Houston health tech startup revolutionizing spinal taps receives FDA clearance

tap in

Co-founded by CEO Jessica Traver, IntuiTap says it plans to roll out the device at U.S. hospitals within the next year. Photo courtesy of IntuiTap

Houston startup IntuiTap Medical has gained clearance from the U.S. Food and Drug Administration for its VerTouch medical device.

The company says VerTouch is designed to make spinal punctures more accurate and consistent. The handheld imaging tool helps health care providers perform spinal punctures at a patient’s bedside.

IntuiTap says it plans to roll out the device at U.S. hospitals within the next year. The company is mulling global partnerships to help launch VerTouch.

IntuiTap’s proprietary spinal-mapping technology enables VerTouch to generate a 2D image of lumbar spinal anatomy, helping health care providers visualize a patient’s spine and guide them toward more precise needle placement.

Each year, 12.7 million Americans undergo an epidural, spinal block, or lumbar puncture, says IntuiTap.

“Having spent more than two decades pioneering the use of ultrasound to improve emergency lumbar punctures, I know the challenge of these procedures and that difficult training and image interpretation prevent ultrasound from being a complete solution,” Dr. Michael Blaivas, co-founder past president of the Society of Ultrasound in Medical Education, says in a news release.

IntuiTap says the FDA clearance “validates the safety and effectiveness” of VerTouch. The device has undergone testing at several institutions in the U.S., including Houston’s Texas Medical Center and Chicago’s Northwestern Memorial Hospital.

Jessica Traver, co-founder and CEO of IntuiTap, says the FDA clearance “marks a crucial milestone in our team’s journey to making epidurals, spinals, and lumbar punctures more accurate and efficient.”

Investors in IntuiTap include:

Dr. Paul Klotman, president of the Baylor College of Medicine
Venture capitalist Tim Draper
William Hawkins III, retired CEO of medical device giant Medtronic
Dr. Vip Patel, Founder of the Global Robotics Institute
Dr. Mary Klotman, dean of the Duke University’s medical school
Carrie Colbert, founder of Houston-based Curate Capital, a female-focused VC firm

“Our investment in IntuiTap was just as much about our faith in the technology, our faith in Jessica as the founder, and our conviction that innovation was sorely needed in this area,” Colbert says.

“The fact that the company is receiving FDA clearance is a huge leap forward, and as a venture capital fund who focuses on female-founded companies that benefit women, it’s extremely rewarding to know this device will impact so many women’s lives.”

In 2021, IntuiTap announced it had closed a $5.5 million series A funding round led by Curate Capital and The Pink Ceiling, a woman-centered investment firm. The startup was founded in 2016.

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A Houston company with a promising immuno-oncology is one step closer to delivering its cancer-fighting drug to patients who need it. Photo via Getty Images

Houston immuno-oncology company reaches next FDA milestone, heads to phase 2 trial

green light

A Houston immuno-oncology company has recently made major headway with the FDA, including both a fast track and an orphan drug designation. It will soon start a phase 2 trial of its promising cancer fighting innovation.

Diakonos Oncology was born in 2016, the brainchild of Baylor researchers already hard at work in the realm of dendritic cell vaccines. Drs. Will Decker, Matt Halpert, and Vanaja Konduri partnered with Dan Faust, a Houston businessman and pharmacist, to bring their treatment to the public, says COO Jay Hartenbach.

The name Diakonos means “deacon or servant in Greek,” he explains. “A lot of companies end up focusing on treating a specific disease or cancer and what you end up having is a significant amount of potential but with a lot of tradeoffs and downsides. And so our goal is we need to eliminate the cancer but we can't harm or dramatically malign the patient in doing so.”

How do they do that? Because the therapy catalyzes a natural immune response, it’s the patient’s own body that’s fighting the cancer. Hartenbach credits Decker with the idea of educating dendritic cells to attack cancer, in this case, glioblastoma multiforme (GBM), one of the most aggressive cancers with which doctors and patients are forced to tangle.

“Our bodies are already very good at responding very quickly and aggressively to what it perceives as virally infected cells. And so what Dr. Decker did was basically trick the immune system by infecting these dendritic cells with the cancer specific protein and mRNA,” details Hartenbach.

