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Monday, May 3, 2021

Siemens Healthineers 2Q Profit Rose; Lifts 2021 Outlook

 Siemens Healthineers AG said Monday that profit and revenue rose in the second quarter on the back of strong demand, and raised its outlook for the full year.

The German medical-equipment maker said quarterly net profit came in at 447 million euros ($537.3 million) from EUR414 million a year earlier.

Revenue was EUR3.97 billion in the period, up from EUR3.69 billion during the same period the year prior, a 12.9% increase on a comparable basis. The result was supported by continued demand for rapid Covid-19 antigen tests boosting the Diagnostic segment.

"As a result of the very strong revenue development in the second quarter, ongoing pandemic-related demand, higher confidence in the normalization of the business development as well as the closing of the Varian acquisition, we again raise our outlook for fiscal year 2021," Siemens Healthineers said.

The company now targets comparable revenue growth of between 14% and 17% compared with a previous target of 8% to 12%. Adjusted basic earnings per share are seen at between EUR1.90 and EUR2.05, up from EUR1.63 and EUR1.82 previously.

https://www.marketscreener.com/quote/stock/SIEMENS-HEALTHINEERS-AG-42379342/news/Siemens-Healthineers-2Q-Profit-Rose-Lifts-2021-Outlook-33137325/

EU drug regulator evaluating Pfizer vaccine for young

 The European Union’s drug regulator said Monday it has begun evaluating a request by Pfizer Inc. and BioNTech to extend approval of their coronavirus vaccine to include children ranging in age from 12 to 15.

The European Medicines Agency’s human medicines committee will carry out an accelerated assessment of data submitted by Pfizer and BioNTech and is expected to reach a decision in June, unless it requires extra information, the agency said.

In a statement Friday, the two pharmaceuticals said their request is based on an advanced study in more than 2,000 adolescents that showed their vaccine to be safe and effective. The children will continue to be monitored for longer-term protection and safety for another two years.

The companies’ vaccine is currently approved for use in people ages 16 years and older. Extending that approval to the younger age group could offer younger and less at-risk populations in Europe access to the shot for the first time.

Most COVID-19 vaccines approved by authorities around the world are for adults, who are at higher risk, but health officials believe vaccinating children of all ages will be critical to stopping the pandemic. Some research has shown that older children may play a role in spreading the virus.

https://apnews.com/article/europe-coronavirus-health-business-government-and-politics-3dd9307d86d5da55ffa04f32ec33358a

Russia turns to China to make Sputnik shots to meet demand

 Russia is turning to multiple Chinese firms to manufacture the Sputnik V coronavirus vaccine in an effort to speed up production as demand soars for its shot.

Russia has announced three deals totaling 260 million doses with Chinese vaccine companies in recent weeks. It’s a decision that could mean quicker access to a shot for countries in Latin America, the Middle East, and Africa that have ordered Russia’s vaccine, as the U.S. and the European Union focus mainly on domestic vaccination needs.

Earlier criticism about Russia’s vaccine have been largely quieted by data published in the British medical journal The Lancet that said large-scale testing showed it to be safe, with an efficacy rate of 91%.

Yet, experts have questioned whether Russia can fulfill its pledge to countries across the world. While pledging hundreds of millions of doses, it has only delivered a fraction.

Kremlin spokesman Dmitry Peskov has said demand for Sputnik V significantly exceeds Russia’s domestic production capacity.

To boost production, the Russian Direct Investment Fund, which bankrolled Sputnik V, has signed agreements with multiple drug makers in other countries, such as India, South Korea, Brazil, Serbia, Turkey, Italy and others. There are few indications, however, that manufacturers abroad, except for those in Belarus and Kazakhstan, have made any large amounts of the vaccine so far.

Airfinity, a London-based science analytics company, estimates Russia agreed to supply some 630 million doses of Sputnik V to over 100 countries, with only 11.5 million doses exported so far.

RDIF declined to disclose how many doses are going to other countries. Through April 27, less than 27 million two-dose sets of Sputnik V have been reportedly produced in Russia.

