Houston medtech startup clears FDA approval for new surgical tool

precision surgery

Prana Surgical has developed a minimally invasive, image-guided, single-use tissue extraction tool. Photo via LinkedIn

Houston-based Prana Surgical will soon bring a new electrosurgical tool to operating rooms around the country. The Prana System officially cleared U.S. Food and Drug Administration (FDA) approval earlier this month.

"Receiving FDA clearance for the Prana System represents a defining milestone for our company," Joanna Nathan, CEO and co-founder of Prana Surgical, said in a news release. "Surgeons today are increasingly focused on achieving precise outcomes while minimizing disruption to healthy tissue. The Prana System was designed to support that shift by integrating targeting and excision into a single, streamlined tool."

Prana Surgical began as Prana Thoracic in 2022. Back then, the company primarily focused on developing screening tools for lung cancer diagnosis. It raised $6 million in series A funding rounds in 2023 and 2024 before transitioning to broader surgical needs in 2025.

The Prana System is a minimally invasive, image-guided, single-use tissue extraction tool designed to retrieve samples without damaging healthy tissue. The tool is still designed with the respiratory system in mind, helping Prana in the fight against lung cancer and other thoracic diseases.

Reducing the impact of tissue extraction via electrosurgery and enhanced image scanning can significantly reduce complications. The Prana System combines localization and tissue-cutting capabilities in one, which keeps surgeons from having to swap out components during a procedure, making for a smoother process. It can core, cut and feel blood vessels on the way toward the intended target, giving surgeons greater control over tissue preservation.

"Electrosurgery is foundational to modern surgery, but there is still opportunity to improve how energy-based tools are applied in minimally invasive settings," Nathan added. "Our goal is to introduce a new class of image-guided surgical tools that enable more precise intervention across a range of procedures."

The company projects the market size for lung nodules to be $7.5 billion in the United States, estimating that 2.5 million nodules will be able to benefit from the new tool. While starting out focused on biopsies, the company plans to evolve the system into other procedures, such as ablation, in the future. It is also planning for a controlled U.S. clinical rollout as it moves toward commercialization

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

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

CORONAVIRUS RESPONSE

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.

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New UH survey reveals concerns over AI data center growth in Houston

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A new report out of the University of Houston shows that area residents remain wary of the long-term effects of operating data centers.

The recent survey from the University of Houston’s latest SPACE City Panel, conducted by the Center for Public Policy at the Hobby School of Public Affairs, shows that while 85 percent of Houston-area residents use AI, nearly 63 percent oppose the construction of AI data centers within 1 mile of their homes.

Respondents’ concerns centered around data centers’ high energy demand and the area’s power grid reliability. According to the survey, 32 percent of residents who oppose local data center projects would be more likely to support the centers if they relied on renewable energy over fossil fuels.

“Respondents understand that AI can bring economic and educational benefits, but they are also concerned about the physical infrastructure needed to fuel AI, especially data centers,” Soran Mohtadi, post-doctoral fellow at the Hobby School and a researcher on the report, said in a news release. “This physical infrastructure demands more electricity and water, leading to environmental impacts.”

Experts estimate that 6.5 gigawatts of data center capacity will be added to the Texas grid by 2030. And Houston’s data center capacity is predicted to more than double by 2028.

The Electric Reliability Council of Texas also projects electricity demand could reach 218 gigawatts by 2031, which would be more than double the record peak set in August 2023. Data centers are expected to account for 86 gigawatts of that new demand.

Survey respondents also said they are concerned about the state's future water supply, given the large amounts of water that data centers need to stay cool.

In terms of who’s responsible for that issue, 57.6 percent of respondents said they put the onus on Texas lawmakers, while 31.5 percent say tech companies should be responsible.

Additionally, more than 75 percent of respondents believed that data center developers and technology companies—not residents—should bear the cost of infrastructure upgrades to support data centers.

“Every decision legislators make has implications on residents’ everyday lives and local infrastructure now and in the future,” Maria P. Perez Arguelles, lead researcher on the report and research assistant professor at the Hobby School, added in the news release. “This issue is going to become more important in years to come, so this is just the beginning.”

