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."

Houston, home to the largest medical center in the world, had a lot of trending health tech stories this year. Photo by Dwight C. Andrews/Greater Houston Convention and Visitors Bureau

Editor's note: As 2019 comes to a close, InnovationMap is looking back at the year's top stories in Houston innovation. Within the health category, top stories included new details from the Texas Medical Center's ongoing TMC3 project, health tech and medical device startups in Houston, and more.

Texas Medical Center reveals new details and renderings for its TMC3 campus

The design and construction team has been announced for TMC3. Courtesy of Elkus Manfredi Architects

The Texas Medical Center just announced the dream team of architects and designers that are making TMC3 into a reality.

Elkus Manfredi Architects, Transwestern, and Vaughn Construction are the three companies that will serve as the architectural and development team for the 37-acre research campus. TMC3's founding institutions — TMC, Baylor College of Medicine, Texas A&M University Health Science Center, The University of Texas Health Science Center at Houston, and The University of Texas MD Anderson Cancer Center — decided on the three entities.

"Texas Medical Center is eager to move forward with a bold, imaginative and dynamic new design vision for the TMC3 Master Plan," says TMC CEO and president, Bill McKeon, in a press release. "With the combined talents of Elkus Manfredi Architects, Transwestern, and Vaughn Construction on-board, I couldn't be more confident that this dream team will flawlessly execute the totality of the project's vision and fulfill its mission to bring together leading researchers and top-tiered expertise from the private sector to create the number one biotechnology and bioscience innovation center in the entire world."

TMC3 was first announced just over a year ago and is planned to open in 2022. The campus will incorporate research facilities, retail space, residential plans, a hotel and conference center, and green space. Parking will be underground to optimize surface area. To continue reading this top story, click here.

5 Houston medical device companies changing the industry

As medicine and technology both advance, these Houston startups are at the forefront of the industry. Getty Images

With the Texas Medical Center at the heart of Houston, health advancement opportunities are endless. Medical breakthroughs are happening across town, but as technology advances, the industry is seeing more and more startups popping up to take new tech tools and applying them to traditional medical devices and procedures.

These five Houston startups are developing the future of the industry — one device at a time. To continue reading this top story, click here.

Houston medical device company gains FDA approval

Houston-based Saranas has received de novo distinction from the FDA for its bleed monitoring technology. Courtesy of Saranas

When it comes to early bleeding detection, Houston-based Saranas, which closed $2.8 million in funding last year, is ahead of the game with its Early Bird Bleed Monitoring System. The Food and Drug Administration has recognized the medical device company and granted it De Novo distinction.

"Gaining FDA approval for the Early Bird is a significant milestone for Saranas as it demonstrates our continued commitment to address an unmet need for real-time detection and monitoring of endovascular bleed complications," says Saranas president and CEO, Zaffer Syed in a release. "As the first and only device on the market for early bleed detection, we have the potential to significantly reduce bleeding complications and related healthcare costs, while improving clinical outcomes in patients undergoing endovascular procedures."

The Early Bird technology is designed to detect bleeding from vessel injury caused by a surgery, for instance. One in five patients experienced a bleed complication in over 17,000 large-bore transcatheter procedures, according to the release which cites the National Inpatient Sample Database. To continue reading this top story, click here.

5 Houston biotech companies taking health care to new levels

With the Texas Medical Center in their backyard, these Houston biotech companies are creating breakthrough technologies. Getty Images

Houston is the home of the largest medical center in the world, so it comes as no surprise that the Bayou City is also home to breakthrough technologies. Here are five Houston companies developing some of this biotech advancements. To continue reading this top story, click here.

TMCx announces its next medical device cohort with 5 startups hailing from Houston

The next TMCx cohort begins August 5. Courtesy of TMC

The Texas Medical Center's startup accelerator, TMCx, has added 19 companies from all around the world to join its medical device family.

The TMC Innovation Institute team narrowed down 140 applications to 40 for the second round of the process, which includes face-to-face interviews, according to a release. After those, 18 companies were selected to join the TMCx09 class, which focuses on medical devices. The last cohort, which specialized in digital health, concluded on June 6.

Out of the 18 companies, five are from Houston. Four other startups hail from other corners of the United States, while 10 international companies also made the cohort. The program commences on August 5, and will run for four months before concluding in a demo day event in November. To continue reading this top story, click here.