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."

Healthiby's motto is "health is wealth." Getty Images

Everything is different when money is on the line, and a Houston startup is using financial incentives as a motivator for its users to make smart, healthy lifestyle changes to enhance their wellness.

Healthiby, a cost-effective wellness program, is changing the game of health solutions by addressing chronic and pre-chronic conditions through innovative prevention and management methods, all incentivized by both short-term and long-term financial benefits.

"Healthiby incentivizes and empowers people to achieve better health outcomes in a team context," says Mary Beth Snodgrass, managing director and co-founder. "We're different from other wellness solutions because we're focused on changing habits, as well as incentivizing better health outcomes, providing both immediate and long-term rewards."

The company launched in May 2019 and is still in its pilot stage. Snodgrass and co-founder Dr. Tristan Hartzell, a surgeon based in Nebraska, have remained committed to their foundational concept for their startup, which is to empower people on their wellness journeys and spread knowledge about the financial benefits of leading a healthy lifestyle.

Mary Beth Snodgrass (pictured) founded Healthiby with Nebraska-based surgeon Dr. Tristan Hartzell. Photo courtesy of Healthiby.

Healthiby's notion that "health is wealth" relates to the idea that engaging in a healthy lifestyle will ultimately benefit individuals financially long-term, as healthcare costs can be avoided. Essentially, Healthiby qualifies health goals as preventative measures for chronic and pre-chronic diseases. Not only does Healthiby inform its users about the long-term financial benefits of healthy living, the program introduces exciting contests in which users are eligible to win financial rewards if they meet certain health-related criteria.

In time for the start of the new year and the health-related resolutions buzz, Healthiby enacts their user-friendly digital software application, social programs, expert health advice and financial incentives to serve their goal-oriented consumers with an engaging health management regiment that is sure to keep them on track throughout the year.

"What we're really focused on this year is, in addition to our incentives, digital content and coach guidance, is making sure that participants are engaging among themselves," Snodgrass tells InnovationMap. "Science shows there are benefits to surrounding yourself with other people who share similar health goals."

In what the program's founders refer to as a "wellness rewards solution," users are able to tap into the Healthiby digital platform to track their progress, participate in social wellness groups, invest in long-term financial incentives and access digestible, cutting edge wellness literature; all components of Healthiby's "journey goals," the program's building blocks to achieving a healthy lifestyle.

"Our software application manages our contests and our rewards, but we also have a very social component, in which participants are meeting online regularly with a dietician coach," Snodgrass explains. "The reason for this is because when we're talking about chronic and pre-chronic conditions, it's important for people to have a strong understanding of how these issues affect the body and what kinds of lifestyle changes are most effective at helping people better manage or reverse them."

Photo courtesy of Healthiby

For an annual minimum of $8 each month, individual consumers have the opportunity to invest in their own long-term wellness through this interactive, user-friendly health progress program.

"Healthiby is providing a really low cost solution for people to get additional social motivation, information, and incentives so that they can stick with their goals throughout the year," Snodgrass said.

Healthiby is currently available to individual consumers in Texas, but its founders have their sights set on expanding the business and sharing their solutions to companies vested in the importance of healthy living for their employees. For now, Houston's health and wellness consumers just got richer — both physically and financially — when Healthiby opened its digital doors to the city.