Houston medical device company gains FDA approval

EarlyBird got the worm

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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Houston researchers make headway on affordable, sustainable sodium-ion battery

Energy Solutions

A new study by researchers from Rice University’s Department of Materials Science and NanoEngineering, Baylor University and the Indian Institute of Science Education and Research Thiruvananthapuram has introduced a solution that could help develop more affordable and sustainable sodium-ion batteries.

The findings were recently published in the journal Advanced Functional Materials.

The team worked with tiny cone- and disc-shaped carbon materials from oil and gas industry byproducts with a pure graphitic structure. The forms allow for more efficient energy storage with larger sodium and potassium ions, which is a challenge for anodes in battery research. Sodium and potassium are more widely available and cheaper than lithium.

“For years, we’ve known that sodium and potassium are attractive alternatives to lithium,” Pulickel Ajayan, the Benjamin M. and Mary Greenwood Anderson Professor of Engineering at Rice, said in a news release. “But the challenge has always been finding carbon-based anode materials that can store these larger ions efficiently.”

Lithium-ion batteries traditionally rely on graphite as an anode material. However, traditional graphite structures cannot efficiently store sodium or potassium energy, since the atoms are too big and interactions become too complex to slide in and out of graphite’s layers. The cone and disc structures “offer curvature and spacing that welcome sodium and potassium ions without the need for chemical doping (the process of intentionally adding small amounts of specific atoms or molecules to change its properties) or other artificial modifications,” according to the study.

“This is one of the first clear demonstrations of sodium-ion intercalation in pure graphitic materials with such stability,” Atin Pramanik, first author of the study and a postdoctoral associate in Ajayan’s lab, said in the release. “It challenges the belief that pure graphite can’t work with sodium.”

In lab tests, the carbon cones and discs stored about 230 milliamp-hours of charge per gram (mAh/g) by using sodium ions. They still held 151 mAh/g even after 2,000 fast charging cycles. They also worked with potassium-ion batteries.

“We believe this discovery opens up a new design space for battery anodes,” Ajayan added in the release. “Instead of changing the chemistry, we’re changing the shape, and that’s proving to be just as interesting.”

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This story originally appeared on EnergyCapitalHTX.com.

FAA demands investigation into SpaceX's out-of-control Starship flight

Out of this world

The Federal Aviation Administration is demanding an accident investigation into the out-of-control Starship flight by SpaceX on May 27.

Tuesday's test flight from Texas lasted longer than the previous two failed demos of the world's biggest and most powerful rocket, which ended in flames over the Atlantic. The latest spacecraft made it halfway around the world to the Indian Ocean, but not before going into a spin and breaking apart.

The FAA said Friday that no injuries or public damage were reported.

The first-stage booster — recycled from an earlier flight — also burst apart while descending over the Gulf of Mexico. But that was the result of deliberately extreme testing approved by the FAA in advance.

All wreckage from both sections of the 403-foot (123-meter) rocket came down within the designated hazard zones, according to the FAA.

The FAA will oversee SpaceX's investigation, which is required before another Starship can launch.

CEO Elon Musk said he wants to pick up the pace of Starship test flights, with the ultimate goal of launching them to Mars. NASA needs Starship as the means of landing astronauts on the moon in the next few years.

TMC med-tech company closes $2.5M series A, plans expansion

fresh funding

Insight Surgery, a United Kingdom-based startup that specializes in surgical technology, has raised $2.5 million in a series A round led by New York City-based life sciences investor Nodenza Venture Partners. The company launched its U.S. business in 2023 with the opening of a cleanroom manufacturing facility at Houston’s Texas Medical Center.

The startup says the investment comes on the heels of the U.S. Food and Drug Administration (FDA) granting clearance to the company’s surgical guides for orthopedic surgery. Insight says the fresh capital will support its U.S. expansion, including one new manufacturing facility at an East Coast hospital and another at a West Coast hospital.

Insight says the investment “will provide surgeons with rapid access to sophisticated tools that improve patient outcomes, reduce risk, and expedite recovery.”

Insight’s proprietary digital platform, EmbedMed, digitizes the surgical planning process and allows the rapid design and manufacturing of patient-specific guides for orthopedic surgery.

“Our mission is to make advanced surgical planning tools accessible and scalable across the U.S. healthcare system,” Insight CEO Henry Pinchbeck said in a news release. “This investment allows us to accelerate our plan to enable every orthopedic surgeon in the U.S. to have easy access to personalized surgical devices within surgically meaningful timelines.”

Ross Morton, managing Partner at Nodenza, says Insight’s “disruptive” technology may enable the company to become “the leader in the personalized surgery market.”

The startup recently entered a strategic partnership with Ricoh USA, a provider of information management and digital services for businesses. It also has forged partnerships with the Hospital for Special Surgery in New York City, University of Chicago Medicine, University of Florida Health and UAB Medicine in Birmingham, Alabama.

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