LabReady ensures samples make it from the patient to the lab without compromising the quality of the sample. Photo via vaximmune.com

Houston-based Vax-Immune Diagnostics has commenced on a new multicenter clinical trial to roll out a specific lab test as a part of its LabReady product.

The 12-week study will analyze results from Group B Streptococcus lab tests in expecting mothers. Currently, 16 to 20 percent of pregnant women are affected by GBS, according to a news release, which will then infect their newborn through the childbirth process.

Vax-Immune's product, LabReady, enhances the transportation process of lab samples and aims to improve the quality of results in patients. The company is expected to report data from the trial this summer.

"Currently samples are not regulated through transport from the patient to the lab often causing inaccurate test results. And inaccurate test results can cause significant problems since medical decisions are based on these results," Dr. Leonard E. Weisman, president and chief technology officer at Vax-Immune Diagnostics, says in the release.

"Our device, LabReady collects, protects, processes, and prepares the sample from the patient through transport, so when it arrives at the laboratory, infection can easily and accurately be diagnosed."

This study is planned to randomize approximately 300 patients from 35 to 37 weeks of pregnancy, according to the release. GBS is the most common cause of infections such as sepsis, meningitis, and pneumonia among newborns. The Centers for Disease Control and Prevention, among other organizations, have launched efforts for screenings and tests to reduce cases of neonatal GBS disease.

Vax-Immune was a member of the Texas Medical Center's 2018 TMCx Medical Device cohort and pitched at the 7th TMCx Demo Day. The company is a JLABS @ TMC resident.

Over 700 people watched TMCx's Demo Day either in person or online. Photo by Cody Duty/TMC

5 Texas companies present the future of health care at TMCx's Demo Day

Homegrown heroes

After four months of product design, networking with medical professionals, pitching to investors, and more, 23 startup leaders had just a few minutes to show the medical community what they've achieved and where they're going next.

Over 700 attendees made it to TMCx's 7th Demo Day or tuned in online to see the results of Houston's award-winning medical devices accelerator program.

"It's really the draw of the experts within our 23 hospitals and clinics that really makes us quite special in our ecosystem compared to the East and West coasts," Texas Medical Center CEO Bill McKeon says. "We're proud to call ourselves the Third Coast of the life sciences."

The cohort, which is the most international to date with nine international companies, has already raised $73 million and confirmed 108 signed agreements for medical professional partnerships.

"The thing that cracks me up from time to time," says Erik Halvorsen, director of the TMC Innovation Institute, "is when you see these talks that say, 'what can the Houston ecosystem learn from Silicon Valley.' Well you know what, I think we're ready to flip that, and say, 'here's what can Silicon Valley learn from us here in Houston — what we've built and where we're headed.'"

From a wearable device that reduces back pain to a new technology that reduces suicidal thoughts, the cohort's presentations didn't disappoint. While all the cohorts made business connections to Houston in the months they were at TMCx, five of the 23 companies are based in Texas. Here are the companies with Lone Star State roots.

Articulate Labs

Articulate Labs' KneeStim allows for everyday activities to be muscle-building exercises.

Photo via articulatelabs.com

Herbie Kirn, co-founder and chief scientific officer of Articulate Labs, lost his leg from the knee down in a motorcycle accident and quickly wore through his other knee's cartilage. If he didn't do sufficient rehabilitation and physical therapy, he would lose function of that leg too.

Over 14 million people in the United States individuals suffer from chronic knee problems; however, whether it be due to time or cost, over 70 percent of those affected cannot attend the prescribed physical therapy.

Dallas-based Articulate Labs has a solution. The KneeStim device allows the patient to turn daily activities into rehabilitation exercises.

The company has raised a little over $500,000 already, but looks to raise $1 million with its next round of funding. Articulate Labs is also looking for more scientific and strategic partners.

Intelligent Implants

intelligent implants

Intelligent Implant's co-founder, Juan Pardo, told the crowd at Demo Day that his company's device allows for 50 percent faster bone growth in patients.

Photo by Cody Duty/TMC

Chronic lower back pain can result in a need for spinal fusion surgery — and 40 percent of those surgeries fail, says Juan Pardo, co-founder of Intelligent Implants, which has an office in Houston. Pardo and his team have come up with an implant that tracks post-op healing and introduces electronic stimulation wirelessly.

The device is the same size and shape as the spacer that surgeons currently use, but contains a technology that can deliver electronic stimulation therapy and monitor progress without needing batteries. The doctor is able to adjust treatment remotely, and the device can heal the patient 50 percent faster than the standard care.

