Houston regenerative medicine company to IPO, move toward more human trials

ready to list

FibroBiologics will IPO this week. Photo via Getty Images

Want a piece of one of Houston’s most promising biotech companies? On January 31, FibroBiologics will begin the trading of its common stock on the Nasdaq stock exchange.

While most labs in the realm of regenerative medicine are focused on stem cells, FibroBiologics has bet on fibroblasts as the secret to treating myriad ailments. Fibroblasts, the most common type of cell in the body, are the primary cells that compose connective tissue.

Interested investors can find a prospectus to peruse before taking the leap. FibroBiologics filed with the U.S. Securities & Exchange Commission (SEC) on November 7, 2023. In September, FibroBiologics CEO Pete O’Heeron told InnovationMap, “I think what we're going to see is that fibroblasts are going to end up winning... They're just a better overall cell than the stem cells.”

O’Heeron was first exposed to the possibilities of fibroblasts as a means of regrowing discs in the spine. Since starting the company in 2008 as SpinalCyte, O’Heeron and FibroBiologics have organically written and filed more than 320 patents. Potential treatments go far beyond spinal surgery to include wound care, cancer, and multiple sclerosis.

According to O’Heeron, the goal in going public is to raise capital for human trials.

“We’ve had really fantastic results with animals and now we’re ready for humans,” he explained in September. “We've done small human trials, but we haven't done the large ones that are going to get the commercialization approval from the FDA.”

FibroBiologics is growing with impressive speed. O’Heeron told us that he is hiring as quickly as he is able to find qualified scientists with the expertise to do the one-of-a-kind work required. The company opened a new lab last fall at the UH Technology Bridge, Newlin-Linscomb Lab for Cell Therapies. With its new status as a publicly traded company, FibroBiologics is primed to break even more ground.

FibroBiologics is opening a unique new lab at the University of Houston's Technology Bridge. Photo by Natalie Harms/InnovationMap

Houston regenerative medicine company opens new lab at UH

cell therapy innovation

Pete O’Heeron wants you to know that “Bohemian Rhapsody” was originally released as a B-side. What does this nugget about Queen have to do with regenerative medicine? For O’Heeron and his company, FibroBiologics, it means everything.

That’s because most scientists consider stem cells the A-side when it comes to the race to curing disease. But FibroBiologics has set its sights on fibroblasts. The most common cell in the body, fibroblasts are the main cell type in connective tissue.

“Everyone was betting on stem cells, and we started betting on fibroblasts,” says O’Heeron, who started the company in 2008 as SpinalCyte. “I think what we're going to see is that fibroblasts are going to end up winning, there are more robust, more that are lower cost cell, they have higher therapeutic values, higher immune modulation. They're just a better overall cell than the than the stem cells.”

Since a neurosurgeon and a dermatologist first introduced O’Heeron to the idea of using fibroblasts to regrow discs in the spine, the company has expanded its reach to include promising treatments for multiple sclerosis and cancer and in wound care. Imagine a world where doctors lay fibroblasts directly onto surgical incisions after surgery, cutting the time for healing in half.

FibroBiologics has organically written and filed more than 320 patents.

“It's quite a unique situation. I don’t think that in other areas of science that you have such a wide open area to go out and patent. It's just it was a brand new area nobody had been working on,” O’Heeron explains.

And soon, investors will be able to own a stake in the impressive work being forged in Houston. FibroBiologics, previously FibroGenesis, was formed in order to go public in a direct NASDAQ listing. The goal is to access the capital necessary to go to human trials. Earlier this year, the company also launched a crowdfunding campaign.

“We’ve had really fantastic results with animals and now we’re ready for humans,” says O’Heeron. “We've done small human trials, but we haven't done the large ones that are going to get the commercialization approval from the FDA.”

With that in mind, the company just signed a deal with University of Houston’s Innovation Center. On Thursday, September 7, FibroBiologics will dedicate the Newlin-Linscomb Lab for Cell Therapies in the UH Technology Bridge. The new lab is named for former player and color commentator for the Houston Rockets, Mike Newlin and his wife, Cindy, as well as Pam and Dan Linscomb, a founding partner of Kuhl-Linscomb, one of the largest wealth management companies in Houston.

Other big local names newly attached to the company are astronaut Kate Rubins and Elizabeth Shpall, the director of the cell therapy laboratory at MD Anderson Cancer Center. Both have joined FibroBiologics as members of its scientific advisory board.

