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-based Saranas' technology is now being premiered in the United States. Courtesy of Saranas

A Houston company is changing the game when it comes to early bleed detection, and now the company can provide its life-saving service to the United States.

Saranas Inc., which received FDA approval for its Early Bird Bleed Monitoring System in March, announced that it is launching its device in the US. at the Transcatheter Cardiovascular Therapeutics Conference next week in San Francisco. The device is designed to detect and track bleeding complications related to endovascular procedures. These medical procedures treat problems, such as aneurysms, that affect blood vessels.

"As the first and only early bleed detection system on the market, the Early Bird is ideally positioned to play a key role in making the rapidly expanding, minimally-invasive catheter-based procedures safer by providing physicians with bleed monitoring in real-time," says Saranas president and CEO, Zaffer Syed, in a news release. "With the launch of the Early Bird, physicians will now have a standard of care to monitor the bleed status of the patient during and post procedure, receive timely notifications of actual bleeds, and potentially reduce the severity of bleeding complications and resulting costs, while protecting clinical outcomes in patients undergoing endovascular procedures."

Around 20 percent of patience suffer a bleeding complication during endovascular procedures, like transcatheter aortic valve replacement, endovascular aneurysm repair, and percutaneous hemodynamic support, and, according to a report in the Journal of the American Medical Association, these complications result in higher mortality, longer hospital stays, and higher medical bills.

In other exciting news for the company, Saranas hired Tom Lucas as vice president of sales and marketing. He has 28 years of experience in medical sales, and he is tasked with business development, marketing, sales, and more for the company.

"Tom is a critical strategic hire for Saranas as we launch our first product in the U.S.," Syed says in the release. "His expertise will be invaluable as we expand distribution of the Early Bird into additional centers of excellence."

Saranas began its clinical trials last year after raising $2.8 million. The company revealed the results of those trials earlier this year, leading to the FDA approval.

"Our first-in-human study demonstrated that clinical concordance with Early Bird detection and CT scans (primary endpoint) was near perfect, and the early discovery of bleed onset and progression during the procedure occurred in 31 percent of cases with 69 percent occurring post procedure," says Saranas Chief Medical Officer Dr. Philippe Généreux in the release. "Compared to the current paradigm of waiting for symptoms, which could take hours to develop, the Early Bird allows physicians to detect bleeding in real-time and take the necessary actions quickly to protect the outcomes of the procedure and aid recovery for the patient."