Allergan Aesthetics, an Abbvie company based in Irvine, Calif., has entered a warrant agreement with Cypris Medical, which is based in Chicago. Following the completion of a clinical trial to be initiated this year, Allergan Aesthetics will have the right to exercise an option to acquire Cypris Medical, including the company's Xact device. The planned clinical trial will evaluate the safety and effectiveness of Xact in treating midface descent and neck lifts.
New York-based Daxor Corp. has signed a new distribution agreement with L1 Enterprises, a Frederick, Md.-based provider of medical equipment and supplies to the government marketplace. Daxor and L1 Enterprises will work together to provide Daxor’s BVA-100 (blood volume analysis) diagnostic blood test, driving the use of BVA to help guide precise, individualized volume management in a variety of medical conditions, including heart failure and critical care.
La Jolla, Calif.-based Dermtech Inc. said that noninvasive genomic patch testing for melanoma, like its Pigmented Lesion Assay, has received a recommendation from the National Comprehensive Cancer Network (NCCN). The recommendation indicates that there is uniform NCCN consensus that the intervention is appropriate.
Elixir Medical Corp., of Milpitas, Calif., said that the first patient has been treated in the BIOADAPTOR randomized, controlled trial of the Dynamx Coronary Bioadaptor system, the first drug-eluting coronary artery implant that adapts to vessel physiology.
Madison, Wis.-based Exact Sciences Corp. said that it has acquired a worldwide exclusive license to the Tardis technology from The Translational Genomics Research Institute, an affiliate of City of Hope.
Piscataway N.J.-based Genscript USA Inc. has submitted an application to the U.S. FDA's Center for Biologics Evaluation and Research for use of the Cpass SARS-CoV-2 Neutralization Antibody Detection Kit in convalescent plasma screening.
Hibercell, a New York-based biotechnology company that is developing novel therapeutics for cancer relapse and metastasis, reported an agreement with Boulder, Colo.-based Biodesix Inc. to further the development of an enzyme-linked immunosorbent assay as a companion diagnostic in future registrational trials in breast cancer for Imprime Pgg programs. Terms of the partnership were not disclosed.
Virginia Beach, Va.-based Lifenet Health reported the launch of its newly expanded Lifesciences division, which is offering human cell- and tissue-based research solutions.
Tel Aviv-based Nuvo Group, which is commercializing Invu, said that it has filed a 510(k) notice with the U.S. FDA to add a new uterine activity module that provides capability for remote monitoring of maternal uterine activity.
Oxford Immunotec Global plc, of Oxford, U.K., reported the start of a collaboration with Valneva SE, of Saint-Herblain, France. The company will perform T cell testing on participants receiving Valneva’s inactivated whole-virus COVID-19 vaccine candidate with the research use-only T-Spot Discovery SARS-CoV-2 test. The VLA2001-201 study is a randomized phase I/II clinical study designed to evaluate the safety, tolerability and immunogenicity of an inactivated SARS-CoV-2 virus vaccine candidate in healthy subjects.
Pacific Biosciences of California Inc. (Pacbio), of Menlo Park, Calif., has entered a multiyear collaboration with San Francisco-based Invitae Corp. to develop an ultra-high-throughput clinical whole genome sequencing platform leveraging Pacbio’s hi-fi sequencing to expand Invitae’s whole genome testing capabilities.
Baltimore-based Personal Genome Diagnostics Inc. (PGDx) is collaborating with Qiagen NV, of Hilden, Germany, to provide comprehensive genomic profiling tests and clinical decision support molecular labs. Under the nonexclusive agreement, PGDx will be responsible for the distribution of the PGDx Elio oncology products and kitted solutions. Laboratories that purchase the Elio products will have an option to receive standardized reporting from Qiagen.
Promega Corp., of Madison, Wis., said laboratories performing the CDC’s Flu SC2 Multiplex Assay, a single test to diagnose infections caused by SARS-CoV-2, influenza A and influenza B, may now use Promega’s Maxwell Rsc 48 and Maxwell Csc 48 instruments and its Maxwell Rsc Viral Total Nucleic Acid Purification Kit for the test procedure.
Retia Medical, of Valhalla, N.Y., reported the successful implementation of its Argos Cardiac Output Monitor with the cardiac anesthesiology operating rooms at University Hospitals Cleveland Medical Center.
Rouen, France-based Robocath SA reported the completion of the first remote robotic-assisted coronary angioplasty in Europe. The procedure was carried out at the Rouen Medical Training Center and Caen University Hospital, 75 miles apart, using the Robocath’s R-One platform.
Scapa Healthcare, of Windsor, Conn., said it has expanded medical-grade adhesive coating capabilities in its Windsor and Gargrave, U.K. facilities.
Chicago-based Tempus Inc., an artificial intelligence and precision medicine company, is teaming up with A2 Biotherapeutics Inc., of Agoura Hills, Calif., to develop a companion diagnostic for A2’s therapy targeting patients with loss of heterozygosity. The collaboration could provide a platform for future CDx tests for A2’s other clinical development programs.
Brussels-based Union Chimique Belge SA (UCB) has launched Nile AI Inc., a digital health company developing a care management platform for patients with epilepsy. UCB invested €25 million (US$29.3 million) in the company and, as a majority shareholder, will sit on the Nile board with opportunities to acquire insights and data from Nile’s platform.
Campbell, Calif.-based Vivalnk Inc. said it will supply its wearable ECG monitors to Stanford University for research on sleep bruxism. The NIH-funded study spans 150 subjects with data collection over a 21-day period during sleep, including emotion reactivity and regulation, subjective sleep perceptive, sleeptime rhythmic masticatory muscle activity and actigraphy.