Houston medtech startup clears FDA approval for new surgical tool

precision surgery

Prana Surgical has developed a minimally invasive, image-guided, single-use tissue extraction tool. Photo via LinkedIn

Houston-based Prana Surgical will soon bring a new electrosurgical tool to operating rooms around the country. The Prana System officially cleared U.S. Food and Drug Administration (FDA) approval earlier this month.

"Receiving FDA clearance for the Prana System represents a defining milestone for our company," Joanna Nathan, CEO and co-founder of Prana Surgical, said in a news release. "Surgeons today are increasingly focused on achieving precise outcomes while minimizing disruption to healthy tissue. The Prana System was designed to support that shift by integrating targeting and excision into a single, streamlined tool."

Prana Surgical began as Prana Thoracic in 2022. Back then, the company primarily focused on developing screening tools for lung cancer diagnosis. It raised $6 million in series A funding rounds in 2023 and 2024 before transitioning to broader surgical needs in 2025.

The Prana System is a minimally invasive, image-guided, single-use tissue extraction tool designed to retrieve samples without damaging healthy tissue. The tool is still designed with the respiratory system in mind, helping Prana in the fight against lung cancer and other thoracic diseases.

Reducing the impact of tissue extraction via electrosurgery and enhanced image scanning can significantly reduce complications. The Prana System combines localization and tissue-cutting capabilities in one, which keeps surgeons from having to swap out components during a procedure, making for a smoother process. It can core, cut and feel blood vessels on the way toward the intended target, giving surgeons greater control over tissue preservation.

"Electrosurgery is foundational to modern surgery, but there is still opportunity to improve how energy-based tools are applied in minimally invasive settings," Nathan added. "Our goal is to introduce a new class of image-guided surgical tools that enable more precise intervention across a range of procedures."

The company projects the market size for lung nodules to be $7.5 billion in the United States, estimating that 2.5 million nodules will be able to benefit from the new tool. While starting out focused on biopsies, the company plans to evolve the system into other procedures, such as ablation, in the future. It is also planning for a controlled U.S. clinical rollout as it moves toward commercialization

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A new cancer-fighting drug will move to clinical trials after being tested on Axiom's Ax-2 and Ax-3 missions. Photo courtesy Axiom Space.

Axiom Space-tested cancer drug advances to clinical trials

mission critical

A cancer-fighting drug tested aboard several Axiom Space missions is moving forward to clinical trials.

Rebecsinib, which targets a cancer cloning and immune evasion gene, ADAR1, has received FDA approval to enter clinical trials under active Investigational New Drug (IND) status, according to a news release. The drug was tested aboard Axiom Mission 2 (Ax-2) and Axiom Mission 3 (Ax-3). It was developed by Aspera Biomedicine, led by Dr. Catriona Jamieson, director of the UC San Diego Sanford Stem Cell Institute (SSCI).

The San Diego-based Aspera team and Houston-based Axiom partnered to allow Rebecsinib to be tested in microgravity. Tumors have been shown to grow more rapidly in microgravity and even mimic how aggressive cancers can develop in patients.

“In terms of tumor growth, we see a doubling in growth of these little mini-tumors in just 10 days,” Jamieson explained in the release.

Rebecsinib took part in the patient-derived tumor organoid testing aboard the International Space Station. Similar testing is planned to continue on Axiom Station, the company's commercial space station that's currently under development.

Additionally, the drug will be tested aboard Ax-4 under its active IND status, which was targeted to launch June 25.

“We anticipate that this monumental mission will inform the expanded development of the first ADAR1 inhibitory cancer stem cell targeting drug for a broad array of cancers," Jamieson added.

According to Axiom, the milestone represents the potential for commercial space collaborations.

