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.

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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CultureMap Emails are Awesome

Looking back: Top 5 most-read Houston sports tech stories of 2024

year in review

Editor's note: As the year comes to a close, InnovationMap is looking back at the year's top stories in Houston innovation. Houston is a city primed for sports tech innovation — with its collection of major sports teams, vibrant population, and tech workforce. Here are five sports tech news stories that stood out to readers this year — be sure to click through to read the full story.

10 sports tech startups named to Houston-based hybrid accelerator

Introducing the 10 startups participating in the Spring 2024 cohort of the DivInc Sports Tech Accelerator, a hybrid program based in the Ion. Photo via DivInc.com

DivInc has named its latest sports tech-focused cohort of its hybrid accelerator that is housed out of the Ion.

The Sports Tech Accelerator has selected the 10 companies — with technology across human performance, fan experience, and more — for its 13th cohort to participate in the 12-week hybrid program this month and through July.

The program receives support from underdog venture team, Women In Sports Tech, The Collectiv, and HTX Sports Tech, with partners Bank of America, J.P. Morgan Chase & Co., Gunderson Dettmer, Brown Advisory, Ion, and Mercury. Continue reading.

High-tech virtual racing experience to rev up in Houston

Houston is getting 16 racing simulators, each equipped with full motion systems and immersive, 180-degree panoramic displays. Photo by Dylan McEwan

Come next year, some high-speed and high-tech race simulators will be added to one of Houston's growing districts.

Velocity - Sim Racing Lounge, described in press materials as Houston’s first premium simulation racing experience, is slated to open in early 2025 at 2110 Edwards St.Velocity will bring sim racing to Houston through 16 racing simulators, each equipped with full motion systems and immersive, 180-degree panoramic displays. The goal is provide customers with a truly authentic, virtual driving experience.

Customers will have the ability to virtually drive sports cars from iconic brands like Porsche and Lamborghini and race on world famous tracks, including the Circuit of the Americas, Laguna Seca, and the Silverstone Circuit. Classic roads, such as California’s Pacific Coast Highway, provide a more leisurely alternative to driving flat out. Continue reading.

Rice University announces partnership with Houston sports tech startup to enhance student athletics

Rice University's athletic programs will be supported by Houston startup BeOne Sports' technology. Photo courtesy of Rice University

Rice University — in an effort to enhance athletics and research-driven innovation — has formed a partnership with a startup founded by its alumni.

BeOne Sports, a sports performance technology company developed a platform for mobile motion-capture AI and advanced data analytics, will integrate its technology within Rice's sports medicine and rehabilitation programs.

“This partnership aligns perfectly with Rice University’s mission to harness innovation for the betterment of our community,” Rice President Reginald DesRoches says in a news release. “By integrating cutting-edge technology from BeOne Sports with our already world-class athletic and academic programs, we are providing our student athletes with the tools they need to excel both on the field and in life. This collaboration is a testament to Rice’s commitment to leading through innovation and offering unparalleled opportunities for our students.” Continue reading.

Diversity-focused sports tech accelerator opens applications to Houston innovators for the first time

Calling all sports tech startups founded by Black or Hispanic innovators. Photo via Getty Images

A global organization has announced it's opening applications to its equity-focused sports tech accelerator to Houston founders for the first time.

Thanks to a collaboration with Impact Hub and Black Ambition, the adidas Community Lab has expanded its footprint and is now accepting applicants from new markets, including Houston, Toronto, Los Angeles, Atlanta, and New York, for its 2024-2025 cohort.

The initiative, which has been running for three years, has a goal of supporting Black and Latino/a/e founders with mentorship, pitch training, event programming, and networking. The eight-month program also has $75,000 in grant funding to dole out to participants as well. Continue reading.

Houston sports tech startup aims to optimize unsold resale ticket market with new platform

Looking to score the best deal on your next game ticket? A new Houston-founded app promises to revolutionize the resale market. Photo via Getty Images

Online platforms have long simplified the process of buying, selling, and trading event tickets. But what happens when your tickets don’t sell or when you’re stuck with costly season tickets you can’t use? You might end up giving them away or leaving them unused, leading to a financial loss either way.

This is the challenge that Houstonian Jerin Varkey is willing to address with Offer Approved, a new platform that empowers sellers and buyers, guaranteeing that no seat goes unused.

The idea took root around two years ago when Varkey, a passionate sports fan and season ticket holder, faced a new challenge. After becoming a parent, he found himself unable to attend every game. Frustrated with traditional resale platforms, he quickly realized that high fees and limited time made it difficult to sell all his tickets, causing him to lose money each time. Continue reading.

Meeting America’s growing energy demands: Houston expert on how to build a workforce to fuel the future

guest column

U.S. energy consumption is projected to rise nearly 20 percent over the next decade — driven by advancements like AI, increasing electrification, and the growing demand for electric vehicles. While attention often centers on the technologies that generate power, the driver behind this transformation is the skilled workforce, which comprises men and women dedicated to enabling the nation's growth. Ensuring a steady supply of qualified workers is imperative for meeting the energy demands of the coming decade.