Jay Hartenbach is the COO of Diakonos Oncology. Photo courtesy of Diakonos Oncology

But GBM isn’t the only cancer on which Diakonos Oncology has its sights set. Other notably stubborn-to-treat cancers that they’re working on include pancreatic cancer and angiosarcoma. The scientists are focused on meeting unmet medical needs, but also realize that treating such cancers would allow for the fastest determination of whether or not the treatment was effective.

The fast track designation, originally received last fall, means that the drug approval time for DOC1021, Diakonos’ glioblastoma vaccine, will be only six months. But Hartenbach highlights an additional boon, the fact that the special designation also allows for more frequent communications with the FDA.

“That’s very helpful for us, right as we're contemplating how to design the upcoming trials. From a business standpoint, it also is incredibly helpful because it provides a third party validation of what we're doing and the results that we're seeing,” he says.

What they’re seeing includes the survival of 13 out of 16 patients from the initial October 2021 enrollment. The three patients who passed away received the lowest dose of DOC1021. Hartenbach says that the remaining patients are thriving, with no serious adverse effects. With a median survival rate of 15 to 21 months, it’s hard to understate the significance of these patients’ success.

Diakonos Oncology is headquartered in Houston, with a staff of 10 in Space City and an additional eight distributed employees. Hartenbach says that the company’s hometown has been instrumental in its success. He mentions that the robust innovation of the Texas Medical Center meant that as the company has grown, there has never been a motivation to leave Houston.

“You're having a lot of both investment and companies actually moving to Houston,” Hartenbach says. “So we’ve been fortunate to have started there. There are bigger traditional biotech hubs, San Diego, Boston, and San Francisco, but Houston really is now putting itself on the map and it's getting a lot of attention.”

One of the companies responsible for that improved reputation? Diakonos Oncology and its promising approach to aggressive cancers.

A Houston health care company received the green light from the FDA to advance a treatment that's targeting a deadly cancer. Photo via Getty Images

Houston immunotherapy company achieves FDA designation for cancer-fighting vaccine

got the green light

The FDA has granted a Houston-based company a Fast Track designation.

Diakonos Oncology Corp. is a clinical-stage immuno-oncology company that has developed a unique dendritic cell vaccine, DOC1021. The vaccine targets glioblastoma multiforme (GBM), the most common and most lethal malignant brain tumor in adults. The aggressive tumors come with a life expectancy of about 15 months following diagnosis. About 7 percent of those diagnosed survive five years, while the 10-year outlook only sees a one-percent survival rate.

“The FDA’s decision acknowledges the potential of this new treatment approach for a very challenging disease,” Diakonos CEO Mike Wicks says in a press release. “Our protocol represents a first for cancer immunotherapy and could be viable for many types of cancers beyond GBM.”

FDA Fast Track designations are intended to expedite the haste with which drugs with early clinical promise are reviewed, likely taking them to market faster.

DOC1021 uses the body’s natural anti-viral immune response to fight GBM. The vaccine mimics viral infection with the patient’s cancer markers. Essentially, DOC1021 uses the body’s own natural ability to detect and eliminate infected cells.

The technology uses dendritic cells, white blood cells that are able to perceive threats, to its advantage. The unique cancer markers are loaded both internally and externally into the immune cells, just as they would simultaneously occur in a viral infection. The individualized treatment is administered through three precise injections that target deep cervical lymph node chains. By dosing this way, the immune responses are directed straight to the central nervous system.

The results have spoken for themselves: All of the patients who have tried the treatment have exceeded survival expectations. And just as importantly, DOC1021 appears to be extremely safe. No serious adverse effects have been reported.

“Because Phase I clinical trials are generally not statistically powered to demonstrate efficacy, detection of a statistically significant efficacy signal is very promising,” says William Decker, associate professor of immunology at Baylor College of Medicine and inventor of the DOC1021 technology.

The Phase 1 open-label trial of DOC1021 (NCT04552886) is currently taking place at both the University of Texas Health Science Center in Houston and at the MD Anderson Cancer Center at Cooper University Health Care in Camden, NJ. The trial is expected to complete this year.

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.

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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Houston space tech leader lands up to $10 million for Earth re-entry vehicle and lab

space funding

Houston-based space technology, infrastructure, and services company Intuitive Machines has been awarded a state grant of up to $10 million to help develop an Earth re-entry vehicle and in-space biomanufacturing lab.

The Texas Space Commission approved the grant, which is coming from the state’s Space Exploration and Research Fund.

