VenoStent's innovative medical device is officially enrolling subjects in a clinical trial. Image courtesy of VenoStent

A Houston-based company has enrolled the initial subjects in a first-of-its-kind trial.

VenoStent was created to improve vascular surgery outcomes for patients undergoing arteriovenous fistula (AVF) creation surgery.

“When a vein is connected to an artery, as in AVF creation, the vein experiences a 10x increase in pressure and flow that is traumatizing to veins. Many fail to become usable for dialysis,” Geoffrey Lucks, VenoStent COO and co-founder, says in a news release.

Enter VenoStent’s SelfWrap Bioabsorbable Perivascular Wrap, better known as simply SelfWrap. In May 2023, SelfWrap gained FDA approval to begin its US IDE Study, SAVE-FistulaS: The SelfWrap-Assisted ArterioVEnous Fistula Study.

Roughly half a million Americans need hemodialysis just to survive another day. Nearly all of those patients require a vascular access creation surgery, but the procedure has a 50-percent failure rate in its first year. VenoStent and SelfWrap are aimed at improving those odds. It works by using the body’s own healing mechanism.

SelfWrap is a flexible, bioabsorbable vascular wrap that helps to recreate the arterial environment in veins. Over time, the body replaces the SelfWrap with venous tissue.

The company has begun to enroll patients for what will eventually be a 200-subject study. Some of those people have radiocephalic fistulas, others have brachiocephalic ones. This is important, because it will likely prove that the technology works for most types of AVFs. The sites for this clinical trial are at the Surgical Specialists of Charlotte, P.A. in Charlotte, NC, and the Cardiothoracic and Vascular Surgeons in Austin.

“While it’s ambitious and sets a high bar for FDA Approval, we owe it to the chronic kidney disease (CKD) patient community to provide the highest level of clinical evidence,” Timothy Boire, CEO and cofounder, says in the release. “We’re confident based on years of preclinical and clinical data that we’ll demonstrate superiority to standard of care with this breakthrough technology.”

VenoStent recently completed a $16 million Series A, financed by Good Growth Capital and IAG Capital. This is the first-ever randomized controlled trial of a medical device designed to improve outcomes from arteriovenous fistula (AVF) creation surgery in the United States.

Motif Neurotech, which develops minimally invasive bioelectronics for mental health treatment, closed its series A round with an oversubscribed $18.75 million. Photo via Rice.edu

Rice University medical device spinout secures nearly $19M series A

fresh funding

A health tech startup based out of a newly formed accelerator program at Rice University has raised venture funding.

Motif Neurotech closed its series A round with an oversubscribed $18.75 million. The company, which develops minimally invasive bioelectronics for mental health treatment, was formed out of the Rice Biotech Launch Pad that launched last fall.

The round was led by Arboretum Ventures, with participation from new investors KdT Ventures, Satori Neuro, Dolby Family Ventures, re.Mind Capital and existing investors Divergent Capital, TMC Venture Fund, PsyMed Ventures, Empath Ventures and Capital Factory, according to a news release from Rice.

“Minimally invasive bioelectronics are the future of mental health treatment,” Jacob Robinson, CEO and founder of Motif Neurotech, says in the release. “Thirty percent of patients with depression don’t respond to two or more medications, and there is a significant need for additional treatment options that are effective and easily accessible."

The fresh funding will go toward developing the inaugural product, the DOT microstimulator, a wireless, battery-free device that can provide at-home therapy for treatment-resistant depression, or TRD, a major depressive disorder.

“This is a pivotal moment for the company as it closes its Series A in addition to the recent successful completion of the proof-of-concept first-in-human implant of the DOT stimulator device," Tom Shehab, managing partner of Arboretum Ventures, says in the release. "We believe Motif’s device will greatly improve the quality of life for patients who have been diagnosed with difficult to treat mental health disorders, including TRD."

Shehab, along with Amy Kruse, chief investment officer of Satori Neuro, will reportedly join Motif Neurotech's board of directors alongside Anthony Arnold, president and CEO of Sensydia Corporation, and Jacob Robinson, professor of electrical and computer engineering and bioengineering at Rice.

The Rice Biotech Launch Pad was established to take biotech innovations from concept to clinical trials in five years or less. It occupies 15,000 square feet of space on campus and is funded through federal grants and donations.

A unique innovation from the University of Houston has the potential to help stroke victims recover mobility. Photo courtesy of UH

Houston innovator makes major headway on his portable stroke rehab device

research milestone

A University of Houston professor has taking a huge step in advancing his game-changing stroke recovery tech.

Jose Luis Contreras-Vidal, the director of the UH BRAIN Center, recently published his work on a noninvasive brain-machine in a summer issue of the journal Sensors. InnovationMap first reported on Contreras-Vidal's technology in 2022, when it was being tested.

