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."

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Building Houston

 
 

The HX Venture Fund has grown its portfolio of venture capital firms with its latest investments. Getty Images

The HX Venture Fund, which invests in out-of-town venture capital funds that have their eyes on Houston startups, has grown its portfolio.

The fund of funds now has a portfolio of 10 VCs from across the country, across industries, and across startup stages. According to a recent announcement, the HX Venture Fund has invested in New York-based Greycroft Venture Partners and Washington D.C.-based Revolution Ventures. The announcement also included Boston-based Material Impact and San Francisco-based venBio Global Strategic Fund, however those had been previously reported by InnovationMap.

"We are delighted to partner with the general partners of Greycroft Venture Partners, Material Impact, Revolution Ventures, and venBio Global Strategic Fund," says Sandy Guitar, managing director of HX Venture Fund, in the release. "With their proven expertise and exceptional track records, we are excited to integrate them into Houston networks and not only give them access to the Fund's innovative corporate limited partners, but also harness their knowledge to empower Houston entrepreneurs."

These four VC funds join six others that HXVF has invested in: Austin-based LiveOak Venture Partners and Next Coast Ventures, Washington D.C.-based Updata Partners, Chicago-based Baird Capital, and Boston-based .406 Ventures and OpenView Venture Partners.

"The receptivity of the HX Venture Fund model has exceeded all our expectations. Since early 2019, over 217 venture capital funds across the U.S. have expressed definitive interest in participating in our model," says Guillermo Borda, managing director of HX Venture Fund, in the release.

"It is especially noteworthy that collectively, the ten funds selected for HX Venture Fund's portfolio have $3.7 billion in committed capital in their funds to be invested with Houston on their investment radar," Borda adds. "This is at a time that provides compelling investment opportunities in the economic cycle. This is an exciting time for Houston entrepreneurs and our innovation ecosystem."

Guitar previously told InnovationMap that she's looking to curate a portfolio of VCs that is diverse in industries and stage. Additionally, before investing in a VC, the HX Venture Fund looks for an interest in investing into Houston startups. The hope is that, while not required, the HXVF portfolio funds invest in a Houston startup down the road. Earlier this year, Houston-based Liongard became the fund of funds' first example of that.

"The innovation and talent in Houston are best-in-class; we want to be investing there," says Tige Savage, managing partner at Revolution Ventures, in the release.

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