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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With this new grant, UH has a new center for researching bioactive materials crystallization. Photo via UH.edu

A new hub at the University of Houston is being established with a crystal-clear mission — and fresh funding.

Thanks to funding from Houston-based organization The Welch Foundation, the University of Houston will be home to the Welch Center for Advanced Bioactive Materials Crystallization. The nonprofit doled out its inaugural $5 million Catalyst for Discovery Program Grant to the new initiative led by Jeffrey Rimer, Abraham E. Dukler Professor of Chemical Engineering, who is known internationally for his work with crystals that help treat malaria and kidney stones.

“Knowledge gaps in the nascent and rapidly developing field of nonclassical crystallization present a wide range of obstacles to design crystalline materials for applications that benefit humankind, spanning from medicine to energy and the environment,” says Rimer in a news release. “Success calls for a paradigm shift in the understanding of crystal nucleation mechanisms and structure selection that will be addressed in this center.”

The Welch Foundation, which was founded in 1954, has granted over $1.1 billion to scientists in Texas. This new grant program targets researchers focused on fundamental chemical solutions. Earlier this year, the organization announced nearly $28 million in grants to Texas institutions.

"Support from the Welch Foundation has led to important advances in the field of chemistry, not only within Texas, but also throughout the United States and the world as a whole,” says Randall Lee, Cullen Distinguished University Chair and professor of chemistry, in the release. “These advances extend beyond scientific discoveries and into the realm of education, where support from the Welch Foundation has played a significant role in building the technological workforce needed to solve ongoing and emerging problems in energy and health care.”

Rimer and Lee are joined by the following researchers on the newly announced center's team:

  • Peter Vekilov, Moores Professor, chemical and biomolecular engineering
  • Alamgir Karim, Dow Chair and Welch Foundation Professor, chemical and biomolecular engineering;
  • Jeremy Palmer, Ernest J. and Barbara M. Henley Associate Professor, chemical and biomolecular engineering
  • Gül Zerze, chemical and biomolecular engineering
  • Francisco Robles Hernandez, professor of engineering technology.

The University of Houston also received another grant from the Welch Foundation. Megan Robertson, UH professor of chemical engineering, received $4 million$4 million for her work with developing chemical processes to transform plastic waste into useful materials.

“For the University of Houston to be recognized with two highly-competitive Welch Foundation Catalyst Grants underscores the exceptional talent and dedication of our researchers and their commitment to making meaningful contributions to society through discovery,” Diane Chase, UH senior vice president for academic affairs and provost, says in the release.

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