Contreras-Vidal's device uses a wireless, mobile dry-electrode headset placed on the scalp to convert electroencephalography (EEG) recordings (or measurements of electrical activity in different parts of the brain) to interface with a closed-loop brain–computer (BCI) and communicate with exoskeleton devices. Together, the technology triggers robotic movement based on the wearer's brain activity.

The technology has potential to boost cortical plasticity after a stroke, which can improve motor skills recovery.

According to a statement from UH, a patent is pending on Contreras-Vidal's BCI algorithm and the self-positioning dry electrode bracket used on the scalp. The technology has also now been validated and tested at the University of Houston.

Contreras-Vidal says the technology makes stroke recovery easier for the user and even possible at home.

“Most commercial EEG-based BCI systems are tethered to immobile processing hardware or require complex programming or set-up, making them difficult to deploy outside of the clinic or laboratory without technical assistance or extensive training," he says in a statement. "A portable and wireless BCI system is highly preferred so it can be used outside lab in clinical and non-clinical mobile applications at home, work, or play.”

Additionally, the technology uses off-the-shelf components and is adjustable to fit about 90 percent of the population, according to UH.

"Current commercial EEG amplifiers and BCI headsets are prohibitively expensive, lack interoperability, or fail to provide a high signal quality or closed-loop operation, which are vital for BCI applications,” Contreras-Vidal adds.

The development of this technology was originally funded in part by an $813,999 grant from the National Science Foundation’s Division of Translational Impacts. UH reports that about 795,000 people in the United States suffer from a stroke annually.

Other leaders in Houston’s medical industry have tapped into innovative ways to treat and rehabilitate stroke patients in recent years. Baylor St. Luke's Hospital began using AI to reduce the time it takes to treat patients who've suffered from a stroke in 2021.

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

The Texas Medical Center Innovation Factory has named the 16 companies making up the inaugural cohort in the Innovate UK Global Incubator Programme. Photo via tmc.edu

TMC names inaugural cohort for unique accelerator with UK

coming to HOU

Sixteen digital health and medical device startups founded in the United Kingdom have been selected for a customized accelerator at the Texas Medical Center's Innovation Factory.

In partnership with Innovate UK, TMCi created the Innovate UK Global Incubator Programme, a new accelerator that supports UK businesses as they build their United States go-to-market plan. The program builds the BioBridge relationship between TMC and the UK that was originally established five years ago.

“The TMC UK BioBridge program was launched with the UK Department for Business and Trade in 2018 to serve as a gateway for advancing life sciences and foster innovation and research between our two countries," says Ashley McPhail, chief external affairs and administration officer for TMC, in a news release. "We saw an opportunity to work with Innovate UK to develop a larger program with the UK after the success of the 11 companies that previously participated in our health tech accelerator."

The 16 companies will participate in the program from June to November. The cohort is expected to arrive in Houston on June 5 and have access to TMCi's facilities, network of mentors and potential clients, funding, potential customers, and curated programing — all while being a unique entry point into the US. The new offering joins three other globally recognized curriculums: Biodesign, Accelerator for Cancer Therapeutics, and Health Tech.

“TMCi nurtures long-term growth, development, and competitiveness to increase startups chances of success and global expansion," says Emily Reiser, associate director of TMC Innovation. "By bringing their novel technologies and exposing them to a curated selection of TMC’s expert network, startups receive support and evaluation to build, scale, and expand in the US market."

Two of the cohort's specialties include cardiovascular and oncology — two of TMC's strongest areas of expertise — with solutions ranging from surgical devices to AI-enabled risk stratification and hospital efficiency.

Innovate UK is the country's national innovation agency dedicated to supporting business-led innovation in all sectors.

“The United Kingdom is fully committed to improving global healthcare through scientific collaboration," says His Majesty’s Consul General in Texas Richard Hyde in the release. "Through the expansion of the TMC UK BioBridge and in partnership with Innovate UK, this programme will help to expose the brightest and best British companies to the world’s largest medical city. Our companies will collaborate and grow as they work to develop cutting edge technology. The partnership between the UK Government and TMC demonstrates that international collaboration can drive both economic growth and improvement to quality of life.”

The 16 companies making up the inaugural cohort are as follows, according to TMC.

