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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Procyrion has announced the closing of its series E round of funding. Photo via Getty Images

Houston medical device company secures $57.7M to fund journey to FDA approval, commercialization

fresh funding

Houston-born and bred medical device company, Procyrion, has completed its series E with a raise of $57.7 million, including the conversion of $10 million of interim financing.

Procyrion is the company behind Aortix, a pump designed to be placed in the descending thoracic aorta of heart failure patients, which has been shown to improve cardiac performance in seriously ill subjects. The money raised will allow the company to proceed with a the DRAIN-HF Study, a pivotal trial that will be used for eventual FDA approval and commercialization.

The Aortix is the brainchild of Houston cardiologist Reynolds Delgado. According to Procyrion’s CSO, Jace Heuring, Delgado, gained some of his experience with devices for the heart working with legendary Texas Heart Institute surgeon O.H. “Bud” Frazier. He filed his first patents related to the Aortix in 2005.

Heuring says that the first prototypes were built in 2011, followed by the final design in 2018. CEO Eric Fain, a California-based MD and with more than 30 years in the medical device industry, joined the company in 2018 ahead of the final design, primed to bring Aortix to the public. He visits the company’s Houston headquarters, across the street from Central Market, on a regular basis.

The device’s pilot study of 18 patients was completed in 2022. Those encouraging results paved the way for the current study, which will include an enrollment of 134 patients. The randomized study will seek to treat patients with acute decompensated heart failure. Half will be treated with standard-of-care therapy, the other half will be catheterized with an Aortix pump. A separate arm of the study will seek to treat end-stage heart failure patients who would otherwise be deemed too sick for either a transplant or an LVAD permanent pump. Fort-five healthcare centers in the United States will participate, including Texas Heart Institute.

“One of the key characteristics is [the patients] are retaining a lot of fluid,” explains Heuring in a video interview. “And when I say a lot, I mean it could be 25 or 30 or 40 pounds of fluid or more. When we put our pump in, one of the main goals is to reduce that fluid load.”

On average, about 11 liters of fluid came off of each patient. Many of those end-stage patients had previously been considered for both a heart and kidney transplant, but after using the Aortix, their kidneys responded so well that they were able to get only the heart transplant.

“These patients really are in dire straits and come into the hospital and today the only proven therapy to help these patients is to administer high doses of intravenous diuretic and some other cardiac drugs and in about 25 percent of patients those therapies are ineffective,” says Fain.

If Aortix gains approval, these sickest of the sick, usually consigned to hospice care, will have hope.

Thanks to the Series E, led by Houston’s Fannin Partners, returning investors, including Bluebird Ventures, the Aortix is inching closer to commercialization. Besides funding the DRAIN-HR study, Procyrion will also use the funds for internal programs to improve product manufacturability. One more step towards meaning advanced heart failure may not always be a death sentence.

Last month, Atul Varadhachary, managing director of Fannin, joined the Houston Innovators Podcast and alluded to Procyrion's raise. The company was born out of Fannin and still resides in the same building as Fannin.

Aortix is a pump designed to be placed in the descending thoracic aorta of heart failure patients. Photo via Procyrion

A Houston startup based out of the TMC Innovation Factory has announced funding and upcoming trials. Photo courtesy of TMC

Houston health tech startup secures $16M series A, prepares for first U.S. clinical trials

money moves

Fueled by fresh funding in the bank, a medical device startup has announced upcoming trials.

VenoStent, Inc., a company developing an innovative tool to improve outcomes for hemodialysis patients, has closed $16 million in a series A round of financing. Two Charleston, South Carolina-based firms — Good Growth Capital and IAG Capital Partners — led the round.

The company also announced it received Investigational Device Exemption from the FDA for its United States clinical trial, SAVE-FistulaS.

“Our mission at VenoStent is to improve the quality and length of life of dialysis patients. On the heels of our very promising results in several preclinical studies and a 20-patient feasibility study that led to our Breakthrough Designation last year, this recent IDE approval is perhaps our biggest milestone to date," Tim Boire, CEO of VenoStent, says in a news release. "We now enter an exciting new epoch in our company’s development that we believe will ultimately result in FDA Approval and vastly improve the quality and length of life for patients."

VenoStent's novel therapeutic medical device is a bioabsorbable wrap. Image courtesy of VenoStent

VenoStent's series A will fund the trial, expand manufacturing capabilities, and more. The company is targeting the more than 800,000 people in the U.S. with end-stage renal disease. Currently, more than half of the surgeries performed to initiate hemodialysis fail within a year. VenoStent's novel therapeutic medical device is a bioabsorbable wrap that reduces vein collapse by providing mechanical support and promoting outward vein growth.

“This trial is designed to provide the highest level of clinical evidence. We’re excited to be in this position to treat the first patients in the United States with this technology, and demonstrate the safety and efficacy of our device,” continues Boire in the release.

