Houston Methodist's Dr. Ron Moses has created NanoEar, which he calls “the world’s smallest hearing aid.” Photo via Getty Images.

“What is the future of hearing aids?” That’s the question that led to a potential revolution.

“The current hearing aid market and technology is old, and there are little incremental improvements, but really no significant, radical new ideas, and I like to challenge the status quo,” says Dr. Ron Moses, an ENT specialist and surgeon at Houston Methodist.

Moses is the creator of NanoEar, which he calls “the world’s smallest hearing aid.” NanoEar is an implantable device that combines the invisibility of a micro-sized tympanostomy tube with more power—and a superior hearing experience—than the best behind-the-ear hearing aid.

“You put the NanoEar inside of the eardrum in an in-office procedure that takes literally five minutes,” Moses says.

As Moses explains, because of how the human cochlea is formed, its nerves break down over time. It’s simply an inevitability that if we live long enough, we will need hearing aids.

“The question is, ‘Are we going to all be satisfied with what exists?’” he asks.

Moses says that currently, only about 20 percent of patients who need hearing aids have them. That’s because of the combination of the stigma, the expense, and the hassle and discomfort associated with the hearing aids currently available on the market. That leaves 80 percent untapped among a population of 466 million people with hearing impairment, and more to come as our population ages. In a nearly $7 billion global market, that additional 80 percent could mean big money.

Moses initially patented a version of the invention in 2000, but says that it took finding the right team to incorporate as NanoEar. That took place in 2016, when he joined forces with cofounders Michael Moore and Willem Vermaat, now the company’s president and CFO, respectively. Moore is a mechanical engineer, while Vermaat is a “financial guru;” both are repeat entrepreneurs in the biotech space.

Today, NanoEar has nine active patents. The company’s technical advisors include “the genius behind developing the brains in this device,” Chris Salthouse; NASA battery engineer Will West; Dutch physicist and audiologist Joris Dirckx; and Daniel Spitz, a third-generation master watchmaker and the original guitarist for the famed metal band Anthrax.

The NanoEar concept has done proof-of-concept testing on both cadavers at the University of Antwerp and on chinchillas, which are excellent models for human hearing, at Tulane University. As part of the TMC Innovation Institute program in 2017, the NanoEar team met with FDA advisors, who told them that they might be eligible for an expedited pathway to approval.

Thus far, NanoEar has raised about $900,000 to get its nine patents and perform its proof-of-concept experiments. The next step is to build the prototype, but completing it will take $2.75 million of seed funding.

Despite the potential for making global change, Moses has said it’s been challenging to raise funds for his innovation.

“We're hoping to find that group of people or person who may want to hear their children or grandchildren better. They may want to join with others and bring a team of investors to offset that risk, to move this forward, because we already have a world-class team ready to go,” he says.

To that end, NanoEar has partnered with Austin-based Capital Factory to help with their raise. “I have reached out to their entire network and am getting a lot of interest, a lot of interest,” says Moses. “But in the end, of course, we need the money.”

It will likely, quite literally, be a sound investment in the future of how we all hear the next generation.

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

FDA greenlights Houston surgery robotics company's unique technology

headed to clinical trials

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.

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Houston cell therapy company launches second-phase clinical trial

fighting cancer

A Houston cell therapy company has dosed its first patient in a Phase 2 clinical trial. March Biosciences is testing the efficacy of MB-105, a CD5-targeted CAR-T cell therapy for patients with relapsed or refractory CD5-positive T-cell lymphoma.

Last year, InnovationMap reported that March Biosciences had closed its series A with a $28.4 million raise. Now, the company, co-founded by Sarah Hein, Max Mamonkin and Malcolm Brenner, is ready to enroll a total of 46 patients in its study of people with difficult-to-treat cancer.

The trial will be conducted at cancer centers around the United States, but the first dose took place locally, at The University of Texas MD Anderson Cancer Center. Dr. Swaminathan P. Iyer, a professor in the department of lymphoma/myeloma at MD Anderson, is leading the trial.

“This represents a significant milestone in advancing MB-105 as a potential treatment option for patients with T-cell lymphoma who currently face extremely limited therapeutic choices,” Hein, who serves as CEO, says. “CAR-T therapies have revolutionized the treatment of B-cell lymphomas and leukemias but have not successfully addressed the rarer T-cell lymphomas and leukemias. We are optimistic that this larger trial will further validate MB-105's potential to address the critical unmet needs of these patients and look forward to reporting our first clinical readouts.”

The Phase 1 trial showed promise for MB-105 in terms of both safety and efficacy. That means that potentially concerning side effects, including neurological events and cytokine release above grade 3, were not observed. Those results were published last year, noting lasting remissions.

In January 2025, MB-105 won an orphan drug designation from the FDA. That results in seven years of market exclusivity if the drug is approved, as well as development incentives along the way.

The trial is enrolling its single-arm, two-stage study on ClinicalTrials.gov. For patients with stubborn blood cancers, the drug is providing new hope.

Elon Musk's SpaceX site officially becomes the city of Starbase, Texas

Starbase, Texas

The South Texas home of Elon Musk’s SpaceX rocket company is now an official city with a galactic name: Starbase.

