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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$5B Austin medical center, anchored by MD Anderson, to break ground this fall

moving forward

Construction on the $1 billion first phase of the AI-native University of Texas Dell Medical Center in Austin—which will feature a hospital operated by Houston’s UT MD Anderson Cancer Center—is set to start this fall.

The UT System Board of Regents approved funding for first-phase construction on Aug. 12.

The medical center—now expected to cost $5 billion, up from the initial $2.9 billion estimate—will span about 2.5 million square feet. It will include 300 to 500 patient beds, outpatient facilities, an emergency department and specialized care for cancer patients.

MD Anderson will bring its world-renowned oncology programs to the center’s integrated health care model, Dr. Claudia Lucchinetti, senior vice president of medical affairs at UT Austin and dean of the university’s Dell Medical School, tells Health Leaders.

Earlier this year, Austin tech billionaire Michael Dell and his wife, Susan, pledged $750 million for development of the medical center. The medical center, scheduled for completion in December 2030, will be a cornerstone of the new 300-acre UT Dell Campus for Advanced Research, a medical education and research hub.

“Through this new campus and medical center, Texas will lead America in health care innovation,” Gov. Greg Abbott said when the research campus was announced in April. “The next generation of medical breakthroughs will take place in Central Texas.”

The medical center will fold AI tools and other technology into the infrastructure, rather than having them added after it’s built. Among other capabilities, the technology will monitor real-time medical data, automate data entry, and help health care professionals quickly predict and identify risks to patients, according to Health Leaders.

“We are not just building a new medical center,” Lucchinetti says. “We are building a fundamentally new model of health. It’s not just a new facility. It’s not just a new collaboration. It is a convergence of capabilities that rarely come together at the same time.”

Rice lands $15M U.S. Army award to launch next-gen wireless research center

defense funding

The U.S. Army Research Office has awarded Rice University $15 million to establish a new center for next-generation sensing and communications.

The five-year research center—dubbed the Center for Large Aperture Secure Sensing, Imaging and Communications (CLASSIC)—will unite researchers from universities and national laboratories to develop advanced antenna technologies for future wireless systems. Edward Knightly, the Sheafor-Lindsay Professor of Electrical and Computer Engineering at Rice, will lead the center that “combines expertise in wireless networking, antennas, radar, artificial intelligence, circuits and physics to address growing demands on wireless systems,” according to Rice.

“The challenges we’re tackling require advances that span physics, hardware, communications and computing," Knightly said in a news release. “By combining those strengths in a single center, we can accelerate the development and demonstration of technologies that would not be possible through individual efforts alone.”

Joining Knightly will be Ashutosh Sabharwal of Rice, Sensen Li of the University of Texas at Austin, Hou-Tong Chen of Los Alamos National Laboratory, Danijela Cabric of UCLA, Josep M. Jornet and Tommaso Melodia of Northeastern University, Daniel M. Mittleman of Brown University, and Willie Padilla of Duke University.

Industry partners include Booz Allen Hamilton, Intel, Keysight, Lockheed Martin, MITRE, Northrop Grumman, Qualcomm and Raytheon.

CLASSIC researchers will investigate how large-scale antenna arrays (ELSAAs) can expand the capabilities of wireless systems where technology is limited.

ELSAAs use thousands of coordinated antenna elements to direct radio waves. Researchers aim to develop ways to use the technology to help maintain steady communication when signals are blocked or disrupted and to detect and generate detailed images of concealed objects.

Along with ELSAAs, the center will work to develop sensing techniques for threat detection, study wireless jamming and build resilient high-speed wireless networks. Researchers will ultimately validate the technology in labs and via drone-based field trials.

CLASSIC will also work on developing an AI-driven modeling framework that will simulate complex electromagnetic environments in real time.

“This award demonstrates Rice’s leadership in tackling complex national research challenges through collaboration across disciplines and institutions,” David Sholl, executive vice president for research at Rice, added in the release.