Developing this talent pipeline starts with a commitment to education. As the energy landscape evolves rapidly, educators play a crucial role in equipping the next generation with the skills to embrace new technologies and adapt to changing industry demands. This commitment to education is central to the Energy Education Foundation's (EEF) mission. It's also a cornerstone of EEF partner and board member, Coterra Energy's, efforts to be recognized as a leader in energy education.

At a recent Energy Education Exchange, hosted by Coterra and EEF, in collaboration with industry partners such as the American Petroleum Institute (API) and the Consumer Energy Alliance, over 50 educators and industry leaders gathered in Houston to address this need.

During the three-day event, educators, administrators, and industry professionals were immersed in the many facets of the oil and gas industry, learning best practices for incorporating energy education into their programs.

Educators experienced an in-depth tour of the San Jacinto College Center for Petrochemical, Energy, and Technology. As the largest petrochemical training facility in the Gulf Coast region, the center offered a unique look at industry-standard equipment, including a multifunctional glass pilot plant lab, a glycol distillation unit, and 35 specialized training labs. Participants engaged in demonstrations led by faculty and students, exploring circuits, on-campus refineries, and advanced machinery — essential experiences that bring classroom lessons to life.

The event also highlighted efforts at the high school level, exemplified by a presentation and tour at Energy Institute High School in Houston's historic Third Ward. The Institute showcased how project-based learning, robotics, and hands-on fabrication labs are shaping students' skills for the energy sector. The high school's mission aligns perfectly with EEF’s goals: sparking interest in energy among younger students, developing their skills, and paving a pathway toward lifelong careers in the industry.

API's "Lights On" reception concluded the first day, promoting networking among educators and industry professionals. By facilitating these connections, we are ensuring that educators learn about energy careers and establish ongoing relationships that can translate into opportunities for their students.

Keynotes throughout the exchange included Peter Beard, Senior Vice President of the Greater Houston Partnership, and Chris Menefee, President of Unit Drilling Company, who further emphasized the critical need for workforce development. Beard noted, "As our economy grows, we must ensure we have the electrons and the workforce to support that growth." He stressed that aligning skills with job requirements is more than just matching credentials; it's about upskilling and offering real career mobility.

Menefee echoed this sentiment, acknowledging the pressures on educators to prepare students for an ever-changing job market. He underscored his company's commitment to "quality over quantity" in hiring, prioritizing well-trained individuals, and emphasizing the value of strong foundational skills, which begin in the classroom, especially career and technology classrooms.

The Energy Day Festival in Houston provided an additional opportunity for educators and administrators to engage directly with the industry. Thousands attended, visiting booths set up by companies, trade groups, and educational institutions. EEF's own Mobile Energy Learning Units offered interactive exhibits designed to teach students of all ages about energy and career opportunities. The Units appearance at Energy Day was made possible by the American Petroleum Institute.

Looking forward, the U.S. must expand opportunities for the next generation of energy workers and provide educators with the necessary resources. The Energy Education Exchange is a significant step forward, but one initiative alone cannot shape an entire workforce. All stakeholders involved must invest in tools, training, and programs that empower educators and provide opportunities for students. As Domestic Policy Advisor Neera Tanden recently stated, "Apprenticeships are essential for advancing the economy and building critical skills."

It's time for a broader approach to ensure that the U.S. meets energy demands and leads the world in innovation and education. At the Energy Education Foundation, we are proud to be at the forefront of this mission, working alongside Coterra and other partners. By empowering educators, we empower the next generation—one that will fuel our nation's future. Together, we can build a workforce ready for the challenges ahead.

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Kristen Barley is the executive director of the Energy Education Foundation, an organization dedicated to inspiring the next generation of energy leaders by providing comprehensive, engaging education that spans the entire energy spectrum.

This article originally ran on EnergyCapital.

Houston startup acquired, plans to expand global medical device software solutions

exit this way

Houston-based Galen Data, a provider of cloud-based connectivity software for medical devices, has been acquired by health care-focused asset manager Lauxera Capital Partners. Financial terms weren’t disclosed.

Lauxera, based in France, says the Galen Data acquisition complements its 2022 purchase of Germany-based Matrix Requirements, a provider of software for medical device R&D and quality control teams.

“The Galen team has built an exceptional product providing medical device companies a cost-effective, compliant, and secure solution for medical device cloud connectivity,” Samuel Levy, founding partner of Lauxera, says in a news release.

Chris DuPont, co-founder and CEO of Galen Data, says the Lauxera deal “empowers us to take our business to the next level and better serve our clients while pushing forward the innovation that’s at the core of everything we do.”

Chris DuPont is the co-founder and CEO of Galen Data. Photo via LinkedIn

Galen Data had raised $7.21 million in venture capital since its founding in 2016, according to PitchBook. Investors included the Texas HALO Fund, the Houston Angel Network, Tamiami Angel Fund IV, and Zeeland Ventures. As of November 2023, Galen Data was valued at $18 million, according to Dealroom.co.

Customers of Galen Data include Austin-based Cardi/o, Houston-based Delphi Diagnostics, Houston-based Future Caridia, Austin-based Harmonic Bionics, Houston-based Tienovix, and Houston-based Zibrio.