Axiom Space-tested cancer drug advances to clinical trials

mission critical

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.

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.”

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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

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

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10 Houston companies clock in with best corporate cultures, says Forbes

Where to Work

Two of Houston's biggest medical institutions – Houston Methodist and MD Anderson Cancer Center – have just landed top-50 spots on Forbes' new ranking of "America's Best Employers for Company Culture." The report highlighted eight more Houston-area companies for their inspiring company culture.

Forbes partnered with market research firm Statista to survey over 218,000 workers at companies with at least 1,000 employees throughout the U.S, and relied on data from the past three years of employee surveys (with an emphasis on the most recent data and recommendations from current employees). Companies don't pay to be included, Forbes additionally noted.

Among the final list of 600 U.S. companies, 30 Texas employers were praised for providing "a unifying company culture that inspires a sense of purpose and loyalty among employees."

Houston Methodist climbed into the No. 15 spot nationally and outranked all other Texas companies on the list, while MD Anderson ranked 47th nationwide. Both institutions have dominated U.S. News' annual rankings of the best Texas hospitals for over a decade, proving exactly how having a great company culture can also improve the service provided to patients.

MD Anderson Cancer Center MD Anderson Cancer Center has been the No. 1 best cancer hospital in the U.S. for over a decade. Photo courtesy of KVUE

According to the report's research, employers with a successful company culture don't rely on "surface-level perks" such as free lunches, wellness apps, and flex days to inspire employee engagement. Instead, employers that focused on conflict resolution and coaching their managers saw a reduction in employee burnout and an increase in "perceptions of fairness and leadership care."

"In fact, the researchers noted that when 'senior leaders changed how they led — how they ran meetings, gave feedback, made decisions and responded to challenge — trust scores rose by an average of 26 percent,'" the report said.

The eight other Houston-area companies that earned national acclaim for their company culture are:

  • No. 220 – Stewart Info Services
  • No. 325 – BP
  • No. 332 – Baylor College of Medicine
  • No. 492 – Chevron Phillips Chemical, The Woodlands
  • No. 525 – Insperity
  • No. 558 – NRG Energy
  • No. 586 – Waste Management
  • No. 593 – LyondellBassell

Other Texas employers with great company culture:

Elsewhere in Texas, 15 North Texas companies and five Central Texas companies were included on Forbes' list of employers with the best company culture.

The three Austin-area companies that earned spots on the list include Austin Community College District (No. 56), Round Rock-based Dell Technologies (No. 207), and Keller Williams Realty (No. 352).

The two San Antonio-based companies that made the cut are beloved Texas grocery chain H-E-B (No. 445), and municipal electric utility company CPS Energy (No. 551).

The 15 Dallas-Fort Worth-based companies that made the list include:

  • No. 58 – The Container Store, Coppell
  • No. 73 – Lewisville Independent School District, Lewisville
  • No. 117 – Southwest Airlines, Dallas
  • No. 123 –Topgolf, Dallas
  • No. 170 – McKesson, Irving
  • No. 190 – Kimberly-Clark, Irving
  • No. 245 – Jacobs Solutions,Dallas
  • No. 312 – Brinker International, Coppell
  • No. 350 – Texas Health Resources, Arlington
  • No. 482 – Toyota North America, Plano
  • No. 562 – Dallas Area Rapid Transit (DART), Dallas
  • No. 567 – AT&T, Dallas
  • No. 569 – Energy Transfer, Dallas
  • No. 591 – American Airlines Group, Fort Worth
  • No. 597 – Aimbridge Hospitality, Plano
---

This article originally appeared on CultureMap.com.

Eli Lilly to build $6.5B pharmaceutical factory at Generation Park

coming soon

Pharmaceutical giant Eli Lilly and Co. plans to build a $6.5 billion manufacturing plant at Houston’s Generation Park. More than 300 locations in the U.S. competed for the factory.

The Houston site will be the first major pharmaceutical manufacturing plant in Texas, according to the Greater Houston Partnership.

Lilly said it plans to hire 615 full-time workers for the 236-acre plant, including engineers, scientists and lab technicians. The company will collaborate with local colleges and universities to help build its talent pipeline.

The plant will also generate an estimated 4,000 construction jobs.

Lilly said every dollar it spends in the Houston area will contribute an additional $4 to the local economy.

“This is a transformative moment for the Houston region and our life sciences industry,” Steve Kean, president and CEO of the Greater Houston Partnership, said in a release. “The Lilly project represents one of the largest for-profit life sciences investments in Texas history and is a powerful endorsement of Houston’s growing position as a global hub for innovation, advanced manufacturing, and biomedical excellence.”

The factory, expected to go online by 2030, will make small-molecule medicines for fields such as oncology, immunology and neuroscience. Perhaps most notably, the site will manufacture orforglipron, Lilly's first oral small-molecule GLP-1 medicine for treatment of obesity and type 2 diabetes. The drug is currently undergoing clinical trials.

“Our new Houston site will enhance Lilly’s ability to manufacture orforglipron at scale and, if approved, help fulfill the medicine’s potential as a metabolic health treatment for tens of millions of people worldwide who prefer the ease of a pill that can be taken without food and water restrictions,” David Ricks, chairman and CEO of Lilly, said in a release.

The company said it chose Generation Park, a 4,300-acre, master-planned commercial district near Lake Houston, because of factors such as financial incentives, access to utilities and transportation, and the region’s business-friendly environment. Generation Park is home to campuses for San Jacinto College and Lone Star College.

The plant will be outfitted with machine learning, AI, advanced data analytics, digital automation, and similar tools to streamline operations, Lilly said.

Houston engineering firm lands $400M NASA contract

space deal

NASA has granted Houston-based Bastion Technologies Inc. the Safety and Mission Assurance II (SMAS II) award with a maximum potential value of $400 million.

The award stipulates that the engineering and technical services company provide safety and mission services for the agency’s Marshall Space Flight Center in Huntsville, Alabama, according to a release from NASA.

In the deal, Bastion’s services include system safety, reliability, maintainability, software assurance, quality engineering, independent assessment, institutional safety and pressure systems. Bastion’s work will support research and development projects, hardware fabrication and testing, spaceflight and science missions, and other activities at NASA Marshall, Michoud Assembly Facility in New Orleans, Stennis Space Center in Bay St. Louis, Mississippi, NASA’s Kennedy Space Center in Florida and various other sites.

The first base period for the SMASS II award has already begun, with the option for a base ordering period of four years to extend services through March 2034.

Bastion has been a key player in NASA’s Artemis program, and was also awarded a contract to support occupational safety, health and mission assurance at NASA’s Ames Research Center in Silicon Valley in 2024. Also in 2024, Bastion was awarded the NASA Glenn Research Center (GRC) Environmental, Safety, Health, and Mission Assurance (ESHMA) contract.

Since 1998, Bastion has held over 350 contracts at almost every NASA center and most major aerospace industry partners.

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