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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Houston family's $20M donation drives neurodegeneration research

big impact

Neurodegeneration is one of the cruelest ways to age, but one Houston family is sharing its wealth to invigorate research with the goal of eradicating diseases like Alzheimer’s.

This month, Laurence Belfer announced that his family, led by oil tycoon Robert Belfer, had donated an additional $20 million to the Belfer Neurodegeneration Consortium, a multi-institutional initiative that targets the study and treatment of Alzheimer’s disease.

This latest sum brings the family’s donations to BNDC to $53.5 million over a little more than a decade. The Belfer family’s recent donation will be matched by institutional philanthropic efforts, meaning BNDC will actually be $40 million richer.

BNDC was formed in 2012 to help scientists gain stronger awareness of neurodegenerative disease biology and its potential treatments. It incorporates not only The University of Texas MD Anderson Cancer Center, but also Baylor College of Medicine, Massachusetts Institute of Technology (MIT) and Icahn School of Medicine at Mount Sinai.

It is the BNDC’s lofty objective to develop five new drugs for Alzheimer’s disease and related disorders over the next 10 years, with two treatments to demonstrate clinical efficacy.

“Our goal is ambitious, but having access to the vast clinical trial expertise at MD Anderson ensures our therapeutics can improve the lives of patients everywhere,” BNDC Executive Director Jim Ray says in a press release. “The key elements for success are in place: a powerful research model, a winning collaborative team and a robust translational pipeline, all in the right place at the right time.”

It may seem out of place that this research is happening at MD Anderson, but scientists are delving into the intersection between cancer and neurological disease through the hospital’s Cancer Neuroscience Program.

“Since the consortium was formed, we have made tremendous progress in our understanding of the molecular and genetic basis of neurodegenerative diseases and in translating those findings into effective targeted drugs and diagnostics for patients,” Ray continues. “Yet, we still have more work to do. Alzheimer's disease is already the most expensive disease in the United States. As our population continues to age, addressing quality-of-life issues and other challenges of treating and living with age-associated diseases must become a priority.”

And for the magnanimous Belfer family, it already is.

3 Houston innovators to know this week

who's who

Editor's note: Every week, I introduce you to a handful of Houston innovators to know recently making headlines with news of innovative technology, investment activity, and more. This week's batch includes a podcast with the founder of a new venture firm, a former astronaut and recent award recipient, and a health care innovator with fresh funding.

Zach Ellis, founder and managing partner of South Loop Ventures

Zach Ellis explains on the Houston Innovators Podcast that South Loop Ventures plans to invest in promising companies from across the country and bring them into Houston's ecosystem to grow and scale. Photo via LinkedIn

Houston has a lot of the right ingredients for commercialization and scaling up companies, so when Zach Ellis moved to town to stand up a venture capital firm that made investments in diverse founders, he decided to go about it in an innovative way.

South Loop Ventures, which Ellis launched two years ago, invests in pre-seed and seed-stage startups across health care, climatetech, aerospace, sports, and fintech. While the first handful of investments, which have already been made, are into Houston-based companies, Ellis explains on the Houston Innovators Podcast that the firm plans to invest in promising companies from across the country and bring them into Houston's ecosystem to grow and scale.

"Any investor wants to feel like they are looking at the best possible investment opportunities in which to deploy capital," Ellis says on the show. "So that's reason No. 1 to cast your net as widely as possible.

"At the same time, you want to give any investment that you make greatest chances of success," he continues. "The biggest factor of success outside of the team and the capital you give them, is the customers that they can call upon. In bringing targeted companies to Houston or connecting them with Houston, you introduce the opportunity for them to achieve rapid scale and work with world-class partners very efficiently." Read more.


Toby R. Hamilton, founder and CEO of Hamilton Health Box

Dr. Toby Hamilton has secured $10 million to grow his company. Photo via tmc.edu

A Houston company that is working on a value-based model for primary care has fresh funding to support its mission.

