First Patient Enrolled in Merit Medical’s Multicenter Observational Study to Evaluate the Use of EmboCube® Embolization Gelatin to Control Bleeding or Hemorrhage

Rhea-AI Summary

Merit Medical Systems (NASDAQ: MMSI) has successfully enrolled its first patient in a new observational study of EmboCube Embolization Gelatin, a product designed to control bleeding during trauma. This minimally-invasive embolization technique is crucial as uncontrolled bleeding is a leading cause of preventable death globally. The EmboCube, which offers uniformly pre-cut gelatin foam for efficient delivery, is currently approved in Europe and Canada but not yet in Australia. The study aims to enroll 100 patients across Australia and France.

Positive

• Successful enrollment of the first patient in the EmboCube study, indicating progress in clinical development.
• EmboCube presents a significant advancement in embolization techniques by providing pre-cut gelatin foam for quicker, safer delivery during emergency situations.

Negative

• EmboCube is not approved for commercial distribution in Australia, limiting potential market access in that region.

SOUTH JORDAN, Utah, Dec. 05, 2022 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, announced today the successful enrollment of the first patient in its prospective, observational study of EmboCube Embolization Gelatin used to control bleeding or hemorrhage.

Uncontrolled bleeding, particularly as a result of trauma, is a leading cause of preventable death.¹ Globally, roughly 40% of trauma-related deaths result from bleeding.² Embolization is a minimally-invasive alternative to surgery that can help stop bleeding. The procedure entails the injection of particles (embolic agents) into blood vessels to stop blood flow temporarily or permanently. The choice of embolic agent depends on a variety of factors such as the size of a patient’s blood vessel and location of bleeding or hemorrhage.

Gelatin-based embolic agents have been used for over 50 years.³ Since their first reported use in 1945,⁴ gelatin-based embolic agents have helped clinicians control bleeding in various organs throughout the body (e.g., intestine, spleen, liver, uterus, kidney). Historically, gelatin foam was manually cut by clinicians prior to embolization, a time-consuming and imprecise process that results in particles that are inconsistent in size which can clog the catheter during the procedure and result in embolization of non-target areas. EmboCube Embolization Gelatin is provided as uniformly pre-cut gelatin foam that is pre-loaded into syringes. This preparation allows for safer and faster delivery to control bleeding or hemorrhage.

“In patients with acute hemorrhage, endovascular control of blood loss is a vital adjunct to resuscitation and may be necessary to save a life. It is important that interventionalists have access to a full suite of embolic agents,” said Associate Professor Warren Clements, an interventional radiologist at The Alfred Hospital in Melbourne, Australia, and one of the study’s lead investigators. “EmboCube presents an exciting opportunity as the next iteration of gelatin sponge, arriving pre-prepared and pre-sized so that delivery is as quick and seamless as possible. When a patient is bleeding and unstable, every second counts.”

“Enrollment of the first patient in the EmboCube Embolization Gelatin study is a key step toward expanding our clinical portfolio of embolic agents that provide critical relief to diverse patient populations worldwide,” said Fred P. Lampropoulos, Merit Medical’s Chairman and CEO.

The EmboCube Embolization Gelatin study is designed to enroll 100 patients across multiple centers in Australia and France. Currently, EmboCube is not approved for commercial distribution in Australia. EmboCube has received the Conformité Européenne (CE) mark approval in Europe, 510(k) clearance in the United States, and is registered in Canada. Based on the CE-mark, EmboCube is currently marketed in countries in the European Union, Argentina, Columbia, New Zealand, South Korea, and Hong Kong. For additional information on Merit Medical’s EmboCube Embolization Gelatin study, including ongoing updates, please visit: https://clinicaltrials.gov/ct2/show/NCT05307783.

ABOUT MERIT MEDICAL 

Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 600 individuals. Merit employs approximately 6,800 people worldwide. 

TRADEMARKS 
Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc. and its subsidiaries in the United States and other jurisdictions. 

CONTACTS 
PR/Media Inquiries 
Sarah Comstock
Merit Medical 
+1-801-432-2864 | sarah.comstock@merit.com

Investor Inquiries 
Mike Piccinino, CFA, IRC 
Westwicke - ICR 
+1-443-213-0509 | mike.piccinino@westwicke.com

References 

1. Moore EE, Moore HB, Kornblith LZ, et al. Trauma-induced coagulopathy. Nat Rev Dis Primers. Apr 29 2021;7(1):30. doi:10.1038/s41572-021-00264-3
2. US Department of Homeland Security. S&T Helps ‘Stop the Bleed’—FAST. Updated 19 May 2022. Accessed 11 October 2022, https://www.dhs.gov/science-and-technology/news/2022/05/19/st-helps-stop-bleed-fast
3. Speakman TJ. Internal Occlusion of a Carotid-Cavernous Fistula. J Neurosurg. Apr 1964;21:303-5. doi:10.3171/jns.1964.21.4.0303
4. Jenkins HP, Janda R. Studies on the Use of Gelatin Sponge or Foam as an Hemostatic Agent in Experimental Liver Resections and Injuries to Large Veins. Ann Surg. Nov 1946;124(5):952-61.

 

FAQ

What is the purpose of the EmboCube Embolization Gelatin study?

The study aims to evaluate EmboCube's effectiveness in controlling bleeding during trauma by enrolling 100 patients across Australia and France.

Where is EmboCube currently approved for use?

EmboCube has received CE mark approval in Europe, 510(k) clearance in the United States, and is registered in Canada.

How does EmboCube differ from traditional gelatin-based embolic agents?

EmboCube offers uniformly pre-cut gelatin foam pre-loaded into syringes, which allows for safer and faster delivery compared to manually cut agents.

What are the implications of uncontrolled bleeding in trauma cases?

Uncontrolled bleeding is a leading cause of preventable death globally, with around 40% of trauma-related deaths attributed to it.

Who is leading the EmboCube study?

The study is being led by Associate Professor Warren Clements, an interventional radiologist at The Alfred Hospital in Melbourne, Australia.