Solana Company Q1 FY2022 Earnings Call

· Earnings call transcript and AI-powered summary

  • PoNS Therapy U.S. Launch: Q1 2022 marked the commercial launch of PoNS Therapy in the U.S. for gait deficit in patients with mild-to-moderate MS. The therapy combines neuromodulation with supervised physical therapy to stimulate neuroplasticity and improve gait function.
  • Therapeutic Experience Program (TEP): This open-label observational trial aims to evaluate PoNS Therapy in real-world scenarios. TEP launched in Q4 2021 with a 2022 goal to treat 40–50 patients across 10–12 Centers of Excellence. NYU Langone Health is among the planned sites.
  • Pricing and Reimbursement Strategy:
    • U.S. list price for PoNS: $25,700 (Controller: $17,800, Mouthpiece: $7,900).
    • Sales are currently on a cash-pay basis, with third-party coverage in development.
    • Helius targets inclusion in CMS's Transitional Coverage for Emerging Technologies (TCET) due to PoNS' FDA breakthrough designations in MS and stroke.
  • Prescription Activity: 23 prescriptions received to date, with 2 patients purchasing on a cash-pay basis. Most patients are awaiting insurance reimbursement decisions.
  • Marketing & Sales Rollout:
    • Efforts are focused on neurologists (approx. 16,000 in the U.S.), PTs, and patients.

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Operator: Welcome to the Helius Medical Technologies Q1 2022 Earnings Conference Call. My name is Richard, and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. As a reminder, the conference is being recorded. I'll now turn the call over to Judy DiClemente. You may begin. Judy DiClemente: Thank you, operator. Welcome to the first quarter 2022 earnings conference call for Helius Medical Technologies. This is Judy DiClemente of In-Site Communications, Investor Relations for Helius. With me on today's call are Dane Andreeff, Helius Medical’s President and Chief Executive Officer; Jeff Mathiesen, Chief Financial Officer; Antonella Favit-Van Pelt, Chief Medical Officer; and Fred Fantazzia, Vice President-Sales and Marketing, North America. At this time, all participants have been placed in a listen-only mode. Please note that this call is being recorded and access to the webcast can be obtained through the Investors section of the Helius website at www.heliusmedical.com. Before we begin, I would like to remind everyone that our remarks and responses to your questions today may contain forward-looking statements that are based on the current expectations of management. These forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including those identified in the risk factors section of our most

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