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 fundingfrom 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

 
 

Based on business activity in town, a new study ranks Houston as a top city for Asian Americans. Photo via Getty Images

Known for its diversity, Houston ranks as the third best major metro area in the U.S. for Asian American entrepreneurs, according to a new study.

Personal finance website SmartAsset analyzed data for 52 of the largest metro areas to come up with the ranking. The analysis looked at nine metrics in three categories: prevalence of Asian-owned businesses, success of new businesses, and income and job security.

About 9 percent of the Houston metro area’s residents identify as Asian.

The SmartAsset study puts Houston in fifth place for the number of Asian-owned businesses (nearly 19,900) and in fourth place for the share of Asian-owned businesses (almost 17.9 percent) among all businesses. Furthermore, Houston ranks 14th for the increase (nearly 9.6 percent) in the number of Asian-owned businesses from 2017 to 2019.

Leading the SmartAsset list is the San Francisco metro area, followed by Dallas-Fort Worth. Austin comes in at No. 11 and San Antonio at No. 14.

The largest minority-owned business in the Houston area, as ranked by annual revenue, is Asian-owned private equity firm ZT Corporate.

Founded in 1997 by Chairman and CEO Taseer Bada, who was born in Pakistan, ZT Corporate is valued at more than $1 billion. ZT Corporate generates more than $600 million in annual revenue and employs over 3,000 people.

“As we look ahead, the vision for ZT Corporate is limitless. Our team will continue pushing boundaries and finding the bright spots in the economy that produce consistent financial gains for our investors,” Bada says in a news release marking his company’s 25th anniversary.

ZT Corporate’s flagship businesses are:

  • Altus Community Healthcare, a provider of health care services.
  • ZT Financial Services, a wealth management firm.
  • ZT Motors, which owns and operates auto dealerships. Last year, ZT Motors bought three Ron Carter dealerships in the Houston area.

“ZT Corporate is a vital asset to our citizens as a longtime local employer,” Houston Mayor Sylvester Turner says, “and has positively affected many lives through their health care organizations and philanthropic efforts.”

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