Houston company wins AHA competition for pediatric heart valve design

winner, winner

Houston-based PolyVascular won the American Heart Association’s annual Health Tech Competition. Courtesy of TMC Innovation

Houston-based PolyVascular, which develops minimally invasive solutions for children with congenital heart disease, was named the overall winner of the American Heart Association’s annual Health Tech Competition earlier this month.

The company was founded in 2014 by Dr. Henri Justino and Daniel Harrington and was part of TMCi's 2017 medical device cohort. It is developing the first polymer-based transcatheter pulmonary valve designed specifically for young children, allowing for precise sizing and redilation as the child grows while also avoiding degradation. PolyVascular has completed preclinical studies and is working toward regulatory submissions, an early feasibility study and its first-in-human clinical trial thanks to a recent SBIR grant from the National Heart, Lung, and Blood Institute.

With the new AHA honor, PolyVascular will be invited to join the association’s Center for Health Technology & Innovation Innovators’ Network, which connects entrepreneurs, providers and researchers to share and advance innovation in cardiovascular and brain health.

“This is a tremendous honor for PolyVascular—we’re especially proud to bring hope to families and children living with congenital heart defects,” Justino said in a news release. “Our technology—a minimally invasive valve that can be expanded over time to grow with the child—has the potential to dramatically reduce the need for repeated open-heart surgeries.”

The Health Tech Competition is a live forum for health care innovators to present their digital solutions for treating or preventing cardiovascular diseases and stroke.

Finalists from around the world addressed heart failure, hypertension, congenital heart defects and other issues that exist in cardiovascular, brain and metabolic health. Solutions were evaluated on the criteria of validity, scientific rigor and impact.

The judges included Texas-based Dr. Eric D. Peterson, professor of medicine in the division of cardiology at UT Southwestern Medical Center, and Dr. Asif Ali, clinical associate professor of cardiovascular medicine at the University of Texas Medical School in Houston and director at Cena Research Institute.

According to the American Heart Association, nearly half of U.S. adults live with some form of cardiovascular disease or stroke.

“The American Heart Association plays a pivotal role in advancing innovative care pathways, and we’re excited that our solution aligns with its guidelines and mission,” Justino said in a news release. “It’s time these life-changing technologies reach the youngest patients, just as they already do for adults.”

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Six Houston startups — from health tech to aerospace — have moved into the new East End Maker Hub. Image courtesy of East End Maker Hub

New innovation hub grows with the addition of 6 Houston startups

moving in

The East End Maker Hub in Houston's East End District is growing with the recent addition of six startups.

"All of these companies cite the East End Maker Hub's physical innovation infrastructure, customizable spaces, strategic location, and potential collaborators as motivations for moving their operations into the hub," Patrick Ezzell, president of Urban Partnerships Community Development Corp., one of the hub's creators, says in an April 26 news release. "All are in the process of growing their teams and view Houston and, more specifically, the East End as a key resource for human capital heading into the future."

The companies that recently joined the East End Maker Hub are:

Alchemy Industrial. The company is a contract manufacturer that uses advanced technologies to develop industrial products for the medical, renewable energy, and drone sectors. Mush Khan, a British-born entrepreneur, established the startup last year.
CarbonATM. Led by Frank Zamarron and a group of former NASA engineers, CarbonATM aims to improve monitoring of ambient air quality with a low-cost portable device.
Gbowo Inc. This startup, founded in 2020, seeks to help companies reduce the environmental and financial costs of last-mile deliveries through the use of low-speed electrical vehicles. Ganiu Ladejobi is the founder and CEO.
Horizon Aeromarine. Established in 2020, the startup develops software and electronics from unmanned aerial and marine vehicles. Laura Sammons and Denver Hopkins are the founders.
Parallax 621. Founded by Benjamin Peters and Phillip Lentz, the Parallax 621 tech think tank develops technology based on theoretical physics research.
Polyvascular. The startup, established in 2014, makes a polymer-based heart valve for children with congenital heart disease.

