Francisco Dotendo MicroRNA-based assay Diagnosis of active endometriosis Began enrollment in the EMPOWER study; plans to enroll 750 women at more than 10 centers across the U.S.; participants in the prospective study will be of reproductive potential aged 18-49 who have been referred to undergo laparoscopy or laparotomy or other operative procedures for suspected endometriosis and other benign gynecological indications
Limflow SA, of Paris Limflow system Percutaneous deep vein arterialization (pDVA) system For the treatment of chronic limb-threatening ischemia (CLTI) The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved its clinical trial notification for the Japanese cohort of the ongoing PROMISE II pivotal trial of the Limflow pDVA system; plans to enroll 60 to 120 "no option" CLTI patients at 25 sites, 4 of which will be in Japan; the primary endpoint is amputation-free survival at 6 months; additional endpoints include limb salvage and wound healing; subjects will be followed out to 3 years

Notes

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