First Patient Enrolled in the Streamlined Localization (STREAMLoc) Registry Study Using SCOUT® at Biopsy in Canada

Rhea-AI Summary

Merit Medical Systems (NASDAQ: MMSI) has initiated a prospective observational study in Canada to assess the effectiveness of the SCOUT® Radar Localization System in breast-conserving surgeries. The first patient has been enrolled in the study, which aims to include 500 patients and evaluate outcomes from the SCOUT procedure to surgery. The study is crucial for improving patient care, especially during the ongoing COVID-19 pandemic, and will examine safety, efficacy, and satisfaction levels among patients and clinicians.

Positive

• Enrollment of the first patient in the STREAMLoc registry study.
• Potential to demonstrate benefits and improve efficiency in breast cancer surgeries.
• Engagement in a study involving 500 patients could enhance SCOUT's data portfolio.

Negative

• None.

Prospective, observational study to assess the clinical utility of the SCOUT® Radar Localization System (SCOUT) in real-world practice

SOUTH JORDAN, Utah, July 13, 2022 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, announced today the enrollment of the first patient in its Canadian prospective, post-market, observational study to further demonstrate the benefits of SCOUT, a wireless, radar-guided localization system used to assist breast surgeons in identifying biopsied tumors for removal during breast-conserving surgery.

Globally, over two million women were diagnosed with breast cancer in 2020.¹ Radar localization procedures may help physicians surgically remove abnormal tissue while minimizing trauma to surrounding healthy tissue. By implanting a tiny reflector, the size of a grain of rice, physicians may be able to precisely target affected tissue. “I am looking forward to treating patients and the positive outcomes of using the only radar technology on the market," said Isabelle Trop, MD, a radiologist in the Department of Radiology, Radiation Oncology, and Nuclear Medicine at the University of Montreal, and investigator of the STREAMLoc registry study.

The STREAMLoc registry study will add to the body of research supporting the use of the SCOUT system to improve efficiency in patient care between biopsy and surgery. This is of high importance, particularly during the ongoing COVID-19 pandemic which has imposed substantial logistical challenges to healthcare delivery in Canada. “It is an easy one-step procedure before surgery and a less painful and time-consuming technique on the day of surgery,” said Christine Desbiens, MD, a surgical oncologist at the CHU de Québec-Laval University and fellow investigator of the STREAMLoc registry study.

STREAMLoc will enroll 500 patients with high-risk breast lesions categorized as Breast Imaging Reporting and Data System (BI-RADS) 4C or 5. Study outcomes will be assessed from the initial placement of the SCOUT reflector during biopsy to its removal. Subsequent pathology reports will include the impact on the number of patient visits for invasive procedures between biopsy and surgery and additional post-market data on safety and efficacy of the system. Patient and clinician satisfaction with the device will also be evaluated.

“The successful enrollment of the first patient in the STREAMLoc registry study will add to our robust portfolio of evidence regarding the benefits of the SCOUT system,” said Fred Lampropoulos, Merit Medical’s Chairman and CEO. “We anticipate that the safety and efficacy data collected, as well as data on patient and provider satisfaction, will help us continue to improve the clinical management of breast cancer.”

For additional information on the STREAMLoc registry study, including ongoing updates, please visit: https://clinicaltrials.gov/ct2/show/NCT04815291

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 6,500 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Rockland, Massachusetts; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore. 

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 

Reference
¹World Health Organization. 2021. Breast cancer. https://www.who.int/news-room/fact-sheets/detail/breast-cancer

FAQ

What is the SCOUT Radar Localization System used for?

The SCOUT Radar Localization System helps breast surgeons identify biopsied tumors for removal during breast-conserving surgery.

How many patients will be enrolled in the STREAMLoc registry study?

The STREAMLoc registry study will enroll 500 patients with high-risk breast lesions.

What outcomes will be assessed in the SCOUT study?

The study will assess patient visits for procedures, safety, efficacy, and satisfaction with the SCOUT system.

When was the first patient enrolled in the SCOUT study?

The first patient was enrolled on July 13, 2022.

What is the significance of the STREAMLoc registry study?

It aims to provide evidence on the benefits of SCOUT and improve patient care, especially in the context of COVID-19.