By Meg Flippin Benzinga
DETROIT, MICHIGAN - May 13, 2025 (NEWMEDIAWIRE) - When it comes to approving medical devices, the U.S. Food and Drug Administration can be notoriously slow. To speed up the process, about ten years ago, the FDA launched its Breakthrough Device Designation (BDD) program. It’s designed to encourage speedier development of certain medical devices when there is a reasonable chance of providing a better treatment or diagnosis than the current standard of care. The BDD status is reserved for those diseases that are life-threatening or can cause irreversibly debilitating effects on patients.
To be granted this status, the medical device has to meet certain criteria, including representing breakthrough technology, having no approved or cleared alternatives already on the market, offering significant advantages over the current standard of care and being in the best interest of patients. These factors highlight the importance of BDD in improving and saving lives.
With BDD, medical device manufacturers have greater access and more interaction with the FDA, priority review of submissions and the potential for quicker clinical trial designs. As it stands, medical devices only need one pivotal trial for approval unlike drugs, which require a minimum of two trials. Being granted BDD has the potential to supercharge that approval time frame.
SeaStar Wins Six Breakthrough Device Designations
The number of medical devices granted this coveted status is few and far between. As of last September, only about 1,041 medical devices had received Breakthrough Device Designation. In fact, the Center for Biologics Evaluation and Research (CBER) - the division of the FDA that will review SeaStar Medical’s Post Marketing Approval (PMA) application that is focused on regulating and evaluating biological products - has only granted 12 medical device BDDs between 2015 and September 2024.
As a result, achieving BDD can be considered truly groundbreaking - giving innovators like SeaStar Medical (NASDAQ: ICU) bragging rights and highlighting the impact their innovation could potentially have.
The commercial stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life has received not one but six BDDs from the CBER between April 2022 and March 2025 for the treatment of adult acute kidney injury, systemic inflammatory response in adult cardiac surgery, systemic inflammatory response in pediatric cardiac surgery to prevent postoperative adverse complications and outcomes, adult cardiorenal syndrome awaiting LVAD implantation, end-stage renal disease (ESRD) requiring chronic dialysis and adult hepatorenal syndrome (HRS). All told, the company says it has the potential to treat nearly a million patients afflicted with conditions with limited effective treatments today.
SCD Therapy For The Win
How? When patients face trauma – from serious injury, surgery or infection – the immune system can overreact. Instead of helping the recovery, immune cells can become the cause of destruction to tissues and organs, which, in many cases, results in loss of life. SeaStar’s Selective Cytopheretic Device (SCD) therapy targets and neutralizes these destructive hyperinflammatory cells, particularly neutrophils and monocytes, to help restore immune balance and improve outcomes for critically ill patients.
SeaStar first received BDD in April 2022 to treat adult acute kidney injury (AKI). Shortly after, in September 2023, SCD received BDD for use in ICU patients with acute or chronic systolic heart failure and worsening renal function due to cardiorenal syndrome or right ventricular dysfunction awaiting implantation of a left ventricular assist device (LVAD). The following month, SeaStar received BDD for SCD for use in ICU patients with AKI and acute chronic liver failure. In November 2024, SeaStar received another SCD BDD to treat chronic systemic inflammation in end-stage renal disease (ESRD) patients who require chronic hemodialysis.
More recently, in early April, SeaStar received two more BDDs for SCD to treat systemic inflammatory response in adult patients undergoing cardiac surgery and in pediatric patients undergoing cardiac surgery toward the prevention of post-operative adverse complications and outcomes. SeaStar says about 15% of the 300,000 adults who have cardiac surgery annually are considered high risk and could benefit from SCD therapy to prevent post-surgical complications. Furthermore, the company believes that of the 40,000 pediatric patients who undergo congenital heart surgery each year, one-third might benefit from SCD therapy.
“These two new Breakthrough Device Designations bring our total to six, underscoring the importance and critical need for a therapy that can effectively treat hyperinflammation that destroys organs and takes far too many lives each year,” said Eric Schlorff, SeaStar Medical CEO. “These new indications add to our growing pipeline of product candidates and extend further our total market opportunity.”
Already Bringing Treatments To Market
Getting Breakthrough Device Designation is an important achievement for the company as it speeds up the process of getting medical devices approved, but receiving marketing authority is the end goal. SeaStar has been able to achieve that, too, with the QUELIMMUNE SCD therapy. QUELIMMUNE was approved by the FDA under a humanitarian device exemption to treat pediatric patients with AKI due to sepsis or a septic condition. And with good reason: SeaStar reports that these young kids face a 50% mortality rate that hasn’t changed in decades. The company believes there’s now hope for better survival and possibly fewer patients who require lifelong dialysis. The device itself is intended to be easy to use – it connects in-line to the patient’s existing continuous kidney replacement therapy (CKRT) circuit in the ICU setting.
SeaStar launched QUELIMMUNE in the second half of 2024 and a number of specialty pediatric sites have already adopted the therapy. What makes QUELIMMUNE so promising, reports SeaStar, is that customers are already reporting life-saving results where patients who previously had little hope for survival have returned to a normal life.
The company is now engaged in a trial evaluating the safety and efficacy of its second proprietary SCD therapy in 200 adults with AKI in the ICU receiving CRRT. The historical survival rate here is also about 50%, reports SeaStar. The company hopes for the approval and launch of the treatment sometime in 2026, thanks to its Breakthrough Device Designation. SeaStar has indicated that this market is 50 times larger than the important, but smaller, pediatric AKI market.
“With our first commercial product, QUELIMMUNE, in the initial launch phase and the potential PMA filing in 2026 that would follow a successful NEUTRALIZE‑AKI trial, we believe we are executing on our strategic commercial plans to effectively address severely underserved markets with our first-in-class SCD therapy,” said Schlorff.
Featured image by National Institute of Allergy and Infectious Diseases on Unsplash.
This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice.
This content was originally published on Benzinga. Read further disclosures here.
View the original release on www.newmediawire.com