- Artrya (ASX:AYA) provides a quarterly update on activities through the September quarter
- The company has made further progress in advancing the 510k application process for its Salix solution with the US FDA
- During the quarter, Artrya enhanced the speed, usability, and functionality of its Salix platform
- AYA has also reduced its monthly cash burn rate by 27 per cent
- AYA last traded at 22.5 cents
Medical technology company Artrya (ASX:AYA) has provided a quarterly update on its activities during the three-month period ending on September 30, 2023.
Artrya is dedicated to advancing its proprietary artificial intelligence (AI) platform designed for the detection, diagnosis, and management of coronary artery disease.
FDA approval
The company has made significant progress in advancing the 510k application process for its Salix software system solution with the US Food and Drug Administration (FDA).
The company expressed its commitment to ensuring that the submission meets the highest standards, with the goal of increasing the likelihood of receiving FDA approval, which is anticipated by late June 2024.
“The additional time taken in this phase means our submission will not be made at the end of October, as previously estimated,” AYA CEO Mathew Regan said.
“The deferral of the submission ensures it will be of the highest standard and compliant with all FDA requirements, important to support a timely approval process, which we anticipate to be late June 2024.”
Final FDA approval will position Artrya to enter the rapidly expanding US market.
Product development
During the quarter, Artrya enhanced the speed, usability, and functionality of its Salix platform.
“We have methodically worked through the priority checklist set out in the roadmap and are on track to deliver a quality application in coming months,” Mr Regan said.
The company believes that the development of its product will enable it to engage with key future commercial clients.
Cost efficiencies and financials
Artrya reduced its monthly cash burn rate by 27 per cent compared to the same quarter last year ($3.8 million in Q1 FY24, down from $5.2 million in Q1 FY23).
As of September 30, 2023, AYA holds a cash position of $16.4 million with an average net monthly cash burn for the quarter of $1.3 million.
Net operating cash outflow for the quarter was $3.8 million, up from $2.7 million in Q4 FY23.
AYA last traded at 22.5 cents.