The Russian Direct Investment Fund, which has been in charge of international cooperation for Sputnik V, said in April it would produce 100 million doses in collaboration with Hualan Biological Bacterin Inc., in addition to an earlier deal announced in March for 60 million doses with Shenzhen Yuanxin Gene tech Co.

The two deals are in addition to a deal announced last November with Tibet Rhodiola Pharmaceutical Holding Co, which had paid $9 million to manufacture and sell the Sputnik V vaccine in China. RDIF said in April the terms of the deal were for 100 million doses with a subsidiary company belonging to Tibet Rhodiola.

Russia is “very ambitious and unlikely to meet their full targets,” said Rasmus Bech Hansen, founder and CEO of Airfinity. Working with China to produce Sputnik V could be a win-win situation for both Russia and China, he added.

In recent years, Chinese vaccine companies have turned from largely making products for use domestically to supplying the global market, with individual firms gaining WHO preapproval for specific vaccines — seen as a seal of quality. With the pandemic, Chinese vaccine companies have exported hundreds of millions of doses abroad.

Chinese vaccine makers have been quick to expand capacity and say they can meet China’s domestic need by the end of the year.

“This is an acknowledgment of the Chinese vaccine manufacturers who can produce at volume,” said Helen Chen, head of pharmaceuticals LEK Consulting, strategy consultancy firm in Shanghai, in an email.

However, none of the three Chinese companies have yet to start manufacturing Sputnik V.

Tibet Rhodiola started constructing a factory in Shanghai at the end of last year and expects production to start in September, the company said at an annual meeting for investors last month. Tibet Rhodiola’s chairman Chen Dalin also said that after the successful technology transfer, they will start with an order of 80 million doses to sell back to Russia. An employee at the company declined to transfer a phone call request to the company’s media department for comment.

The timeline for the newest deals are also unclear. Hualan Bio was among the 10 largest vaccines manufacturers in China in 2019. Phone calls to Hualan Bio went unanswered.

A spokeswoman for Shenzhen Yuanxing declined to say when the company will start production but said their order would not be for sale within China. RDIF had said the production will start this month.

In spite of the delays, Russia’s vaccine diplomacy has made gains.

From the outset, Russia, the first country to approve a coronavirus vaccine, aimed to distribute it globally. Within weeks of giving Sputnik V regulatory approval, RDIF started actively marketing it abroad, announcing multiple deals to supply the shot to other countries. It is so far winning the “public relations” battle, analysts said in a new report examining Russia and China’s vaccine diplomacy from the Economist Intelligence Unit.

“Russia has been able to build stronger diplomatic ties and in areas where it hasn’t been able to,” before, said Imogen Page-Jarrett, an analyst at EIU. “They have this window of opportunity while the US, E.U. and India are focusing on domestic and the rest of the world is crying out for a vaccine supply.”

https://apnews.com/article/middle-east-europe-russia-china-coronavirus-b041b3ad9d699de25a05c8f7ebcb4eb9

DermTech started at Buy by BTIG

 Target $53

https://finviz.com/quote.ashx?t=DMTK

Vaccines Being Wasted; Pfizer Will Send Smaller Shipments To Help

 Pfizer will begin distributing smaller packages of COVID-19 vaccine to states by the end of May to reduce potential waste. As public demand for vaccine teeters, health officials see smaller clinical settings as the next step in vaccinating Americans who haven’t sought out a shot already. 

https://khn.org/morning-breakout/vaccines-are-being-wasted-pfizer-will-send-smaller-shipments-to-help/

Biotechs mining gut microbiome to treat difficult diseases

 Poor germs. They just can’t catch a break.

Many people, not only germaphobes, spend lots of energy trying to avoid germs like, well, the plague.

I get it, but there’s a grand irony here, too. Because inside the body, trillions of various kinds of bacteria, yeast, fungi and viruses team up to form a germ squad that helps us fight everything from cancer, diabetes and heart disease to weight gain. The squad also improves our moods and brain power.


Gut network

I list and describe, below, key publicly traded companies in this niche.

Without this “microbiome” in our intestines and on our skin, we’d be far worse off. 

