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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Yaxin Wang is director of THI's Innovative Device & Engineering Applications Lab. Photo via texasheart.org

Houston health tech innovator collaborates on promising medical device funded by DOD

team work

The United States Department of Defense has awarded a grant that will allow the Texas Heart Institute and Rice University to continue to break ground on a novel left ventricular assist device (LVAD) that could be an alternative to current devices that prevent heart transplantation and are a long-term option in end-stage heart failure.

The grant is part of the DOD’s Congressionally Directed Medical Research Programs (CDMRP). It was awarded to Georgia Institute of Technology, one of four collaborators on the project that will be designed and evaluated by the co-investigator Yaxin Wang. Wang is part of O.H. “Bud” Frazier’s team at Texas Heart Institute, where she is director of Innovative Device & Engineering Applications Lab. The other institution working on the new LVAD is North Carolina State University.

The project is funded by a four-year, $7.8 million grant. THI will use about $2.94 million of that to fund its part of the research. As Wang explained to us last year, an LVAD is a minimally invasive device that mechanically pumps a person’s own heart. Frazier claims to have performed more than 900 LVAD implantations, but the devices are far from perfect.

The team working on this new research seeks to minimize near-eventualities like blood clot formation, blood damage, and driveline complications such as infection and limitations in mobility. The four institutions will try to innovate with a device featuring new engineering designs, antithrombotic slippery hydrophilic coatings (SLIC), wireless power transfer systems, and magnetically levitated driving systems.

Wang and her team believe that the non-contact-bearing technology will help to decrease the risk of blood clotting and damage when implanting an LVAD. The IDEA Lab will test the efficacy and safety of the SLIC LVAD developed by the multi-institutional team with a lab-bench-based blood flow loop, but also in preclinical models.

“The Texas Heart Institute continues to be a leading center for innovation in mechanical circulatory support systems,” said Joseph G. Rogers, MD, the president and CEO of THI, in a press release.

“This award will further the development and testing of the SLIC LVAD, a device intended to provide an option for a vulnerable patient population and another tool in the armamentarium of the heart failure teams worldwide.”

If it works as hypothesized, the SLIC LVAD will improve upon current LVAD technology, which will boost quality of life for countless heart patients. But the innovation won’t stop there. Technologies that IDEA Lab is testing include wireless power transfer for medical devices and coatings to reduce blood clotting could find applications in many other technologies that could help patients live longer, healthier lives.

The study will include 10 hospitals enrolled as possible sites and is slated to begin in 2024. One location is Houston’s own Texas Heart Institute. Photo courtesy of BiVACOR

Houston medical device company with long-lasting artificial heart reaches FDA milestone

feasibility focused

A Houston company with a breakthrough heart health tech has received a green light from the FDA.

BiVACOR, a Houston-headquartered medical device company, has received FDA approval for its Total Artificial Heart (BTAH) IDE first-in-human early feasibility study (EFS). The BTAH device itself is designed to take over all function for patients with heart failure. The BTAH is roughly the size of a human fist, which means that, while it could support an active adult male, it may also fit many women and children.

Led by CEO Thomas Vassiliades, a former heart surgeon, BiVACOR is based on a system of magnetic levitation. “Our pump is just one moving impeller that sits in the middle of the housing where the blood is. Imagine an artificial heart — the container that has your blood — and the device spinning in the inside — basically a wheel spinning your blood to the rest of your body. The device is suspended by magnets — it's not touching anything,” Vassiliades told InnovationMap in a podcast earlier this year.

Because of that, BiVACOR could potentially last for a patient’s entire life with no wear — something, Vassiliades explains, is new to the field.

The EFS includes 10 hospitals enrolled as possible sites and is slated to begin in 2024. One location is Houston’s own Texas Heart Institute.

“I am eager to begin the BiVACOR Total Artificial Heart EFS to evaluate what I believe is a promising and potentially life-saving technology,” Joseph Rogers, CEO of the Texas Heart Institute, says in a press release. “The implantation of a TAH system is a potential treatment option for patients with heart failure who need support while on the heart transplant waiting list and for those who do not qualify for a transplant. The BTAH is designed to replace the function of the native heart completely. It is an impressive technology, and I am excited to see the potential of BTAH in treating patients with severe heart failure.”

BiVACOR’s chief medical officer is Texas Heart Institute cardiac surgeon William Cohn. He said that this EFS is a “critical milestone” for him and the BiVACOR team.

“This device will provide a unique approach to help patients currently with limited clinical options,” he explains.

The upcoming study is planned for biventricular heart failure patients who need a mechanical circulatory support device as a bridge to later transplantation. However, the team hopes that future studies will follow to chart the BTAH’s success with short-term and long-term destination therapy.

