The MOOD study has 11 activated sites, with 17 ongoing subjects. Device replacements have been distributed to sites and subjects. The preventive migraine study design is in process, including scenarios for sample size. Publications from previous studies are being submitted or options for new journals are being considered. Regulatory strategies are underway for FDA, EU, and UK approval. Audits and submissions to maintain approvals are ongoing.

1. 1
Clinical Affairs
 MOOD study:
- 12 Sites initiated (10 in the US, 2 in IL) ; 11 sites activated (1 in IL and 10 in the US)
- Pending Feb-Mar: 2 SIVs (1 US, 1 IL) + 1 US SQV (Northwestern Uni)
- 17 subjects on-going (4 screened, 13 randomized), 3 completed, at least 7 additional screening visits pending beginning of Mar
- Device stock replacement status
 Device's replacement (new plastic) – 24 devices distributed to sites & 36 devices are on their way from Brent to Rachel.
 Power-cord replacements- all sent to ongoing subjects.
Activity
2022
Jan Feb Mar Apr May June July Aug Sep Oct Nov Dec
Clinical studies
Relivion DP - MOOD study
Relivion DP - MOOD MOA add-on study
Relivion migraine preventive study (SP-303)
Post launch Investigator Initiated Studies (EU/USA) - TBD
R&D in-house study - SP-100
China & Japan support

2. 2
MOOD Enrollment status
Visits status per site
0 0 0
3
0 0 0 0 0 0 0
1
0 0
0
1
0
0
1 1
0
2 2
0
1
2
0 0
0
0
0
1
0
1
0
1
0
0
0
0
0 0
0
0
0
1
0
0
2
0
0
0
0
0
0 0
0
1
2
3
4
5
6
7
8
9
10
completed
OLE
DB
screenings
5 screen failures
2 subjects withdrew consent
1
3
4
6
9
18
1
3
5
13
16
27
0
2
4
6
8
10
12
14
16
18
20
22
24
26
28
30
32
34
36
38
40
Sep-21 Oct-21 Nov-21 Dec-21 Jan-22 Feb-22
#
subjects
Enrollment rate (cumulative)
randomized screened

3. 3
Clinical Affairs - general
 Preventive study (SP-303):
 FDA pre-sub write up initiated
 Regulatory strategy- clinical- done; Technical - gap analysis for FDA done, for EU and UK on-going. aim to be ready by EO Feb
 Study design- in process, sample size scenarios (for open label & double-blind study)
 Approached Megan to explore reimbursement needs to be implemented in the clinical study
 Initiated work to establish medical advisory board for the study
 2022 work plan – discussions on-going in collaboration with R&D
 Publications:
 RIME paper; Finalized will be submitted this week
 SP-301 paper finalized, Submitted and rejected; need to decide a 2nd option of journal – in discussions
 Sawai additional requests – in process, additional requests received ; approved to search for an outsource
 Neurofront migraine study; held 2 meetings, Neurofront reached to schedule another meeting re study operations- meeting currently postponed by me
 R&D in-house study to support V&V activities; approved to search for an outsource
 HR: CV review for a replacement CTA

4. 4
RAQA
 FDA LTF - to be finalized this week (needed for pre-submission)
 Un-announced audit:
 Nir to provide PM schedule of availability (probably close PM production line for a few months) – needs to be communicated with BSI
 Shlomo to prepare Rotem & PM
 EU MDR /UKCA submission schedule, communication with BSI:
 One tech file for Relivion + PMI (RLV4) per each region (EU and UK)
 Combined submission MDR+UKCA- still not clear; discussions on UKCA strategy
 MDR QMS transition audit will be combined with 2022 surveillance audit (October 2022)
 Pending MDR submission data to BSI in order to schedule the actual submission
 FDA MDR reporting system establishment – in process (may need outsource)
 EUDAMED registration – initiated
 Gap analyses –
 MDR, UKCA – gap analyses in process, including “app controls the device”
 FDA - gap analysis app controls the device” feature - done
 QMS maintenance:
 Quality forms update – in process
 Training plan compliance- initiated, maybe placed on hold due to resources
 Advanced Medical SOPs- Lauren & Shlomo working on this (2 new SOPs finalized: UM print outs, PMI accounts set up- not sure status of training & implementation)