Intelligent Implants was announced as the first in-residence company at the Center for Device Innovation by Johnson and Johnson and also launched its large animal studies. The company has a goal to raise $1.6 million, and has already secured $900,000 — $250,000 of which came from the new TMC Venture Fund.

Noleus Technologies

Swarna Balasubramaniam, an experienced surgeon, created a device that heal gastrointestinal surgery patients faster.

Photo by Cody Duty/TMC

Swarna Balasubramaniam watched helplessly as her mom slowly healed from gastrointestinal surgery. She couldn't eat and had trouble sleeping — both of which hindered her ability to heal quickly.

Balasubramaniam, founder of Houston-based Noleus Technologies, created a solution that reduces swelling in the bowels after operation. The disposable device is inserted into the abdomen at the time of surgery, and folds up like a fan to be removed without another surgery.

The invention is attractive to all parties involved. Patients are able to heal quicker, and surgeons are able to provide better care for their patients. Additionally, hospitals, which have bundled reimbursement for surgeries like this, are able to shorten the recovery time for patients thus reducing the costs spent on caring for the patient. Balasubramaniam says she estimates the device saving hospitals $4,000 per patient.

Vax-Immune Diagnostics

LabReady ensures samples make it from the patient to the lab without compromising the quality of the sample.

Photo via vaximmune.com

Over 70 percent of care decisions come from lab results, but more than 20 percent of microbiology lab tests are inaccurate due to problems in transport from the patient to the lab. Leonard Weisman, founder and chief technology officer of Houston-based Vax-Immune Diagnostics, invented Lab Ready — a tool for protecting the quality of the sample for testing.

The device is easy for patients to use at home and send to the lab directly, and the device is likewise easy to use by lab technicians.

Lab Ready is prepared to launch in 2019, immediately following FDA approval. Vax-Immune is on track to meet its funding goal of $5 million in the first quarter of 2019.

VenoStent

VenoStent wants every external stent procedure is successful on its first try.

Photo via venostent.com

Patients with kidney disease or diabetes have four chances to get an external stent successfully inserted into their arms for dialysis treatment, and the current standard of care results in a failure in half of these access sites, says Tim Biore, founder of Houston-based VenoStent.

It was Biore's vision to create a device that allows a successful stent implementation on the first try. VenoStent's SelfWrap is made from a shape-memory polymer that uses body heat to mold the stent into the vein-artery junction.

One in eight people suffer from kidney disease, and Biore says SelfWrap would save Medicare upwards of $200 million annually, while improving the success rate by 20 to 30 percent.

VenoStent has seven signed agreements from partners as a result of the accelerator program. The company is seeking $2.4 million to continue manufacturing as they await FDA clearance — expected in early 2022.

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Health tech startup launches Houston study improve stroke patients recovery

now enrolling

A Houston-born company is enrolling patients in a study to test the efficacy of nerve stimulation to improve outcomes for stroke survivors.

Dr. Kirt Gill and Joe Upchurch founded NeuraStasis in 2021 as part of the TMC Biodesign fellowship program.

“The idea for the company manifested during that year because both Joe and I had experiences with stroke survivors in our own lives,” Gill tells InnovationMap. It began for Gill when his former college roommate had a stroke in his twenties.

“It’s a very unpredictable, sudden disease with ramifications not just for my best friend but for everyone in his life. I saw what it did to his family and caregivers and it's one of those things that doesn't have as many solutions for people to continue recovery and to prevent damage and that's an area that I wanted to focus myself on in my career,” Gill explains.

Gill and Upchurch arrived at the trigeminal and vagus nerves as a potential key to helping stroke patients. Gill says that there is a growing amount of academic literature that talks about the efficacy of stimulating those nerves. The co-founders met Dr. Sean Savitz, the director of the UTHealth Institute for Stroke and Cerebrovascular Diseases, during their fellowship. He is now their principal investigator for their clinical feasibility study, located at his facility.

The treatment is targeted for patients who have suffered an ischemic stroke, meaning that it’s caused by a blockage of blood flow to the brain.

“Rehabilitation after a stroke is intended to help the brain develop new networks to compensate for permanently damaged areas,” Gill says. “But the recovery process typically slows to essentially a standstill or plateau by three to six months after that stroke. The result is that the majority of stroke survivors, around 7.6 million in the US alone, live with a form of disability that prevents complete independence afterwards.”

NeuraStasis’ technology is intended to help patients who are past that window. They accomplish that with a non-invasive brain-stimulation device that targets the trigeminal and vagus nerves.

“Think of it kind of like a wearable headset that enables stimulation to be delivered, paired to survivors going through rehabilitation action. So the goal here is to help reinforce and rewire networks as they're performing specific tasks that they're looking to improve upon,” Gill explains.