  • AINOSTICS aims to revolutionize the treatment and prevention of neurological conditions, such as dementia, by developing innovative AI-enabled solutions that draw novel insights from routinely acquired non-invasive medical scans to deliver accurate diagnosis and outcome prediction, and in turn facilitate personalized care and timely access to disease-modifying treatments for patients.
  • Alvie is a blended human plus AI-enabled digital solution providing personalised pre and rehabilitation coaching and supportive care for cancer and surgery. Alvie's technology combines data profiling, risk-stratification and tailored prescriptions of health and well-being with curated educational content, targeted behaviour change coaching and expert support through chat messaging and virtual consultations.
  • C the Signs™ is a validated AI cancer prediction platform, which can identify patients at risk of cancer at the earliest and most curable stage of the disease. Used by healthcare professionals, C the Signs can identify which tumor type a patient is at risk of and recommend the most appropriate next step in less than 30 seconds. The platform has detected over 10,000 patients with cancer, with over 50 different types of cancer diagnosed, and with a sensitivity of >98% for cancer.
  • At PEP Health, We believe all patients deserve the best care possible. Our cutting-edge machine-learning technology enables healthcare organisations, regulators, and insurers the real-time, actionable insights they need to have a direct and dramatic impact on patient experiences.
  • PreciousMD improves the lives of lung-cancer and other lung-related illnesses patients worldwide by enabling imaging-based diagnostics needed for personalized treatment pathways.
  • Ufonia is an autonomous telemedicine company, we use large language models and voice AI to increase the capacity of clinical professionals.
  • My mhealth offers digital therapeutics for a range of long-term conditions- COPD, Asthma, Diabetes and Heart Disease. Our product has been successfully deployed in the UK and India, with >100,000 users registered to date. Our solutions empower patients to self-manage their conditions, resulting in dramatic improvements in outcomes, as evidenced through multiple clinical trials and real-world evaluations.
  • At Surgery Hero, we offer a clinically backed solution that ensures whole-human support before and after surgery. We help health systems, employers and health plans cut costs without sacrificing quality of care.
  • Panakeia's software platform enables extremely rapid multi-omics profiling in minutes directly from routinely used tissue images without needing wet lab assays.
  • QV Bioelectronics are striving to deliver longer, better quality lives for brain tumour patients. Using their first-of-its-kind implantable electric field therapy device, GRACE, QV will provide effective, focal & continuous treatment without impacting patient quality of life.
  • 52 North is a med-tech company focused on improving health outcomes and health equity by reinventing care pathways. The NeutroCheck® solution is a finger-prick blood test and digital platform built to significantly improve safety and quality of life for cancer patients, by helping to identify at-home those patients who are at risk of the most fatal side-effect of chemotherapy: neutropenic sepsis.
  • Somnus is fulfilling an unmet need in global healthcare by developing real-time, point of care blood propofol monitoring. Its products will improve the care of sedated and anaesthetised patients, save money for hospitals, and facilitate a major reduction in greenhouse gas emissions.
  • ScubaTx is a breakthrough organ transplant preservation company established to solve the global unmet need for cost-efficient and longer-duration organ preservation technology. ScubaTx has developed a simple, small and affordable device which uses Persufflation to extend the preservation of organs.
  • IBEX is on a mission to help people live active, healthy and productive lives by increasing their access to early diagnosis of osteoporosis. The IBEX BH software as medical device delvers routine, automated assessment of fracture risk from routine radiology for earlier detection and more equitable treatment of osteoporosis.
  • NuVision produces products derived from donated human amniotic membrane that are used in ophthalmology to help patients with chronic, traumatic and post-surgical wounds of the eye to be treated earlier and recover more fully and more quickly. The company’s products are also used in the management of dry eye disease, a debilitating conditions that affects around 17m people in the USA.
  • Calon Cardio-Technology is on a mission to improve quality of life for patients with Left Ventricular Assist devices (LVAD) and reduce the common post operative complications associated with these implantable heart pumps. We plan to do this by introducing a completely wireless heart pump system and augment patient follow-up with built-in remote monitoring capabilities.
Thomas Vassiliades, CEO of BiVACOR, joins the Houston Innovators Podcast. Photo courtesy of BiVACOR

How this Houston-headquartered company is innovating the future of heart replacement

HOUSTON INNOVATORS PODCAST EPISODE 183

Heart disease is one of the most common causes of death in the United States — one in five deaths, according to the CDC. But there's not a long-term solutions for patients — even for those lucky enough to have a successful heart transplant. But a Houston-headquartered medical device company is working on one.

BiVACOR has created a technology that, theoretically, could completely replace a patient's heart and last them the rest of their lives.

"The design is critical," says Thomas Vassiliades, CEO of BiVACOR, on the Houston Innovators Podcast. He joined the organization last year after spending 20 years of a heart surgeon, then transitioning to medical device development over a decade ago.

Vassiliades explains the industry's challenges on the show, saying that there's no comprehensive, lasting replacement to the human heart on the market. While some treatments — like transplants and medical devices that partially replace the heart's capabilities — exist, nothing that completely replaces the heart lasts longer than 10 to 12 years.

