ROSENBERG, Texas, Jan. 8, 2018 /PRNewswire/ -- OCuSOFT Inc., a privately-held eye and skin care company with an established reputation for innovation in eyelid hygiene and ocular health, is pleased to announce 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. 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.
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."
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."
For more information about the I-PEN® or OCuSOFT Inc., please visit www.ocusoft.com or call (800 233-5469.
About OCuSOFT Inc.
OCuSOFT Inc. is a privately-held Richmond, TX USA-based ophthalmic research, development and supply company with an established reputation for innovation, particularly in Ocular Surface Disease (OSD). Since 1986, OCuSOFT® served the ophthalmic industry with a unique selection of proprietary brands. A pioneer in ophthalmology, OCuSOFT® introduced the first eyelid cleanser, the first topical anesthetic gel, the first "leave-on" antibacterial eyelid cleaner, the first supplement to enhance botulinum toxin injections and the first fourth generation preservative-free ophthalmic emulsion eye drop. Today, the company is most recognized for its #1 Doctor Recommended Brand of Eyelid Cleansers, OCuSOFT® Lid Scrub®, in addition to its standing as the preferred distributor of ophthalmic products and supplies by eye care professionals. For more information, please call 800-233-5469 or visit www.ocusoft.com.
About I-MED Pharma
I-MED Pharma Inc. is a privately held Canadian company, headquartered in Montreal, Quebec, servicing Canadian ophthalmologists, optometrists and the global eye care community. Established almost thirty years ago, I-MED Pharma creates and distributes innovative medical, surgical and veterinary eye care products worldwide. It continually researches, develops and sources the most effective and advanced solutions to eye disorders like cataracts, corneal degeneration, dry eye, glaucoma and Meibomian gland disease.
I-MED Pharma is proud to have been at the forefront of treating Dry Eye Syndrome as a serious disease and invests heavily into education and developing effective dry eye products. I-MED Pharma's ocular surface disease product range includes diagnostic tools, ocular hygiene, nutrition, dry eye drops and ocular occlusion devices.
Contact: Troy Smith, Vice President Professional & Technical Relations
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SOURCE OCuSOFT Inc.