Houston medical device startup implants artificial heart in first human patient

big win

BiVACOR and The Texas Heart Institute have celebrated a major milestone in the future of heart health. Photo courtesy of BiVACOR

Heart health tech company BiVACOR and The Texas Heart Institute announced that they successfully implanted the company's first Total Artificial Heart in a human at Baylor St. Luke’s Medical Center in the TMC.

The milestone is part of an FDA-approved early feasibility study that will test the safety and performance of the TAH device, which is based on a magnetically levitated rotor that takes over functions of a failing heart while a patient is awaiting a heart transplant, according to a statement from the organizations.

The "bridge-to-transplant" device could support an active adult male, as well as many women and children suffering from severe biventricular heart failure or univentricular heart failure.

"With heart failure remaining a leading cause of mortality globally, the BiVACOR TAH offers a beacon of hope for countless patients awaiting a heart transplant,” Dr. Joseph Rogers, president and CEO of THI and national principal investigator on the research, says in a statement. “We are proud to be at the forefront of this medical breakthrough, working alongside the dedicated teams at BiVACOR, Baylor College of Medicine, and Baylor St. Luke’s Medical Center to transform the future of heart failure therapy for this vulnerable population.”

BiVACOR received approval from the FDA for the early feasibility study in late 2023 and has four other patients enrolled in the study. At the time the study was approved, 10 hospitals were enrolled as possible sites.

“I’m incredibly proud to witness the successful first-in-human implant of our TAH. This achievement would not have been possible without the courage of our first patient and their family, the dedication of our team, and our expert collaborators at The Texas Heart Institute ... our TAH brings us one step closer to providing a desperately needed option for people with end-stage heart failure who require support while waiting for a heart transplant. I look forward to continuing the next phase of our clinical trial,” Daniel Timms, PhD, founder and CTO of BiVACOR, adds.

About 100,000 patients suffering from severe heart failure could benefit from BiVACOR’s artificial heart, the company says. Globally, only about 6,000 heart transplants are performed each year, while 26 million people worldwide are affected by heart failure.

BiVACOR was founded in 2008 and maintains its headquarters in Houston, along with offices in Huntington Beach, California, and Brisbane, Australia.

To date, the company has raised nearly $50.8 million, according to CB Insights. The company raised $18 million in 2023, and $22 million in 2021.

Earlier this year, BiVACOR named a new CEO in Jim Dillon, a longtime executive in the medical device sector.

Last summer, Rogers joined the Houston Innovators Podcast to share his excitement with THI's innovations.


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Autonomous truck company rolls out driverless Houston-Dallas route

up and running

Houston is helping drive the evolution of self-driving freight trucks.

In October, Aurora opened a more than 90,000-square-foot terminal at a Fallbrook Drive logistics hub in northwest Houston to support the launch of its first “lane” for driverless trucks—a Houston-to-Dallas route on the Interstate 45 corridor. Aurora opened its Dallas-area terminal in April and the company began regular driverless customer deliveries between the two Texas cities on April 27.

Close to half of all truck freight in Texas moves along I-45 between Houston and Dallas.

“Now, we are the first company to successfully and safely operate a commercial driverless trucking service on public roads. Riding in the back seat for our inaugural trip was an honor of a lifetime – the Aurora Driver performed perfectly and it’s a moment I’ll never forget,” Chris Urmson, CEO and co-founder of Pittsburgh-based Aurora, said in a news release.

Aurora produces software that controls autonomous vehicles and is known for its flagship product, the Aurora Driver. The software is installed in Volvo and Paccar trucks, the latter of which includes brands like Kenworth and Peterbilt.

Aurora previously hauled more than 75 loads per week under the supervision of vehicle operators from Houston to Dallas and Fort Worth to El Paso for customers in its pilot project, including FedEx, Uber Freight and Werner. To date, it has completed over 1,200 miles without a driver.

The company launched its new Houston to Dallas route with customers Uber Freight and Hirschbach Motor Lines, which ran supervised commercial pilots with Aurora.

“Transforming an old school industry like trucking is never easy, but we can’t ignore the safety and efficiency benefits this technology can deliver. Autonomous trucks aren’t just going to help grow our business – they’re also going to give our drivers better lives by handling the lengthier and less desirable routes,” Richard Stocking, CEO of Hirschbach Motor Lines, added in the statement.

The company plans to expand its service to El Paso and Phoenix by the end of 2025.

“These new, autonomous semis on the I-45 corridor will efficiently move products, create jobs, and help make our roadways safer,” Gov. Greg Abbott added in the release. “Texas offers businesses the freedom to succeed, and the Aurora Driver will further spur economic growth and job creation in Texas. Together through innovation, we will build a stronger, more prosperous Texas for generations.”

In July, Aurora said it raised $820 million in capital to fuel its growth—growth that’s being accompanied by scrutiny.

In light of recent controversies surrounding self-driving vehicles, the International Brotherhood of Teamsters, whose union members include over-the-road truckers, recently sent a letter to Lt. Gov. Dan Patrick calling for a ban on autonomous vehicles in Texas.

