In an article titled ‘Integrum awaits an important milestone on the road to commercial breakthrough‘ published August 2020, Biostock interviews Professor Rickard Brånemark, co-founder and Chairman of the Board.
The interview touches upon the history of Integrum with the discovery of Osseointegration and dental implant technology. It visits several milestones for the company, such as the ongoing agreement with the US Department of Defense, collaboration with Onkos Surgical, and the Pre-Market Approval application with the FDA.
Integrum received the Human Device Exemption (HDE) in 2015 for the transfemoral OPRA™ Implant System, making it the only bone-anchored prosthesis system approved in the USA. Since 2018, the US Department of Defence has been using our products, and they have two ongoing clinical trials with the upper limb and the lower limb OPRA™ Implant System.
‘In our primary market, the USA, Integrum is the only company with an FDA-approved product.’- Rickard Brånemark, Co-Founder and Chairman of the Board Integrum
Another significant milestone for the company discussed in the article is the Pre-Market Approval application under process with the FDA. A favorable decision would further testify Integrum’s position as the world leader in osseointegrated prosthetics and allow faster expansion in the USA by making it easier for patients to access the technology through the health care system.
‘The more leading hospitals in the US, like e.g. Johns Hopkins, which is starting to use Integrum’s products, the more other hospitals will be interested – and not just in the US.’- Rickard Brånemark, Chairman of the Board and Co-Founder, Integrum
Integrum prepares for an exciting future with the addition of a sales and marketing manager to the team who will focus on market penetration outside of the US and scalability.
Access the full article in Swedish here.
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