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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Houston urban agricultural nonprofit gears up for opening of new farm in Second Ward

GROWING FOR GOOD

Small Places, a Houston-based urban agricultural nonprofit, is looking forward to putting down roots beyond the fresh vegetables they grow in the East End.

After securing a 40-year land agreement with Harris County, the organization, which provides produce to families facing food insecurity in the Second Ward, is expecting to open their new farm in February 2025. Small Places’ founders hope the 1.5 acres of land named Finca Tres Robles, located at 5715 Canal Street, will be the beginning of Houston’s urban farming movement.

Founded in 2014 by brothers Daniel, Mark, and Thomas Garcia-Prats, Small Places was born out of the latter brother’s desire to work on an organic farm in his hometown of Houston. After farming in Maine, Iowa, and Nicaragua, Thomas had hoped to manage an urban farm but was unable to find a place. He then roped his brothers, who had no agricultural background at the time, into creating one.

“I joke that my journey in agriculture started the day we started out there. We didn’t grow up gardening or farming or anything of the sort,” says Daniel, Small Places’ director of operations. “It was a big learning curve, but how we approached it to our benefit was through our diverse set of backgrounds.”

Small Places began their need-based produce distribution programs through a partnership with nearby pre-school, Ninfa Lorenzo Early Childhood Center, providing food insecure families with fresh produce and later cooking lessons in 2017. When COVID-19 hit Houston in 2020, Daniel says Small Places pivoted towards becoming a redistribution center for their farming contacts who needed to offload produce as restaurants shut down, selling their crops through the organization. Their neighborhood produce program was then born, providing free boxes of produce to nearly 200 families in the East End at the pandemic’s peak.

“We found ourselves in the middle of two communities who were in need, one being people in our community who were losing jobs and were in need of food as well as our farming connections who were losing restaurant accounts,” Daniel explains.

Small Places grows a variety of vegetables at their East End based farm, selling them at a weekly farm stand. (Photo courtesy Small Places)Small Places grows a variety of vegetables at their East End based farm, selling them at a weekly farm stand. (Photo courtesy Small Places)

Small Places currently assists 65 families living predominantly within two miles of their original location and they recently restarted their programming with Ninfa Lorenzo Early Childhood Center, and accepts Supplemental Nutrition Assistance Program benefits (SNAP) at their farm stand. Daniel says once Finca Tres Robles opens, Small Places plans to bring back cooking classes and educational seminars on healthy eating for which his brother Mark, a former teacher, created the original curriculum. The farm will also have a grocery store stocked with Finca Tres Robles' produce and eventually food staples from local vendors.

“Being social and preparing a meal can be fun, interesting, and delicious. Being able to pull all of that into a program was really important for us,” Daniel explains.

Farming successfully in the middle of Houston for their subsidized programs and produce market requires Small Places’ team to be strategic in their operations. Using his background in engineering and manufacturing, Daniel says they’ve closely monitored trends in which crops perform the best in Houston’s varied, humid climate over the past decade.

They also follow Thomas’s philosophy of allowing nature to work for them, planting crops at times when specific pests are minimal or integrating natural predators into their environment. And lots of composting. Daniel says they accept compostable materials from community members, before burying the raw organic matter in the earth in between their plant beds, allowing it to mature, then later using it to nourish their crops. Daniel says he and his co-founders hope to see more community-focused, sustainable operations like theirs spring up across Houston.

“Small Places is about hopefully more than one farm and really trying to turn urban agriculture and a farm like ours from a novel thing into something that’s just a part of communities and the fabric of Houston for generations to come,” Daniel says.

Houston female-focused health tech accelerator names top companies at annual event

you go girls

A Houston organization that accelerates and supports female founders leading innovative health tech startups has concluded its 2024 program with the announcement of this year's top companies.

Ignite Health, an accelerator founded in 2017 by longtime Houston health care professional Ayse McCracken, named its 2024 winners at its annual Fire Pitch Competition in Houston last month. The companies pitched health tech solutions across lung health, renal therapy, breastfeeding tech, and more.

"This year’s competition was a culmination of passion, innovation, and hard work from the top startups in our 2024 Accelerator Program," reads a LinkedIn post from Ignite. "These trailblazing founders earned their spot on the stage by demonstrating exceptional leadership and the potential to revolutionize the healthcare industry with their solutions and devices."