Intuitive Machines says the money will support its “critical risk-reduction platform” for returning lunar samples to Earth. The funding will go toward an early 12-month phase of the project.

“Returning samples from space is one of the most complex challenges in exploration,” says Tim Crain, chief growth officer at Intuitive Machines.

In 2022, Intuitive Machines began preliminary design work on an Earth re-entry vehicle for missions returning from low Earth orbit, the moon, or Mars. In tandem with development of the re-entry vehicle, the company has teamed up with Houston-based biotech company Rhodium Scientific on in-space biomanufacturing. This biomanufacturing will involve certain materials, processes and pharmaceuticals that can be handled more efficiently in space or that exhibit unique non-Earth properties.

Gámez Holzhaus, founder and CEO of Rhodium Scientific, says his company’s federally backed work “has enabled us to establish all hardware and protocols necessary for a pipeline to develop and scale biomanufacturing in space.”

Intuitive Machines and Rhodium Scientific say the state grant should pave the way for future grants and large-scale projects to bring the re-entry system closer to flight readiness.

9 can't-miss Houston business and innovation events for May

where to be

There's a lot to learn this month at events around Houston. Hear from AI and energy experts or gain insights into how to tap into funding at informative panels or sessions.

Here are the Houston business and innovation events you can't miss in May and how to register. Please note: This article might be updated to add more events.

May 1 - Ion Block Party + 3rd Annual Crawfish Cookoff

Head to this special edition Block Party, featuring a crawfish cook-off competition among the Ion’s businesses. Competing teams include Ion/Rice Alliance, Transwestern, Black at Microsoft, United Protective Services, Nexus, PersonaAI, South Main Baptist, Late August, Lymbar and LickleLab/Sports Monkey.

This event is Thursday, May 1, from 4-7 p.m. at the Ion. Register here.

May 5 - Fireside Chat and Book Launch: ‘AI Made Simple: Results Made Real.’

Learn more about how AI is reshaping business and what leadership in the AI era looks like at the launch of Kathleen Perley’s book, AI Made Simple: Results Made Real, hosted by Rice Business Executive Education. Perley is founder and CEO of DemystifAI and an instructor and advisor at Rice University. She will sit down with Marie Myers, CFO of Hewlett Packard Enterprise, for a discussion and will be signing copies of her book after the fireside chat.

This event is Monday, May 5, from 5:30-7:30 p.m. at the Ion. Register here.

May 6 - Houston’s AI-Driven Data Center Boom: Investment, Innovation, and Policy

In light of Houston’s growing influence as a data center hub, the Greater Houston Partnership will present an informative panel focused on the investment landscape, technological advancements, and policy considerations shaping the future of AI-driven data centers in Houston. Panelists include leaders from Moelis, Quanta, and the Houston Northwest Chamber of Commerce.

This event is Tuesday, May 6, from 11:30 a.m.-1 p.m. at Partnership Tower. Register or become a member here.

May 6 - Doing Business with the Federal Government - The Woodlands

The SBA Houston District Office, in collaboration with Sam Houston State University SBDC, will host an informative session to share insights on how small business owners can work with the U.S. government. Topics include how the government buys goods and services, the SBA’s role in government contracting, federal government contracting programs, the advantages of small business set-asides, marketing your business, identifying federal opportunities and more.

This event is Tuesday, May 6, from 10-11:30 a.m. at Sam Houston State University - The Woodlands Center. Register here.

May 8 - Industrious Launch Party

Attend the opening of Industrious’ new coworking space at the Ion. Anteendees can tour the new space, meet the team, enjoy a silent disco and network. Light bites will be provided by Late August, Lymbar, and Stuff’d.

This event is Thursday, May 8, from 5-8 p.m. at the Ion. Register here

May 12 - Headshot Happy Hour

Hosted by Natalie Presnediue, Headshot Happy Hour caters to entrepreneurs, business owners, creatives and professionals who want to enhance or update their online presence. Each session includes a 15- to 20-minute mini shoot and three professionally retouched images. Light refreshments will be served.

This event is Monday, May 12, at the Ion. Learn more here.

May 12-14 - Greentown Labs’ Investor Activation Series

Greentown Labs will host a three-day series for investors interested in climatetech, centered around the incubator’s invitation-only Manufacturing Sector Pitch Day. Panels throughout the event will focus on early-stage investment, emerging opportunities, and tools for investors, presented by organizations like Houston Angel Network and New Climate Ventures.

