KOOL’s Res-Q™60 BMC System (Res-Q) has been registered by the Central Drugs Standard Control Organization of India (CDSCO), allowing its commercial sale in the country.
KOOL is initiating the market roll out for Res-Q in India and expects to record initial revenues from the launch during the current quarter, supported by existing clinical trial programs also managed through its partner, Totipotent serves as the exclusive distributor for Res-Q and MXP™ MarrowXpress™ in India, Malaysia, Thailand and Mauritius.
The Bottom Line: Totipotent initiated enrollment in a clinical evaluation to establish the safety and efficacy of Res-Q for use in treating patients with Critical Limb Ischemia (NYSE:CLI). Enrollment in the study is expected to be completed in the near future. This phase 1b trial is 1 among several the group expects to execute through its 50 plus partner hospital network sites. New stem cell technologies, such as Res-Q, are being adopted at a gradual but growing rate in India. This is a regulatory milestone representing market expansion. The Res-Q™ 60 BMC (Res-Q), a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates. KOOL is up mid-day $0.05 (2.18%) to $2.27.