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

 
 

"There's something magical happening in Houston, and [VCs] want a piece of it." Photo via Getty Images

Houston's seen a growth in startup and venture investment — even amid the pandemic — and a group of Houston innovators sat down for a virtual event to discuss what's lead to this evolution.

The Greater Houston Partnership hosted an installment of its Houston Industry Series focused on Digital Tech on Thursday, September 24. The panel of experts, moderated by Krisha Tracy of Google Cloud, discussed how they've observed the paradigm shift that's occurred in Houston over the past few years — and why.

Missed the discussion? Here are some significant overheard moments from the virtual event.

“I think there really is an interest for venture capital here, both locally and also welcoming it from outside of Houston. … There’s something magical happening in Houston, and [VCs] want a piece of it. I think that magical piece is a renewed interest in collaborating.”

Stephanie Campbell, managing director of Houston Angel Network and co-founder of The Artemis Fund. "I think a lot [of this progress] is due to the GHP, Houston Exponential, and the founding of the HX Venture Fund to bring those venture funds to Houston to say, 'what's happening here?'" Campbell adds, saying that this connectivity and collaboration that's happening in Houston VC is unique.

“I think there’s a misconception around all we do is oil and gas and life science in Houston, but when you think about what VC-backable companies look like, they’re tech, they’re B2B SaaS, they’re highly scalable, and they don’t tend to be capital-intensive types of things we see corporate venture backing.”

Campbell says, adding "the connectivity and the interest in VC is really taking off. It's an exciting time to be in Houston and Texas in general."

“Plug and Play’s ventures team is based in Silicon Valley and one thing they enjoy about meeting Houston-based founders is valuations tend to be more reasonable than in the Bay Area."

Payal Patel, director of Plug and Play Tech Center in Houston. "There are gems to be found," she adds.

“I don’t know what it is — if it’s something in the water or just Texans being very friendly, but the investors here share deal flow. It takes a village, and I think we all understand a rising tide lifts all boats."

Patel says on the collaborative nature of Houston. "It's really magical."

“What you’re witnessing is a city that has been waiting for industrial innovation to reach the point where it can be adopted at a really high scale, and that happened around 2017.”

Jon Nordby, managing director at MassChallenge Texas in Houston. Nordby adds that MassChallenge in Houston hasn't been keen on consumer tech, or the "grilled cheese delivery apps," as he describes. "We like companies that are in love with problems, not so much in love with solutions. … We build really meaningful tech."

“Over the last year or two, we’ve seen that sleeping giant get awoken. Open and external innovation is newly adopted by more legacy industries where it wasn’t before — and that’s just created a mountain of opportunities for startups and investors alike.”

Nordby says on the shift toward this meaningful, problem-solving technology, which Houston is full of, as he observes.

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