Alachua, Fla.-based Axogen Inc. reported preliminary first quarter 2020 revenue, while also revealing that it had won approval for a Small Business Administration loan under the Paycheck Protection Program for $7.8 million. In addition, the company reported that the U.S. District Court for the Middle District of Florida dismissed a putative class action complaint filed Jan. 9, 2019, alleging violations of the federal securities laws. The court dismissed the complaint without prejudice, finding the plaintiff failed to state a claim upon which relief could be granted. The plaintiff has 60 days to file an amended complaint or the action will be dismissed with prejudice.
Aytu Bioscience Inc., of Englewood, Colo., reported the signing of a definitive agreement with Singapore-based Biolidics Ltd. to exclusively distribute the latter’s COVID-19 IgG/IgM rapid test in the U.S. Aytu has committed to purchase 500,000 tests within one business day from the date of signing of the agreement. As an additional component of Aytu's exclusivity, the company has committed to purchase a minimum of 1.25 million tests within the first three months of the agreement.
Biocartis Group NV, of Mechelen, Belgium, is suspending its guidance on instrument placements in 2020 and will provide an update as soon as normal business activity resumes. It also has suspended guidance on commercial cartridge volume growth.
South San Francisco-based Caredx Inc. and Johns Hopkins University reported the launch of the Allosure Lung Allograft Remote Monitoring (ALARM) Partnership. During the COVID-19 crisis, Johns Hopkins will partner with Caredx to launch the ALARM Partnership to measure the impact of Allosure and Remotrac on their lung transplant patients.
Carestream Health, of Rochester, N.Y., has increased production of its portable diagnostic imaging systems in response to the need for critical care during the COVID-19 crisis.
Eden Prairie, Minn.-based CHF Solutions shipped the first commercial orders of its next-generation Aquadex Smartflow system to Austria, following shipments to Germany earlier this year. The company has partnered with Neucomed Group, which has a presence in Vienna and Erding, Germany, and its affiliates to serve patients in Germany, Austria and Switzerland.
Daxor Corp., of New York, said the U.S. Department of Defense has awarded the company a $1.1 million contract for the development and deployment of a small, portable, highly accurate, battery-powered blood volume analyzer. Once the company moves into mass-manufacturing, both parties agree that this new technology also is suitable for civilian use in hospitals and outpatient settings.
Scottsdale, Ariz.-based Electromedical Technologies Inc. has completed a collaborative agreement with Nazarbayev University, Nur-Sultan, Kazakhstan, to develop a comprehensive research program in defining the effects of electro-modulation on a physiological state of human body by studying the impacts of alternating electrical fields on cell signaling.
Boulder, Colo.-based Encision Inc. said it has secured a two-year, $598,567 loan, with an interest rate of 1.0%, under the Paycheck Protection Program established under the Coronavirus Aid, Relief, and Economic Security Act. Repayment is deferred for the first six months.
New York-based Enzo Biochem Inc. has released a next-generation COVID-19 test for use with its Genflex open diagnostic platform. Available via U.S. FDA emergency use authorization, the test offers improved scale, sensitivity and an RNA-positive control that confirms the presence of human mucosa cells in the specimen, verifying accurate collections.
Exogenesis Corp., of Billerica, Mass., reported the formation of Nanomesh LLC, a medical device company focused on commercialization of the Exogenesis Hernia Mesh, also known as Nanomesh. FDA-cleared in 2019, the device is expected to be commercially available in the U.S. during the second half of 2020.
Lumex Instruments Ltd., of Mission, British Columbia, reported the development of a microchip RT-PCR COVID-19 detection system. The system, based on Lumex’s microchip real-time PCR analyzer AriaDNA, allows for testing of seven patient samples in one run, in under one hour, with low reagent consumption. The system is currently for research use only.
Opentrons Labworks Inc., of Brooklyn, N.Y., is partnering with Zymo Research Corp., of Irvine, Calif., to create a robust engine for SARS-CoV-2 molecular testing. The collaboration pairs Opentrons’ automated RNA extraction pipeline created with its OT-2 liquid handling robot, verified labware and magnetic module with Zymo’s Quick-DNA/RNA Viral Magbead Kit technology.
Predictive Oncology Inc., of Egan, Minn., reported that CEO Carl Schwartz has agreed to exchange a $2.1 million promissory note for 1,533,481 shares of newly issued common stock at an exchange rate of $1.43 per share, the closing price of the common stock on April 21, 2020. The money was used to cancel outstanding debt.
