Federal health regulators are exploring whether to greenlight the
emergency use of a Gilead Sciences Inc. drug in serious Covid-19
patients, after U.S. government researchers reported the therapy helped
the patients recover faster.
President Trump said he was pushing the U.S. Food and Drug
Administration to grant the emergency-use authorization to the Gilead
drug remdesivir.
The National Institute of Allergy and Infectious Diseases said
Wednesday that advanced Covid-19 patients taking remdesivir in the
institute’s study had a speedier recovery than patients taking placebo,
according to preliminary results.
The reported benefit was moderate, however, with remdesivir patients
recovering in 11 days, or four days faster than the placebo group.
Also on Wednesday, a separate study in China posted negative results
for the drug. The researchers urged more testing, however, because their
trial was stopped early due to problems recruiting subjects as the
pandemic slowed there.
Gilead is in active discussions with the Food and Drug Administration
about securing emergency authorization for remdesivir, Chief Executive
Daniel O’Day said in an interview.
“I know they’re working in earnest to determine the path forward and
make the decision,” he said. “It’s full-steam ahead with this new
clinical data in hand now.”
If emergency authorization is approved, it will allow Gilead to work
with the government to directly ship the drug to hospitals with the
greatest need, Mr. O’Day said.
Gilead expects to have manufactured 1.5 million doses by the end of
May, or up to 210,000 treatment courses, assuming that most patients are
treated for five days, and the company will donate the supply to
hospitals and doctors free of charge, Mr. O’Day said. He declined to say
how much Gilead might charge for remdesivir that it manufactures after
June.
The NIAID-funded study could carry more weight for U.S. health
regulators considering whether to greenlight wider use of remedesivir,
however, since the study was carried out by government researchers and
was fully enrolled.
NIAID Director Anthony Fauci said at the White House the results
appeared to open the door to drug treatment of Covid-19, though he
indicated drugmakers would probably need to build upon the findings to
improve the benefit.
“This will be the standard of care,” he said.
Mr. Trump indicated he would support the FDA issuing an “emergency
use authorization” that could accelerate approval for use of remdesivir.
“I want them to go as quickly as they can,” he told reporters
Wednesday. “We want everything to be safe, but we would like to see very
quick approvals, especially with things that work.”
Researchers run drug trials to establish whether a drug works safely.
The varying outcomes for remdesivir point to the challenges scientists
face finding definitive proof while racing to come up with a treatment
in the middle of a pandemic.
Standards for an emergency-use authorization aren’t as high as they
are for a typical drug approval. The U.S. Food and Drug Administration
grants both. The authorization is to provide speedy access to treatments
for serious diseases during a health emergency.
The agency had granted emergency-use authorization to antimalaria
drugs chloroquine and hydroxychloroquine, though the evidence supporting
their expanded access was thinner.
So far, remdesivir use has been limited to patients testing the drug,
or who were able to make the case for its compassionate use.
“The FDA, literally as we speak, is working with Gilead to figure out
mechanisms to make this easily available to those who need it with
regard to getting to the market,” Dr. Fauci said. “The FDA is very well
aware that this is something that is important so I’m sure they’ll move
very expeditiously.”
The U.S. study compared recovery times for 1,063 hospitalized patients taking either remdesivir or placebo.
The trial’s findings were based on an interim analysis, and more
detailed data will be released in the future, the agency said. The data
hasn’t yet been published in a peer-reviewed journal.
Patients taking remdesivir recovered in 11 days, compared with 15
days for patients taking placebo, a 31% improvement that was
statistically significant, NIAID said in a news release.
In the remdesivir group, 8% of patients died, compared with 11.6% of
patients in the placebo arm. The survival difference wasn’t
statistically significant, however.
Timothy Albertson, a critical-care doctor at the University of
California, Davis said the improvement in recovery times would be
valuable, especially if it helps patients get discharged from the
hospital sooner.
He said he would look to additional remdesivir studies to see if the
drug improved the survival of patients by a statistically significant
degree.
“Survival is the sort of platinum standard that ICU doctors look at and this one doesn’t quite make it,” Dr. Albertson said.
The separate study in China showed that remdesivir didn’t have a
statistically significant benefit over placebo, researchers said.
In that study, the median time to clinical improvement in patients
taking remdesivir was 21 days, compared with 23 days for patients taking
placebo, but the difference wasn’t statistically significant, according
to a paper published in the Lancet, a medical journal.
