US FDA 510(k) submitted for APASĀ® Independence
Key milestone to ensure US commercial launch and sales pipeline in 2019
21 December 2018

Australian medical technology company LBT Innovations Limited (ASX: LBT) (LBT or the Company), a leader in medical technology automation using artificial intelligence, is pleased to announce that the 50% owned joint venture company, Clever Culture Systems (CCS) has filed a 510(k) application with the United States Food and Drug Administration (FDA) for its APASĀ® Independence instrument with associated Urine Analysis Module.

This important milestone for the Company supports the expected commercial launch of the APASĀ® Independence instrument in the United States in 2019. Obtaining FDA clearance for the APASĀ® Independence instrument facilitates commercial market access and the ability for sales to commence in the single largest pathology market globally. This submission follows the recent placement of the first APASĀ® Independence instrument in the United States (for investigational use) into Hennepin Healthcare System, a laboratory in Minneapolis. It is expected that a number of initiatives targeting early market awareness will occur during 2019 calendar year to build up the early sales pipeline in the US.

FDA de novo achievement for APASĀ®

A de novo application is required when there is no existing predicate device cleared by the FDA. In October 2016, CCS received a clearance for its 510(k) de novo submission, which the FDA cleared for APASĀ® as a Class II medical device. The de novo submission used a manual version of APASĀ® to test 10,000 patients in a series of clinical trials conducted in the US and Australia over a 12-month period. This achievement demonstrated the core artificial intelligence and imaging capability of APASĀ®, de-risked the regulatory path to market and was a global first.

FDA 510(k) for APASĀ® Independence

A 510(k) submission requires new devices to be comparable or substantially equivalent to existing predicate device(s) already previously cleared by the FDA. CCS is the originator for the predicate device of APASĀ® and has access to the complete data on both the APASĀ® manual loading instrument and the fully automated APASĀ® Independence instrument, representing an expected straight forward path for 510(k) review. The Company is not aware of any competing 510(k) submissions against its predicate, once again making this a global first.

Timing

The FDA has a very clear and transparent 510(k) submission process. Once the 510(k) is submitted, there is a 90-calendar day review process. There are a number of opportunities for the Company and the FDA to communicate as part of the detailed review process, and during this time the 90-calendar day process may or may not stop depending on the nature of the review questions. The Company expects to have a collaborative dialogue and set of questions and answers with the FDA as it did during the de novo application.

LBT CEO and Managing Director, Brent Barnes, said:

ā€œThe preparation of the submission milestone is a culmination of years of development work on both the physical instrument development as well as the AI platform. Iā€™d like to acknowledge the hard work of our team and partners in putting together a comprehensive dossier. Approval enables CCS to market the APASĀ® Independence in 2019. We understand the typically long sales cycles for capital equipment. This is why in parallel to our regulatory process, we have established a centre of excellence reference site and expect to have a presence at a number of US based conferences to build awareness leading up to the FDA decision. We continue to strive to have the APASĀ® Independence instrument to be the first FDA cleared Class II commercial product of its kind available for sale in the US during 2019.ā€