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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Innovation pioneers on why Pumps & Pipes is so uniquely Houston

A Day of Discussion

Pumps & Pipes 2022, Houston’s premier innovation event, is rapidly approaching on December 5 from 8 am-3 pm at the Ion.

Leading up to this exciting event, InnovationMap spoke with several of the speakers representing various industries to ask them, "What makes Pumps & Pipes uniquely Houston?"

Here are their responses:

Dr. Alan Lumsden, chair of cardiovascular surgery at Houston Methodist and Pumps & Pipes founder:

“…What can we learn from one another? What is inside the other person’s toolkit? A lot of solutions are already out there but sometimes we don’t have the ability to see into their toolkit. This has become the driving force behind Pumps & Pipes throughout the last 15 years…”

Dr. Lucie Low, chief scientist for microgravity research at Axiom Space:

“‘Houston, we have a problem’ — everyone knows Houston as a major player in the aerospace industry as highlighted by this famous quote from Apollo 13. What people may not know and what is exciting to me about Houston are the opportunities for collaboration with other industries that can help drive our mission to build communities of healthy humans in space. With the largest medical center in the world right next to Johnson Space Center, Houston is a prime city for innovation at the intersection of medicine and space.”

David Horsup, managing director of technology at OGCI Climate Investments:

“The remarkable diversity of thought, culture, and expertise that exists in Houston creates an incredible cauldron for innovation. The city has been the leading light in pushing frontiers in energy, aerospace, and medicine for many years, and Pumps & Pipes is a powerful ‘node’ for some of the brightest minds across these industries to connect, collaborate, and innovate. I am extremely excited to see how Houston is pivoting to embrace the challenge that climate change is presenting, and the city will play a defining role going forward.”

Purchase tickets for Pumps & Pipes here and follow Pumps & Pipes on social media at LinkedIn, Twitter, and YouTube.

Houston startup founders report on clean energy tech efficacy

seeing results

A team from Rice University has uncovered an inexpensive, scalable way to produce clean-burning hydrogen fuel.

In research published this month in the journal Science, researchers from Rice’s Laboratory for Nanophotonics, in partnership with Syzygy Plasmonics Inc. and Princeton University’s Andlinger Center for Energy and the Environment, detail how they converted ammonia into carbon-free fuel using a light-activated catalyst.

The new catalyst separates the liquid ammonia into hydrogen gas and nitrogen gas. Traditional catalysts require heat for chemical transformations, but the new catalyst can spur reactions with just the use of sunlight or LED light.

Additionally, the team showed that copper-iron antenna-reactors could be used in these light-driven chemical reactions, known as plasmonic photocatalysis. In heat-based reactions, or thermocatalysis, platinum, and related precious (and expensive) metals like palladium, rhodium, and ruthenium are required.

“Transition metals like iron are typically poor thermocatalysts,” Naomi Halas, a co-author of the report from Rice, said in a statement. “This work shows they can be efficient plasmonic photocatalysts. It also demonstrates that photocatalysis can be efficiently performed with inexpensive LED photon sources.”

Halas, Rice's Stanley C. Moore Professor of Electrical and Computer Engineering, was joined on the project by Peter Nordlander, Rice’s Wiess Chair and Professor of Physics and Astronomy, and Rice alumni and adjunct professor of chemistry Hossein Robatjazi. Emily Carter, the Gerhard R. Andlinger Professor in Energy and Environment, represented Princeton University.

“These results are a great motivator," Carter added. "They suggest it is likely that other combinations of abundant metals could be used as cost-effective catalysts for a wide range of chemical reactions.”

Houston-based Syzygy, which Halas and Nordlander founded in 2018, has licensed the technology used in the research and has begun scaled-up tests of the catalyst in the company’s commercially available, LED-powered reactors. According to Rice, the test at Syzygy showed the catalysts retained their efficiency under LED illumination and at a scale 500 times larger than in tests in the lab setup at Rice.