The East End Maker Hub, at 6501 Navigation Blvd., is a collaboration between TXRX Labs and Urban Partnerships Community Development that houses crafters, fabricators, and tech manufacturers. TXRX Labs invested $1.25 million in equity to set up the hub. Urban Partnerships Community Development raised $35.75 million in capital to get the project off the ground.

Houston-based PolyVascular has invented a polymer-based heart valve for children with congenital heart disease. Photo courtesy of TMC Innovation

Houston startup with life-saving innovation receives $2M grant

for the children

A $2 million federal grant will enable Houston-based PolyVascular to launch human trials of what it hails as the first polymer-based heart valve for children.

In conjunction with the grant, Dr. Will Clifton has joined the medical device company as chief operating officer. He will oversee the grant as principal investigator, and will manage the company's operations and R&D. Clifton is president and co-founder of Houston-based Enventure, a medical innovation incubator and education hub. He previously was senior director of medical affairs at Houston-based Procyrion, a clinical-stage medical device company.

PolyVascular's Phase II grant came from the Small Business Innovation Research (SBIR) program, which promotes technological projects.

The PolyVascular heart valve will help treat congenital heart disease affecting more than 1 million around the world. PolyVascular plans to launch clinical trials of the valve in children 5 and over within two years.

"Congenital heart disease remains the most common category of birth defect and a leading cause of childhood death in the developed world," reads a March 30 news release from PolyVascular, founded in 2014.

PolyVascular says the valve can be implanted without surgery, and can avoid the use of valve replacements from humans or animals. Those valve replacements are difficult to find and often don't last too long, leading to frequent follow-up surgeries.

"Our aim at PolyVascular is to transform the care of children with congenital heart disease by developing an entirely new generation of valves made of medical-grade polymer devoid of any biological tissue," Dr. Henri Justino, chief medical officer at PolyVascular, says in a release. "The valves in use so far for children have been made of biological tissue. Unfortunately, our immune systems target and destroy this biological tissue, sometimes rapidly, rendering the valve ineffective."

The SBIR grant isn't the only win for PolyVascular in recent years.

In 2019, the startup came away with several honors in the 2019 Texas A&M New Ventures Competition. It won the pitch competition (complete with a $5,000 cash award), and received the Biotex Investment Prize, Amerra Visualization Services Prize, and GOOSE Society Investment Prize.

Also in 2019, PolyVascular, a member of TMCx's 2017 medical device cohort, won in the medical device and health disparities and equity categories at the fifth annual Impact Pediatric Health pitch competition. Additionally, the Southwest National Pediatric Device Consortium granted the company up to $25,000.

Last year, MedTech Innovator, a nonprofit accelerator in the medical technology sector, announced PolyVascular was one of 50 companies chosen to participate in the organization's flagship four-month accelerator program.

"During these uncertain and challenging times, the need for health innovations — specifically those that promise to deliver long-term value to the health care system and patients — is more critical than ever," said Paul Grand, CEO of MedTech Innovator.

Another Houston startup, Vivante Health, also was picked for the MedTech Innovator program. Vivante is a digital health company that helps people address digestive health and wellness.

Spark Biomedical took home first place at the Texas A&M New Ventures Competition. Courtesy of Texas A&M

Houston companies take home big prizes from a Texas A&M startup competition

Big winners

Earlier this month, 16 startups competed in the 2019 Texas A&M New Ventures Competition for more than $350,000 in cash and in-kind services — the largest pool of prizes in the contest's history.

Houston had a huge presence at TNVC this year. Several Houston startups competed in the technology- and science-focused pitch competition, and the top three prizes were claimed by Houstonians. Of the 13 health and life science companies that were named semifinalists, seven were related to the TMC Innovation Institute.

Here are the Houston companies that walked away from the TNVC with cash and/or prizes.

Spark Biomedical

Friendswood-based medical device company Spark Biomedical took home the top prize at TNVC, which came with a $50,000 check. Spark's technology uses a noninvasive neurostimulation treatment for opioid addiction recovery.

