Emerson Perin of the Texas Heart Institute, recently published the largest clinical trial of cell therapy for patients with chronic heart failure to-date included 580 patients at 52 sites throughout North America. Photo via texasheart.org

Emerson Perin’s end goal isn’t to treat heart failure. The medical director of The Texas Heart Institute says that he has his sights set firmly on curing the malady altogether. And, with the power of innovation and a strong team, the Houston-based cardiologist has a good chance of meeting his objective.

Perin first came to THI for fellowship training in 1988, following his residency in Miami and medical school in his birthplace of Brazil.

“This is a very special place,” the physician and researcher, whose titles also include director for THI’s Center for Clinical Research and vice president for medical affairs, tells InnovationMap. “It has a worldwide-reaching reputation. I’ve always liked research and this is a great place in terms of innovation and practicing high-level cardiology.”

For decades, Perin has followed in THI founder Denton Cooley’s footsteps with world-changing research. In 2001, the founding medical director of THI’s Stem Cell Center was the first person to inject stem cells into a failing human heart. It led to a trial of 17 patients that year.

“A couple of the patients did remarkably well — more than you could ever expect. These guys who couldn’t’ walk across the room pretty much were jogging on the beach. That gave me the initial insight that this works,” Perin recalls.

What exactly is heart failure? The term refers to the condition of a heart that can’t pump enough blood to sustainably power the body through oxygenation of the tissues from blood flow. It may sound like a death sentence, but with appropriate care, it can usually be managed with medicines and if worsening occurs, devices and, ultimately, heart transplantation.

And Perin is proving that there’s a lot of life ahead for heart failure patients. Earlier this year, he published another groundbreaking clinical trial, DREAM-HF. The largest clinical trial of cell therapy for patients with chronic heart failure to-date included 580 patients at 52 sites throughout North America.

With the goal of getting a new cell therapy approved for heart failure, the primary endpoint was to prove that the therapy could prevent recurrent hospitalizations.

“It was a total negative,” says Perin. That’s because the cells don’t have a decongestant effect such as the medicines currently used to treat heart failure.

But that doesn’t mean that the trial was a failure. Quite the opposite. That’s because Perin and his team proved something else: The trial was able to prove that there was significant improvement in patients with inflammation. After those patients were injected with mesenchymal precursor cells (MPC), they showed a 70-percent reduction in heart attacks and strokes. Cardiovascular deaths also decreased.

These are blockbuster numbers, and big news for patients dealing with heart failure. What it means is that the cells addressed a different aspect of heart failure that until now had been left untreated which was the inflammation — how heart failure starts and what keeps it going.

So what’s next? Going to the FDA.

“They said, ‘We can’t approve it with one trial, but we’ll approve it with two,’” says Perin.

This time, his primary endpoint will be tailored to suit the positive outcome he knows he’ll be able achieve. This next round will begin in 2024.

Once the FDA approves a new catheter system for injecting the heart with stem cells and genes, the team will proceed with new studies. Gene therapy will be another frontier for Perin — and patients with heart failure.

“I think the combination of cells and genes is even more powerful,” he says. “That will help save lives in a completely new way and do away with heart failure.”

Perin's work is just one piece of the puzzle, and Dr. Joseph Rogers, who was appointed president and CEO of THI in 2021, is leading the organization's initiative in several ways. THI, recently buoyed by a $32 million donation from a patient — the largest charitable donation in its history — is exploring several innovative therapeutics, devices, and treatments.

THI recently received a two-year, $1.14 million grant from The National Heart, Lung, and Blood Institute to develop a novel, first-in-class drug to treat the cardiovascular disease that arises from atherosclerosis. Another THI innovator, Camila Hochman-Mendez — along with her research team — is studying the effects of regenerative medicine on hearts.

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Houston healthtech leader launches clinical trial for innovative anxiety-treating device

making waves

Houston-based Nexalin Technology’s proprietary neurostimulation device will move forward with a new clinical trial evaluating its treatment of anxiety disorders and chronic insomnia in Brazil.

The first of Nexalin’s Gen-2 15-milliamp neurostimulation devices have been shipped to São Paulo, Brazil, and the study will be conducted at the Instituto de Psiquiatria university hospital (IPq-HCFMUSP). The shipments aim to support the launch of a Phase II clinical trial in adult patients suffering from anxiety and insomnia, according to a news release.

“Brazil is an important emerging market for mental health innovation, and this collaboration marks our first IRB-approved study in the region,” Mike White, CEO of Nexalin, said in the release.

The study will be led by Dr. Andre Russowsky Brunoni, who specializes in neuromodulation and interventional psychiatry. He currently serves as director of the interventional psychiatry division at IPq-HCFMUSP and this summer will join UT Southwestern in Dallas and its Peter O’Donnell Jr. Brain Institute as a professor of psychiatry.

The Phase II study plans to enroll 30 adults in São Paulo and assess the efficacy of Nexalin’s non-invasive deep intracranial frequency stimulation (DIFS™) of the brain in reducing anxiety symptoms and improving sleep quality, according to the company. Using the Hamilton Anxiety Rating Scale (HAM-A), the trial’s goal is a reduction in anxiety symptoms, and assessments of sleep onset latency, total sleep time, overall sleep quality, depressive symptoms and clinical impression of improvement. The company plans to share results in a peer-reviewed scientific journal.

“Anxiety and insomnia are very common conditions that often occur together and cause significant distress,” Brunoni added in the news release. “In this study, we are testing a new, non-invasive brain stimulation technology that has shown promising results in recent research. Our goal is to offer a safe, painless, and accessible alternative to improve people’s well being and sleep quality.”

The Nexalin Gen-2 15-milliamp neurostimulation device has been approved in China, Brazil, and Oman.

