Avita Medical Ltd., which has a presence in Valencia, Calif., and Melbourne, Australia, said the Federal Court of Australia approved orders to convene a meeting of the company’s shareholders to consider and, if thought fit, approve the proposed scheme of arrangement under which Avita Therapeutics Inc., a newly formed company incorporated in Delaware in the United States of America, will become the parent company for the purposes of effecting a redomiciliation of the Avita Group from Australia to the U.S.
Bellerophon Therapeutics Inc., of Warren, N.J., said the U.S. FDA accepted its investigational new drug application, allowing the company to initiate a phase III study of INOpulse inhaled nitric oxide (INO) therapy in up to 500 patients infected with COVID-19.
Toronto-based Datametrex AI Ltd. secured nonexclusive rights to COVID-19 test kits with Health Canada approval, Kingdom of Saudi Arabia, Saudi Food & Drug Authority approval, and CE marking certification. The latest kit to be added by Datametrex to distribute is the 1copy COVID-19 qPCR Multi Kit. The kits are made by 1drop Inc. in South Korea and are immediately ready for sales orders in Canada.
Waltham, Mass.-based Fresenius Medical Care North America's Renal Therapies Group is preparing its first shipment of Multibic dialysate solutions for use in continuous renal replacement therapy. These efforts will support hospitals faced with COVID-19 pandemic-related increases in acute kidney injury.
Inspire Medical Systems Inc., of Golden Valley, Minn., said that Palmetto GBA LLC reported the release date of June 21 for its final local coverage decision policy covering Inspire therapy.
Intel Labs, of Santa Clara, Calif., and the Perelman School of Medicine at the University of Pennsylvania (Penn Medicine) are co-developing technology to enable a federation of 29 international health care and research institutions led by Penn Medicine to train artificial intelligence models that identify brain tumors using a privacy-preserving technique called federated learning.
Kc Wearable, of Shenzhen, China, revealed new partnerships with national authorities across Europe related to COVID-19. Partnerships with the Italian police and an airport in Rome have seen the Kc Smart Helmet used in Europe for the first time, and conversations are continuing with various public authorities across the continent. The helmet provides officials with a solution for combatting the spread of COVID-19. The fast-scanning, infrared camera is connected to an augmented reality headset, allowing users to measure people's temperature in real time.
Mevion Medical Systems, of Littleton, Mass., signed a letter of intent to provide the Mevion S250i proton therapy system with Hyperscan pencil beam scanning to an independent service provider in Texas. The contract is expected to be completed in the second half of the year.
Mologic Ltd., of Thurleigh, U.K., said it has joined forces with Biosure U.K., of Nazeing, U.K., to produce a COVID-19 antibody self-test. The Biosure COVID-19 Antibody Self-Test will be ready for mass production at the beginning of June. It will be available to the U.K. and global markets and be available to be directly purchased by end-consumers.
Orexo AB, of Uppsala, Sweden, has acquired the exclusive rights to market Hamburg, Germany-based Gaia AG’s Deprexis digital therapy for depression in the U.S. The agreement builds on Orexo’s earlier acquisition of U.S. rights to Gaia’s Vorvida and Oxd01 digital tools for alcohol use disorder and opioid use disorder, respectively.
Ortho Clinical Diagnostics, of Raritan, N.J., is partnering with Quest Diagnostics Inc., of Secaucus, N.J., to expand COVID-19 antibody testing to more than 20 Quest laboratories across the U.S. Under the agreement, Quest will use Ortho’s Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG test to test patients for detectable levels of antibodies to the novel coronavirus.
Waltham, Mass.-based Perkinelmer Inc. said its Solus One Salmonella assay and methods have achieved First Action Official Methods of analysis status from the Association of Official Analytical Collaboration International.
Sanara Medtech Inc., of Fort Worth, Texas, reported a new license agreement with Rochal Industries LLC, of San Antonio, for an autolytic debrider wound dressing that is under development. The companies have prior agreements for other wound and skin care products.
Jerusalem-based Seevix Material Sciences Ltd. said it plans to use its synthetic Svx spidersilk to create disposable filters to entrap and neutralize COVID-19 and other coronaviruses.
Tearlab Corp., of Escondido, Calif., said it has agreed to be acquired by New York-based private equity firm Accelmed Partners II (AP-II). As part of the agreement, AP-II will invest $25 million over two tranches in conjunction with Tearlab’s delisting from the OTCQB market. After the deal closes, Tearlab will be a private company, with AP-II as its controlling shareholder. Proceeds from the AP-II investment will be used to pay down existing debt and fund growth opportunities.
Technopath Clinical Diagnostics Holdings Ltd., of Ballina, Ireland, has released its Multichem ID-COVID-19 quality control solutions, providing laboratories with independent quality control checks and longer-term monitoring to aid in detecting instrument, reagent and procedural errors.
Telemedicine Clinic, the teleradiology unit of Geneva, Switzerland-based Unilabs, said it is partnering with Aidoc Medical Ltd., of Tel Aviv, to roll out artificial intelligence-powered diagnostic tools and improve patient triage.
Tissue Regenix Group plc, of Leeds, U.K., reported a collaboration for white label manufacturing with a leading global health care company that is bringing a newly developed product to address orthopedic soft tissue repairs. Processing for the product has begun, and initial orders have been received. During the first quarter, Tissue Regenix also signed further distribution agreements with selected partners to expand market penetration of its Amnioworks, Matrix Oi and Dentalfix brands in areas such as ocular, spinal and dental.
Zoll Medical Corp., of Chelmsford, Mass., said it has returned funds its Cardiac Management Solutions division received from HHS as part of the CARES Act Provider Relief Fund. The company said that while it qualified for the funds, it had not requested them and believed there were other businesses in greater need of financial assistance during the COVID-19 pandemic.