"I'm very humbled and grateful," says Daniel Powell, CEO of Spark, in a release. "This award means a lot because Texas A&M is my alma mater. Being back here is fantastic, and this win is a testament to the work we're doing and our dedication to making a difference with this product."

Spark also was recognized with the Southwest Pediatric Device Prize and the Aggie Angel Network Investment Prize. Recently, Spark announced a partnership with another Houston startup, Galen Data.

SurfEllent

Photo via surfellent.com

Coming in at No. 2 overall and receiving a $35,000 prize was Houston-based advanced coating company, SurfEllent. The company, which is based out of the University of Houston's Technology Park, has designed an anti-icing technology that can be used in any type of situation from de-icing cars to aeronautical applications.

SurfEllent was also recently recognized as one of the top three innovators at NASA's 2017 iTech forum, out of 130 entries across the US.

The company also walked away with the TEEX Product Development Center Prize.

Intelligent Implants

Photo by Cody Duty/TMC

Intelligent Implants called Houston home during the 2018 TMCx medical device cohort and still has a presence in town. The company, which created a, implantable wireless device that stimulates bone growth using electrical stimulation, claimed third prize and $25,000.

Last fall, following its success at TMCx, Intelligent Implants was named the "Most Promising Life Science Company" at the 2018 Texas Life Science Forum hosted by the Rice Alliance and BioHouston.

VenoStent

Photo via venostent.com

Another 2018 TMCx medical device cohort member competed at the TNVC and left with fresh funds. VenoStent took fifth place and a $10,000 prize. VenoStent has a device that allows a successful stent implementation on the first try, called the SelfWrap. The device is made from a shape-memory polymer that uses body heat to mold the stent into the vein-artery junction.

VenoStent, which has its headquarters in Nashville, Tennessee, also won the Ramey & Schwaller IP Legal Services Prize.

PolyVascular

Courtesy of TMC Innovation

Houston-based PolyVascular walked away a big winner of multiple prizes. The company, a member of TMCx's 2017 medical device cohort, creates polymeric transcatheter valves for children with congenital heart disease.

PolyVascular won the TNVC pitch competition, which came with a $5,000 prize. The startup also walked away with the Biotex Investment Prize, the Amerra Visualization Services Prize, and the GOOSE Society Investment Prize.

Ictero Medical

Ictero Medical, which operates out of JLABs at TMC, took home several prizes, including the Thomas | Horstemeyer IP Legal Services Prize, the TMC Accelerator Admission Prize, and the Engineering Vice Chancellor Innovation Prize — a new award that came with a $15,000 prize.

Ictero created the CholeSafe System — a minimally invasive device that treats gallstone disease patients in a procedure with "only minimal local anesthesia to defunctionalize the gallbladder without having to remove it," according to the website.

Sun Co. Tracking

Sun Co. Tracking was the other of the two startups to receive the new Engineering Vice Chancellor's Innovation Prize and its own $15,000 prize. The Houston-based company is developing shape memory alloy actuators for solar panels.

"This unique prize is intended to help the awardees access the world-class engineering capabilities at Texas A&M to obtain technical assistance toward solving their most challenging technical problems in product design, manufacturing or testing," says Dr. Balakrishna Haridas, TEES director for technology commercialization and entrepreneurship, in a release.

"These collaborations between the prize winners and Texas A&M Engineering will generate technical data to support on Small Business Innovation Research/grant proposal funding or private capital investments to the company."

GaitIQ

Photo via LinkedIn

GaitIQ is based in San Antonio, but is automatically accepted into TMCx's tenth cohort if they'd like, since the company won the TMC Investment Prize. The company, which created a primary care app that uses artificial intelligence and cloud-based technology, also won sixth place overall and $5,000.

GaitIQ also won the Ark Pharmacies, Inc. Regional Prize, the Hollinden Marketing and Strategists Services Prize, and the Schwegman Lundberg and Woessner IP Legal Services Prize.

