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.

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Building Houston

 
 

Shortages in health care staffing are growing. Here's what this Houston expert has to say about the state of the labor market within the industry. Photo via Getty Images

Long before COVID-19 became a part of our new normal, the concerns around shortages in health care staffing were present.

To put this in real terms, according to the Bureau of Labor Statistics, the latest projection of employment through the end of this decade is an increase of nearly 12 million jobs. A fourth of those — 3.3 million to be exact — are expected to go towards health care and social assistance roles.

Before the pandemic, the concerns centered around managing a growing retired population and a slowing in higher education nurse enrollment. Then amid the growing shortage concerns surrounding the support for aging baby boomers, we were all thrusted into a pandemic.

The stressors on health care professional staffing have doubled down and what the increased shortage has shown us is the need to intervene and change the traditional hiring practices. Speed to place a nurse on assignment doesn’t just ensure productivity — it is a matter of life or death.

Over the past several years, the evolution of technology has drastically changed how health care facilities operate and interact with their employees as well as patients. There was a point in time where the structure in health care staffing was rigid without flexibility or varieties of employment type. Conversations around travel positions, per diem, and permanent are all now commonplace as the recent shortages caused us to normalize the discussion around role type and use of technology to influence speed to hire.

This whole evolution was put to test when April 2020 came, and the initial brunt of the pandemic was in full swing. The entire world was in panic mode. During these quarantine times, we were in a state of a health care emergency with thousands of patients seeking health care. Unfortunately, hospitals could not keep up with this demand with their existing nurse professionals, and became severely overloaded and dangerous. Due to this the United States saw unprecedented labor shortages, impacting a large number of nurses and health care workers as it pertains to both their physical and mental health.

What we are seeing now is a period classified as the “The Great Rethinking,” where nurses and health care workers alike are speaking up for what they believe in and deserve. Salary transparency and flexibility are just the tip of the iceberg for this movement.

SkillGigs is unique in that we are giving the power back to registered nurses and health care professionals, while meeting the demand created by the pandemic. Our team has been fortunate to be a catalyst to direct the change in the future of work, and we look forward to continuing to innovate.

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Bryan Groom is the division president of health care at Houston-based SkillGigs.

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