Why RA Medical Systems Is Trading Higher

 RA Medical Systems Inc 

RMED 19.24% shares are trading higher Monday morning as traders circulate an FDA filing showing the company received an FDA 510(k) Premarket Notification for the DABRA Laser System for indication 'Catheter For Crossing Total Occlusions.'

RA Medical Systems is a commercial-stage medical device company leveraging its laser-based platform for use in the treatment of vascular and dermatological immune-mediated inflammatory diseases.

The company's products restore blood flow in arteries and clear chronic skin conditions. The firm's products include DABRA and Pharos.

DABRA System is used as a tool in the treatment of peripheral artery disease, or PAD, a form of peripheral vascular disease, which commonly occurs in the legs. Pharos is designed for use in the treatment of inflammatory skin conditions and as a tool in the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma. 

https://www.benzinga.com/markets/penny-stocks/21/08/22277227/why-ra-medical-systems-stock-is-trading-higher-today

Statement by Psaki on Eviction Prevention Efforts

 Today, President Biden is taking further action to prevent Americans from experiencing the heartbreak of eviction. Thanks to State eviction moratoria, almost 33% of the country will be spared evictions for the rest of this month. But in the remaining States, action is needed.

Thanks to the bipartisan COVID relief act Congress passed in December 2020 and the American Rescue Plan Congress and the Biden Administration enacted in March 2021, State and local governments long ago received Emergency Rental Assistance—a $46.5 billion plan to protect millions of Americans facing deep rental debt and potential eviction during the pandemic. Some cities and States have demonstrated their ability to release these funds efficiently to tenants and landlords in need. But even though funds began to be distributed in February by the Biden Administration, too many States and cities have been too slow to act.

As the Administration made clear last week, there is no excuse for any State or locality not to promptly deploy the resources that Congress appropriated to meet the critical need of so many Americans. This assistance provides the funding to pay landlords current and back rent so tenants can remain in their homes or apartments, not be evicted. No one in America should be evicted when Federal funds are available, in the hands of State and local government, to pay back rent due.

Last week the Administration also made clear that given the spread of the Delta variant among those Americans most likely to face eviction and lacking vaccinations, the President would have strongly supported a decision by the Centers for Disease Control and Prevention (CDC) to further extend its eviction moratorium to protect renters at this moment of heightened vulnerability. Unfortunately, the Supreme Court declared on June 29^th that the CDC could not grant such an extension without “clear and specific congressional authorization (via new legislation).”

Given the rising urgency of containing the spread of the Delta variant, on Sunday, the President asked the CDC to consider once again the possibility of executive action. He raised the prospect of a new, 30-day eviction moratorium—focused on counties with High or Substantial case rates—to protect renters. This temporary measure would spur States and localities to ramp up Emergency Rental Assistance programs to full speed this month, giving every landlord the opportunity to collect the rent they are owed and ensuring no eligible family gets evicted.

To date, CDC Director Rochelle Walensky and her team have been unable to find legal authority for a new, targeted eviction moratorium. Our team is redoubling efforts to identify all available legal authorities to provide necessary protections.

In the meantime, the President will continue to do everything in his power to help renters from eviction. The Administration has provided States and local governments with the flexibility to get funds out efficiently without burdensome documentation; to use funds to help those who are homeless or in need of new housing; and to use American Rescue Plan State and local funds to expand any effort to help those whose housing is at risk due to the pandemic.

Today, the President is taking these additional measures:

• Directing his White House policy, implementation, and legal teams to assemble all Federal agencies to reexamine whether there are any other authorities to take additional actions to stop evictions.
• Calling on States and localities to extend or put in place evictions moratoria for at the least the next two months. Among those behind on their rent, 1 in 3 renters live in States that have already extended protections against evictions due to State eviction moratoria—which are not covered by the Supreme Court’s ruling. The rest of the States should follow course by also extending eviction moratoria.
• Calling on State and local courts to heed the call of the Justice Department to pause eviction proceedings until tenants and landlords can first seek to access Emergency Rental Assistance—making evictions a last, not first—resort.
• Directing his Cabinet Departments to use their powers to prevent evictions and tell landlords: If your government is backing your mortgage or providing you housing tax relief, you should not be choosing eviction over the Emergency Rental Assistance we have provided to make you whole and keep your tenants and their families safely housed.
• Challenging every landlord to hold off on evictions for the next 30 days and instead seek out the Emergency Rental Assistance Congress and the Administration meant for them.
• Challenging utilities providers to work with State and local governments to access Emergency Rental Assistance and other resources made available by Congress and the Administration to avoid cutting off services for those behind in payments due to the pandemic and at risk of eviction.
• Directing the Treasury Department to make clear that States and localities can use emergency housing and State and local relief to support eviction prevention efforts by courts, legal aid, and housing counselors, as well as to give incentives to landlords who cooperate in these efforts by offering housing to those who have been evicted or are homeless, or by offering leases to the most hard-pressed tenants at a length that ensures true housing stability.
• At the request of Congressional leadership, directing the White House, Treasury Department, and other relevant Federal agencies to continue examining why State and local governments have failed to distribute rental assistance Congress has provided, and explore any authorities the Federal government has to press the States and localities to make these distributions.

