Latham, N.Y.-based Angiodynamics Inc. reported the enrollment of the first patient in the Pathfinder I: Post-Market registry (PATHFINDER I-Registry, EX-PAD-05). The PATHFINDER I registry is a pilot study to evaluate the safety and efficacy of the Auryon atherectomy system in the real-world treatment of de novo, re-stenotic, and in-stent restenosis lesions in infrainguinal arteries of patients with peripheral artery diseases (PAD). Jason Yoho, of the Heart and Vascular Institute of Texas enrolled the first PATHFINDER I registry patient, a 61-year-old woman with a past medical history of atrial fibrillation, hypertension, hyperlipidemia, and prior myocardial infarction. Ten health care delivery sites in the U.S. are expected to participate in the registry. Sites are in Texas, Iowa, Arizona, New Jersey, and Florida. Angiodynamics expects a total of 100 eligible PAD patients to participate in the registry, which will track outcomes for patients for 24 months after treatment with the Auryon system.
Indianapolis-based Anthem Inc. and Secaucus, N.J.-based Quest Diagnostics have entered a strategic relationship by collaborating on a variety of outcomes-based programs designed to create an improved health care experience for consumers and providers beginning Aug. 1. The strategic relationship will focus on consumers in California, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri, New Hampshire, New York, Ohio, Virginia, and Wisconsin.
Jena, Germany-based Avateramedical GmbH reported the acquisition of Hanover, Germany-based Forwardttc GmbH, an automation technology company with special focus on robotics hard- and software. The transaction was closed on July 30. Forwardttc will operate within the group as Avateramedical Digital Solutions, alongside the previously acquired Avateramedical Mechatronics in Ilmenau, Germany. Financial details will not be disclosed. Forwardttc was spun off from the Institute of Mechatronic Systems, Leibniz University in 2012.
New York-based Brain Scientific Inc. reported an expansion of their facilities via a headquarter relocation to Bohemia, New York in central Long Island. The additional space will give the Brain Scientific team the ability to conduct more comprehensive and advance in-house R&D and product development.
Salt Lake City-based Carterra Inc. reported the availability of an assay for simultaneously measuring the concentration and binding of IgG, IgM, and IgA antibodies to the receptor binding domain (RBD) of SARS-CoV-2. Carterra’s new label-free assay provides, for the first time, detailed resolution of the immune response of patients recovering from COVID-19 in a single assay and represents a significant development for clinical research teams studying immune responses to SARS-CoV-2. The new SARS-CoV-2 Spike Protein RBD SPR Biosensor Chip can be used for COVID-19-related antibody therapeutics screening, vaccine development, and serology-based clinical research applications. The assay and chip run on Carterra’s LSA high-throughput Surface Plasmon Resonance (HT-SPR) biosensor platform.
Herzlia, Israel-based Endospan received approval from FDA of an investigational device exemption, or IDE, to start the TRIOMPHE study on the Nexus aortic arch stent graft system. Earlier this year, the U.S. FDA granted Nexus designation as a breakthrough device. The prospective and multiarm pivotal IDE TRIOMPHE study will evaluate in up to 30 centers, the safety and effectiveness of the Nexus for the endovascular treatment of thoracic aortic lesions involving the aortic arch including chronic dissections, aneurysms, penetrating aortic ulcers and intramural hematoma.
Carlsbad, Calif.-based Genmark Diagnostics Inc. has notified the U.S. FDA of the intent to commercially distribute its eSensor SARS-CoV-2 test for clinical use. The company has also submitted an emergency use authorization to the FDA for the eSensor SARS-CoV-2 test.
Microbot Medical Inc., of Hingham, Mass., reported the successful conclusion of its feasibility animal study using the company’s Liberty robotic system. The study met all its endpoints with no intraoperative adverse events, supporting the company’s objectives to allow physicians to conduct a catheter-based procedure from outside the catheterization laboratory.
Sectra AB, of Linköping, Sweden, will install its enterprise imaging solution throughout Michigan Medicine. This unified imaging strategy will support work-sharing, subspecialty interpretation of studies acquired at any location within the system and remote reading.
Sirtex Medical US Holdings Inc., of Woburn Mass., reported a collaboration with Magle Chemoswed, a Malmö, Sweden-based contract development and manufacturing organization that serves companies in the pharmaceutical and medical device industry on a contract basis. Sirtex Medical and Magle Chemoswed's development and commercial agreement is focused on generating a novel imaging agent for use in the interventional oncology field.
Ann Arbor, Mich.-based Swift Biosciences Inc. recently launched a new ACE2 Swift Normalase Amplicon Panel to further research on the main functional receptor for viral entry of coronavirus.
Thermo Fisher Scientific Inc., of Waltham, Mass., has signed a companion diagnostic (CDx) agreement with Hengrui Therapeutics Inc., a Princeton, N.J.-based subsidiary of Chinese pharmaceutical company Jiangsu Hengrui Medicine Co. Ltd. (JHM), to develop a CDx that will leverage the Oncomine Precision Assay, which runs on the new Ion Torrent Genexus System. Once commercialized, the CDx will be used to identify non-small-cell lung cancer patients who may be eligible for pyrotinib, JHM's novel, irreversible pan-HER2 tyrosine kinase inhibitor.
Todos Medical Ltd., of Rehovot, Israel, reported positive proof-of-concept data for its 10-minute rapid point-of-care saliva-based test for detecting active SARS-CoV-2 infections. The analytical performance data demonstrate that the assay is able to accurately detect the SARS-CoV-2 3C-Protease in human saliva samples spiked with recombinant 3C protease, and that the protease signal was specifically and significantly distinguishable from background protease activity present in normal saliva. Based on these data, the company has initiated a multicenter clinical trial at Assuta Ashdod Hospital and Tel Aviv University in Israel.
Tissue Regenix Group, a regenerative medical devices company, revealed the relocation of the company's U.K. head office and manufacturing facilities to Garforth, Leeds, in November. The strategic decision to relocate from nearby Swillington, Leeds, was made as part of the ongoing overhead cost saving initiatives being implemented by Tissue Regenix.