Houston health tech startup revolutionizing spinal taps receives FDA clearance

tap in

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

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

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

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

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

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

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

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

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

Investors in IntuiTap include:

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

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

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

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

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

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

green light

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Houston immunotherapy company achieves FDA designation for cancer-fighting vaccine

got the green light

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

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

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

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

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

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

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

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

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

The at-home COVID-19 tests are now available. EverlyWell/Facebook

Texas startup’s at-home COVID-19 test finally approved by feds

CORONAVIRUS RESPONSE

After its earlier effort was tripped up, Austin-based startup Everlywell on May 16 finally gained approval from the U.S. Food and Drug Administration to launch its at-home coronavirus test.

In a May 18 release, Everlywell says the self-administered test will be available later this month. The company, which specializes in at-home tests for an array of conditions, is the first to receive approval from the FDA for an at-home coronavirus test that's not associated with a lab or a manufacturer of diagnostic products.

The FDA's emergency authorization allows Everlywell to work with a number of certified labs that process authorized tests, rather than just a single lab.

"The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, says in a release.

Everlywell's at­-home test determines the presence or absence of the novel coronavirus, which causes COVID­-19 illness. Everlywell's test kit uses a short nasal swab and includes:

  • A digital screening questionnaire reviewed by a healthcare provider.
  • Instructions on how to ship the test sample to a lab.
  • Digital results within 48 hours of the sample being received by the lab.
  • Results reviewed by an independent physician.

Anyone who tests positive test will receive a telehealth consultation. All positive test results are reported to federal and local public health agencies when mandated.

On March 23, Everlywell was supposed to start shipping 30,000 coronavirus test kits to U.S. consumers. But before a single test was sent, the FDA blocked distribution of at-home, self-administered tests from Everlywell and other companies. After that, Everlywell pivoted to supplying coronavirus tests to health care providers and organizations.

As with the company's previously approved coronavirus test, Everlywell says its test for individuals is sold at no profit. The $109 price covers costs such as overnight shipping to a lab, lab-processing fees, and kit components. Some health insurers cover coronavirus tests.

Everlywell says it's working with members of Congress to enable companies that are neither healthcare providers nor labs to be directly reimbursed by health insurers. The startup also is exploring how its coronavirus test could be made available for free.

"Widespread access to convenient testing will play a crucial role in the country's ability to address the pandemic and prevent overburdening our healthcare facilities. As the national leader in connecting people with high­-quality laboratory testing, we are committed to fighting the spread of this virus in America," Julia Cheek, founder and CEO of Everlywell, says in the Everlywell release.

The company continues to supply its coronavirus tests to qualified healthcare organizations and government agencies.

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This article originally ran on CultureMap.

The results are in for Houston-based Saranas' clinical trials. Courtesy of Saranas

Houston early bleeding detection device company reveals results of its clinical trials

blood tests

A Houston-based startup is closer to taking flight with a medical device designed to catch bleeding complications during medical procedures that involve blood vessels.

On May 22, researchers presented the results of a study showing the Early Bird Bleed Monitoring System from Houston-based Saranas Inc. detected various levels of bleeding in 63 percent of the patients who underwent endovascular procedures. These procedures treat problems, such as aortic aneurysms, that affect blood vessels.

No troubles were reported with the Early Bird device during the clinical trial, the researchers say.

Before this study, the Early Bird device hadn't been tested in humans. In all, 60 patients in five states participated in the clinical trial, which ran from August to December last year. Findings of the study were unveiled at the Society for Cardiovascular Angiography Interventions 2019 Scientific Sessions in Las Vegas.

The study's authors say they plan to continue evaluating the device at medical institutions that want to better manage bleeding during endovascular procedures.

"This is the first time we're seeing how this device could help in a real-world patient setting, and we were very encouraged by the results. Right now, patients have a risk of vessel injury when undergoing endovascular procedures where the femoral artery or vein is used for vascular access," Dr. Philippe Genereux, principal investigator for the study and a cardiologist at Morristown Medical Center in Morristown, New Jersey, says in a news release.

"This technology allows us to detect bleeding in real-time," Genereux adds, "which means we can take action quickly and improve the outcomes of the procedure and recovery for the patient."

In March, the Early Bird device — invented at Houston's Texas Heart Institute — received the U.S. Food and Drug Administration's approval as a "novel" medical device.

Saranas says Early Bird is the first and only device of its type. The FDA approval and the promising results of the clinical trial pave the way for the eventual launch of the device into the healthcare market.

A forecast from professional services firm KPMG predicts the global market for medical devices will reach nearly $800 billion by 2030. Early Bird aims to capture a sliver of that market by addressing an expensive and potentially fatal problem. One-fifth of patients experience bleeding complications during large-bore endovascular procedures. Research shows these complications are associated with a greater risk of death, longer hospital stays, and higher healthcare costs.

