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OCuSOFT, a privately-held eye and skin care company with an established reputation for innovation in eyelid hygiene and ocular health, has announced a new distribution agreement with I-MED Pharma Inc., a Montreal-based biotechnology company to make the I-PEN Osmolarity System available in the United States. 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 Tear Osmolarity System is a handheld device that measures the osmolarity (concentration of dissolved salts in solution) of human tears in normal and dry eye disease (DED) patients. The I-PEN Tear Osmolarity system, used with the I-PEN Single Use Sensors (SUS), provides a quick and simple method for determining tear osmolarity by measuring the tear soaked palpebral conjunctiva. After several seconds of contact with the eyelid tissue, the I-PEN displays a numerical tear osmolarity test result on the liquid crystal display (LCD) in units of mOsms/L with no calculations required. The I-PEN measures the electrical impedance in the tear soaked tissues 192 times in under 5 seconds and calculates corresponding the osmolarity of the tear film of the eye.
Cynthia Barratt, president and chief executive officer 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.”
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.”
Ocusoft, i-med pharma partner, distribute i-pen osmolarity system in us market
