Mind Cure Health (MCURF) Maxim Report
Psychophysiology Laboratory at the University of Texas in Austin, and Dr. Robert Pyke, who led Addyi though P2 and P3. The company has completed the draft research protocols for MDMA + psychotherapy in HSDD and pre-IND meetings are planned to be scheduled for C1Q22 with a P2 study to follow in C3Q22. iSTRYM mental health digital therapeutics update. iSTRYM leverages AI to improve psychedelic-assisted psychotherapy outcomes, provide and distribute personalized treatment protocols, and extend therapeutic interventions beyond the clinic. The launch initially targets psychedelic centers and is planned to expand to integrated clinics (traditional and psychedelic medicine) and eventually the broader mental health market. Initial minimal viable product (MVP) launch is currently underway and MINDCURE has exceeded its goal to expand to 10 clinics during the MVP launch before YE21, with 20 ketamine clinics across 9 states using iSTRYM. The full launch is planned for C1Q22 and expansion to Europe by YE22. Management expects to serve 150 customers by C4Q22 and intends to file for FDA approval under the software as a medical device (SaMD) pathway, streamlining reimbursement and providing validation as a therapeutic intervention. One of the key value drivers for iSTYRM is its use as a distribution platform for protocols in psychedelic medicine (and potentially mental health more broadly). The company recently made progress on this front with a non-binding letter of intent signed with Awakn (AWKNF - Buy) to distribute its KARE protocol for ketamine in alcohol use disorder (AUD) in North America (see note 10/28, LINK ). We note KARE is the only P2 validated protocol for ketamine in AUD. MINDCURE also plans to release an additional internally developed ketamine protocol to build on its existing library in C1Q22. MINDCURE recently announced that its Integration Protocol Research Study has completed with the data being incorporated into the MVP version of iSTRYM; the next step is publication. This research should provide MINDCURE with a better understanding of best practices for integration therapy and help build out iSTRYM to be a best in class tool for psychedelic medicine. 2 Maxim Group LLC Mind Cure Health Inc. (MCURF) INSTITUTIONAL USE ONLY
Made with FlippingBook
RkJQdWJsaXNoZXIy NDMyMDk=