Houston-based PolyVascular earned recognition in two categories, as well as nabbing up to $25,000. Courtesy of TMC Innovation

2 TMCx companies leave SXSW with awards and grant money

Med tech

Two Houston companies are walking away from SXSW with awards and grant funds.

PolyVascular, a member of TMCx's 2017 medical device cohort, won the fifth annual Impact Pediatric Health pitch competition's medical device and health disparities and equity categories. Additionally, the Southwest National Pediatric Device Consortium granted the company up to $25,000.

PolyVascular co-founder Henri Justino represented his company in three-minute pitch, and team members Dan Harrington and Kwon Soo Chun were also in attendance.

The company was one of 12 finalists in the competition, which took place on March 8 at SXSW in Austin. Among the judges was Houston doctor, Chester Koh, professor of urology, pediatrics, and OB/GYN at Baylor College of Medicine and Pediatric Urologist at Texas Children's Hospital.

"At the Southwest National Pediatric Device Consortium, we are always looking for the next cutting-edge breakthrough in the world of medical devices," says Koh in a release. "Impact Pediatric Health's reputation for bringing together the leaders in pediatric medical technology innovations makes it the perfect venue to help identify and accelerate the next generation of medical device companies impacting our youngest of patients."

Founded in 2014, PolyVascular produces polymeric transcatheter valves for children with congenital heart disease — the most common birth defect and number one cause of infant mortality in the developed world. The company's goal is to reduce that number of infant deaths by introducing a higher quality of valves.

Meanwhile, VastBiome, a 2018 biodesign TMCx company, received a $1,000 grant and is now one of two finalists for the San Francisco-based Illumina Accelerator program. The company works with scientists with ongoing clinical trials focusing on the microbiome as it pertains to therapy.

Another TMCx company, Zibrio, was up for an award in the 2019 SXSW Pitch event, but left the contest empty handed.

TMCx has multiple representatives at the festival, and the organization partnered with Energizing Health to host events throughout the first weekend of the conference.

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Elon Musk's SpaceX is about to make its debut on Wall Street

Money Moves

Elon Musk's rocket company SpaceX will make its debut on Wall Street Friday, June 12, and both institutional and retail investors are expected to gobble up the 555.6 million shares going up for sale at $135 apiece. Musk, already the world's richest man, could become its first trillionaire.

SpaceX is likely to become the biggest IPO ever, with proceeds of around $75 billion. SpaceX hopes to become the first company to send people to Mars. In fact, part of Musk’s future compensation depends on SpaceX eventually establishing a colony of at least 1 million people on the red planet.

Why SpaceX is going public now

In a video conference on Musk's social media platform X, he told JPMorgan CEO Jamie Dimon that people have suggested for the last 10 years that he take SpaceX public. He's doing it now because the company plans to put 100,000 next-generation Starlink satellites into orbit. Deploying AI data centers in space is a “massive new growth base and you need capital for that,” he said.

Going public provides access to the capital that SpaceX needs. But it also exposes it to more scrutiny from shareholders and more regulatory oversight. That includes filing quarterly financial reports, which critics say incentivizes short-term thinking over longer-term planning and creates unnecessary costs for a company. Securities regulators are currently soliciting public comment on a proposal to require public companies to file the financial reports only twice every year.

How the IPO impacts the company

Musk will hold the majority of a special class of shares, giving him control over decisions related to company strategy, finances and personnel. On the latter, because of his ownership of most of these Class B shares, the only person who can fire Musk as CEO is Musk.

The company credits Musk with being the “driving force” behind its growth, innovation and success. But what happens if Musk is no longer in the picture? SpaceX warns that the loss of Musk could disrupt its ability to execute its strategy as well as hurt its “reputation and relationships with customers, partners and other stakeholders.”

The company also warns that finding a replacement with the same skills and experience as Musk would be time-consuming, if not nearly impossible. As Wedbush Securities analyst Dan Ives wrote Wednesday, “At the end of the day Musk is SpaceX and SpaceX is Musk.”

