Why this Houston medical device innovator is pumped up for the first total artificial heart

HOUSTON INNOVATORS PODCAST EPISODE 248

Dr. William Cohn is the chief medical officer for BiVACOR, a medical device company creating the first total artificial heart. Photo via TMC

It's hard to understate the impact Dr. William Cohn has had on cardiovascular health as a surgeon at the Texas Heart Institute or on health care innovation as the director of the Center for Device Innovation at the Texas Medical Center. However, his role as chief medical officer of BiVACOR might be his most significant contribution to health care yet.

The company's Total Artificial Heart is unlike any cardiovascular device that's existed, Cohn explains on the Houston Innovators Podcast. While most devices are used temporarily for patients awaiting a heart transplant, BiVACOR's TAH has the potential to be a permanent solution for the 200,000 patients who die of heart failure annually. Last year, only around 4,000 patients were able to receive heart transplants.

"Artificial hearts historically have had bladders that ejected and filled 144,000 times a day. They work great for temporary support, but no one is suggesting they are permanent devices," Cohn says on the show.

The difference with BiVACOR's device is it abandons the bladder approach. Cohn explains that as assist pumps evolved — something his colleague, Dr. Bud Frasier, had a huge impact on — they featured new turbine and rotor technology. Daniel Timms, BiVACOR's founder and CTO, iterated on this technology beginning when he was a postdoctoral student at Queensland University of Technology in Australia.

"BiVACOR is the first artificial heart that leverages what we learned from that whole period — it has no bladders, it has no valves. It has one moving part, and that moving part is suspended in an electromagnetic field controlled by a computer and changed thousands of times a second," Cohn says. "It will never wear out, and that's why we think it's the world's first total artificial heart."

The company is seeing momentum, celebrating its first successful human implantation last month. The device was used for eight days on a patient at Baylor St. Luke’s Medical Center before the patient received a heart transplant.

Cohn says that BiVACOR has plans to use the TAH as "bridge-to-transplant" device in several other surgeries and expects to get FDA approval for that purpose in the next three to four years before working toward clearance for total artificial heart transplants.

Cohn has worked to support medical device startups at CDI at TMC for the seven years it has existed — first under Johnson and Johnson and then under TMC when it took the program over. He describes the center and its location as the ideal place for developing the future of health care, with Houston rising up to compete with regions known for medical device success — both coasts and Minnesota.

"Being in the shadow of the largest medical center on the planet — 106,000 employees show up there every 24 hours," Cohn says, "if you want to innovate, this is the place to do it."

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Revisiting a conversation with Dr. Joseph Rogers, president and CEO of the Texas Heart Institute, on the Houston Innovators Podcast. Photo via texasheart.org

Play it back: How this Houstonian is leading heart health innovation

HOUSTON INNOVATORS PODCAST EPISODE 246

Heart health innovation is at a major moment in history — and Houston is at the center of it.

Last summer, Dr. Joseph Rogers, president and CEO of the Houston-based Texas Heart Institute, joined the Houston Innovators Podcast to share how he came to be at the helm of THI, as well as the incredible technologies the institute is working on to address heart failure, a global epidemic affecting at least 26 million people worldwide, 6.2 million adults in the U.S.

This month, one of THI’s technologies reached a major milestone. BiVACOR, a Houston company successfully implanted the company's first Total Artificial Heart in a human. The device was implanted in the patient on July 9. Eight days later, a donor heart became available and was transplanted into the patient, removing the TAH, establishing the device as a successful bridge-to-heart-transplant solution for patients, THI reported.

In addition to this breakthrough in health tech, THI is focused on addressing Cardiometabolic Syndrome at a new conference on Friday, August 23, in Houston. The full-day symposium will take place in collaboration with Arianna Huffington, the founder and CEO of Thrive Global. Dr. Rogers is co-directing the program with Dr. Stephanie Coulter, medical director for THI Center for Women’s Heart & Vascular Health.

In the episode, Rogers explains why he's bullish on Houston and THI leading heart health innovation alongside other health care organizations — nonprofits, universities, local government — to collaborate in ways never been done before. And THI is dedicated to this mission.

