Houston-based Saranas' technology is now being premiered in the United States. Courtesy of Saranas

A Houston company is changing the game when it comes to early bleed detection, and now the company can provide its life-saving service to the United States.

Saranas Inc., which received FDA approval for its Early Bird Bleed Monitoring System in March, announced that it is launching its device in the US. at the Transcatheter Cardiovascular Therapeutics Conference next week in San Francisco. The device is designed to detect and track bleeding complications related to endovascular procedures. These medical procedures treat problems, such as aneurysms, that affect blood vessels.

"As the first and only early bleed detection system on the market, the Early Bird is ideally positioned to play a key role in making the rapidly expanding, minimally-invasive catheter-based procedures safer by providing physicians with bleed monitoring in real-time," says Saranas president and CEO, Zaffer Syed, in a news release. "With the launch of the Early Bird, physicians will now have a standard of care to monitor the bleed status of the patient during and post procedure, receive timely notifications of actual bleeds, and potentially reduce the severity of bleeding complications and resulting costs, while protecting clinical outcomes in patients undergoing endovascular procedures."

Around 20 percent of patience suffer a bleeding complication during endovascular procedures, like transcatheter aortic valve replacement, endovascular aneurysm repair, and percutaneous hemodynamic support, and, according to a report in the Journal of the American Medical Association, these complications result in higher mortality, longer hospital stays, and higher medical bills.

In other exciting news for the company, Saranas hired Tom Lucas as vice president of sales and marketing. He has 28 years of experience in medical sales, and he is tasked with business development, marketing, sales, and more for the company.

"Tom is a critical strategic hire for Saranas as we launch our first product in the U.S.," Syed says in the release. "His expertise will be invaluable as we expand distribution of the Early Bird into additional centers of excellence."

Saranas began its clinical trials last year after raising $2.8 million. The company revealed the results of those trials earlier this year, leading to the FDA approval.

"Our first-in-human study demonstrated that clinical concordance with Early Bird detection and CT scans (primary endpoint) was near perfect, and the early discovery of bleed onset and progression during the procedure occurred in 31 percent of cases with 69 percent occurring post procedure," says Saranas Chief Medical Officer Dr. Philippe Généreux in the release. "Compared to the current paradigm of waiting for symptoms, which could take hours to develop, the Early Bird allows physicians to detect bleeding in real-time and take the necessary actions quickly to protect the outcomes of the procedure and aid recovery for the patient."

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

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

blood tests

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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European spacecraft developer expands to Houston with U.S. business, new lab

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European aerospace manufacturer The Exploration Company has established its first U.S. entity and named Space City as its headquarters.

The company announced earlier this month that it has launched TEC Federal to support U.S. government customers and agencies, and to scale The Exploration Company's engineering operations in the country.

Mark Kirasich serves as president of TEC Federal. Kirasich most recently served as the senior director of human spaceflight at Blue Origin after a nearly 40-year career at NASA.

The Exploration Company is developing the reusable Nyx space vehicle. Nyx is designed to take off from any heavy launcher in the world. It will then dock at space stations, retrieve up to 3,000 kilograms of cargo, splash down and return the cargo to Earth. The company aims to make Nyx fully reusable for up to 10 missions, making it a more affordable and sustainable option for aerospace missions.

The Exploration Company completed a successful drop test of the spacecraft in May in the Mojave Desert. The company says Nyx is slated to perform its first flight demonstration in 2028.

In addition to launching the Houston business, The Exploration Company also opened its new Rapid Innovation Lab near Houston's NASA Johnson Space Center on Space Park Drive.

The Exploration Company opened its Rapid Innovation Lab earlier this month. Photo via LinkedIn

The Rapid Innovation Lab features a full-scale mockup of the future Nyx crew capsule as well as ongoing development and testing of the Nyx cargo capsule, according to the company.

The Exploration Company says the new lab will allow its engineers, designers, and operators to prototype and test crew interfaces. It will also support partnerships with NASA personnel and astronauts.

“Houston gives us direct access to the people and expertise that have built and operated human spaceflight systems for decades. We’re excited to invest and expand around that— engineers, operators, and astronauts working together and moving quickly towards building a crew capsule.” Hélène Huby, founder and CEO of The Exploration Company, said in a blog post.

According to The Houston Chronicle, The Exploration Company has about 30 employees in the Houston area.

The company was founded in 2021 by Huby, a French rocket scientist, and has raised more than $350 million in venture capital. It operates out of Germany, France, Luxembourg, Spain and Italy, with offices in the U.S. and the United Arab Emirates. It is also developing a reusable, high-thrust rocket engine known as Storm.

UH lands $4M NIH grant to study early signs of autoimmune disease

NIH funding

The University of Houston recently received a $4 million National Institutes of Health grant to support a 10-year longitudinal study to identify the earliest biological markers of autoimmune disease.

Led by Chandra Mohan, the Hugh Roy and Lillie Cranz Cullen Endowed Professor of Biomedical Engineering, the study aims to examine what causes Systemic Autoimmune Rheumatic Diseases (SARDs) and to identify targets for future treatments. The study will be carried out in collaboration with Dr. Karen Costenbader at Harvard Medical School, Boston.

SARDs include conditions like rheumatoid arthritis, systemic lupus erythematosus, Sjögren’s syndrome and systemic sclerosis—all are considered chronic diseases currently without a cure. Autoimmune diseases affect over 30 million people globally, according to UH.

SARDs occur when the body’s immune system attacks healthy, non-threatening tissues and organs. According to UH, in these diseases, the body often attacks nuclear antigens, creating anti-nuclear autoantibodies, which can be early detection signs for SARDs in more than 50 percent of patients, Mohan says.

Researchers will study blood samples and environmental exposure over the 10 years to better understand anti-nuclear autoantibodies.

“Collectively, these studies will help identify the genetic, environmental and cellular factors that are operative at the two steps of SARD development, namely the emergence of anti-nuclear autoantibodies and disease onset,” Mohan said in a news release. “ More importantly, these studies will highlight functional molecular pathways and mechanisms that may be operative at each step."

Mohan predicts that looking at SARDs’ shared characteristics, rather than each disease individually, could help identify more treatment methods.

“Individual SARDs have been examined in silos without an attempt to discern shared underlying features at the molecular level,” he added in the release. “Current understanding of the initial (and likely shared) origins of SARDs is only rudimentary but urgently needed to develop means for prevention and treatment.”

Earlier this year, UH also received an $11 million NIH grant to conduct a first-of-its-kind study of early language development in children ages 18 to 24 months. Read more here.