Hamilton Health Box announced the completion of a $10 million series A funding round led by 1588 Ventures with participation from Memorial Hermann Health System, Impact Ventures by Johnson & Johnson Foundation, Texas Medical Center Venture Fund, and the Sullivan Brothers.

The company, founded in 2019 by Dr. Toby R. Hamilton, will use the funding to fuel its expansion into rural areas to help assist those living in Health Professional Shortage Areas, or HPSAs. Read more.

Ellen Ochoa, former astronaut and center director at the NASA's Johnson Space Center

Ellen Ochoa was recognized for her leadership at NASA Johnson and for being the first Hispanic woman in space. Photo via NASA

Two astronauts recently received Presidential Medals of Freedom from President Joe Biden for their leadership in space.

Ellen Ochoa, the former center director and astronaut at the NASA's Johnson Space Center in Houston, and Jane Rigby, senior project scientist for NASA’s James Webb Space Telescope, were honored at the White House on May 3.

Ochoa spent 30 years with NASA, which included being the 11th director of JSC, deputy center director of JSC, and director of Flight Crew Operations. She served on the nine-day STS-56 mission aboard the space shuttle Discovery in 1993, and became the first Hispanic woman in space. She flew four more times to space with STS-66, STS-96, STS-110, and more.

“I’m so grateful for all my amazing NASA colleagues who shared my career journey with me,” Ochoa says in a NASA news release. Read more.

Houston health care institutions receive $22M to attract top recruits

coming to Hou

Houston’s Baylor College of Medicine has received a total of $12 million in grants from the Cancer Prevention & Research Institute of Texas to attract two prominent researchers.

The two grants, which are $6 million each, are earmarked for recruitment of Thomas Milner and Radek Skoda. The Cancer Prevention & Research Institute of Texas (CPRIT) announced the grants May 14.

Milner, an expert in photomedicine for surgery and diagnostics, is a professor of surgery and biomedical engineering at the Beckman Laser Institute & Medical Clinic at the University of California, Irvine and the university’s Chao Family Comprehensive Cancer Center

In 2013, Milner was named Inventor of the Year by the University of Texas at Austin. At the time, he was a professor of biomedical engineering at UT. One of his major achievements is co-development of the MasSpec Pen, a handheld device that identifies cancerous tissue within 10 seconds during surgical procedures.

Skoda is a professor of molecular medicine in the Department of Biomedicine at the University of Basel and the University Hospital Basel, both in Switzerland. He specializes in developing treatments for myeloproliferative neoplasms, which are a group of blood diseases including leukemia.

Other recruitment grants provided by the institute to Houston-area organizations are:

  • $4 million for recruitment of Susan Bullman to the University of Texas M.D. Anderson Cancer Center. She was an assistant professor at Seattle’s Fred Hutchinson Cancer Center, where she studied the connection between microbes and cancer.
  • $4 million for recruitment of Oren Rom to the University of Texas M.D. Anderson Cancer Center. Rom is an assistant professor of pathology and translational pathobiology at Louisiana State University Shreveport.
  • Nearly $2 million for recruitment of Lauren Hagler to conduct RNA cancer biology at Texas A&M University. She is a postdoctoral scholar in biochemistry at Stanford University.

The institute also awarded grants to five companies in the Houston area:

  • $4.7 million to 7 Hills Pharma for development of immunotherapies to treat cancer and prevent infectious diseases.
  • $4.5 million to Indapta Therapeutics for the Phase 1 trial of a cell therapy for treatment of multiple myeloma and non-Hodgkin’s lymphoma.
  • $2.75 million to Bectas Therapeutics for development of antibodies and biomarkers to overcome a type of resistance T-cell checkpoint therapy.
  • $2.69 million to MS Pen Technologies for development of technology that differentiates between normal tissue and cancerous tissue during surgery.
  • $2.58 million to Crossbridge Bio for development of an antibody-drug combination to treat certain solid tumors.