This event begins Monday, May 12, at Greentown Labs. Register here.

May 13 - Women in Venture Investing: Expanding Influence and Building Wealth

Houston Angel Network will host a luncheon focused on how women can enter and thrive in the venture capital space. Anthea Zhang, professor of strategic management at Rice University, will present the keynote address along with a panel featuring leaders from Hunton, JP Morgan Private Bank, HRSS CPAs, Weathergage Capital, and Houston Angel Network.

This event is Tuesday, May 13, from 11 a.m.-1:30 p.m. at the Junior Leauge of Houston. Get tickers here.

May 28-30 - CHARGE North America

This intimate, immersive experience is tailored to forward-thinking energy professionals. The conference includes hands-on interactive workshops led by top strategists; real-world case studies; and insights from leading speakers on resilient branding, consumer expectations, and climate action. Attendees will engage in panel discussions on sustainability and energy diversification and enjoy exclusive networking opportunities with global executives and innovators.

This event begins Wednesday, May 28, at the Ion. Register here.

Houston clean energy co. wins $50 million at Elon Musk-backed competition

xprize winners

Houston-based Mati Carbon has won the $50 million grand prize in the XPRIZE Carbon Removal competition, backed by Elon Musk’s charitable organization, The Musk Foundation.

Mati was selected in 2024 as one of 20 global finalists. The company removes carbon through its Enhanced Rock Weathering (ERW) program that works with agricultural farms in Africa and India.

The 3-year-old startup accelerates the natural process of rock weathering (ERW) by applying pulverized basalt to croplands of partnered smallholder farmers, free of charge. Mati says the farmers it partners with are some of the most vulnerable to the impacts of climate change.

“Winning this XPRIZE competition is an incredible honor and a definitive validation of our research and development, and building out the infrastructure needed to impact millions of farmers while delivering verifiable carbon dioxide removal at a gigaton scale,” Mati Carbon Founder and CEO Shantanu Agarwal, said in a news release. “I couldn’t be prouder, not just of the Mati team, but of our collaborators, research partners and the thousands of smallholder farmers who let us be part of their lives. This XPRIZE recognition will allow us to collaborate with local partners to accelerate the use of enhanced rock weathering across the Global South.”

Mati reports that it plans to use the award to “scale its efforts working with smallholder farmers worldwide.” Apart from the XPRIZE funding, Mati plans to grow its model through the sale of CDR credits. According to the company, it counts Shopify, Stripe, and H&M among its early carbon credit buyers.

“Mati Carbon’s deployments bolster farmers’ livelihoods through improved soil health, reduced agricultural inputs, and increased income at zero cost to them. Mati Carbon’s team has developed a scientifically rigorous approach to monitoring and verification, and excelled across each of XPRIZE’s prize evaluation criteria – operational, sustainability, and cost metrics – giving the XPRIZE judges the highest confidence in Mati Carbon’s solution’s long-term scalability,” the XPRIZE judges wrote.

Houston-based Vaulted Deep took home the second-runner-up prize in the competition and $8 million for its organic waste storage process. The company provides permanent carbon storage by injecting nonhazardous organic waste deep underground. It spun off with $8 million in seed funding from Advantek Waste Management Services in 2023.

"Our approach is grounded in geomechanical injection techniques that have been safely deployed globally for decades by our team and predecessors," Omar Abou-Sayed, co-founder and executive chairman of Vaulted, said in a separate release. "XPRIZE recognized that this is a proven approach—already in use, delivering impact, and built on the kind of reliability the industry needs to scale responsibly."

Launched in 2021, the four-year XPRIZE Carbon Removal competition challenged global innovators to deploy scalable solutions for removing carbon dioxide from the atmosphere and oceans. More than 1,300 teams from 88 countries competed. XPRIZE finalists were required to remove at least 1,000 tonnes of CO2 over a one-year demonstration period.

French company NetZero took home the first-runner-up prize of $15 million, and London-based UNDO came in as third-runner-up with a $5 million prize.

Since the announcement of the XPRIZE Carbon Removal competition, the Musk-led Department of Government Efficiency has cut climate funding for agencies, projects and research. While the Musk Foundation sponsored the XPRIZE event, it is not affiliated with the California-based organization, according to the Associated Press.

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

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