San Diego-based Axim Biotechnologies Inc., an international health care solutions company targeting oncological and COVID-19 research, has filed an emergency use authorization (EUA) application with the U.S. FDA for measuring COVID-19 neutralizing antibodies in plasma and serum through its first-in-class rapid diagnostic test. Axim believes its rapid diagnostic test is expected to be the market’s first COVID-19 rapid diagnostic test for measuring levels of functional neutralizing antibodies in a lateral flow assay format. Neutralizing antibodies prevent SARS-CoV-2, the virus responsible for the current COVID-19 pandemic, from binding to and entering host cells. Last month, Axim signed an exclusive limited licensing, manufacturing and distribution agreement with Empowered Diagnostics LLC for high volume production of the company’s rapid diagnostic test. Under this agreement, Empowered Diagnostics will manufacture the lateral flow assays under the name Tru-19 Neutralizing Antibody Test (Tru-19). With the filing of this EUA, the company is now able to begin selling Tru-19 to clinics immediately.
Deerfield, Ill.-based Baxter International Inc. reported a distribution agreement with Marcy-l'Étoile-France-based Biomérieux SA for the Nephproclear CCL14 diagnostic test. The test is currently in development for use in assessing the risk of developing persistent severe acute kidney injury (AKI). The agreement is part of a previously reported collaboration between Baxter and Biomérieux to improve identification and treatment of AKI. Financial terms of the agreement were not disclosed. As part of the agreement, Baxter will be Biomérieux’s exclusive distributor of the Nephproclear CCL14 diagnostic test in Europe and the U.S. following regulatory approval and launch in both markets. Baxter and Biomérieux will share in-country commercialization, while Biomérieux will retain control over the regulatory approval process.
Atlanta-based BioIQ, an aggregator of testing solutions and optimizer of lab capacity for employers and health plans, said it is the first Georgia company to be approved as a qualified vendor for tax credits under the George Entertainment Investment Incentive Act. Using BioIQ’s COVID-19 testing solution, production companies working in the state can qualify for up to 30% in tax credits under the act.
Canexia Health, of Vancouver, British Columbia, said it has closed a new financing round from Pacbridge Capital Partners Ltd. to propel the company’s long-term global growth and accelerate its roadmap to make cancer testing for treatment selection and monitoring accessible to all cancer patients. The company did not disclose the amount of funding raised.
San Diego-based Dexcom Inc. reported the first-ever registry dedicated to tracking the outcomes of patients and health care professionals using continuous glucose monitoring (CGM) in hospitals in response to the COVID-19 pandemic. The data could support future efforts to make real-time CGM a standard tool for glycemic assessment in the hospital setting, the company said.
Yavne, Israel-based Mediwound Ltd. reported U.S. FDA acceptance of its biologics license application for Nexobrid for the treatment of severe thermal burns. The agency assigned a Prescription Drug User Fee Act target date of June 29, 2021, and communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.
Dublin-based Medtronic plc reported new data from the landmark WRAP-IT study showing the Tyrx Absorbable Antibacterial Envelope is cost-effective for patients at increased risk of infections who receive cardiac implantable electronic devices. The prespecified analysis of the global WRAP-IT (World Randomized Antibiotic Envelope Infection Trial) study compared costs and patient outcomes of patients who received the Tyrx Envelope and patients who received standard care. The Tyrx Envelope’s incremental cost-effectiveness ratio (ICER) is well below the upper willingness pay threshold of $150,000. The analysis was published in Circulation: Arrhythmia and Electrophysiology.
Cambridge, Mass.-based Myomo Inc., a wearable medical robotics company focused on increasing functionality for those suffering from neurological disorders and upper-limb paralysis, said that CMS has authorized the company as a Medicare provider. The designation enables Myomo to bill Medicare directly when it delivers its Myopro powered orthosis in 39 states and the District of Columbia. The company is working to complete requirements in the remaining states.
Nano-X Imaging Ltd., of Neve Ilan, Israel, said it believes unusual trading activities in its ordinary shares were due to a report published by Citron Research on Sept. 15, 2020, which contains factual errors and misleading speculations. The company is carefully reviewing the report, but believes the allegations are without merit.
Gaithersburg, Md.-based Opgen Inc. reported that scientists at its subsidiary Ares Genetics GmbH in Vienna, Austria, in collaboration with researchers from the Johns Hopkins University School of Medicine, have published a peer-reviewed study on modifiable risk factors for the emergence of ceftolozane-tazobactam resistance in P. aeruginosa in the journal Clinical Infectious Diseases. The findings demonstrate the potential of next-generation sequencing (NGS) to investigate mechanisms of resistance by analyzing whole-genome sequencing data from P. aeruginosa isolates that developed resistance under treatment with ceftolozane-tazobactam. The researchers propose extending ceftolozane-tazobactam infusions as a potential protective measure against acquired mutational resistance.
