Koligo Therapeutics, Inc. today announced the formal introduction of KYSLECEL in the Eastern United States.
| LOUISVILLE, Ky., /PRNewswire/ -- Koligo Therapeutics, Inc. today announced the formal introduction of KYSLECEL in the Eastern United States. What is KYSLECEL? KYSLECEL is a minimally-manipulated autologous cell-based product regulated by the FDA solely under section 361 of the PHS Act and 21 CFR Part 1271. The need for KYSLECEL The KYSLECEL launch dramatically increases patient access to TP-IAT. Until now, TP-IAT could only be performed at a handful of hospitals with access to specialized laboratories. Qualified hospitals who do not have the requisite processing capabilities are now able to perform TP-IAT without incurring the risk, expense and uncertainty of establishing in-house laboratories. Importantly, patients are now able to undergo TP-IAT locally at a qualified center. KYSLECEL may be covered by commercial health insurance, most Medicaid carriers, and Veterans Affairs. Patients must check with their physician and insurance provider for eligibility. Further detail about KYSLECEL To make KYSLECEL, the surgeon at a qualified hospital removes the diseased pancreas and sends it to Koligo’s FDA-registered facility in Louisville. Koligo isolates the pancreatic islets to make KYSLECEL. Koligo ships KYSLECEL back for re-infusion into the liver, where the islets are intended to engraft and produce insulin. Matthew Lehman, Koligo CEO: “In recent months, Koligo has delivered KYSLECEL for 12 patients at select centers. We are delighted to now offer the product across the Eastern United States. KYSLECEL addresses a major clinical need for patients suffering from debilitating pancreatitis pain by improving access to TP-IAT. TP-IAT often leads to profound patient improvements in pain and quality of life, and to significant reductions in the need for opioids. Our goal is to make TP-IAT available to all eligible patients across the U.S. “Currently, the labeled shelf life of KYSLECEL is six hours from the time it leaves Koligo’s facility in Louisville. This allows for delivery to most metropolitan areas in the Eastern U.S. Ongoing product development is expected to extend the shelf life of KYSLECEL and expand access nationwide by 2019. “We are also encouraged by the interest shown in KYSLECEL outside of the United States. After completing our development work to extend the KYSLECEL shelf life, we will work on potential partnerships that may allow access to TP-IAT in several regions globally.” Koligo has assembled a highly experienced management team:
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