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."

Capital Factory will have a branded area in The Cannon when it opens its new facility. Courtesy of The Cannon

A major Texas innovation player with roots in Austin has now staffed its recently announced Houston outpost in partnership with The Cannon Houston. Capital Factory hired two Houstonians to help provide resources for its growing Houston-based portfolio companies.

Kendrick Alridge has been hired as mentor coordinator, and Brittany Barreto, who founded Pheramor and WeHaveChemistry, has been named the venture associate. Aldridge will focus on growing and cultivating relationships with Houston mentors, and Barreto is dedicated to reaching out to Houston startups to gauge their potential for Capital Factory participation.

Hiring these Houstonians and having these new boots on the ground is a key factor for Capital Factory as it grows its Houston presence, says Gordon Daugherty, president at Capital Factory.

"It's important for us to think Texas, but act local," Daugherty says. "What that means is we can't just assume that the way we do things and the things that made us successful in Austin will directly translate to Houston. Houston is a different market. That's one of the things we learned from Dallas."

Acting locally entails listening and learning to what the community wants and engaging with local organizations to contribute value to the market.

"We don't know how or in which ways, but we know Houston will be different from Dallas and Austin," Daugherty says. "In this way, we are advantaged by our two employees being from the Houston area. They're our eyes and ears, for one, but they are also the voice of Houston to us along with other ecosystem players."

While local resources and personnel are both new for Capital Factory, the organization already has over 20 portfolio companies that are based in the Houston area. Now, these companies will have new resources close to home and can also act as Capital Factory representatives in the community, Daugherty says.

One of the biggest benefits Capital Factory is bringing into town is investment opportunities. Daugherty says that he predicts that Capital Factory, which tends to invest many small-sum deals, will quickly become the most active early stage investor in Houston. The organization has already made a few investments in Houston companies — and this isn't even counting the dollars invested by the investment partners.

"Our mission, as it pertains to Houston, is to help the best Houston startups get funded. We will tap into our network of investors across the state and country to try to find the best matches."

If Houston can take any indication from Capital Factory's Dallas location, which opened earlier this year, Capital Factory will be making a big impact on Houston startups.

"In 2018, 25 percent of the startups we onboarded into the accelerator were from outside of Austin," Daugherty tells InnovationMap. "The first half of this year, a third or more have come from Dallas alone. And I expect the same from Houston. Next year, easily more than half of our new accelerator companies will be outside of Austin."

Capital Factory will have branded space in The Cannon when it opens its new facility later this month.