Medtronic execs see quick recovery, increased M&A

Medtronic CEO Geoff Martha

If Medtronic’s troubling Q4 report offers a snapshot of a company hit hard by COVID-19, the next image in the sequence may show a faster-than-expected recovery and increased merger-and-acquisition of smaller companies.

In the quarterly call on Thursday morning, Medtronic CEO Geoff Martha and CFO Karen Parkhill expressed optimism that the company’s businesses already are showing signs of a rebound in the month of May.

At the same time, Medtronic executives believe the broader financial pressures on the industry will create attractive opportunities to acquire companies that will add to its growth rate.

Get the full story at our sister site, MassDevice.

 

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NFL looking at modified facemasks for helmets

NFL Players Association medical director Thom Mayer told ESPN that the league is developing facemasks to protect players from COVID-19.

Speaking to ESPN reporter Adam Schefter on The Adam Schefter Podcast, Mayer said the league and Oakley are testing prototypes of helmets with a modified facemask that could contain surgical material or even the material used in the 3M (NYSE:MMM) N95 respirator masks that have seen heightened demand during the coronavirus pandemic.

“They’ve got some prototypes,” Mayer said on the podcast. “Some of them, when you first look at them, you think, ‘Gosh, no’ because you’re not used to seeing it. You’re just not used to seeing it. But they’re looking at every issue you can imagine, including when it fogs up. What do we do with that? But these guys are used to dealing with this stuff.”

In another exchange in the podcast, Schefter asked Mayer if it’s realistic to think that players could have fully covered facemasks. Despit…

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Health Canada authorizes Abbott COVID-19 antibody test

Abbott (NYSE:ABT) announced today that Health Canada has granted interim authorization for its Architect SARS-CoV-2 IgG serology test for COVID-19.

The Abbott Park, Ill.-based company won an FDA emergency use authorization and the CE Mark for the same antibody test for use on its Architect system in April. The test is designed to detect the IgG antibody, a protein that the body produces in the late stages of infection and may remain up to months after a person has recovered from the novel coronavirus.

A recent study published in the Journal of Clinical Microbiology found that Abbott’s SARS-CoV-2 IgG antibody test had 99.9% specificity and 100% sensitivity for detecting the IgG antibody in patients 17 days or more after symptoms began. Abbott has come under scrutiny for the accuracy of one of its COVID-19 molecular diagnostic tests.

The company said it expects to begin shipping antibody tests to Canada this week and intends to distribute 30 million …

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Medtronic misses mark in Q4 as sales decline 26%

Medtronic (NYSE:MDT) announced fourth-quarter results today that were even worse than expected, but the world’s largest medical device company is still upping its dividend and investing in future growth.

The Fridley, Minn.–based medtech giant reported profits of $646 million, or $0.48 per share, on sales of $6.0 billion for the three months ended April 24, 2020, for a bottom-line slide of 46% on a sales decline of 26% compared with Q4 2019.

Adjusted to exclude one-time items, earnings per share were 58¢, 48¢ behind The Street, where analysts were looking EPS of $1.06 on sales of $7.02 billion.

Because Medtronic’s previous quarter unlike many other medical device companies finished at the end of April versus the end of March, the results out today are some of the first to truly reflect the economic devastation wrought by the COVID-19 pandemic. Medtronic had already warned that its weekly revenue was down 60% in April as hospitals ended electiv…

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Mammoth deal with GSK could lead to home COVID-19 test

CRISPR startup Mammoth Biosciences will partner with GlaxoSmithKline’s (NYSE:GSK) consumer healthcare division to develop a home-based diagnostic capable of detecting active SARS-CoV-2, the novel coronavirus that causes COVID-19.

The collaboration will use Mammoth Biosciences’ CRISPR-based Detectr  platform to design “guide-RNA” that can identify and signal the presence of viral strands obtained through a simple nasal swab, according to Mammoth Biosciences CEO Trevor Martin.

Martin said he couldn’t speak to the specifics of the deal with GSK.

“This is really a long-term play in the next generation of diagnostics,” he said in an interview with MassDevice. “One of the powers of the CRISPR-based platform is you can switch out the guide-DNA, so over the long term you can imagine using the same platform for a variety of diseases.”

The company intends to file for an FDA emergency use authorization for the test by the end of 2020. If it’s app…

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This patient-mover got an emergency COVID-19 nod from the FDA

The Patient Isolation Transportation Unit (PITU) [Image courtesy of AR Tech, a division of A&R Tarpaulins]

AR Tech, a division of A&R Tarpaulins, announced today that the FDA has granted an EUA for its Patient Isolation Transportation Unit (PITU) to help hospitals better manage the COVID-19 pandemic.

