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."

Houston, home to the largest medical center in the world, had a lot of trending health tech stories this year. Photo by Dwight C. Andrews/Greater Houston Convention and Visitors Bureau

Editor's note: As 2019 comes to a close, InnovationMap is looking back at the year's top stories in Houston innovation. Within the health category, top stories included new details from the Texas Medical Center's ongoing TMC3 project, health tech and medical device startups in Houston, and more.

Texas Medical Center reveals new details and renderings for its TMC3 campus

The design and construction team has been announced for TMC3. Courtesy of Elkus Manfredi Architects

The Texas Medical Center just announced the dream team of architects and designers that are making TMC3 into a reality.

Elkus Manfredi Architects, Transwestern, and Vaughn Construction are the three companies that will serve as the architectural and development team for the 37-acre research campus. TMC3's founding institutions — TMC, Baylor College of Medicine, Texas A&M University Health Science Center, The University of Texas Health Science Center at Houston, and The University of Texas MD Anderson Cancer Center — decided on the three entities.

"Texas Medical Center is eager to move forward with a bold, imaginative and dynamic new design vision for the TMC3 Master Plan," says TMC CEO and president, Bill McKeon, in a press release. "With the combined talents of Elkus Manfredi Architects, Transwestern, and Vaughn Construction on-board, I couldn't be more confident that this dream team will flawlessly execute the totality of the project's vision and fulfill its mission to bring together leading researchers and top-tiered expertise from the private sector to create the number one biotechnology and bioscience innovation center in the entire world."

TMC3 was first announced just over a year ago and is planned to open in 2022. The campus will incorporate research facilities, retail space, residential plans, a hotel and conference center, and green space. Parking will be underground to optimize surface area. To continue reading this top story, click here.

5 Houston medical device companies changing the industry

As medicine and technology both advance, these Houston startups are at the forefront of the industry. Getty Images

With the Texas Medical Center at the heart of Houston, health advancement opportunities are endless. Medical breakthroughs are happening across town, but as technology advances, the industry is seeing more and more startups popping up to take new tech tools and applying them to traditional medical devices and procedures.

These five Houston startups are developing the future of the industry — one device at a time. To continue reading this top story, click here.

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. To continue reading this top story, click here.

5 Houston biotech companies taking health care to new levels

With the Texas Medical Center in their backyard, these Houston biotech companies are creating breakthrough technologies. Getty Images

Houston is the home of the largest medical center in the world, so it comes as no surprise that the Bayou City is also home to breakthrough technologies. Here are five Houston companies developing some of this biotech advancements. To continue reading this top story, click here.

TMCx announces its next medical device cohort with 5 startups hailing from Houston

The next TMCx cohort begins August 5. Courtesy of TMC

The Texas Medical Center's startup accelerator, TMCx, has added 19 companies from all around the world to join its medical device family.

The TMC Innovation Institute team narrowed down 140 applications to 40 for the second round of the process, which includes face-to-face interviews, according to a release. After those, 18 companies were selected to join the TMCx09 class, which focuses on medical devices. The last cohort, which specialized in digital health, concluded on June 6.

Out of the 18 companies, five are from Houston. Four other startups hail from other corners of the United States, while 10 international companies also made the cohort. The program commences on August 5, and will run for four months before concluding in a demo day event in November. To continue reading this top story, click here.