The Early Bird device is meant to decrease those complications by quickly alerting medical professionals to signs of bleeding during endovascular procedures.

As explained by the Texas Heart Institute, the Early Bird employs a sheath — a plastic tube that helps keep arteries and vessels open — embedded with sensors that measure the electrical resistance across a blood vessel. When the Early Bird senses a change in the electrical resistance, medical professionals receive audible and visual notifications about potential internal bleeding. If detected early, this bleeding can be minimized.

Altogether, Saranas has raised $12 million from investors, including a $2.8 million round in May 2018. The company was founded in 2013.

"What attracted me to Saranas is that our solution has the potential to meaningfully reduce serious bleeding complications that worsen clinical outcomes and drive up healthcare costs," says Zaffer Syed, who joined the startup as president and CEO in 2017. "In addition, our device may support access of important minimally invasive cardiac procedures by allowing them to be performed more safely."

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Houston chemist lands $2M NIH grant for cancer treatment research

future of cellular health

A Rice University chemist has landed a $2 million grant from the National Institute of Health for his work that aims to reprogram the genetic code and explore the role certain cells play in causing diseases like cancer and neurological disorders.

The funds were awarded to Han Xiao, the Norman Hackerman-Welch Young Investigator, associate professor of chemistry, from the NIH's Maximizing Investigators’ Research Award (MIRA) program, which supports medically focused laboratories.

Xiao will use the five-year grant to develop noncanonical amino acids (ncAAs) with diverse properties to help build proteins, according to a statement from Rice. He and his team will then use the ncAAs to explore the vivo sensors for enzymes involved in posttranslational modifications (PTMs), which play a role in the development of cancers and neurological disorders. Additionally, the team will look to develop a way to detect these enzymes in living organisms in real-time rather than in a lab.

“This innovative approach could revolutionize how we understand and control cellular functions,” Xiao said in the statement.

According to Rice, these developments could have major implications for the way diseases are treated, specifically for epigenetic inhibitors that are used to treat cancer.

Xiao helped lead the charge to launch Rice's new Synthesis X Center this spring. The center, which was born out of informal meetings between Xio's lab and others from the Baylor College of Medicine’s Dan L Duncan Comprehensive Cancer Center at the Baylor College of Medicine, aims to improve cancer outcomes by turning fundamental research into clinical applications.

They will build upon annual retreats, in which investigators can share unpublished findings, and also plan to host a national conference, the first slated for this fall titled "Synthetic Innovations Towards a Cure for Cancer.”

Houston neighbor ranks as one of America's most livable small cities

mo city

Some Houston suburbs stick out from the rest thanks to their affluent residents, and now Missouri City is getting time in the spotlight, thanks to its new ranking as the No. 77 most livable small city in the country.

The tiny but mighty Houston neighbor, located less than 20 miles southwest of Houston, was among six Texas cities that earned a top-100 ranking in SmartAsset's 2024 " Most Livable Small Cities" report. It compared 281 U.S. cities with populations between 65,000 and 100,000 residents across eight metrics, such as a resident's housing costs as a percentage of household income, the city's average commute times, and the proportions of entertainment, food service, and healthcare establishments.

According to the U.S. Census Bureau, Missouri City has an estimated population of over 76,000 residents, whose median household income comes out to $97,211. SmartAsset calculated that a Missouri City household's annual housing costs only take up 19.4 percent of that household's income. Additionally, the study found only six percent of the town's population live below the poverty level.

Here's how Missouri City performed in two other metrics in the study:

  • 1.4 percent – The proportion of arts, entertainment, and recreation businesses as a percentage of all businesses
  • 29.9 minutes – Worker's average commute time

But income and housing aren't the only things that make Missouri City one of the most livable small cities in Texas. Residents benefit from its proximity from central Houston, but the town mainly prides itself on its spacious park system, playgrounds, and other recreational activities.

Missouri City, Texas

Missouri City residents have plenty of parkland to enjoy. www.missouricitytx.gov

The Missouri City Parks and Recreation Departmen meticulously maintains 21 parks spanning just over 515 acres of land, an additional 500 acres of undeveloped parkland, and 14.4 miles of trails throughout the town, according to the city's website."Small cities may offer cost benefits for residents looking to stretch their income while enjoying a comfortable – and more spacious – lifestyle," the report's author wrote. "While livability is a subjective concept that may take on different definitions for different people, some elements of a community can come close to being universally beneficial."

Missouri City is also home to Fort Bend Town Square, a massive mixed-use development at the intersection of TX 6 and the Fort Bend Parkway. It offers apartments, shopping, and restaurants, including a rumored location of Trill Burgers.

Other Houston-area cities that earned a spot in the report include

Spring (No. 227) and Baytown (No. 254).The five remaining Texas cities that were among the top 100 most livable small cities in the U.S. include Flower Mound (No. 29), Leander (No. 60), Mansfield (No. 69), Pflugerville (No. 78), and Cedar Park (No. 85).

