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 cell therapy company launches second-phase clinical trial

fighting cancer

A Houston cell therapy company has dosed its first patient in a Phase 2 clinical trial. March Biosciences is testing the efficacy of MB-105, a CD5-targeted CAR-T cell therapy for patients with relapsed or refractory CD5-positive T-cell lymphoma.

Last year, InnovationMap reported that March Biosciences had closed its series A with a $28.4 million raise. Now, the company, co-founded by Sarah Hein, Max Mamonkin and Malcolm Brenner, is ready to enroll a total of 46 patients in its study of people with difficult-to-treat cancer.

The trial will be conducted at cancer centers around the United States, but the first dose took place locally, at The University of Texas MD Anderson Cancer Center. Dr. Swaminathan P. Iyer, a professor in the department of lymphoma/myeloma at MD Anderson, is leading the trial.

“This represents a significant milestone in advancing MB-105 as a potential treatment option for patients with T-cell lymphoma who currently face extremely limited therapeutic choices,” Hein, who serves as CEO, says. “CAR-T therapies have revolutionized the treatment of B-cell lymphomas and leukemias but have not successfully addressed the rarer T-cell lymphomas and leukemias. We are optimistic that this larger trial will further validate MB-105's potential to address the critical unmet needs of these patients and look forward to reporting our first clinical readouts.”

The Phase 1 trial showed promise for MB-105 in terms of both safety and efficacy. That means that potentially concerning side effects, including neurological events and cytokine release above grade 3, were not observed. Those results were published last year, noting lasting remissions.

In January 2025, MB-105 won an orphan drug designation from the FDA. That results in seven years of market exclusivity if the drug is approved, as well as development incentives along the way.

The trial is enrolling its single-arm, two-stage study on ClinicalTrials.gov. For patients with stubborn blood cancers, the drug is providing new hope.

Elon Musk's SpaceX site officially becomes the city of Starbase, Texas

Starbase, Texas

The South Texas home of Elon Musk’s SpaceX rocket company is now an official city with a galactic name: Starbase.

A vote Saturday, May 3, to formally organize Starbase as a city was approved by a lopsided margin among the small group of voters who live there and are mostly Musk’s employees at SpaceX. With all the votes in, the tally was 212 in favor to 6 against, according to results published online by the Cameron County Elections Department.

Musk celebrated in a post on his social platform, X, saying it is “now a real city!”

Starbase is the facility and launch site for the SpaceX rocket program that is under contract with the Department of Defense and NASA that hopes to send astronauts back to the moon and someday to Mars.

Musk first floated the idea of Starbase in 2021 and approval of the new city was all but certain. Of the 283 eligible voters in the area, most are believed to be Starbase workers.

The election victory was personal for Musk. The billionaire’s popularity has diminished since he became the chain-saw-wielding public face of President Donald Trump’s federal job and spending cuts, and profits at his Tesla car company have plummeted.

SpaceX has generally drawn widespread support from local officials for its jobs and investment in the area.

But the creation of an official company town has also drawn critics who worry it will expand Musk’s personal control over the area, with potential authority to close a popular beach and state park for launches.

Companion efforts to the city vote include bills in the state Legislature to shift that authority from the county to the new town’s mayor and city council.

All these measures come as SpaceX is asking federal authorities for permission to increase the number of South Texas launches from five to 25 a year.

The city at the southern tip of Texas near the Mexico border is only about 1.5 square miles (3.9 square kilometers), crisscrossed by a few roads and dappled with airstream trailers and modest midcentury homes.

SpaceX officials have said little about exactly why they want a company town and did not respond to emailed requests for comment.

“We need the ability to grow Starbase as a community,” Starbase General Manager Kathryn Lueders wrote to local officials in 2024 with the request to get the city issue on the ballot.

The letter said the company already manages roads and utilities, as well as “the provisions of schooling and medical care” for those living on the property.

SpaceX officials have told lawmakers that granting the city authority to close the beach would streamline launch operations. SpaceX rocket launches and engine tests, and even just moving certain equipment around the launch base, requires the closure of a local highway and access to Boca Chica State Park and Boca Chica Beach.

Critics say beach closure authority should stay with the county government, which represents a broader population that uses the beach and park. Cameron County Judge Eddie Trevino, Jr. has said the county has worked well with SpaceX and there is no need for change.

Another proposed bill would make it a Class B misdemeanor with up to 180 days in jail if someone doesn’t comply with an order to evacuate the beach.

The South Texas Environmental Justice Network, which has organized protests against the city vote and the beach access issue, held another demonstration Saturday that attracted dozens of people.

Josette Hinojosa, whose young daughter was building a sandcastle nearby, said she was taking part to try to ensure continued access to a beach her family has enjoyed for generations.

With SpaceX, Hinojosa said, “Some days it’s closed, and some days you get turned away."

Organizer Christopher Basaldú, a member of the Carrizo/Comecrudo Nation of Texas tribe, said his ancestors have long been in the area, where the Rio Grande meets the Gulf.

“It’s not just important,” he said, “it’s sacred.”

Texas-based 'DoorDash for laundry' startup tumbles into Houston market

No Scrubs

Laundry may seem like an endless task that piles up, but a new service offers a solution to overwhelmed Houston families.

NoScrubs, an Austin-based home laundry pickup service has just expanded to Houston. Described by the company as "DoorDash — but for laundry," they wash customer's clothes at local laundromats and return them the same day, folded and ready to be put away.

The service took off like gangbusters in Austin, making an expansion to the state's largest city an obvious choice. It's not universal coverage just yet.

For now, only the following ZIP codes have NoScrubs service available: 77002, 77004, 77005, 77006, 77007, 77008, 77009, 77010, 77018, 77019, 77024, 77025, 77027, 77046, 77056, 77057, 77081, 77098, 77401, 77030, 77003.

A single pickup starts at $40 for 20 pounds of laundry, while the basic monthly subscription is $60 for two pickups. All services use hypoallergenic detergents.

The average American family spends about 240 hours a year on laundry, making it a very time-consuming chore. For people with disabilities, difficult work schedules, and other circumstances, it can be a real help, says co-founder Matt O'Connor.

"Some of our favorite customer stories simply revolve around saving people time when they have something challenging going on," he writes in an email. "For example, one customer reviewed NoScrubs saying 'So happy I could cry! (Partially because I'm pregnant and my emotions are heightened!)...1000% recommend if you have time restrictions or physical restrictions! ' So, whether it’s saving time, the affordability, or the pleasantly surprising turnaround time, NoScrubs has a variety of benefits for any customer."

NoScrubs is also a new opportunity for Houston's gig workers. Because there are no passengers, it can be a safer alternative to driving ride share for women and other people apprehensive about having strangers in their cars. As NoScrubs partners with local laundromats, drivers are also going to centralized locations rather than all over the map, leading to less wear and tear on their cars. The laundromats benefit as well, since NoScrubs loads are ones that would otherwise be done at home.

"Our model makes driving a tiny fraction of the time, so folks who don’t want to wear down their vehicles and spend a ton on gas love working at NoScrubs," added O'Connor.

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