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.

From Your Site Articles
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.

------

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."

Ad Placement 300x100
Ad Placement 300x600

CultureMap Emails are Awesome

Property Showcase

2 Houston space tech cos. celebrate major tech milestones

big wins

Two Houston aerospace companies — Intuitive Machines and Venus Aerospace — have reached testing milestones for equipment they’re developing.

Intuitive Machines recently completed the first round of “human in the loop” testing for its Moon RACER (Reusable Autonomous Crewed Exploration Rover) lunar terrain vehicle. The company conducted the test at NASA’s Johnson Space Center.

RACER is one of three lunar terrain vehicles being considered by NASA for the space agency’s Artemis initiative, which will send astronauts to the moon.

NASA says human-in-the-loop testing can reveal design flaws and technical problems, and can lead to cost-efficient improvements. In addition, it can elevate the design process from 2D to 3D modeling.

Intuitive Machines says the testing “proved invaluable.” NASA astronauts served as test subjects who provided feedback about the Moon RACER’s functionality.

The Moon RACER, featuring a rechargeable electric battery and a robotic arm, will be able to accommodate two astronauts and more than 880 pounds of cargo. It’s being designed to pull a trailer loaded with more than 1,760 pounds of cargo.

Another Houston company, Venus Aerospace, recently achieved ignition of its VDR2 rocket engine. The engine, being developed in tandem with Ohio-based Velontra — which aims to produce hypersonic planes — combines the functions of a rotating detonation rocket engine with those of a ramjet.

A rotating detonation rocket engine, which isn’t equipped with moving parts, rapidly burns fuel via a supersonic detonation wave, according to the Air Force Research Laboratory. In turn, the engine delivers high performance in a small volume, the lab says. This savings in volume can offer range, speed, and affordability benefits compared with ramjets, rockets, and gas turbines.

A ramjet is a type of “air breathing” jet engine that does not include a rotary engine, according to the SKYbrary electronic database. Instead, it uses the forward motion of the engine to compress incoming air.

A ramjet can’t function at zero airspeed, so it can’t power an aircraft during all phases of flight, according to SKYbrary. Therefore, it must be paired with another kind of propulsion, such as a rotating detonation rocket engine, to enable acceleration at a speed where the ramjet can produce thrust.

“With this successful test and ignition, Venus Aerospace has demonstrated the exceptional ability to start a [ramjet] at takeoff speed, which is revolutionary,” the company says.

Venus Aerospace plans further testing of its engine in 2025.

Venus Aerospace, recently achieved ignition of its VDR2 rocket engine. Photo courtesy of Venus Aerospace

METRO rolls out electric shuttles for downtown Houston commuters

on a roll

The innovative METRO microtransit program will be expanding to the downtown area, the Metropolitan Transit Authority of Harris County announced on Monday.

“Microtransit is a proven solution to get more people where they need to go safely and efficiently,” Houston Mayor John Whitmire said in a statement. “Connected communities are safer communities, and bringing microtransit to Houston builds on my promise for smart, fiscally-sound infrastructure growth.”

The program started in June 2023 when the city’s nonprofit Evolve Houston partnered with the for-profit Ryde company to offer free shuttle service to residents of Second and Third Ward. The shuttles are all-electric and take riders to bus stops, medical buildings, and grocery stores. Essentially, it works as a traditional ride-share service but focuses on multiple passengers in areas where bus access may involve hazards or other obstacles. Riders access the system through the Ride Circuit app.

So far, the microtransit system has made a positive impact in the wards according to METRO. This has led to the current expansion into the downtown area. The system is not designed to replace the standard bus service, but to help riders navigate to it through areas where bus service is more difficult.

“Integrating microtransit into METRO’s public transit system demonstrates a commitment to finding innovative solutions that meet our customers where they are,” said METRO Board Chair Elizabeth Gonzalez Brock. “This on-demand service provides a flexible, easier way to reach METRO buses and rail lines and will grow ridership by solving the first- and last-mile challenges that have hindered people’s ability to choose METRO.”

The City of Houston approved a renewal of the microtransit program in July, authorizing Evolve Houston to spend $1.3 million on it. Some, like council member Letitia Plummer, have questioned whether microtransit is really the future for METRO as the service cuts lines such as the University Corridor.

However, the microtransit system serves clear and longstanding needs in Houston. Getting to and from bus stops in the city with its long blocks, spread-out communities, and fickle pedestrian ways can be difficult, especially for poor or disabled riders. While the bus and rail work fine for longer distances, shorter ones can be underserved.

Even in places like downtown where stops are plentiful, movement between them can still involve walks of a mile or more, and may not serve for short trips.

“Our microtransit service is a game-changer for connecting people, and we are thrilled to launch it in downtown Houston,” said Evolve executive director Casey Brown. “The all-electric, on-demand service complements METRO’s existing fixed-route systems while offering a new solution for short trips. This launch marks an important milestone for our service, and we look forward to introducing additional zones in the new year — improving access to public transit and local destinations.”

———

This article originally ran on CultureMap.

Cart.com's M&A move, energy innovators recognized, and more top articles from the week

trending news

Editor's note:Let's roundup the most-read Houston innovation news from the week. Trending Houston tech and startup articles from InnovationMap and its daily newsletter included a new health tech grant for Houston researchers, Cart.com's latest acquisition, and more.