The Texas Heart Institute recently received its largest charitable donation in its history. Photo courtesy of THI

Massive $32M gift from former patient, new UH deal pump big changes into Houston organization

all heart

Leadership at The Texas Heart Institute has two major things to celebrate. First, it just received a $32 million donation from a patient — the largest charitable donation in its history.

Shortly after that news came out, the institute announced a new partnership with the University of Houston Tilman J. Fertitta Family College of Medicine that allows those UH medical students to join a clinical rotation at The Texas Heart Institute. The alliance means valuable insights and experience with both inpatient and outpatient cardiology for UH's future doctors.

"Students will have the chance to develop their skills in the diagnosis and management of cardiovascular conditions and will be taught by outstanding clinical educators,” said Dr. Joseph G. Rogers, president and CEO of The Texas Heart Institute and heart failure specialist at The Texas Heart Institute Center for Cardiovascular Care, in a press release announcing the news.

A game-changing gift that's all heart

As for that mammoth gift, the $32 million donation comes from Dr. Frederick M. Weissman, a neurologist from New York who was a patient at the Institute 40 years ago. Fittingly, huis gift will be used to support cardiovascular research.

This isn't Weissman's first gift to the institution. That came following his experience there in the mid-1980s, when he was treated by world-renowned cardiac surgeon Dr. Denton A. Cooley.

In November of 1986, Weissman wrote a check for $5,000; another followed the next month, with a note that read, in part, “my conscience compels me to make another contribution to The Texas Heart Institute. I don’t think I could ever repay you for what you and your staff have done for me.” Weissman and Cooley would go on to be friends throughout their lives.

When Dr. Weissman died in 2005, he left The Texas Heart Institute $500,000. The organization recently received the residual of his estate — valued at more than $32 million.

“Those of us who were fortunate enough to work with and be trained by Dr. Cooley know he was much more than just an incredibly gifted surgeon," renowned transplant surgeon and Co-director of THI’s Center for Preclinical Surgical & Interventional Research, Dr. O.H. “Bud” Frazier, said in press materials announcing the donation. "He established lifelong relationships with his patients and encouraged all of us to do the same. Dr. Weissman’s extraordinary generosity reflects the impact Dr. Cooley still has on the Institute he founded.”

A big leap for THI and the Coogs

Looking ahead, this game-changing gift and new affiliation with UH promises big things for students, doctors, researchers, and patients.

Medical students in rotation at The Texas Heart Institute will be exposed to progressive clinical care, allowing them to gain a deep understanding of the etiology, pathophysiology and management of cardiovascular disease from prevention to the most contemporary treatments available today. This level of hands-on experience is invaluable for future physicians, and will certainly contribute to the advancement of cardiovascular medicine.

"We are honored to launch this new affiliation with Fertitta Family College of Medicine,” said Dr. Jorge Escobar, director of undergraduate medical education at The Texas Heart Institute. "With new advances in diagnostic imaging, bedside testing, and clinical trials coupled with the complex care we provide to our patients, the rotation will be an impactful experience for the students."

Pumping with growth

Meanwhile, THI recently established The Texas Heart Institute Research Innovation Fund to propel the next generation of cardiovascular research by sparking discovery, supporting innovation, and recognizing excellence in high-risk, high-reward scientific exploration.

To that end, $5 million of the Weissman bequest has been designated to match philanthropic commitments of $10,000 or greater made to THI’s Research Innovation Fund and its priority initiatives in 2023, allowing donors the opportunity to double the impact of their research investment.

Founded in 1962, THI performed the first successful heart transplant and total artificial heart implant in the United States. It has gone on to become one of the world's leading institutions for cardiovascular treatment and research.

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This article originally ran on CultureMap.

This week's roundup of Houston innovators includes Dr. Joseph Rogers of the Texas Heart Institute, Allie Danziger of Ampersand, Jeff Carlson of RioRaiz. Photos courtesy

3 Houston innovators to know this week

WHO'S WHO

Editor's note: In this week's roundup of Houston innovators to know, I'm introducing you to three local innovators across industries — from SaaS to biotech — recently making headlines in Houston innovation.

Dr. Joseph Rogers, president and CEO of the Texas Heart Institute

Dr. Joseph Rogers has been at the helm of the Texas Heart Institute for around two years. He shares on the Houston Innovators Podcast about the innovative past, present, and future of THI. Photo via texasheart.org

Dr. Joseph Rogers, the president and CEO of the Texas Heart Institute, is passionate about preventative health care for THI and its patients, as he shares on the Houston Innovators Podcast. What's required is a comprehensive culture shift away from just using a pill to accomplish this goal.