“The Teamsters believe that a human operator is needed in every vehicle—and that goes beyond partisan politics,” the letter states. “State legislators have a solemn duty in this matter to keep dangerous autonomous vehicles off our streets and keep Texans safe. Autonomous vehicles are not ready for prime time, and we urge you to act before someone in our community gets killed.”

Houston cell therapy company launches second-phase clinical trial

fighting cancer

A Houston cell therapy company has dosed its first patient in a Phase 2 clinical trial. March Biosciences is testing the efficacy of MB-105, a CD5-targeted CAR-T cell therapy for patients with relapsed or refractory CD5-positive T-cell lymphoma.

Last year, InnovationMap reported that March Biosciences had closed its series A with a $28.4 million raise. Now, the company, co-founded by Sarah Hein, Max Mamonkin and Malcolm Brenner, is ready to enroll a total of 46 patients in its study of people with difficult-to-treat cancer.

The trial will be conducted at cancer centers around the United States, but the first dose took place locally, at The University of Texas MD Anderson Cancer Center. Dr. Swaminathan P. Iyer, a professor in the department of lymphoma/myeloma at MD Anderson, is leading the trial.

“This represents a significant milestone in advancing MB-105 as a potential treatment option for patients with T-cell lymphoma who currently face extremely limited therapeutic choices,” Hein, who serves as CEO, says. “CAR-T therapies have revolutionized the treatment of B-cell lymphomas and leukemias but have not successfully addressed the rarer T-cell lymphomas and leukemias. We are optimistic that this larger trial will further validate MB-105's potential to address the critical unmet needs of these patients and look forward to reporting our first clinical readouts.”

The Phase 1 trial showed promise for MB-105 in terms of both safety and efficacy. That means that potentially concerning side effects, including neurological events and cytokine release above grade 3, were not observed. Those results were published last year, noting lasting remissions.

In January 2025, MB-105 won an orphan drug designation from the FDA. That results in seven years of market exclusivity if the drug is approved, as well as development incentives along the way.

The trial is enrolling its single-arm, two-stage study on ClinicalTrials.gov. For patients with stubborn blood cancers, the drug is providing new hope.

Elon Musk's SpaceX site officially becomes the city of Starbase, Texas

Starbase, Texas

The South Texas home of Elon Musk’s SpaceX rocket company is now an official city with a galactic name: Starbase.

A vote Saturday, May 3, to formally organize Starbase as a city was approved by a lopsided margin among the small group of voters who live there and are mostly Musk’s employees at SpaceX. With all the votes in, the tally was 212 in favor to 6 against, according to results published online by the Cameron County Elections Department.

Musk celebrated in a post on his social platform, X, saying it is “now a real city!”

Starbase is the facility and launch site for the SpaceX rocket program that is under contract with the Department of Defense and NASA that hopes to send astronauts back to the moon and someday to Mars.

Musk first floated the idea of Starbase in 2021 and approval of the new city was all but certain. Of the 283 eligible voters in the area, most are believed to be Starbase workers.

The election victory was personal for Musk. The billionaire’s popularity has diminished since he became the chain-saw-wielding public face of President Donald Trump’s federal job and spending cuts, and profits at his Tesla car company have plummeted.

SpaceX has generally drawn widespread support from local officials for its jobs and investment in the area.

But the creation of an official company town has also drawn critics who worry it will expand Musk’s personal control over the area, with potential authority to close a popular beach and state park for launches.

Companion efforts to the city vote include bills in the state Legislature to shift that authority from the county to the new town’s mayor and city council.

All these measures come as SpaceX is asking federal authorities for permission to increase the number of South Texas launches from five to 25 a year.

The city at the southern tip of Texas near the Mexico border is only about 1.5 square miles (3.9 square kilometers), crisscrossed by a few roads and dappled with airstream trailers and modest midcentury homes.

SpaceX officials have said little about exactly why they want a company town and did not respond to emailed requests for comment.

“We need the ability to grow Starbase as a community,” Starbase General Manager Kathryn Lueders wrote to local officials in 2024 with the request to get the city issue on the ballot.

The letter said the company already manages roads and utilities, as well as “the provisions of schooling and medical care” for those living on the property.

SpaceX officials have told lawmakers that granting the city authority to close the beach would streamline launch operations. SpaceX rocket launches and engine tests, and even just moving certain equipment around the launch base, requires the closure of a local highway and access to Boca Chica State Park and Boca Chica Beach.

Critics say beach closure authority should stay with the county government, which represents a broader population that uses the beach and park. Cameron County Judge Eddie Trevino, Jr. has said the county has worked well with SpaceX and there is no need for change.

Another proposed bill would make it a Class B misdemeanor with up to 180 days in jail if someone doesn’t comply with an order to evacuate the beach.

The South Texas Environmental Justice Network, which has organized protests against the city vote and the beach access issue, held another demonstration Saturday that attracted dozens of people.

Josette Hinojosa, whose young daughter was building a sandcastle nearby, said she was taking part to try to ensure continued access to a beach her family has enjoyed for generations.

With SpaceX, Hinojosa said, “Some days it’s closed, and some days you get turned away."

Organizer Christopher Basaldú, a member of the Carrizo/Comecrudo Nation of Texas tribe, said his ancestors have long been in the area, where the Rio Grande meets the Gulf.

“It’s not just important,” he said, “it’s sacred.”

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