Per the release, the company is aiming for FDA Approval and be the first-to-market device to improve hemodialysis access surgery.

“We’re extremely pleased to be partnering with VenoStent on this critical mission. This company and technology are poised for commercial success to address a critical, unmet need,” says Bob Crutchfield, operating partner at Good Growth Capital, in the release.

The TMC Venture Fund also contributed to the series A investment round, along with SNR, Baylor Angel Network / Affinity Fund, Creative Ventures, Cowtown Angels, Alumni Ventures, and other notable angel investors. Past investors in VenoStent include KidneyX, National Science Foundation, National Institute of Health, Y Combinator, Health Wildcatters, and the Texas Halo Fund.

“VenoStent’s data and traction to date is impressive and gives us a lot of confidence in their continued success. We look forward to helping them get this Breakthrough product to market and help patients that are in dire need of this innovative technology,” says Joel Whitley, partner at IAG Capital Partners, in the release.

Tim Boire is the CEO of VenoStent. Photo via LinkedIn

A new innovation out of the Texas Medical Center's Biodesign Program is enhancing efficacy of a life-saving aortic aneurysm rupture procedure. Photo via Getty Images

Houston biodesign innovators ready to spin out startup with life-saving vascular tech

heartbreak healers

Yes, you can die of a broken heart — although it's not in the hyperbolic way you might be thinking. Fewer than 20 percent of people who have an aortic aneurysm rupture survive the event. But aortic aneurysms can be treated if they’re caught before they burst. A new Houston company is devoted to a novel solution to helping patients with abdominal aortic aneurysms (AAA).

That company is Taurus Vascular. As part of the current class of the TMC Innovation Biodesign Program, fellows Matthew Kuhn and Melanie Lowther were tasked with creating a biomedical company in a year. The founders started their journey last August. At the end of this month, they'll be kicked out of the nest, Kuhn tells InnovationMap. Taurus is also in Rice University's 2023 cohort of OwlSpark, an ongoing summer program for startups founders from the Rice community.

Kuhn is a biomedical engineer who just scored his forty-fifth patent. The CEO says that he hit it off quickly with his co-founder and COO, Lowther, former director entrepreneurship and innovation at Texas Children’s Hospital.

Matthew Kuhn and Melanie Lowther co-founded Taurus Vascular as TMC Biodesign fellows. Photos via taurusvascular.com

Members of the Biodesign Program are paid a livable stipend to devote themselves fully to creating a pioneering company. Kuhn says that he became interested in finding a more effective way to heal AAAs during his four and a half years as a project leader at the Center for Device Innovation at the Texas Medical Center.

“It was ripe for innovation and we landed on a concept of some merit,” he says.

The current standard of care for AAAs is EVAR, or endovascular aneurysm repair, in which a surgeon inserts a stent to relieve pressure on the aneurysm.

“It used to be if you had a AAA, you had a gnarly procedure,” he says, which included a large incision across the abdomen. EVAR eliminated that, but its problem is that it often results in endoleaks. As many as 20 percent of patients need another EVAR within five years.

Taurus Vascular’s technology improves on EVAR by placing a self-deploying stent to create a drainage pathway between the high-pressure aneurysm sac and a low-pressure nearby vein — mitigating the adverse impact of endoleaks that would otherwise cause the aneurysm to continue to grow. The simple solution will allow patients to live longer, healthier lives after their procedure.

Kuhn says that being in Houston has been and will continue to be instrumental in his company’s success. Part of that, of course, is his relatively cosseted status as a founder in the Innovation Biodesign Program. But he says that the industry as a whole has become almost like a family.

“It feels very different from startup life for other industries where it feels competitive,” he explains. "You have to be a little crazy to start a medical device company and there’s a sense that we’re all in the same boat. People are so generous with their time to share resources. I feels like I have 100 co-founders."

Following the end of Taurus Vascular’s time in the program that helped conceived it, its founders will remain in the same building, continuing to work to support their technology. The next step is raising a seed round that will pay for the company’s chronic animal studies. Because Taurus Vascular is producing a Class III medical device, its approval process to get to market is the most stringent the FDA has.

The goal is to be commercial by 2030, says Kuhn. By then, Taurus Vascular will have healed many a heart.

InformAI has three AI-based products geared at improving health care. Photo via Getty Images

Fresh off grant, Houston health tech company's AI aims to revolutionize diagnostics, care

data-driven

In Houston, we’re lucky to have top-tier doctors in the Texas Medical Center, ready to treat us with the newest technology. But what about our family members who have to rely on rural hospitals? Thanks to one Houston company, doctors in smaller community hospitals may soon have new tools at their disposal that could improve outcomes for patients around the world.

