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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Nearly half of Houston workers complain of serious burnout, says new report

working hard

Local workers who're especially dreading that commute or cracking open the laptop in the morning aren't alone. A new study reveals that nearly half of Houston laborers are more burned out on the job.

Some 49 percent of Bayou City residents report to be burned out at work, according to employment industry website Robert Half. That's significantly higher than last year, when only 37 percent reported burnout in a similar poll.

Meanwhile, more than one in four Houston workers (28 percent) say that they will not unplug from work when taking time off this summer.

Not surprisingly, American workers are ready for a vacation. Per a press release, the research also reveals:

  • One in four workers lost or gave up paid time off in 2020
  • One in three plans to take more than three weeks of vacation time this year

Elsewhere in Texas, the burnout is real. In Dallas, 50 percent of workers report serious burnout. More than a quarter — 26 percent — of Dallasites fear they won't disconnect from the office during summer vacation.

In fun-filled Austin, 45 percent of the workforce complain of burnout. Some 32 percent of Austinites feel they can unplug from work during the summer.

Fortunately for us, the most burned-out city in the U.S. isn't in the Lone Star State. That dubious title goes to the poor city of Charlotte, North Carolina, where 55 percent of laborers are truly worn out.

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This article originally ran on CultureMap.

Houston small biz tech platform raises $21M series B

money moves

A tech company focused on supporting and growing startups and small businesses has reached its own next big growth milestone this week.

Machine learning-enabled small business support company Hello Alice, founded in Houston with a large presence in California, has closed its $21 million series B raise led by Virginia-based QED Investors with participation from new investors including Backstage Capital, Green Book Ventures, Harbert Growth Partners, and How Women Invest.

The raise comes at a pivotal time for the company, which worked hard during the pandemic to support struggling business and now aims to support entrepreneurs of all backgrounds as the world re-emerges out of the COVID-19 era. The fresh funds, according to a press release, will be used to refine the predictive capabilities on its platform, launch a mobile application, and more.

"These investments signal that despite the recent challenges small business owners have faced, there is an economic tidal wave that will revitalize Main Street, led by the entrepreneurs we serve," says Elizabeth Gore, co-founder and president of Hello Alice, in the release.

Since April 2020, Hello Alice has granted over $20 million in emergency funds and resources for small business owners affected by the pandemic. According to the release, the largest percentage of those grants went to "New Majority owners," especially people of color and women. Additionally, the company has reportedly experienced 1,100 percent growth and has expanded to support 500,000 small business owners weekly, with an increased revenue of more than 600 percent through its SaaS platform.

"We are thrilled to have a cap table as diverse as the business owners we serve," says Carolyn Rodz, co-founder and CEO of Hello Alice, in the release. "Our investors are leaders from the Black, Hispanic, LGBTQ+, Women, and US Veteran communities. As a Latina founder and fellow small business owner, I want to ensure that as our company grows, we are fueling future diversity in capital and breaking through ceilings for the benefit of our community."

According to a recent report Hello Alice produced in partnership with GGV Capital, now is the time to support small businesses. The report found that 83 percent of owners surveyed (which included 97,739 founders operating in all 50 states) believe their business will perform better in 2021 than in 2020. Most of the founders — 93 percent — plan to hire this year compared to the almost half — 45 percent — that laid off employees in 2020. Additionally, founders have an increased focus on tech — 75 percent said they are going to spend more on tech this year compared to last.

"Small business owners are the backbone of the U.S. economy, but many fail before they've had an opportunity to meaningfully serve the community in which they're based," says Frank Rotman, QED Investors Founding Partner, in the release. "Access to both capital and business expertise remain the biggest obstacles for SMBs, challenges heightened for women- and minority-owned businesses.

"Traditionally, corporations and government grants want to engage and support, but there hasn't been a source of truth on who can qualify for their diversity grants, funds and programs," he continues. "Hello Alice solves this problem, building tools that empower the new majority and enabling corporations and governments to support SMBs. Founders Carolyn and Elizabeth and the entire Hello Alice team are having a real, tangible impact on the ecosystem. We are incredibly excited to help them help others."

3 Houston innovators to know this week

who's who

Editor's note: In this week's roundup of Houston innovators to know, I'm introducing you to two local innovators, as well as one honorary Houstonian, across industries — energy, manufacturing, and more — recently making headlines in Houston innovation.

Juliana Garaizar, head of Greentown Houston and vice president of Greentown Labs

Juliana Garaizar is transitioning her role at Greentown Houston. Courtesy photo

Juliana Garaizar has a new role within Greentown Labs. She's lead the local team as launch director, and now is taking a new role now that Greentown Houston has opened its doors. Garaizar recently discussed with InnovationMap why now is the perfect time for Greentown to premiere in Houston.

"I think that if Greentown had happened one year before or even one year later, it wouldn't be the right time. I really believe that our main partners are transitioning themselves — Shell, Chevron, and many others are announcing how they are transitioning," she says. "And now they look at Greentown as an execution partner more than anything. Before, it was a nice initiative for them to get involved in. Now, they are really thinking about us much more strategically." Click here to read more.

Misha Govshteyn, CEO of MacroFab

Misha Govshteyn joins the Houston Innovators Podcast to discuss the evolving electronics manufacturing industry. Photo courtesy of MacroFab

Electronics manufacturer and MacroFab, run by CEO Misha Govshteyn, much like the rest of the business world, was not immune to the effects of the pandemic. But as some business returned last summer, Govshteyn says MacroFab bounced back in a big way.

"In a lot of ways, the concepts we've been talking about actually crystalized during the pandemic. For a lot of people, it was theoretically that supply chain resiliency is important," Govshteyn says on this week's episode of the Houston Innovators Podcast. "Single sourcing from a country halfway around the world might not be the best solution. ... When you have all your eggs in one basket, sooner or later you're going to have a break in your supply chain. And we've seen nothing but breaks in supply chains for the last five years." Click here to read more.

Kerri Smith, interim executive director of the Rice Alliance Clean Energy Accelerator

A new clean energy accelerator has announced its first cohort. Photo via rice.edu

The Rice Alliance Clean Energy Accelerator, a 12-week program that will prepare startups to grow their business, connect them with strategic partners and mentors, launch pilots, and fundraise, has named its inaugural cohort.

"We were impressed with the quality, potential and range of clean energy solutions being commercialized by our applicant pool and took great care in assessing their potential as well as our ability to meet their identified needs," says Kerri Smith, the accelerator's interim executive director. "The selection process was very competitive. We had a difficult time paring down the applications but are looking forward to working with our first class of 12." Click here to read more.

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