Welwaze Chooses bioaccess™ to Access the Colombian Medical Device Market with its Celbrea® Product
[ORLANDO, FL, September 3, 2021] - Welwaze Medical Inc., the manufacturer of the innovative Celbrea® medical device for the detection of early signs of breast disease, has decided to enter the Latin American market and through its master distributor in Latin America, has chosen bioaccess™ as its regulatory and market access consulting firm to aid it in entering the Colombian market.
Celbrea® was developed to support the early detection of breast disease, including breast cancer. Welwaze's mission is to help every woman, around the world, monitor the health of their breasts. Celbrea® is an FDA-cleared Class I medical device that is painless, easy-to-use and in just 15 minutes may alert physicians and patients of potential underlying breast pathology.
Celbrea’s potential to impact billions of women around the world by addressing issues concerning breast cancer, women’s health, and access to care. Celbrea® does not replace a mammogram, and Welwaze encourages women to keep up with their scheduled appointments. Every 2 minutes a woman is diagnosed with breast cancer. Every 13 minutes a woman dies in the United States. Early detection and a healthy lifestyle are key to improving health outcomes and preventing this disease.
In the early stage of cancer’s growth, tumors are dependent upon the surrounding vascularity. As cancer cells begin to divide more quickly, new blood vessel formation is required (angiogenesis). An increase in temperature at the site of the lesion is transmitted to the surrounding tissue. Celbrea® has 1188 nano-sensors embedded within a biocompatible multilayer pad that accurately measures temperature differences on the surface of the breast, using liquid crystal thermographic technology. Clinical studies have shown that a significant temperature difference of 2 °F or more could be an indication of potential underlying pathology. Our device visually displays color changes from blue to red in response to the thermal activity of your breasts, allowing for immediate results.
bioaccess™ will help Welwaze register its Celbrea® device at Colombia's regulatory agency, INVIMA, and to find a strategic partner and distributor in Colombia.
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About Welwaze
Welwaze’s (https://celbrea.com/) mission is to prevent more breast cancer deaths. We are a purpose-driven health tech company that sits at the intersection of Artificial Intelligence and the healthcare industry. We strive to deliver innovative, viable, and scalable medical technology. Our unique ecosystem includes Celbrea®, an FDA-cleared medical device that supports early detection of breast abnormalities, and a comprehensive companion app that will allow women to manage their breast health throughout their lives.
About bioaccess™
bioaccess™ (www.bioaccessla.com) is a Colombia and US-based Contract Research Organization, regulatory and market access consulting company that delivers a full spectrum of offerings from bench to commercialization so that global pharmaceutical and medical device companies can have long-term success in Colombia, Brazil, Mexico, Argentina, and the rest of Latin America.
Media Contact:
Ambiance Ventures™
Stephan Wullinger,
Welwaze Master Distributor for Colombia
stephan@zintra.de
bioaccess™
Julio G. Martinez-Clark,
Chief Executive Officer
jmclark@bioaccessla.com
