covid-19 Archives - Page 90 of 113 - Medical Design Sourcing

ResMed beats Street with boost in ventilator sales

ResMed (NYSE:RMD) shares took a slight hit after hours despite on fourth-quarter results that beat the consensus forecast.

The San Diego-based respiratory support device maker posted profits of $177.8 million, or $1.22 per share, on sales of $770.3 million for the three months ended June 30, 2020, for a more than 158% bottom-line gain on sales growth of 9.3%.

Adjusted to exclude one-time items, earnings per share were $1.33, 11¢ ahead of Wall Street, where analysts were looking for sales of $746.9 million.

Increased demand for ResMed’s ventilator devices amid the COVID-19 pandemic contributed massively to the company’s growth in the fourth quarter, although it was partially offset by a decrease in demand for the company’s sleep devices.

“Our fourth-quarter results reflect the strength and resiliency of our business in today’s uncertain environment,” ResMed CEO Mick Farrell said in the news release. “Throughout our fis…

States band together to purchase BD, Quidel antigen tests for COVID-19

Seven U.S. states have formed an interstate compact with the Rockefeller Foundation to expand the use of rapid point-of-care antigen tests to better manage the COVID-19 pandemic.

The compact — announced yesterday by a bipartisan group of governors leading the states — includes Louisiana, Ohio, Maryland, Massachusetts, Michigan, North Carolina and Virginia.

The idea is that by working together, the states are demonstrating to private manufacturers that there is significant demand to scale up the production of antigen tests. Now that the compact is in place, the states are in discussions with Becton Dickinson (NYSE:BDX) and Quidel to purchase 500,000 tests per state, for a total of 3.5 million tests.

“With severe shortages and delays in testing and the federal administration attempting to cut funding for testing, the states are banding together to acquire millions of faster tests to help save lives and slow the spread of COVID-19,” said Maryland Gov. Lar…

CHF Solutions sales up 11% in Q2 amid increased COVID-19 demand

CHF Solutions (NSDQ:CHFS) shares took a hit today despite second-quarter revenues that received a boost amid the COVID-19 pandemic.

The Eden Prairie, Minn.-based fluid overload treatment developer posted losses of -$3.9 million, or -10¢ per share, on sales of $1.9 million for the three months ended June 30, 2020, for an 11.5% bottom-line gain on sales growth of 11.1%.

CHF Solutions got that sales boost in part due to increased demand in its Aquadex SmartFlow consoles for removing excess fluid from patients suffering from hypervolemia (fluid overload), which was related to treating patients with COVID-19.

In April, the company announced that it had doubled its production staff to cope with the heightened demand for the consoles.

“We continue to be very pleased that we produce a product that is providing a meaningful therapy for treating the COVID-19 patients,” CHF Solutions chairman & CEO John Erb said in a news release. “We know we are very fo…

NuVasive dips despite Street-beating Q2

NuVasive (NSDQ:NUVA) shares closed today on the downturn despite second-quarter results that beat the consensus forecast.

The San Diego-based spine surgery technology developer posted losses of -$50 million, or -98¢ per share, on sales of $203.6 million for the three months ended June 30, 2020, for a bottom-line slide from profits of nearly $15 million year-over-year on a sales decline of 30.3%.

Adjusted to exclude one-time items, losses per share were -40¢, 7¢ ahead of Wall Street, where analysts were looking for sales of $175.8 million.

Last month, NuVasive announced preliminary results that revealed an operating loss of between -$35 million and -$40 million on a GAAP basis, with losses of between -$17 million and -$23 million on a non-GAAP basis.

Stay-at-home orders and elective surgical procedure delays as a result of COVID-19 were reflected in NuVasive’s net sales for the quarter, which it had expected to come in between $202 million and $205…

Neuronetics rises on Street-beating Q2

Neuronetics (NSDQ:STIM) shares ticked up today on second-quarter losses that managed to top the consensus forecast.

The Malvern, Pa.-based psychiatric disorder treatment developer posted losses of $-7.8 million, or -41¢ per share, on sales of $9.7 million for the three months ended June 30, 2020, for a -9.5% bottom-line slide on a sales decline of -41.2%.

Adjusted to exclude one-time items, losses per share were also -41¢, 10¢ ahead of Wall Street, where analysts were looking for sales of $8.2 million.

Neuronetics, which develops a transcranial magnetic stimulation system to treat major depressive disorder, reported that its revenue decreases were primarily driven by the closure of practices or limited access in response to the COVID-19 pandemic.

“This quarter was negatively impacted due to the effects of COVID-19; however, our results were favorable to our internal expectations established at the beginning of the quarter,” Neuronetics CFO S…

New Siemens antibody test can help quantify level of immune response to COVID-19

Siemens Healthineers (ETR: SHL) today announced that it’s secured an FDA emergency use authorization for its SARS-CoV-2 IgG (COV2G) antibody test, which the company touts as the first authorized with semi-quantitative detection.

The COV2G test not only provides positive or negative result for IgG antibodies but also reports a numerical result expressed as index value — helping clinicians to gauge the level of IgG antibodies in a patient’s blood sample. The idea is that the test will help clinicians better understand how people’s immune response changes over time after exposure to the virus that causes COVID-19.

The test has also attained the CE Mark in the European Union and is now broadly available globally. The test, according to Siemens, has b sensitivity and specificity that is greater than 99%.