“PITU is a game-changer in this fight against the pandemic because it is a negative pressure isolation enclosure that makes working with highly contagious diseases a safer process,” said Carmen Weisbart, a registered nurse who is president of A&R Tarpaulins.

Get the full story on our sister site MassDevice. 

 

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This patient-mover got an emergency COVID-19 nod from the FDA

The Patient Isolation Transportation Unit (PITU) [Image courtesy of AR Tech, a division of A&R Tarpaulins]

AR Tech, a division of A&R Tarpaulins, announced today that the FDA has granted an EUA for its Patient Isolation Transportation Unit (PITU) to help hospitals better manage the COVID-19 pandemic.

“PITU is a game-changer in this fight against the pandemic because it is a negative pressure isolation enclosure that makes working with highly contagious diseases a safer process,” said Carmen Weisbart, a registered nurse who is president of A&R Tarpaulins.

“PITU also allows properly attired family members to see patients who are infected with COVID-19,” Weisbart said in a news release.

Dr. Mark Comunale, head of anesthesiology at Arrowhead Medical Center (Colton, Calif.), developed the unit in 2015 with the Ebola outbreak in mind. AR Tech (Fontana, Calif.) joined his efforts two yea…

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FDA approves Phase 3 trial for coronavirus drug

Octapharma announced today that the FDA approved its investigational new drug (IND) application for a Phase 3 clinical trial for its drug therapy in COVID-19 patients.

Octagam 10% [Immune Globulin Intravenous (Human)] therapy will be observed for efficacy and safety in use with COVID-19 patients with severe disease progression, according to a news release.

Get the full story at our sister site, Drug Discovery & Development.

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G Medical Innovations ECG Patch receives FDA EUA for use in COVID-19 patients

G Medical Innovations recently announced that it received FDA emergency use authorization for its vital signs monitoring system ECG patch for remote monitoring of patients who are being treated for COVID-19.

The patch monitors the QT interval of an ECG in patients to watch for fatal arrhythmias that may occur from treatment drugs. Prolonged QT intervals could indicate a rhythm disorder in the heart, according to the company. The condition can lead to fainting, seizures or sudden death.

“This authorization from the FDA is an outstanding development for G Medical and its value cannot be underestimated. It is heartening to see that our technology has been recognized as being able to help ease the burden of COVID-19 on the US healthcare system,” CEO Yacov Geva said in a news release.

Under the emergency use authorization, the FDA said that “there is no adequate, approved and available alternative to the emergency use of the VSMS Patch for r…

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Bio-Techne, Kantaro Biosciences to produce COVID-19 serology test

Bio-Techne (NSDQ:TECH) and Kantaro Biosciences announced a partnership to manufacture and distribute COVID-19 serology tests.

Kantaro, a commercial affiliate of the Mount Sinai Health System in New York, will collaborate with Bio-Techne to develop a test kit based on the Mount Sinai-developed coronavirus test and scale the manufacturing and distribution of those kits. The companies formed a joint commercialization and distribution team to support the rapid distribution of the assay.

Initial kit production capacity is expected to allow laboratories to conduct more than 10 million tests monthly, starting in July and scaling to higher capacity in the following months.

Mount Sinai’s test kit, which received FDA emergency use authorization (EUA) in April, is an enzyme-linked immunosorbent assay (ELISA) for measuring the presence or absence of anti-COVID-19 antibodies and the level of antibodies a person has produced. It uses a blood-draw designed for ea…

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Phlow lands $354m government contract for COVID-19 medications

Phlow announced today that it received $354 million in U.S. government funding to manufacture essential medicines at risk of shortage, including those involved in the COVID-19 pandemic response.

Richmond, Va.–based Phlow’s manufacturing is being funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Dept. of Health and Human Services (HHS).

The total contract awarded to Phlow by the government totals up to $812 million with a four-year base award of $354 million, plus an additional $458 million included as potential options for long-term stability, according to a news release.

“BARDA has long focused on expanding pharmaceutical manufacturing infrastructure in the United States, not only to develop and produce vaccines, but also for essential medicines, and their key ingredients used to make these drugs,” BARDA acting director, Dr. Gary Disbro…

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Phlow lands $354m government contract for COVID-19 medications

Phlow announced today that it received $354 million in U.S. government funding to manufacture essential medicines at risk of shortage, including those involved in the COVID-19 pandemic response.

Richmond, Va.-based Phlow’s manufacturing is being funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Dept. of Health and Human Services (HHS).

Get the full story at our sister site, Drug Discovery & Development.

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