PINK LUMINOUS BREAST TAKES STEPS TOWARD FDA CLASS III APPROVAL. NEW CLINICAL STUDY VALIDATES PLB AS A QUALITY BREAST SCREENING TOOL.
“Our goal, since inception, has been to create awareness and make self-familiarity a part of a woman’s daily routine,” said Marylin Dans, founder, and CEO of Pink Luminous Breast. “Pink Luminous Breast is more than a device, it is a lifestyle. Thanks to the generosity of donors to the Pink Luminous Advocacy Project we are able to continue on the path of FDA Class III approval and becoming an industry gold standard.”
The PLB works by emitting a RED LED light with a harmless spectrum of 640-800 nanometers, the trans-illuminated breast tissue allows the observation of abnormalities represented by darker or shadow areas. This double blinded study evaluated the sensitivity and specificity of the PLB device as a screening tool for the early detection of breast abnormalities when compared with mammography as the gold standard. The results showed that the PLB device has a high sensitivity (89.6%) and specificity (96.4%) for detecting breast abnormalities comparable to the adjusted mammography variables: 86.3% and 68.9% respectively. Importantly, the percentage of positive dense tissue findings from a total of 340 events was 266 (78.2%) using PLB vs. 248 (72.9%) detected by the mammography (MedRxiv, 2021).
“The results obtained using the PLB revolutionize the early detection of potential cancer lesions, positively changing the outcomes of cancer survival at any population,” said Dr. Edu B. Suarez, author of the study.
Following the success of the initial clinical study, the PLB moves on to seek Class III approval by the FDA. In order to do so, the organization is seeking support from the community to be able to raise funds for additional research and development resources that will put the PLB in the hands of more women around the world. This is a historical event, giving women everywhere the power to have an at-home breast screening tool for the first time ever, and allowing them to live an awareness lifestyle. The company counts on the support of a diversity of ambassadors, and stakeholders, including Tony Figueroa Cisneros and family, a select group of doctors such as Dr. Moises Irizarry- Roman, and the pop star, entrepreneur and education advocate, Armando Christian Perez (Pitbull).
In December 2018, we started a journey to Haiti with the hope of bringing light to the women of the island through the implementation of a breast cancer awareness program with the help of: the LETS Foundation, the Renand Foundation, Dr. Moises Irizarry (our medical specialist and ally), and Dr. Roosevelt ( a doctor of the local clinic). The group embarked to Bassin-Bleu, to meet with the community where they facilitated breast examinations along with an educational session led by Kristin Van Wey of the LETS Foundation and Marylin Dans of The Pink Luminous Advocacy Project in which the citizens were taught a class on fertility and wellness curing. Many women in developing countries will never have the access to a mammogram or sonogram and with the help of the Pink Luminous Breast devices, donated by The Pink Luminous Advocacy Project, we immediately identified 9 women with breast abnormalities.
We took a step further and we provided individual surgeries, biopsis and post care. These cases and results were also sent to doctors who are collaborating with our cause in the United States with the hopes of beating this disease. The purpose of this project and our foundation is to be able to diagnose these women as well as providing them a longer and happier life in which they can watch their kids and communities grow.
LETS believes that when adults get access to open and appropriate education about basic health, the fertility cycle, menstruation and the tools to manage this natural process effectively, the result will be fundamental and positive change in communities. The project is led by Kristen Van Wey. Kristin is an internationally recognized leader, educator, speaker and trainer in innovative approaches to wellbeing and has helped thousands experience insights, understanding and remarkable results. With over 25 years of professional experience in health, Kristin is one of the leading voices on the use of essential oils. Her humanitarian efforts have brought hope and empowerment to communities in crisis and she’s dedicated to partnering with others to serve communities globally.
The Renand Foundation provides rural families in Haiti with the means and infrastructure to help them build a strong home and future for their kids. They facilitate, support, educate and get out of the way as they firmly believe a child’s success resides at home. They also support job creation, home build outs and repairs, as well as giving them access to wellness programs. It is the responsibility of the Wellness Program to create and implement sustainable programs for health and wellness in all areas of life for the Haitian communities.