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Thursday, July 8, 2021

SeaSpine 7D Surgical Percutaneous Spine Module Gets FDA 501(k) Clearance

 Shares of SeaSpine Holdings Corp. are trading higher in Wednesday's after-hours market, following news its 7D Percutaneous Spine Module received 510(k) clearance from the U.S. Food and Drug Administration.

The company said the clearance for its 7D Percutaneous Spine Module for minimally invasive surgery "represents a new application and increased functionality for its 7D Flash Navigation System."

At 4:57 p.m. EDT, shares were trading 26% higher at $23.80. Volume at the time topped 17,000 shares.

The stock finished the day's regular-trading session with a 4.41% loss, closing at $18.84.

SeaSpine's stock hit a 52-week high of $22.97 on April 9.

SeaSpine said it is preparing a limited release of the Percutaneous Spine Module in the third quarter.

https://www.marketscreener.com/quote/stock/SEASPINE-HOLDINGS-CORPORA-22497349/news/SeaSpine-Shares-Higher-7D-Surgical-Percutaneous-Spine-Module-Gets-FDA-501-k-Clearance-35811420/

F-star Therapeutics in Licensing Deal with AstraZeneca

 F-star Therapeutics Inc. said it is in an exclusive licensing agreement with AstraZeneca PLC, sending shares higher premarket.

AstraZeneca will receive global rights to research, develop and commercialize next generation Stimulator of Interferon Genes, or STING, inhibitor compounds. F-star is a clinical-stage biopharmaceutical company focused on bispecific immunotherapies for cancer.

AstraZeneca will be responsible for all future research, development and commercialization of the STING inhibitor compounds, and F-star will retain rights to all STING agonists, currently in clinical development for patients with cancer.

F-star is eligible to receive upfront and near-term payments of up to $12 million. F-star can also receive development and sales milestone payments of more than $300 million, as well as single digit percentage royalty payments.

F-star shares were up 8% to $7.95 premarket.

https://www.marketscreener.com/quote/stock/F-STAR-THERAPEUTICS-INC-115594552/news/F-star-Therapeutics-in-Licensing-Deal-with-AstraZeneca-Shares-Up-35815578/

Humana Hiring up to 200 Virtual, Seasonal Positions in San Antonio

 Humana Inc. (NYSE: HUM) today announced it is looking to hire up to 200 virtual, seasonal Enrollment Representatives in and around San Antonio.

Humana’s Medicare Enrollment Representatives respond to inquiries from current and prospective members seeking to enroll into a 2022 Medicare Advantage or Prescription Drug Plan. They also review and process member applications.

These seasonal employees will serve for six months or less through the Medicare Advantage and Prescription Drug Plan open enrollment window, which runs from Oct. 15 to Dec. 7, 2021. Although these positions are home-based, Humana is seeking applicants who live within a 50-mile radius of the company’s San Antonio location at 8119 Datapoint Dr., as there may be opportunities for some of these roles to transition to full-time employment.

These positions offer competitive compensation with a strong hourly rate and eligibility for a retention bonus up to $1000.

Virtual interviews begin this month and start dates for the Enrollment Representatives will range from late August through October. Humana is looking for professionals with customer service experience, attention to detail, and proficiency in Microsoft Outlook and Excel. Candidates interested in the seasonal positions can apply online at careers.humana.com and enter #HumanaSeasonalJobs in the keyword search box.

Humana is working with a number of community organizations to recruit candidates for these positions.

https://finance.yahoo.com/news/humana-hiring-200-virtual-seasonal-170000368.html

Portable MRI Device Maker Hyerfine Going Public Via SPAC

 Portable MRI Device Maker Hyerfine Going Public Via SPAC: What Investors Should Know

An MRI scanner on wheels is the highlight of Hyperfine, a company that announced a SPAC merger Thursday morning.

The SPAC Deal: Hyperfine Inc and Liminal Sciences are merging with HelathCor Catalio Acquisition Corp HCAQ 2.1% valuing the company at an enterprise value of $580 million.

A $126 million PIPE for the deal includes investments by Ark Invest.

The merger marks the third company founded by Dr. Jonathan Rothberg to go public via SPAC with Butterfly Network Inc BFLY 3.63% and Quantum-Si Inc QSI 2.07% previously completing deals.

Public HCAQ shareholders will own 21.7% of the company. The new company will trade on the Nasdaq as HYPR after the merger is complete.

About Hyperfine, Liminal: Hyperfine is the creator of the portable MRI system named Swoop. Liminal Sciences is dedicated to non-invasive brain monitoring.

The Swoop was FDA approved in 2020 and offers an easy-to-use interface and portable design providing accessibility for hospitals and other medical facilities.

Hyperfine utilizes a subscription-based business model and provides tools and software for its customers.