To fill the lab, O’Heeron says that he is adding to his team as quickly as he is able. The barrier is the fact that there are few, if any people in the world with the exact qualifications he’s seeking.

“Anytime you're breaking new scientific ground, you can't really just go out and recruit someone with that background because it really doesn't exist,” he says. But he is willing to teach and challenge scientists who are the right fit, and is hoping to expand the team in the new lab.

But like Queen did in 1975, FibroBiologics is pioneering a category of its own. And that’s something worth betting on.

A Houston research team is studying the effects of regenerative medicine on hearts. Photo via TMC.org

Innovative Houston lab works with 'ghost hearts' to study impact of regenerative medicine

stem cell magic

Ask any high achiever and they’ll tell you — failure is the path to success.

As Camila Hochman-Mendez puts it, “I’m like Thomas Edison, right? I know a thousand ways of how not to create a lightbulb.” But she’s not really talking about electricity. Hochman-Mendez is director of Regenerative Medicine Research and the Biorepository Core at Texas Heart Institute.

Hochman-Mendez follows another pioneering woman in the role, Doris Taylor. The younger scientist took on the prime job when Taylor left in 2020. By then, Hochman-Mendez had been at The Texas Heart Institute for three years, moving from research scientist to assistant director in just four months.

Regenerative Medicine is every bit as exciting as it sounds. At Hochman-Mendez’s lab, her team creates ghost hearts — organs from which all cells are scrubbed, leaving collagen, fibronectin, and laminin in the shape of the formerly beating ticker. The goal is to use the decellularized organs as protein scaffolds that, once injected with stem cells, will once again contract and pump blood.

Hochman-Mendez cautions that we are still years away from that point, but her lab is working hard to get there.

“The ultimate goal is to develop functional hearts that can be used for transplant,” says Hochman-Mendez.

Those hearts would be made from the patient’s own cells, avoiding organ rejection, which the scientist says is essentially trading one disease for another. But she is realistic about that fact that there are many barriers to her success.

“It does come with a lot of technical challenges,” she says.

These challenges include the simple number of cells that billions, and potentially hundreds of billions of cardiomyocytes are needed to recreate a human heart. The necessary protocols, Hochman-Mendez explains, are extremely costly and labor intensive.

It also takes 60 days for the cells to reach a maturity at which they can function. The lab recently received a pair of grants targeted at creating bioreactors that can be reliable for at least those 60 days.

The third major issue facing the Regenerative Medicine lab is contamination.

“It needs to be very sterile,” says Hochman-Mendez. “It needs to be so clean that if you have one tiny bacteria there, you’re screwed.”

Fortunately, the scientist says that her favorite hobby is computer programming. She and a physician colleague have created a robotic arm that can help to prevent the contamination that often stemmed from humans manually injecting stem cells into the decellularized organs.

This not only works towards solving the contamination problem, it also allows the team to more accurately distribute the cells that they add, using an injection map. To that end, she is producing a three-dimensional model of a protein scaffold that will allow her team and other scientists in the field of regenerative medicine to understand how the cells really disperse when they inject them.

When will her lab produce working hearts?

“I try to be very conservative on timing,” she says.

She explains that it will take significant leaps in technology to make a heart mature to the level at which it’s usable for an adult body in 60 days.

“That’s magic and I don’t believe in magic,” she says, but adds that she hopes to have a prototype ready to be tested in five years.

Hochman-Mendez does this all with a small team of nine researchers, most of whom happen to be female.

“The best candidates are the ones that I select," she says. "The majority are females. I think it’s a mix of trying to be very unbiased, but I usually don’t even look at the name before looking at the CV to preselect the people that I interview.”

And together, Hochman-Mendez are making medical history, one success-spawning failure at a time.

Camila Hochman-Mendez is director of Regenerative Medicine Research and the Biorepository Core at Texas Heart Institute. Photo via texasheart.org

You can now hop online and invest in this promising cell therapy startup. Photo via Getty Images

Houston biopharma company launches equity crowdfunding campaign

money moves

A clinical-stage company headquartered in Houston has opened an online funding campaign.

FibroBiologics, which is developing fibroblast cell-based therapeutics for chronic diseases, launched a campaign with equity crowdfunding platform StartEngine. The platform lets anyone — regardless of their net worth or income level — to invest in securities issued by startups.

The funding, according to a press release, will be used to support ongoing operations of Fibrobiologics and advance its clinical programs in multiple sclerosis, degenerative disc disease, wound care, extension of life, and cancer.

