Virtual Vascular Company Partners with NAMSA to Accelerate 510(k) Clearance by 30 Percent

ICHOR Vascular, Inc. is a U.S.-based virtual start-up medical device firm focused on the treatment of Peripheral Arterial Disease (PAD). Worldwide, 14+ million suffer from PAD with the most severe forms presenting as Acute and Critical Limb Ischemias—both underserved disease states that have not experienced advances in treatment for over 30 years.

Seeking to bring to the U.S. marketplace a new non-surgical, non-drug therapy for Limb Ischemias, ICHOR was faced with the challenge of introducing a 510(k) device to the vascular market with limited development knowledge, restricted resources and a desire to make a timely exit following device clearance.

Ultimately, ICHOR selected NAMSA as their trusted Contract Research Organization (CRO) partner to conduct the complete continuum of development activities under one roof via the NAMSA APEX Program. Through this partnership, ICHOR saved over 30% in development timelines and $26M in development costs, compared to industry averages.

We invite you to access this case study to learn how the NAMSA APEX Program delivered ICHOR Vascular, Inc. with superior results. Please fill out the form below to access this case study.