To understand what’s going on here, the key is to know that the small intestine is actually the biggest part of the immune system. Your gut plays a major role in helping your body fight diseases.

“Immune cells from the gut migrate to lymph nodes where they condition other important immune cells including T-cells,” explains Peter Attia, a medical doctor who does a regular podcast on the science of longevity. “These conditioned T-cells then travel throughout the body via the lymphatic system to impact disease.”

This network literally connects the gut to all organs and tissues.

You don’t need kombucha to make this happen. A varied diet provides the necessary probiotics (live microorganisms) and prebiotics (nondigestible foods that stimulate the microorganisms).

The problem is, antibiotics and infections can upset the balance or introduce malicious bacteria, creating health problems. This is called “dysbiosis.” Researchers are looking for ways to tweak the germ squad back into a healthy state to treat these diseases. Several companies are already proving they can do this, and they’re poised to deliver more evidence this year. The news will attract interest to the space, and probably move their stocks higher.

Key players

Welcome to the brave new world of microbiome companies developing bugs as drugs.

“We believe microbiome-based therapies are on the precipice of mainstream acceptance,” says Chris Howerton, the Jefferies analyst who covers this space.

This is a relatively new field. Until last year, the space had no major wins in clinical trials, and it still has no drug approvals. Now it could be on the cusp of a major turning point, which makes it a potentially interesting place for investors.

The big picture is that drugs from bugs may be developed to:

* Treat inflammation, including inflammatory bowel disease and ulcerative colitis in particular. Advances in therapies here could be the breakthrough that draws more big pharma interest and funding into the space.

* Treat neurological disorders including autism and Parkinson’s disease. “Gastro intestinal issues are a common but overlooked aspect of these diseases,” says Howerton.

* Fight the development of antibiotic-resistant bacteria. These nasty bugs could become a leading cause of death globally and even drag down gross domestic product (GDP) by 3% annually, says Howerton.

“The basic concept is that the more the bacteria are exposed to antibiotics, the higher the chances are that antibiotic resistant bacteria will multiply and go on to show very high levels of resistance,” he says.

Using the microbiome to treat infection reduces this likelihood.

Catalysts are on the way

In one of the first major breakthroughs in drugs from bugs space, Seres Therapeutics MCRB, -1.01% has recently made major strides toward marketing the first ever microbiome-based therapy. It’s for the superbug Clostridium difficile (C. diff), a life-threatening, antibiotic-resistant bacterial infection. Almost 10% of people over 65 with C. diff infection die within one month.

In Phase III trial results last year, Seres demonstrated that its SER-109 for C. diff works, and it updated results earlier this year. The funding should lead to approval by the Food and Drug Administration, says Howerton, possibly in two years. He predicts we may eventually see two or three microbiome-based therapeutics to treat C. diff on the market over the next few years, including possible therapies from Finch Therapeutics FNCH, -0.14% and Rebiotix, a private company.

After that, microbiome companies may advance therapies for ulcerative colitis and psoriasis. Seres and Evelo Biosciences  EVLO, -15.74% could post Phase II readouts on these two ailments, respectively, in mid-2021 and the third quarter.

Many other companies have late-stage Phase II and III studies on microbiome therapies, and several promising early-stage candidates. Before we get to a quick roundup, here are some of the challenges facing this space.

Here are some key obstacles:

Big pharma is not all in. Pfizer PFE, +2.68% has taken a stake in the privately held microbiome company Vedanta, but drugs from bugs still aren’t seeing much support from big pharma. Running successful trials is all well and good, but turning a therapy into a final product is another matter altogether. “This is a box yet to be checked,” says Howerton. “The true commercial opportunity for microbiome therapies is still unknown.” This is one reason why many large pharma players see the field as risky.

There is so much more to learn. Researchers know relatively little about what strains of microbes are linked to which diseases, or how different strains interact in the body once they’re shown to be effective in combination in the petri dish. “Our understanding of the microbiome is in its early days, particularly as it relates to more complex diseases,” says Howerton.

Microbiome therapies need to show they work better than traditional meds. The jury is still out on this. Without superior performance, doctors may favor existing therapies that come in the form of a pill. It would also help if drugs from bugs treat diseases with no available therapies, the holy grail of “unmet medical needs,” in biotech. So far, that’s not the case.

