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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Houston's Texas Medical Center wins prestigious global award recognizing leaders in life science innovation

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Last month, a global organization honored innovation leaders in life sciences, and the Texas Medical Center was among the recipients of the prestigious awards program.

The 18th annual Prix Galien Awards Gala awarded TMC Innovation with the win in the "Incubators, Accelerators and Equity" category. The Galien Foundation created the awards program in 1970 in honor of Galien, the father of medical science and modern pharmacology. Alongside TMC, the other winners represented biotech, digital health, startups, and more.

"We are super proud of this distinction," Tom Luby, director of TMC Innovation says at Envision 2024 last month, crediting the TMCi team and TMC leadership for the award. "We lean on a lot of advisers and experts — people who volunteer their time to work with startups. Without (them), we would not have been successful."

Luby explains that a Prix Galien Award holds a Nobel Prize level of significance for the community.

TMCi was named a finalist in August, and competed against programs from Cedars-Sinai, Mayo Foundation for Medical Education and Research, TechConnect, and more.

"The Awards Committee is honored to witness the exceptional dedication and creativity of our nominees as they turn visionary ideas into transformative solutions for patients worldwide," says Michael Rosenblatt, chair of the Prix Galien USA Awards Committee, in a news release. "Their unwavering commitment to advancing patient care is truly commendable, and we are honored to celebrate their outstanding contributions to global health."

The award is displayed at TMC Innovation's office, located in the medical center at 2450 Holcombe Blvd.

Houston energy transition tech SPAC goes public through IPO

BLANK CHECK

Houston-based CO2 Energy Transition Corp. — a “blank check” company initially targeting the carbon capture, utilization, and storage (CCUS) sector — closed November 22 on its IPO, selling 6 million units at $10 apiece.

“Blank check” companies are formally known as special purpose acquisition companies (SPACs). A SPAC aims to complete a merger, acquisition, share exchange, share purchase, reorganization or similar business combination in certain business sectors. CO2 Energy Transition will target companies valued at $150 million to $250 million.

Each CO2 Energy Transition unit consists of one share of common stock, one warrant to purchase one share of common stock at a per-share price of $11.50, and the right to receive one-eighth of a share of common stock based on certain business conditions being met.

The IPO also included the full exercise of the underwriter’s option to buy 900,000 units to cover over-allotments. Kingswood Capital Partners LLC was the sole underwriter.

Gross proceeds from the IPO totaled $69 million. The money will enable the company to pursue CCUS opportunities.

“Recent bipartisan support for carbon capture legislation heavily emphasized the government’s willingness to advance and support technologies for carbon capture, utilization, storage, and other purposes as efforts to reduce greenhouse gas emissions [continue],” Co2 Energy Transition says in an October 2024 filing with the U.S. Securities and Exchange Commission (SEC).

Brady Rogers is president and CEO of CO2 Energy Transition. He also is CEO of Carbon Capture Development Co., a Los Angeles-based developer of direct air capture (DAC) technology, and president of Houston-based Antelope Energy Partners LLC, a provider of oil and gas services.

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This article originally ran on EnergyCapital.

Mastering control room management for smoother critical infrastructure operations

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Control room management (CRM) systems play an integral role in ensuring the safe and efficient remote operations of automated processes for the world's most critical infrastructures (CI). If anything goes wrong with these CIs, the risks are major: loss of life or catastrophic environmental disasters. For this reason, rigorous regulatory requirements are crucial.

CRM systems give operators the ability to automate and take control of CI processes, giving operators situational awareness and real-time visibility of remote assets. This minimizes the need for manual work and inspection, and scales a company's ability to safely manage many assets over a large geographical area from one control room.

Most CI have to handle hazardous material in some, if not all, of their operational areas. Though different by industry, regulations and oversight are extremely necessary.

ICS (Industrial Control Systems) and CRM tools are key components of real-time monitoring for advanced warning and emergency alarming. The combination of a “green, amber, red” alert on the screen of an operator's control console will prompt them to respond, and potentially lead to following emergency shut-down response procedures. Training and testing of the control systems and their related standards, procedures, and activities are all recorded in a system of record in compliance with regulatory requirements.

Current challenges
One of the biggest challenges is the ability to easily aggregate the data from the many different systems and integrate them with the operator's daily activity and responses to the many notifications they receive. This makes it difficult for handover, when a new control room operator comes in fresh to take over from the operator coming off duty. Ensuring a clean and clear handover that encompasses all the pertinent information, so that the new operator can take over the console with ease and clarity, is much more difficult than some would imagine.

Another issue is the sheer volume of data. When you have thousands of sensors streaming data, it is not unrealistic for a console to receive a few thousand data points per second. Performance and continuity are priorities on a CI control room console(s). So there is no room for error — meaning there is no room for big (quite literally) data.

All of this means that real-time data must be pushed off the operational and process control network and moved into an area where there are no controls, but big data can be stored to produce big-data analytic capabilities, enabling AI, machine learning, and other data science.

Controller/operator fatigue is also an issue. Manual tracking, documenting, and record-keeping increases fatigue, leading to more mistakes and omissions.

Opportunities for improvement
The Houston-based Tory Technologies, Inc.is a corporation specializing in advanced software applications, creating and integrating various innovative technologies, and providing solutions for control room management and electronic flow measurement data management.

Tory Technologies, Inc. can help with the auto population of forms, inclusion of historical alarms and responses, and easy handover of control with active/open issues highlighted, making for an easier transition from one operator to the next.

"CRM is essential for keeping operations safe and efficient in industries where mistakes can lead to serious problems," says Juan Torres, director of operations - MaCRoM at Tory Technologies, Inc. "While many control rooms have worked hard to meet compliance standards, challenges remain that can affect performance and safety. It's not enough to just meet the basic rules; we need to go further by using smarter tools and strategies that make CRM more than just compliant, but truly effective."

Shaun Six, president of UTSI International, notes that, "CRM solutions are scalable. A smart integration with relevant systems and related data will reduce 'white noise' and increase relevance of data being displayed at the right time, or recalled when most helpful."

The future state
Offering CRM as a service for non-regulated control rooms will give economies of scale to critical infrastructure operators, which will allow dispatching, troubleshooting, and network monitoring so operators can focus on more value-add activities.

It can also virtualize network monitoring, ensuring that field machines and edge computers are compliant with industry and company standards and are not exposed to external threats.

Even better: Much of this can be automated. Smart tools can look through each device and test that passwords are changed, configurations are secure, and firmware/software has been properly patched or safeguarded against known exploits.

The sheer volume of data from these exercises can be overwhelming to operators. But a trained professional can easily filter and curate this data, cutting through the noise and helping asset owners address high-risk/high-probability exploits and plan/manage them.

Ultimately, the goal is to make control rooms efficient, getting the right information to the right people at the right time, while also retaining and maintaining required documents and data, ensuring an operators “license to operator” is uninterrupted and easily accessible to external parties when requested or needed.

Integrating smart CRM systems, network monitoring tools, and testing/validating processes and procedures are all easily accessible with current technological capabilities and availability, letting operators focus on the task at hand with ease and peace of mind.