“This discovery paves the way for sustainable, low-cost hydrogen that could be produced locally rather than in massive centralized plants,” Nordlander said in a statement.

Earlier this month, Syzygy closed its $76 million series C round to continue its technology development ahead of future deployment/

Houston is home to many other organizations and researchers leading the charge in growing the hydrogen economy.

Earlier this year, Mayor Sylvester Turner announced he's determined to position the city as hub for hydrogen innovation as one of the EPA's Regional Clean Hydrogen Hubs. Organizations in Texas, Southwest Louisiana and the surrounding Gulf Coast region, known and HyVelocity Hub, also announced this month that it would be applying for the regional funding.

And according to a recent report from The Center for Houston's Future, the Bayou City is poised to "lead a transformational clean hydrogen hub with global impact."

7+ can't-miss Houston business and innovation events for December

where to be

Houstonians have yet another good batch of in-person and online innovation events, and you and your tech network need to know about them.

Here's a roundup of virtual events not to miss this December — like pitch nights, workshops, conventions, and more.

Note: This post might be updated to add more events.


December 1 — 2022-2023 UH Energy Symposium Series

The Division of Energy and Innovation, along with the UH Center for Carbon Management in Energy, are hosting a day-long symposium to discuss pathways and solutions to make Texas carbon neutral by 2050. UH experts and energy industry partners will serve as panelists to discuss the drivers, opportunities, and challenges for change, and more.

The event is on Thursday, December 1, from 9 am to 7 pm, at University of Houston (Houston Room - University of Houston Student Center South). Click here to register.

December 5 — Pumps & Pipes: Ion to Infinity

Highlighting innovations in Web3, Artificial Intelligence, Extended Reality, and Robotics, attendees will hear from visionaries across medicine, energy, and aerospace who are developing and launching technologies in these fields.

The event is on Monday, December 5, from 8 am to 3 pm at The Ion. Click here to register.

December 6 — Softeq Venture Studio Demo Day

The Softeq Venture Studio's 2H 2022 cohort is the largest yet with 22 member companies, which brings the total portfolio to 49 companies. This cohort includes entrepreneurs from several global locations as diverse as the United Kingdom, Iceland, Mexico, and Peru. In this capstone event, founders have three minutes each to present their pitch deck, demo their product, outline their ask, and answer questions.

The event is on Tuesday, December 6, from 8 am to 3 pm at The Ion. Click here to register.

December 7 — Houston Veterans In Residence Showcase

Bunker Labs’ Veterans in Residence Showcase is a nationwide event, celebrating over 500 veteran and military spouse entrepreneurs launching their startups and businesses.

The event is on Wednesday, December 7, from 6 to 8 pm at Sesh Coworking. Click here to register.

December 8 — 8th Annual SWPDC Symposium on Pediatric Device Innovation and Business Meeting:

The 8th Annual SWPDC Symposium on Pediatric Device Innovation and Business Meeting will feature the keynote presentation "Non-Dilutive Federal Funding for Pediatric Device Startups" by Michael Heffernan, Director of Research & Technology at Fannin Innovation Studio.

The event is on Thursday, December 8, from 4 to 7 pm, at the Queensbury Theatre. Click here to register.

December 8 — HAN Holiday Party

Join the Houston Angel Network for their annual party.

The event is on Thursday, December 8, from 6 to 8 pm, at Postino City Centre. Click here to register.

December 10 — TXRX Holiday Make-a-thon

Get your festive fun on by participating in one of our hands-on workshops. Learn more about how we make through our live demos.

The event is on Saturday, December 10, from 3 to 6 pm, at TXRX. Click here to register.

December 13 — Future of the Houston Region

The reimagined Future of the Houston Region event features one of the fastest-growing areas in the Houston region - Montgomery County. Conversations will be focused on the county’s rapid growth, business developments within the area, future plans of expansion and its overall importance to the region.

The event is on Tuesday, December 13, from 10:30 am to 1:30 pm at The Woodlands Waterway Marriott. Click here to register.