OCuSOFT has announced a new distribution agreement with I-MED Pharma, 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 510(k), 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. Through this new distribution agreement, the I-PEN Tear Osmolarity System will now be available for purchase in the United States through OCuSOFT by calling (800) 233-5469 or online at www.ocusoft.com.
"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," Cynthia Barratt, President and CEO of OCuSOFT, said in a company news release. "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."