"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."

Emerson Perin of the Texas Heart Institute, recently published the largest clinical trial of cell therapy for patients with chronic heart failure to-date included 580 patients at 52 sites throughout North America. Photo via texasheart.org

Houston health care leader on a mission to innovate an end to heart failure

cardiology cured

Emerson Perin’s end goal isn’t to treat heart failure. The medical director of The Texas Heart Institute says that he has his sights set firmly on curing the malady altogether. And, with the power of innovation and a strong team, the Houston-based cardiologist has a good chance of meeting his objective.

Perin first came to THI for fellowship training in 1988, following his residency in Miami and medical school in his birthplace of Brazil.

“This is a very special place,” the physician and researcher, whose titles also include director for THI’s Center for Clinical Research and vice president for medical affairs, tells InnovationMap. “It has a worldwide-reaching reputation. I’ve always liked research and this is a great place in terms of innovation and practicing high-level cardiology.”

For decades, Perin has followed in THI founder Denton Cooley’s footsteps with world-changing research. In 2001, the founding medical director of THI’s Stem Cell Center was the first person to inject stem cells into a failing human heart. It led to a trial of 17 patients that year.

“A couple of the patients did remarkably well — more than you could ever expect. These guys who couldn’t’ walk across the room pretty much were jogging on the beach. That gave me the initial insight that this works,” Perin recalls.

What exactly is heart failure? The term refers to the condition of a heart that can’t pump enough blood to sustainably power the body through oxygenation of the tissues from blood flow. It may sound like a death sentence, but with appropriate care, it can usually be managed with medicines and if worsening occurs, devices and, ultimately, heart transplantation.

And Perin is proving that there’s a lot of life ahead for heart failure patients. Earlier this year, he published another groundbreaking clinical trial, DREAM-HF. The largest clinical trial of cell therapy for patients with chronic heart failure to-date included 580 patients at 52 sites throughout North America.

With the goal of getting a new cell therapy approved for heart failure, the primary endpoint was to prove that the therapy could prevent recurrent hospitalizations.

“It was a total negative,” says Perin. That’s because the cells don’t have a decongestant effect such as the medicines currently used to treat heart failure.

But that doesn’t mean that the trial was a failure. Quite the opposite. That’s because Perin and his team proved something else: The trial was able to prove that there was significant improvement in patients with inflammation. After those patients were injected with mesenchymal precursor cells (MPC), they showed a 70-percent reduction in heart attacks and strokes. Cardiovascular deaths also decreased.

These are blockbuster numbers, and big news for patients dealing with heart failure. What it means is that the cells addressed a different aspect of heart failure that until now had been left untreated which was the inflammation — how heart failure starts and what keeps it going.

So what’s next? Going to the FDA.

“They said, ‘We can’t approve it with one trial, but we’ll approve it with two,’” says Perin.

This time, his primary endpoint will be tailored to suit the positive outcome he knows he’ll be able achieve. This next round will begin in 2024.

Once the FDA approves a new catheter system for injecting the heart with stem cells and genes, the team will proceed with new studies. Gene therapy will be another frontier for Perin — and patients with heart failure.

“I think the combination of cells and genes is even more powerful,” he says. “That will help save lives in a completely new way and do away with heart failure.”

Perin's work is just one piece of the puzzle, and Dr. Joseph Rogers, who was appointed president and CEO of THI in 2021, is leading the organization's initiative in several ways. THI, recently buoyed by a $32 million donation from a patient — the largest charitable donation in its history — is exploring several innovative therapeutics, devices, and treatments.

THI recently received a two-year, $1.14 million grant from The National Heart, Lung, and Blood Institute to develop a novel, first-in-class drug to treat the cardiovascular disease that arises from atherosclerosis. Another THI innovator, Camila Hochman-Mendez — along with her research team — is studying the effects of regenerative medicine on hearts.

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2 Houston companies collaborating to develop lunar rideshare services

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Houston-based space exploration company Intuitive Machines soon will be the Uber of space.