Read the full report here.

Houston-born Cemvita makes breakthrough in sustainable fuel production

clean fuels

Houston-based biotech company Cemvita announced that it recently reached a critical milestone in the development of its FermOil product, which can be used to create Sustainable Aviation Fuel (SAF) and other renewable fuels at industrial scale.

The company shared in a news release that it completed a 75,000-liter industrial fermentation run at Belgium's Bio Base Europe Pilot Plant.

The campaign achieved target technical metrics for the production of FermOil, Cemvita’s renewable natural oil (RNO). FermOil is produced from industrial crude glycerin, an industrial byproduct, as opposed to traditional sugar-based feedstocks used in many bio-oil fermentation processes. It's designed to be a drop-in feedstock for creating SAFs.

Cemvita had previously advanced its FermOil production process through multiple scale-up stages before successfully reaching the 75,000-liter demonstration campaign, according to the company.

“This is not just a fermentation milestone,” Moji Karimi, CEO at Cemvita, said in the release. “It is a blueprint for how existing industrial infrastructure can evolve into circular bioeconomy infrastructure. Every biodiesel plant generating crude glycerin is a potential platform for renewable natural oil production.”

The milestone also supports the deployment of Cemvita’s industrial biomanufacturing platform, FermWorks, which integrates with existing energy and industrial infrastructure to turn waste carbon streams into SAFs and other materials. According to the release, Cemvita plans to move forward with commercial deployment discussions with partners in Brazil, Europe and in the UK. Cemvita already has a partnership with the Brazilian sustainable research institution REMA.

“We are proud to support innovative companies like Cemvita in scaling breakthrough industrial biotechnology solutions,” Hendrik Waegeman, head of business operations at Bio Base Europe Pilot Plant, added in the release. “Successfully operating at the 75,000-liter scale using a feedstock such as crude glycerin highlights both the maturity of the technology and the quality of the scale-up execution achieved by the Cemvita team.”

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This article originally appeared on our sister site, EnergyCapitalHTX.com.

Eli Lilly scoops up Houston biotech startup in $300 million deal

big pharma deal

Pharmaceutical giant Eli Lilly has acquired Houston biotech startup CrossBridge Bio, which develops antibody-drug conjugates for cancer, in a deal worth up to $300 million. The deal was celebrated by TMC Venture Fund and the University of Texas Health Science Center at Houston last week.

CrossBridge, founded in 2023, is developing ADCs based on research by Kyoji Tsuchikama and Zhiqiang An, both of UT Health Houston. Tsuchikama is an associate professor of medicinal chemistry and a globally recognized ADC pioneer, and An is a professor of molecular science and vice president of drug discovery.

Antibody-drug conjugates (ADCs) are a potent combination of targeted therapy and chemotherapy that kills cancer cells while saving healthy tissue.

Clinical trials for CrossBridge’s primary ADC candidate, CBB-120, are expected to start this year, pending approval from the U.S. Food and Drug Administration (FDA).

“I’m proud of how well our team has executed and advanced our platform in such a short time since the company’s founding,” Michael Torres, co-founder and CEO of CrossBridge, said in a news release. “By becoming a part of Lilly, a leader in patient-focused therapeutic development, we are well-positioned to further accelerate the clinical potential of this approach.”

Under the Lilly deal, CrossBridge shareholders were expected to receive an upfront payment along with a follow-up payment based on the achievement of certain milestones.

In 2024, CrossBridge closed a $10 million seed round. Among the investors in CrossBridge are the Texas Medical Center Venture Fund, CE-Ventures, Alexandria Venture Investments, Portal Innovations, Linden Lake Labs, and the Cancer Prevention and Research Institute of Texas (CPRIT). It was formed in TMC Innovation’s Accelerator for Cancer Therapeutics program."Built within the TMC ecosystem, CrossBridge Bio grew with the support, funding, and resources that helped shape its trajectory. TMC led the company's early financing and watched it evolve from its earliest days to its acquisition by Eli Lilly," William McKeon, president and CEO of the Texas Medical Center, shared in a LinkedIn post. "[This is a] strong reminder that breakthrough science and the right early backing can change what’s possible."
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