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

fresh funding

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

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 organizations launch collaborative center to boost cancer outcomes

new to HOU

Rice University's new Synthesis X Center officially launched last month to bring together experts in cancer care and chemistry.

The center was born out of what started about seven years ago as informal meetings between Rice chemist Han Xiao's research group and others from the Baylor College of Medicine’s Dan L Duncan Comprehensive Cancer Center at the Baylor College of Medicine. The level of collaboration between the two teams has grown significantly over the years, and monthly meetings now draw about 100 participants from across disciplines, fields and Houston-based organizations, according to a statement from Rice.

Researchers at the new SynthX Center will aim to turn fundamental research into clinical applications and make precision adjustments to drug properties and molecules. It will focus on improving cancer outcomes by looking at an array of factors, including prevention and detection, immunotherapies, the use of artificial intelligence to speed drug discovery and development, and several other topics.

"At Rice, we are strong on the fundamental side of research in organic chemistry, chemical biology, bioengineering and nanomaterials,” Xiao says in the statement. “Starting at the laboratory bench, we can synthesize therapeutic molecules and proteins with atom-level precision, offering immense potential for real-world applications at the bedside ... But the clinicians and fundamental researchers don’t have a lot of time to talk and to exchange ideas, so SynthX wants to serve as the bridge and help make these connections.”

SynthX plans to issue its first merit-based seed grants to teams with representatives from Baylor and Rice this month.

With this recognition from Rice, the teams from Xiao's lab and the TMC will also be able to expand and formalize their programs. They will build upon annual retreats, in which investigators can share unpublished findings, and also plan to host a national conference, the first slated for this fall titled "Synthetic Innovations Towards a Cure for Cancer.”

“I am confident that the SynthX Center will be a great resource for both students and faculty who seek to translate discoveries from fundamental chemical research into medical applications that improve people’s lives,” Thomas Killian, dean of the Wiess School of Natural Sciences, says in the release.

Rice announced that it had invested in four other research centers along with SynthX last month. The other centers include the Center for Coastal Futures and Adaptive Resilience, the Center for Environmental Studies, the Center for Latin American and Latinx Studies and the Rice Center for Nanoscale Imaging Sciences.

Earlier this year, Rice also announced its first-ever recipients of its One Small Step Grant program, funded by its Office of Innovation. The program will provide funding to faculty working on "promising projects with commercial potential," according to the website.

Houston physicist scores $15.5M grant for high-energy nuclear physics research

FUTURE OF PHYSICS

A team of Rice University physicists has been awarded a prestigious grant from the Department of Energy's Office of Nuclear Physics for their work in high-energy nuclear physics and research into a new state of matter.

The five-year $15.5 million grant will go towards Rice physics and astronomy professor Wei Li's discoveries focused on the Compact Muon Solenoid (CMS), a large, general-purpose particle physics detector built on the Large Hadron Collider (LHC) at CERN, a European organization for nuclear research in France and Switzerland. The work is "poised to revolutionize our understanding of fundamental physics," according to a statement from Rice.

Li's team will work to develop an ultra-fast silicon timing detector, known as the endcap timing layer (ETL), that will provide upgrades to the CMS detector. The ETl is expected to have a time resolution of 30 picoseconds per particle, which will allow for more precise time-of-flight particle identification.

The Rice team is collaborating with others from MIT, Oak Ridge National Lab, the University of Illinois Chicago and University of Kansas. Photo via Rice.edu

This will also help boost the performance of the High-Luminosity Large Hadron Collider (HL-LHC), which is scheduled to launch at CERN in 2029, allowing it to operate at about 10 times the luminosity than originally planned. The ETL also has applications for other colliders apart from the LHC, including the DOE’s electron-ion collider at the Brookhaven National Laboratory in Long Island, New York.

“The ETL will enable breakthrough science in the area of heavy ion collisions, allowing us to delve into the properties of a remarkable new state of matter called the quark-gluon plasma,” Li explained in a statement. “This, in turn, offers invaluable insights into the strong nuclear force that binds particles at the core of matter.”

The ETL is also expected to aid in other areas of physics, including the search for the Higgs particle and understanding the makeup of dark matter.

Li is joined on this work by co-principal investigator Frank Geurts and researchers Nicole Lewis and Mike Matveev from Rice. The team is collaborating with others from MIT, Oak Ridge National Lab, the University of Illinois Chicago and University of Kansas.