Liminal has a vision to make brain monitoring as simple as taking blood pressure measurements, according to the release. A non-invasive brain monitoring device is currently being developed by the company. The company believes its sensors can help in traditional care settings like the ICU and operating rooms with a long-term goal of monitoring patients at home.

“We are taking the next step in our mission to provide affordable and accessible imaging, sensing and guided robotic intervention to democratize and bring equity to healthcare for people around the world,” Rothberg said.


Growth Ahead: The imaging market is listed with a $23 billion total addressable market, according to the company. The company’s additional markets of sensing and guided intervention could add addressable markets of $22 billion and $28 billion, respectively.

Sense and Intervene businesses both have products in development that could complement the existing imaging business. The company has the potential to “build an ecosystem across the care continuum,” according to the presentation.

The company has 46 installed portable MRI devices with a target market size of over 100,000 hospitals and outpatient centers.

The portable MRI device reduces workflow time by 94% to 90 minutes and can help tackle the 22% to 46% of cases that see adverse events happen during transport of patients according to the presentation.

A $7,250 monthly subscription model could produce a high recurring revenue model for the company.

Financials: The combined company is expecting revenue of $2.3 million in fiscal 2021 and $16.3 million in fiscal 2022. Revenue is expected to grow at a compounded annual growth rate of 238% from fiscal 2021 to fiscal 2025.

The company projects revenue out to fiscal 2025 with a total of $301.6 million projected. The company lists gross margins of 47.9% in fiscal 2022 growing to 71.9% in fiscal 2025.

HCAQ Price Action: HCAQ shares are up 3% to $10 on Thursday.

https://www.benzinga.com/m-a/21/07/21898048/portable-mri-device-maker-hyerfine-going-public-via-spac-what-investors-should-know

Yes, COVID Vaccines Work in People With Obesity

 All COVID-19 vaccines authorized for emergency use in the U.S. are effective in people with obesity, according to a new position statement issued by the Obesity Society.

In a review of data available on the Pfizer-BioNTech, Moderna, and Johnson & Johnson vaccines, efficacy was not significantly different between people with obesity versus those without obesity, reported W. Scott Butsch, MD, MSc, of the Cleveland Clinic in Ohio, and colleagues in the journal Obesity.

Therefore, the Obesity Society recommended that all people with obesity -- a BMI of 30 or higher -- get vaccinated with any of the current options.

"At present, there is no definitive way to determine which COVID vaccine is 'best' for patients overall or for specific patient subgroups, including those with obesity," they stated. "Current FDA-approved COVID-19 vaccines from Pfizer-BioNTech, Moderna and Johnson & Johnson were all highly efficacious against COVID-19-associated hospitalization and death in trials, and were found to be equally efficacious in persons with obesity compared to normal weight individuals."

In addition, because obesity was identified as a "high-risk" condition prioritized for vaccination in phase 1c by the CDC, the society likewise recommended that COVID care plans acknowledge that people with obesity are at higher risk for more severe infection and death.

Using data from FDA briefing documents and peer-reviewed literature, Butsch's group looked at the efficacy for each available vaccine in the overall trial population and subgroups of people with obesity.

"Analysis of COVID-19 vaccine efficacy in certain disease subgroups has been difficult because the number of trial participants with the disease was too small," said co-author Alexandra Hajduk, PhD, MPH, of Yale School of Medicine in New Haven, Connecticut, in a statement.

"This was not the case for obesity. Because the prevalence of obesity among trial participants was high, and because obesity is highly associated with hospital admission and death in COVID-19, the trial results were able to show that, contrary to concerns of reduced vaccine efficacy in people with obesity, that the vaccines were just as efficacious among persons with obesity compared with persons without obesity," she added.

Looking at the Pfizer vaccine first, the overall efficacy in over 36,000 people without prior infection was 95.0% (95% CI 90.0-97.9) compared with placebo.

When this cohort was divided into those with and without obesity, the vaccine efficacy was 95.4% (95% CI 86.0-99.1) in 13,218 participants ages 16 and older (roughly 32% of the cohort) with a BMI of 30 or higher. Conversely, efficacy was 94.8% (95% CI 87.4-98.3) among the participants without obesity.

For the Moderna vaccine, the overall efficacy was 94.1% (95% CI 89.3-96.8) among participants without prior COVID infection. Among those with obesity, which was about 35% of the overall cohort, efficacy was 95.8% (95% CI 82.6-99.0). Taking that one step further, in a subgroup of participants with severe obesity -- a BMI of 40 or higher -- vaccine efficacy was 91.2% (95% CI 32.0-98.9). In the 901 participants with severe obesity, there was only one case of severe COVID-19 that occurred after vaccination versus 11 cases in 884 participants with severe obesity in the placebo group.

