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Merit Medical Receives FDA 510(k) Clearance for SCOUT® MD™ Surgical Guidance System

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Rhea-AI Summary
Merit Medical Systems, Inc. (MMSI) receives FDA clearance for SCOUT MD Surgical Guidance System, a breakthrough in breast cancer care. The system targets tumor location in multiple dimensions for precise excision, reducing the need for repeat surgeries and improving patient outcomes.
Positive
  • Merit Medical Systems, Inc. receives FDA 501(k) clearance for SCOUT MD Surgical Guidance System.
  • SCOUT MD marks a significant advancement in breast cancer care by pinpointing tumor location for precise excision.
  • The system supports implantation of up to four different reflector configurations, enhancing surgical precision.
  • SCOUT MD aims to reduce damage to healthy tissue, decrease re-excision rates, and minimize emotional and physical trauma.
  • Localization procedures with SCOUT MD may lead to more successful surgeries and improved patient outcomes.
  • Merit has distributed over 500,000 devices, gathering real-world evidence to enhance oncology care.
  • Fred P. Lampropoulos, Merit's Chairman and CEO, emphasizes the company's commitment to innovation for breast cancer patients.
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  • None.

Merit Medical Systems' FDA clearance for the SCOUT® MD™ Surgical Guidance System represents a noteworthy stride in the realm of oncology, particularly in breast cancer treatment. The system's ability to facilitate precise tumor excision by using multiple reflectors to locate tumors in various dimensions could potentially reduce the rate of re-excision surgeries. This is significant considering the high prevalence of breast cancer and the emotional and physical toll of repeat surgeries on patients.

From a research perspective, the SCOUT MD system could lead to improved surgical outcomes and patient satisfaction. Moreover, the real-world evidence gathered from the widespread use of Merit's devices could be invaluable for ongoing oncological research, potentially leading to further innovations in cancer care technologies.

The announcement by Merit Medical Systems is likely to have a positive impact on its market position within the healthcare technology sector. The SCOUT MD system expands Merit's oncology portfolio, which may enhance its competitive edge and could be reflected in investor confidence and stock performance. The technology's potential to decrease the need for repeat surgeries aligns with the broader industry trend towards cost-effective and patient-centered care.

Long-term, the success of SCOUT MD could influence healthcare providers' procurement decisions, insurance coverage policies and could even become a standard of care in breast cancer surgeries, thereby affecting the company's revenue streams and market share.

The FDA clearance is a critical regulatory milestone that can have immediate financial implications for Merit Medical Systems. The clearance not only allows the commercialization of SCOUT MD in a significant market but also serves as a catalyst for potential growth in sales. The company's history of distributing over 500,000 devices suggests a strong distribution network and customer base, which could be leveraged for the new system's rollout.

Investors should monitor the adoption rate of the SCOUT MD system and its impact on Merit's financials in subsequent quarters. The system's ability to meet the clinical and economic needs of healthcare providers will be crucial in determining its success and, by extension, its influence on the company's profitability and stock valuation.

New guidance system marks significant advancement in breast cancer care, targeting tumor location in multiple dimensions for precise excision and successful surgeries

SOUTH JORDAN, Utah, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, has received US Food and Drug Administration (FDA) 501(k) clearance for the SCOUT® MD™ Surgical Guidance System.

The release of the new guidance system demonstrates Merit’s ongoing leadership in oncology and marks a significant advancement in breast cancer care. SCOUT MD broadens Merit’s oncology portfolio, designed to enhance diagnosis and treatment of breast and other soft tissue cancers. Products include the SCOUT Radar Localization System with SCOUT Mini Reflector and SCOUT Bx™ Delivery System as well as the SAVI® Brachy System.

A breakthrough solution, SCOUT MD supports implantation of up to four different reflector configurations. When implanted within abnormal breast or other soft tissue, the reflectors are designed to pinpoint tumor location in multiple dimensions for more precise excision. A targeted approach can help minimize damage to surrounding healthy tissue, decrease the likelihood of re-excision, and avoid the emotional and physical trauma associated with a second surgery.

