Texas startup’s at-home COVID-19 test finally approved by feds

CORONAVIRUS RESPONSE

The at-home COVID-19 tests are now available. EverlyWell/Facebook

After its earlier effort was tripped up, Austin-based startup Everlywell on May 16 finally gained approval from the U.S. Food and Drug Administration to launch its at-home coronavirus test.

In a May 18 release, Everlywell says the self-administered test will be available later this month. The company, which specializes in at-home tests for an array of conditions, is the first to receive approval from the FDA for an at-home coronavirus test that's not associated with a lab or a manufacturer of diagnostic products.

The FDA's emergency authorization allows Everlywell to work with a number of certified labs that process authorized tests, rather than just a single lab.

"The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, says in a release.

Everlywell's at­-home test determines the presence or absence of the novel coronavirus, which causes COVID­-19 illness. Everlywell's test kit uses a short nasal swab and includes:

  • A digital screening questionnaire reviewed by a healthcare provider.
  • Instructions on how to ship the test sample to a lab.
  • Digital results within 48 hours of the sample being received by the lab.
  • Results reviewed by an independent physician.

Anyone who tests positive test will receive a telehealth consultation. All positive test results are reported to federal and local public health agencies when mandated.

On March 23, Everlywell was supposed to start shipping 30,000 coronavirus test kits to U.S. consumers. But before a single test was sent, the FDA blocked distribution of at-home, self-administered tests from Everlywell and other companies. After that, Everlywell pivoted to supplying coronavirus tests to health care providers and organizations.

As with the company's previously approved coronavirus test, Everlywell says its test for individuals is sold at no profit. The $109 price covers costs such as overnight shipping to a lab, lab-processing fees, and kit components. Some health insurers cover coronavirus tests.

Everlywell says it's working with members of Congress to enable companies that are neither healthcare providers nor labs to be directly reimbursed by health insurers. The startup also is exploring how its coronavirus test could be made available for free.

"Widespread access to convenient testing will play a crucial role in the country's ability to address the pandemic and prevent overburdening our healthcare facilities. As the national leader in connecting people with high­-quality laboratory testing, we are committed to fighting the spread of this virus in America," Julia Cheek, founder and CEO of Everlywell, says in the Everlywell release.

The company continues to supply its coronavirus tests to qualified healthcare organizations and government agencies.

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This article originally ran on CultureMap.
The results are in for Houston-based Saranas' clinical trials. Courtesy of Saranas

Houston early bleeding detection device company reveals results of its clinical trials

blood tests

A Houston-based startup is closer to taking flight with a medical device designed to catch bleeding complications during medical procedures that involve blood vessels.

On May 22, researchers presented the results of a study showing the Early Bird Bleed Monitoring System from Houston-based Saranas Inc. detected various levels of bleeding in 63 percent of the patients who underwent endovascular procedures. These procedures treat problems, such as aortic aneurysms, that affect blood vessels.

No troubles were reported with the Early Bird device during the clinical trial, the researchers say.

Before this study, the Early Bird device hadn't been tested in humans. In all, 60 patients in five states participated in the clinical trial, which ran from August to December last year. Findings of the study were unveiled at the Society for Cardiovascular Angiography Interventions 2019 Scientific Sessions in Las Vegas.

The study's authors say they plan to continue evaluating the device at medical institutions that want to better manage bleeding during endovascular procedures.

"This is the first time we're seeing how this device could help in a real-world patient setting, and we were very encouraged by the results. Right now, patients have a risk of vessel injury when undergoing endovascular procedures where the femoral artery or vein is used for vascular access," Dr. Philippe Genereux, principal investigator for the study and a cardiologist at Morristown Medical Center in Morristown, New Jersey, says in a news release.

"This technology allows us to detect bleeding in real-time," Genereux adds, "which means we can take action quickly and improve the outcomes of the procedure and recovery for the patient."

In March, the Early Bird device — invented at Houston's Texas Heart Institute — received the U.S. Food and Drug Administration's approval as a "novel" medical device.

Saranas says Early Bird is the first and only device of its type. The FDA approval and the promising results of the clinical trial pave the way for the eventual launch of the device into the healthcare market.

