Medimaps Group Appoints bioaccess.™ as Regulatory Consultant and Legal Representative in Colombia for TBS iNsight® – a Novel Osteoporotic Fracture Assessment Diagnostic Tool
[ORLANDO, FL, DECEMBER 23, 2017] - Medimaps Group has appointed bioaccess.™ as its regulatory consultant and legal representative in Colombia. bioaccess.™ will help Medimaps Group register its novel method for improving osteoporotic fracture risk assessment, TBS iNsight®, at Colombia's medical device regulatory agency, INVIMA.
On December 9, 2017, Medimaps Group – developers of the TBS iNsight® diagnostic tool – and bioaccess.™ signed a service agreement to have Medimaps Group's TBS iNsight® product registered for sales in the Colombian territory.
TBS iNsight® is a unique, easy-to-use software application that assesses bone texture - an index of bone microarchitecture – which in turn is expressed as the Trabecular Bone Score (TBS). The measurement is performed seamlessly using DXA images acquired from a bone mineral densitometry (BMD) scan. No additional patient scan time or radiation exposure is required and results are easily interpreted by physicians to enable them to better manage patients with high risk of fractures. TBS iNsight® has been cleared for marketing by the U.S. Food and Drug Administration.
It is well documented that 40-50% of osteoporotic fracture occurs in patients who are not determined to be osteoporotic by BMD alone, yet BMD remains the only diagnostic method available to most clinicians. A significant body of literature, including a recent study of over 29,000 women, has demonstrated that TBS iNsight®, when combined with hip and/or spine BMD and FRAX® clinical factors, can help improve the prediction of future osteoporotic fracture risk in a clinically meaningful way.
About Medimaps Group
Medimaps Group – a Swiss company founded by a group of clinical practitioners and researchers - is a developer of innovative imaging software used in clinical practice for improved patient management with minimum impact on the workflow of the practitioner. The company has raised several rounds of venture capital to further commercialize TBS iNsight® in the osteoporosis treatment market and for product development of the TBS iNsight® tool for optimizing implant surgery in the dental and orthopedic markets.
Julio G. Martinez-Clark, +1 (954) 903-7210
Chief Executive Officer