Vancouver, British Columbia-based Pacgen Life Science Corp. reported shareholder approval of its acquisition by General Biologicals Corp. (GBC), of Hsinchu, Taiwan. Under the transaction, GBC will acquire all issued and outstanding common shares, other than shares owned by GBC, its executive chairman and affiliated companies, for cash consideration of $0.0275 per share.
Pathogenx Inc., of Carmel, Calif., has partnered with Toronto-based Invotek Group Inc. to help ramp up production and distribution of Pathogenx’s Px2 technology, a standalone, double-batch, on-site sterilization device that renders medical sharps and red bag waster sterilize, unrecognizable and nonreusable in compliance with EPA, CDC and OSHA standards.
Chicago-based PhysIQ Inc. has been awarded a contract from the National Cancer Institute and the National Institute of Biomedical Imaging and Bioengineering to develop an artificial intelligence-based COVID-19 Decompensation Index (CDI) digital biomarker to address the rapid decline of high-risk COVID-19 patients. The company will develop and validate a CDI algorithm that builds off existing wearable biosensor-derived analytics generated by its PinpointIQ end-to-end cloud platform for continuous monitoring of physiology. The data will be gathered through a clinical study of COVID-19-positive patients in collaboration with University of Illinois Hospital and Health Sciences System and build on work already in place for monitoring COVID-19 patients convalescing at home.
Solutions in Critical Care, a national network of specialty distribution partners in the medical device industry, has been awarded a group purchasing agreement for specialty distributor of respiratory products with Charlotte, N.C.-based Premier Inc. Products on the contract include the SCC CPAP system with inspiratory and expiratory HEPA filter, the Artemis Pedi-Fit noninvasive pediatric nasal mask and the Trinity Circuit.
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said it has entered an agreement to divest its Tachosil fibrin sealant patch to Corza Health Inc., of Del Mar, Calif. Takeda will receive €350 million (US$414 million) in cash for the assets and licenses that support the development and commercialization of Tachosil, a surgical patch that provides bleeding control. The transaction is expected to close by March 31, 2021, subject to customary legal and regulatory closing conditions.
Tempus Labs Inc., a Chicago-based company focused on precision medicine through the application of artificial intelligence in health care, reported a collaboration with Covance, the drug development business of Laboratory Corp. of America Holdings (Labcorp). Burlington, N.C.-based Labcorp will participate in Tempus's TIME Trial Network, and the companies will work together to accelerate patient enrollment for oncology clinical trials through a data-driven approach.
Todos Medical Ltd., of Rehovot, Israel, said it has expanded its partnership with Care G.B. Plus Ltd., of Tel Aviv, Israel, for the development and commercialization of its Tbia cancer diagnostic platform to include Europe and Africa. Todos originally executed an agreement with Care G.B. in 2018 for the development and commercialization in Israel. In this expanded agreement, the companies have formed a joint venture – with Care G.B. owning 67% and Todos owning 33%.
Palo Alto, Calif.-based Varian Medical Systems Inc. has received notice from the Customs Tariff Commission of the State Council of China that the first exclusion of the additional tariffs China imposed on U.S. products will expire Sept. 16. In accordance with procedures, the exclusion will be extended by one year to Sept. 16, 2021. Varian medical linear accelerators are one of the first items to be excluded from additional tariffs.
Vibrent Health, of Fairfax, Va., said it has been awarded a contract worth a potential value of $4.23 million from the U.S. National Institutes of Health’s National Cancer Institute and National Institute of Biomedical Imaging and Bioengineering to develop a large-scale, data-driven approach to fight COVID-19. Vibrent Health will expand and enhance its Digital Health Solutions Platform for Wi-Fi-enabled contact tracing to reduce the risk of COVID-19 infection.
Vitalconnect Inc., of San Jose, Calif., reported it has begun the TELESTAR-TAVR clinical study. The study will evaluate patients who undergo a transcatheter aortic valve replacement (TAVR) and monitor them following the procedure using Vitalconnect’s latest technology, Vistasolution Live. The primary objective is to measure the impact of remote patient monitoring and telehealth on patient satisfaction, clinical outcomes and readmission rates for patients. TELESTAR-TAVR will enroll a total of 100 patients, 50 each in the control and treatment groups, with initial study results available in six months and complete study results in 12 months.
Newport Beach, Calif.-based Vivera Pharmaceuticals Inc. reported the launch of Biozone, a device designed for sanitization in high occupancy settings. Biozone uses facial recognition, integrated biometrics and a hospital-grade sanitization mist. The device can detect body temperature, assign custom profiles for users and provide surface disinfection of clothing and personal belongings.