San Carlos, Calif.-based Biocardia Inc. reported a pivotal trial studying the company’s investigational Cardiamp cell therapy in the treatment of chronic myocardial ischemia (CMI), as well as completion of the first site initiation visit in the trial. The U.S.-FDA approved study is expected to enroll up to 343 patients at up to 40 centers. Its purpose is to determine the safety and efficacy of Cardiamp cell therapy in the treatment of patients with refractory angina pectoris and CMI.
Eurofins Technologies, of Budapest, Hungary, reported the launch of CE-IVD marked rapid point-of-care testing devices to identify a person’s past exposure to COVID-19 in only 10 minutes. The serology-based, finger-prick tests detect virus antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms, the company said.
Hitachi Ltd. and Thinkcyte Inc., both headquartered in Tokyo, reported a collaboration to develop an artificial intelligence-driven cell analysis and sorting system. The companies are looking to partner with pharmaceutical companies and research institutes working in the field of regenerative medicine and cell therapy to speed the development of the system to commercialization.
Elmwood, N.J.-based Opko Health’s Bioreference Laboratories reported results of COVID-19 nearly a quarter million nursing home and live-in facility employees. Overall, Bioreference performed 222,000 COVID-19 PCR and 3,500 antibody tests in over 350 facilities. Of those, 29% of nursing home employees tested positive for antibodies, while 2.9% tested positive for active infection.
Specialty diagnostics company Precipio Inc., of New Haven, Conn., said it has regained is listing compliance with the Nasdaq minimum bid requirement, following a 10-day span when its closing bid price was $1 or higher. The company received notice from Nasdaq of its renewed compliance on June 29.
Beverly, Mass.-based Quantabio said its Ultraplex 1-Step Toughmix real-time quantitative PCR (RT-qPCR) assay has been recognized as part of the expanded emergency use authorization for the CDC COVID-19 testing protocol.
Quotient Ltd., of Eysins, Switzerland, reported that it has been added to the Russell 2000 and Russell 3000 Indexes, effective June 29, 2020.
Renovacare Inc., of Roseland, N.J., has launched the Renovacare R&D Innovation Center for organ and tissue regeneration in Berlin. The center is the result of a multiyear collaboration with Berlin-based Stemcell Systems GmbH, Renovacare’s strategic partner since 2014, and inventors and developers of the Renovacare Skingun and triple-enzyme cell isolation, Cellmist.
Silk Road Medical Inc., of Sunnyvale, Calif., reported that new Society for Vascular Surgery guidelines on training and credentialing for transcarotid artery revascularization (TAR) are consistent with Silk Road Medical’s certification process for TAR.
Sherlock Biosciences Inc., of Cambridge, Mass., and Boston-based Binx Health Inc. are partnering to develop the first CRISPR-based point-of-care diagnostic test for COVID-19. Under the agreement, the companies will combine he Binx io molecular diagnostic platform with Sherlock’s CRISPR technology to create a simple-to-use, rapid test that can be used across diverse CLIA-waved settings.
Houston-based Soliton Inc. said it has filed a 510(k) application with the U.S. FDA for its second-generation Rapid Acoustic Pulse (RAP) device for the reduction of cellulite. In a clinical trial, the RAP device demonstrated an average reduction of 32.5% in the Cellulite Severity Score and strong patient satisfaction, with 91.9% of subjects agreeing or strongly agreeing their cellulite was less visible.
T2 Biosystems Inc., of Lexington, Mass., reported the U.S. launch of its COVID-19 molecular diagnostic test, the T2SARS-CoV-2 Panel. The test was developed under a license with the Center of Discovery and Innovation at Hackensack Meridian Health, in New Jersey, and is being commercialized following validation for an emergency use authorization request to the FDA. It will run on the T2dx Instrument.