Early bird gets the worm

Houston medical device company launches is product in the U.S. and hires new exec

Houston-based Saranas' technology is now being premiered in the United States. Courtesy of Saranas

A Houston company is changing the game when it comes to early bleed detection, and now the company can provide its life-saving service to the United States.

Saranas Inc., which received FDA approval for its Early Bird Bleed Monitoring System in March, announced that it is launching its device in the US. at the Transcatheter Cardiovascular Therapeutics Conference next week in San Francisco. The device is designed to detect and track bleeding complications related to endovascular procedures. These medical procedures treat problems, such as aneurysms, that affect blood vessels.

"As the first and only early bleed detection system on the market, the Early Bird is ideally positioned to play a key role in making the rapidly expanding, minimally-invasive catheter-based procedures safer by providing physicians with bleed monitoring in real-time," says Saranas president and CEO, Zaffer Syed, in a news release. "With the launch of the Early Bird, physicians will now have a standard of care to monitor the bleed status of the patient during and post procedure, receive timely notifications of actual bleeds, and potentially reduce the severity of bleeding complications and resulting costs, while protecting clinical outcomes in patients undergoing endovascular procedures."

Around 20 percent of patience suffer a bleeding complication during endovascular procedures, like transcatheter aortic valve replacement, endovascular aneurysm repair, and percutaneous hemodynamic support, and, according to a report in the Journal of the American Medical Association, these complications result in higher mortality, longer hospital stays, and higher medical bills.

In other exciting news for the company, Saranas hired Tom Lucas as vice president of sales and marketing. He has 28 years of experience in medical sales, and he is tasked with business development, marketing, sales, and more for the company.

"Tom is a critical strategic hire for Saranas as we launch our first product in the U.S.," Syed says in the release. "His expertise will be invaluable as we expand distribution of the Early Bird into additional centers of excellence."

Saranas began its clinical trials last year after raising $2.8 million. The company revealed the results of those trials earlier this year, leading to the FDA approval.

"Our first-in-human study demonstrated that clinical concordance with Early Bird detection and CT scans (primary endpoint) was near perfect, and the early discovery of bleed onset and progression during the procedure occurred in 31 percent of cases with 69 percent occurring post procedure," says Saranas Chief Medical Officer Dr. Philippe Généreux in the release. "Compared to the current paradigm of waiting for symptoms, which could take hours to develop, the Early Bird allows physicians to detect bleeding in real-time and take the necessary actions quickly to protect the outcomes of the procedure and aid recovery for the patient."

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Building Houston

 
 

Five research teams are studying space radiation's effect on human tissue. Photo via NASA/Josh Valcarcel

A Houston-based organization has named five research projects to advance the understanding of space radiation using human tissue. Two of the five projects are based in Houston.

The Translational Research Institute for Space Health, or TRISH, is based at Baylor College of Medicine and funds health research and tech for astronauts during space missions. The astronauts who are headed to the moon or further will be exposed to high Galactic Cosmic Radiation levels, and TRISH wants to learn more about the effects of GCR.

"With this solicitation, TRISH was looking for novel human-based approaches to understand better Galactic Cosmic Rays (GCR) hazards, in addition to safe and effective countermeasures," says Kristin Fabre, TRISH's chief scientist, in a news release. "More than that, we sought interdisciplinary teams of scientists to carry these ideas forward. These five projects embody TRISH's approach to cutting-edge science."

The five projects are:

  • Michael Weil, PhD, of Colorado State University, Colorado — Effects of chronic high LET radiation on the human heart
  • Gordana Vunjak-Novakovic, PhD of Columbia University, New York — Human multi-tissue platform to study effects of space radiation and countermeasures
  • Sharon Gerecht, PhD of Johns Hopkins University, Maryland — Using human stem-cell derived vascular, neural and cardiac 3D tissues to determine countermeasures for radiation
  • Sarah Blutt, PhD of Baylor College of Medicine, Texas — Use of Microbial Based Countermeasures to Mitigate Radiation Induced Intestinal Damage
  • Mirjana Maletic-Savatic, PhD of Baylor College of Medicine, Texas — Counteracting space radiation by targeting neurogenesis in a human brain organoid model

The researchers are tasked with simulating radiation exposure to human tissues in order to study new ways to protect astronauts from the radiation once in deep space. According to the release, the tissue and organ models will be derived from blood donated by the astronaut in order to provide him or her with customized protection that will reduce the risk to their health.

TRISH is funded by a partnership between NASA and Baylor College of Medicine, which also includes consortium partners Caltech and MIT. The organization is also a partner to NASA's Human Research Program.

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