Danvers, Mass.-based Abiomed Inc. reported that the first two patients have been treated with the Impella ECP expandable percutaneous heart pump. Impella ECP is the smallest heart pump in the world, according to the company. Impella ECP is being studied under a U.S. FDA early feasibility study. It is designed to provide temporary circulatory support and left ventricular unloading in patients undergoing a high-risk PCI. The primary endpoint of the FDA early feasibility study is successful delivery, initiation and maintenance of adequate hemodynamic support and a composite rate of major device-related adverse events during high-risk PCI. The study protocol will enroll and treat up to five U.S. patients who require revascularization. If successful, enrollment will be expanded to additional patients, pending FDA approval.
Sunnyvale, Calif.-based Accuray Inc. reported a collaboration with Brainlab, a Munich, Germany-based company in the digital surgery and precision radiotherapy space. The collaboration aims to expand the Accuray Cyberknife treatment platform for the neuro-radiosurgery market. The partners intend to provide the neuro-radiosurgery community with access to Brainlab Elements planning software, which will give contouring capabilities optimized for neurosurgeons. The partners also will aim to leverage interoperability with Snke OS, the Brainlab health tech platform to improve the experience of those administering and receiving radiation treatments.
Parsippany, N.J.-based Diaceutics plc, reported the launch of Dxrx – The Diagnostic Network, which has been designed to accelerate the end-to-end development and commercialization of precision medicine diagnostics by reducing time to peak biomarker test adoption for cancer testing from years to months.
Innovation Sprint, of Brussels, Belgium, is partnering with Fondazione Policlinico Universitario “Agostino Gemelli” IRCCS, of Rome, to co-sponsor the APACHE clinical trial, involving both the Gemelli advanced radiotherapy center and the gynecology department. The primary objective of this 24-month trial is to evaluate whether monitoring oncological patients during multimodal cancer therapies may represent a significant step towards a comprehensive and reliable quality of life assessment, prevention of toxicity before its clinical onset and treatment outcomes prediction.
Invitae Corp., of San Francisco, said that at the American Society of Human Genetics Virtual Meeting, it was reported that one in 10 men with prostate cancer harbor genetic changes linked to hereditary cancer syndromes and three-quarters of those patients met criteria for changes in cancer management or treatment based on their genetic findings. The study of more than 4,000 men with prostate cancer also found no statistical difference in the rate of cancer-causing genetic changes based on stage of disease, suggesting common criteria used to restrict testing would miss clinically important changes for many patients and their families.
Notable Labs, of Foster City, Calif., and Seattle-based All4cure reported their partnership. Notable will leverage All4cure’s network to enhance and expand its functional precision oncology platform.
Kantaro Biosciences LLC, a joint venture between the Mount Sinai Health System and Cardiff, U.K.-based RenalytixAI plc, and manufacturing partner Minneapolis-based Bio-Techne Corp. entered a two-year marketing and distribution agreement with Cardiff, U.K.-based Ekf Diagnostics. Ekf will offer COVID-Seroklir, Kantaro's quantitative SARS-CoV-2 IgG antibody test kit, in Europe with exclusive rights in the U.K. and Germany, and COVID-Seroindex, for the European research market, on a nonexclusive basis.
Nottingham, U.K.-based Oncimmune Holdings plc reported the initiation of a study by Boulder, Colo.-based Biodesix Inc. using Oncimmune's EarlyCDT Lung blood test, which is marketed in the U.S. by Biodesix as NodifyCDT. Biodesix has initiated the ALTITUDE clinical utility study to evaluate the performance of Nodify Lung.
Oxford, U.K.-based Oxford Biodynamics plc has signed a Human Material and Data Transfer Agreement with Oregon Health & Science University as part of its Episwitch COVID-19 disease severity test program. The goal is to give insight into a range of COVID-19 responses, from mild to severe.
Irvine, Calif.-based Pathnostics has launched a multiplex polymerase chain reaction test that simultaneously detects multiple respiratory infections, including COVID-19, influenzas A/B and respiratory syncytial virus.
Pentax Medical, which has a U.S presence in Montvale, N.J., revealed a distribution agreement with Medford, Mass.-based Sofregen Medical Inc. for its Silk Voice Injectable Implant. Pentax Medical will serve as the exclusive U.S. sales agent of the Silk Voice product.
Quva Pharma Inc., of Sugar Land, Texas, expanded its collaboration with Kit Check Inc., of Washington, to help hospitals improve medical management and automation through radiofrequency identification (RFID) tagging. Under the agreement, Quva is expanding its portfolio of Kit Check RFID-tagged compounded sterile products. It will also utilize Kit Check’s tunnel association technology and register its products in the cloud-based registry, making them easily identifiable as RFID-ready.
Wayne, Pa.-based Teleflex Inc. said it has expanded its Urolift System portfolio with the release of the Urolift Advanced Tissue Control System. The new system features several enhancements to enable urologists to more easily treat benign prostatic hyperplasia patients with challenging anatomies. The company is planning a limited launch while its business unit scales up capacity to meet demand.
Toronto-based Vitalhub Corp. said it has licensed newly acquired subsidiary Intouch With Health’s digital, at-home, preoperative solution, Synopsis Iq, to Northumbria Healthcare NHS Foundation Trust in the U.K. The Trust will use the tool to launch a digital pre-op assessment pathway to improve demand and capacity planning and resource utilization.
Xphyto Therapeutics Corp., of Vancouver, British Columbia, said its exclusive partner, 3a-Diagnostics GmbH, of Frickenhausen, Germany, is developing a reverse transcription polymerase chain reaction (RT-PCR) kits targeting COVID-19 diagnostic results in 25 minutes. The test is planned for commercial release as a CE-IVD-certified product in the European Union in the first quarter of 2021.