The study, which hopes to enroll around 25 subjects, is intended to help people with residual arm and hand deficits six months or more after their ischemic stroke. The patients enrolled will receive nerve stimulation three times a week for six weeks. It’s in this window that Gill says he hopes to see meaningful improvement in patients’ upper extremity deficits.

Though NeuraStasis currently boasts just its two co-founders as full-time employees, the company is seeing healthy growth. It was selected for a $1.1 million award from the National Institutes of Health through its Blueprint MedTech program. The award was funded by the National Institute of Neurological Disorders and Stroke. The funding furthers NeuraStasis’ work for two years, and supports product development for work on acute stroke and for another product that will aid in emergency situations.

Gill says that he believes “Houston has been tailor-made for medical healthcare-focused innovation.”

NeuraStasis, he continues, has benefited greatly from its advisors and mentors from throughout the TMC, as well as the engineering talent from Rice, University of Houston and Texas A&M. And the entrepreneur says that he hopes that Houston will benefit as much from NeuraStasis’ technology as the company has from its hometown.

“I know that there are people within the community that could benefit from our device,” he says.

Texas Space Commission launches, Houston execs named to leadership

future of space

Governor Greg Abbott announced the Texas Space Commission, naming its inaugural board of directors and Texas Aerospace Research and Space Economy Consortium Executive Committee.

The announcement came at NASA's Johnson Space Center, and the governor was joined by Speaker Dade Phelan, Representative Greg Bonnen, Representative Dennis Paul, NASA's Johnson Space Center Director Vanessa Wyche, and various aerospace industry leaders.

According to a news release, the Texas Space Commission will aim to strengthen commercial, civil, and military aerospace activity by promoting innovation in space exploration and commercial aerospace opportunities, which will include the integration of space, aeronautics, and aviation industries as part of the Texas economy.

The Commission will be governed by a nine-member board of directors. The board will also administer the legislatively created Space Exploration and Aeronautics Research Fund to provide grants to eligible entities.

“Texas is home to trailblazers and innovators, and we have a rich history of traversing the final frontier: space,” Lieutenant Governor Dan Patrick says in a news release. “Texas is and will continue to be the epicenter for the space industry across the globe, and I have total confidence that my appointees to the Texas Space Commission Board of Directors and the Texas Aerospace Research and Space Economy Consortium Executive Committee will ensure the Texas space industry remains an international powerhouse for cutting-edge space innovation.”

TARSEC will independently identify research opportunities that will assist the state’s position in aeronautics research and development, astronautics, space commercialization, and space flight infrastructure. It also plans to fuel the integration of space, aeronautics, astronautics, and aviation industries into the Texas economy. TARSEC will be governed by an executive committee and will be composed of representatives of each higher education institution in the state.

“Since its very inception, NASA’s Johnson Space Center has been home to manned spaceflight, propelling Texas as the national leader in the U.S. space program,” Abbott says during the announcement. “It was at Rice University where President John F. Kennedy announced that the U.S. would put a man on the moon—not because it was easy, but because it was hard.

"Now, with the Texas Space Commission, our great state will have a group that is responsible for dreaming and achieving the next generation of human exploration in space," he continues. "Texas is the launchpad for Mars, innovating the technology that will colonize humanity’s first new planet. As we look into the future of space, one thing is clear: those who reach for the stars do so from the great state of Texas. I look forward to working with the Texas Space Commission, and I thank the Texas Legislature for partnering with industry and higher education institutions to secure the future of Texas' robust space industry."

The Houston-area board of directors appointees included:

  • Gwen Griffin, chief executive officer of the Griffin Communications Group
  • John Shannon, vice president of Exploration Systems at the Boeing Company
  • Sarah "Sassie" Duggleby, co-founder and CEO of Venus Aerospace
  • Kirk Shireman, vice president of Lunar Exploration Campaigns at Lockheed Martin
  • Dr. Nancy Currie-Gregg, director of the Texas A&M Space Institute

Additionally, a few Houstonians were named to the TARSEC committee, including:

  • Stephanie Murphy, CEO and executive chairman of Aegis Aerospace
  • Matt Ondler, president and former chief technology officer at Axiom Space
  • Jack “2fish” Fischer, vice president of production and operations at Intuitive Machines
  • Brian Freedman, president of the Bay Area Houston Economic Partnership and vice chairman of Wellby Financial
  • David Alexander, professor of physics and astronomy and director of the Rice Space Institute at Rice University

To see the full list of appointed board and committee members, along with their extended bios, click here.