"We're excited to partner with StartEngine on this campaign. StartEngine has over 600,000 investors as part of their community and has raised over half a billion dollars for its clients," says FibroBiologics' Founder and CEO Pete O'Heeron, in the release.

"This is an exciting time at FibroBiologics as we continue progressing our clinical pipeline and developing innovative therapies to treat chronic diseases," he continues. "This new funding will fuel our growth in the lab and bring us one step closer to commercialization."

The campaign, launched this week, already has over 100 investors, at the time of publication, and has raised nearly $2 million, according to the page. The minimum investment is set at around $500, and the company's indicated valuation is $252.57 million.

In 2021, FibroBiologics announced its intention of going public. Last year, O'Heeron told InnovationMap on the Houston Innovators Podcast of the company's growth plans as well as the specifics of the technology.

Only two types of cells — stem cells and fibroblasts — can be used in cell therapy for a regenerative treatment, which is when specialists take healthy cells from a patient and inject them into a part of the body that needs it the most. As O'Heeron explains in the podcast, fibroblasts can do it more effectively and cheaper than stem cells.

"(Fibroblasts) can essentially do everything a stem cell can do, only they can do it better," says O'Heeron. "We've done tests in the lab and we've seen them outperform stem cells by a low of 50 percent to a high of about 220 percent on different disease paths."

Celltex is looking into using stem cells to treat COVID-19, and the Houston biotech company just got the green light to go to trials. Photo courtesy of Celltex

Houston biotech company gets FDA greenlight to move forward with COVID-19 stem cell treatment

coronavirus cure?

A Houston-based biotech company announced last week that it has gotten the approval it was seeking from the U.S. Food and Drug Administration to continue testing its COVID-19 treatment that uses stem cells.

Celltex has received approval from its Investigational New Drug application, or IND, to look into stem cells — specifically Autologous Adipose Tissue-Derived Mesenchymal Stem Cells, or AdMSCs — and their effect on COVID-19 patients.

"The FDA's approval of our IND is not only a critical milestone for Celltex, but also for everyone who has been affected by COVID-19," says David G. Eller, Celltex chairman and CEO. "I am optimistic that our findings will result in favorable outcomes that will improve lives today and for generations to come."

Celltex has been in the stem cell business for nearly a decade and has treated patients with debilitating diseases like multiple sclerosis, Parkinson's, rheumatoid arthritis, and more. Eller says he's been considering how Mesenchymal Stem Cells, or MSCs, could be used amid the pandemic.

"Throughout the entire pandemic, MSCs have shown promise for combatting symptoms and complications associated with COVID-19, and as the nation's leading commercial MSC banking and technology company, Celltex has the unique ability to transition these initial findings into a clinical trial," Eller says.

The FDA clearance will allow for a phase two trial "that will evaluate the safety and prophylactic efficacy of AdMSCs against COVID-19," according to the release. There will be 200 patients across multiple centers that will be involved in the placebo-controlled study.

Celltex offices out of the Galleria area and has laboratory operations of its wholly-owned Mexican subsidiary are located in Hospital Galenia in Cancún, Quintana Roo, Mexico. Last year, Celltex planned an expansion into Saudi Arabia and also has a presence in Europe.

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Building a biotech workforce: How this Houston program is shaping the next generation

future focused

Houston is currently in need of biomanufacturing professionals to keep up with the ever-growing industry. That's what Saniya Mansuri, health care consultant for BioPath @ TMC, says.

“Houston has lost out on a big biopharmaceutical company. And when there was a feasibility study that was done, it was identified that one of the reasons that Houston wasn't chosen was the lack of a workforce and a lack of workforce development programs,” she explains.

Mansuri and the TMC Innovation team are doing just that with the introduction of the new program. She moved from Toronto in 2023. When she applied for a role at TMC Innovation, she was handpicked to help shepherd the BioPath program, thanks to her background that included starting a nonprofit for underserved youth in Canada.

The goal of the BioPath program is to attract young people considering going into the trades to learn the skills to become biomanufacturing professionals. According to BioPath’s website, 42 percent of TMC institutions anticipate a great need for biotechnicians in the near future, but there’s a lack of places for workers to train that aren’t part of a four-year degree. BioPath not only helps to recruit youths to careers that only require two years of training, but educates them for success in their newly chosen jobs.