Rogers says health care organizations are going to need to partner with other players — nonprofits, universities, local government — in ways never been done before. And THI is dedicated to this mission.

"Houston is the place to do this," he says. "The reason I think this is such an important community to address this problem is it's the most diverse city in the United States. And I've never lived anywhere or heard of another city that I was so convinced believed they could do anything they set their minds to. It's about making the community aware of the problem and a potential solution — and then working on trying to solve it."Read more.

Allie Danziger, senior vice president and general manager of student success at Ascent

Ampersand has been acquired by a college loan and student services provider based in San Diego. Photo ampersandpro.com

San Diego, California-based Ascent, a collegiate student loan company that also provides student support services, announced it has acquired Houston-based Ampersand, a software platform that provides skills training to young professionals.

With the acquisition, Allie Danziger, co-founder and CEO of Ampersand, joins Ascent as senior vice president and general manager of student success. She will lead the company's educational program that focuses on equipping students with skills from education to employment.

“Since launching Ampersand in 2020, we’ve received constant praise from employers, students, and universities on the real education-to-employment skills gap we are filling,” says Danziger in a news release. “I take immense pride in the fact that we’ve helped thousands of students enter the workforce with confidence, earn higher salaries, and get set on the right career path. I know joining the Ascent team will unlock even more opportunities for our combined companies, expanding our collective impact to millions of students and job seekers.” Read more.

Jeff Carlson, president and CEO of RioRaiz

With its blend of biotechnology, conservation, and education, RioRaiz seeks to inspire a new generation of conservationists. Photo via RioRaiz.org

Not only is Houston-based nonprofit RioRaiz looking to preserve biodiversity through biotechnology, the innovative organization also wants to offer transformative learning experiences to contribute to a healthier planet.

Led by Jeff Carlson, the president and CEO, RioRaiz's mission is driven by three core pillars: conservation, scientific discovery, and education.

"We have a list of priorities that is cataloged from input from our scientific collaborators, as well as our ability to deliver on our promises to our donors and supporters,” Carlson tells InnovationMap. Read more.

Houston health care leader drives innovation, preventive cardiovascular care

HOUSTON INNOVATORS PODCAST EPISODE 196

For 60 years, the Texas Heart Institute has been a part of Houston's innovation DNA. The organization's founder, Dr. Denton Cooley, performed first total artificial heart implantation in 1969 at THI. Now, decades later, the institutions third CEO continues to lead the innovation within cardiovascular care.

"Despite all of the advances, cardiovascular disease is still one of the largest killers of Americans. It actually kills more Americans than all types of cancer combined," Dr. Joseph Rogers, who was appointed president and CEO of THI in 2021, says on the Houston Innovators Podcast.

Rogers shares just a fraction of what the medical professionals are working on at THI on the show — from developing a drug that can improve the efficacy cell therapies, vaccines, and more to revolutionary stem cell treatments. Even with all this groundbreaking innovation in cardiovascular treatment, Rogers says one of the most crucial elements is prevention.

"The challenge of preventative medicine in general terms is there has been an under investment in terms of research," Rogers says. "I also think that many of us who live in developed countries have said, 'I think I can just take a pill to manage an underlying problem and I can continue to do whatever I'd like.'

"We use medicine as a crutch to allow us to continue living an opulent lifestyle," he continues.

THI is on a mission to evolve that way of thinking, Rogers says, but it's a comprehensive cultural shift that's needed.

"Medicine can control about 20 percent of this," Rogers says. "The rest is driven by the social drivers of health — early childhood experiences, food deserts, a lack of safe exercise facilities."

"We should act as a convener," Rogers says. "Houston is the place to do this.

"The reason I think this is such an important community to address this problem is it's the most diverse city in the United States. And I've never lived anywhere or heard of another city that I was so convinced believed they could do anything they set their minds to. It's about making the community aware of the problem and a potential solution — and then working on trying to solve it," he continues. "But I think all of the pieces are here to show the world how to do this at a community level."

Rogers shares more of his optimism about Houston as a heart health leader and innovator on the show. Listen to the interview below — or wherever you stream your podcasts — and subscribe for weekly episodes.

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Here's how much it takes to earn a top 1 percent salary in Texas

wealthy lifestyle

With two Houston-area neighbors cashing in among the most wealthy suburbs in America, Houstonians may be wondering how much money they need to make to secure a place in the top one percent of earners. According to a new study from SmartAsset, the pre-tax salary required to be considered one of the highest earners in Texas amounts to $762,090 in 2024.