Intuitive Machines has signed a deal with Houston-based launch services company SEOPS to offer lunar rideshare services. Under the deal, Intuitive Machines will enable SEOPS to deliver customers' payloads to the surface of the moon, as well as to Lagrange points and geostationary transfer orbits. Essentially, this will let SEOPS hitch a ride on missions already planned by Intuitive Machines.

As NASA explains, spacecraft occupy Lagrange points between the earth and moon as “parking lots” so they can stay in a fixed position while conserving fuel. And according to the European Space Agency, transfer orbits “are a special kind of orbit used to get from one orbit to another.”

“Intuitive Machines’ rideshare capacity not only satisfies a growing market need, but it’s completely in our wheelhouse — leveraging our expertise in solving complex launch challenges for our customers,” Chad Brinkley, CEO of SEOPS, says in a news release. “It makes financial sense to take advantage of the excess capacity on Intuitive Machines’ lunar missions, while also supporting our customers' goals for lunar exploration.”

Intuitive Machines CEO Steve Altemus says the SEOPS deal underscores the aspirations of the space industry.

“SEOPS entrusting us with the delivery of its customers’ payloads to space highlights our capabilities to provide the essential infrastructure and services that support all groundbreaking commercial ambitions in space,” Altemus says.

Speaking of groundbreaking developments, Intuitive Machines recently pinned down a landing site for its sold-out mission to the South Pole. The mission will prospect for water ice.

NASA calls water ice “a valuable resource” for exploration of the moon, as it could provide drinking water, cool equipment, and generate fuel and oxygen.

The more than 650-foot-in-diameter South Pole landing site, chosen by Intuitive Machines and NASA, sits on the Shackleton connecting ridge. The ridge connects two craters.

NASA says the Shackleton ridge receives enough sunlight to power a lander for a roughly 10-day mission while offering a clear line of sight for satellite communications.

The mission, featuring an Intuitive Machines lander and NASA ice-mining equipment, is set for late 2024. The work must take place between November 2024 and January 2025 to capitalize on ideal conditions.

“A sold-out commercial and civil government mission early in our commercialization roadmap validates our approach to supporting an economy in deep space,” Altemus says in a news release. “Our expertise in landing site selection is world-class, and we believe the ability to identify landing areas with valuable resources will be essential to the future of the lunar economy.”

Ohio startup joins Houston clean tech accelerator

onboarding

A clean energy startup has joined Houston-based Halliburton Labs, an incubator for early-stage energy tech companies.

Adena Power, based in Ohio, uses three patented materials to produce a sodium-based battery that delivers clean, safe, long-lasting energy storage. The startup is trying to capitalize on the 100 terawatt-hour potential for energy storage in the U.S. grid.

“With Halliburton Labs’ support and operational expertise, Adena Power looks to accelerate scaling and take advantage of the high-growth market opportunity,” Nathan Cooley, co-founder and CEO of Adena Power, says in a news release.

Adena, founded in 2022, supplies energy storage batteries for the commercial, industrial, and utility sectors. The startup has collected funding from four investors, according to PitchBook: OhioXcelerate, Third Derivative, BRITE Energy Innovators, and For ClimateTech.

Adena’s addition to Halliburton Labs comes during a momentous year for the company. For example:

Adena won the People’s Choice Award at the National Renewable Energy Labs Industry Growth Forum.
Adena earned the MAKE IT (Manufacture of Advanced Key Energy Infrastructure Technologies) Prize from the U.S. Department of Energy.

“Our team is ready to collaborate with Adena to help them accelerate their growth to meet the demand for behind-the-meter storage solutions,” says Dale Winger, managing director of Halliburton Labs.

Halliburton Labs is a wholly owned subsidiary of Halliburton, a provider of products and services for the energy industry. The incubator will have pitches at the inaugural Houston Energy and Climate Startup Week next month.

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This article originally ran on EnergyCapital.

Expert: Demystifying SBIR grants for Houston startups

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Grants are everywhere, all the time, but often seem unobtainable for startups. Most companies tell me about their competitors winning grants but don’t know how to secure non-dilutive funding for themselves. It’s true that the SBIR program is competitive — with only 10 to 15 percent of applicants receiving awards — but with a little guidance and perseverance, they are most definitely obtainable.

