LivaNova LifeSparc ACS pump cleared for extended use

LifeSparc includes a sterile, on-patient pump. The reduced circuit surface area decreases inflammatory response and eliminates the need for a heater/cooler. [Image courtesy of LivaNova]LivaNova (Nasdaq: LIVN) says a new FDA clearance expands how long health providers can use its LifeSparc advanced circulatory support (ACS) pump for extracorporeal membrane oxygenation (ECMO).

The new clearance makes permanent some of the temporary emergency guidelines under which LifeSparc provided ECMO therapy during the height of the COVID-19 pandemic.

In a news release posted yesterday, London-based LivaNova said it used existing real-world evidence to receive the new indication. The evidence included data collected during the pandemic.

“The onset of the global pandemic elevated ECMO to the forefront as an effective treatment option for patients in need of emergent rescue who had limited, if any, options,” said Dr. Raymond Yau, director of Cardiogenic Shock at the Heart H…

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Bio-Rad stock dips as COVID-19-related sales taper off in Q3

Bio-Rad (NYSE:BIO) shares took a hit on third-quarter results that came in mixed compared to the consensus forecast.

BIO shares were down more than 6% at $359.75 apiece this morning — a day after the company released its results. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down more than 2%.

The Hercules, California–based clinical diagnostics company posted losses of $164.2 million for the quarter. That’s a loss of $5.52 per share on sales of $680.8 million for the three months ended Sept. 30, 2022.

Bio-Rad registered a massive bottom-line slide into the red on a sales decline of 8.9%. Life sciences sales sank by 14.9% for the quarter. Lower COVID-related sales, legal settlements in the year-ago period and supply chain constraints led to the dip. Excluding COVID-19-related sales and legal settlements, the segment grew by 9.4%.

Additionally, Bio-Rad’s clinical diagnostics …

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3M launches Verify platform to spot counterfeit products

3M (NYSE:MMM) announced today that it established a new 3M Verify platform to report potential counterfeit 3M products.

The effort builds upon its anti-counterfeit efforts during the height of the COVID-19 pandemic. At the time, a number of sellers claimed to offer 3M respirators. Instead, many offered fake, defective and damaged N95 masks at inflated prices.

St. Paul, Minnesota-based 3M worked closely with law enforcement and governments around the world to stop counterfeit 3M respirators and COVID-19-related fraud. According to a news release, the company seized more than 58 million counterfeit respirators. It removed tens of thousands of fraudulent e-commerce offerings and suing wrongdoers to stop misleading schemes targeting frontline workers.

3M said the platform expands its counterfeit reporting process to include all products made by the company. The platform can be found HERE. It offers resources and information to help customers, distributors, e…

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Vaxxas receives more than $5 million grant for vaccine delivery patch

Vaxxas’ patch comes in a hockey-puck-shaped applicator with a foil seal. [Image courtesy of Vaxxas]Vaxxas announced today the Australian government is granting it nearly $5.5 million for the manufacturing of its vaccine delivery device.

Cambridge, Massachusetts-based Vaxxas picked up AU$8.2 million ($5.48 million). The second-round grant represents part of the Australian government’s Modern Manufacturing Initiative (MMI). Funding supports the manufacturing scale-up of Vaxxas’ device for applying vaccines to the skin using a small patch.

Get the full story at our sister site, Drug Delivery Business News.

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Medtech sales reach a record high as R&D spend and employee counts climb

The Medtech Big 100: The world’s largest medical device companies

The medtech industry is bouncing back from the economic fallout caused by the COVID-19 pandemic, according to an analysis of our Medtech Big 100 data.

The medical device industry has seemingly recovered from the economic headwinds caused by the COVID-19 pandemic, according to a Medical Design & Outsourcing analysis of financial data from the Medtech Big 100, 100 of the largest medical device companies’ most recent annual results.

More than half of the companies listed in this year’s Big 100 ranking reported positive growth over their prior-year sales. Total revenue, research spending and employment figures were up significantly as the industry adjusts to a world with COVID-19 challenges.

For this analysis, we compared the performance of the Medtech Big 100 companies in 2021 and early 2022 with their results in 2020. Due to t…

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Medtech executive convicted of COVID-19 tests fraud

A federal jury convicted the president of a medtech company — Arrayit — accused of participating in a scheme to mislead investors over COVID-19 tests.

In June 2020, the U.S. Department of Justice (DOJ) charged Arrayit president March Schena for alleged involvement with fraudulent claims for allergy and COVID-19 testing. The charges alleged a scheme to mislead investors, commit health care fraud, and pay illegal kickbacks in connection with the submission of over $77 million in false and fraudulent claims for COVID-19 and allergy testing.

Schena, 59, engaged in a scheme to defraud Arrayit’s investors, according to court documents and evidence presented at trial. He allegedly claimed he invented revolutionary technology to test for virtually any disease using just a few drops of blood.

In a 2020 affidavit in support of the claim, Schena claimed that Sunnyvale, Calif–-based Arrayit was the only laboratory in the world offering microarray technology th…

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Bavarian Nordic launches Phase 3 clinical study of COVID-19 booster candidate

Bavarian Nordic (OMX:BAVA) has dosed the first subject in a Phase 3 clinical study of the COVID-19 vaccine candidate ABNCoV2.

