FDA greenlights Houston surgery robotics company's unique technology

headed to clinical trials

EndoQuest Robotics secured an Investigational Device Exemption from the FDA for its clinical study. Photo via Getty Images

A Houston surgical robotics company has gotten a Investigational Device Exemption from the FDA to go forward with human trials.

This news allows EndoQuest Robotics to begin its Prospective Assessment of a Robotic-Assisted Device in Gastrointestinal Medicine (PARADIGM) study, which will be conducted at leading United States health care facilities, including Brigham and Women’s Hospital (Boston), Mayo Clinic (Scottsdale), Cleveland Clinic (Cleveland), AdventHealth (Orlando), and HCA Healthcare (Houston). The study will include surgeries on 50 subjects, who will hopefully begin to enroll in January.

“The foundational thesis is we're trying to make sure that the world's largest medical center is also the world's largest med tech innovation center,” Eduardo Fonseca, interim CEO of EndoQuest Robotics, tells InnovationMap.

His company is well on its way to helping to assure that, through making history of its own. EndoQuest is behind the world's first Flexible Robotic Surgical System, a technology that may one day transform surgery as we know it.

The idea to use these novel robots for surgery came from Dr. Todd Wilson, a surgeon at UTHealth Houston, who spent his medical education, residency, and fellowship at the institution.

“I had really focused in my practice on trying to do everything possible to improve outcomes for patients,” Wilson explains. “And there seemed to be a pretty good correlation that the smaller the incisions or the fewer incisions, the better patients would do.”

The stumbling block? The necessary small incisions are difficult for human surgeons to make with current technology. But UTHealth was part of the solution.

“Right there in the University of Texas was a microsurgical lab where they were focusing on trying to develop robotics, but the application was still a little bit fuzzy,” Wilson says.

Using their innovations to solve Wilson’s problem turned out to be the start of the company now known as EndoQuest Robotics.

The first indication for the system is for colon lesions. But in the future it could be used for practically any minimally invasive surgery (MIS). That means that the robots could help to perform anything from a tonsillectomy to cholecystectomy (gallbladder removal) to non-invasive colorectal procedures, should those lesions prove to be cancerous.

According to Fonseca, last year was the first on record that there were more MIS, including laparoscopic and robotic surgeries, than conventional ones in the U.S. The time is right to forge ahead with the flexible robotic surgical system. Days ago, the EndoQuest team announced that its Investigational Device Exemption (IDE) application for its pivotal colorectal clinical study was approved by the FDA.

“Our end point is a device that can be mass-manufactured and very safe for patients and has a short learning curve, so therefore, we intend to learn a lot during these trials that will inform our ultimate design,” says Fonseca.

He adds that it’s a “brilliant” group of engineers that has set EndQuest apart, including both teams in Houston and in South Korea.

“We can move twice as fast as anyone else,” jokes engineer Jiwon Choi.

Despite the extra brain power provided by the South Korea engineers, Fonseca says that EndoQuest’s beginnings are “as much of a Houston story as you could find.”

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

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

HOUSTON INNOVATORS PODCAST EPISODE 248

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."

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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Biosciences startup becomes Texas' first decacorn after latest funding

A Dallas-based biosciences startup whose backers include millionaire investors from Austin and Dallas has reached decacorn status — a valuation of at least $10 billion — after hauling in a series C funding round of $200 million, the company announced this month. Colossal Biosciences is reportedly the first Texas startup to rise to the decacorn level.

Colossal, which specializes in genetic engineering technology designed to bring back or protect various species, received the $200 million from TWG Global, an investment conglomerate led by billionaire investors Mark Walter and Thomas Tull. Walter is part owner of Major League Baseball’s Los Angeles Dodgers, and Tull is part owner of the NFL’s Pittsburgh Steelers.

Among the projects Colossal is tackling is the resurrection of three extinct animals — the dodo bird, Tasmanian tiger and woolly mammoth — through the use of DNA and genomics.

The latest round of funding values Colossal at $10.2 billion. Since launching in 2021, the startup has raised $435 million in venture capital.

In addition to Walter and Tull, Colossal’s investors include prominent video game developer Richard Garriott of Austin and private equity veteran Victor Vescov of Dallas. The two millionaires are known for their exploits as undersea explorers and tourist astronauts.

Aside from Colossal’s ties to Dallas and Austin, the startup has a Houston connection.

The company teamed up with Baylor College of Medicine researcher Paul Ling to develop a vaccine for elephant endotheliotropic herpesvirus (EEHV), the deadliest disease among young elephants. In partnership with the Houston Zoo, Ling’s lab at the Baylor College of Medicine has set up a research program that focuses on diagnosing and treating EEHV, and on coming up with a vaccine to protect elephants against the disease. Ling and the BCMe are members of the North American EEHV Advisory Group.

Colossal operates research labs Dallas, Boston and Melbourne, Australia.

“Colossal is the leading company working at the intersection of AI, computational biology, and genetic engineering for both de-extinction and species preservation,” Walter, CEO of TWG Globa, said in a news release. “Colossal has assembled a world-class team that has already driven, in a short period of time, significant technology innovations and impact in advancing conservation, which is a core value of TWG Global.”

Well-known genetics researcher George Church, co-founder of Colossal, calls the startup “a revolutionary genetics company making science fiction into science fact.”

“We are creating the technology to build de-extinction science and scale conservation biology,” he added, “particularly for endangered and at-risk species.”

Houston investment firm names tech exec as new partner

new hire

Houston tech executive Robert Kester has joined Houston-based Veriten, an energy-focused research, investment and strategy firm, as technology and innovation partner.

Kester most recently served as chief technology officer for emissions solutions at Honeywell Process Solutions, where he worked for five years. Honeywell International acquired Houston-based oil and gas technology company Rebellion Photonics, where Kester was co-founder and CEO, in 2019.

Honeywell Process Solutions shares offices in Houston with the global headquarters of Honeywell Performance Materials and Technologies. Honeywell, a Fortune 100 conglomerate, employs more than 850 people in Houston.

“We are thrilled to welcome Robert to the Veriten team,” founder and CEO Maynard Holt said in a statement, “and are confident that his technical expertise and skills will make a big contribution to Veriten’s partner and investor community. He will [oversee] every aspect of what we do, with the use case for AI in energy high on the 2025 priority list.”

Kester earned a doctoral degree in bioengineering from Rice University, a master’s degree in optical sciences from the University of Arizona and a bachelor’s degree in laser optical engineering technology from the Oregon Institute of Technology. He holds 25 patents and has more than 25 patents pending.

Veriten celebrated its third anniversary on January 10, the day that the hiring of Kester was announced. The startup launched with seven employees.

“With the addition of Dr. Kester, we are a 26-person team and are as enthusiastic as ever about improving the energy dialogue and researching the future paths for energy,” Holt added.

Kester spoke on the Houston Innovators Podcast in 2021. Listen here

Startup funding, sportstech win and more trending innovation news for January

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