Amarex Clinical Research LLC, of Ann Arbor, Mich., said it has made five submissions to the U.S. FDA, seeking expedited approvals related to COVID-19. The submissions include an IND, IND amendment and compassionate use approval for Vancouver, Wash.-based Cytodyn Inc.’s monoclonal antibody product, leronlimab, a compassionate use approval for a device that is currently in IDE testing for another medical condition and an emergency use authorization for a PCR-based in vitro diagnostic for COVID-19 detection.
Amra Medical AB, based in Linköping, Sweden, and Fulcrum Therapeutics Inc., of Cambridge, Mass., have developed a standardized whole-body imaging protocol that accurately quantifies muscle fat fraction, lean muscle volume and muscle fat infiltration in patients with neuromuscular disease. They plan to use it in clinical trials for Fulcrum’s losmapimod, a small molecule candidate for facioscapulohumeral dystrophy, a slow progressing form of muscular dystrophy.
A group of Auburn University engineers has developed a way to quickly and inexpensively convert continuous positive airway pressure (CPAP) machines into ventilators to help COVID-19 patients. The Auburn, Ala.-based institution said the design, called RE-INVENT, is an accessory that would safely repurpose a CPAP into a functional ventilator.
Irvine, Calif.-based Biomerica Inc. has inked two license agreements with Mount Sinai’s Icahn School of Medicine aimed at scaling up a laboratory version serological test for COVID-19 and supporting high-volume screenings.
CDx Diagnostics Inc., of Suffern, N.Y., reported a new contract with Blue Cross Blue Shield of Massachusetts for its WAT3D (wide area transepithelial sampling with 3D tissue analysis) biopsy instrument.
Cerus Corp., of Concord, Calif., reported that the University of Basel, Switzerland, transfused the first two COVID-19 patients with coronavirus convalescent plasma treated by its Intercept system.
Eden Prairie, Minn.-based CHF Solutions Inc. has doubled the production staff for its Aquadex Smartflow consoles to meet increased hospital demand during the COVID-19 outbreak.
London-based Element Materials Technology Ltd. is assisting in the U.K. drive to increase ventilator production by providing a testing regime covering electromagnetic compatibility and basic safety requirements for a rapidly manufactured ventilator system prototype being developed by a consortia of companies.
Evotec SE, of Hamburg, Germany, reported a licensing and investment agreement with Toronto-based Pancella Inc. The agreement provides Evotec a nonexclusive license to access Pancella’s iPS cell lines, iACT Stealth Cells, as well as next-generation cloaking technology known as hypoimmunogenic cells. Evotec will use the cell lines to develop iPSC-based, off-the-shelf cell therapies for immune system suppression without medication. Additionally, Evotec has acquired a minority stake in Pancella and nominated Andreas Scheel to Pancella’s supervisory board.
Mesa, Ariz.-based Eyetech Digital Systems has launched the U.S. FDA-registered Eyeon Lifeline, an eye tracking communication tablet that aims to help health care professionals communicate easily and quickly with COVID-19 patients who are unable to speak while confined to their hospital beds.
Foracare Suisse AG, of St. Gallen, Switzerland, reported the launch of its Fora Autonomous Temperature Measuring Station, which allows forehead temperature to be read remotely with non-contact technology.
Gerber Technology, of Tolland, Conn., has partnered with Hardwire LLC, a Pocomoke City, Md.-based manufacturer of protective armor, to produce face shields for medical professionals and first responders fighting COVID-19 on the front lines.
GN Hearing, part of Ballerup, Denmark-based GN Group, reported the launch of Resound Assist Live, a real-time, video-enabled hearing care service, to help the elderly and other vulnerable populations stay connected during stay-at-home recommendations due to the COVID-19 pandemic.
Boston-based Haemonetics Corp. has acquired Enicor GmbH, of Munich, Germany, a company focused on whole blood coagulation testing. Financial terms of the deal were not disclosed.
The Hong Kong Polytechnic University (PolyU) reported the launch of two reusable face shields, both of which soon will be available at what the institution called affordable prices. In February, PolyU designed and started producing disposable face shields for the Hospital Authority to help alleviate the need for protective gear.
Scottsdale, Ariz.-based Imaging Endpoints' radiomic imaging technology has identified a potentially useful biomarker to noninvasively evaluate DKK1 expression, according to updated clinical data presented by Cambridge, Mass.-based Leap Therapeutics Inc. The findings come from a recently completed phase I/II clinical trial of DKN-01 in patients with advanced or recurrent esophagogastric cancer presented at the recent 2020 American Society of Clinical Oncology GI annual meeting.
Japan’s Jolly Good Inc. and the National Center for Cognitive Behavior Therapy and Research have entered a clinical trial collaboration agreement directed toward the development of digital health solutions. As a result, Jolly Good will develop and commercialize Cognitive Behavioral Therapy Virtual Reality in Japan and certain other overseas markets for patients with depression.