“For the role of biomanufacturing technician, you can do a certificate program, get certified and enter into an entry level career that pays upwards of $50,000 — a stable career where there is a lot of development and job mobility involved,” says Mansuri.

This school year saw the debut of a pilot program that began with marketing and awareness to begin to get kids excited. Working with the organization Bridge Year, BioPath has created a booth for career fairs at which there’s a simulation of the skills involved in column chromatography that potential technicians would be learning. The booth is currently touring HISD high schools.

BioPath is also partnering with the national nonprofit, Learning Undefeated, to create a mobile STEM lab that will park at schools starting in January.

“Instead of students going to a biology class, you would swap it out for a class on this mobile STEM lab, and we have a biomanufacturing activity and curriculum that the students would learn,” explains Mansuri.

But that’s only the beginning. BioPath is looking at securing internships for the students, as well as sponsoring interested students in attending a biomanufacturing summer camp run by Texas A&M. Once educated, Mansuri and her team will help their charges with certification, mentorship and finding jobs post-certification.

Mansuri says she’s already received emails from interested students who have taken part in the “Career Test Drive” booth, but expects more after a soft launch in February in which 200 high school students will come to the TMC to learn more. The future for biomanufacturing in Houston is looking more promising already.

Coming soon: Houston Astros unveil new ballpark naming partner for 2025

welcome to the ice box

The Houston Astros are about to have the coolest ballpark in Major League Baseball. The team announced on Monday, November 18 that its has reached a naming rights agreement HVAC manufacturer Daikin Comfort Technologies North America, Inc.

Beginning on January 1, 2025, the stadium will be known as Daikin Park (die-kin). Scheduled to run through the 2039 season, the new name replaces Minute Maid Park, which has been the stadium’s name since 2002. It opened in 1999 as Enron Field.

Astros fans online are already calling the new stadium “The Ice Box,” replacing its informal “The Juice Box” moniker. That name feels likely to stick.

Japan-based Daikin Industries is a leading manufacturer of HVAC systems. It sells air conditioning units and other products under brand names such as Daikin, Goodman, Amana® and Quietflex. Critically, it operates Daikin Texas Technology Park in nearby Waller, which is the largest HVAC manufacturing facility in North America. The company employs approximately 10,000 people in Greater Houston, according to a release.

“We are excited to be partnering with Daikin for our ballpark’s naming rights,” Astros owner Jim said. “Daikin is an international company that proudly calls the Greater Houston area its North American home. The Houston Astros and Daikin share the same values, a commitment to excellence and a desire to give back to our local community. As we celebrate the 25th anniversary of this ballpark in 2025, I am proud to have Daikin alongside us to create even more special memories for our fans now and in the future.”

The Astros will use the revenue for new stadium amenities and other upgrades. It will also continue the team’s various community initiatives. Terms of the deal were not disclosed. the Houston Chronicle notes that naming rights deals may be worth anywhere from $3.5 million per year (T-Mobile park in Seattle) to $11 million per year for the Texas Rangers’ Globe Life Field.

The team’s first game in Daikin Park will take place on Monday, March 24, which it plays an exhibition against its Triple-A affiliate, the Sugar Land Space Cowboys. It will open the regular season on Thursday, March 27 against the New York Mets.

“Daikin fit all of the criteria we set out to find in a naming rights partner,” Astros senior vice president Matt Brand added. “Their name and reputation fit our iconic downtown Houston home, and their values mesh perfectly with those of the Astros. We are grateful to partner with the entire Daikin team and to help them succeed in their business goals. Daikin Park will be a special place for our fans for many years to come.”

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This article originally ran on CultureMap.

Photos: Houston Innovation Awards celebrates city's startup, tech leaders at annual event

event recap

The 2024 Houston Innovation Awards season has come to a close with last week's event.

With a crowd of around 500 attendees, the Houston Innovation Awards, which took place on November 14, celebrated over 40 finalists and a dozen winners across categories. Click here to see who won an award.

Learn more about this year's honorees in InnovationMap's the editorial series:

Special thanks to this year's sponsors: The Houston Innovation Awards is sponsored by Texas Medical Center, Milam & Greene Whiskey, Weber Ranch Vodka, EIGHT Beer, Karbach Brewing Company, Topo Chico, Houston Community College, Microsoft, Halliburton Labs, Mercury, Pillsbury Winthrop Shaw Pittman LLP, Rice Innovation & Ion District, Growth Pods, and Hunton Andrews Kurth.