“We’re proud to work with Aspera Biomedicines and the UC San Diego Sanford Stem Cell Institute, as together we have achieved a historic milestone, and we’re even more excited for what’s to come,” Tejpaul Bhatia, the new CEO of Axiom Space, said in the release. “This is how we crack the code of the space economy – uniting public and private partners to turn microgravity into a launchpad for breakthroughs.”

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

Houston doctor aims to revolutionize hearing aid industry with tiny implant

small but mighty

“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

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7+ can't-miss Houston business and innovation events in May

where to be

Editor’s note: Houston is living up to its nicknames as Space City and the Energy Capital of the World this month with a lineup of insightful talks, pitch days and industry conferences. Plus, there are opportunities to network over crawfish, learn about brain health and more. Here’s what not to miss and how to register. Please note: this article may be updated to add more events.

May 7 – Ion Block Party and Crawfish Boil

Head to this special edition Block Party, featuring a crawfish cook-off competition among the Ion’s businesses. Competing teams include Transwestern, Microsoft, Rice Alliance, Rice Nexus, South Main Baptist, Per Scholas, Industrious and many others. Taste test crawfish while supplies last, and sip a complimentary drink from Second Draught.

This event is Thursday, May 7, from 4-7 p.m. at the Ion. Register here.

May 12 – Why the Next Decade of Breakthrough Brain Tech Matters For You, and What to Do About It

Hear from Matias Serebrinsky, co-founder and general partner of San Francisco-based PsyMed Ventures, at this talk presented by EO Houston. Serebrinsky will discuss why founders are disproportionately affected by brain health issues and look at breakthrough brain and mental health tech.

This event is Tuesday, May 12, from 11:20 a.m.-1 p.m. at Tony's on Richmond Avenue. Register here.

May 18-19 — Geothermal Transition Summit North America

This two-day summit serves as the meeting point for the geothermal and oil and gas industries and will focus on geothermal energy, including scaling plants and navigating state regulations. The event promises 40 expert speakers, 15 exhibition spaces, and networking opportunities with 250 industry decision makers.

This event begins May 18 at Norris Conference Center. Register here.

May 19 – IOT Innovation Day

IoT Innovation Day will present a series of fast‑paced, 15‑minute tech talks focused on the future of connected devices. These sessions feature insights from founders, engineers, product innovators and industry leaders. Attendees are also invited to sign up to present their own tech talk showcasing their expertise, startup or solution.

This event is Tuesday, May 19, from 10 a.m.-6 p.m. Register here.

May 20-21 — ESF North America

ESF North America returns for its 5th edition, under the theme of “innovation and adaptation.” Attendees will explore how technology, innovation, and collaboration can drive a resilient, competitive refining and chemicals industry.

This event begins May 20 at The Westin Oaks Houston at the Galleria. Register here.

May 21 – AI + Energy Sector Pitch Day

Hear from startups powering the AI boom or using AI to support the energy transition at Greentown's latest installment of its Sector Pitch Day series. Brian Walker, program manager for emerging technologies in the U.S. Department of Energy’s Building Technologies Office, will present the keynote address. Six Greentown startups will present pitches, as well as others from IMPEL, a DOE tech-to-market program, and more. Stick around for a networking happy hour.

This event is Thursday, May 21, from 1:30-6:30 p.m. at the Ion. Register here.

May 28 – NASA Stories at the Ion: A Conversation with NASA’s Artemis II Orion Vehicle Manager Branelle Rodriguez

NASA’s Artemis II Orion Vehicle Manager Branelle Rodriguez will discuss what it took to ready the spacecraft for its mission and return to Earth at this special installment of NASA Stories. Rodriguez will share insights on Orion’s high-speed reentry, the views of the Moon and Earth witnessed by the crew, and what’s next for Orion on NASA’s upcoming Artemis missions in 2027 and 2028. Complimentary breakfast and networking take place before each talk.

This event Thursday, May 28, from 8:30-10 a.m. at the Ion. Register here.