The rate of death was similar in both groups, with 14% of the
patients taking remdesivir dying compared with 13% of patients in the
placebo group. The difference wasn’t statistically significant.
Bin Cao, a physician who led the Chinese study, said in an interview
that he thinks remdesivir did perform somewhat better than placebo in
the study, but that the difference was small.
He also said remdesivir may have a role to play in treating Covid-19,
but that further studies would have to be done to determine how early
in the disease to treat patients and if it should be combined with other
drugs.
Dr. Cao noted that patients in the Chinese study were extremely sick
and weren’t treated with remdesivir until a median of 10 days after
their symptoms appeared. Patients may be too sick at that stage for a
single antiviral drug to clear the virus, he said.
He also noted that the remdesivir group had a higher proportion of
patients with pre-existing conditions like diabetes and hypertension,
which may have also influenced the results.
Some experts said the Chinese study data were inconclusive because
the trial was stopped early due to a lack of patients. Researchers
intended to enroll 453 patients, but had only 237 patients enrolled when
the study was stopped.
“The study has not shown a statistically significant finding that
confirms a remdesivir treatment benefit of at least the minimally
clinically important difference, nor has it ruled such a benefit out,”
wrote John David Norrie of the Usher Institute’s Edinburgh Clinical
Trials Unit, in a commentary accompanying the Lancet paper.
Gilead’s remdesivir, an antiviral drug administered intravenously and
previously tested in Ebola, is among the most closely watched
experimental treatments for Covid-19, and is being studied in multiple
clinical trials around the world. If approved by regulators, the drug
would be the first proven to be effective against Covid-19.
Also on Wednesday, Gilead said a separate study it funded showed that
Covid-19 patients taking remdesivir for five days had similar results
as patients taking a 10-day course of the drug. The study didn’t compare
the drug with a control group of patients not taking the drug, making
the results difficult to interpret.
“The study demonstrates the potential for some patients to be treated
with a 5-day regimen, which could significantly expand the number of
patients who could be treated with our current supply of remdesivir,”
Gilead’s Chief Medical Officer Merdad Parsey said.
The company said it is conducting the study at 180 sites, including
in countries with high levels of Covid-19 infection such as China, the
U.S. and Italy. The study’s initial phase involved 397 patients, and
Gilead said it would enroll another 5,600 patients.
Gilead expects data at the end of May from another study assessing
the two dosing durations of remdesivir in patients with moderate
Covid-19 compared with patients receiving standard treatment.
Remdesivir hasn’t been approved anywhere and has yet to be deemed safe or effective for Covid-19 treatment.
Remdesivir hasn’t been approved anywhere and has yet to be deemed safe or effective for Covid-19 treatment.
https://www.marketscreener.com/GILEAD-SCIENCES-4876/news/Gilead-Sciences-Study-Shows-Shorter-Course-of-Gilead-Drug-as-Effective-Against-Covid-19-8th-Upd-30499571/
Saturday, May 2, 2020
U.S. court dismisses New York nurses’ plea for COVID-19 protection
A U.S. District Court on Friday dismissed a nurse association’s plea
against New York state and two hospitals to provide safety equipment and
adopt measures to stop the spread of COVID-19 among its members, asking
the parties to reach an amicable agreement.
Last month, the New York State Nurses Association (NYSNA) sued the New York Department of Health, Montefiore Medical Center and the parent company of the Westchester Medical Center, saying the hospitals were ignoring requirements that healthcare workers each receive an N95 respirator mask daily, and that the health department was not enforcing it.
The Court said the parties are in a better position than the court to reach a resolution, adding that the court lacks the authority to address the nurse association’s concerns.
“Both sides presumably share the ultimate goal of maximizing protections for healthcare workers on the front lines of the battle against a vicious disease without compromising patient care,” U.S. District Judge for the Southern District of New York Jesse Fruman said in the proceeding.
“The parties are plainly in a better position than either the Court or an arbitrator to find the best ways to achieve that goal despite limited resources and ever-changing circumstances,” Fruman said.
The judge also asked the health department and the hospitals to take swift action in addressing the nurses’ requests. The state and two hospitals had earlier said they were taking necessary actions to protect the healthcare workers.
The judge said that if the two sides fail to reach an amicable resolution, they can expedite a court proceeding.
https://www.reuters.com/article/us-health-coronavirus-usa-nurses/u-s-court-dismisses-new-york-nurses-plea-for-covid-19-protection-idUSKBN22E061
Last month, the New York State Nurses Association (NYSNA) sued the New York Department of Health, Montefiore Medical Center and the parent company of the Westchester Medical Center, saying the hospitals were ignoring requirements that healthcare workers each receive an N95 respirator mask daily, and that the health department was not enforcing it.