Lantheus Holdings Inc. the North Billerica, Mass.-based parent company of Lantheus Medical Imaging Inc., and Progenics Pharmaceuticals Inc., of New York, have decided to reschedule their respective special meetings of stockholders to vote on matters related to the proposed merger of Lantheus and Progenics from April 28 to June 16. The rescheduled meetings will allow both entities the time necessary to respond to the COVID-19 pandemic and its effect on each company’s business and on the combined entity. Further details about the time, location and record date for the meetings will be announced when finalized.
Lifesignals Group Inc., of Fremont, Calif., reported that a single-use, wireless biosensor patch for the early detection and monitoring of coronavirus symptoms is being fast tracked for introduction within weeks. The Biosensor Patch 1AX, simply affixed on the chest, will record temperature, respiration, electrocardiogram trace, heart rate and movement in real time.
Microgendx Laboratories, of Lubbock, Texas, has validated a real-time Reverse Transcriptase PCR (rRT-PCR) assay for the specific detection of the SARS-CoV-2 virus. In addition to being validated for both nasopharyngeal and oropharyngeal swabs, the company offers COVID-19 testing using saliva and sputum samples.
Misonix Inc., of Farmingdale, N.Y., has withdrawn its previously issued financial guidance for the company’s fiscal 2020 performance.
Nanomosaic LLC, of Boston, said it is commercializing technology for high-throughput, high-sensitivity analyte detection initially developed at Harvard University, through an exclusive license agreement with Harvard Office of Technology Development. Nanomosaic's screening tools may aid in several biomedical fields, including the early detection of disease, prognostic monitoring, biomarker discovery and infectious disease monitoring.
Nanovibronix Inc., of Elmsford, N.Y., signed a license agreement with of Suwanee Ga.-based Sanuwave Health Inc. for the manufacture and delivery of its Woundshield technology. Under the terms of the agreement, Nanovibronix will receive 100,000 warrants of Sanuwave stock, a $250,000 milestone payment based on U.S. FDA approval, and 10% royalty on Sanuwave's gross revenues from sales or rentals of Woundshield. In return, Sanuwave has received the worldwide, exclusive rights to the company's Woundshield product and technology. In addition, Sanuwave will bear the costs and clinical validation responsibilities associated with obtaining approval for Woundshield from the FDA and other regulatory agencies around the world.
Madison, Wis.-based Promega Corp.’s Gotaq Probe 1-Step RT-qPCR System is now in a CDC COVID-19 diagnostic protocol for emergency use. The Promega tool is an approved master mix option for the CDC’s 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel that is available through the CDC’s emergency use authorization.
Los Angeles-based Science 37 Inc. has partnered with Innovo Research, of Wilmington, N.C., to accelerate COVID-19 research for vaccines, drugs, and diagnostics. Innovo will utilize their national network of sites and patients for recruitment and initial screening and Science 37 will utilize its technology platform and at-home nursing capabilities for ongoing virtual or at-home study visits.
Ansan, South Korea-based Seoul Viosys and Columbia, S.C.-based Sensor Electronic Technology Inc. (“SETi”), said they have been successful in achieving 99.9% sterilization of coronavirus (COVID-19) in 30 seconds. Tests were conducted with the research group of Korea University, Korea’s top rank university, by using a compound semiconductor Violeds technology that is being mass-produced. In the study by SETi and Seoul Viosys, Violeds technology is used to show just how strong the sterilization effect can be on COVID-19 when exposed to Violeds photons for 30 seconds. The study also finds the coronavirus becomes even more sterile when placed closer to the photon with longer exposure time. In addition to testing the coronavirus, the Violeds technology also proved to be successful in sterilizing 99.9% of other harmful bacteria such as Escherichia coli, Staphylococcus Aureus, Pseudomonas Aeruginosa, Klebsiella Pneumonlae, and Salmonella Typhimurium.
Siemens Healthineers AG, of Erlangen, Germany, reported the availability of its molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit used to aid in the diagnosis of infection by the SARS-CoV-2 virus that causes the COVID-19 disease. Test kits are already being shipped within the EU for research use only (RUO) to expedite availability while the company continues to pursue emergency use assessment and listing (EUAL) from the World Health Organization for clinical use. In addition, the company has begun discussions with the U.S FDA for release of the test under emergency use authorization.
Cambridge, Mass.-based Vericel Corp. said that due to the significant uncertainty regarding the duration and impact of restrictions on elective procedures related to the COVID-19 pandemic, and the fact that the U.S. Biomedical Advanced Research and Development Authority may adjust the emergency stockpile delivery plan for Nexobrid due to shifting priorities related to the pandemic, it is withdrawing its previously reported 2020 financial guidance, which was issued on Feb. 25, 2020. The company plans to provide additional information, to the extent practicable, during its first quarter earnings call in May.