Microbiome stocks

Challenges aside, I expect several key data readouts from this group over the next 12 months could attract investor attention to the microbiome theme and these names.

Here’s a roundup of the key pure plays on drugs from bugs.

Seres Therapeutics has demonstrated an effective microbiome-based therapy against C. diff, in Phase III trials. It may be approved in 2023. The company also has Phase II trials testing a therapy for ulcerative colitis, and a possible metastatic melanoma cancer therapy in preclinical research.

Finch is a busted IPO that has completed a Phase II trial testing the use of a microbiome therapy code named CP101 against C. diff. It has ongoing preclinical studies on therapies for ulcerative colitis, Crohn’s disease, autism, hepatitis B and oncology. The company has a partnership with Takeda Pharmaceutical TKPHF, +0.32%.

Evelo Biosciences has possible Covid-19 therapies in Phase II and III trials. It has a therapy for psoriasis in Phase II trials, possible treatments for atopic dermatitis (eczema) in Phase I trials, and therapies for cancer, inflammation and metabolic disorders in preclinical studies.

BiomX PHGE, -2.02% thinks it can deploy viruses in the body to target and remove bad bacteria. The viruses,, called phages, are safe and can be effective. The company has possible therapies for acne in Phase II trials. It is testing treatments for inflammatory bowel disease in Phase I trials. It’s doing preclinical research on treatments for eczema, cystic fibrosis and colorectal cancer. BiomX has a partnership with Johnson & Johnson JNJ, +1.42%, and it may partner with cosmetic companies.

Synlogic SYBX, +0.86% uses genetically engineered bacteria to develop microbiome therapies that work by doing things like degrading harmful proteins. It has possible therapies for cancer and the metabolic disorders phenylketonuria and enteric hyperoxaluria in Phase I and II trials. It’s doing preclinical research on cures for inflammation and metabolic disorders.

Kaleido Biosciences KLDO, -5.45% thinks it can improve the microbiome by tweaking how various bacteria behave, rather than introducing new bacteria into the gut. It has possible therapies for Covid-19, inflammatory bowel disease, urea cycle disorders that affect how the body removes waste, and hepatic encephalopathy, a decline in brain function caused by liver disease.

https://www.marketwatch.com/story/biotech-companies-are-trying-to-solve-stubborn-illnesses-using-drugs-from-bugs-11619793684

Schools spend millions on air purifiers, amid warnings of overblown claims, harm to kids

 Last summer, Global Plasma Solutions wanted to test whether the company’s air-purifying devices could kill COVID-19 virus particles but could find only a lab using a chamber the size of a shoebox for its trials. In the company-funded study (PDF), the virus was blasted with 27,000 ions per cubic centimeter.

In September, the company’s founder incidentally mentioned that the devices being offered for sale actually deliver a lot less ion power—13 times less—into a full-sized room.

The company nonetheless used the shoebox results—over 99% viral reduction—in marketing its device heavily to schools as something that could combat COVID in classrooms far, far larger than a shoebox.

School officials desperate to calm worried parents bought these devices and others with a flood of federal funds, installing them in more than 2,000 schools across 44 states, a KHN investigation found. They use the same technology—ionization, plasma and dry hydrogen peroxide—that the Lancet COVID-19 Commission (PDF) recently deemed “often unproven” and potential sources of pollution themselves.

In the frenzy, schools are buying technology that academic air-quality experts warn can lull them into a false sense of security or even potentially harm kids. And schools often overlook the fact that their trusted contractors—typically engineering, HVAC or consulting firms—stand to earn big money from the deals, KHN found.

Academic experts are encouraging schools to pump in more fresh air and use tried-and-true filters, like HEPA, to capture the virus. Yet every ion- or hydroxyl-blasting air purifier sale strengthens a firm’s next pitch: The device is doing a great job in the neighboring town.

“It’s a self-fulfilling prophecy. The more people buy these technologies, the more they get legitimacy,” said Jeffrey Siegel, a civil engineering professor at the University of Toronto. “It’s really the complete Wild West out there.”