Last year, fellow Rice physicist Qimiao Si, a theoretical quantum physicist, earned the prestigious Vannevar Bush Faculty Fellowship grant. The five-year fellowship, with up to $3 million in funding, will go towards his work to establish an unconventional approach to create and control topological states of matter, which plays an important role in materials research and quantum computing.

Meanwhile, the DOE recently tapped three Houston universities to compete in its annual startup competition focused on "high-potential energy technologies,” including one team from Rice.

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This article originally ran on EnergyCapital.

Cart.com makes acquisition, events not to miss, and more trending Houston innovation news

top stories

Editor's note:Let's roundup the top Houston innovation news from the week. Trending Houston tech and startup articles on InnovationMap included news of a Houston company acquiring an Amazon partner, Houston events not to miss this month, and more.

Houston ecommerce scale-up company acquires Amazon advertising partner

With the acquisition of Amify, Cart.com has expanded its workforce and grown its suite of services. Photo courtesy of Cart.com

A Houston tech company has tapped an Amazon partner in a strategic acquisition and is bringing the company's full team on board.

Cart.com acquired Ohio-based Amify, a company that provides optimization and advertising solutions. The terms of the deal were not disclosed but Cart.com will on board Amify’s entire employee base, including its founder Ethan McAfee, CEO Chris Mehrabi, and COO Christine McCambridge.

As chief delivery officer, Mehrabi will take the helm of Cart.com’s professional services business and McCambridge will lead Cart.com’s marketplace services team as vice president of marketplace services operations.

“I’m happy to welcome the entire Amify team to Cart.com and have industry veterans Chris Mehrabi and Christine McCambridge join our leadership team,” Cart.com Founder and CEO Omair Tariq says in a news release. “Amify has been widely recognized for their expertise and technology and we’re excited to leverage their experience to help our customers maximize their potential across channels.” Continue reading.

10+ can't-miss Houston business and innovation events for April

Houston innovators — put these April events on your radar. Photo via Getty Images

From pitching competitions to expert speaker summits, April is filled with opportunities for Houston innovators.

Here's a roundup of events you won't want to miss out on so mark your calendars and register accordingly. Continue reading.

Health tech startup launches Houston study improve stroke patients recovery

NeuraStasis, which originated out of the TMC Biodesign program, is launching its latest study in Houston. Photo via Getty Images

A Houston-born company is enrolling patients in a study to test the efficacy of nerve stimulation to improve outcomes for stroke survivors.

Dr. Kirt Gill and Joe Upchurch founded NeuraStasis in 2021 as part of the TMC Biodesign fellowship program.

“The idea for the company manifested during that year because both Joe and I had experiences with stroke survivors in our own lives,” Gill tells InnovationMap. It began for Gill when his former college roommate had a stroke in his twenties.

“It’s a very unpredictable, sudden disease with ramifications not just for my best friend but for everyone in his life. I saw what it did to his family and caregivers and it's one of those things that doesn't have as many solutions for people to continue recovery and to prevent damage and that's an area that I wanted to focus myself on in my career,” Gill explains. Continue reading.

Houston startup scores $12M grant to support clinical evaluation of cancer-fighting drug

The funds will support the clinical evaluation of a therapeutic antibody that targets acute lymphoblastic leukemia, one of the most common childhood cancers. Photo via Getty Images

Allterum Therapeutics, a Houston biopharmaceutical company, has been awarded a $12 million product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

The funds will support the clinical evaluation of a therapeutic antibody that targets acute lymphoblastic leukemia (ALL), one of the most common childhood cancers.

However, CEO and President Atul Varadhachary, who's also the managing director of Fannin Innovation, tells InnovationMap, “Our mission has grown much beyond ALL.” Continue reading.

Texas Space Commission launches, Houston execs named to leadership

Here's who's at the helm of the newly announced Texas Space Commission. Photo courtesy of the Office of the Governor

Governor Greg Abbott announced the Texas Space Commission, naming its inaugural board of directors and Texas Aerospace Research and Space Economy Consortium Executive Committee.

The announcement came at NASA's Johnson Space Center, and the governor was joined by Speaker Dade Phelan, Representative Greg Bonnen, Representative Dennis Paul, NASA's Johnson Space Center Director Vanessa Wyche, and various aerospace industry leaders.

According to a news release, the Texas Space Commission will aim to strengthen commercial, civil, and military aerospace activity by promoting innovation in space exploration and commercial aerospace opportunities, which will include the integration of space, aeronautics, and aviation industries as part of the Texas economy. Continue reading.

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