Medifirst Solutions Announces a Clinical Study for a Breast Cancer Diagnostic Medical Device

In Clinical Studies News by Barbara Jacoby

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Source: Globe Newswire

From: biospace.com

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MEDIFIRST SOLUTIONS, INC. (OTC: MFST) (the “Company” or “Medifirst”), is pleased to announce it is a Sponsor and Collaborator for an upcoming breast cancer clinical study for real-time margin detection.

About 1 in 8 U.S. women will develop invasive breast cancer over the course of her lifetime. Besides skin cancer, breast cancer is the most commonly diagnosed cancer among American women. The purpose of this study is to evaluate the effectiveness and accuracy of an investigational diagnostics FLIM imaging device to provide direct support during lumpectomy cancer surgery to achieve the common goal of improving patient quality of life by decreasing the rates of re-operation.  It is estimated that up to 24% of women have a second surgery because the margins were not clear as per the pathology results. This causes great distress to the patient and adds additional burden to the hospital system and surgeons. We believe there is a need for real-time imaging, a device that can show us where a tumor ends and healthy tissue begins while the patient is still asleep on the operating table.

The FLIM Diagnostics imaging device was created to improve patient quality of life by decreasing rates of re-operation. FLIM has the potential to be able to visualize cancer margins in real-time, during surgery and FLIM Diagnostic can potentially differentiate between cancerous and non-cancerous specimens. FLIM analysis by the surgeon will not take more than several minutes, therefore not adding any significant time for patient to be under anesthesia. All specimens will be (In-Vitro) removed from the patient’s body prior to their evaluation by the FLIM technique. FLIM margin results will be compared directly with pathology results for accuracy of the findings.

Breast-conserving surgery is a critical first step of treatment for many women with breast cancer. The goal is to remove all the cancer cells, leaving behind only healthy tissue. However, today, surgeons do not use a diagnostic device to determine if all cancer has been removed during the initial surgery; instead, patients must wait until days after surgery to find out if all the cancer has been removed and the margins were cleared.

This study is to evaluate the FLIM Diagnostic ((Fluorescent Lifetime Imaging Microscopy), a medical device that can immediately, during surgery, analyze the removed breast tissue to confirm that the margins are cancer free. The removed tissue is not damaged and can still get sent out for routine pathology testing to confirm the results of the FLIM diagnostics technology. We further believe that this technology would present a dramatic improvement in treating breast cancer patients.

Every cell in the body contains mitochondria, so the FLIM has a high probability of serving as a platform technology. Failure to achieve clean margins in other cancer (liver, lung, pancreas, etc.) can have very serious consequences. Since mitochondria are not specific to any specific organs, the same FLIM technology can have the potential to technically be able to confirm margins for these other solid tumors as well.

Our goal is to provide the best outcomes for patients who must have surgery to remove cancer. One of the most important ways we do that is through innovative technology. The FLIM Diagnostics system has the potential to show promising results to improve confidence during lumpectomy procedures; for the numerous patients that will be enrolled in the Non-Significant risk clinical trial and prove our theory that the FLIM Diagnostics technology can show margin accuracy between 90 to 99 percent accuracy and the results will be compared directly with pathology results for proof of concept. There is no risk to the patient at any stage of this research protocol.

Medifirst anticipates an announcement with further specifics and details about the study and a general company update addressing its overall status and direction and Time Machine Laser update in the upcoming days and weeks. We appreciate all the support and patience by our shareholder through the pandemic and the last year.