Finally, for the Janssen/Johnson & Johnson vaccine, vaccine efficacy was 66.1% (95% CI 55.0-74.8) for the prevention of moderate to severe or critical COVID-19 infection 28 days after vaccination.

This vaccine's trial included 12,492 participants with obesity, accounting for 29% of the overall cohort. For these participants specifically, efficacy was 66.8% (95% CI 54.1-76.3) 14 days after vaccination and 65.9% (95% CI 47.8-78.3) 28 days after vaccination.

Of note, AstraZeneca's vaccine candidate, which isn't yet cleared for use in the U.S., doesn't have available efficacy data in people with obesity in its primary safety or efficacy trials.

The Obesity Society said there are plans to continue to evaluate additional vaccine data as they become available. In order to best evaluate and compare outcomes, the society is also strongly encouraging that long-term efficacy outcomes be stratified by obesity status, including with new data against emerging variants, like the Delta variant.

"In addition to general misconceptions about the disease of obesity, speculation on the effectiveness of COVID-19 vaccines in obesity has certainly added to vaccine hesitancy in those individuals with obesity," Butsch said. "I hope this position statement not only will encourage those with and without obesity to get vaccinated, but to continue the conversations on the existing weight bias in our current health policies and poor coverage and reimbursement of effective treatments for obesity."


Disclosures

Butsch reported relationships with Rhythm Pharmaceuticals and Novo Nordisk.

Other co-authors also reported disclosures.

Covid's delta variant is highly contagious. Will vaccines work against it?

 The delta variant now accounts for half of the Covid-19 cases in many areas of the U.S., President Joe Biden said Tuesday, urging unvaccinated Americans to get the Covid-19 shots as the U.S. faces a dramatic rise in the "hypertransmissible" variant of the coronavirus. His plea included reassurances about the strength of the Covid-19 vaccines available in the U.S.


"Fully vaccinated Americans have a high degree of protection, including against this delta variant," Biden said at a news briefing, pointing out that virtually all Covid-19 hospitalizations and deaths in recent months have been among the unvaccinated.

Former Defense Department immunologist John Grabenstein, a former executive director of medical affairs for vaccines at Merck, said the delta variant is "more contagious, more spreadable."

"That makes it dangerous, because it's more likely to find the people who are not vaccinated," he said.

The variant has risen as the U.S. vaccination rate has stalled, and recent reports about a drop in vaccine effectiveness have triggered worries even among people who are fully vaccinated.

How effective are the vaccines against the delta variant?

There are two ways to answer this question. One is by analyzing blood samples from people who have been fully vaccinated.

Scientists can take Covid-19 antibodies found in the blood and test them against variants. Several such independent lab studies (here and here, for example) found that the vaccines in use do, in fact, protect against the delta variant of SARS-CoV-2, as well as reduce hospitalizations. The studies are considered preliminary and haven't been peer-reviewed.

They also provide a limited picture of all the ways the immune system works against Covid-19, because they measure only antibody response. Certain cellular responses also play key roles. T cells, for example, help by killing infected cells and harnessing the power of other immune cells in the fight against viruses. Lab studies don't usually measure T-cell response.

The second — and maybe more important — way to determine vaccine effectiveness is by simply observing what's happening in the real world in real time.

"It's very hard to translate laboratory data into 'what's going to happen if I'm vaccinated and someone sneezes on me and spreads delta all over my face?'" said Dr. David Wohl, a professor of medicine in the infectious diseases division at the University of North Carolina at Chapel Hill, who runs UNC's vaccine clinics.

That's why it's important for scientists to look to places like the United Kingdom, where the delta variant accounts for nearly 100 percent of current Covid-19 cases. Despite having higher vaccination rates than the U.S. — 68 percent in the U.K. have had at least one dose, compared to just under 55 percent in the U.S. — cases are rising in the U.K.

"The only real difference between us and them is delta," Wohl said. "I'm really worried that what's going on in the U.K. is precisely what's going to happen here."

"If you're waiting for some magical moment" to get vaccinated, he said, "this is it."

While Covid-19-related hospitalizations in the U.K. have risen slightly in recent weeks, they are nowhere near what they were at the peak of the pandemic in January.

Experts say reports from Israel about a drop in vaccine effectiveness against the delta variant are intriguing because the country vaccinated a majority of its population before the U.S. did, and it now faces a surge in variant-related cases. A recent study from Israel found that the Pfizer vaccine was just 64 percent effective in preventing symptomatic illness in fully vaccinated people.

At the same time, the report found that the vaccine was 93 percent effective at preventing hospitalizations and serious illness — a significant benefit, experts say.

"Maybe the vaccine isn't preventing the really mild cases. That's OK," Grabenstein said. "It is preventing the really severe infections, the things that we fear the most."


Experts have been skeptical about the report from Israel's Health Ministry, mainly because the study's authors neglected to provide many details about how they did their research and who participated.