Marwa Zaatari, a member of the American Society of Heating, Refrigerating and Air-Conditioning Engineers’ (ASHRAE's) Epidemic Task Force, first compiled a list of schools and districts using such devices.

Schools have been “bombarded with persistent salespersons peddling the latest air and cleaning technologies, including those with minimal evidence to-date supporting safety and efficacy” according to a report released Thursday by the Center for Green Schools and ASHRAE.

Zaatari said she was particularly concerned that officials in New Jersey are buying thousands of devices made by another company that says they emit ozone, which can exacerbate asthma and harm developing lungs, according to decades of research.

“We’re going to live in a world where the air quality in schools is worse after the pandemic, after all of this money,” Zaatari said. “It’s really sickening.”

The sales race is fueled by roughly $193 billion in federal funds allocated to schools for teacher pay and safety upgrades—a giant fund that can be used to buy air cleaners. And Democrats are pushing for $100 billion more that could also be spent on air cleaners.

In April, Global Plasma Solutions said further tests show its devices inactivate (PDF) COVID in the air and on surfaces in larger chambers. The company studies still use about twice the level (PDF) of ions than its leaders have publicly said the devices can deliver, KHN found.

There is virtually no federal oversight or enforcement of safe air-cleaning technology. Only California bans air cleaners that emit a certain amount of ozone.

U.S. Rep. Robert “Bobby” Scott, D-Virginia, chair of the education and labor committee, said the federal government typically is not involved in local decisions of what products to buy, although he hopes for more federal guidance.

In the meantime, “these school systems are dealing with contractors providing all kinds of services,” he said, “so you just have to trust them to get the best expert advice on what to do.”

These go-between contractors—and the air cleaner companies themselves—have a stake in the sales. While their names might appear in school board records, their role in selling the device or commission from the deal is seldom made public, KHN found.

A LinkedIn job ad with the logo for one air purifier company, ActivePure Technology, which employs former Trump adviser Deborah Birx, M.D., as its chief medical and science adviser, recruited salespeople this way: “Make Tons of Money with this COVID-killing Technology!!” The commission, the post said, is up to $900 per device.

“We have reps [who] made over 6-figures in 1 month selling to 1 school district,” the ad says. “This could be the biggest opportunity you have seen!”

'A tiny bit of ozone'

Schools in New Jersey have a particularly easy time buying air cleaners called Odorox: A state education agency lists them on their group-purchasing commodity list, with a large unit selling for more than $5,100. Originally used in home restoration and mold remediation, the devices have become popular in New Jersey schools as the company says its products can inactivate COVID (PDF).

In Newark, administrators welcomed students back to class last month with more than 3,200 Odorox units, purchased with $7.5 million in federal funds, said Steven Morlino, executive director of Facilities Management for Newark Public Schools.

“I think parents feel pretty comfortable that their children are going to a safe environment,” he said. “And so did the staff.”

Environmental health and air-quality experts, though, are alarmed by the district’s plan.

The Pyure company’s Odorox devices are on California air-quality regulators’ list of “potentially hazardous ozone generators sold as air purifiers” and cannot be sold in the state.

The company’s own research shows that its Boss XL3 device pumps out as much as 77 parts per billion of ozone, a level that exceeds limits set by California lawmakers for the sale of indoor air cleaners and the EPA standard for ground-level ozone—a limit set to protect children from the well-documented harm of ozone to developing lungs.

That level exceeds the industry’s self-imposed limit by more than 10 times and is “unacceptable,” according to William Bahnfleth, an architectural engineering professor at Penn State who studies indoor air quality and leads the ASHRAE Epidemic Task Force.

Jean-Francois “JF” Huc, CEO of the Pyure company, pointed out that the company’s study was done in a space smaller than they would recommend for such a powerful Odorox device. He cautioned that it was done that way to prove that home-restoration workers could be in the room with the device without violating work-safety rules.

“We provide very stringent operating guidelines around the size of room that our different devices should be put in,” he said. But school staffers are often not warned about the problems they could face if a too-powerful device is used in a too-small room, he acknowledged.