“Our high-quality antibody test helps clinicians assess the level of a person‘s immune response, which is an important tool to have at this stage…

Henry Schein dips on Q2 losses

Henry Schein (NSDQ:HSIC) shares dipped slightly today on second-quarter losses that still managed to top the consensus forecast.

The Melville, N.Y.-based medical device maker posted losses of -$13.3 million, or -8¢ per share, on sales of $1.7 billion for the three months ended June 27, 2020, for a bottom-line slide into the red from profits of $119.2 million last year. Sales declined by 31.2%.

Adjusted to exclude one-time items, earnings per share came in at $0.00, 12¢ ahead of Wall Street, where analysts were looking for sales of $1.4 billion.

The ongoing COVID-19 pandemic negatively impacted Henry Schein’s quarter, particularly with its dental business, as the company reported a 41.2% drop in sales for that segment. However, the company said in a news release that it saw positive trends as procedures delayed by the pandemic began to slowly trickle back.

“Regarding our second-quarter financial results, COVID-19 significantly impacted our wo…

FDA issues EUA for Abiomed Impella heart pumps for COVID-19 therapy

Abiomed (NSDQ:ABMD) announced today that the FDA issued emergency use authorization (EUA) for its Impella heart pumps in COVID-19 therapy.

The EUA covers the left-sided Impella pumps in providing left ventricular unloading, supporting COVID-19 patients who are undergoing extracorporeal membrane oxygenation (ECMO) treatment and develop pulmonary edema or myocarditis, according to a news release.

Impella, the world’s smallest heart pump, combined with ECMO therapy (Abiomed’s therapy is called ECpella) helps to treat COVID-19 patients suffering from both heart and lung failure due to the virus’ capabilities of causing widespread inflammation that damages the heart and lungs.

“The early clinical evidence continues to accrue in favor of including left ventricular unloading in many patients on ECMO,” University of Pennsylvania professor of surgery & surgical director of lung transplantation & ECMO Dr. Christian Bermudez said in the re…

Steris ticks up on Street-beating Q1

Steris (NYSE:STE) shares ticked up as the market closed today after reporting first-quarter results that beat the consensus forecast.

The Dublin, Ireland-based sterilization and surgical products company posted profits of $88.1 million, or $1.03 per share, on sales of $668.9 million for the three months ended June 30, 2020, for a 3.9% bottom-line gain despite a sales decline of 4%.

Adjusted to exclude one-time items, earnings per share were $1.31, 35¢ ahead of Wall Street, where analysts were looking for sales of $635.98 million.

Steris reported a -10% decline in revenues for its healthcare segment, along with a 1% drop in applied sterilization technologies. However, those dips were offset by 21% growth in life sciences because of increased demand for vaccines and biologics amid the COVID-19 pandemic.

“We are pleased with our overall performance during such a challenging time,” Steris president & CEO Walt Rosebrough said in a news release. “Ou…

Yale studying possible COVID-19 treatment

[Photo by Fusion Medical Animation on Unsplash]

Yale School of Medicine and AI Therapeutics announced the launch of a multi-institutional clinical trial for a drug for treating COVID-19.

LAM-002A (apilimod) has a proven safety record and preliminary research has shown that it can block the cellular entry and trafficking of the SARS-CoV-2 virus that is causing COVID-19, according to a news release. Guilford, Conn.-based AI Therapeutics owns the intellectual property rights to the drug.

Enrollment has now begun for a Phase II trial for the drug’s use as a COVID-19 treatment, with the expectation of enrolling 142 newly diagnosed patients to test the safety and efficacy of the drug in reducing virus levels in infected individuals. Previous trials of more than 700 patients have shown LAM-002A to be safe in treating autoimmune diseases and follicular lymphoma, as well.

A study published in Natur…

J&J starts clinical trial on vaccine candidate after strong non-human results

Johnson & Johnson (NYSE:JNJ) announced that its lead SARS-CoV-2 vaccine candidate protected against infection of the virus causing COVID-19 in pre-clinical studies.

New Brunswick, N.J.-based J&J published data in Nature that showed the company’s investigational adenovirus serotype 26 (Ad26), vector-based vaccine elicited a robust immune response with “neutralizing antibodies” to prevent subsequent infection and provide complete or near-complete protection in the lungs from the virus in non-human primates.

Researchers immunized the non-human primates with a panel of vaccine prototypes before challenging them with SARS-CoV-2 infection. Of seven vaccine prototypes tested, Ad26.COV2.S elicited the highest level of neutralizing antibodies, which correlated with the level of protection, confirming early suggestions that they could be a potential biomarker for vaccine-mediated protection.

The six non-human primates that received a sing…

Sanofi, GSK to supply up to 60 million doses of COVID-19 vaccine to UK

Sanofi (NYSE:SNY) and GlaxoSmithKline (NYSE:GSK) announced that they reached an agreement with the UK government to supply up to 60 million doses of a COVID-19 vaccine.

Subject to a final contract, the UK government will receive the doses of a vaccine candidate developed by the two companies in partnership and based on the recombinant protein-based technology Sanofi used to produce an influenza vaccine, along with GSK’s pandemic adjuvant technology, according to a news release.

Sanofi expects a Phase 1/2 study for the vaccine candidate to begin in September, followed by a Phase 3 study by the end of 2020. If the sudies report positive data, regulatory approval could be garnered by the first half of 2021, while the two companies are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year overall.

“With our partner GSK, we are pleased to cooperate with the UK government as well as several other…