Spectral Medical Inc T.EDT

How many of these milestones do you guys think

[Inca2020]

the company is going to hit on their projected timeline?

 

FDA Approvals:

• FDA home HD usability and safety trial in Q4 2020. This will be a required six-month, 25-patient safety and usability trial which tests the ability of non-medical professionals to assist the patient in setting up and running the dialysis treatment; 
   
• PD FDA 510(k) submission expected in Q4 2020. This enables patients to use DIMI for automated PD treatments at home, especially for those who are transitioning from PD to home HD; 
   
• Special FDA 510(k) application for remote monitoring software submission expected in Q1 2021. This unlocks the full remote monitoring software suite, allowing physicians to remotely check-in and adjust a patient’s treatment regime; 
   
• Special FDA 510(k) application for home HD submission expected in Q2 2021. This is the final step approval to allow for in-home use of DIMI.

Health Canada Approvals:

• In Q2 2020, Dialco submitted its application for DIMI. With respect to Health Canada approval timelines, there are no standard turnaround times. However, Dialco anticipates a Health Canada response in H2 2020; 
   
• Health Canada PD use submission expected in Q4 2020 with possible approval in early 2021.