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.


Thomas Vassiliades, CEO of BiVACOR, joins the Houston Innovators Podcast. Photo courtesy of BiVACOR

How this Houston-headquartered company is innovating the future of heart replacement

HOUSTON INNOVATORS PODCAST EPISODE 183

Heart disease is one of the most common causes of death in the United States — one in five deaths, according to the CDC. But there's not a long-term solutions for patients — even for those lucky enough to have a successful heart transplant. But a Houston-headquartered medical device company is working on one.

BiVACOR has created a technology that, theoretically, could completely replace a patient's heart and last them the rest of their lives.

"The design is critical," says Thomas Vassiliades, CEO of BiVACOR, on the Houston Innovators Podcast. He joined the organization last year after spending 20 years of a heart surgeon, then transitioning to medical device development over a decade ago.

Vassiliades explains the industry's challenges on the show, saying that there's no comprehensive, lasting replacement to the human heart on the market. While some treatments — like transplants and medical devices that partially replace the heart's capabilities — exist, nothing that completely replaces the heart lasts longer than 10 to 12 years.

"The BiVACOR system is based on magnetic levitation," Vassiliades says about the technology. "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," he continues. "So, theoretically, the device has no wear and can last as long as the patient can possibly live. That's new to the field."

Daniel Timms, BiVACOR's founder and CTO, knew there had to be a better, more permanent solution and has been working on the technology since he was a postdoctoral student at Queensland University of Technology in Australia. His work took him to Houston's Texas Heart Institute, the "center of the universe when it comes to blood pumps," says Vassiliades.

The company recently raised $18 million in funding to support its growing team and continued growth. BiVACOR is a Class 3 medical device — the most rigorously regulated type of device, so the funding raised will support the company as it continues to meet the FDA's requirements and proceeds into implantation and clinical trials.

While headquartered in Houston and has close ties to THI, most of BiVACOR's team works out of Huntington Beach, California, just 30 minutes away from its manufacturing partner — something that has been critical for the design phase. Other employees work in Europe and Australia, which has resulted in government grant funding. Each market the company works in has a strategic purpose — and Houston's role is testing.

"We're going to be training all our clinical sites in Houston, and we're going to continue to do ongoing testing," he says. "We're very comfortable with the design of the device, ... but there's always more. And we have a long-term plan to iterate on the device to make it even better."

Vassiliades shares more of the challenges he's facing as he commercializes BiVACOR's technology on the podcast. Listen to the interview below — or wherever you stream your podcasts — and subscribe for weekly episodes.


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10+ can't-miss Houston business and innovation events for January

WHERE TO BE

From networking meetups to tech talks, January is filled with opportunities for Houston innovators. Here's a roundup of events you won't want to miss out on so mark your calendars and register accordingly.

Note: This post might be updated to add more events.

January 3 — Cup of Joey Networking

Create a connected culture of coffee shop-open networking across our region. Every Friday morning, you’ll have the opportunity to meet new people and expand your current networks, talk about tech, inspire innovation, and create community.

This event is Friday, January 3, from 8:30 to 10:30 am at the Ion. Click here to register.

January 7 — Discover Your Creative Goldmine: The Millions are in your Micro-Niche

In this high-energy workshop, you’ll learn how identifying and embracing your unique micro-niche can simplify your business and fast-track your success. Through a dynamic mix of strategy and mindset mastery, you’ll leave equipped with actionable insights to transform your brand. Don’t miss this opportunity to align your business for growth and connect with like-minded creatives.

This event is Tuesday, January 7, from 12:30 to 1:30 pm at SheSpace. Click here to register.

January 15 — Angel Investing 101: Introduction to Angel Investing

Join the Urban Capital Network team for an evening of learning, discussion and possibilities as we explore the basics of angel investing and the role it plays in bringing new products and services to market and the impact it has on wealth and job creation. At this event, you’ll learn the key components to successfully navigate the critical-path of investing in private, early-stage companies.

This event is Wednesday, January 15, from 5:30 to 6:30 pm at the Ion. Click here to register.

January 15 — In the Age of the Humanoid Robot

Persona AI cofounder & seasoned roboticist Nicolaus Radford will discuss the promise of embodied AI and the adoption of humanoid robots—two advancements likely to impact every market sector. Humanoids coupled to artificial intelligence are poised to reshape the global work landscape; to learn more, check out the Q&A, and Second Draught happy hour.

This event is Wednesday, January 15, from 5 to 7 pm at the Ion. Click here to register.

January 16 — NAWBO Houston Conference: The Power of Women in Business 2025

This event is your opportunity to connect with influential speakers, successful entrepreneurs, and industry experts who are shaping the future of business. From inspiring keynotes to thought-provoking panels, this conference is designed to provide attendees with actionable insights and strategies to elevate their careers.

This event is Thursday, January 16, from 9 am to 3 pm at Norris Conference Centers - Houston/CityCentre. Click here to register.

January 16 — Houston Methodist Innovation TechHub Event

Join the Houston chapter of the Healthcare Information and Management Systems Society for a discussion on the Houston Methodist TechHub, innovative ideas, and a tour of the Ion.

This event is Thursday, January 16, from 5:30 to 7:30 pm at the Ion. Click here to register.

