With almost half a million daily readers, Dagens Industri is Sweden’s largest financial newspaper. Their independent Investor Relations platform, Invest Talks, which interviews coporate leaders of listed companies, interviewed founder and chairman, Rickard Brånemark regarding the recent PMA (premarket approval) for the OPRA™️ Implant System received from the FDA in the US, and its implications in terms of a virtual monopoly in the multi-billion dollar US market.
During the interview, Professor Brånemark describes how achieving the incredible milestone of being the first and only company to have received a PMA, enables Integrum to ramp up activities in the US dramatically, and realize the full potential in a market worth approximately 5 billion dollars.
Read the full interview here (in Swedish)
Integrum AB is a publicly-traded company (INTEG B: Nasdaq First North exchange) based outside of Gothenburg, Sweden, with a US subsidiary in San Francisco, CA. Since 1990 osseointegration, the science behind the OPRA™ Implant System has been helping individuals with amputations towards an improved quality of life. Thorough surgical experience gained over almost three decades from 500 surgeries in 14 countries has led to the development of Integrum’s system for bone-anchored prosthetics – a beneficial alternative to the traditionally used socket prosthesis. Integrum’s OPRA™ Implant System was approved by the US Food and Drug Administration (FDA) in 2015 for use in the US under a Humanitarian Use Device (HUD) designation, which was reviewed through the Humanitarian Device Exemption (HDE) pathway, which limited the level of marketing and sales activities. In December 2020, Integrum successfully completed the most stringent medical device regulatory procedure in the world, and based on the solid scientific data submitted, was granted a PMA by the FDA for the OPRATM Implant System, which is the only technology approved for above knee, bone-anchored prosthetics in the U.S. More information on the company and its innovative solutions for amputees can be found at www.integrum.se.