Micro Medical Solutions

Intervention Progress

Evaluation of BTK intervention with pedal access device

Micro Medical Solutions is taking a stand against the impact of critical limb ischemia (CLI) amputations by developing innovations that will allow interventionists to improve clinical outcomes and patient quality of life. Micro Medical Solutions has a specific goal: to improve Below the Knee (BTK) interventions, thereby reducing the number of amputations due to peripheral artery disease (PAD) and CLI and minimizing the significant morbidity, mortality, and healthcare burden associated with atherosclerotic disease.

Progress toward better BTK interventions

The Micro Vascular Integrated Platform (mVIP), comprised of the MicroStent, MicroBalloon, and MicroGuide, has full EU CE Mark approval. The MicroBalloon and MicroGuide have US FDA 510K clearance, with commencement of the U.S. IDE clinical trial for MicroStent expected in 2023.

About CLI

Peripheral artery disease (PAD) and critical limb ischemia (CLI) affected 215 million people worldwide in 2015, predicted to be 230 million by 2020.¹ CLI currently afflicts 2.8 to 3.5 million of those with PAD and is projected to rise to 4.5 to 5.6 million.² Rates of amputations in the general population with PAD are declining, but amputations in CLI continue to escalate. It has been estimated that 25% of CLI patients will undergo major amputation. Prognosis with respect to limb preservation in CLI patients is poor, particularly in no-option CLI patients, where six-month major amputation rates have been reported to be as high as 50%.³ If something doesn’t change, the number of amputations due to CLI could exceed one million by 2030.

References: 1. Global Peripheral Artery Disease Market: Trends & Opportunities (2015-2020), February 2016 (Page 19). Daedal Research Group. 2. Critical Limb Ischemia. Volume 1 United States Epidemiology, 2010. Accessed at http://thesagegroup.us/pages/rep[orts/cliepiusreprot.php., October 14, 2016. 3. Teraa M, Conte MS, Moll FL, Verhaar MC. Contemporary Reviews: Critical Limb Ischemia: Current Trends and Future Directions. J Am Heart Assoc 2016; 5: e002938.

This website includes forward-looking statements regarding MMS business and the therapeutic and commercial potential of MMS technologies and products in development. Any statement describing MMS goals, expectations, financial or other projections, intentions, or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing, and commercializing devices that are safe and effective for use as human therapeutics and in the endeavor of building a business around such devices. MMS forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause their results to differ materially from those expressed or implied by such forward-looking statements. Although MMS forward-looking statements reflect the good-faith judgment of its management, these statements are based only on facts and factors currently known by MMS. As a result, you are cautioned not to rely on these forward-looking statements.