A vote Saturday, May 3, to formally organize Starbase as a city was approved by a lopsided margin among the small group of voters who live there and are mostly Musk’s employees at SpaceX. With all the votes in, the tally was 212 in favor to 6 against, according to results published online by the Cameron County Elections Department.

Musk celebrated in a post on his social platform, X, saying it is “now a real city!”

Starbase is the facility and launch site for the SpaceX rocket program that is under contract with the Department of Defense and NASA that hopes to send astronauts back to the moon and someday to Mars.

Musk first floated the idea of Starbase in 2021 and approval of the new city was all but certain. Of the 283 eligible voters in the area, most are believed to be Starbase workers.

The election victory was personal for Musk. The billionaire’s popularity has diminished since he became the chain-saw-wielding public face of President Donald Trump’s federal job and spending cuts, and profits at his Tesla car company have plummeted.

SpaceX has generally drawn widespread support from local officials for its jobs and investment in the area.

But the creation of an official company town has also drawn critics who worry it will expand Musk’s personal control over the area, with potential authority to close a popular beach and state park for launches.

Companion efforts to the city vote include bills in the state Legislature to shift that authority from the county to the new town’s mayor and city council.

All these measures come as SpaceX is asking federal authorities for permission to increase the number of South Texas launches from five to 25 a year.

The city at the southern tip of Texas near the Mexico border is only about 1.5 square miles (3.9 square kilometers), crisscrossed by a few roads and dappled with airstream trailers and modest midcentury homes.

SpaceX officials have said little about exactly why they want a company town and did not respond to emailed requests for comment.

“We need the ability to grow Starbase as a community,” Starbase General Manager Kathryn Lueders wrote to local officials in 2024 with the request to get the city issue on the ballot.

The letter said the company already manages roads and utilities, as well as “the provisions of schooling and medical care” for those living on the property.

SpaceX officials have told lawmakers that granting the city authority to close the beach would streamline launch operations. SpaceX rocket launches and engine tests, and even just moving certain equipment around the launch base, requires the closure of a local highway and access to Boca Chica State Park and Boca Chica Beach.

Critics say beach closure authority should stay with the county government, which represents a broader population that uses the beach and park. Cameron County Judge Eddie Trevino, Jr. has said the county has worked well with SpaceX and there is no need for change.

Another proposed bill would make it a Class B misdemeanor with up to 180 days in jail if someone doesn’t comply with an order to evacuate the beach.

The South Texas Environmental Justice Network, which has organized protests against the city vote and the beach access issue, held another demonstration Saturday that attracted dozens of people.

Josette Hinojosa, whose young daughter was building a sandcastle nearby, said she was taking part to try to ensure continued access to a beach her family has enjoyed for generations.

With SpaceX, Hinojosa said, “Some days it’s closed, and some days you get turned away."

Organizer Christopher Basaldú, a member of the Carrizo/Comecrudo Nation of Texas tribe, said his ancestors have long been in the area, where the Rio Grande meets the Gulf.

“It’s not just important,” he said, “it’s sacred.”

Texas-based 'DoorDash for laundry' startup tumbles into Houston market

No Scrubs

Laundry may seem like an endless task that piles up, but a new service offers a solution to overwhelmed Houston families.

NoScrubs, an Austin-based home laundry pickup service has just expanded to Houston. Described by the company as "DoorDash — but for laundry," they wash customer's clothes at local laundromats and return them the same day, folded and ready to be put away.

The service took off like gangbusters in Austin, making an expansion to the state's largest city an obvious choice. It's not universal coverage just yet.

For now, only the following ZIP codes have NoScrubs service available: 77002, 77004, 77005, 77006, 77007, 77008, 77009, 77010, 77018, 77019, 77024, 77025, 77027, 77046, 77056, 77057, 77081, 77098, 77401, 77030, 77003.

A single pickup starts at $40 for 20 pounds of laundry, while the basic monthly subscription is $60 for two pickups. All services use hypoallergenic detergents.

The average American family spends about 240 hours a year on laundry, making it a very time-consuming chore. For people with disabilities, difficult work schedules, and other circumstances, it can be a real help, says co-founder Matt O'Connor.

"Some of our favorite customer stories simply revolve around saving people time when they have something challenging going on," he writes in an email. "For example, one customer reviewed NoScrubs saying 'So happy I could cry! (Partially because I'm pregnant and my emotions are heightened!)...1000% recommend if you have time restrictions or physical restrictions! ' So, whether it’s saving time, the affordability, or the pleasantly surprising turnaround time, NoScrubs has a variety of benefits for any customer."

NoScrubs is also a new opportunity for Houston's gig workers. Because there are no passengers, it can be a safer alternative to driving ride share for women and other people apprehensive about having strangers in their cars. As NoScrubs partners with local laundromats, drivers are also going to centralized locations rather than all over the map, leading to less wear and tear on their cars. The laundromats benefit as well, since NoScrubs loads are ones that would otherwise be done at home.

"Our model makes driving a tiny fraction of the time, so folks who don’t want to wear down their vehicles and spend a ton on gas love working at NoScrubs," added O'Connor.