San Diego-based Aethlon Medical Inc. reported the first patient has been treated in the company's first-in-human early feasibility study (EFS) evaluating the Hemopurifier in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The study is enrolling patients at UPMC Hillman Cancer Center in Pittsburgh. The EFS is a single-center, open-label trial in 10 to 12 subjects. The study is evaluating the Hemopurifier for reducing cancer-associated exosomes prior to the administration of standard-of-care Keytruda (pembrolizumab), which is a first-line therapy for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The primary endpoint for the study is safety of the Hemopurifier in a clinical setting. Secondary endpoints include efficacy based on response rates, progression-free and overall survival, and changes in exosome concentration after Hemopurifier treatment.
Richmond, Va.-based, Brainbox Solutions Inc. reported that it is beginning enrollment in its pivotal clinical trial, HeadSMART II (Head injury Serum markers and Multi-modalities for Assessing Response to Trauma), of the company's concussion diagnostic and prognostic test, Brainbox TBI. The multinational, multisite trial, which will enroll up to 2,000 patients from more than 18 sites across the U.S., as well as the U.K. and New Zealand, aims to generate data to support an application for regulatory clearance by the U.S. FDA. The Brainbox TBI test will be the first objective test designed to assist in the diagnosis of concussion and provide an assessment of the risk of chronic injury. The FDA has granted the test a breakthrough device designation.
Toronto-based Cardiocomm Solutions Inc. has entered a technology integration agreement with New York-based Livecare Corp. and a value-added reseller and distribution agreement with Alliance Tele-Med, to provide integrated ECG monitoring through the Livecare Link+ device and telemedicine platform. Under the agreement, the GEMS Mobile app technology was embedded into the Link+ gateway device allowing ECGs to be transferred through the Link+ platform to the Cardiocomm Smart Monitoring ECG reading service. Once an ECG report is completed, the report findings are then securely transmitted to the Link+ platform and from there to the Link+ platform's remote patient monitoring teams.
Suffern, N.Y.-based Cdx Laboratories Inc. has been awarded GSA Contract #36F79721D0050 for Wats3D, an artificial intelligence-powered diagnostic platform developed to identify precancerous cells in the esophagus. As of Dec. 1, access to the Wats3D catalog and pricelist will be available to federal purchasers via the National Acquisition Center and the GSA e-library.
Cleveland-based Centerline Biomedical Inc. reported the completion of the first surgical case in its MOTION clinical study of its Intra-Operative Positioning System surgical navigation platform. The U.S. FDA-cleared technology is already being deployed in a controlled launch at Cleveland Clinic and other institutions in the U.S. The MOTION study will be used to support the company's submission for market clearance in Europe and other international markets. The primary objective of the MOTION study is to formally clinically evaluate the effectiveness and safety of the technology in providing accurate navigation during endovascular aortic repair procedures. The study will consist of 30 total cases divided among Cleveland Clinic and UNC Medical Center.
Palo Alto, Calif.-based Emedgene Inc. reported a nonexclusive partnership with San Diego-based Illumina Inc. and the integration of automated interpretation into Illumina's Trusight Software Suite for rare genetic diseases. Emedgene's Clinical Rare Disease application is one of a portfolio of artificial intelligence (AI)-powered applications for high-throughput genomic interpretation across clinical and research use cases.
Mountain Lakes, N.J.-based Euroimmun US Inc., a Perkinelmer Inc. company, reported the launch of the CE marked SARS-CoV-2 Antigen ELISA for specific determination of the SARS-CoV-2 protein
Johnson City, N.Y.-based Ia, a provider of software-enabled pharmacy automation solutions for retail, hospital, federal health care and mail-order pharmacy markets, reported a reseller agreement with Becton, Dickinson and Co. (BD), a Franklin Lakes, N.J.-based global medical technology company. The effort is aiming for the integration of BD’s Rowa Pouch Packaging Solution into Ia’s Symphony Software platform, with the latter serving as the exclusive distributor of BD’s Rowa Pouch Packaging Solution in specific market segments across the U.S.
New York-based Eyenovia Inc. said that the first set of patients has been enrolled in the company’s phase III VISION-1 study of Microline, its pilocarpine formulation delivered via its Optejet dispenser, for the improvement in near vision in patients with presbyopia.