A forecast from professional services firm KPMG predicts the global market for medical devices will reach nearly $800 billion by 2030. Early Bird aims to capture a sliver of that market by addressing an expensive and potentially fatal problem. One-fifth of patients experience bleeding complications during large-bore endovascular procedures. Research shows these complications are associated with a greater risk of death, longer hospital stays, and higher healthcare costs.

The Early Bird device is meant to decrease those complications by quickly alerting medical professionals to signs of bleeding during endovascular procedures.

As explained by the Texas Heart Institute, the Early Bird employs a sheath — a plastic tube that helps keep arteries and vessels open — embedded with sensors that measure the electrical resistance across a blood vessel. When the Early Bird senses a change in the electrical resistance, medical professionals receive audible and visual notifications about potential internal bleeding. If detected early, this bleeding can be minimized.

Altogether, Saranas has raised $12 million from investors, including a $2.8 million round in May 2018. The company was founded in 2013.

"What attracted me to Saranas is that our solution has the potential to meaningfully reduce serious bleeding complications that worsen clinical outcomes and drive up healthcare costs," says Zaffer Syed, who joined the startup as president and CEO in 2017. "In addition, our device may support access of important minimally invasive cardiac procedures by allowing them to be performed more safely."
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Houston startup uses AI and data to predict energy usage across sectors

crystal ball

Among the many complications presented by the coronavirus pandemic is coping with power needs. Movie theaters, malls, schools, and stadiums are among the places where energy use has been uneven at best. And the unevenness promises to continue as a lot of locations turn the lights back on but their operating hours remain in flux.

Houston-based Adapt2 Solutions Inc. believes its software can help energy companies power their way through the pandemic-driven haziness of power demand from commercial and residential customers.

"Today's energy companies need the speed and flexibility that cloud-native technology provides to fully leverage the massive amounts of data available to them," Jason Kram, executive vice president of Adapt2 Solutions, said in a December 2019 release.

Kram says that by capitalizing on artificial intelligence, machine learning, and cloud computing, his company's predictive analytics models forecast unexpected fluctuations in power capacity. Amid the pandemic, this technology enables energy companies to map out demand at a time when they're balancing strained revenue and squeezed spending is paramount, according to Kram.

Armed with this forecast data, Adapt2 Solutions' customers — including utility companies, energy traders, and power generators — can more easily plot power production, sales, and purchases, Kram tells InnovationMap. This data can be applied to conventional power, renewable energy, and battery-stored power.

"In times of disruption, big data can inform decision-making for energy companies to optimize energy-market operations with timely and reliable data," Kram says.

Adapt2 Solutions' load forecasting feature generates the predictive analytics models. This feature is embedded within the company's Adapt2 Bid-to-Bill flagship product, which helps energy companies manage front-office and back-office operations. Its other products are Adapt2 Green, designed for the renewable energy market, and Adapt2 Trade-to-Tag, aimed at improving management of energy trades.

"With Adapt2's AI-enabled solutions, we strive to help more customers focus on their core operations and bring business units together on a single platform to create an integrated approach," Kram says.

The company's customers include Consolidated Edison Inc. (ConEd), Duke Energy Corp., the East Kentucky Electric Cooperative, Exelon Corp., Invenergy LLC, Sempra Energy, the Tri-State Generation and Transmission Association, Tyr Energy LLC, and Vistra Energy Corp.

Adapt2 Solutions employs about 40 people, Kram says, and plans to grow its revenue and headcount by 25 percent to 40 percent this year. He says Adapt2 Solutions has managed to turn a profit even though it hasn't taken any outside funding since Francisco Diaz founded the company in 2008.

In March, Inc. magazine placed Adapt2 Solutions at No. 222 on its inaugural list of the fastest-growing private companies in Texas. The company's revenue shot up 72 percent from 2016 to 2018.

"The growth in our business reflects a growth in our customers' business, further validating that we have taken the right steps to help energy enterprises better respond to market and technology changes," Diaz said in a March release.


Jason Kram is the executive vice president of Adapt2 Solutions. Photo courtesy of Adapt2 Solutions

Here's what challenges — and opportunities — Houston startups are facing amid COVID-19

Houston voices

There are startups struggling to keep their heads above the deluge of a pandemic-induced depression.

