health care tech

Houston med device company secures first patient for clinical trial

Saranas has enrolled its first patient in its clinical trials. Photo courtesy of Saranas

The first patient has been enrolled in a nationwide clinical trial that will evaluate the safety of Houston-based Saranas’ device for early detection of bleeding during minimally invasive heart procedures.

The initial patient was enrolled earlier this month at Morristown Medical Center in Morristown, New Jersey. The trial will eventually enroll up to 265 patients across the U.S.

Saranas’ Early Bird Bleed Monitoring System aids the detection of bleeding during high-risk percutaneous coronary intervention (PCI) procedures using mechanical circulatory support (MCS). In the clinical trial, the MCS will be the Impella heart pump.

PCI refers to minimally invasive procedures for opening clogged coronary arteries. MCS boosts heart function when the organ can’t perform at its best. The trial will test the ability of the Early Bird Bleed Monitoring System to detect serious or potentially fatal bleeding.

“As the field of minimally invasive, catheter-based procedures continues to advance, patient safety is paramount,” Dr. Babar Basir, director of acute mechanical circulatory support at Detroit’s Henry Ford Health System and co-principal investigator of SAFE-MCS, says in a news release. “This study will collect comprehensive procedural data in patients undergoing PCI with MCS.”

The data then will be reviewed to determine how real-time monitoring of bleeding can improve a patient’s health, Basir says.

Dr. Philippe Généreux, co-director of the Structural Heart Program at Morristown Medical Center, is the other co-principal investigator for the clinical trial.

“SAFE-MCS is the first prospective trial focused exclusively on the impact of integrating bleed monitoring in large-bore access for high-risk protected PCI patients,” says James Reinstein, president and CEO of Saranas, a medical device startup.

About one-fifth of patients will experience bleeding complications during “large bore” blood vessel procedures such as percutaneous MCS, transcatheter aortic valve replacement, and endovascular aneurysm repair. The estimated cost of one bleeding complication during these large-bore procedures is $18,000, adding up to an annual cost of $729 million for health care providers.

The Early Bird Bleed Monitoring System is the first and only device approved by the U.S. Food and Drug Administration (FDA) for real-time monitoring of bleeding problems during endovascular procedures for repair of blood vessels.

Saranas’ collaborators in the clinical trial are Proxima Clinical Research, a Houston-based contract research organization, and South Korea’s CardioVascular Research Foundation. The Early Bird study is expected to be completed by January 2023.

Since being founded in 2013, Saranas has collected $31.5 million in funding. This includes a $12.8 million Series B round that Saranas received this summer from Chicago-based Baird Capital and Austin-based S3 Ventures.

The Early Bird device was developed at Houston’s Texas Heart Institute. The FDA approved the device in 2019.

Trending News

Building Houston

 
 

Catch up on two big pieces of news landing at the Houston Spaceport. Image via fly2houston.com

The Space City is starting 2022 off strong with news launching out of the Houston Spaceport — a TK-acre space in TK Houston.

The two big headlines include a unicorn company releasing the latest details of its earthbound project and fresh funds from the state to support the space ecosystem in Texas.

Governor Abbott doles out $10M in spaceport grants

Texas has launched fresh funding into two spaceport projects. Image via fly2houston.com

Last week, Gov. Greg Abbott announced $10 million in funding to two Texas spaceports as a part of the state's Spaceport Trust Fund. The Houston Spaceport Development Corp. received $5 million and the Cameron County Spaceport Development Corp. received $5 million.

The fund is administered by the Governor's Office of Economic Development and Tourism and was created to support the development of spaceport infrastructure, create quality jobs, and attract continuing investments that will strengthen the economic future of the state, according to a news release.

"For decades, Texas has been a trailblazer in space technology and we are proud to help cultivate more innovation and development in this growing industry in Cameron and Harris County," says Abbott in the release. "This investment in the Cameron County and Houston Spaceport Development Corporations will create even more economic opportunities for Texans across the state and continue our legacy as a leader in space technology."

Axiom Space hires Dallas-based architecture and engineering firm

Axiom Space has made progress on developing its 14-acre headquarters. Image via axiomspace.com

Houston-based unicorn Axiom Space has announced that it awarded Dallas-based Jacobs the architecture and engineering phase one design contract. The firm will be working on the 100,000-square-foot facility planned for the 400-acre Houston Spaceport at Ellington Airport.

Axiom Space's plans are ro build the first commercial space station that will provide a central hub for research, to support microgravity experiments, manufacturing, and commerce in low Earth orbit missions, according to a news release.

"This is an exciting and historic moment for Axiom and the greater Houston area," says Axiom CTO Matt Ondler in the release. "For the first time, spacecraft will be built and outfitted right here in Houston, Texas. This facility will provide us with the infrastructure necessary to scale up operations and bring more aerospace jobs to the area. With this new facility, we are not only building next generation spacecraft, but also solidifying Houston as the U.S. commercial industry's gateway to space."

Axiom Space, which raised $130M in venture capital last year, is building out its 14-acre headquarters to accommodate the creation of more than 1,000 high-paying jobs, from engineers to scientists, mathematicians, and machinists.

"Houston is a city built on innovation and is becoming a next-generation tech hub in the United States," says Ron Williams, senior vice president at Jacobs. "Privately funded infrastructure will drive U.S. leadership in space. Jacobs is committed to providing integrated solutions to accelerate the future of commercial space operations."

Trending News