May 28 – NASA Tech Talks: Texas-France Space Hub Business Accelerator Initiative

NASA Tech Talks is partnering with the Rice Space Institute (RSI) this month to host the second cohort of the Texas-France Space Hub in Houston. The hub aims to unite academic institutions and private enterprises to expand commercial space presence in both countries. Startups from the hub will present during the event, followed by drinks and networking at Second Draught.

This event Thursday, May 28, from 6-7 p.m. at the Ion. Register here.

New TMC partnership aims to grow Houston’s biomanufacturing workforce

workforce partnership

Houston is a frontrunner in the race to introduce and manufacture advanced therapeutics to the medical world. A new agreement between the Texas Medical Center (TMC) and San Jacinto College (SJC) aims to speed more experts and their technologies towards the finish line.

Earlier this month, the world's largest medical center and the nation’s second-ranked community college announced their new partnership that will set students on a path towards careers not only in life sciences in general, but also in pharmaceutical and biomanufacturing specifically.

SJC already has programs in those majors—its first graduates are now joining the workforce—but working with TMC will help the college recruit new students, as well as aid in enrollment and participation. Thanks to this collaboration, SJC students will benefit from more experiential learning and be able to transition more smoothly into the next steps in their training.

“Houston is a premier global hub for life sciences and biotechnology, and the talent we need to advance therapeutic drugs, diagnostics, and cell and gene therapy is already here,” William McKeon, the TMC’s president and CEO, said in a news release. “With more companies choosing to establish their headquarters in Houston and the daily breakthroughs happening across the TMC campus, partnering with San Jacinto College is an important step toward sustaining that momentum and unlocking even greater innovation and growth through the promising talent that already exists within our state.”

The partnership is currently slated to last two years, but the institutions have the option to extend after that.

For students, their journey to becoming scientists will likely start with Biopath @ TMC, a program that introduces high school students to biomanufacturing careers and what it takes to pursue one. Since its inception two years ago, the program has worked with more than 2,000 students around Harris County.

“This partnership exemplifies San Jacinto College’s ability to design and deliver programs that align with current workforce demands while opening doors for untapped talent across the Houston region,” Brenda Hellyer, SJC chancellor, said in the release. “TMC is a key industry leader in our region, and San Jacinto College has a unique global curriculum that provides the foundation and skills required for students to succeed and graduates to thrive in meaningful careers that will contribute to the innovation and advancement of the life sciences.”

Thanks to this new collaboration, more of Houston’s biomanufacturing workforce will soon be locally grown.

Houston legacy planning platform secures $2.5M investment, adds to board

fresh funding

Houston-based Paige, a comprehensive life planning and succession software company, has secured a $2.5 million investment to expand the AI-driven tools on its platform.

The funding comes from Alabama-based 22nd State Banking Company, according to a news release. Paige says it will use the funding to expand automation, AI-driven onboarding and self-service tools, as well as add to its sales and customer success teams.

The company was originally founded by CEO Emily Cisek in 2020 as The Postage and rebranded to Paige last year. It helps users navigate and organize end-of-life planning with features like document storage and organization, password management, and funeral and last wishes planning.

“Too many families are left trying to piece together important information during some of the hardest moments of their lives,” Cisek said in the news release. “This investment allows us to accelerate the next phase of growth for Paige by improving the product and expanding support for our members, our financial institution partners and the communities they serve,”

In addition to the funding news, the company also announced that 22nd State Banking CEO and President Steve Smith will join Paige's board of directors.

“We believe banking should be grounded in relationships and built around the real needs of the people and communities we serve. Paige brings something deeply relevant to that mission," Smith added in the release. "It helps families prepare for the future in a practical and meaningful way, and it gives the banking community new pathways to support customers through important life transitions.”

Paige estimates that $124 trillion in assets will change hands through 2048. Yet about 56 percent of Americans do not have an estate plan.

Read more on the topic from Cisek in a recent op-ed here; or listen to InnovationMap's 2021 interview with her here.

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