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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Texas female-founded companies raised more than $1 billion in 2024, VC data shows

by the numbers

Female-founded companies in Dallas-Fort Worth may rack up more funding deals and more money than those in Houston. However, Bayou City beats DFW in one key category — but just barely.

Data from PitchBook shows that in the past 16 years, female-founded companies in DFW collected $2.7 billion across 488 deals. By comparison, female-founded companies in the Houston area picked up $1.9 billion in VC through 343 deals.

Yet if you do a little math, you find that Houston ekes out an edge over DFW in per-deal values. During the period covered by the PitchBook data, the value of each of the DFW deals averaged $5.53 million. But at $5,54 million, Houston was just $6,572 ahead of DFW for average deal value.

Not surprisingly, the Austin area clobbered Houston and DFW.

During the period covered by the PitchBook data, female-founded companies in the Austin area hauled in $7.5 billion across 1,114 deals. The average value of an Austin deal: more than $6.7 million.

Historically, funding for female-established companies has lagged behind funding for male-established companies. In 2024, female-founded companies accounted for about one-fourth of all VC deals in the U.S., according to PitchBook.

PitchBook noted that in 2024, female-founded companies raised $38.8 billion, up 27 percent from the previous year, but deal count dropped 13.1 percent, meaning more VC for fewer startups. In Texas, female-founded companies brought in $1.3 billion last year via 151 deals. The total raised is the same as 2023, when Texas female founders got $1.3 billion in capital across 190 deals.

“The VC industry is still trying to find solid footing after its peak in 2021. While some progress was made for female founders in 2024, particularly in exit activity, female founders and investors still face an uphill climb,” says Annemarie Donegan, senior research analyst at PitchBook.

Here are 3 Houston innovators to know right now

Innovators to Know

Editor's note: These Houston innovators are making big strides in the fields of neurotechnology, neurodevelopmental diagnosis, and even improving the way we rest and recharge.

For our latest roundup of Innovators to Know, we meet a researcher who is working with teams in Houston and abroad to develop an innovative brain implant; a professor who has created an AI approach to diagnosis; and a local entrepreneur whose brand is poised for major expansion in the coming years.

Jacob Robinson, CEO of Motif Neurotech

Houston startup Motif Neurotech has been selected by the United Kingdom's Advanced Research + Invention Agency (ARIA) to participate in its inaugural Precision Neurotechnologies program. The program aims to develop advanced brain-interfacing technologies for cognitive and psychiatric conditions. Three Rice labs will collaborate with Motif Neurotech to develop Brain Mesh, which is a distributed network of minimally invasive implants that can stimulate neural circuits and stream neural data in real time. The project has been awarded approximately $5.9 million.

Motif Neurotech was spun out of the Rice lab of Jacob Robinson, a professor of electrical and computer engineering and bioengineering and CEO of Motif Neurotech.

Robinson will lead the system and network integration and encapsulation efforts for Mesh Points implants. According to Rice, these implants, about the size of a grain of rice, will track and modulate brain states and be embedded in the skull through relatively low-risk surgery. Learn more.

Dr. Ryan S. Dhindsa, Dhindsa Lab

Dr. Ryan S. Dhindsa, assistant professor of pathology and immunology at Baylor and principal investigator at the Jan and Dan Duncan Neurological Research Institute at Texas Children’s Hospital, and his team have developed an artificial intelligence-based approach that will help doctors to identify genes tied to neurodevelopmental disorders. Their research was recently published the American Journal of Human Genetics.

Dhindsa Lab uses “human genomics, human stem cell models, and computational biology to advance precision medicine.” The diagnoses that stem from the new computational tool could include specific types of autism spectrum disorder, epilepsy and developmental delay, disorders that often don’t come with a genetic diagnosis.

“Although researchers have made major strides identifying different genes associated with neurodevelopmental disorders, many patients with these conditions still do not receive a genetic diagnosis, indicating that there are many more genes waiting to be discovered,” Dhindsa says. Learn more.

Khaliah Guillory, Founder of Nap Bar

From nap research to diversity and inclusion, this entrepreneur is making Houston workers more productiveFrom opening Nap Bar and consulting corporations on diversity and inclusion to serving the city as an LGBT adviser, Khaliah Guillory is focused on productivity. Courtesy of Khaliah Guillory

Khalia Guillory launched her white-glove, eco-friendly rest sanctuary business, Nap Bar, in Houston in 2019 to offer a unique rest experience with artificial intelligence integration for working professionals, entrepreneurs and travelers who needed a place to rest, recharge and rejuvenate.

Now she is ready to take it to the next level, with a pivot to VR and plans to expand to 30 locations in three years.

Guillory says she’s now looking to scale the business by partnering with like-minded investors with experience in the wellness space. She envisions locations at national and international airports, which she says offer ripe scenarios for patrons needing to recharge. Additionally, Guillory wants to build on her initial partnership with UT Health by going onsite to curate rest experiences for patients, caregivers, faculty, staff, nurses and doctors. Colleges also offer an opportunity for growth. Learn more.

United breaks ground on $177 million facility and opens tech center at IAH

off the ground

United Airlines announced new infrastructure investments at George Bush Intercontinental Airport as part of the company’s ongoing $3.5 billion investment into IAH.

United broke ground on a new $177 million Ground Service Equipment (GSE) Maintenance Facility this week that will open in 2027.

The 140,000-square-foot GSE facility will support over 1,800 ground service vehicles and with expansive repair space, shop space and storage capacity. The GSE facility will also be targeted for LEED Silver certification. United believes this will provide more resources to assist with charging batteries, fabricating metal and monitoring electronic controls with improved infrastructure and modern workspaces.

Additionally, the company opened its new $16 million Technical Operations Training Center.

The center will include specialized areas for United's growing fleet, and advanced simulation technology that includes scenario-based engine maintenance and inspection training. By 2032, the Training Center will accept delivery of new planes. This 91,000-square-foot facility will include sheet metal and composite training shops as well.

The Training Center will also house a $6.3 million Move Team Facility, which is designed to centralize United's Super Tug operations. United’s IAH Move Team manages over 15 Super Tugs across the airfield, which assist with moving hundreds of aircraft to support flight departures, remote parking areas, and Technical Operations Hangars.

The company says it plans to introduce more than 500 new aircraft into its fleet, and increase the total number of available seats per domestic departure by nearly 30%. United also hopes to reduce carbon emissions per seat and create more unionized jobs by 2026.

"With these new facilities, Ground Service Equipment Maintenance Facility and the Technical Operations Training Center, we are enhancing our ability to maintain a world-class fleet while empowering our employees with cutting-edge tools and training,” Phil Griffith, United's Vice President of Airport Operations, said in a news release. “This investment reflects our long-term vision for Houston as a critical hub for United's operations and our commitment to sustainability, efficiency, and growth."

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