First place winner was Sarah Lee, CEO and co-founder of Relavo, a New York-based company that's making home dialysis more effective, safer, and more affordable. Lee accepted awards from Johnson & Johnson and Wilson Sonsini Goodrich & Rosati.

Therese Canares, CEO and founder of CurieDx, took second place and won its awards from SWPDC - Southwest National Pediatric Device Innovation Consortium and Wilson Sonsini. CurieDx, based in Baltimore, Maryland, is creating remote diagnostic tools using smartphone technology.

In third place is Andrea Ippolito, CEO and founder of SimpliFed, a company focused on democratizing access to baby feeding and breastfeeding services through virtual care that's covered by insurance. The startup won awards from Texas Children's Hospital and Wilson Sonsini Goodrich & Rosati.

Three other finalists won other awards, including:

  • Kadambari Beelwar, CEO and co-founder, Henderson, Nevada-based Truss Health, which created an AI-powered sensor fusion platform that's designed to detect early signs of infection, won an award presented by Memorial Hermann Health System and Golden Seeds
  • Mimi Gendreau Kigawa, CEO and co-founder of New York-based Zeph Technologies, an AI-lung care company with technology for clinicians to deliver pulmonary care to patients with chronic respiratory disease, won an award presented by CU Innovations and Houston Methodist
  • Ashley Yesayan, CEO and co-founder, New York-based OneVillage, a software platform meant to support patients and family members through trying health events, won an award presented by CU Innovations

The companies were evaluated by the 2024 judges, which included: Allison Rhines, head of JLABS Houston; Andrew Truscott, global health technology lead at Accenture; Angela Shippy, senior physician executive at Amazon Web Services; Kimberly Muller, executive director of CU Innovations at University of Colorado Anschutz Medical Campus; Myra Davis, chief innovation and information officer at Texas Children's Hospital; and Winjie Tang Miao, senior executive vice president and COO of Texas Health Resources.

Houston expert: Balancing flexibility, accountability, and performance in a hybrid world

guest column

Amazon, Salesforce, and Nike are just a few companies making headlines in 2024 for requiring employees to return to the office.

At the same time, technology is evolving, automation and efficiency gains are taking center stage, and employees continue to seek greater flexibility. This has fueled the debate around the future of where work gets done in 2025 and beyond.

Proponents of a remote or hybrid work model believe it leads to increased employee productivity, higher job satisfaction, and access to a larger talent pool. Detractors have a different viewpoint – suggesting employee isolation is greater, cyber security concerns are more complex to manage, and it’s hard to accurately evaluate employee performance.

So, what’s the answer?

The future of work lies in harnessing the power of the employer/employee relationship. This involves establishing clear guidelines for what working “looks like” inside and outside the company, measuring performance tied to company goals, and holding leaders and employees accountable for how these interactions occur.

A remote work policy helps establish clear guidelines. For example, should business cameras be on for all meetings? What is considered an acceptable business casual dress code? Can pets be on screen? Addressing the issues around a remote workspace, how to interact during a meeting, and what to wear helps to define company expectations and how you would like your business to be represented.

Formal performance management tools and processes have been in place for decades. While an annual event is important, encouraging managers and employees to have regular and structured performance conversations and share transparent feedback (regardless of where they work) helps you celebrate what’s exceptionally good, acknowledge what’s on track, and quickly course correct when needed.

Accountability in the remote work environment goes both ways, and leaders must model the behaviors they expect from employees. When the rule is cameras on, that means everyone, regardless of their title. When you’ve established working hours, be available to take the call or respond to the Teams chat within a reasonable timeframe. And when you need to be away from work, set expectations for when and how to reach you.

So, where is the best place to start when updating or establishing guidelines? First, review your key business objectives and work out what’s required to support the successful achievement of those goals. Design your remote and/or hybrid model around those objectives and place employees at the forefront of that design.

If you think about it, it’s no different than being in the office. You expect your employees and managers to show up, be fully present, and hold themselves accountable. That should be the expectation no matter where you “sit.”

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Michelle Mikesell is the chief people officer at Houston-based G&A Partners.

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