The Court said the parties are in a better position than the court to reach a resolution, adding that the court lacks the authority to address the nurse association’s concerns.
“Both sides presumably share the ultimate goal of maximizing protections for healthcare workers on the front lines of the battle against a vicious disease without compromising patient care,” U.S. District Judge for the Southern District of New York Jesse Fruman said in the proceeding.
“The parties are plainly in a better position than either the Court or an arbitrator to find the best ways to achieve that goal despite limited resources and ever-changing circumstances,” Fruman said.
The judge also asked the health department and the hospitals to take swift action in addressing the nurses’ requests. The state and two hospitals had earlier said they were taking necessary actions to protect the healthcare workers.
https://www.reuters.com/article/us-health-coronavirus-usa-nurses/u-s-court-dismisses-new-york-nurses-plea-for-covid-19-protection-idUSKBN22E061
Friday, May 1, 2020
Broad antiviral activity of naproxen: from Influenza A to SARS-CoV-2
This article is a preprint and has not been certified by peer review [what does this mean?].
Abstract
There is an urgent need for specific antiviral drugs
directed against SARS-CoV-2 both to prevent the most severe forms of
COVID-19 and to reduce viral excretion and subsequent virus
dissemination; in the present pandemic context, drug repurposing is a
priority. Targeting the nucleoprotein N of the SARS-CoV-2 coronavirus in
order to inhibit its association with viral RNA could be a strategy to
impeding viral replication and possibly other essential functions
associated with viral N. The antiviral properties of naproxen, belonging
to the NSAID family, previously demonstrated against Influenza A virus,
were evaluated against SARS-CoV-2. Naproxen binding to the
nucleoprotein of SARS-CoV2 was shown by molecular modeling. In VeroE6
cells and reconstituted human primary respiratory epithelium models of
SARS-CoV-2 infection, naproxen inhibited viral replication and protected
the bronchial epithelia against SARS-CoV-2 induced-damage. The benefit
of naproxen addition to the standard of care is tested in an on-going
clinical study.
Competing Interest Statement
The authors have declared no competing interest.
Paper in collection COVID-19 SARS-CoV-2 preprints from medRxiv and bioRxivPreview PDF
https://www.biorxiv.org/content/10.1101/2020.04.30.069922v1
Republicans push for coronavirus lawsuit immunity for business
The top Republicans in the U.S. Congress displayed a united front on
Friday in their drive for coronavirus-related liability protections for
businesses, saying such measures will be crucial to talks about future
relief legislation.
Senate majority leader Mitch McConnell and House of Representatives Republican leader Kevin McCarthy issued a joint statement redoubling their demands that “Americans on the front lines of this fight must receive strong protections from frivolous lawsuits.”
“Senate and House Republicans agree these protections will be absolutely essential to future discussions surrounding recovery legislation,” they said.
The statement marks a hardening line of demarcation between Republicans and Democrats over the question of business liability as the two sides spar over the prospects of a new coronavirus relief package. Democrats are pushing for nearly $1 trillion in federal assistance to states and local governments.
With half of all U.S. states forging ahead with strategies for easing restrictions on restaurants, retail and other businesses shuttered by the coronavirus crisis, business groups have been pushing for protection against COVID-19-related lawsuits for companies that follow health and safety guidelines.
The Trump administration is also pushing for liability safeguards, as well as a reduction in business regulations.
But Democrats have dismissed Republican calls to include liability protections in legislation, saying it could jeopardize workers and coronavirus patients.
White House economic adviser Larry Kudlow said on Friday that liability protections should be included in new legislation among pro-growth measures including payroll tax cuts for workers and business investment expensing.
“We’ll probably come together in a few weeks, and resume the discussions. But our emphasis, I believe, is going to be on future growth incentives,” Kudlow said in an interview with Fox News.
House Speaker Nancy Pelosi said on Thursday that money for state and local governments would form the core of the next legislative package that House Democrats are drafting. Other Democratic priorities include extending broadband access.
With the Senate poised to hold regular sessions next week for the first time since March, the U.S. Capitol’s attending physician issued a six-page document to congressional offices laying out health and safety practices for the sprawling complex.