The Administration remains deeply committed to doing everything in its power to keep people safely and securely housed, which is essential to the health, well-being, and dignity of us all.

https://www.whitehouse.gov/briefing-room/statements-releases/2021/08/02/statement-by-press-secretary-jen-psaki-on-eviction-prevention-efforts/

UK scientists: ‘Almost certain’ coronavirus variant will emerge that beats current vaccines

 An analysis by British academics, published by the UK Government’s official scientific advisory group, says that they believe it is “almost certain” that a SARS-Cov-2 variant will emerge that “leads to current vaccine failure.” SARS-CoV-2 is the virus that causes Covid-19.

The analysis has not been peer-reviewed, the early research is theoretical, and does not provide any proof that such a variant is in circulation now. Documents like it are released “as pre-print publications that have provided the government with rapid evidence during an emergency.”

The paper is dated July 26, and was published by the British government on Friday.

The scientists write that because eradication of the virus is “unlikely,” they have “high confidence” that variants will continue to emerge. They say it is “almost certain” that there will be “a gradual or punctuated accumulation of antigenic variation that eventually leads to current vaccine failure.”

They recommend that authorities continue to reduce virus transmission as much as possible to reduce the chance of a new, vaccine-resistant variant.

They also recommend that research focus on new vaccines that not only prevent hospital admission and disease, but also “induce high and durable levels of mucosal immunity.”

The goal, they say, should be “to reduce infection of and transmission from vaccinated individuals,” and to “reduce the possibility of variant selection in vaccinated individuals.” Research is already underway at several companies that make the Covid-19 vaccines to address new variants.

The views were expressed in a paper “by group of academics on scenarios for the longer term evolution of SARS-CoV-2,” and discussed and published by the UK’s Scientific Advisory Group for Emergencies (SAGE).

They write that some variants that have emerged over the past few months “show a reduced susceptibility to vaccine-acquired immunity, though none appears to escape entirely.”

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But they caution that these variants emerged “before vaccination was widespread,” and that “as vaccines become more widespread, the transmission advantage gained by a virus that can evade vaccine-acquired immunity will increase.”

This is an issue that SAGE has warned about before.

In minutes from its July 7 meeting, SAGE scientists wrote that “the combination of high prevalence and high levels of vaccination creates the conditions in which an immune escape variant is most likely to emerge.” It said at the time that “the likelihood of this happening is unknown, but such a variant would present a significant risk both in the UK and internationally.”

https://www.cnn.com/2021/08/01/health/uk-scientists-covid-variant-beat-vaccines-intl/index.html

WV Gov launches Booster Battlefield Assessment to measure antibody levels among vaccinated

 

BOOSTER BATTLEFIELD ASSESSMENT: FIRST STATEWIDE ANTIBODY TESTING PROGRAM IN THE COUNTRY AMONG NEW EFFORTS UNDERWAY AS DELTA VARIANT CONTINUES TO SPREAD During Thursday’s briefing, Gov. Justice announced that the State of West Virginia is launching the first statewide program in the country to test and measure antibody levels among vaccinated individuals. This new “Booster Battlefield Assessment” program is among several additional proactive efforts that are now underway as the number of Delta variant cases across the state continues to climb sharply. “In West Virginia, we now have 100 Delta variant cases,” Gov. Justice said. “This variant is different. It is much, much more contagious.”

VIEW PHOTO ALBUM

The current statewide case count of 100 is a 132.6% increase in Delta variant cases since the Governor’s previous COVID-19 briefing two days ago.