The study will test whether ABNCoV2 is non-inferior to Comirnaty from Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) in terms of neutralizing antibodies it produces against the original strain of SARS-CoV-2. Secondary endpoints in the study will assess how the vaccine stacks up against other variants of concern.

In May, Bavarian Nordic announced that a Phase 2 study found that ABNCoV2 induced a solid boost in neutralizing antibodies against the original omicron strain.

The non-adjuvanted ABNCoV2 vaccine candidate uses a virus-like particles (VLP) platform.

Copenhagen, Denmark–based Bavarian Nordic has become best known recently for its monkeypox and smallpox  vaccine. Known as Jynneos in the U.S., the monkeypox vaccine is named Imvanex in Europe and Imvamune in Canada.

Bavarian Nordic’s product portfolio includes…

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Moderna says Pfizer-BioNTech COVID vaccine infringed its patents

Moderna (Nasdaq:MRNA) announced today that it is suing Pfizer and its COVID-19 vaccine partner BioNTech over patent infringement in U.S. and German courts.

Cambridge, Massachusetts–based Moderna said it is in the process of filing the complaints in U.S. District Court in Massachusetts and the Regional Court of Düsseldorf in Germany.

The suits could pit three of the most significant COVID-19 vaccine makers against each other in an IP battle with billions of dollars potentially at stake. COVID-19 vaccine revenue boosted Pfizer to the top of the list among the Pharma 50 largest pharmaceutical companies on Drug Discovery & Development. Moderna and BioNTech also joined the Pharma 50 for the first time in the most recent edition.

“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic,” Moderna CEO…

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A next-gen vaccine that could help end COVID-19 whack-a-mole 

COVID-19 is an emerging focus for EpicentRx, a private biotech focused on multiple immune-mediated disorders. The La Jolla, California–based company is developing a next-gen COVID vaccine for SARS-CoV-2 based on nucleocapsid rather than spike protein. 

The recombinant replication-competent adenoviral vaccine that expresses the SARS-CoV-2 nucleocapsid protein could be more resistant to COVID-19 variants. 

The real-world effectiveness of spike-protein-based COVID-19 vaccines has generally dipped since their integration as a wave of SARS-CoV-2 variants has emerged. 

But while the spike protein mutates frequently, nucleocapsid doesn’t.

“The RNA for the virus is wrapped around it,” said EpicentRx CEO Dr. Tony Reid. “If it mutates and alters its three-dimensional structure very much, the RNA will unwind, and the virus will be nonviable.” 

EpicentRx plans to work with partners to take a nucleocapsid-based next-gen CO…

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FDA re-authorizes Meridian Bioscience’s COVID-19 assay

Meridian Bioscience (Nasdaq:VIVO) announced today that the FDA re-authorized the emergency use authorization (EUA) for its COVID-19 test.

Cincinnati-based Meridian received EUA from the FDA on Nov. 10, 2021, for its Revogene SARS-CoV-2 assay. Following authorization, it was determined that the original design of the assay would not detect the Omicron variant, leading Meridian to delay marketing so it could modify the design to correctly detect the variant.

According to a news release, Meridian completed the development work and submitted an initial data set to the FDA to validate the performance of the redesigned assay in March, then completed additional clinical studies in order to garner re-authorization.

The company intends to begin shipping the product by the end of its fiscal fourth quarter on Sept. 30, 2022.

“There continues to be demand for fast, accurate detection of COVID-19 especially considering the high transmissibility of these …

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Fall 2022 COVID-19 vaccine candidate tracker

[Photo from Pexels]

Approximately two-thirds of Americans have received at least one dose of a COVID-19 vaccine. 

But COVID-19 cases remain elevated following the spread of a series of omicron sublineages, which pose a threat to those vaccinated and naturally infected with various lineages of the coronavirus. 

A variety of companies are developing next-generation COVID-19 vaccines that could potentially optimize the strength and durability of immune protection compared to the first crop of vaccines. 

Here, we round up notable COVID-19 vaccine candidates that, at least, could help pave the way for the fall 2022 booster drive.

BNT162b5

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) are developing a bivalent COVID-19 vaccine candidate known as BNT162b5 based on the ancestral strain and a BA.1 Omicron variant. The vaccine has a modified spike protein design to optimize the immune response …

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Customizing textiles to design formfitting face masks

Image courtesy of MIT and Lavendar Tessmer

Researchers at the Massachusetts Institute of Technology have developed an active fiber and process that uses heat to activate face masks and conform to an individual’s face.

The COVID-19 pandemic has emphasized the importance of face masks that effectively seal around the nose and mouth. However, faces and their features vary and make standard one-size-fits-all face masks less effective.

Lavender Tessmer, who is a doctoral candidate in MIT’s Department of Architecture, created an active fiber and process that uses heat with specific knit textile architecture to activate a mask to conform to specific faces. It uses standard textile equipment and a new customization process that allows any manufacturer to create a customized mask.

Prior to the pandemic, Tessmer was working with associate professor Skylar Tibbits in the department of archite…

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