Texas has the 14th highest pre-tax salary needed to be considered in the top one percent of earners in the U.S. for the second year in a row. Texas' income threshold is not too far off from the national average, which is $787,712.

The study further revealed 126,128 Texans are within the top one percent of earners. For more context, the U.S. Census Bureau says over 30 million people lived in Texas as of 2022, and Houston's population grew to 2.3 million people in 2023.

Connecticut continues to lead the nation with the highest income threshold required to be in the top one percent, with residents needing to make over $1.15 million pre-tax.

To determine the income needed to be in the top one percent of earners in each state, SmartAsset analyzed 2021 IRS data for individual tax filers, which is the most recent year where data was available. Income data was then adjusted to June 2024 dollars.

Compared to SmartAsset's 2023 report, Texans now need to make $130,241 more in 2024 to maintain their status as one of the highest earners in the state. Last year, the income threshold was $631,849.

If Houstonians aim to be within the top five percent of earners in Texas, the pre-tax income threshold is drastically lower, at $280,676. However, for many Houston residents, achieving even a "middle class" status means making between $40,280 and $120,852 a year.

Meanwhile, the study says the median income in the U.S. comes out to roughly $75,000, and half of Americans are making even less than that. The income disparity is plainly obvious when high-income earners make (at a minimum) 10 times more than the national median income.

The report goes on to say top-earning Americans make up a "disproportionately large part of the tax base," as their income results in paying a 37 percent federal tax bracket rate. (That is, if these high earners are even paying taxes in the first place, considering America's wealthiest are already evading over $150 billion a year in taxes.)

"While state and local level taxes may impact the spread of high earners in those areas, the cost of living can also be drastically different nationwide," the report said. "As a result, what it takes to be considered a top one percent income earner can differ by over $500,000 from state to state."

The top 10 states with the highest thresholds to be considered in the top one percent of earners in the U.S. are:

No. 1 – Connecticut ($1,152,254)
No. 2 – Massachusetts ($1,113,662)
No. 3 – California ($1,035,673)
No. 4 – Washington ($989,649)
No. 5 – New Jersey ($975,645)
No. 6 – New York ($965,645)
No. 7 – Colorado ($865,700)
No. 8 – Florida ($852,206)
No. 9 – Wyoming ($843,121)
No. 10 – New Hampshire ($811,098)

The full report can be found on smartasset.com

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This article originally ran on CultureMap.

Houston fintech co. offers new grants, chemist scores funding for cancer treatment, and more top stories

Houston hospitals recognized as best in state, nation in annual report

better than all the rest

Houston’s University of Texas MD Anderson Cancer Center has retained its U.S. News & World Report crown as the best cancer hospital in the U.S.

In the same ranking, Houston Methodist Hospital once again came out on top as the best hospital in Texas. Last year, the hospital shared the top spot. Baylor St. Luke’s Medical Center ranked No. 4, followed by No. 5 Memorial Hermann Hospital.

The accolades appear in U.S. News’ 2024-25 ranking of the country’s best hospitals. Each hospital also ranked among various specialties, such as orthopedics; cardiology, heart, and vascular surgery; cancer; and neurology and neurosurgery.

Since U.S. News introduced its annual hospital survey in 1990, MD Anderson has been ranked one of the two best U.S. hospitals for cancer care. It has maintained its No. 1 ranking for 10 consecutive years.

“At MD Anderson, our mission is clear: to end cancer,” Dr. Peter WT Pisters, president of MD Anderson, says in a news release. “This ranking reflects our relentless commitment to excellence in patient care, research, prevention, and education.”

MD Anderson also ranked highly in three specialties:

No. 2 for ear, nose, and throat.
No. 9 for urology.
No. 14 for gastroenterology and GI surgery.

“The consistent top national recognitions [that] MD Anderson receives for delivering compassionate, evidence-based care is a testament to our dedication to those we serve,” Pisters says.

Elsewhere at the Texas Medical Center, Houston Methodist Hospital was named the No. 1 hospital in Texas for the 13th year in a row. Also, it was lauded as one of the country’s 20 best hospitals for the eighth time.

Along with the general ranking, Houston Methodist Hospital scored high marks in 10 specialties. These include diabetes and endocrinology (No. 6), gastroenterology and GI surgery (No. 7), and pulmonology and lung surgery (No. 8).

Meanwhile, four Houston Methodist community hospitals ranked well in Texas:

Houston Methodist The Woodlands Hospital (No. 8).
Houston Methodist Sugar Land Hospital (No. 9).
Houston Methodist Baytown Hospital (tied at No. 18).
Houston Methodist Willowbrook Hospital (tied at No. 23).

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