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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Rice University's edtech company receives $90M to lead NSF research hub

major collaboration

An educational technology company based out of Rice University has received $90 million to create and lead a research and development hub for inclusive learning and education research. It's the largest research award in the history of the university.

OpenStax received the grant funding from the U.S. National Science Foundation for a five-year project create the R&D hub called SafeInsights, which "will enable extensive, long-term research on the predictors of effective learning while protecting student privacy," reads a news release from Rice. It's the NSF's largest single investment commitment to national sale education R&D infrastructure.

“We are thrilled to announce an investment of $90 million in SafeInsights, marking a significant step forward in our commitment to advancing scientific research in STEM education,” NSF Director Sethuraman Panchanathan says in the release. “There is an urgent need for research-informed strategies capable of transforming educational systems, empowering our nation’s workforce and propelling discoveries in the science of learning.

"By investing in cutting-edge infrastructure and fostering collaboration among researchers and educators, we are paving the way for transformative discoveries and equitable opportunities for learners across the nation.”

SafeInsights is funded through NSF’s Mid-scale Research Infrastructure-2 (Mid-scale RI-2) program and will act as a central hub for 80 partners and collaborating institutions.

“SafeInsights represents a pivotal moment for Rice University and a testament to our nation’s commitment to educational research,” Rice President Reginald DesRoches adds. “It will accelerate student learning through studies that result in more innovative, evidence-based tools and practices.”

Richard Baraniuk, who founded OpenStax and is a Rice professor, will lead SafeInsights. He says he hopes the initiative will allow progress to be made for students learning in various contexts.

“Learning is complex," Baraniuk says in the release. "Research can tackle this complexity and help get the right tools into the hands of educators and students, but to do so, we need reliable information on how students learn. Just as progress in health care research sparked stunning advances in personalized medicine, we need similar precision in education to support all students, particularly those from underrepresented and low-income backgrounds.”

OpenStax awarded $90M to lead NSF research hub for transformational learning and education researchwww.youtube.com

2 Houston startups selected by US military for geothermal projects

hot new recruits

Two clean energy companies in Houston have been recruited for geothermal projects at U.S. military installations.

Fervo Energy is exploring the potential for a geothermal energy system at Naval Air Station Fallon in Nevada.

Meanwhile, Sage Geosystems is working on an exploratory geothermal project for the Army’s Fort Bliss post in Texas. The Bliss project is the third U.S. Department of Defense geothermal initiative in the Lone Star State.

“Energy resilience for the U.S. military is essential in an increasingly digital and electric world, and we are pleased to help the U.S. Army and [the Defense Innovation Unit] to support energy resilience at Fort Bliss,” Cindy Taff, CEO of Sage, says in a news release.

A spokeswoman for Fervo declined to comment.

Andy Sabin, director of the Navy’s Geothermal Program Office, says in a military news release that previous geothermal exploration efforts indicate the Fallon facility “is ideally suited for enhanced geothermal systems to be deployed onsite.”

As for the Fort Bliss project, Michael Jones, a project director in the Army Office of Energy Initiatives, says it’ll combine geothermal technology with innovations from the oil and gas sector.

“This initiative adds to the momentum of Texas as a leader in the ‘geothermal anywhere’ revolution, leveraging the robust oil and gas industry profile in the state,” says Ken Wisian, associate director of the Environmental Division at the U.S. Bureau of Economic Geology.

The Department of Defense kicked off its geothermal initiative in September 2023. Specifically, the Army, Navy, and Defense Innovation Unit launched four exploratory geothermal projects at three U.S. military installations.

One of the three installations is the Air Force’s Joint Base San Antonio. Canada-based geothermal company Eavor is leading the San Antonio project.

Another geothermal company, Atlanta-based Teverra, was tapped for an exploratory geothermal project at the Army’s Fort Wainwright in Alaska. Teverra maintains an office in Houston.

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This article originally ran on EnergyCapital.

Houston investor calls for all angels to move the ecosystem forward

houston innovators podcast episode 233

One of the biggest components of a well-functioning startup ecosystem is inarguably access to capital, and Mitra Miller is dedicated to enhancing education around investment and growing Houston's investor base.

As vice president and board member of the Houston Angel Network, the oldest angel network in Texas and one of the most active angel networks in the country, Miller strives to provide guidance to new and emerging angel investors as well as founders seeking to raise money from them.

"Most founders have no idea or understanding of how investors think — we are not an ATM," Miller says on the Houston Innovators Podcast. "We are really partners you are getting married to for the next 5, 8, 10 years — sometimes longer. We need to bring your allies in every sense of the word."

HAN, a nonprofit, provides a unique opportunity for its members, as Miller explains. The group consists of around 100 individuals from all business backgrounds, so evaluating companies together brings more than just a wealth of capital — but also a wealth of knowledge.

"What HAN provides is access to investments," Miller says, adding that members have the benefit in evaluating companies together with people from different backgrounds. "Inside a group like HAN, we have extraordinary expertise."

In addition to educating both founders and investors in the process, Miller has dedicated herself to providing opportunities for students in low-income parts of Houston to learn about the startup world. Eight years ago, she founded Eagle Investors, an organization that provides a year-long program that culminates in a group of students participating as judges for the Rice Business Plan Competition.

"They spend a year learning about innovation, entrepreneurship, and investing by meeting local investors, entrepreneurs, and service providers. They go around Houston to get to visit and ... experience all of the ecosystem," Miller says.

At RBPC, the cohort of high school students evaluate the pitches and select a company to provide a $5,000 prize.

Miller herself has been a judge at RBPC for 20 years now, and she's had a front row seat for watching Houston develop as an ecosystem. She's seen the city make real progress, but has one major call to action.

"The piece that I am most aware of that I would like to see grow is activating more accredited investors who are interested in this asset class of early-stage companies and plugging in," Miller says. "They can also invest their time and knowledge to help companies in our region grow and scale."

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