Between 2016 and 2018, the global startup economy generated over $3 trillion — a far cry from today's economic value. Today, startups struggle to keep operations running during the pandemic. Web companies throughout Europe have lost close to 400 billion euros during the coronavirus pandemic. Chinese venture capital investing has dipped 50 percent compared to everyone else.

"Startups that are supported by venture capital funds are merely a small part of the startup ecosystem. Startups that don't have venture capital funding, which is the majority of them, stand to lose substantial money during this pandemic-caused shutdown," says Dane Stangler, a business writer for Forbes.

"All across the country, there are startups that, while they may not have hefty venture capital funding, are still significant to the ecosystem because of their job creation," he continues.

These startups face serious setbacks and are expected to see a giant decline of growth during this pandemic. Small businesses are already in a bind because of forced closures and rapidly waning sales.

Far-reaching effects

Startups supported by venture capital have far-reaching effects on the rest of the economy. These high-tech companies generate up to five jobs for every one job they directly create.

"That means that the inevitable economic bodyslam they're about to receive or have already received will be felt by almost every other facet of the job market," explains Stangler.

According to the Startup Genome report, the pandemic will damage startups that were in the process of raising capital and will likely kill the majority of them.

What can be done?

"Federal emergency support for small businesses is certainly the right play here. The deli down the street, the local mechanic, the mom and pop burger joint; they all need help right now," Stangler says.

Tech and science startups need help too — and many of which were in the middle of getting off the ground when the corona crisis crashed the economy.

"Pumping money into them right now is the best thing that can be done to help them in the now."

The low-interest rate climate that has helped boost venture funds has also pushed many startups to survive on debt. We'll have to come to terms with this for now.

"Market momentum isn't necessarily ideal for the time being. Moreover, the "reallocation" forces that you hear entrepreneurs mention a lot has been kiboshed for now," explains Stangler.

Startups struggling to put the pieces of their company back together might see a glimmer of hope on the horizon, though.

Hope is on the horizon

Recessions breed good businesses. Don't believe me? According to the Startup Genome report, over 50 billion dollar tech startups were created during the recession of 2007 to 2009. Fun fact: more than 50 percent of the companies on the Fortune 500 list to date were founded during a recession.

Sure, startups struggling during a national pandemic can paint a demoralizing picture. But there might be some good news peaking through the dark clouds. It's clear that venture capital funding is at a standstill right now. But it could mean that more startups will get funded when things return to somewhat-normal.

The Startup Genome report shows us that during the 2001 and 2009 recessions, the number of companies that were funded by venture capitalists exploded and fast. For example, in the four years after the 2009 recession, the number of venture capital deals spiked by 25 percent every year.

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This article originally appeared on the University of Houston's The Big Idea.

Rene Cantu, the author of this piece, is the writer and editor at UH Division of Research.

Houston accelerator leader shares how the cohort has seen success through virtual programming

HOUSTON INNOVATORS PODCAST EPISODE 34

In January, when Eléonore Cluzel was named the director of gBETA Houston, she had no clue Houston's first cohort of the international, early-stage accelerator would be conducted virtually. Now, five weeks in, the program and its five startups have adapted to provide programming and mentorship online only.

"Going virtual was a really good pivot on our end. I think that the cohort has adjusted very well," Cluzel says on the Houston Innovators Podcast. "It is tough. They put tremendous effort into it and I'm proud to be working with them."

Last week, gBETA Houston announced the five companies currently in the program. And, Cluzel is already excited about the second cohort, which opens applications after the first cohort's virtual pitch night on June 18. Cluzel says in light of how many applications she got for the first time around, she knows there's a lot of impact gBETA can make in Houston,

"I was really quite surprised — in a good way — how the first application round was really competitive," Cluzel says, "which shows that there is a lot of room to grow for accelerators in town."

Cluzel shares some of the challenges and opportunities gBETA Houston has seen throughout this time, and introduces each of the companies in the cohort, which represents sports tech, consumer tech, and more. Listen to the full interview with Cluzel below — or wherever you get your podcasts — and subscribe for weekly episodes.

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