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."

From Your Site Articles
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.

Ad Placement 300x100
Ad Placement 300x600

CultureMap Emails are Awesome

Property Showcase

Where to work: These 2024 Houston Innovation Awards finalists are hiring

growing biz

About a third of this year's startup finalists for the Houston Innovation Awards are hiring — from contract positions all the way up to senior-level roles.

The finalists, announced last week, range from the medical to energy to AI-related startups and will be celebrated next month on Thursday, November 14, at the Houston Innovation Awards at TMC Helix Park. Over 50 finalists will be recognized for their achievements across 13 categories, which includes the 2024 Trailblazer Legacy Awards that were announced earlier this month.

Click here to secure your tickets to see which growing startups win.

Let's take a look at where you could land a job at one of Houston's top startups.

Double-digit growth

When submitting their applications for the 2024 Houston Innovation Awards, every startup was asked if it was hiring. Four Houston startups replied that they are growing their teams rapidly.

Houston e-commerce startup Cart.com, one of the city's few $1 billion-plus “unicorns," reported that it is hiring approximately 50 new employees. The company, which focuses on commerce and logistics software development, secured $105 million in debt refinancing from investment manager BlackRock this summer following a $25 million series C extension round that brought Cart.com’s Series C total to $85 million. It currently has about 1,500 employees and 4 offices in three companies since it was founded in 2020, according to its website.

Houston energy tech company Enovate Ai (previously known as Enovate Upstream) reported that it is hiring 10-plus positions. The company, with 35 current employees, helps automate business and operational processes for decarbonization and energy optimization. Its CEO and founder, Camilo Mejia, sat down for an interview with InnovationMap in 2020. Click here to read the Q&A.

Square Robot is hiring about 10 new Houston employees and 15 total between Houston and other markets, according to its application. The advanced robotics company was founded in Boston in 2016 and opened its Houston office in August 2019. It develops submersible robots for the energy industry, specifically for storage tank inspections and eliminating the need for humans to enter dangerous and toxic environments. Last year it reported to be hiring 10 to 30 employees as well, ahead of the 2023 Houston Innovators Award. It currently has 25 Houston employees and about 50 nationally.

InnoVent Renewables LLC is also hiring 15 new employees to be based in Mexico. The company launched last year with its proprietary continuous pyrolysis technology that can convert waste tires, plastics, and biomass into fuels and chemicals. The company scaled up in 2022 and has operations in Pune, India, and Monterrey, Mexico, with plans for aggressive growth across North America and Latin America. It has 20 employees in Mexico and one in Houston currently.

Senior roles

Geothermal energy startup Sage Geosystems reported that it is looking to fill two senior roles in the company. It also said it anticipates further staff growth after its first commercial energy storage facility is commissioned at the end of the year in the San Antonio metro area. The company also recently expanded its partnership with the United States Department of Defense's Defense Innovation Unit and announced this month that it was selected to conduct geothermal project development initiatives at Naval Air Station in Corpus Christi. It has 12 full-time employees, according to its application.

Steady growth

Other companies reported that they are hiring a handful of new workers, which for some will increase headcount by about 50 percent to 100 percent.

Allterum Therapeutics reported that it is adding six employees to its current team of 13. The biopharmaceutical company that is under the Fannin Partners portfolio of med tech companies was awarded a $12 million product development grant from the Cancer Prevention and Research Institute of Texas this spring.

Dauntless XR will add between five and eight employees, according to its application. It currently has four employees. The augmented reality software company, originally founded as Future Sight AR in 2018, recently secured a NASA contract for space weather technology after rebranding and pivoting. The company's CEO, Lori-Lee Elliott, recently sat down with the Houston Innovators Podcast. Click here to hear the interview.

Syzygy Plasmonics is hiring four positions to add to its team of 120. The company was named to Fast Company's energy innovation list earlier this year.

Venus Aerospace is adding five to 10 key hires to its team of 72. Andrew Duggleby founded the company with his wife and CEO Sassie in 2020, before relocating to the Houston Spaceport in 2021. Last year, Venus raised a $20 million series A round, and it successfully ran the first long-duration engine test of their Rotating Detonation Rocket Engine in partnership with the Defense Advanced Research Projects Agency, or DARPA, earlier this year.

​Seeking selectively

Other finalists are adding to their teams with a handful of new hires of contract gigs.

​Future roles

Other finalists reported that they are currently not hiring, but had plans to in the near future.

NanoTech Materials Inc., which recently moved to a new facility, is not currently. Hiring but said it plans with new funding during its series B.

Renewable energy startup CLS Wind is not hiring at this time but reported that it plans to when the company closes funding in late 2024.

Houston-area researchers score $1.5M grant to develop storm response tech platform

fresh funding

Researchers from Rice University have secured a $1.5 million grant from the National Science Foundation to continue their work on improving safety and resiliency of coastal communities plagued by flooding and hazardous weather.

The Rice team of engineers and collaborators includes Jamie Padgett, Ben Hu, and Avantika Gori along with David Retchless at Texas A&M University at Galveston. The researchers are working in collaboration with the Severe Storm Prediction, Education and Evacuation from Disasters (SSPEED) Center and the Ken Kennedy Institute at Rice and A&M-Galveston’s Institute for a Disaster Resilient Texas.