Dr. Brian Monahan’s guidance strongly urged the use of face masks in congressional workplaces. But Capitol Police will not enforce that suggestion. For those not wearing face masks, a six-foot distance with others is being required. Workers are also being instructed to measure their body temperatures each morning at home before reporting to work.
It was not yet clear when the House of Representatives would return to regular sessions in Washington.
https://www.marketscreener.com/news/U-S-Republicans-push-for-coronavirus-lawsuit-immunity-for-business–30511828/?countview=0
Senate majority leader Mitch McConnell and House of Representatives Republican leader Kevin McCarthy issued a joint statement redoubling their demands that “Americans on the front lines of this fight must receive strong protections from frivolous lawsuits.”
“Senate and House Republicans agree these protections will be absolutely essential to future discussions surrounding recovery legislation,” they said.
The statement marks a hardening line of demarcation between Republicans and Democrats over the question of business liability as the two sides spar over the prospects of a new coronavirus relief package. Democrats are pushing for nearly $1 trillion in federal assistance to states and local governments.
With half of all U.S. states forging ahead with strategies for easing restrictions on restaurants, retail and other businesses shuttered by the coronavirus crisis, business groups have been pushing for protection against COVID-19-related lawsuits for companies that follow health and safety guidelines.
The Trump administration is also pushing for liability safeguards, as well as a reduction in business regulations.
But Democrats have dismissed Republican calls to include liability protections in legislation, saying it could jeopardize workers and coronavirus patients.
White House economic adviser Larry Kudlow said on Friday that liability protections should be included in new legislation among pro-growth measures including payroll tax cuts for workers and business investment expensing.
“We’ll probably come together in a few weeks, and resume the discussions. But our emphasis, I believe, is going to be on future growth incentives,” Kudlow said in an interview with Fox News.
House Speaker Nancy Pelosi said on Thursday that money for state and local governments would form the core of the next legislative package that House Democrats are drafting. Other Democratic priorities include extending broadband access.
With the Senate poised to hold regular sessions next week for the first time since March, the U.S. Capitol’s attending physician issued a six-page document to congressional offices laying out health and safety practices for the sprawling complex.
Dr. Brian Monahan’s guidance strongly urged the use of face masks in congressional workplaces. But Capitol Police will not enforce that suggestion. For those not wearing face masks, a six-foot distance with others is being required. Workers are also being instructed to measure their body temperatures each morning at home before reporting to work.
It was not yet clear when the House of Representatives would return to regular sessions in Washington.
https://www.marketscreener.com/news/U-S-Republicans-push-for-coronavirus-lawsuit-immunity-for-business–30511828/?countview=0
Structural basis for SARS-CoV-2 inhibition by Remdesivir uncovered
A team of Chinese scientists have reported the high-resolution
cryo-EM structure of Remdesivir-bound RNA replicase complex from
SARS-CoV-2, the infective virus of COVID-19.
The research, published online in Science on May 1, was conducted by Prof. Xu Huaqiang and Prof. Xu Yechun from the Shanghai Institute of Materia Medica (SIMM) of the Chinese Academy of Sciences (CAS), Prof. Zhang Yan from the Zhejiang University School of Medicine, Prof. Zhang Shuyang from Peking Union Medical College and Chinese Academy of Medical Sciences, and their collaborators.
COVID-19 has spread rapidly around the world and is an ongoing humanitarian crisis. Many countries are now facing tremendous challenges in the fight against SARS-CoV-2. Finding an effective treatment is a very urgent matter.
SARS-CoV-2 is a positive-strand RNA virus that mainly infects human cells through the mucosal system. The massive replication of the virus requires the rapid synthesis of its genetic RNA. This process is mediated by a multi-subunit replication transcription complex composed of multiple non-structural proteins (nsp) of the virus. The core element is the replicase complex, which is the core component of coronavirus replication. Numerous nucleoside drugs targeting replicase are currently under clinical testing, including Remdesivir.
After 46 days of hard work, the scientists were able to elaborate the replicase-targeting mechanism underlying the antiviral efficacy of these nucleoside drugs. Their study reports the cryo-EM structure of the SARS-CoV-2 replicase both in the apo form at 2.8 Å resolution and in complex with a template-primer RNA and Remdesivir at 2.5 Å resolution. The overall conformation of the complex structure is very similar to that of the apo form, with the identical structures at the core catalytic active site. Comprehensive analysis of the structures showed that the SARS-CoV-2 replicase complex is a very efficient enzyme. During RNA extension, conformational change is small, which also explains the highly contagious nature of SARS-CoV-2.
