Solana Company Q3 FY2021 Earnings Call

· Earnings call transcript and AI-powered summary

  • Commercial Launch of PoNS: Helius confirmed plans to commercialize PoNS therapy in the U.S. in Q1 2022 for gait deficit due to mild-to-moderate symptoms of multiple sclerosis (MS). PoNS is the only device of its kind approved in the U.S. for this indication.
  • Therapeutic Experience Program (TEP): A new observational study starting with NYU Langone Health and eventually expanding to 10–12 centers. The goal is to assess adherence to PoNS therapy and support early commercial adoption.
  • Australian Market Entry: The company received market authorization from the Australian Therapeutic Goods Administration (TGA) to sell PoNS as a Class IIa medical device, allowing a broad use for balance and gait improvement under healthcare supervision.
  • FDA Breakthrough Designation: PoNS received a second breakthrough designation from the FDA, now also for treatment of dynamic gait imbalance following a stroke—broadening future market opportunities. A pivotal stroke trial is planned for Q2 2022 with potential launch in H1 2024.
  • Canadian Market Update: There are 36 PoNS-authorized clinics in Canada treating gait deficits linked to MS and traumatic brain injury. Recovery from COVID restrictions is underway, supporting commercial activity.

Financial Highlights (Q3 2021 vs Q3 2020)

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Disclaimer*: This transcript is designed to be used alongside the freely available audio recording on this page. Timestamps within the transcript are designed to help you navigate the audio should the corresponding text be unclear. The machine-assisted output provided is partly edited and is designed as a guide.: Operator: 00:06 Thank you all for standing by. And welcome to the Helius Medical Technologies Q3 twenty twenty one Earnings Conference Call and Webcast. Please note that all lines will be in listen-only mode until the question-and-answer session of today's conference. Please also note that today's call is being recorded. 00:24 I'll now turn the call over to your host . Ma'am, you may now begin. Unidentified Company Representative: 00:32 Thank you, Jesse. Welcome to the Q3 twenty twenty one earnings conference call for Helius Medical Technologies. This is of Insight Communications, Investor Relations for Helius. With me on today's call, are Dane Andreeff, Helius Medical’s President and Chief Executive Officer and Jeff Mathiesen, Chief Financial Officer. 00:59 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 to the Investors section of the Helius website at www.heliusmedical.com. 01:15 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 expec

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