San Diego-based Quidel Corp. said it has applied to the U.S. FDA for emergency use authorization of its Lyra Direct SARS-CoV-2 assay. The test will run on the same six instruments as the Lyra SARS-CoV-2 assay.
Rewalk Robotics Inc., of Marlborough, Mass., said it has finalized national agreements with top German statutory health insurers Techniker Krankenkasse and Deutsche-Angestellten-Krankenkasse-Gesundheit, both headquartered in Hamburg. The agreements provide for reimbursement for the Rewalk 6.0 exoskeleton system.
Arezo, Italy-based Seco is teaming up with Italian Biomedical Devices srl, of Forli’-Cesena, Italy, to develop Respira, a noninvasive pulmonary ventilator to address the COVID-19 pandemic. The portable, high-flux ventilators are equipped with touchscreen displays and designed for home and hospital use.
Singapore-based Sengenics Corp. Pte. Ltd. has launched its Immukyne protein array to identify autoantibodies linked to the development of acute respiratory distress syndrome in COVID-19 patients.
Siemens Healthineers AG, of Erlangen, Germany, said it has developed a laboratory-based total antibody test to detect SARS-CoV-2 antibodies, IgM and IgG, in blood, with 99% specificity and sensitivity. The company is pursuing both U.S. FDA emergency use authorization and the CE mark for the test, which will be available by late May.
London-based Signifier Medical Technologies said it is partnering with 27 key opinion leaders in sleep disorders to test and build awareness of its Snoozeal product ahead of its commercial launch. The genioglossal muscle-neurostimulation technology is intended to treat snoring and sleep apnea.
Spineway SA, of Lyon, France, has inked an agreement with Osaka-based Muranaka Medical Instruments Co. Ltd., for distribution of its products in Japan. The company’s Mont-Blanc Mis minimally invasive surgical line received approval from Japanese health authorities in October 2019.
Cambridge, Mass.-based Trinetx Inc. reported that Synteract, of Carlsbad, Calif., successfully used the COVID-19 Rapid Response Network to identify European study sites for an investigational COVID-19 medicinal product and was able to engage all of the sites required for the trial in one week. Trinetx launched the network to enable the pharmaceutical community to design clinical trials with real-world data and quickly engage organizations interested in participating in COVID-19 trials.
Tearlab Corp., of Escondido, Calif., said the U.S. FDA has accepted the resubmission of its 510(k) application for the potential clearance of its Tearlab Discovery MMP-9 test, an in-vitro diagnostic testing system. The submission covers the Tearlab Discovery platform and its single-use, disposable test card measuring the inflammatory biomarker, matrix metalloproteinase 9. Tearlab Discovery also will be capable of performing the company’s current FDA-cleared tear osmolarity test.
Veracyte Inc., of South San Francisco, and Yale University, of New Haven, Conn., reported an exclusive licensing agreement to advance the first genomic test for predicting disease progression in patients with idiopathic pulmonary fibrosis (IPF). The agreement gives Veracyte rights to a 52-gene signature developed by Yale researchers, for use on the Ncounter Flex Analysis system. Veracyte plans to make the noninvasive, blood-based test available as a complement to its Envisia Genomic Classifier, as part of a comprehensive offering to aid in the diagnosis and treatment of patients with IPF.
Webb Diagnostic Technologies (Webbdx), of Nashville, Tenn., said it will begin marketing a point-of-care serology test in the U.S. that can instantly detect antibodies in whole blood, serum and plasma for SARS-CoV-2. The test was developed and validated in North America using Rapid Vertical Flow Technology from Medmira Inc., of Halifax, Nova Scotia. Medmira has submitted FDA notification under the name RevealCOVID-19. Webbdx is the exclusive U.S. distributor, and the test will be manufactured in the U.S.
Wytcote Inc., of Irvine, Calif., reported the launch of a rapid-result COVID-19 antibody test. The company has applied for U.S. FDA emergency use authorization and is partnering with CHOC Children's to determine how many patient-facing clinicians and staff in their emergency department have developed COVID-19-fighting antibodies. During this study, participants will undergo rapid antibody serological testing for IgG and IgM through a simple finger prick, once per shift, with results available in three minutes. The study expects to enroll up to 250 subjects total, with about 100 participants being tested each day.
Zeus Scientific Inc., of Branchburg, N.J., reported the submission for an emergency use authorization to the U.S FDA for its rapid, in vitro diagnostic test for the qualitative detection of IgG and/or IgM antibodies to SARS-CoV-2. The lateral flow test uses patient serum, plasma or whole blood and provides results in 15 minutes. The company also said it is developing a corresponding ELISA test system, also for detection of antibodies to SARS-CoV-2.