"The BiVACOR system is based on magnetic levitation," Vassiliades says about the technology. "Our pump is just one moving impeller that sits in the middle of the housing where the blood is. Imagine an artificial heart — the container that has your blood — and the device spinning in the inside — basically a wheel spinning your blood to the rest of your body.

"The device is suspended by magnets — it's not touching anything," he continues. "So, theoretically, the device has no wear and can last as long as the patient can possibly live. That's new to the field."

Daniel Timms, BiVACOR's founder and CTO, knew there had to be a better, more permanent solution and has been working on the technology since he was a postdoctoral student at Queensland University of Technology in Australia. His work took him to Houston's Texas Heart Institute, the "center of the universe when it comes to blood pumps," says Vassiliades.

The company recently raised $18 million in funding to support its growing team and continued growth. BiVACOR is a Class 3 medical device — the most rigorously regulated type of device, so the funding raised will support the company as it continues to meet the FDA's requirements and proceeds into implantation and clinical trials.

While headquartered in Houston and has close ties to THI, most of BiVACOR's team works out of Huntington Beach, California, just 30 minutes away from its manufacturing partner — something that has been critical for the design phase. Other employees work in Europe and Australia, which has resulted in government grant funding. Each market the company works in has a strategic purpose — and Houston's role is testing.

"We're going to be training all our clinical sites in Houston, and we're going to continue to do ongoing testing," he says. "We're very comfortable with the design of the device, ... but there's always more. And we have a long-term plan to iterate on the device to make it even better."

Vassiliades shares more of the challenges he's facing as he commercializes BiVACOR's technology on the podcast. Listen to the interview below — or wherever you stream your podcasts — and subscribe for weekly episodes.


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CultureMap Emails are Awesome

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. That same year, CEO Eric Fain, a California-based MD and with more than 30 years in the medical device industry, joined the company, 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

Explore the eco-friendly commuting app that's driving change at Houston area employers

Going My Way?

The Texas Department of Transportation’s Houston-based mobile app called ConnectSmart is on a mission to make the region more connected and less congested. With its ability to generate personalized travel recommendations and provide exclusive access to unique transportation tools, information and services, the app has been instrumental in helping many Houstonians experience a less stressful ride throughout the city.

While the app has already helped tens of thousands of Houstonians improve their daily travel, the program’s latest addition — the ConnectSmart Employer Commute Suite — is aimed at helping Houston-area employers increase their staff’s access to affordable and sustainable mobility options to and from work.

“As more residents throughout the Houston-Galveston region become familiar with the Houston ConnectSmart app, we encourage area employers to embrace and consider incorporating it into their commuter programs,” says Jamila Owens, travel demand manager for the Houston Galveston Area Council. “Whether a commuter is looking for the perfect transit route or coworkers for a carpool, this is one way the business community can play a significant role in improving the regional commute and greatly increase their staff’s commute options.”

The Employer Commute Suite supports businesses seeking to manage, measure, and report on the impact of commuting programs on their Environmental, Social, and Governance (ESG) and decarbonization initiatives. The best part is that it is entirely adaptable to any company's unique culture and structure. Whether it be carpooling, utilizing public transit, or working from home, the Employer Commute Suite offers an array of commuting options from which to choose.

As an employer, you can engage your employees in your ESG initiatives and help transform their daily commutes into a more eco-friendly and cost-effective experience by becoming a Houston ConnectSmart Partner.

The app’s state-of-the-art employer carpooling feature is designed to match employees with colleagues traveling in the same direction, reducing vehicle expenses, toll costs, and fuel consumption. The carpool trips are then recorded for reporting purposes.

Employer Partners have access to the Commute Suite dashboard that is designed specifically to help companies monitor their commuting programs, including carpool matches and trips, and calculate total reduction of CO2 emissions from carpooling, biking, riding transit , and telework, for their entire team.

But that’s not all — being an Employer Partner means contributing to the reduction of traffic congestion in the Houston area.

“We specifically developed the app to help individuals from across the Greater Houston region improve their daily travel,” says ConnectSmart’s Program Manager Brenda Bustillos. “We’ve worked closely with H-GAC and local employers alike to design a program and one-stop mobility app that increases employees’ travel options to work while reducing the cost and stress of daily commuting. By helping employers achieve their corporate goals, we can simultaneously reach our objectives of improving the Greater Houston region’s air quality, decrease congestion, and ultimately improve safety on these same roadways.”

The ConnectSmart Employer Commute Suite is a valuable resource in helping businesses transition toward a more sustainable future.

Become an Employer Partner today and see how the ConnectSmart Employer Commute Suite can help your organization and support your ESG goals.