Abbott Park Ill.-based Abbott Laboratories reported the start of the LIFE-BTK clinical trial to evaluate the safety and effectiveness of the company's new Esprit BTK (below-the-knee) everolimus-eluting resorbable scaffold system. This is the first investigational device exemption (IDE) trial in the U.S. to evaluate a fully resorbable device to treat blocked arteries below the knees, or critical limb ischemia, in people battling advanced stages of peripheral artery disease (PAD). The first patient was enrolled by Danielle Bajakian, a vascular surgeon at New York-Presbyterian/Columbia University Irving Medical Center. Once fully enrolled, the LIFE-BTK trial will evaluate the Esprit BTK resorbable scaffold in 225 patients at centers around the world. The study is the first of its kind and an evolution of prior studies examining resorbable technology in treating diseased vessels and blocked arteries.
Sweden-based Acarix AB reported that the German Ministry of Health has said that phonocardiography for ruling out coronary artery disease has potential for general use in Germany. The German Federal Joint Committee (G-BA) has outlined basic elements of a possible study to be conducted by an independent scientific institution in accordance with the guidelines from G-BA.
Vista, Calif.-based Access Biologicals LLC, completed what it said is the first-ever commercially available COVID-19 seroconversion panel to confirm the presence of anti-SARS-CoV-2 antibodies. With Access Biologicals' seroconversion panel, diagnostic manufacturers, clinical laboratories and researchers will have a reliable benchmark against which they can develop, validate and troubleshoot other COVID-19 serological assays and testing. The COVID-19 seroconversion panel was tested against enzyme-linked immunosorbent assays and chemiluminescent assays to track anti-SARS-CoV-2 antibody generation over time.
Loma Linda, Calif.-based Aditx Therapeutics Inc. has signed a collaboration agreement with Richmond, Va.-based Salveo Diagnostics Inc. Aditxt said the collaboration provides it with access to a regulatory path, operational foundation and sales channels that will enable it to accelerate the launch of the Aditxtscore platform.
Caredfor Inc., a digital patient engagement platform headquartered in Brentwood, Tenn., has integrated with The Gateway Foundation, of Alta Loma, Calif., Hampton, N.J.-based software consultancy Fivebase and Myavatar, an integrated electronic health record from Netsmart, of Overland Park, Kan.
San Francisco-based Castlight Health Inc. reported that it has regained compliance with the New York Stock Exchange’s continued listing standards. The company regained compliance after both its average closing price for the 30 days ended Aug. 31, 2020, and its closing price on Aug. 31 exceeded $1 per share.
Centogene NV, of Rostock, Germany, said its dataset, “Successful application of genome sequencing in a diagnostic setting: 1,007 index cases from a clinically heterogeneous cohort,” was published in the European Journal of Human Genetics.
San Diego-based Deep Longevity Inc., a company focused on artificial intelligence for aging and longevity research, has agreed to be acquired by Regent Pacific Group Ltd., of Hong Kong, for HKD29.56 million (US$3.8 million).
Fulgent Genetics Inc., of Temple City, Calif., said that beginning Sept. 28, it will run COVID-19 and Influenza A/B tests on a single nasal swab, at no additional cost to patients.
Melville, N.Y.-based Henry Schein Inc. has entered an agreement with Zyris Inc., of Goleta, Calif., to be the exclusive distributor of Zyris’ dental isolation systems.
Impulse Dynamics Inc., of Mt. Laurel, N.J., said CMS’ proposed Medicare Coverage of Innovative Technology rule would improve coverage of cardiac contractility modulation (CCM) therapy delivered by its Optimizer system, giving Medicare patients immediate access to breakthrough heart failure therapy. The Optimizer system was granted breakthrough status by the U.S. FDA in March 2019 and is the only FDA-approved device for the delivery of CCM therapy. Comments on the proposed rule are due Nov. 2, 2020.
Houston-based nonprofit Indemic reported the launch of its COVID-19 knowledge management system. The initial focus is on COVID-19 therapies and vaccines.
Poulsbo, Wash.-based Lumithera Inc. was awarded a $1.5 million Small Business Innovation Research phase II grant from the National Eye Institute to support a U.S. multicenter trial in patients being treated for diabetic retinopathy and macular edema. The prospective, randomized Photobiomodulation Reduction in Macular Edema (PRIME) trial, which is subject to U.S. FDA IDE approval, will test vision and examine disease pathology in the eye following photobiomodulation treatments using the company’s Valeda Light Delivery System. Subjects will be followed up for six months.
MDclone Ltd., a Beer-Sheva, Israel-based digital health company, and Intermountain Healthcare, of Salt Lake City, reported 12-month results from a clinic service program implemented for patients with chronic kidney disease (CKD) and end stage renal disease. They partnered in September 2019 to reduce hospitalizations and prevent unnecessary morbidity and mortality by identifying and engaging patients in early stages of CKD. The program enabled early intervention and 86% avoidance in unplanned admissions for the risk population, well surpassing the target of 50%.
Oncocyte Corp., of Irvine, Calif., and the Guardian Research Network (GRN), a nationwide hospital consortium based in Spartanburg, S.C., reported a strategic collaboration to create a comprehensive solution for pharma clients from patient recruitment to regulatory approvals. The partnership will combine GRN’s clinical trial enrollment and data science technology with Oncocyte’s molecular tests as well as its pharma and companion diagnostic development services.
Seattle-based Safeology, a manufacturer of UVC-light disinfection systems and other light-mirror technology products, has formed a scientific advisory board to navigate the use of UVC technology to fight COVID-19 and other pathogens.
Speedx Pty. Ltd., a Sydney-based developer of innovative molecular diagnostic solutions, and Nepean Blue Mountains Local Health District researchers were awarded funding through the Mtpconnect Biomedical Translation Bridge program. Funds will support the commercialization of a respiratory virus host response test.
Verto Health, a Toronto-based provider of health care software, said it is partnering with Hamilton, Ontario-based Mcmaster Healthlabs (MHL), who is conducting a COVID-19 study of international travelers arriving at Toronto Pearson International Airport. MHL will use Verto Health’s Digital Twin platform to conduct the study.
Viz.ai Inc., of San Francisco, said the Centers for Medicare and Medicaid Services has selected Viz LVO, the company’s stroke software that was formally known as Viz Contact, as the first artificial intelligence software to receive a Medicare New Technology Add-on Payment (NTAP). Viz LVO has been granted an NTAP of up to $1,040 per use in patients with suspected strokes.