What could make or break SpaceX

Currently in the test phase, the gigantic reusable Starship rocket is key to SpaceX realizing Musk's ambitions. Much of the commercial space business hinges on SpaceX developing Starship’s capability to be fully reusable and hearty enough for a quick turnaround between flights. If that doesn't happen, SpaceX warns that putting data centers and satellites in space will take longer and cost more money, meaning it risks customers bailing on the company.

Analysts say that by pioneering reusable rockets, SpaceX has established a clear lead on competitors such as Blue Origin, led by Amazon founder Jeff Bezos. The Starlink satellite business competes with, among others, AST SpaceMobile – which is relying on a SpaceX rocket to send its latest generation of satellites into orbit next week.

The prospectus filed last week says SpaceX’s biggest potential market is the sale of business-oriented artificial intelligence products designed to transform how people get work done. It’s an opportunity SpaceX predicts would be worth $22.7 trillion if it could somehow dominate rivals like Anthropic, OpenAI and Microsoft in a highly competitive industry. But the prospectus shows no clear path to profitability for the xAI business, which merged with SpaceX earlier this year.

Why Wall Street is paying attention

If the SpaceX IPO is as successful, the stock could quickly join the Nasdaq 100, a widely followed index that tracks the 100 largest non-financial companies in the composite. That's important because some popular funds, such as the $460 billion QQQ exchange-traded fund, mimic the index and will automatically buy whatever is listed in the index.

Nasdaq recently changed its rules to allow select companies to enter the Nasdaq 100 after just 15 trading days.

S&P Dow Jones Indices, on the other hand, is sticking to established and more traditional thresholds that will not allow SpaceX or other companies with gargantuan IPOs faster entry into its S&P 500 index. That means even high-profile companies will still need to wait for their stocks to trade a full 12 months before they can enter the index.

Companies want to be in the S&P 500 in particular because it's arguably the most important index on Wall Street, with trillions of dollars either mimicking it exactly or benchmarked against it. Vanguard's VOO fund that tracks the S&P 500 has roughly $950 billion invested in it, for example.

NASA unveils Artemis III astronauts at Johnson Space Center in Houston

To the moon

NASA on Tuesday, June 9, revealed the crew for its Artemis III mission, the next step in the space agency's plan to eventually land astronauts on the moon.

The announcement came two months after Artemis II's record-breaking trip around the moon that surpassed the distance record of Apollo 13.

NASA's Randy Bresnik, Frank Rubio, Andre Douglas and the European Space Agency's Luca Parmitano won't fly to the moon or land on the surface. Instead, they’ll orbit Earth while practicing docking their Orion capsule with two lunar landers.

“To the Artemis III crew, we wish you Godspeed on the journey ahead,” said NASA administrator Jared Isaacman.

Elon Musk’s SpaceX and Jeff Bezos’ Blue Origin are racing to deliver the lunar landers. The two-week demo is targeted for 2027. Blue Origin suffered a recent setback when its massive rocket exploded during an engine-firing test on the launch pad in Florida, shaking nearby homes and illuminating the sky with an orange fireball.

NASA's Jeremy Parsons said the setback is a learning opportunity and that the space agency is confident Blue Origin's rocket will be ready in time.

NASA's Artemis program aims to return astronauts to the moon's surface for the first time since the 1970s. A recent revamp of the program announced by Isaacman aims to fast-track it similarly to the Apollo era, adding the upcoming spaceflight around Earth before eyeing a lunar landing in 2028.

“We are certainly humbled as a crew to be able to be your crew that executes this Artemis III mission in space,” said Bresnik, Artemis III commander.

Added Douglas, mission specialist: “My brain — it is going a mile a minute right now. But my heart, it is so warm. It is so full."

In May, NASA awarded hundreds of millions of dollars in contracts to four companies, including Blue Origin, to build landers, rovers and drones for a future moon base. Isaacman said the goal of the moon base is to lay the foundation for a Mars expedition.

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