The replicase complex recognizes RNA—but not DNA—through a sequence-independent binding way. The structure of the complex explains how Remdesivir enters the replication active site and covalently links with the viral genome, thereby inhibiting virus replication.
The residues involved in RNA binding as well as those comprising the catalytic active site are highly conserved among most RNA viruses. This shows the conservative mechanism of the replicase complex during gene replication and suggests it may be possible to develop broad spectrum antiviral inhibitors.
The structures described in this study reveal potential binding patterns that offer theoretical support for the design of more powerful, efficient and specific anti-SARS-CoV-2 drugs. In this way, they provide a basis for the design of the antiviral drugs, which are so urgently needed to fight the COVID-19 crisis.
Structure-based design of antiviral drug candidates targets SARS-CoV-2 main protease
The research, published online in Science on May 1, was conducted by Prof. Xu Huaqiang and Prof. Xu Yechun from the Shanghai Institute of Materia Medica (SIMM) of the Chinese Academy of Sciences (CAS), Prof. Zhang Yan from the Zhejiang University School of Medicine, Prof. Zhang Shuyang from Peking Union Medical College and Chinese Academy of Medical Sciences, and their collaborators.
COVID-19 has spread rapidly around the world and is an ongoing humanitarian crisis. Many countries are now facing tremendous challenges in the fight against SARS-CoV-2. Finding an effective treatment is a very urgent matter.
SARS-CoV-2 is a positive-strand RNA virus that mainly infects human cells through the mucosal system. The massive replication of the virus requires the rapid synthesis of its genetic RNA. This process is mediated by a multi-subunit replication transcription complex composed of multiple non-structural proteins (nsp) of the virus. The core element is the replicase complex, which is the core component of coronavirus replication. Numerous nucleoside drugs targeting replicase are currently under clinical testing, including Remdesivir.
After 46 days of hard work, the scientists were able to elaborate the replicase-targeting mechanism underlying the antiviral efficacy of these nucleoside drugs. Their study reports the cryo-EM structure of the SARS-CoV-2 replicase both in the apo form at 2.8 Å resolution and in complex with a template-primer RNA and Remdesivir at 2.5 Å resolution. The overall conformation of the complex structure is very similar to that of the apo form, with the identical structures at the core catalytic active site. Comprehensive analysis of the structures showed that the SARS-CoV-2 replicase complex is a very efficient enzyme. During RNA extension, conformational change is small, which also explains the highly contagious nature of SARS-CoV-2.
The replicase complex recognizes RNA—but not DNA—through a sequence-independent binding way. The structure of the complex explains how Remdesivir enters the replication active site and covalently links with the viral genome, thereby inhibiting virus replication.
The residues involved in RNA binding as well as those comprising the catalytic active site are highly conserved among most RNA viruses. This shows the conservative mechanism of the replicase complex during gene replication and suggests it may be possible to develop broad spectrum antiviral inhibitors.
The structures described in this study reveal potential binding patterns that offer theoretical support for the design of more powerful, efficient and specific anti-SARS-CoV-2 drugs. In this way, they provide a basis for the design of the antiviral drugs, which are so urgently needed to fight the COVID-19 crisis.
Explore further
More information: Wanchao Yin et al. Structural basis for inhibition of the RNA-dependent RNA polymerase from SARS-CoV-2 by remdesivir. Science 01 May 2020: DOI: 10.1126/science.abc1560
Can germ-zapping robot kill coronavirus?
As doctors continue to debate how the fast-spreading coronavirus
rose to pandemic levels, a Texas medical engineering company claims
their $125,000 “germ-zapping” robot may be our best hope on the front
lines against the invisible enemy.
San Antonio-based Xenex developed a robot that tracks, disinfects and collects data on hospital-acquired infections. Now, the company hopes its LightStrike robot, a “full germicidal spectrum” UV light smart cleaning device, will be used to combat COVID-19.
The autonomous tech is already being used in some of the world’s best hospitals, including health-care facilities for the Department of Defense. And this week, the independent Texas Biomedical Research Institute announced that Xenex’s latest bot can deactivate 99.99% of SARS-CoV-2 in just two minutes.
In 2015, the lab shared similar praise, claiming the LightStrike killed Ebola in just 60 seconds.