To view COVID-19 variant data: Go to the WV COVID-19 Dashboard at Coronavirus.wv.gov Make sure the “Overview” tab is selected Click yellow box reading: “Click here to view variant data”

“In my stomach, I believe and I feel that the enemy is coming. And that enemy is this Delta variant,” Gov. Justice said. “We’ve got to do something, and we’ve got to do something really fast.” The Governor went on to announce several action steps that will be taken immediately.   Booster Battlefield Assessment: The Booster Battlefield Assessment program will be an opportunity for West Virginia’s long-term care facility residents and other West Virginians ages 60 and above who were vaccinated more than six months ago to volunteer to have their blood drawn and have their antibody levels measured. “That will allow us to gain data on antibodies and how protected you really are,” Gov. Justice said.  State Coronavirus Czar Dr. Clay Marsh, who attended Thursday’s briefing in-person, noted that early studies have indicated that there may be a “significant reduction” in the amount of antibodies present in individuals six months after being vaccinated.

“We are worried that people who are older, who are more vulnerable – including our nursing home population, our long-term care facilities, and all people who are over 60 years old – who were vaccinated back in December and January when we first saw the vaccines, that they may be seeing their immune protection start to go down,” Dr. Marsh said. “With this Booster Battlefield Assessment program, we think that we can gather very valuable information that we can share with the CDC and the FDA – hopefully working hand in glove with the vaccine manufacturers – to be able to demonstrate real-world data in the U.S. that we may be able to use to benefit our population; to protect them from getting sick and dying.” If a participant’s antibody levels are found to be low, those individuals may then qualify to receive another booster of the vaccine, should such booster shots become available. The Booster Battlefield Assessment program is the first statewide antibody testing program in the country. “West Virginia has always been on the forefront with our response to COVID,” Gov. Justice said. “I am very hopeful that, with this program, West Virginia will lead the way for the nation yet again.” Fortifying Supplies and Resources: The Governor also announced that he has directed West Virginia’s Joint Interagency Task Force (JIATF) on COVID-19 to evaluate PPE supply levels across the state. The JIATF has also been directed to evaluate hospital staffing and bed availability, long-term care facility staffing and preventative measures, and monoclonal antibody treatment levels statewide. “We’re moving proactive and will be doing a foundational emergency planning program,” Gov. Justice said. “We need to be ready because this Delta variant is here. We have 100 cases now and we know more will be coming in the days ahead. I’ve been advised by top medical professionals that, over the next few weeks, this thing is going to get significantly worse.” “The Governor’s primary objectives are to reduce the loss of life among West Virginians and to maintain the integrity of our hospital system,” JIATF Director Jim Hoyer said during his remarks Thursday. “What the Governor has directed us to do is to give him, as the commander of our response, a better focus on what is out in front of us and what we need to do to maintain the level of effort to achieve those two objectives that we need to get to.”

Increasing Briefing Schedule: The Governor also announced that, in order to continue keeping the public adequately informed about developments in regard to the State’s response to the Delta variant, that he will be increasing the frequency of his COVID-19 news briefings to three per week. “I wish to goodness we could be announcing that we could be changing our briefings to one day per week or eliminating the briefings altogether. But we need to be here,” Gov. Justice said. “We need to be ahead of the curve. West Virginia has always been ahead of the curve.” https://governor.wv.gov/News/press-releases/2021/Pages/COVID-19-UPDATE-Gov.-Justice-launches-Booster-Battlefield-Assessment.aspx

Israeli ‘precision’ COVID drug wrapping up early trial

The Israeli inventor of a “precision medicine” for COVID-19 is “very optimistic,” after an 88-person hospital trial entered its final day without a single patient ending up on a ventilator.

The next phase of the drug trial will see a trial performed with some in a group given a placebo.

After a first trial in Israel, this trial, which will wrap up on Tuesday, is taking place in Greece, sponsored by the government in Athens, involving moderate and serious patients aged up to 85.

Almost 90 percent of them were released within five days, although some remain hospitalized.

The patients were given the inhaled drug EXO-CD24, developed at Tel Aviv’s Ichilov Medical Center.

“Doctors reported good responses, and this is very encouraging and supports our hope that this drug could be a game changer,” the medication’s inventor, senior Ichilov doctor Prof. Nadir Arber, told The Times of Israel.