Houston med school lands $3.5M grant to rollout genetic telehealth platform for underserved newborns

Baylor College of Medicine received $3.5 million to expand its telehealth platform to improve genomic diagnostics and care for critically ill newborns in underserved neonatal intensive care units in West and South Texas. Photo by Tim Bish on Unsplash

Baylor College of Medicine received $3.5 million to help hospitals in Texas better care for and diagnose some of the state's most vulnerable patients.

The funds come from the National Human Genome Research Institute for the Making Genomics Accessible to Newborns in Texas, or MAGNET, program. They'll be used to adapt BCM's Consultagene telehealth platform to be used in underserved neonatal intensive care units in West and South Texas, according to a statement.

Families in this region of the state currently can travel up to 300 miles to reach the nearest in-state geneticist, according to MAGNET. The program aims to help close that gap through BCM's established remote consultation service. Investigators also plan to create educational videos in English and Spanish to educate providers and patient caregivers on genetic diagnoses.

“Only 20 years ago, less than 3 percent of genetic conditions in newborns could be molecularly diagnosed,” Dr. Brendan Lee, co-principal investigator and professor and chair of the Department of Molecular and Human Genetics and Robert and Janice McNair Endowed Chair in Molecular and Human Genetics at BCM, says in a statement. Continue reading.

Houston e-commerce platform expands logistics network with acquisition of fulfillment operations arm

Cart.com has acquired OceanX, adding two new facilities and expanding its logistics network to enhance efficiency and support high-volume beauty, wellness, and lifestyle brands. Photo courtesy of Cart.com

A Houston e-commerce unicorn has made its latest strategic acquisition.

Cart.com, which operates a multichannel commerce platform, announced that it has acquired Guthy-Renker's wholly-owned fulfillment operations arm OceanX. The terms of the deal were not disclosed. Around 200 OceanX employees will be assumed onto the Cart.com team, and the fast-growing company will add two new facilities totaling over 600,000 square feet to its network, expanding to include a West Coast distribution hub in Southern California and its third facility near Columbus, Ohio.

"Acquiring OceanX is part of Cart.com’s strategy to continue to scale our platform and capabilities across industries, leveraging our proprietary technology to improve efficiency and deliver superior results to our clients and their customers,” Omair Tariq, Cart.com founder and CEO, says in a news release. “By deploying our Constellation OMS and WMS software and seasoned operations team across these two new facilities, we will improve order visibility, labor efficiency, shipping costs and customer satisfaction for the benefit of our new clients.” Continue reading.

3 clean energy innovators make Forbes list of top young energy professionals

Three young professionals have made the cut for this year's Forbes Under 30 list in the Energy and Green Tech list for 2025. Photos via Forbes

A handful of Houstonians have been named to the Forbes 30 Under 30 Energy and Green Tech list for 2025.

Kip Daujotas is an investment associate at Aramco Ventures, a $7.5 billion venture capital arm of the world's largest energy company. Houston is the Americas headquarters for Saudi Aramco. Since its inception in 2012, Aramco Ventures has invested in more than 100 tech startups. Daujotas joined the team over two years ago after studying for an MBA at Yale University. He led Aramco’s first direct air capture (DAC) investment — in Los Alamos, New Mexico-based Spiritus.

Also representing the corporate side of the industry, Wenting Gao immigrated from Beijing to obtain an economics degree from Harvard University, then got a job at consulting giant McKinsey, where she recently became the firm’s youngest partner. Gao works on bringing sustainability strategies to energy and materials companies as well as investors. Her areas of expertise include battery materials, waste, biofuels, and low-carbon products.

Last but not least, Houston entrepreneur Rawand Rasheed is co-founder and CEO of Houston-based Helix Earth. He co-founded the startup after earning a doctoral degree from Rice University and co-inventing Helix’s core technology while at NASA, first as a graduate research fellow and then as an engineer. The core technology, a space capsule air filtration system, has been applied to retrofitting HVAC systems for commercial buildings. Continue reading.

Rice University, Houston Methodist launch new institute to revolutionize health care through AI, innovation

Rice University and Houston Methodist have partnered to create the Digital Health Institute, combining advanced technology, artificial intelligence, and interdisciplinary expertise to transform health care. Photos courtesy

Rice University and Houston Methodist have established through a multi-year joint effort the Digital Health Institute, which aims to transform healthcare through advanced technology and the collaborative expertises of the university and hospital.

Rice’s leadership in engineering, digital health and artificial intelligence will combine with Houston Methodist’s academic medicine and research infrastructure.

“This partnership embodies Rice’s bold vision to lead at the forefront of innovation in health and responsible AI,” Rice President Reginald DesRoches says in a news release. “By combining our strengths with Houston Methodist, we are creating a transformative platform to address critical challenges in healthcare with solutions that are ethical, accessible and impactful. This initiative exemplifies our commitment to driving interdisciplinary collaboration and advancing global health for the benefit of humanity.” Continue reading.

2 Houston professors named as fellows for prestigious group of inventors

Omid Veiseh from Rice University and Edward Ratner from the University of Houston have been named 2024 National Academy of Inventors fellows for their innovative contributions. Courtesy photos

The highest professional distinction awarded to academic inventors, the National Academy of Inventors, have elected two fellows from Rice University and the University of Houston for its 2024 class.

Edward Ratner, computer information systems lecturer in the Department of Information Science Technology at the University of Houston’s Cullen College of Engineering, and Omid Veiseh, bioengineer at Rice University and director of the Biotech Launch Pad, were two of the 170 honorees representing 39 states and 12 countries.

The 2024 class will be honored and presented their medals on June 26 in Atlanta, Georgia by a senior official of the U.S. Patent and Trademark Office. Continue reading.

View All Listings