The top 10 most livable small cities in the U.S. are:

  • No. 1 – Troy, Michigan
  • No. 2 – Rochester Hills, Michigan
  • No. 3 – Eau Claire, Wisconsin
  • No. 4 – Franklin, Tennessee
  • No. 5 – Redmond, Washington
  • No. 6 – Appleton, Wisconsin
  • No. 7 – Apex, North Carolina
  • No. 8 – Plymouth, Minnesota
  • No. 9 – Livonia, Michigan
  • No. 10 – Oshkosh, Wisconsin

The report examined data from the U.S. Census Bureau's 2022 1-year American Community Survey and the 2021 County Business Patterns Survey to determine its rankings.The report and its methodology can be found on

smartasset.com

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This article originally ran on CultureMap.

Cart.com's $130M payday, Houston sees VC uptick and more top stories

top stories

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 big startup financing and VC funding, a feature on a Houston startup working on data solutions in the wake of Hurricane Beryl, and more.

Houston e-commerce unicorn secures $130M in financing

Cart.com announced a $25 million series C extension round and $105 million in debt refinancing from investment manager BlackRock. Photo courtesy of Cart.com

Houston-based Cart.com, which operates a multichannel commerce platform, has secured $105 million in debt refinancing from investment manager BlackRock.

The debt refinancing follows a recent $25 million series C extension round, bringing Cart.com’s series C total to $85 million. The scaleup’s valuation now stands at $1.2 billion, making it one of the few $1 billion-plus “unicorns” in the Houston area.

Cart.com says the new term loan facility from BlackRock consolidates its venture debt into one package “at competitive terms.” Those terms weren’t disclosed. Continue reading.

Report: Amid difficult market, Houston sees uptick in VC funding

In the first six months of this year, Houston-area startups attracted $760.55 million in VC funding, which is up 17.7 percent from the same time last year. Photo via Getty Images

Houston-area startups saw a healthy increase in venture capital funding during the first half of 2024 compared with the same period last year, new data shows.

In the first six months of this year, Houston-area startups attracted $760.55 million in VC funding, according to the latest PitchBook-NVCA Venture Monitor. That’s up 17.7 percent from the $645.99 million collected in the first six months of 2023. Continue reading.

Houston cardiac health startup raises $43 million series B to grow AI-backed platform

Octagos Health has announced a $43 million series B raise that will bring their technology to many more hearts. Image via octagoshealth.com

A Houston-based tech company that has a product line of software solutions for cardiac health has raised funding.

Octagos Health, the parent company of Atlas AI — a software platform for cardiac devices like pacemakers, defibrillators, ambulatory monitors and consumer wearables — has announced a $43 million series B raise that will bring their technology to many more hearts.

Morgan Stanley Investment Capital led the investment, which also included funds from Mucker Capital and other continuing strategic investors. The goal of the raise is to supply funds to accelerate Atlas AI’s growth across the United States and to expand into other areas of care, including ambulatory monitors, consumer wearables, and sleep. Continue reading.

Houston startup taps into tech to provide key data in the wake of Hurricane Beryl

Resilitix AI is contributing to relief efforts of Hurricane Beryl. Photo by Brandon Bell/Getty Images

A disaster AI startup based in Houston is using tech to aid in the relief effort of Hurricane Beryl and beyond.

Resilitix AI is an AI-based digital twin for “disaster situational awareness” that has partnered with local organizations to assist in the wake of Hurricane Beryl, a Category 1 storm that hit Houston Sunday, July 7, resulting in power outages for over 2 million Houstonians and other structural and environmental damage. The storm is estimated to have had a $3.3 billion impact.

“Our mission statement is that we want to disrupt disaster impact with intelligence — intelligence of knowing what is going on and emergency teams will have the information so it can provide and identify the areas in need since the information they currently have has significant lag, and the effort they need to go to get that information is significant,” Ali Mostafavi, Resilitix's founder, tells InnovationMap. Continue reading.

Energy giant announces deal retail company to bring EV tech to Houston malls

Two malls in town — The Galleria and Katy Mills Mall — soon see bp's EV charging Gigahubs. Photo via Wikipedia

Two Houston-area malls will be getting bp's electric vehicle charging technology thanks to a new global collaboration.

The global energy company will be bringing its global EV charging business, bp pulse, to 75 shopping facilities across the country thanks to a partnership with Simon Malls. Two malls in town — The Galleria and Katy Mills Mall — soon see bp's EV charging Gigahubs. The company will install and operate the chargers at the two area sites.

The deal aims to deliver over 900 ultra-fast charging bays that will support most make and model of EVs with the first locations opening to the public in early 2026. Other Texas locations include Grapevine Mills in Grapevine, and Austin’s Barton Creek Square. Continue reading.

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