You can’t see or smell ozone, but lungs treat it like a “foreign invader,” said Michael Jerrett, who has studied its health effects as director of the UCLA Center for Occupational and Environmental Health.

Lung cells mount an immune-like response, which can trigger asthma complications and divert energy from normal lung function, he said. Chronic exposure has been linked to more emergency room visits and can even cause premature death. Once harmed, Jerrett said, children’s lungs may not regain full function.

“Ozone is a very serious public health problem,” Jerrett said.

Newark has some of the highest childhood asthma rates in the state, affecting 1 in 4 kids. Scholars have linked outdoor ozone levels in Newark to elevated childhood ER visits and asthma is the leading cause of school absenteeism there.

Adding ozone into the classroom is “just nightmarish,” Siegel, of the University of Toronto, said.

Morlino said the district plans to monitor ozone levels in each classroom, based on the federal Occupational Safety and Health Administration level for working adults, which is 100 parts per billion.

“In our research of the product,” he said, “we’ve determined it’s within the guidelines the federal government produces.”

While legal for healthy working adults, the work-safety standard should not apply to developing children, said Michael Kleinman, an air-quality researcher at the UC Irvine School of Medicine. “It’s not a good device to be using in the presence of children,” he said.

But the devices are going into schools throughout the state that will not be monitoring ozone levels, acknowledged Dave Matisoff, owner of Bio-Shine, a New Jersey-based distributor of Odorox. He said the main safeguard is informing schools about the appropriate-size room each device should be deployed to, a factor in ozone concentration.

Huc, the CEO, said his team has measured levels of ozone that are higher outdoors in Newark than inside—with his company’s units running.

“There is a tiny bit of ozone that is introduced, but it’s very, very low,” he said. “And you get the benefit of the antimicrobial effect, you get the benefit of reduction of pathogens, which we’ve demonstrated in a number of studies, and you get the reduction of VOC [volatile organic compounds].”

Meanwhile, despite expert concerns, the devices continue to pop up in classrooms and school nurses’ offices across the state, said Allen Barkkume, an industrial hygienist for the New Jersey teachers union.

He doesn’t blame schools for buying them, as they’re a lot less expensive than overhauling ventilation systems. Teachers often push for the devices in their classrooms, he said, as they see them in the nurses’ offices and think it’ll keep them safe. And superintendents are not well-versed in air quality’s complex scientific concepts.

“Nothing sounds better than something that’s cheap, quiet, small and easy to find, and we can stick them in every classroom,” Barkkume said.

Tested in shoebox, sold for classrooms

While New York officials are “not permitting” (PDF) the installation of ionization devices due to “potential negative health effects,” schools across the state of New Jersey are installing ionizing devices.

Ten miles away from Newark in Montclair, New Jersey, parents have been raising hell over the new Global Plasma Solutions’ ionizing devices in their children’s classrooms. The company website promises a product that emits ions like those “created with energy from rushing water, crashing waves and even sunlight.”

The devices emit positive and negative ions that are meant to help particles clump together, making them easier to filter out. The company says the ions can also reduce the viral particles that cause COVID-19.

But Justin Klabin, a building developer with a background in indoor air quality and two sons in the district, was not convinced.

He spent hours compiling scientific evidence. He created painstaking YouTube videos picking apart the ionizers’ viability and helped organize a petition signed by dozens of parents warning the school board against the installation.

Even so, the district spent $635,900 on installing ionizers, which would go in classrooms serving more than 6,000 kids. The devices are often installed in ducts, an important consideration, the company founder Charles Waddell said, because the ions that are emitted lose their power after 60 seconds.

But the company’s shoebox study and inflated ion blast numbers that helped sell the product last year leave a potential customer with little sense of how the device would perform in a classroom, Zaatari said.

“It’s a high cost for nothing,” Zaatari said. The company has sued her and another air-quality consultant for criticizing their devices. Of the pending case, Zaatari said it is a David-versus-Goliath situation, but she will not be deterred from speaking on behalf of children.

“Size of the [test] chamber has proved not to play a role in efficacy results but rather ion density,” GPS spokesperson Kevin Boyle said in an email. The company notes by its COVID-inactivating test results that they “may include … higher-than-average ion concentrations.”