“Merit’s development of different reflectors with different signals will allow surgeons to better delineate the edges of resection,” said John Vincent Kiluk, MD, FACS, Breast Surgical Oncologist at the Moffitt Cancer Center and Professor of Oncologic Sciences at USF, Tampa, Florida. “The subsequent result of this surgical precision should improve a surgeon’s ability to obtain adequate margins on larger tumors and decrease the need for repeat surgery.”

Every fourteen seconds, a woman is diagnosed with breast cancer.1 In 2020, 2.3 million women were diagnosed, and 685,000 died of breast cancer globally, making it the world’s most prevalent cancer.2 Lumpectomy (a type of breast-conserving surgery) is often performed as treatment. However, an estimated 20% ̶ 30% of women who undergo lumpectomy will need a repeat surgery.3 Localization procedures help surgeons precisely target breast cancer, which may result in more successful surgeries and improved patient outcomes.

The release of SCOUT MD coincides with an important milestone for Merit and breast surgery patients worldwide. As of January 2024, Merit has distributed more than 500,000 devices for placement in patient procedures.

“This momentum has enabled us to collect valuable real-world evidence through physician feedback, giving us a better understanding of what’s needed to improve oncology care,” said Fred P. Lampropoulos, Merit’s Chairman and CEO. “In turn, we’re developing new technologies, like SCOUT MD, that enhance the patient experience and reduce the burden breast cancer places on women worldwide. We’re honored to be a part of their care journey, and we intend to continue innovating for them.”

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 in excess of 700 individuals. Merit employs approximately 7,000 people worldwide.

TRADEMARKS Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors.

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. Breast Cancer Research Foundation. 2023. “Breast Cancer Statistics and Resources.” https://www.bcrf.org/breast-cancer-statistics-and-resources/

2. World Health Organization. 26 Mar 2021. “Breast Cancer.” https://www.who.int/news-room/fact-sheets/detail/breast-cancer

3. Havel et al. 2019. “Impact of the SSO-ASTRO Margin Guideline on Rates of Re-Excision after Lumpectomy for Breast Cancer: a Meta-Analysis.” Annals of Surgical Oncology 26 (5): 1238 ̶ 1244. (PMID: 30790112)


FAQ

What is the significance of the FDA clearance received by Merit Medical Systems, Inc. (MMSI)?

Merit received FDA clearance for the SCOUT MD Surgical Guidance System, a breakthrough in breast cancer care.

How does SCOUT MD target tumor location for precise excision?

SCOUT MD supports implantation of different reflector configurations to pinpoint tumor location in multiple dimensions.

What is the aim of SCOUT MD in breast cancer care?

SCOUT MD aims to reduce damage to healthy tissue, decrease re-excision rates, and minimize emotional and physical trauma.

How many devices has Merit distributed for patient procedures?

Merit has distributed over 500,000 devices, gathering real-world evidence to enhance oncology care.

Who is Fred P. Lampropoulos and what is his role at Merit Medical Systems, Inc. (MMSI)?

Fred P. Lampropoulos is Merit's Chairman and CEO, emphasizing the company's commitment to innovation for breast cancer patients.

Merit Medical Systems, Inc.

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About MMSI

merit medical systems, inc. (nasdaq: mmsi) is a leading manufacturer of medical devices used in diagnostic & interventional cardiology & radiology procedures. its primary products consist of inflation devices used in angioplasty, stent placement & discography; diagnostic & therapeutic catheters used for various procedures in cardiology & radiology; guide wires used to place balloon angioplasty catheters within a patient's coronary arteries; products used to manage & monitor the administration of contrast & other fluid solutions during diagnostic & therapeutic procedures; thrombolytic catheters & fluid dispensing systems; angiography accessories; & standard & custom angiography kits. headquartered in south jordan, utah, a suburb of salt lake city, merit employs approximately 1,900 people worldwide. merit markets its products in the united states & europe (direct sales force) & the world (distributors). they call directly on physicians & clinicians in hospitals & clinics worldwide. the c