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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3 Houston innovators to know this week

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Editor's note: In the week's roundup of Houston innovators to know, I'm introducing you to three female innovators across industries recently making headlines — all three focusing on investing in innovation from B2B software to energy tech.

Samantha Lewis, principal at Mercury Fund

Samantha Lewis, principal at Mercury Fund, joins this week's episode of the Houston Innovators Podcast. Photo courtesy of Mercury Fund

When Samantha Lewis started her new principal role at Houston-based Mercury Fund, she hit the ground running. Top priority for Lewis is building out procedure for the venture capital firm as well as finding and investing in game-changing fintech.

"(I'm focused on) the democratization of financial services," Lewis says on this week's episode of the Houston Innovators Podcast. "Legacy financial institutions have ignored large groups of our population here in America and broader for a very long time. Technology is actually breaking down a lot of those barriers, so there are all these groups that have traditionally been ignored that now technology can reach to help them build wealth." Click here to read more and stream the episode.

Barbara Burger, president of Chevron Technology Ventures

Houston-based Chevron Technology Ventures, spearheaded by Barbara Burger, has announced their latest fund. Courtesy of CTV

Chevron Technology Ventures LLC's recently announced $300 million Future Energy Fund II builds on the success of the first Future Energy Fund, which kicked off in 2018 and invested in more than 10 companies specializing in niches like carbon capture, emerging mobility, and energy storage. The initial fund contained $100 million.

"The new fund will focus on innovation likely to play a critical role in the future energy system in industrial decarbonization, emerging mobility, energy decentralization, and the growing circular carbon economy," Houston-based Chevron Technology Ventures says in a February 25 release.

Future Energy Fund II is the eighth venture fund created by Chevron Technology Ventures since its establishment in 1999. Click here to read more.

Lauren Bahorich, CEO and founder of Cloudbreak Enterprises

Cloudbreak Enterprises, founded by Lauren Bahorich is getting in on the ground level with software startups — quickly helping them take an idea to market. Photo courtesy of Cloudbreak

Lauren Bahorich wanted to stand up a venture studio that really focused on growing and scaling B-to-B SaaS-focused, early-stage technology. She founded Cloudbreak Enterprises last year and already has three growing portfolio companies.

"We truly see ourselves as co-founders, so our deals are structured with co-founder equity," Bahorich says, explaining that Cloudbreak is closer to a zero-stage venture capital fund than to any incubator. "We are equally as incentivized as our co-founders to de-risk this riskiest stage of startups because we are so heavily invested and involved with our companies."

This year, Bahorich is focused on onboarding a few new disruptive Houston startups. Click here to read more.

Sustainable plastics manufacturing company expands in Houston and beyond

Growing green

An under-the-radar company in Houston has ramped up its manufacturing capacity as it seeks to seize upon rising interest in sustainable plastics.

Houston-based Inhance Technologies, a sustainable manufacturer that transforms conventional plastics into high-performance materials, has a new site in St. Louis that comprises 75,000 square feet — more than double the size of the company's old facility there. As a result of the expansion, Inhance Technologies' headcount in St. Louis will rise to about 40. The size of the company's entire workforce wasn't available.

"The expansion in St. Louis is a great moment for the company and a sign of the organization's ambition in sustainable solutions for plastics," Patricia van Ee, chief commercial officer at Inhance Technologies, says in a release. "We know consumers are favoring more recyclable plastics, especially in packaging … ."

In January, the company promoted van Ee to her current role. She joined Inhance Technologies in 2019 as senior vice president of sales and marketing.

Patricia van Ee was recently named chief commercial officer at Inhance Technologies. Photo via inhancetechnologies.com

The announcement of van Ee's elevation to chief commercial officer came on the heels of Inhance Technologies occupying its new global headquarters at 22008 N. Berwick Dr. in northwest Houston. The company was founded in 1983, and about 75 people work at the Houston headquarters, which includes a science and technology center. That location is adjacent to one of its Texas manufacturing plants.

Among other products, the new plant in St. Louis makes Enkase, which transforms conventional plastics into fully recyclable packaging, and DuraBloc, which prevents fuel from seeping through plastic tanks on gas-powered equipment like motorcycles and personal watercraft. Customers include original equipment manufacturers, molders, and retailers in sectors such as consumer packaged goods, health care, and transportation.

"With a large expansion of warehouse space, a doubling of our manufacturing capacity, and new rapid-response lead times, our expanded St. Louis operation is equipped to meet new levels of demand as product brands, retailers, and consumers make a conscious choice to [purchase] more sustainable plastics," Michael Koma, chief operating officer at Inhance Technologies, says in a release.

ResearchAndMarkets.com predicts the global market for sustainable plastic packaging will jump from $89 billion in 2020 to $117.3 billion by 2025.

"The sustainable plastic packaging industry has been growing as a result of stringent laws and regulations levied by governments and governing bodies, as well as a shift in consumer preference toward recyclable and eco-friendly packaging materials," the research firm says.

Inhance Technologies' global presence should put it in a good position to capitalize on that market. The Houston and St. Louis sites are among more than 20 Inhance Technologies locations around the world, including offices in Australia, Brazil, Germany, and Mexico.

Los Angeles-based private equity firm Aurora Capital Partners bought Inhance Technologies from New York City-based private equity firm Arsenal Capital Partners in 2018 for an undisclosed amount. Arsenal bought Inhance Technologies from founders Monty Ballard and Bill Brown in 2012.

"Inhance fits seamlessly into our strategy of partnering with a market leader to support their vision and accelerate both organic and acquisition-driven growth," Michael Marino, a partner at Aurora Capital Partners, said in 2018.

A year after its acquisition by Aurora, Inhance Technologies bought Germany's Fluor Technik System for an undisclosed amount.

"Over the course of its history, Inhance has continually sought to expand both its breadth of technical capabilities and its geographical reach," said Andy Thompson, the company's president and CEO.

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