An SBIR overview

The Small Business Innovation Research program was introduced on the federal level in 1982 with the purpose of de-risking early technologies. While most investors are hesitant to invest in a company that’s still in ideation, the SBIR program would provide an initial level of feasibility funding to develop a prototype. The program issues funds to companies without taking any equity, IP, or asking for the money back.

Since its inception, the SBIR program has funded over 200,000 projects through 11 different federal agencies, including, but not limited to, the Department of Defense, the National Institute of Health, and the National Science Foundation. Federal agencies with R&D budgets over $100 million dedicate at least 3.2 percent of their budget to the SBIR program to fund research initiated by small businesses.

Eligibility and application process

It is no surprise that only small businesses can apply for this non-dilutive funding. For SBIR purposes, a small business is defined as being a for-profit entity, smaller than 500 employees, 51 percent owned by US citizens or permanent residents, and not primarily owned by venture capital groups. This small business must also have the rights to the IP that needs de-risking.

To apply, the small business must have a specific project that needs funding. Normally, this project will have three specific aims that detail the action items that will be attempted during the funded period. Some agencies require a pre-application, like a letter of intent (DOE) or a project pitch (NSF). Others don’t have a screening process and you can simply submit a full application at the deadline. Most agencies published examples of funded or denied applications for you to review.

SBIR phases

Phase I of the SBIR program is the normal entry point for every agency. It takes your product from ideation, through a feasibility study, to having a prototype. While agencies provide various funding amounts, the range is between $75,000 to $300,000 for 3 to 12 months of R&D activities. Applications contain a feasibility research plan (around six pages), an abstract, specific aims, supporting documents, and a budget.

While some programs allow for Direct to Phase II (D2P2) applications, most don’t apply for Phase II until they have secured Phase I funding. This second phase allows companies with completed feasibility studies to test their new prototype at a larger scale. The budgets for this phase range from $600,000 to $3 million and span an average of two years. The research plan is twice as robust and a commercialization plan is also needed.

Tips for success

If you’re wondering if your technology would be a good fit for a certain program, you can start by looking at the SBIR website to see the previously funded projects. The more recent projects will give you an idea of the funding priorities for each agency. Most abstracts will allude to the specific aims, meaning you can get a sense of the research projects that were approved. If you regularly see an agency funding projects similar to yours, you can search sbir.gov/topics for that agency’s research topics and upcoming deadlines.

Your team is one of the most important aspects of the application. Since you will be reviewed by academic experts, it’s helpful to have a principal investigator on your project that has a history of experience or publications with similar technology. Keep in mind that this principal investigator must be primarily employed by your company at the time of the grant. If this individual is employed by a university or nonprofit research organization, consider taking the STTR route so you can utilize their expertise.

Preparing Phase I applications should take no less than eight weeks, and Phase II should take at least ten. Your first step should be read the entire solicitation and create action items. The early action items should be

Completing government registrations, like SAM.gov
Writing your abstract and specific aims
Contacting the program manager or director for early feedback

Any bids, estimates, or letters of support may also take time to receive, so don’t delay pursuing these items.

Don’t stop trying

If you speak to any program officer, they will encourage you to keep applying. For resubmissions, you will have a chance to explain why your previous application was denied and what you’ve done to improve. Most companies receive funding on the resubmission. If you get the feeling that a specific agency isn’t the right fit, reach out to other agencies that may be interested in the technology. You may realize that a small pivot may open up better opportunities.

There are frequently published webinars from different agencies that will give overviews of the specific solicitations and allow for Q&A. If you feel stuck or are still concerned about getting started, reach out to an individual or group that can provide guidance. There are plenty of grant writers, some of which have reviewed for the SBIR program for different agencies, who can provide strategy, guidance, reviews, and writing services to provide different levels of help.

Securing SBIR funding can be a game-changer for startups. While the process may seem daunting at first, with the right approach and persistence, it’s very obtainable. Remember, each application is a learning experience, and every iteration brings you closer to success. Whether you seek support from webinars, program officers, or professional grant writers, the key is to keep pushing forward. The potential rewards far outweigh the challenges, and with determination, your startup could be the next SBIR success story.