Illustrative: A coronavirus ward in Athens, Greece. (AP Photo/Thanassis Stavrakis)

As well as reporting what appeared to be positive responses, doctors found that none of the patients needed to be intubated and placed on ventilators, and none died, despite the severity of their conditions.

“Patients selected had moderate to high severity disease, and you would expect some would be intubated or stay in hospital for longer,” said Arber.

He stressed that he was not involved in running the trial, which was conducted by Greek doctors and overseen by Dr. Sotiris Tsiodras, the national coronavirus commissioner for Greece.

Arber acknowledged that firm conclusions can’t be drawn until the trial is followed up by testing that involves a group with some patients being given a placebo for comparison.

“As much as we are optimistic now, there must be a placebo trial,” Arber said.

The drug tackles the coronavirus using a molecule, CD24, that Arber spent 25 years researching in the hope it would help cancer patients.

In February, the approach impressed visiting Greek Prime Minister Kyriakos Mitsotakis, who decided to initiate and sponsor the trial in Greece.

Ichilov has since teamed up with an Israeli pharmaceutical company to advance the testing process.

Then-Prime Minister Benjamin Netanyahu meeting with Prof. Nadir Arber (2nd left)  in Jerusalem on February 8, 2021. (Amos Ben-Gershom/Israeli Government Press Office)

Arber thinks that the big advantage of his drug over steroids, which are now commonly given to coronavirus patients, is that it doesn’t impact the immune system as a whole but rather takes a “precision” approach.

“We are not suppressing or altering the immune system, but rather restoring it to normality by controlling the aspect of the system that causes the cytokine storm, the overreaction of the immune system that is often the cause of serious COVID illness,” he said.

https://www.timesofisrael.com/88-patients-0-intubated-israeli-precision-covid-drug-wrapping-up-early-trial/

For-profit hospitals saw volumes rebound in Q2, but delta variant poses threat

 A major question for health systems is how long it will take to fully return to pre-pandemic volumes after shutdowns and virus fears took a major toll on operations last year. They're also wondering when a patchy rally in deferred care will come to push them past pre-pandemic levels.

In the second quarter of this year, for-profit hospital operators saw their volumes largely rebound as COVID-19 cases decreased and more patients sought non-COVID-19 care. Tenet, HCA, Universal Health Services and Community Health Systems all beat Wall Street expectations on earnings and revenue.

Some services were near or back to pre-pandemic levels in the second quarter, though others like emergency room visits are still lagging. A major challenge now is increasing cases of the delta variant that could hinder full recoveries this year, some executives cautioned on calls with investors.

Tenet CEO Ron Rittenmeyer said the first half of the year was "better than expected on many fronts," but added: "Please realize we're not claiming any victory, and we're not relaxing."

The Dallas-based chain posted a $120 million profit in Q2, compared to $88 million during the same time last year, and upped its full-year guidance for the second time this year, citing volume growth and operational improvements as well as federal bailout income.

Nashville-based HCA saw its profit jump 37% year-over-year in the second quarter. And some volume metrics, like same-facility admissions and same-facility equivalent admissions, increased about 3% and 1% respectively compared to the pre-coronavirus baseline. It too raised its guidance, forecasting current levels of demand will continue over the rest of 2021.

After last year's mandated lockdowns and cancellations in elective procedures, health system executives said they're much better positioned to ride future virus waves while continuing operations.

Franklin, Tennessee-based Community Health Systems was somewhat of an outlier, posting a $6 million second quarter profit, down from $70 million during the same quarter last year.

On a call with investors, CHS executives downplayed concerns about the highly transmissible delta variant, saying they were confident in "the ability of our teams to safely and effectively manage COVID surges, while also meeting the increasing demand for our services and to meet the healthcare needs of non-COVID patients."

Universal Health Services posted a $325 million profit in the second quarter, up from $251.9 million during the same quarter last year, and also boosted its full-year guidance. But the delta variant and corresponding labor pressures pose some ongoing uncertainties.

"The concern is with the resurgence of COVID that turnover rates could increase because we've seen turnover rates increase every time that COVID volumes increase," CEO Marc Miller said on a call with investors.

https://www.healthcaredive.com/news/for-profit-hospitals-saw-volumes-rebound-in-q2-but-delta-variant-poses-thr/604244/

ResMed cut to Hold by Needham

 from Buy 

https://finviz.com/quote.ashx?t=RMD&ty=c&ta=1&p=d