I-MED Pharma Inc., a Canadian company based in Montreal specializing in dry eye diagnosis and management, announced the signing of an exclusive agreement with OCuSOFT Inc. for distribution rights in the United States for its patented I-PEN® Osmolarity System. On December 22, 2017 the FDA issued an Acceptance Review Notification for the I-PEN® Osmolarity System 510k submission. This distribution partnership will officially commence upon final FDA approval of the 510k, which is anticipated in the first quarter of 2018.
The I-PEN® Osmolarity System is the world’s first, handheld platform that offers eye care professionals a quick and reliable tool for screening dry eye patients.
Daniel Hofmann, President of I-MED Pharma stated, “We are thrilled to partner with OCuSOFT, a company recognized for addressing clinical needs with innovative solutions. The I-PEN® Osmolarity System is an invaluable asset for measuring tear osmolarity, a key step in identifying the presence and severity of dry eye disease. We believe that this partnership will offer the first economical solution for eye care professionals looking for an efficient and reliable diagnostic tool in this area.”
Cynthia Barratt, President and CEO of OCuSOFT states, “OCuSOFT is extremely excited about the I-Pen® Osmolarity System and we know clinicians will be too. Continuing research demonstrates the importance of testing tear film osmolarity and now with I-Pen®, there is an affordable means to do so. I-Pen® is a hand-held device that practitioners can utilize in-office. It is efficient and highly reliable, enabling practitioners to diagnose and treat Dry Eye with confidence.” OCuSOFT Inc. will be making a future announcement as to availability.