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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These are the 10 most promising energy tech startups, according to judges at Rice Alliance forum

best of the best

This week, energy startups pitched virtually for venture capitalists — as well as over 1,000 attendees — as a part of Rice Alliance for Technology and Entrepreneurship's 18th annual Energy and Clean Tech Venture Forum.

At the close of the three-day event, Rice Alliance announced its 10 most-promising energy tech companies. Here's which companies stood out from the rest.

W7energy

Based in Delaware, W7energy has created a zero-emission fuel cell electric vehicle technology supported by PiperION polymers. The startup's founders aim to provide a more reliable green energy that is 33 percent cheaper to make.

"With ion exchange polymer, we can achieve high ionic conductivity while maintaining mechanical strength," the company's website reads. "Because of the platform nature of the chemistry, the chemical and physical properties of the polymer membranes can be tuned to the desired application."

Modumetal

Modumetal, which has its HQ in Washington and an office locally as well, is a nanotechnology company focused on improving industrial materials. The company was founded in 2006 by Christina Lomasney and John Whitaker and developed a patented electrochemical process to produce nanolaminated metal alloys, according to Modumetal's website.

Tri-D Dynamics

San Francisco-based Tri-D Dynamics has developed a suite of smart metal products. The company's Bytepipe product claims to be the world's first smart casing that can collect key information — such as leak detection, temperatures, and diagnostic indicators — from underground and deliver it to workers.

SeekOps

A drone company based in Austin, SeekOps can quickly retrieve and deliver emissions data for its clients with its advance sensor technology. The company, founded in 2017, uses its drone and sensor pairing can help reduce emissions at a low cost.

Akselos

Switzerland-based Akselos has been using digital twin technology since its founding in 2012 to help energy companies analyze their optimization within their infrastructure.

Osperity

Osperity, based in Houston's Galleria area, is a software company that uses artificial intelligence to analyze and monitor industrial operations to translate the observations into strategic intelligence. The technology allows for cost-effective remote monitoring for its clients.

DroneDeploy

DroneDeploy — based in San Francisco and founded in 2013 — has raised over $92 million (according to Crunchbase) for its cloud-based drone mapping and analytics platform. According to the website, DroneDeploy has over 5,000 clients worldwide across oil and gas, construction, and other industries.

HEBI Robotics

Pittsburgh-based HEBI Robotics gives its clients the tools to build custom robotics. Founded 2014, HEBI has clients — such as NASA, Siemens, Ericsson — across industries.

CarbonFree Chemicals

CarbonFree Chemicals, based in San Antonio and founded in 2016, has created a technology to turn carbon emissions to useable solid carbonates.

SensorUp

Canadian Internet of Things company, SensorUp Inc. is a location intelligence platform founded in 2011. The technology specializes in real-time analysis of industrial operations.

"Whether you are working with legacy systems or new sensors, we provide an innovative platform that brings your IoT together for automated operations and processes," the company's website reads.

Amazon unlocks 2 prime brick-and-mortar stores in the Houston area

THAT'S SOME PRIME SHOPPING

The juggernaut that is Amazon considers to rule the universe and expand. Now, local fans of Jeff Bezos' digital behemoth can look forward to two new brick-and-mortar stores in the Houston area.

Amazon announced the opening of two Houston stores on September 18: Amazon 4-star in The Woodlands Mall and Amazon Books in Baybrook Mall.

For the uninitiated, the Amazon 4-star is a new store that carries highly rated products from the top categories across all of Amazon.com — including devices, consumer electronics, kitchen, home, toys, books, games, and more.

As the name implies, all products are rated four stars and above by Amazon customers. Other determinants include the item being a top seller, or if it is new and trending on Amazon.com, according to a press release.

Shoppers can expect fun features such as "Bring Your Own Pumpkin Spice," "Stay Connected Home Tech for Work and Play," "Fresh Off the Screen," and "Trending Around Houston" to discover must-have products. The Woodlands Amazon 4-star (1201 Lake Woodlands Dr.) is the 23rd Amazon 4-star location nationwide.

Meanwhile, shoppers in Baybrook Mall's Amazon Books (1132 Baybrook Mall Dr.) can expect myriad titles rated as customer favorites, whether trending on the site, devices, or listed as customer favorites. Amazon Books in the Baybrook Mall is the 23rd Amazon Books location nationwide.

Books customers can shop cookbooks alongside a highly curated selection of cooking tools, as well as, popular toys, games, and other home items. Amazon Books is open to all: Prime members pay the Amazon.com price in store, and customers who aren't already Prime members can sign up for a free 30-day trial and instantly receive the Amazon.com price in store, according a release.

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This article originally ran on CultureMap.