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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Promising Houston sleep tech startup readies for big year of growth, work toward FDA clearance

HOUSTON INNOVATORS PODCAST EPISODE 268

There's a slew of treatment options for people living with sleep apnea. But, the bigger problem, as Meagan Pitcher realized during her time at the Texas Medical Center's Biodesign program, is that there's no easy way to reliably diagnose and determine a treatment plan for patients.

"We saw all of the companies trying to solve the problem of making the airway collapse less or make the air way wider — it might be surgery, might be medication, or nerve stimulation," Pitcher says on the Houston Innovators Podcast. "One of the things we found was that it was really hard to match a patient with sleep apnea with a good treatment for them. One of the reasons is it's hard to get an understanding of where the individual's site of collapse is as sleep medicine is currently practiced."

As Pitcher went through the TMC Biodesign program, she teamed up with her co-founders — CTO Onur Kilicand and CMO Britt Cross — to find a solution, and together they developed Bairitone Health. The company's technology provides at-home medical imaging using sonar sensing. The non-invasive device has the potential to replace the current standard of care, which is a surgical procedure.



This year, the company joined Activate Houston's inaugural cohort as the lone biotech company. Activate, which announced its expansion to Houston in 2023, helps hardtech founders develop and grow their companies from bench to commercialization, though it mostly focuses on industrial or climatetech innovators. In addition to this accomplishment, Bairitone Health was among the 2024 Houston Innovation Awards finalists.

While 2024 was successful for the company, next year should bring even more milestones for Bairitone, Pitcher says, including a seed round of funding that will support the growth of their team, fund early testing, and fuel Baritone's path toward FDA clearance.

"2025 is going to be a big year for Bairitone, especially around solidifying our regulatory plan. The device we're making is really low risk — we're not putting anything into the body, and we're potentially replacing a surgical procedure," Pitcher says. "We've always hypothesized that we'll have a 510(k) clearance with the FDA, but we're moving toward having our first meeting with the FDA to solidify those plans."

Bairitone's journey so far has been a uniquely Houston story, as Pitcher acknowledges.

"I really love Houston — especially for med tech. The medical center is just awesome, you have all these brilliant people coming in from the entire world to work at these institutions," Pitcher says. "It's kind of because of this atmosphere of excellence around health care, innovation, open mindedness, and collaboration — those are reasons why I really love working in Houston."

Top stories: Houston's most-read health tech news of 2024

year in review

Editor's note: As the year comes to a close, InnovationMap is looking back at the year's top stories in Houston innovation. In the health tech category on InnovationMap, top stories included startup funding raised, IPO plans, FDA clearance, and more. Be sure to click through to read the full story.

New report ranks Houston top market for life sciences

Houston lands in the No. 7 spot for growth in the granting of degrees in biological and biomedical sciences. Photo by Natalie Harms/InnovationMap

Thanks in large part to producing hundreds of college-trained professionals, Houston’s life sciences industry ranks among the top U.S. markets for talent in 2024.

In a report published by commercial real estate services company CBRE, Houston lands in the No. 7 spot for growth in the granting of degrees in biological and biomedical sciences. From 2017 to 2022, Houston notched a growth rate of 32.4 percent in this category.

In 2022, the University of Houston led the higher education pack in the region, graduating 746 people with a bachelor’s degree or above in biological or biomedical sciences, according to the report. Continue reading.

Houston innovator raises pre-seed funding for health care staffing platform

Ayoade Joy Ademuyewo founded Lokum last year to create a solution to better connecting medical specialists with health care facilities nationwide. Photo courtesy of Lokum

A Houston health care innovator is celebrating an oversubscribed round of pre-seed funding to improve on her startup's unique staffing platform.

Ayoade Joy Ademuyewo founded Lokum last year to create a solution to better connecting medical specialists with health care facilities nationwide. The new platform, which cuts out the middleman and lowers staffing costs, raised $700,000 in pre-seed funding that will go toward further development of the technology.

