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Will Irby, Senior Global VP, Merit Medical
Merit Medical prioritizes research and development to bring products to market that will have a meaningful, positive impact on patient care and the ability of physicians to deliver excellent patient outcomes. The $1.2 billion global company remains nimble and focuses on responding to identified customer needs.
“Merit Medical maintains (and continues to invest) in regulatory expertise and capacity in critical markets around the globe. While we would like to pursue every new idea, we also have a rigorous prioritization process to ensure critical projects receive the resources needed for timely approval,” says Will Irby, Senior Global VP of Merit Oncology.
The Only Localization Solution from Biopsy to Surgery
A deep understanding of the disease state and patient care pathways is always critical to focus product development in areas that can truly make a difference in patient care. Merit Medical looks for ways to introduce new technology for improving patient care.
The SCOUT® Radar Localization System is a great example of this. The localization procedure for breast cancer is an additional patient procedure after diagnosis/biopsy (but before surgery). SCOUT is the only wire-free localization product that can be used at the time of biopsy to eliminate the localization procedure entirely. As a result, patients do not need to undergo another stressful procedure. Additionally, the removal of the secondary localization procedure allows the entire healthcare system to reduce cost and patient wait time from the first diagnosis to treatment.
Offering a Localization System under MRI guidance
SCOUT has a clinically insignificant MRI artifact, meaning it will not obscure MRI imaging interpretation.
All of the other non-radioactive, wire-free localization systems have a significant MRI artifact that limits the options to place in patients that may need subsequent MRI Studies. SCOUT is also the only localization system that can be placed under MRI guidance via Merit Medical’s SCOUT BxTM delivery system. It is the first and only device that enables placement at the time of biopsy under stereotactic or MRI guidance.
Many of Merit Medical’s customers have standardized SCOUT Localization at the time of biopsy for lesions that are highly suspicious on imaging. For these lesions, the radiologist can place a SCOUT reflector instead of a biopsy clip, obviating the need for a patient to have to return to the imaging center for a pre-surgical localization. This helps reduce patient anxiety, and patient out-of-pocket costs while improving workflow for busy breast centers. It can potentially reduce the time to surgery as well. Intermountain Healthcare, Pennsylvania Hospital System, and multiple Kaiser facilities have adopted this.
The use of Neoadjuvant Chemotherapy (NAC) has increased in the U.S. with the goal of minimizing the extent of disease prior to surgery. There are several studies that show the placement of the SCOUT Reflector prior to the initiation of NAC enables physicians to localize lesions in the axilla and the breast when they are most visible on imaging. SCOUT will not interfere with the MRI imaging studies that are standard of care to monitor the patient’s response to NAC. Merit Medical is also currently sponsoring the STREAMLoc time of biopsy localization registry in Northern America (US and Canada) —a prospective, post-market, 500-patient registry.
Merit Medical maintains (and continues to invest) in regulatory expertise and capacity in critical markets around the globe. While we would like to pursue every new idea, we also have a rigorous prioritization process to ensure critical projects receive the resources needed for timely approval
“It is an easy one-step procedure before surgery and a less painful and time-consuming technique on the day of surgery,” says Christine Desbiens, MD, a surgical oncologist at the CHU de Québec-Laval University and fellow investigator of the STREAMLoc registry study.
Going forward, Merit Medical will be moving beyond breast cancer into other areas of the body for the localization of soft tissue to include lymph nodes, melanoma, and soft tissue sarcoma. Since the acquisition of Cianna in 2018, the company has continued to invest in the Oncology space with multiple product line extensions and new capabilities to the SCOUT platform.
“We look forward to bringing our next generation of SCOUT, SCOUT MDTM to the market in 2023,” says Irby. “We are excited that SCOUT MD was recently awarded Breakthrough Medical Device Designation from the FDA.”
Company
Merit Medical
Management
Will Irby, Senior Global VP, Merit Medical
Description
As a global healthcare company, Merit Medical understands customer needs and innovate and deliver medical solutions that transform patient care. 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 Medical News
Merit Medical Announces New Five-Year Senior Secured Credit Agreement
SOUTH JORDAN - Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced that it has entered into a new, five-year senior secured credit agreement. The credit agreement includes a revolving credit facility in an aggregate principal amount of up to $700 million and a term loan facility in an aggregate principal amount of up to $150 million. Wells Fargo Bank, National Association is acting as administrative agent for a group of financial institutions providing the new credit facilities. Merit has borrowed approximately $242 million under the new credit facilities and intends to use the proceeds for general corporate purposes and the repayment of outstanding borrowings on its previous senior secured term loan and revolving credit facility. As a result, Merit's total indebtedness remains substantially unchanged following the execution of the new credit agreement.
“Wells Fargo Bank has been a trusted partner for Merit Medical and we appreciate their continued support, as well as our continuing group of lenders and the new banks that chose to participate, in this new credit agreement,” said Raul Parra, Merit Medical’s Chief Financial Officer. “This new credit agreement enhances our balance sheet and financial condition by extending our revolving credit facility and debt maturities. It also increases our financial flexibility and, combined with our improving profitability and free cash flow generation, gives us a solid foundation to support our growth initiatives.”
The new credit facilities are scheduled to mature on June 6, 2028. The terms of the new credit agreement are substantially consistent with Merit’s existing credit agreement. Additional details on the new credit agreement are outlined in Merit’s Current Report on Form 8-K filed with the Securities and Exchange Commission.