Miraculins Inc. is pleased to announce that it has signed a non-binding term sheet with VeraLight, Inc. to acquire all assets related to the SCOUT DS® technology, a groundbreaking diabetes screening technology that non-invasively measures changes in a person's skin indicative of prediabetes and type 2 diabetes, enabling cost-effective, easily accessible screening of those at risk.
The Term Sheet sets out the key financial terms of the proposed acquisition including pricing, future milestone payments, ongoing responsibilities and considerations related to an equity position in Miraculins by VeraLight and participation on Miraculins board of directors. Miraculins has an exclusive period within which to conclude its due diligence process and to finalize definitive documentation. The execution of definitive documentation and the completion of the transaction is subject to all necessary contractual, regulatory and corporate approvals of both Miraculins and VeraLight and the completion of satisfactory due diligence by Miraculins.
The SCOUT DS system is the first non-invasive diabetes screening system in the world designed to provide a highly sensitive and convenient method for screening for prediabetes and type 2 diabetes based on the presence of diabetes-related biomarkers found in the skin. Unlike current screening methods, a SCOUT DS test requires no blood draw, no fasting, and no waiting for a lab result. The patient simply places their forearm on the portable table-top instrument, and a quantitative result is reported in under two minutes.
SCOUT DS is Indicated for Use for the non-invasive screening of individuals 18 years or older who are at risk for prediabetes and/or type 2 diabetes to determine whether diagnostic testing is necessary. Prediabetes is defined as impaired glucose tolerance. SCOUT DS has received clearance from Health Canada for commercial distribution and it has been granted a CE Mark in the European Union, and is also cleared for sale in Mexico. Prior to this acquisition, VeraLight had not yet filed a formal application with the FDA for the clearance of SCOUT DS in the U.S. market. As a result, distribution in the United States of the SCOUT DS system at this time is limited to investigational use only.
In 2010, it was estimated that 629 million adults worldwide had either diabetes or pre-diabetes (Impaired Glucose Tolerance). By 2030, the number is expected to grow to be 910 million adults, an increase of 44%. Today, it is estimated that over 500 million people remain undiagnosed. Complications can begin years before diagnosis, however much of diabetes can be delayed or prevented if detected early. Due to the fact that early diabetes detection is critical in helping stem this epidemic, new tools are needed to play a role in screening for this disease of growing prevalence worldwide.
"There is a tremendous synergy between the SCOUT DS technology and our PreVu Non-Invasive Skin Cholesterol Test," stated Christopher J. Moreau, President and CEO of Miraculins. "Both technologies non-invasively measure the skin in order to deliver a test result for two of the most serious heath concerns in medicine today, coronary artery disease and diabetes. Adding the SCOUT DS system to our product suite would leverage our existing relationship with current and planned distribution partners worldwide, including our primary sales channel - the retail pharmacy market. We would also be leveraging our experience in manufacturing a sophisticated optical medical device and our existing ISO 13485 quality system. As initial market feedback for the SCOUT DS system has been very positive to date, we look forward to the opportunity to contribute significantly to the ongoing success of the SCOUT DS technology. This proposed acquisition will represent another step towards Miraculins' goal of becoming a world-class diagnostic, risk assessment and health screening company."
"We are excited about the proposed transaction with Miraculins, as the SCOUT DS technology would have a significant path to market and renewed opportunity for growth as a result of this relationship," said Lisa Suennen, Chair of VeraLight Inc. "Early identification and treatment of those at risk for type 2 diabetes is one of the most important public health issues in the world today and the SCOUT can play an instrumental role in addressing this critical issue."
It is anticipated that definitive documentation will be executed within 45 days. Further updates will be provided upon the execution of definitive documentation. There is, however, no assurance that the parties will enter into definitive documentation or complete the transaction contemplated by the Term Sheet.