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."

Coding camps continue to grow and expand in Houston. The most recent comes from the University of Texas. Getty Images

As Houston's innovation ecosystem grows, the need for tech talent grows too. It's why the University of Texas and workforce accelerator Trilogy Education decided to bring a series of coding boot camps designed to teach Houstonians the skills they need to excel in the fast-paced world of the tech economy to town.

"Too many working adults lack the skills to succeed in the digital economy," says Liliya Spinazzola, the senior director for professional education and strategic initiatives at the Texas Extended Campus of The University of Texas at Austin. "And that means that employers are lacking a talent pool."

The Houston Coding Boot Camp aims to change all that. The 24-week sessions teach web development and coding skills, allowing adults to take classes even as they're working. That kind of flexibility helps them increase their knowledge as they continue to build career paths.

Houston's seen a good amount of growth when it comes to new coding camps. Digital Crafts, for instance, grew from an inaugural class of eight students to 125 people in just two years. Women Who Code saw a need for female coders in Houston to have a network, and now the city has a newly launched chapter.

Student success
So far, 260 students have completed the programs, going on to work at companies such as JP Morgan, IBM, and Deloitte.

One of those is Rebecca Gemeinhardt, now a full stack developer at Shell. She graduated with her bachelor's in graphic arts from the Kansas City Art Institute in 2017, and found that she missed being in a classroom. When she started the boot camp, she was immediately drawn to the challenge the subject matter offered, as well as the flexible schedule.

"The boot camp was just as formidable as the curriculum promised but extremely fulfilling," she says. "Going into boot camp, I didn't tell anyone I was doing it — what if I struggled and couldn't get through it? I kept it a secret until I found the confidence to identify as a developer."

Once she completed the program, she was hired at Shell.

"My life had changed so much in just six months but definitely for the better," Gemeinhardt says. "By focusing on the ability to adopt new technologies, [the coding boot camp instructors] left us with the invaluable skill of being adaptable and fast-learning full stack developers. This has helped me immensely at my current position as we are always incorporating new languages to our architecture depending on individual project needs."

Filling the need
Spinazzola says the camps deliberately try to create environments that foster the level of problem solving and exploration Gemeinhardt describes. The program partners with employers to discover what skills are most needed, and tailors the curriculum to dovetail with them. She says the skills most in demand right now are coding, cyber security, IT project management, and digital marketing.

"We also look at job description data here in Texas to see what skills are listed," she says. "And while students are in the program, we have a robust network that engages with them upfront, talking to them about what jobs are out there. And we host career fairs where they can show off their portfolios and discuss their skills set with potential employers."

Spinazzola says that students come from all walks of life and employment backgrounds, and that 26 percent of the participants are women. With 25 students per boot camp session, the small classes make for deep instruction. UT offers between three and fours sessions in Houston each year. She says that she finds participants are looking to either break into the tech sector, learn new skills or re-train to be able to advance their careers. The average age of students is somewhere in the low-30s, she says.

"We had a student who owned a cooking school and wanted to start a new career," she says. "[Rebecca] trained as a graphic artist and wanted to be a developer. One student shut down his medical practice and says that he wanted to learn coding so that he could go work for a pharmaceutical company. To me, that's the beauty of this program. These skills are in demand, and our students are able to take what they already know and enhance their abilities to be able to take on new career paths."