GE Healthcare, of Chicago, reported a multiyear agreement with Oregon Health & Science University, permitting the latter to oversee and help provide care to intensive care unit (ICU) patients across eight hospital sites via a virtual ICU using the GE Healthcare Mural Virtual Care Solution.
Genosity Inc., an Iselin, N.J.-based biotechnology company offering software and laboratory solutions to enable development and deployment of complex next-generation sequencing assays, reported an agreement with Cambridge, Mass.-based Gemini Therapeutics to conduct molecular profiling in support of clinical trial patient selection and stratification for Gemini’s GEM103 program in age-related macular degeneration.
Hawkeye Systems Inc., a Savannah, Ga.-based technology holding company focused on pandemic management products and services, has signed a letter of intent (LOI) to acquire New York-based Ikon Supplies LLC, which focuses on personal protective equipment supply chain management. Upon completion of the acquisition, Hawkeye will acquire a 51% interest of all equity of Ikon Supplies LLC and an option to purchase the remaining 49% interest. This LOI is nonbinding and subject to a definitive agreement, which will be negotiated in good faith in the next 30 days.
Iguazio, a developer of the data science platform built for production and real-time machine learning applications that has a presence in New York, Singapore and Herzliya, Israel, reported that it is working with the Sheba Medical Center’s ARC innovation complex to deliver real-time artificial intelligence across a variety of clinical and logistical use cases in order to improve COVID-19 patient treatment.
Silicon Valley, Calif.-based health care innovation hub Inflect Health has spun off from parent company Vituity to form a new nationwide, multispecialty investment partnership, owned and led by physicians and health care business experts.
MDclone, a digital health company founded in Beer-Sheva, Israel, and the VHA Innovation Ecosystem, a division of the U.S. Department of Veterans Affairs reported a partnership that aims to democratize data at the Veterans Health Administration (VHA). The partnership is intended to provide access to clinical data to better understand and improve the health of the more than 9 million veterans it serves.
Cincinnati-based Meridian Bioscience Inc. said it has received a $1 million award from NIH’s Rapid Acceleration of Diagnostics (RADx) initiative to expedite the launch of its Revogen molecular test for SARS-CoV-2. The company applied for emergency use authorization of the assay to the U.S. FDA on Dec. 7.
Woburn, Mass.-based Nanomosaic LLC reported the first Tessie beta placement at Massachusetts General Hospital. The system will be used by MGH researchers to develop a panel of markers for the study of postoperative delirium and postoperative cognitive dysfunction among other potential applications.
Boston-based Nanoview Biosciences Inc. and Quantum Design China Co. Ltd., of Beijing, a subsidiary of Quantum Design International, have entered into an exclusive agreement for Nanoview’s Exoview platform in China.
Oncocyte Corp., of Irvine, Calif., has entered into an exclusive licensing agreement with Burning Rock Biotech Ltd., of Guangzhou, China, to bring Determarx, a risk stratification test for early-stage lung cancer, to China.
Columbus, S.C.-based Rhythmlink LLC has acquired Chalgren Enterprises Inc., a Gilroy, Calif.-based medical device manufacturer that will add to their existing portfolio of products for brain and nervous system monitoring. The transaction closed Dec. 11, 2020. Financial terms were not disclosed.
Sherlock Biosciences Inc., of Cambridge, Mass., received a $5 million grant from the Bill & Melinda Gates Foundation to continue to advance its Inspectr platform for COVID-19 self-testing.
Santa Clara, Calif.-based Si-Bone Inc. said Humana has revised its coverage policies to cover minimally invasive sacroiliac joint fusion using triangular titanium implants such as the Ifuse Implant System.
Carlsbad, Calif.-based Spinal Elements Inc. has purchased the assets of Benvenue Medical Inc., a Santa Clara, Calif., developer of minimally invasive spinal lumbar fusion systems. The company plans to integrate the Benvenue assets and relaunch its Luna and Orbit products by the second quarter of 2021. Financial terms of the deal were not disclosed.
Transcat Inc., a provider of calibration, repair, inspection and laboratory instrument services headquartered in Rochester, N.Y., has acquired the assets of Biotek Services Inc., of Henrico, Va., for $3.5 million. The deal took effect Dec. 16, 2020.
Trevor, Wis.-based Vonco Products LLC, a contract manufacturer of liquid-tight medical devices and fluid bags, biohazard transport bags and infection prevention PPE and equipment covers, said it received ISO 13485:2016 certification of its quality management system.