“Our robots have been adopted as the environmental standard of care by many of the world’s leading hospitals because they work — and they work very quickly,” said Dr. Mark Stibich, chief scientific officer and co-founder of Xenex in a statement.
“We wanted our current and future customers to know with certainty that their pulsed xenon UV robots could stop COVID-19,” Stibich said.
Xenex was founded by two former Johns Hopkins epidemiologists in 2009, Stibich and Julie Stachowiak. Unlike similar infection-blasting bots, their innovation was proven to reduce certain infection rates by up to 100 percent, based on studies published in journals including the American Journal of Infection Control.
Whereas similar companies use pulsed mercury UV devices, Xenex touts their unique pulsed xenon UV technology, which is more efficient and environmentally friendly than the former method, the company’s CEO Morris Miller told Crunchbase News last month.
Since the coronavirus outbreak, Miller said they received “hundreds” of requests for their costly robot, namely from Italy as well as countries in Asia.
“We’ve been working seven days a week for the last three to four weeks,” Miller said. “In addition, we’ve seen an increase in orders from existing hospitals for robots for their emergency rooms.”
Xenex is now looking to fulfill bulk orders “in the thousands,” he added, and projects growth in 2020 to be somewhere between 400 and 600 percent.
Despite sticker shock, the company estimates that the $125,000 price tag breaks down to just $2 to $8 per room. And the cost wasn’t too much for a number of big name hospitals, including the University of Texas MD Anderson Cancer Center, the Mayo Clinic Health System, Stanford University, 55 Veterans Affairs (VA) facilities and 10 DOD health-care buildings, according to Xenex. The company reports that the LightStrike was also sent to countries on almost every continent.
Earlier this year, the spike in sales — thanks to the pandemic — prompted the company’s VP of sales Irene Hahn to email a somber memo to her colleagues, according to Forbes.
“At any other time, we celebrate these wins,” she said. “However, in light of what is happening, this one is different … we are absolutely humbled.”
https://nypost.com/2020/05/01/can-this-germ-zapping-robot-really-kill-the-coronavirus/
San Antonio-based Xenex developed a robot that tracks, disinfects and collects data on hospital-acquired infections. Now, the company hopes its LightStrike robot, a “full germicidal spectrum” UV light smart cleaning device, will be used to combat COVID-19.
The autonomous tech is already being used in some of the world’s best hospitals, including health-care facilities for the Department of Defense. And this week, the independent Texas Biomedical Research Institute announced that Xenex’s latest bot can deactivate 99.99% of SARS-CoV-2 in just two minutes.
In 2015, the lab shared similar praise, claiming the LightStrike killed Ebola in just 60 seconds.
“Our robots have been adopted as the environmental standard of care by many of the world’s leading hospitals because they work — and they work very quickly,” said Dr. Mark Stibich, chief scientific officer and co-founder of Xenex in a statement.
“We wanted our current and future customers to know with certainty that their pulsed xenon UV robots could stop COVID-19,” Stibich said.
Xenex was founded by two former Johns Hopkins epidemiologists in 2009, Stibich and Julie Stachowiak. Unlike similar infection-blasting bots, their innovation was proven to reduce certain infection rates by up to 100 percent, based on studies published in journals including the American Journal of Infection Control.
Whereas similar companies use pulsed mercury UV devices, Xenex touts their unique pulsed xenon UV technology, which is more efficient and environmentally friendly than the former method, the company’s CEO Morris Miller told Crunchbase News last month.
Since the coronavirus outbreak, Miller said they received “hundreds” of requests for their costly robot, namely from Italy as well as countries in Asia.
“We’ve been working seven days a week for the last three to four weeks,” Miller said. “In addition, we’ve seen an increase in orders from existing hospitals for robots for their emergency rooms.”
Xenex is now looking to fulfill bulk orders “in the thousands,” he added, and projects growth in 2020 to be somewhere between 400 and 600 percent.
Despite sticker shock, the company estimates that the $125,000 price tag breaks down to just $2 to $8 per room. And the cost wasn’t too much for a number of big name hospitals, including the University of Texas MD Anderson Cancer Center, the Mayo Clinic Health System, Stanford University, 55 Veterans Affairs (VA) facilities and 10 DOD health-care buildings, according to Xenex. The company reports that the LightStrike was also sent to countries on almost every continent.
Earlier this year, the spike in sales — thanks to the pandemic — prompted the company’s VP of sales Irene Hahn to email a somber memo to her colleagues, according to Forbes.
