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."

Ad Placement 300x100
Ad Placement 300x600

CultureMap Emails are Awesome

Bristol Myers Squibb to build $2.3B Houston pharma manufacturing campus

coming soon

New Jersey-based pharmaceutical giant Bristol Myers Squibb Co. has officially named Houston as the home of its new state-of-the-art manufacturing site.

The 60,000-square-foot facility represents a $2.3 billion investment, according to a news release. It is expected to create 500 skilled jobs and will be located in Houston's Generation Park.

BMS first announced that it was considering Houston among 16 other cities for the facility in May. The new hub will manufacture small molecule, biologic and antibody-drug conjugates and is part of a $40 billion commitment to invest in the United States over five years. Construction is slated to begin next year, with the facility coming online in 2030.

"We're building the domestic manufacturing capabilities needed to deliver the next generation of medicines and support future scientific breakthroughs. Houston and the state of Texas offer the talent, infrastructure, and partnership needed to help bring that vision to life," Christopher Boerner, CEO and board chair of BMS, said in the release.

The new facility will feature a modular, multi-modal design, which will allow the company to reconfigure and add to its manufacturing capabilities over time. BMS says it expects the facility to "(grow) in scale and capability well beyond its opening configuration."

"Our decision to build this state-of-the-art manufacturing campus in Houston, Texas, reflects our confidence in the region’s ability to support a world-class, digitally advanced supply operation,” Karin Shanahan, EVP and chief supply chain and operations officer of BMS, added in the release. “This facility is designed to deliver the speed, quality, and reliability that patients depend on, combining flexible, modular manufacturing with advanced digital capabilities to ensure consistent supply across multiple modalities. It strengthens our ability to operate with resilience and positions us to reliably deliver medicines to patients today while adapting future demands.”

Texas Gov. Greg Abbott shared that the state has granted BMS a $4.89 million Texas Enterprise Fund (TEF) grant for the project. TEF grants, administered by the Texas Economic Development & Tourism Office, support business relocation or expansion projects that create "new, good-paying jobs in the community and attract significant new capital investment to the state." The development is also a qualified project under the Texas Jobs, Energy, Technology, and Innovation (JETI) program.

“Texas is a global hub for life sciences, where today’s innovations shape the future of healthcare,” Abbott said in a news release. “This $2.3 billion investment by Bristol Myers Squibb in the dynamic biotech ecosystem in Houston is a testament to the depth of our skilled workforce and the pipeline of talent coming through our nation-leading technical colleges and research universities. With lower operating costs and easy access to markets across the U.S. and the world, Texas drives affordability for consumers.”

"Bristol Myers Squibb’s announcement is a tremendous win for Texas and the Houston region, further reinforcing our position as a premier destination for life sciences and advanced manufacturing,” added Greater Houston Partnership President and CEO Steve Kean.

Last fall, Eli Lilly and Co. selected Generation Park, a 4,300-acre, master-planned commercial district near Lake Houston, for its $6.5 billion manufacturing plant. More than 300 locations in the U.S. competed for the factory. Read more here.

Texas foundation makes massive $180M donation to Galveston hospital

historic gift

The University of Texas Medical Branch in Galveston (UTMB) has accepted a staggering $130 million grant from the Sealy & Smith Foundation, which, combined with the $50 million that the foundation donated in 2025 to establish the Department of Cardiovascular Medicine, is the largest bequest in UTMB history.

The grant will go to grow cardiovascular imaging, diagnosis, and treatment at UTMB by establishing an inpatient cardiovascular hub on the sixth floor of Jennie Sealy Hospital. In honor of the donation, the department is being renamed the Sealy Heart and Vascular Institute.

“The Sealy & Smith Foundation has a long history of investing in initiatives that transform health care for the people of Galveston and beyond,” said John Kelso, president of The Sealy & Smith Foundation Board of Directors. “We believe the Sealy Heart & Vascular Institute has the potential to redefine cardiovascular care in our region by bringing together exceptional physicians, advanced technology, innovative research and a commitment to improving patient outcomes. This additional investment reflects our confidence in UTMB’s vision and our belief that the Institute will have a lasting impact for generations to come.”

The Sealy & Smith Foundation was established in 1922 by John Sealy II and his sister Jennie Sealy Smith. Bolstered by the Sealy fortune built on shipping, oil, banking, and railroads, the Foundation has donated more than $1.2 billion to UTMB over the last century, linking the family legacy to healthcare, teaching, and research. It was John Sealy Sr. who contributed the initial $50,000 to build a hospital on the island, which opened right alongside the new medical school created by the state legislator in what was then Texas's largest and most economically powerful city.

Since then, the Foundation has helped grow UTMB into a world-class hospital. The cardiovascular care especially is well-regarded, making the 2025 Newsweek/Statista List of America's Best Hospitals.

“This extraordinary investment reflects The Sealy & Smith Foundation’s unwavering commitment to improving health and advancing medical excellence,” said Dr. Jochen Reiser, UTMB president and CEO of the UTMB Health System. “The partnership between UTMB and The Sealy & Smith Foundation is very strong. Built on generations of shared vision and trust, it continues to redefine what an academic health system can achieve. Together, we are building one of the nation’s premier cardiovascular programs integrating exceptional patient care, groundbreaking research, innovation and world-class education to improve the lives of patients throughout Texas and beyond.”

---

This article originally appeared on CultureMap.com.

UTHealth Houston team joins NASA initiative to protect border drinking water

water watch

Climate change means far more to public health than living with hotter days. Transformations in our weather are contributing to challenges in accessing safe drinking water in some communities.

One of the most dire situations is along the US–Mexico border. The National Aeronautics and Space Administration (NASA) is seeking to address that issue with its Water Quality Applications program. An 11-researcher project led by a UTHealth Houston School of Public Health faculty member has been selected to participate.

“Drinking water is one of the most fundamental public health protections, but producing safe drinking water involves a delicate balance,” Yun Hang, assistant professor of environmental and occupational health sciences, said in a news release. Her team’s proposal was one of 93 that were submitted for funding through NASA’s Research Opportunities in Space and Earth Sciences (ROSES)-2025 program.

This is the first time that NASA has worked with a team devoted to water quality applications. The group, which includes researchers from across the nation, will use satellite observations of Earth, as well as hydrologic modeling, to potentially anticipate and act on water quality conditions as they change. Challenges addressed over the course of the three-year program, which kicked off in June, might include problems with water quality due to climate variability and increased pressure on water resources.

Hang’s team will focus on a pair of borderlands: Paso del Norte and the Rio Grande Valley.

“Working closely with El Paso Water ensures that our research addresses real operational needs while helping utilities better prepare for climate-related water quality changes and continue providing safe drinking water to communities across the Texas border region,” Hang added in the release.

She and the team will use data gathered by NASA on both past and future Earth-observing missions, which will allow them to track environmental changes that may affect source water quality. Combined with past water treatment records and hydrologic models, the team will also utilize artificial intelligence to develop predictive tools that aim to stop issues before they become larger hurdles to water safety.

Another one of the project’s goals is to create visualization tools and source water summaries that can be utilized by those without scientific expertise. The tools will be produced in English and Spanish to further broaden their accessibility.

The hope is that the materials made by the team will also go far beyond the border, with protocols that can be adapted or adopted by other areas dealing with water quality issues.