Universal Biosensors, Inc. (ASX: UBI) has received approval from the Indian Central Drugs Standard Control Organisation (CDSCO) for the sale of Xprecia Prime, with the first order received from UBI’s distributor for the region.
This first order is in the process of being delivered and will see first sales into the market in Q3 CY23.
We have been working on the approval of Xprecia Prime in India for more than 12 months, and we are delighted with this significant step forward. Whilst this first order is not material in value (under $100,000), India is a powerful and emerging market, and we are excited for the opportunities Xprecia Prime represents to disrupt this market,” CEO, John Sharman, said.
About Xprecia Prime
The Xprecia Prime Coagulation Analyser is Universal Biosensors second generation, new and improved coagulation monitoring device. Xprecia Prime fits into your palm; is portable, accurate and easy to use. The device is designed for fast and reliable prothrombin time (PT) results displayed in seconds and International Normalised Ratio (INR). It is used to monitor the dosage of vitamin K antagonists in patients to ensure its safety and efficacy.
Dangerous bleeding events can occur if the ideal dosage of the drug is exceeded, while if the dosage is lower than required the patient is at risk of thrombosis. The prothrombin time (PT) test allows physicians to appropriately adjust the patient’s dose of the drug to compensate for any diet and lifestyle changes.
Globally, approximately 10 million patients are taking warfarin, and over 300 million PT/INR tests are conducted annually to monitor the safe and effective dosage of anticoagulants, representing a major market opportunity for Xprecia Prime.