“At any other time, we celebrate these wins,” she said. “However, in light of what is happening, this one is different … we are absolutely humbled.”
https://nypost.com/2020/05/01/can-this-germ-zapping-robot-really-kill-the-coronavirus/
U.S. needs to make more CPAP machines. Our supply chain is blocking that
I don’t want to be intubated.
That was my main thought a few weeks ago as I lay in bed at home, having trouble breathing and watching my pulse oximeter show that my blood oxygen was under 93% when it should have been over 95%.
I had just tested positive for Covid-19 and wanted to stay out of the hospital completely, or at least for as long as I could. Being short of breath meant I could develop hypoxia — too little oxygen in my bloodstream — which would mean I’d need to go to the hospital, something I wanted to avoid because it would increase my chances of being intubated and put on a ventilator.
The thought of being put on a ventilator frightened me, since nearly 90% of Covid-19 patients in the New York City area who were put on ventilators died.
Because I had been short of breath, exhausted, and feeling a tightness in my chest before testing positive for Covid-19, my father sent me a continuous positive airway pressure machine, also known as a CPAP, to help me breathe. This device is commonly used to treat obstructive sleep apnea.
Using CPAP requires wearing a mask that covers the nose and mouth. It
is connected to a blower that pushes air through a hose and into the
mask. Computer logic in the blower sends puffs of air into the mask
timed to the user’s breathing patterns. The extra air pressure in the
mask keeps the airway open and allows the user to breathe. It’s
different in that way from a ventilator, which breathes for you.
I put on the mask, turned on the machine, and watched as my blood oxygen level rose to a manageable level, and helped keep it there over the next few days. I was able to work every day with intermittent use of the CPAP machine, and within a week was back on my feet.
I’m not alone in thinking that CPAP machines can play roles in fighting Covid-19. Emergency physicians I’ve spoken with directly, and others I have seen in the news, such as Colleen Smith from Elmhurst Hospital in Queens, N.Y., say that CPAP machines can be used for some patients in place of ventilators, providing all of the breathing support that’s needed and freeing up scarce ventilators for sicker people. For others, they could act as a bridge before crossing over to a ventilator. For patients coming off ventilators, CPAP machines could initially help regulate their breathing.
One drawback to using CPAP machines or their cousins, bilevel positive airway pressure (BiPAP) machines, at home or in the hospital is the cost of these devices. ResMed, the leading manufacturer of CPAP and BiPAP machines, charges approximately $1,500 for them. While that’s less than the cost of a ventilator, it is too much for individuals, much less for medical systems in crisis.
My father, an inventor and inveterate tinkerer, predicted the value of CPAP in treating patients with Covid-19 weeks before sending me one. With some experimentation, he came up with the prototype below, which could be built for approximately $200 apiece.
But what we found when we began to procure the most basic parts needed for production was that, due to outsourcing, none of the components were currently being made in the U.S., including basic items such as hoses, masks, and blowers. Outsourcing to China had led China to outsource to Vietnam, and so on. Despite the free-trade mantra that outsourcing to lower-wage countries leads to lower-cost products, there has been a persistent creep in the availability and cost of almost everything that Americans need to manufacture our own products.
This wasn’t always the case. Growing up in Cuyahoga Falls, Ohio, my father worked for a company he started in his early 20s called Polymerics, for which he invented PolyGel, a common component in rubber compounds. Polymerics sold to U.S. companies different types of rubber and plastic that were needed to build anything ranging from windshield wipers to medical devices and engine mounts. While the company still exists and is still family-owned, the supply chain it depends on has become so much more complex that today we cannot find a single plastic made in the U.S. that we could use to build a low-cost CPAP device.
This dearth applies to the CPAP mask and blower. The mask involves run-of-the-mill injection molding with either additive manufacturing (3D printing) or craftsmanship machining. The blower is the heart of the CPAP. It inflates and deflates as the patient inhales and exhales. Its parts are similar to a computer fan, and those parts should be in the American arsenal to battle against pathogens. Yet they almost exclusively are made in China.
The upshot is that many individuals and hospitals in need of alternatives to highly invasive and potentially harmful ventilators facing a supply chain that makes it impossible to quickly produce them in this time of need.
What is at the root of this supply chain crisis? It could be our complacency, or unnecessary complexity, or a depletion of our greatest natural resource — expertise. The inability to get parts to make the products that we need in a timely fashion is felt across industries, but it is most relevant now to the medical industry.