"Assuming these data are correct, this is telling us that it's even more urgent than ever for people to get vaccinated," said Dr. Jesse Goodman, a professor of medicine and infectious diseases at Georgetown University Medical Center, who is a former chief scientist with the Food and Drug Administration.

Pfizer didn't respond directly to the Israeli study, but it pointed to lab data about its vaccine response to the delta variant published in early June, suggesting that it had neutralized the variant, although with less strength relative to previous strains. And a recent report from Public Health England found two doses of the Pfizer vaccine to be 96 percent effective against hospitalization for the delta variant.

Grabenstein said that even if the data ultimately check out, he doesn't mind, "because I'm most reassured by the 93 percent against the really severe forms of the infection."

Do vaccinated people spread the virus?

Vaccines aren't meant to prevent infection. Their strength is in preventing the infection from making people sick and landing them in the hospital.

Most breakthrough infections among fully vaccinated people tend to be mild or to occur without symptoms. What remains unknown is whether an unsuspecting carrier can spread the virus to vulnerable people, such as the unvaccinated, children under age 12 or those with compromised immune systems.

Goodman said infected people who have been fully vaccinated probably have less virus in their system and therefore are probably less likely to transmit it to others. The time person is contagious is also probably shorter with vaccination, he said.

Should vaccinated people wear masks indoors?

It's unlikely that the Centers for Disease Control and Prevention will reinstate recommendations to wear masks. But because of the unknown level of transmissibility of delta among fully vaccinated people, experts said in interviews that they continue to wear masks indoors when they are around people they don't know, such as in grocery stores or movie theaters or on public transportation.

"I have never changed my behavior, and I'm fully vaccinated," Wohl said. "If I'm indoors, around other people who could be unvaccinated, I wear a mask.

"With Delta spreading, that's the way we should be."

https://www.nbcnews.com/health/health-news/covid-s-delta-variant-highly-contagious-will-vaccines-work-against-n1273114

Despite Mixed Data, Sinovac's COVID-19 Vaccine is Second Most Used Globally

 While several countries are relying on Sinovac Biotech’s coronavirus disease 2019 (COVID-19) vaccine to end the pandemic once and for all, concerns regarding the shot’s efficacy continue to shroud the vaccine, which is currently the second most used COVID-19 vaccine product across the globe.

Sinovac’s CoronaVac was the first COVID-19 vaccine approved in China for emergency use back in June 2020. Countries relying on the company’s vaccine typically have little access to the mRNA vaccines from Moderna and Pfizer-BioNTech. To date, approximately 380 million doses of this vaccine have been sent across the world.

And although the Beijing-based biotech’s vaccine has demonstrated success in clinical trials, efficacy rates have ranged from 50% to as high as 90% across clinical trials conducted in Turkey, Brazil and Indonesia. Sinovac has since kept mum on these data and hasn’t provided explanations or further details on why protection rates vary from study to study.

In an exclusive interview with Bloomberg, the company’s chief executive officer Yin Weidong indicated the priority has been to approve the vaccine by regulators versus addressing or explaining negative coverage in the media. He told the outlet that little else mattered as long as people were getting vaccinated against the novel coronavirus.

But Sinovac’s lack of media presence and inability to control data access from its trial partners may have tarnished the shot’s reputation, more so than it likely deserves. Real-world evidence suggests the company’s vaccine does indeed possess high levels of efficacy against COVID-19.

In an Indonesia trial, for instance, approximately 94% of 130,000 healthcare workers who were fully inoculated with Sinovac’s vaccine were reportedly protected from symptomatic infection with SARS-CoV-2. Another 96% of healthcare workers in this study were protected from COVID-19-related hospitalization and 98% were protected from death.

Despite these high rates of protection, the CEO of the company was reportedly unaware of this study and the corresponding data.

This lack of awareness didn’t stop the company from submitting other clinical and non-clinical research data to the World Health Organization, which on Wednesday authorized Sinovac’s two-dose CoronaVac COVID-19 vaccine for emergency use in people 18 years and older.

The European Medicine Agency has also started a rolling review of the company’s vaccine, which is the first step toward receiving EU approval for use.

Back in April, Sinovac completed the third phase of a vaccine bulk production manufacturing facility, resulting in the per-year production capacity exceeding 2 billion doses. To date, the total supply of CoronaVac has reached over 600 million doses, while incomplete data show more than 430 million doses have been administered across the globe.

In addition to pending approvals and authorizations, the United Arab Emirates recently reported it will start offering a third booster shot for people treated with the Sinovac vaccine. The country said the booster shot was to be used to counteract the less-than-anticipated antibody generation in some people who received the two-dose inoculation.

https://www.biospace.com/article/-acceptance-of-sinovac-s-covid-19-vaccine-grows-across-the-globe-despite-hurdles-and-disparate-efficacy-data/