The company also enrolled the first patients in its clinical trial at the University of California, San Diego, in collaboration with the VA San Diego Healthcare System for its Nexalin HALO, which looks to treat mild traumatic brain injury and post-traumatic stress disorder in military personnel and the civilian population. It also recently raised $5 million through a public stock offering. Read more here.

Texas university to lead new FAA tech center focused on drones

taking flight

The Texas A&M University System will run the Federal Aviation Administration’s new Center for Advanced Aviation Technologies, which will focus on innovations like commercial drones.

“Texas is the perfect place for our new Center for Advanced Aviation Technologies,” U.S. Transportation Secretary Sean Duffy said in a release. “From drones delivering your packages to powered lift technologies like air taxis, we are at the cusp of an aviation revolution. The [center] will ensure we make that dream a reality and unleash American innovation safely.”

U.S. Sen. Ted Cruz, a Texas Republican, included creation of the center in the FAA Reauthorization Act of 2024. The center will consist of an airspace laboratory, flight demonstration zones, and testing corridors.

Texas A&M University-Corpus Christi will lead the initiative, testing unstaffed aircraft systems and other advanced technologies. The Corpus Christi campus houses the Autonomy Research Institute, an FAA-designated test site. The new center will be at Texas A&M University-Fort Worth.

The College Station-based Texas A&M system says the center will “bring together” its 19 institutions, along with partners such as the University of North Texas in Denton and Southern Methodist University in University Park.

According to a Department of Transportation news release, the center will play “a pivotal role” in ensuring the safe operation of advanced aviation technologies in public airspace.

The Department of Transportation says it chose the Texas A&M system to manage the new center because of its:

  • Proximity to major international airports and the FAA’s regional headquarters in Fort Worth
  • Existing infrastructure for testing of advanced aviation technologies
  • Strong academic programs and industry partnerships

“I’m confident this new research and testing center will help the private sector create thousands of high-paying jobs and grow the Texas economy through billions in new investments,” Cruz said.

“This is a significant win for Texas that will impact communities across our state,” the senator added, “and I will continue to pursue policies that create new jobs, and ensure the Lone Star State continues to lead the way in innovation and the manufacturing of emerging aviation technologies.”

Texas Republicans are pushing to move NASA headquarters to Houston

space city

Two federal lawmakers from Texas are spearheading a campaign to relocate NASA’s headquarters from Washington, D.C., to the Johnson Space Center in Houston’s Clear Lake area. Houston faces competition on this front, though, as lawmakers from two other states are also vying for this NASA prize.

With NASA’s headquarters lease in D.C. set to end in 2028, U.S. Sen. Ted Cruz, a Texas Republican, and U.S. Rep. Brian Babin, a Republican whose congressional district includes the Johnson Space Center, recently wrote a letter to President Trump touting the Houston area as a prime location for NASA’s headquarters.

“A central location among NASA’s centers and the geographical center of the United States, Houston offers the ideal location for NASA to return to its core mission of space exploration and to do so at a substantially lower operating cost than in Washington, D.C.,” the letter states.

Cruz is chairman of the Senate Committee on Commerce, Science, and Transportation; and Babin is chairman of the House Committee on Science, Space, and Technology. Both committees deal with NASA matters. Twenty-five other federal lawmakers from Texas, all Republicans, signed the letter.

In the letter, legislators maintain that shifting NASA’s headquarters to the Houston area makes sense because “a seismic disconnect between NASA’s headquarters and its missions has opened the door to bureaucratic micromanagement and an erosion of [NASA] centers’ interdependence.”

Founded in 1961, the $1.5 billion, 1,620-acre Johnson Space Center hosts NASA’s mission control and astronaut training operations. More than 12,000 employees work at the 100-building complex.

According to the state comptroller, the center generates an annual economic impact of $4.7 billion for Texas, and directly and indirectly supports more than 52,000 public and private jobs.

In pitching the Johnson Space Center for NASA’s HQ, the letter points out that Texas is home to more than 2,000 aerospace, aviation, and defense-related companies. Among them are Elon Musk’s SpaceX, based in the newly established South Texas town of Starbase; Axiom Space and Intuitive Machines, both based in Houston; and Firefly Aerospace, based in the Austin suburb of Cedar Park.

The letter also notes the recent creation of the Texas Space Commission, which promotes innovation in the space and commercial aerospace sectors.

Furthermore, the letter cites Houston-area assets for NASA such as:

  • A strong business environment.
  • A low level of state government regulation.
  • A cost of living that’s half of what it is in the D.C. area.

“Moving the NASA headquarters to Texas will create more jobs, save taxpayer dollars, and reinvigorate America’s space agency,” the letter says.

Last November, NASA said it was hunting for about 375,000 to 525,000 square feet of office space in the D.C. area to house the agency’s headquarters workforce. About 2,500 people work at the agency’s main offices. NASA’s announcement set off a scramble among three states to lure the agency’s headquarters.

Aside from officials in Texas, politicians in Florida and Ohio are pressing NASA to move its headquarters to their states. Florida and Ohio both host major NASA facilities.

NASA might take a different approach, however. “NASA is weighing closing its headquarters and scattering responsibilities among the states, a move that has the potential to dilute its coordination and influence in Washington,” Politico reported in March.

Meanwhile, Congressional Delegate Eleanor Holmes Norton, a Democrat who represents D.C., introduced legislation in March that would prohibit relocating a federal agency’s headquarters (including NASA’s) away from the D.C. area without permission from Congress.

“Moving federal agencies is not about saving taxpayer money and will degrade the vital services provided to all Americans across the country,” Norton said in a news release. “In the 1990s, the Bureau of Land Management moved its wildfire staff out West, only to move them back when Congress demanded briefings on new wildfires.”