blood tests

Houston early bleeding detection device company reveals results of its clinical trials

The results are in for Houston-based Saranas' clinical trials. Courtesy of Saranas

A Houston-based startup is closer to taking flight with a medical device designed to catch bleeding complications during medical procedures that involve blood vessels.

On May 22, researchers presented the results of a study showing the Early Bird Bleed Monitoring System from Houston-based Saranas Inc. detected various levels of bleeding in 63 percent of the patients who underwent endovascular procedures. These procedures treat problems, such as aortic aneurysms, that affect blood vessels.

No troubles were reported with the Early Bird device during the clinical trial, the researchers say.

Before this study, the Early Bird device hadn't been tested in humans. In all, 60 patients in five states participated in the clinical trial, which ran from August to December last year. Findings of the study were unveiled at the Society for Cardiovascular Angiography Interventions 2019 Scientific Sessions in Las Vegas.

The study's authors say they plan to continue evaluating the device at medical institutions that want to better manage bleeding during endovascular procedures.

"This is the first time we're seeing how this device could help in a real-world patient setting, and we were very encouraged by the results. Right now, patients have a risk of vessel injury when undergoing endovascular procedures where the femoral artery or vein is used for vascular access," Dr. Philippe Genereux, principal investigator for the study and a cardiologist at Morristown Medical Center in Morristown, New Jersey, says in a news release.

"This technology allows us to detect bleeding in real-time," Genereux adds, "which means we can take action quickly and improve the outcomes of the procedure and recovery for the patient."

In March, the Early Bird device — invented at Houston's Texas Heart Institute — received the U.S. Food and Drug Administration's approval as a "novel" medical device.

Saranas says Early Bird is the first and only device of its type. The FDA approval and the promising results of the clinical trial pave the way for the eventual launch of the device into the healthcare market.

A forecast from professional services firm KPMG predicts the global market for medical devices will reach nearly $800 billion by 2030. Early Bird aims to capture a sliver of that market by addressing an expensive and potentially fatal problem. One-fifth of patients experience bleeding complications during large-bore endovascular procedures. Research shows these complications are associated with a greater risk of death, longer hospital stays, and higher healthcare costs.

The Early Bird device is meant to decrease those complications by quickly alerting medical professionals to signs of bleeding during endovascular procedures.

As explained by the Texas Heart Institute, the Early Bird employs a sheath — a plastic tube that helps keep arteries and vessels open — embedded with sensors that measure the electrical resistance across a blood vessel. When the Early Bird senses a change in the electrical resistance, medical professionals receive audible and visual notifications about potential internal bleeding. If detected early, this bleeding can be minimized.

Altogether, Saranas has raised $12 million from investors, including a $2.8 million round in May 2018. The company was founded in 2013.

"What attracted me to Saranas is that our solution has the potential to meaningfully reduce serious bleeding complications that worsen clinical outcomes and drive up healthcare costs," says Zaffer Syed, who joined the startup as president and CEO in 2017. "In addition, our device may support access of important minimally invasive cardiac procedures by allowing them to be performed more safely."

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Building Houston

 
 

Axiom Space — along with Collins Aerospace — are teaming up with NASA to create the next generation of astronaut gear. Image via NASA

Two startups — including Houston-based Axiom Space — have been tasked with helping NASA gear up for human space exploration at the International Space Station and on the moon as part of a spacesuit deal potentially worth billions of dollars.

NASA recently picked Axiom and Collins Aerospace to help advance spacewalking capabilities in low-earth orbit and on the moon by outfitting astronauts with next-generation spacesuits. While headquartered in Charlotte, North Carolina, Collins has a significant presence in the Houston Spaceport.

This deal will help support landing the first woman and the first person of color on the moon as part of NASA’s return to our lunar neighbor. The equipment also will help NASA prepare for human missions to Mars.

Under this agreement, NASA, Axiom and Collins “will develop advanced, reliable spacesuits that allow humans to explore the cosmos unlike ever before,” Vanessa Wyche, director of NASA’s Johnson Space Center in Houston, says in a news release. “By partnering with industry, we are efficiently advancing the necessary technology to keep Americans on a path of successful discovery on the International Space Station and as we set our sights on exploring the lunar surface.”

Axiom and Collins were chosen under an umbrella contract known as Exploration Extravehicular Activity Services (xEVAS). The contract carries a potential value of $3.5 billion.

Michael Suffredini, co-founder, president, and CEO of Axiom, says his company’s “innovative approach to xEVAS spacesuits provides NASA with an evolvable design that enables cost-efficient development, testing, training, deployment, and real-time operations to address a variety of EVA needs and operational scenarios for a range of customers, including NASA.”

Axiom’s partners on this project are KBR and Sophic Synergistics, both based in Houston, along with Air-Lock, David Clark Co., Paragon Space Development, and A-P-T Research.

NASA says Axiom and Collins will own the spacesuits, and are being encouraged to explore non-NASA commercial applications for data and technology they co-develop with the space agency.

The EVA & Human Surface Mobility Program at the Johnson Space Center is managing the xEVAS contract.

NASA astronauts have needed updated spacesuits for years.

“The decades-old spacesuit designs currently in use on the International Space Station are well past their prime. NASA had been working on new suits and showed off a patriotic prototype of a moonwalking outfit — called the Exploration Extravehicular Mobility Unit, or xEMU — back in 2019,” according to CNET.

A 2021 report from NASA’s Office of Inspector General called out delays in developing the spacesuits that would make a proposed 2024 human moon landing unfeasible, CNET says. Now, Axiom and Collins, instead of NASA, will create the spacesuits. Demonstration-ready spacesuits are supposed to be ready in 2025.

The spacesuit deal is the latest in a string of milestones for Axiom.

Axiom recently broke ground on its new headquarters at Houston Spaceport. There, the company will build Axiom Station, the world’s first commercial space station.

Axiom also recently welcomed home the crew of Axiom Mission 1 after their successful completion of the first all-private astronaut mission to the International Space Station. The crew came back to earth in a SpaceX capsule. The company has signed agreements with several countries, including Italy, Hungary, and the United Arab Emirates, for future space missions.

Axiom recently tapped Italian Air Force Col. Walter Villadei as its first international professional astronaut. He currently is being trained in Houston and will serve as a backup on Axiom Mission 2.

Founded in 2016, Axiom employs more than 500 people, most of whom work in Houston. The company expects its workforce to exceed 1,000 employees by 2023.

To date, Axiom has raised $150 million in venture capital.

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