My call to action is not to speed up shipments of the parts needed to build medical equipment like CPAP machines from China and Vietnam and beyond. It is to create businesses in the U.S. with the capabilities to quickly and easily build the parts we need to improve the health of Americans.
Matthew Putman, Ph.D., is the cofounder and CEO of Nanotronics, a science technology company that creates AI platforms and advanced inspection tools for manufacturing.
That was my main thought a few weeks ago as I lay in bed at home, having trouble breathing and watching my pulse oximeter show that my blood oxygen was under 93% when it should have been over 95%.
I had just tested positive for Covid-19 and wanted to stay out of the hospital completely, or at least for as long as I could. Being short of breath meant I could develop hypoxia — too little oxygen in my bloodstream — which would mean I’d need to go to the hospital, something I wanted to avoid because it would increase my chances of being intubated and put on a ventilator.
Because I had been short of breath, exhausted, and feeling a tightness in my chest before testing positive for Covid-19, my father sent me a continuous positive airway pressure machine, also known as a CPAP, to help me breathe. This device is commonly used to treat obstructive sleep apnea.
I put on the mask, turned on the machine, and watched as my blood oxygen level rose to a manageable level, and helped keep it there over the next few days. I was able to work every day with intermittent use of the CPAP machine, and within a week was back on my feet.
I’m not alone in thinking that CPAP machines can play roles in fighting Covid-19. Emergency physicians I’ve spoken with directly, and others I have seen in the news, such as Colleen Smith from Elmhurst Hospital in Queens, N.Y., say that CPAP machines can be used for some patients in place of ventilators, providing all of the breathing support that’s needed and freeing up scarce ventilators for sicker people. For others, they could act as a bridge before crossing over to a ventilator. For patients coming off ventilators, CPAP machines could initially help regulate their breathing.
One drawback to using CPAP machines or their cousins, bilevel positive airway pressure (BiPAP) machines, at home or in the hospital is the cost of these devices. ResMed, the leading manufacturer of CPAP and BiPAP machines, charges approximately $1,500 for them. While that’s less than the cost of a ventilator, it is too much for individuals, much less for medical systems in crisis.
My father, an inventor and inveterate tinkerer, predicted the value of CPAP in treating patients with Covid-19 weeks before sending me one. With some experimentation, he came up with the prototype below, which could be built for approximately $200 apiece.
But what we found when we began to procure the most basic parts needed for production was that, due to outsourcing, none of the components were currently being made in the U.S., including basic items such as hoses, masks, and blowers. Outsourcing to China had led China to outsource to Vietnam, and so on. Despite the free-trade mantra that outsourcing to lower-wage countries leads to lower-cost products, there has been a persistent creep in the availability and cost of almost everything that Americans need to manufacture our own products.
This wasn’t always the case. Growing up in Cuyahoga Falls, Ohio, my father worked for a company he started in his early 20s called Polymerics, for which he invented PolyGel, a common component in rubber compounds. Polymerics sold to U.S. companies different types of rubber and plastic that were needed to build anything ranging from windshield wipers to medical devices and engine mounts. While the company still exists and is still family-owned, the supply chain it depends on has become so much more complex that today we cannot find a single plastic made in the U.S. that we could use to build a low-cost CPAP device.
This dearth applies to the CPAP mask and blower. The mask involves run-of-the-mill injection molding with either additive manufacturing (3D printing) or craftsmanship machining. The blower is the heart of the CPAP. It inflates and deflates as the patient inhales and exhales. Its parts are similar to a computer fan, and those parts should be in the American arsenal to battle against pathogens. Yet they almost exclusively are made in China.
The upshot is that many individuals and hospitals in need of alternatives to highly invasive and potentially harmful ventilators facing a supply chain that makes it impossible to quickly produce them in this time of need.
What is at the root of this supply chain crisis? It could be our complacency, or unnecessary complexity, or a depletion of our greatest natural resource — expertise. The inability to get parts to make the products that we need in a timely fashion is felt across industries, but it is most relevant now to the medical industry.
My call to action is not to speed up shipments of the parts needed to build medical equipment like CPAP machines from China and Vietnam and beyond. It is to create businesses in the U.S. with the capabilities to quickly and easily build the parts we need to improve the health of Americans.
Matthew Putman, Ph.D., is the cofounder and CEO of Nanotronics, a science technology company that creates AI platforms and advanced inspection tools for manufacturing.
The U.S. needs to make more CPAP machines. Our supply chain is blocking that
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