January 21 — 2025 Female Founders & Friends

This Sesh Coworking event brings together female founders, funders and allies looking for connections with other like-minded go-getters in the Houston community. Connect over coffee with like-minded individuals

This event is Tuesday, January 21, from 9 to 10:30 am at Sesh Coworking. Click here to register.

January 23 — NASA Tech Talks

Discover NASA’s toughest tech challenges–and apply your skills and expertise to solve them.In these presentations, occurring the fourth Thursdays of the month, Mr. Montgomery Goforth and other aerospace subject matter experts will discuss the technology development challenges faced by NASA’s Johnson Space Center and the surrounding Aerospace community in our ongoing efforts as the hub of human spaceflight. Presentations will focus on the ways in which these challenges, and the associated opportunities, can be leveraged by Houston’s innovation community

This event is Thursday, January 23, from 6 to 7 pm at the Ion. Click here to register.

January 28 — Texas Small Business Expo

Texas Small Business Expo is a premier trade show, educational business to business conference, exhibition, and networking event for entrepreneurs, startups and anyone that owns a business, or looking to start their own business. The focus of the conference is targeted on networking, building new business relationships and learning from Industry Experts on how to enhance your business.

This event is Tuesday, January 28, from 4 to 9 pm at the Bell Tower on 34th. Click here to register.

January 30 —TiE Houston's Investing in the Age of AI

For those involved in AI-driven innovation, building new companies, leading established businesses, or exploring investment opportunities in AI, this event is designed for you. Moderated by Sammy Haroon, founder and CEO of AlphaX Decision Sciences, speakers at this event include Major Tony Cucolo, CEO of PCSI, and Yashwanth Hemaraj, general partner at BGV.

This event is Thursday, January 30, from 6 to 9 pm at the Junior League of Houston. Click here to register.

January 31 — Greater Houston Partnership 2025 Meeting

This signature event brings together business and community leaders from across our region to celebrate achievements and set the course for an even brighter future. The Greater Houston Partnership will welcome incoming Board Chair Gretchen Watkins, President, Shell USA, Inc., and honor the contributions of outgoing chair Eric Mullins, as well as present several prestigious awards that highlight the exceptional leadership driving Houston forward.

This event is Friday, January 31, from 11 am to 1:30 pm at Hilton Americas Houston. Click here to register.


What to know about the new emission inspection to register your car in Texas

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Texas vehicle owners no longer need to obtain a safety inspection prior to vehicle registration. House Bill 3297, which went into effect January 1 and passed during the 88th Legislature in 2023, eliminates the safety inspection program for non-commercial vehicles.

Under the new law, the $7.50 fee that drivers had to pay as a safety inspection fee has not gone away. It now appears on your registration notice under a new name: "Inspection Program Replacement Fee."

This name change comes courtesy of the legislature, who want to keep collecting this fee because the funds go to state programs such as construction and expansion of state highways — funds they previously collected from the Safety Inspection Fee.

And while the safety inspection is gone, state law will still require that drivers in 17 counties must pass an "emission inspection" on vehicles that are 2 to 24 years old, in order to get your vehicle registered.

But what does an "emissions inspection" mean?

The Texas Department of Public Safety (DPS) details the following changes:

Safety inspection out, emissions testing in
Until December 31, 2024, safety inspections were required for vehicle registration in all 254 counties. Since January 1, 2025, noncommercial vehicles in Texas are no longer be required to have an annual safety inspection. Instead, vehicles have to get an emissions inspection on gasoline-powered vehicles that are 2 to 24 years old.

What is no longer going to be "inspected"?
Texas Transportation Code §548.051 specifies the list of old-school inspection items which will no longer be checked. Moving forward, they will no longer be checking: tires, wheel assembly, safety guards, safety flaps, brakes, steering, lighting, horns, mirrors, windshield wipers, sunscreening devices, and front seat belts in vehicles on which seat belt anchorages were part of the manufacturer's original equipment.

What still is inspected are listed as "Items 12–15": exhaust system, exhaust emissions system, fuel tank cap, and emissions control equipment. These are now part of the emissions inspection process in 17 counties.

Those 17 counties where this is relevant include:

  • DFW: Collin, Dallas, Denton, Ellis, Johnson, Kaufman, Parker, Rockwall, and Tarrant
  • Houston: Brazoria, Fort Bend, Galveston, Harris, and Montgomery
  • Austin: Travis and Williamson
  • El Paso County

Beginning on November 1, 2026, emissions inspections will be required for vehicles registered in Bexar County.

Where will emissions inspections be obtained?
Emissions inspections can be obtained at DPS-certified vehicle inspection stations in the 17 emissions counties. These are the exact same inspection locations we've been going to all along, when it was called a safety inspection. Emissions inspections are not available in the other 237 Texas counties.

DPS offers an inspection station locator online.

What is the estimated cost of an emissions inspection?
Vehicle owners are required to pay an emissions inspection fee of $2.50 annually to the Texas Department of Motor Vehicles (TxDMV) at the time of registration. The actual fee you'll pay at the inspection station (as listed on TCEQ’s website) will be $25.50. Just like the former "safety inspection" fee.

In short: There is little that's changing about the entire inspection process, except they won't bother making you honk your horn.

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This article originally ran on CultureMap.