Since InnovationMap last caught up with Jim Havelka, CEO of InformAI, two years ago, that hope has come far closer to a reality. InformAI is a VC-backed digital health company. Part of JLABS @ TMC innovation facilities, the company uses artificial intelligence to develop both diagnostic tools and clinical outcome predictors. And two of the company’s products will undergo FDA regulatory testing this year.

SinusAI, which helps to detect sinus-related diseases in CT scans, received its CE Mark — the European equivalent of FDA approval — last year and is being sold across the Atlantic today, says Havelka. He adds that in the United States alone, there are roughly 700,000 sinus surgeries that the product is positioned to support.

Another product, RadOnc-AI, is designed to help doctors prescribe radiation dose plans for head and neck cancers.

“Ideally the perfect plan would be to provide radiation to the tumor and nothing around it,” says Havelka. “We’ve built a product, RadOnc-AI, which autogenerates the dose treatment plan based on medical images of that patient.”

It can be an hours-long process for doctors to figure out the path and dose of radiation themselves, but the new product “can build that initial pass in about five minutes,” Havelka says.

That in itself is an exciting development, but because this technology was developed using the expertise of some of the world’s top oncologists, “the first pass plan is in line with what [patients would] get at tier-one institutions,” explains Havelka. This creates “tremendous equity” among patients who can afford to travel to major facilities and those that can’t.

To that end, RadOnc-AI was recently awarded a $1.55 million grant from the Cancer Prevention and Research Institute of Texas, or CPRIT, a state agency that funds cancer research. The Radiological Society of North America announced late last year that InformAI was named an Aunt Minnie Best of Radiology Finalist.

“It’s quite prestigious for our company,” says Havelka. Other recent laurels include InformAI being named one of the 10 most promising companies by the Texas Life Science Forum in November.

And InformAI is only gaining steam. A third product is earlier in its stage of development. TransplantAI will optimize donor organ and patient recipient matches.

“A lot of organs are harvested and discarded,” Havelka says.

His AI product has been trained on a million donor transplants to help determine who is the best recipient for an organ. It even takes urgency into account, based on a patient’s expected mortality within 90 days. The product is currently a fully functional prototype and will soon move through its initial regulatory clearances.

The company — currently backed by three VC funds, including DEFTA Partners, Delight Ventures, and Joyance Partners — is planning to do another seed round in Q2 of 2023.

“We’ve been able to get recognized for digital health products that can be taken to market globally,” says Havelka.

But what he says he’s most excited about is the social impact of his products. With more money raised, InformAI will be able to speed up development of additional products, including expanding the cancers that the company will be targeting. And with that, more and more patients will one day be treated with the highest level of care.

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Rice University launches hub in India to drive education, tech innovation abroad

global mission

Rice University is launching Rice Global India, which is a strategic initiative to expand India’s rapidly growing education and technology sectors.

“India is a country of tremendous opportunity, one where we see the potential to make a meaningful impact through collaboration in research, innovation and education,” Rice President Reginald DesRoches says in a news release. “Our presence in India is a critical step in expanding our global reach, and we are excited to engage more with India’s academic leaders and industries to address some of the most pressing challenges of our time.”

The new hub will be in the country’s third-largest city and the center of the country’s high-tech industry, Bengaluru, India, and will include collaborations with top-tier research and academic institutions.

Rice continues its collaborations with institutions like the Indian Institute of Technology (IIT) Kanpur and the Indian Institute of Science (IISc) Bengaluru. The partnerships are expected to advance research initiatives, student and faculty exchanges and collaborations in artificial intelligence, biotechnology and sustainable energy.

India was a prime spot for the location due to the energy, climate change, artificial intelligence and biotechnology studies that align with Rice’s research that is outlined in its strategic plan Momentous: Personalized Scale for Global Impact.

“India’s position as one of the world’s fastest-growing education and technology markets makes it a crucial partner for Rice’s global vision,” vice president for global at Rice Caroline Levander adds. “The U.S.-India relationship, underscored by initiatives like the U.S.-India Initiative on Critical and Emerging Technology, provides fertile ground for educational, technological and research exchanges.”

On November 18, the university hosted a ribbon-cutting ceremony in Bengaluru, India to help launch the project.

“This expansion reflects our commitment to fostering a more interconnected world where education and research transcend borders,” DesRoches says.

UH-backed project secures $3.6M to transform CO2 into sustainable fuel with cutting-edge tech

funds granted

A University of Houston-associated project was selected to receive $3.6 million from the U.S. Department of Energy’s Advanced Research Projects Agency-Energy that aims to transform sustainable fuel production.

Nonprofit research institute SRI is leading the project “Printed Microreactor for Renewable Energy Enabled Fuel Production” or PRIME-Fuel, which will try to develop a modular microreactor technology that converts carbon dioxide into methanol using renewable energy sources with UH contributing research.

