St. Paul, Minn.-based 3M Co. is partnering with Columbus, Ind.-based Cummins Inc. to increase the production of high efficiency particulate filters for use in 3M’s powered air purifying respirators, or PAPRs. The partnership has the potential to more than double the current production of filters for 3M’s PAPRs. The additional filters are needed as 3M has ramped up production of PAPRs to meet a surge in demand for personal protective equipment due to the COVID-19 outbreak. Guided by a 3M design, employees in Cummins’ facility in Neillsville, Wis., will use existing equipment typically used for producing diesel engine filters to make the PAPR filters. After assembly and testing, the filters will be sent to 3M’s plant in Valley, Nebraska, where the company’s PAPRs are manufactured. Production of the filters at Cummins Neillsville location is expected to begin by the end of April. 3M is also working with the Trump administration on a plan to import 166.5 million 3M respirators from its overseas manufacturing facilities, starting this month. In March, 3M announced a separate partnership with Ford to increase the production of PAPRs.
New York-based think tank, Altru Institute has organized the Altru Global Virus Project to aggregate and curate the best information globally and to foster collaboration among scientists, physicians and entrepreneurs developing cures and treatments worldwide. It has produced its first summary report on a Princeton-based company, Sonnet Biotherapeutics Holdings Inc., which has a technology that may be highly applicable to the treatment of viruses. Sonnet developed an ingenious approach that converts endogenous albumin into a drug-loaded and/or immune stimulatory Trojan Horse that is taken up by unknowing cancer cells, leading to their destruction. Their core technology, which was designed for cancer, is a delivery mechanism that can be applied to viruses.
Co-Diagnostics Inc., of Salt Lake City, has contracted with Madison, Wis.-based Promega Corp. for additional manufacturing capacity for immediate production of the company's Logix Smart COVID-19 test, as the company seeks to expand its domestic outreach to public and private laboratories in the U.S. Promega will provide manufacturing support for the company's COVID-19 test kits, helping Co-Diagnostics meet demand that continues to expand during the pandemic. The test kits manufactured by Promega will be produced in large volumes to ensure the company will be able to satisfy demand for the its tests both in the U.S. and the rest of the world.
Fitbit Inc., of San Francisco, is collaborating with The Scripps Research Institute and Stanford Medicine on research aimed at using Fitbit data to help detect, track and contain infectious diseases like COVID-19. This new research consortium invites other institutions to join in this collective effort and share key learnings with the research community. The consortium brings together research already underway by both Scripps and Stanford. The Scripps Research Translational Institute recently launched DETECT, an app-based research program that will analyze participants’ wearable health data to more quickly detect the emergence of influenza, coronavirus and other fast-spreading viral illnesses. The Stanford Healthcare Innovation lab launched the COVID-19 wearables study, which aims to establish whether data collected from wearables can be used to predict the onset of an infectious disease such as COVID-19 before the actual symptoms start.
South San Francisco-based Fluidigm Corp. said it is withdrawing its 2020 financial guidance, due to the unknown duration and extent of the novel coronavirus’ impact.
Golden Valley Minn.-based Inspire Medical Systems Inc., a company focused on the development of minimally invasive solutions for patients with obstructive sleep apnea, reported the withdrawal of its full year 2020 financial guidance issued on Feb. 25, 2020. Inspire said it cannot predict the extent or duration of the impact of the COVID-19 pandemic on its financial results. The company said it plans to provide additional information, to the extent practicable, during its first quarter earnings call in May.
Intersect ENT Inc., of Menlo Park, Calif., a company transforming care for patients with ear, nose and throat (ENT) conditions, reported it is withdrawing its previously reported annual guidance for 2020, which was issued on Feb. 24, 2020. The company plans to provide additional information in conjunction with the release of its full first quarter financial results currently expected to be scheduled for mid-May.
Burlington, Mass.-based Lemaitre Vascular Inc., a provider of vascular devices, implants and services, withdrew prior annual guidance for 2020 due to the potential impact of COVID-19. The company will release its first quarter 2020 financial results, as well as additional information related to the impact of the COVID-19 pandemic, on April 30 after the market close.
Lantheus Holdings Inc., of North Billerica, Mass., the parent company of Lantheus Medical Imaging Inc., and New York-based Progenics Pharmaceuticals Inc. reported that Lantheus has entered a support agreement with Velan Capital related to the proposed merger of Lantheus and Progenics. Velan is a stockholder in both companies. The deal is expected to close in the second quarter of 2020.
Nyon, Switzerland-based Medalliance SA reported enrollment of the first patient in the SAVE study utilizing their sirolimus-eluting balloon, for the treatment of failed arteriovenous (AV) fistulae in renal dialysis patients. The objectives of this prospective, randomized, single-blind multi-center study are to demonstrate the safety and efficacy of Selution SLR in the treatment of failed AV fistulae in patients undergoing renal dialysis. This study will also qualify for EU MDR approval. The company said 84 subjects are being randomized to either Selutio SLR or balloon angioplasty. To qualify for inclusion patients must be aged 18-90, have a dialysis access that has performed at least one successful dialysis session, and a stenosis of more than 50% at the outflow vein. The primary efficacy endpoint of the study will be primary patency of the treated lesion and of the treated circuit at six months post-intervention. The primary safety endpoint will be freedom from any serious adverse events involving the AV access circuit or the patient at 30 days.
Cincinnati-based Meridian Bioscience Inc. reported the launch of several novel recombinant antigens needed for the development of COVID-19 IgG/IgM antibody tests. The product line includes the spike glycoprotein (S1, S2, RBD and NTD) and nucleocapsid protein, which can all be produced at commercial scale.
OralDNA Labs Inc., of Eden Prairie, Minn., has released the Orarisk COVID-19 PCR test, part of a line of salivary diagnostics. The U.S. FDA has been notified of validation and an emergency use authorization will be filed within 15 days, the company said. As a CLIA-certified and CAP-accredited laboratory, OralDNA can use the test pending EUA submission.
Amsterdam-based Royal Philips NV said it plans to double production of hospital ventilators four-fold – to 4,000 per week – by the third quarter of 2020. The company has engaged Singapore-based Flex Ltd. and Jabil Inc., of St. Petersburg, Fla., to assist in the ramp up. Additionally, Philips unveiled its new Philips Respironics E30 ventilator, with immediate production of 15,000 per week.
Repro Medical Systems Inc., of Chester, N.Y., doing business as Koru Medical Systems, said the U.S. Court of Appeals for the Federal Circuit affirmed an earlier decision by the U.S. District Court for the Eastern District of Texas that granted Koru’s motion for summary judgment on noninfringement against Emed Technologies Corp., of El Dorado Hills, Calif. The case alleged patent infringement of one of the company’s needle sets.
Transmedics Group Inc., of Andover, Mass., has withdrawn its 2020 guidance due to uncertainties caused by the COVID-19-pandemic.
New York-based Vault Health Inc. is partnering with Rucdr Infinite Biologics, of Piscataway, N.J., to launch a saliva-based test for COVID-19. Starting today, Vault will make thousands of tests available per week, with plans to scale up availability as Rucdr’s lab capacity expands. The test has FDA emergency use authorization.
Tempe, Ariz.-based Vomaris Innovations Inc. said it is seeking FDA emergency use authorization for a virus-killing face mask that utilizes its bioelectric V.Dox technology.