"Healthcare organizations spend $26 billion annually to support a crippling dependence on third-party agencies for connecting with clinical staff," Ademuyewo says in a news release. "Technological solutions that are pointed precisely to streamline and strengthen the relationships between highly specialized clinicians and their future employers are vital to alleviating this detrimental dependance, and central to our mission." Continue reading.

Houston regenerative medicine company to IPO, move toward more human trials

FibroBiologics will IPO this week. Photo via Getty Images

Want a piece of one of Houston’s most promising biotech companies? On January 31, FibroBiologics will begin the trading of its common stock on the Nasdaq stock exchange.

While most labs in the realm of regenerative medicine are focused on stem cells, FibroBiologics has bet on fibroblasts as the secret to treating myriad ailments. Fibroblasts, the most common type of cell in the body, are the primary cells that compose connective tissue.

Interested investors can find a prospectus to peruse before taking the leap. FibroBiologics filed with the U.S. Securities & Exchange Commission (SEC) on November 7, 2023. In September, FibroBiologics CEO Pete O’Heeron told InnovationMap, “I think what we're going to see is that fibroblasts are going to end up winning... They're just a better overall cell than the stem cells.” Continue reading.

Houston organizations identify promising life science cos. at annual event

The Rice Alliance and BioHouston acknowledged innovations from a dozen promising health tech companies. Photo via Rice University

For the 13th year, the Texas Life Science Forum hosted by BioHouston and the Rice Alliance for Technology and Entrepreneurship celebrated innovative companies from around the world that are creating new treatments and solutions to today's biggest health care challenges.

This week, over 40 companies presenting their innovations across cancer, cardiovascular disease, biotechnology, and more. Nearly 700 venture capitalists, corporate innovation groups, angel networks, industry leaders, academics, service providers, and others attended the event on November 7 at Rice's BioScience Research Collaborative in the Texas Medical Center.

Just like in previous years, the event ended with the announcement of the 10 companies that were deemed "most promising" based on their pitches and technologies. Of the 10 companies named, six are headquartered in Houston and an additional two startups on the list have a presence here. Continue reading.

FDA greenlights Houston surgery robotics company's unique technology

EndoQuest Robotics secured an Investigational Device Exemption from the FDA for its clinical study. Photo via Getty Images

A Houston surgical robotics company has gotten a Investigational Device Exemption from the FDA to go forward with human trials.

This news allows EndoQuest Robotics to begin its Prospective Assessment of a Robotic-Assisted Device in Gastrointestinal Medicine (PARADIGM) study, which will be conducted at leading United States health care facilities, including Brigham and Women’s Hospital (Boston), Mayo Clinic (Scottsdale), Cleveland Clinic (Cleveland), AdventHealth (Orlando), and HCA Healthcare (Houston). The study will include surgeries on 50 subjects, who will hopefully begin to enroll in January.

“The foundational thesis is we're trying to make sure that the world's largest medical center is also the world's largest med tech innovation center,” Eduardo Fonseca, interim CEO of EndoQuest Robotics, tells InnovationMap. Continue reading.

Houston billionaire Tilman Fertitta nominated as ambassador to Italy

foreign affairs

Houston billionaire and Rockets owner Tilman Fertitta has been nominated to serve as the United States ambassador to Italy, according to U.S. President-elect Donald Trump.

On Saturday, Trump sent the following statement via Truth Social Post:

"I am pleased to announce that Tilman J. Fertitta has been nominated to serve as the United States Ambassador to Italy. Tilman is an accomplished businessman, who has founded and built one of our Country's premier entertainment and real estate companies, employing approximately 50,000 Americans. Tilman has a long history of giving back to the community through numerous philanthropic initiatives, which include children's charities, Law Enforcement, and the medical community. Additionally, Tilman is the longest serving Chairman of the Board of Regents for the University of Houston. He also owns the Houston Rockets Basketball Team. Congratulations to Tilman, and his remarkable family!"

Fertitta, 67, also is the chairman, CEO, and president of Landry's Inc. and the chairman of the University of Houston's board of regents.

"It is an honor to be nominated to serve my country as ambassador to Italy and I look forward to the process ahead. Italy is such an extraordinary country with its wonderful people, culture, and history and its strategic importance to The United States of America," Fertitta said.

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