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."

Michael Heckman shares about some exciting new aspects of Houston's 11th annual Comicpalooza. Courtesy of Houston First

Eleven years ago, Comicpalooza was a small event held out in Katy. Over the past few years, with the help of Houston First Corp., the three-day conference has grown to be so big, the 2019 programming will spill out of George R. Brown Convention Center and into Discovery Green, and attract over 50,000 attendees.

"These comic conventions used to just be for the hardcore pop culture fans. What we've attempted to do is make it so there's something for everyone," says Michael Heckman, Comicpalooza president and senior vice president at Houston First. "As a casual pop culture fan, there's a lot to see and do."

The festivities take place Friday, May 10, to Sunday, May 12, and include some big name events. Two Game of Thrones stars — Emilia Clarke (Daenerys Targaryen) and Nathalie Emmanuel (Missandei) — will be on a panel, and ESPN will host its first collegiate esports competition.

Heckman tells InnovationMap more about these big events and how Comicpalooza has transformed over the years.

InnovationMap: How the event has grown over the past decade? 

Michael Heckman: We've really worked hard to increase the impact of the event. There's a lot of out of town visitors that do come in — it has north of a $20 million economic impact every year. When you look at an event that is held during a traditionally slow period of time, it's a really big deal for the hotels and restaurants. The other part about it is when you're able to bring big stars to Houston, they're tweeting about it and posting Instagram stories about it. It does a lot to shine a spotlight on Houston's reputation and image.

IM: What are you most excited about for this year?

MH: It's a big sprawling event that takes place across all 1.2 million square feet of GRBCC. I'm excited about a few things. First, we've got the two folks from Game of Thrones. To be able to get Emilia Clarke in the middle of the final season of Game of Thrones, with only two episodes to go — the hype has been unbelievable. To be able to have a pop culture phenomenon like that come here to Houston — and it will be her first fan event. She's done the San Diego Comic Con, but that was more of a media event.

We've also got the ESPN Collegiate Esports Championship held here. We've done esports and gaming over the past few years, but it's a growth area for the event. To be able to hold that event with dozens of championships from around the country for this inaugural event is very exciting.

What a lot of people don't know is there are so many interesting aspects to Comicpalooza — from literature tracks to a film festival to a makerspace. There are hundreds of exhibitors on the expo showfloor, but there's an area carved out for makers. We have NASA, a cultural arts avenue, there's something for everyone. We're really looking forward to a blockbuster year.

IM: What did it mean for Houston to get ESPN’s collegiate esports program? 

MH: Esports is rapidly growing. That marketplace is developing very quickly. A lot of people and a lot of cities are figuring out what that means. We've understood the value of it for Comicpalooza for a number of years. ESPN is making a big investment — it's their first ever event of this nature, but it won't be their last.

IM: How did it come about?

MH: We've been talking to a number of folks across the landscape about how to best utilize the space that we have at GRBCC and find an opportunity that was a good fit for us. A couple people we were talking to out on the West Coast who connected us to the ESPN people, who happen to be the same division of ESPN that partners with the Houston Texans on a couple things. There's some synergies there, and they're familiar with Houston.

IM: How would you describe Comicpalooza's economic impact on Houston?

MH: Around 20 to 30 percent for the audience of Comicpalooza comes from outside of Houston. Last year, we had attendees from 47 states and 17 countries. It gives great exposure to the city, and the money they leave behind is valuable from an economic impact perspective. We think our numbers will be somewhat similar to last year.

If you look at the long term vision of what this could be, we have a beautiful campus for this event. We've moved some of our programming outside GRBCC onto the Avenida Plaza that connects to Discovery Green. If we have a full campus-wide event, that's something that's highly attractive. You grow that attendance, get up to 70 or 80 thousand people — that's a mega event. It's a snowball — once you get it started and then it just takes off. We're not there yet, but we've had really smart growth.

IM: How is the city as a whole preparing for the event?

MH: Houston's really good about handling events. It takes everything from the fire department to the police department and traffic control and 700 event volunteers — over 2,000 shifts. It's such a big footprint — it's kind of all hands on deck. It also looks like we'll have Astros at home and the Rockets playing game six of the playoffs at home. This major super block in downtown will be absolutely electric this weekend.

IM: What other events are you looking to bring to Houston?

MH: We'll always be chasing our conventions we have here. Our convention sales team looks to break another record this year. We have a lot of major events upcoming — from the college football playoff to the men's basketball Final Four, and we'll eventually pursue another Super Bowl. As we look to develop our portfolio of events that we manage here, there's a lot of opportunities here for events centered around innovation. There's a lot of talk around how Houston needs to have a better reputation for innovation. We've got aerospace, medical, oil and gas — what's an event we can create or partner on that could highlight Houston's innovation.

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Portions of this interview have been edited.