Endomag Announces FDA Approval of Magtrace for All Breast Cancer Staging ProceduresDecember 7, 2022
In news that will completely change the way breast cancer is staged across the U.S. while reducing the reliance on uncertain radioactive tracer availability, Endomag is proud to announce that the Magtrace® lymphatic tracer can now be used for all patients undergoing breast cancer surgery.
Magtrace is the first tracer specifically designed to optimize the breast cancer staging procedure, Sentinel Lymph Node Biopsy. It helps surgeons determine if the tumor has spread beyond the breast by precisely identifying the first draining or 'sentinel' lymph nodes in the armpit for further analysis.
Previously, Magtrace was approved for patients undergoing a mastectomy procedure. Since then, additional data submitted to the FDA has validated its use for all breast cancer patients. This now expands the treatment to all patients choosing breast-conserving surgery.
One of the greatest advantages of Magtrace over the current standard practice of using a radioactive tracer combination is that it is not limited by nuclear medicine supply chain issues. This means there is no need for hospitals to suffer delays to or cancellations of cancer patient surgeries.
"In the past month, there have been a lot of breast cancer patients across the U.S. who have had their surgery delayed due to the ongoing shortages of Technetium-99. Fortunately, we were the first site in the U.S. to adopt Magtrace several years ago, and we've been able to completely avoid these issues.
"What originally drew me to Magtrace were the huge benefits it could provide to our patients, including eliminating the pain of a radioactive injection and reducing unnecessary surgery. I truly believe that with this news, there is no reason why it shouldn't become the new standard of care for sentinel lymph node biopsy." - Michael Alvarado, MD, Professor of Surgery at UCSF
"This much-anticipated approval allows any surgeon, regardless of hospital setting, to offer their patients the best standard of treatment in breast cancer staging. For the first time in the U.S., operating departments will not have to rely on Nuclear Medicine before they can operate on their patients.
"From the many conversations we have every day with surgeons across the U.S., we know they're so excited about what this means for improving efficiencies and the patient experience." - Dr. Eric Mayes, Endomag CEO
Notes to Editors:
- Over 280,000 people are diagnosed with breast cancer every year. Of those, roughly 75% will undergo a sentinel lymph node biopsy procedure.
- Hundreds of physicians across 150+ breast units across the U.S. are already using Magtrace.
- There are 500 centers worldwide also now using it across more than 40 countries.
- Magtrace has been approved for full wider indication use in Europe for 10+ years.
- Earlier this year, Magtrace received an official guidance recommendation from the National Institute for Health and Care Excellence (NICE).
- In a recent poll of predominantly U.S. breast surgeons[i], over 96% of respondents stated that they were either using Magtrace already on patients undergoing mastectomy procedures or were interested in adopting the technology.
- Magtrace and the Sentimag® platform are manufactured by Endomag and distributed by Mammotome.
- Clinically non-inferior to the combined gold-standard of Radioisotope and Blue Dye and already used in over 100,000 surgical procedures worldwide.
- Can be injected weeks ahead of surgery or in the operating room when the patient is under anesthetic, meaning more flexibility around when the surgery takes place.
- Reduced injection pain as patients injected after anesthesia.
- Unlike the blue dyes used, there is no risk of anaphylaxis or significant side effects.
- Simple to store - any hospital across the U.S. can use it regardless of location, size or facilities.
- Only solution that offers a unique 'delayed' sentinel lymph node biopsy procedure, which can spare 80% of high-risk DCIS patients an unnecessary surgical procedure they'd otherwise receive.
Endomag believes everyone deserves the best standard of cancer care. Thousands of physicians across more than 45 countries use our technologies to provide patients with more access to quality care, achieve better surgical outcomes and help them avoid breast cancer surgery when it isn't needed.
At the heart of Endomag's product platform is the Sentimag® localization system. The Sentimag® uses a probe that works like a metal detector and is used to detect Endomag's magnetic seed (Magseed®) and liquid tracer (Magtrace®), for removing tumors and performing minimally invasive staging procedures.
To date, the company has helped over 300,000 women around the world access more precise and less invasive breast cancer care.
[i] Transatlantic Breast Cancer Conference (TBCC) 2022; Data available on file upon request
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Original Source: Endomag Announces FDA Approval of Magtrace for All Breast Cancer Staging Procedures