He also said the company is proud to meet the ASHRAE “zero ozone” certification.

Glenn Morrison, a professor of environmental science and engineering at the University of North Carolina, reviewed a March GPS study on a device combating the COVID virus in the air. The device appears to reduce virus concentrations, he said in an email, but noted it would not be very effective under normal building conditions, outside a test chamber. “A cheap portable HEPA filter would work many times better and have fewer side effects (possibly ozone or other unwanted chemistry),” he wrote.

Other parents joined Klabin’s campaign, including Melanie Robbins, the mom of a kindergartner and a child in pre-K. Armed with her background in nonprofit advocacy, she reached out to experts. She and other parents spoke at local government meetings about their concerns.

In April, the superintendent told parents the school would turn off the devices, but parents say they haven’t turned them all off.

“As far as I understand, the district has relied only on information from GPS, the manufacturer,” Robbins said during a Montclair Board of Education meeting via Zoom on April 19. “This is like only listening to advice from Philip Morris as to whether smoking is safe or not.”

Dan Daniello, of D&B Building Solutions, an HVAC contracting company, defended GPS products during the meeting. He said they are even in the White House, a selling point the company has made repeatedly.

The catch: A GPS contractor installed its ionization technology in the East Wing of the White House after it was purchased in 2018—before COVID emerged, according to GPS’ Boyle. But the company was still using the White House logo as a marketing image on its website when KHN asked the White House about the advertising in April. It was taken down shortly thereafter.

Boyle said GPS was “recently informed that the White House logo may not be used for marketing purposes, and promptly complied.”

The Montclair school district did not respond to requests for comment.

“I want to bang my head against the wall, it’s so black-and-white,” Robbins said. “Admit this is a poor purchase, the district got played.”

Selling 'the Big Kahuna'

Academic air-quality experts agree on what’s best for schools: More outside air pumped into classes, MERV 13 filters in heating systems and portable HEPA filters. The solution is time-tested and effective, they say. Yet as common commodities, like a pair of khaki pants, these items are not widely flogged by a sales force chasing big commissions.

After COVID hit, Tony Barron said the companies pitched air purifying technology nonstop to the Kansas district where he worked as a facility manager last fall.

Pressure came from inside the school as well. Teachers sent links for air cleaners they saw on the news. His superintendent had him meet with a friend who sold ionization products. He got constant calls, mail and email from mechanical engineering companies.

The hundreds of phone calls from air cleaner pitches were overwhelming, said Chris Crockett, director of facilities for Turner USD 202 in Kansas City, Kansas. While he wanted to trust the contractors he had worked with, he tested four products before deciding to spend several hundred thousands of dollars.

“Custodial supply companies see the writing on the wall, that there’s a lot of money out there,” he said. “And then a lot of money is going to be spent on HVAC systems.”

ActivePure says on its website that its air purifiers are in hundreds of schools. In a press release, the company said they were “sold through a nationwide network of several hundred franchises, 5,000 general contractors/HVAC specialists and thousands of individual distributors.”

Enviro Technology Pros, founded in January, is one company pitching ActivePure to HVAC contractors. In a YouTube video, the founders said contractors can make $950 for each air-cleaning device sold, and some dealers can make up to $30,000 a month. Citing the bounty of the billions in federal relief, another video touted ready-made campaigns to target school principals directly.

After KHN asked ActivePure for comment, the Enviro Technology Pros YouTube videos about ActivePure were no longer accessible publicly.

ActivePure did not respond to requests for comment but has said its devices are effective and one is validated by the Food and Drug Administration.

An Enviro Technology Pros founder, Rod Norman, told KHN the company was asked to take the posts down by Vollara, a company related to ActivePure. He called sales to schools “the big kahuna.”

Shortly after he spoke with KHN, the website for his own company was taken down.

In an Instagram post that also disappeared, the company had asked: “4000 classrooms protected why not your kids?”

https://www.fiercebiotech.com/medtech/as-schools-spend-millions-air-purifiers-experts-warn-overblown-claims-and-harm-to-children