K2M signed a 7-year agreement with Japan Medicalnext for exclusive distribution of K2M products across the region.
In early 2Q17, K2M received key product registrations from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), including MESA® and EVEREST® spinal systems and all of the company’s pedicle screws; further registrations will be pursued over the next year. Recall that Japan regulatory issues came to light for K2M in 1Q16—specifically, its local distribution partner completed paperwork incorrectly due to an error in translation from English into Japanese. Japan product sales were suspended pending PMDA satisfaction of corrections, and the distribution partner was approved to sell again toward the end of 3Q16.
Also in 2Q17, K2M and LifeHealthcare entered into a new 5-year supply agreement for distribution in Australia and New Zealand.
Japan Medicalnext is a wholly-owned entity of MC Healthcare, which is part of the Mitsubishi Corporation. Japan Medicalnext's 250 employees throughout Japan include 50 professionals focused on orthopaedic/spinal device sales.
Sources: K2M, Inc.; ORTHOWORLD Inc.