“Renewables-to-liquids fuel production has the potential to boost the utility of renewable energy all while helping to lay the groundwork for the Biden-Harris Administration’s goals of creating a clean energy economy,” U.S. Secretary of Energy Jennifer M. Granholm says in an ARPA-E news release.

The project is part of ARPA-E’s $41 million Grid-free Renewable Energy Enabling New Ways to Economical Liquids and Long-term Storage program (or GREENWELLS, for short) that also includes 14 projects to develop technologies that use renewable energy sources to produce sustainable liquid fuels and chemicals, which can be transported and stored similarly to gasoline or oil, according to a news release.

Vemuri Balakotaiah and Praveen Bollini, faculty members of the William A. Brookshire Department of Chemical and Biomolecular Engineering, are co-investigators on the project. Rahul Pandey, is a UH alum, and the senior scientist with SRI and principal investigator on the project.

Teams working on the project will develop systems that use electricity, carbon dioxide and water at renewable energy sites to produce renewable liquid renewable fuels that offer a clean alternative for sectors like transportation. Using cheaper electricity from sources like wind and solar can lower production costs, and create affordable and cleaner long-term energy storage solutions.

Researchers Rahul Pandey, senior scientist with SRI and principal investigator (left), and Praveen Bollini, a University of Houston chemical engineering faculty, are key contributors to the microreactor project. Photo via uh.edu

“As a proud UH graduate, I have always been aware of the strength of the chemical and biomolecular engineering program at UH and kept myself updated on its cutting-edge research,” Pandey says in a news release. “This project had very specific requirements, including expertise in modeling transients in microreactors and the development of high-performance catalysts. The department excelled in both areas. When I reached out to Dr. Bollini and Dr. Bala, they were eager to collaborate, and everything naturally progressed from there.”

The PRIME-Fuel project will use cutting-edge mathematical modeling and SRI’s proprietary Co-Extrusion printing technology to design and manufacture the microreactor with the ability to continue producing methanol even when the renewable energy supply dips as low as 5 percent capacity. Researchers will develop a microreactor prototype capable of producing 30 MJe/day of methanol while meeting energy efficiency and process yield targets over a three-year span. When scaled up to a 100 megawatts electricity capacity plant, it can be capable of producing 225 tons of methanol per day at a lower cost. The researchers predict five years as a “reasonable” timeline of when this can hit the market.

“What we are building here is a prototype or proof of concept for a platform technology, which has diverse applications in the entire energy and chemicals industry,” Pandey continues. “Right now, we are aiming to produce methanol, but this technology can actually be applied to a much broader set of energy carriers and chemicals.”

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This article originally ran on EnergyCapital.

Houston innovator drives collaboration, access to investment with female-focused group

HOUSTON INNOVATORS PODCAST EPISODE 262

After working in technology in her home country of Pakistan, Samina Farid, who was raised in the United States, found her way to Houston in the '70s where business was booming.

She was recruited to work at Houston Natural Gas — a company that would later merge and create Enron — where she rose through the ranks and oversaw systems development for the company before taking on a role running the pipelines.

"When you're in technology, you're always looking for inefficiencies, and you always see areas where you can improve," Farid says on the Houston Innovators Podcast, explaining that she moved on from Enron in the mid-'80s, which was an exciting time for the industry.

"We had these silos of data across the industry, and I felt like we needed to be communicating better, having a good source of data, and making sure we weren't continuing to have the problems we were having," she says. "That was really the seed that got me started in the idea of building a company."

She co-founded Merrick Systems, a software solutions business for managing oil and gas production, with her nephew, and thus began her own entrepreneurial journey. She came to another crossroads in her career after selling that business in 2014 and surviving her own battle with breast cancer.

"I got involved in investing because the guys used to talk about it — there was always men around me," Farid says. "I was curious."

In 2019, she joined an organization called Golden Seeds. Founded in 2005 in New York, the network of angel investors funding female-founded enterprises has grown to around 280 members across eight chapters. Suzan Deison, CEO of the Houston Women's Chamber, was integral in bringing the organization to Houston, and now Farid leads it as head of the Houston Chapter of Golden Seeds.

For Farid, the opportunity for Houston is the national network of investors — both to connect local female founders to potential capital from coast to coast and to give Houston investors deal flow from across the country.

"It was so hard for me to get funding for my own company," Farid says. "Having access to capital was only on the coasts. Software and startups was too risky."

Now, with Golden Seeds, the opportunity is there — and Farid says its an extremely collaborative investor network, working with local organizations like the Houston Angel Network and TiE Houston.

"With angel investing, when we put our money in, we want these companies to succeed," she says."We want more people to see these companies and to invest in them. We're not competing. We want to work with others to help these companies succeed."

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