Together, the team is developing and hopes to deploy “Open-Source Situational Awareness Framework for Equitable Multi-Hazard Impact Sensing using Responsible AI,” or OpenSafe.AI, a new platform that utilizes AI, data, and hazard and resilience models "to provide timely, reliable and equitable insights to emergency response organizations and communities before, during and after tropical cyclones and coastal storm events," reads a news release from Rice.

“Our goal with this project is to enable communities to better prepare for and navigate severe weather by providing better estimates of what is actually happening or might happen within the next hours or days,” Padgett, Rice’s Stanley C. Moore Professor in Engineering and chair of the Department of Civil and Environmental Engineering, says in the release. “OpenSafe.AI will take into account multiple hazards such as high-speed winds, storm surge and compound flooding and forecast their potential impact on the built environment such as transportation infrastructure performance or hazardous material spills triggered by severe storms.”

OpenSafe.AI platform will be developed to support decision makers before, during, and after a storm.

“By combining cutting-edge AI with a deep understanding of the needs of emergency responders, we aim to provide accurate, real-time information that will enable better decision-making in the face of disasters,” adds Hu, associate professor of computer science at Rice.

In the long term, OpenSafe.AI hopes to explore how the system can be applied to and scaled in other regions in need of equitable resilience to climate-driven hazards.

“Our goal is not only to develop a powerful tool for emergency response agencies along the coast but to ensure that all communities ⎯ especially the ones most vulnerable to storm-induced damage ⎯ can rely on this technology to better respond to and recover from the devastating effects of coastal storms,” adds Gori, assistant professor of civil and environmental engineering at Rice.

------

This article originally ran on EnergyCapital.

3+ Houston innovators to know this week

who's who

Editor's note: Every week, I introduce you to a handful of Houston innovators to know recently making headlines with news of innovative technology, investment activity, and more. This week's batch includes a drone tech startup founder, biotech investor, and health care innovator.

Divyaditya Shrivastava, co-founder of Paladin

Paladin’s AI-enhanced autonomous drones help public safety agencies, such as police and fire departments, respond to 911 calls. Photo via LinkedIn

Houston-based Paladin, whose remotely controlled drones help first responders react quickly to emergencies, has collected $5.2 million in seed funding.

Gradient, a seed fund that backs AI-oriented startups, led the round. Also participating were Toyota Ventures, the early-stage VC arm of Japanese automaker Toyota; venture capital firm Khosla Ventures; and VC fund 1517. The company was co-founded by Divyaditya Shrivastava and Trevor Pennypacker.

Among the agencies that have tried out Paladin’s technology is the Houston area’s Memorial Villages Police Department. The department participated in a three-month Paladin pilot project in 2019. Read more.

Veronica Breckenridge (née Wu), founder of First Bight Ventures

Veronica Breckenridge, founder of First Bight VenturesInvestor advocates now is the time to position Houston as a leading biomanufacturing hub

Veronica Breckenridge is the founder of First Bight Ventures, which just celebrated three portfolio companies. Photo courtesy

Three portfolio companies of Houston venture capital firm First Bight Ventures have received a combined $5.25 million from the U.S. Defense Department’s Distributed Bioindustrial Manufacturing Program.

“The allocation of funds by the federal government will be critical in helping grow biomanufacturing capacity,” Veronica Breckenridge (née Wu), founder of First Bight, says in a news release. “We are very proud to represent three dynamic companies that are awardees of this competitive and widely praised program.” Read more.

Sunil Sheth, associate professor in the Department of Neurology at McGovern Medical School at UTHealth Houston

UTHealth Houston has secured millions in grant funding — plus has reached a new milestone for one of its projects. Photo via utsystem.edu

UTHealth recently received a grant that will improve the odds for patients who have had a stroke with the successful re-opening of a blocked vessel through endovascular surgery. The $2.5 million grant from the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, will fund a five-year study that will include the creation of a machine-learning program that will be able to predict which stroke patients with large blood vessel blockages will benefit most from endovascular therapy.

The investigators will form a database of imaging and outcomes of patients whose blockages were successfully opened, called reperfusion, from three U.S. hospitals. This will allow them to identify clinical and imaging-based predictors of damage in the brain after reperfusion. From there, the deep-learning model will help clinicians to know which patients might go against the tenet that the sooner you treat a patient, the better.

“This is shaking our core of deciding who we treat, and when, and how, but also, how we are evaluating them? Our current methods of determining benefit with imaging are not good enough,” says principal investigator and associate professor in the Department of Neurology at McGovern Medical School at UTHealth Houston, Sunil Sheth. Read more.

Top innovators: 2024 Houston Innovation Awards finalists revealed

Here's what Houston startups and innovators will be honored at the Houston Innovation Awards on November 14. Graphic via Gow Media

After nearly 300 nominations, InnovationMap and its group of judges are ready to reveal the finalists for this year's Houston Innovation Awards.

Taking place on Thursday, November 14, the Houston Innovation Awards celebrates all of Houston's innovation ecosystem — startups, entrepreneurs, investors, mentors, and more. Over 50 finalists will be recognized in particular for their achievements across 13 categories, which includes the 2024 Trailblazer Legacy Awards that were announced earlier this month.

Click here to see the 2024 Houston Innovation Awards finalists.

View All Listings