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 fundingfrom 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

 
 

Asma Mirza joins the Houston Innovators Podcast to explain how a pandemic pivot turned into a global health opportunity. Photo courtesy

In the span of a couple years, a Houston startup went from innovating a way for patients with degenerative eye diseases to see better to creating a portable and affordable breath-based diagnostics tool worthy of a prestigious grant from the Bill and Melinda Gates foundation.

Steradian Technologies, founded in 2018, set out to create human super-sight via proprietary optics. In early 2020, the company was getting ready to start testing the device and fundraising. Then, the pandemic hit, knocking the company completely off course.

Co-founder and CEO of the company, Asma Mirza, says on this week's Houston Innovators Podcast that the Steradian co-founders discussed how their optic technology could detect diseases. Something just clicked, and the RUMI device was born.

"We are from Houston, Texas, which is one of the most diverse and accessible cities in the country, and we were having trouble with basic diagnostic accessibility. It was taking too long, it was complicated, and people were getting sick and didn't know if they were positive or negative," Mirza says on the show. "That's when we pivoted the company and decided we were going to pivot the company and use optics to detect diseases in breath."

Fast forward two years and the company has been recognized by the Bill and Melinda Gates Foundation with a grant to sport the development of the tool — which costs about the same price as a latte to make. The impact for global health is huge, Mirza says, allowing for people to test their breath for diseases from their own homes in the same time it takes to take your temperature.

"You blow into a cartrige and we're able to take the air from your breath into a liquid sample," Mirza says, explaining how the device uses photons to produce quick results. "It's wild that we still don't have something like that yet."

She shares more details about the grant and the future applications for the technology — as well as the role Houston and local organizations have had on the company — on the podcast. Listen to the interview below — or wherever you stream your podcasts — and subscribe for weekly episodes.


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