EarlyBird got the worm

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.

"Bleeding remains an Achilles' heel of advancing minimally-invasive, catheter-based procedures," says Dr. Dimitrios Karmpaliotis, director of Chronic Total Occlusions, Complex and High Risk Angioplasty at Columbia University Medical Center, in the release. "The Early Bird will play a key role in making these procedures safer in the future by providing physicians bleed monitoring in real-time."

In May, Saranas received $2.8 million in funding $2.8 million in funding from investors to enable testing of Early Bird. In all, the startup has collected $12 million from investors. A month after the funding announcement, Saranas was one of 50 startups chosen for the MedTech Innovator program, which nurtures medical technology companies.

Currently in the piloting stage, Saranas plans to commercially launch the Early Bird Bleed Monitoring System in select markets across the United States. Currently, the company hasn't disclosed a timeline for that roll out.

The De Novo distinction's purposes is to review new technologies and mitigate risk as they prepare to enter the market. In December, the FDA proposed new procedures and criteria for the De Novo classification process.

"The De Novo pathway for novel medical devices allows the FDA to conduct a rigorous review of new technologies so that patients have timely access to safe and effective medical devices to improve their health," says FDA Commissioner Scott Gottlieb, in a release. "At the same time, the FDA is modernizing its 510(k) pathway, which is used for clearance of low- to moderate-risk devices that are substantially equivalent to a device already on the market. The De Novo pathway provides a vehicle for establishing new predicates that can reflect modern standards for performance and safety and can serve as the basis for future clearances. Our goal is to make the De Novo pathway significantly more efficient and transparent by clarifying the requirements for submission and our processes for review."

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Building Houston

 
 

Health care leaders joined a virtual panel to discuss the effects of COVID-19 and more. Photo by Dwight C. Andrews/Greater Houston Convention and Visitors Bureau

There has been an undeniable paradigm shift in the health care industry due to COVID-19 as well as the growth of technology. A group of professionals sat down to discuss what in particular has changed for the industry as a whole as well as at local institutions.

At a panel for Venture Houston, a two-day conference put on by the HX Venture Fund on February 4th and 5th, a few health care professionals weighed in on all the changes to the industry for the startups, investors, corporations, and more who attended the virtual event. Here are some significant overheard moments from the virtual panel — Thinking Past a COVID World.

“For most of health care, this last year has been probably five years of rapid cycle re-innovation and movement forward — particularly in the digital realm.”

Marc Boom, president and CEO of Houston Methodist. From rapid adoption of telemedicine to developing a COVID-19 vaccine in less than a year, health care has seen rapid growth. However, there's fine tuning still needed, Boom continues.

"At the end of the day there's only so much we can do virtually," he adds.

“The most incredible thing was how the vaccines got developed so quickly.”

Chris Rizik, CEO of Renaissance Venture Partners. A large portion of the industry wasn't excited about RNA vaccines, but the COVID-19 vaccines might have changed some minds. It took 11 months to get it out into the world, but 10 of that was purely regulatory, he adds.

"One of the sustaining changes of the COVID-19 pandemic is I think RNA vaccines are here to stay."

​— Paul Klotman, executive dean of Baylor College of Medicine. Klotman adds that the vaccine's trials were so impressively quick because there were just so many COVID patients sick and eligible to enroll.

“I think one of the things the TMC institutions did really well was to decide really early on was to share data.”

Boom says, adding that the TMC represents around 70 percent of Houston's adults and around 90 percent of the city's pediatric patients. This opportunity for data is "one of the most robust sources of real-time data."

"Yes, you're going to compete clinically, but there's a lot of collaboration to be done especially during a pandemic," Boom says of the TMC's member organizations prioritizing collaboration with data sharing.

“Houston has done better than almost all major metropolitan areas because we have came together as a city and a community.”

Klotman says, adding that the vast patient base the TMC is key.

"There's a huge opportunity here for early biotech development," he says. "Because there are so many patients, there are huge opportunities to do new trials."

“The real challenge is for investors to be in tune to know what’s here to stay, and to invest around that."

Rizik says, adding that 2020 was the biggest year for health care investment with more money going into deals, rather than more deals occuring.

“We’re seeing a huge uptick in people interested in health professions, thanks to COVID.”

Boom says of the industry's workforce, which has usually been hard to recruit and grow.

“The medical school communities are all racing to change the way we teach and the kind of information we teach.”

Klotman says of the future of the workforce.

“Unlike most industries, technology is tended to be cumbersome in health care.

​— Boom says adding that new technology means added costs and slowed down processes that can't replace the human touch. Houston Methodist is looking for innovations that don't take health care professionals away from patients.

“If there’s anything this last year has shown us is that as fast as we thought we were going, we need to go faster. We’re excited to work with companies with great ideas.”

— Boom says of the future of tech in health care. "I think we're on a very transformational era in digital health right now — but there's a lot of work to be done still."

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