Solana Company

Good day, and thank you for standing by, and welcome to Helios Medical Technologies, Inc., Q4 2023 Earnings Conference Call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you'll need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Michelle Bilski, Insight Communications. Please go ahead.

Thank you, operator. Welcome to the fourth quarter 2023 earnings conference call for Helios Medical Technologies. This is Michelle Bilski of Insight Communications, Investor Relations for Helios. With me on today's call are Dane Andrees, Helios Medical's President and Chief Executive Officer, and Jeff Mathieson, Chief Financial Officer. 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 investor section of the Helios website at www.heliosmedical.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 indicating, including those identified in the risk factors section of our most recent annual report on Form 10-K. Such factors may be updated from time to time in our other filings with the SEC, which are available on our website. All statements made during this call are as of March 28, 2024. We undertake no obligation to publicly update or revise our forward-looking statements as a result of new information, future events, or otherwise, except as required by law. I would now like to turn the call over to Dane Andrews, President and Chief Executive Officer of Helios.

Thanks, Michelle, and thank you to everyone joining us today on Helios Medical's fourth quarter 2023 earnings conference call. I'm happy to report that during 2023 and over the past few months, we've taken several meaningful steps towards two important milestones in the United States. achieving widespread reimbursement for PONS and FDA approval for stroke. I'll start with our pursuit of broad reimbursement for PONS. As you know, PONS is currently authorized in the United States to treat gait deficit due to mild to moderate symptoms from MS. We are thrilled that CMS recently assigned us unique codes for both PONS controller and the Ponds mouthpiece effective April 1, 2024. These codes allow us to begin negotiating reimbursement with third-party payers and gives us the option to submit claims on a case-by-case basis. We now expect to engage with CMS in the coming weeks and at the public meeting this summer with the objective of securing Medicare reimbursement for the PONS controller and mouthpiece in their next cycle. If we are successful, reimbursement will be effective October 1st, 2024. To further support our reimbursement efforts, we anticipate getting primary endpoint data from PONS staff during the third quarter with preliminary study results communication before year-end. As a reminder, PONSSTEP is a company-sponsored research trial designed to evaluate the impact of MS patients' adherence to PONS therapy in a real-world clinical setting. We expect data from this program to underscore the effectiveness of PONS in treating gait imbalance impairment, as well as its long-term therapeutic benefits. we initiated efforts to target the Department of Veterans Affairs. Through their nationwide multiple sclerosis centers of excellence, the VA provides healthcare services to veterans with MS from the time of diagnosis and through the rest of their lives. And more than 28,000 cases are reported to the VA annually. Expect to establish a partnership with an authorized supplier to the VA in the near future. Now onto the achievements we made towards our goal of securing U.S. commercial authorization for stroke. In the U.S., over 5 million stroke survivors are affected by walking and balance disability and falling is a prevalent concern for stroke survivors. Clinical evidence out of Canada shows that patients treated with PONS therapy see substantial improvement in gait imbalance. Furthermore, in the real-world database analysis, the majority of the patients before starting PONS therapy were at risk of falling. While routine rehabilitation physical therapy provides about a 1% to 3% reduction in risk, remarkably, after 14 weeks of treatment with PONS therapy, 28% of the patients were no longer at fall risk. This is a clinically meaningful and impactful improvement. Fall-related events are dangerous to the patient, resulting in additional injuries and new or lengthened hospital stays, which presents a significant financial burden to the healthcare system. With the average treatment cost per fall estimated at $64,500. If you compare that to the number to our list price of PONS system at $25,700, the health economic equation greatly favors the use of PONS. With PONS therapy, we have a huge opportunity to improve the lives of patients suffering from stroke, while also helping to reduce the considerable fall-related economic burden to providers, which totals an estimated of $50 billion per year. In Canada, where PONS is already authorized for stroke, the government and providers are already starting to see the clinical and economic benefit of PONS. Early in the fourth quarter, we received a letter of intent from the Quebec Ministry of Health and Social Services to purchase 30 PONS devices. We are currently working to establish five sites in five separate administrative regions as part of a government-funded initiative designed to further validate the effectiveness of PONS therapy when used by patients suffering the effects of stroke. We believe this program will not only accelerate adoption in Canada, but will also increase the body of therapeutic evidence toward our pursuit of market access and third party coverage here in the United States. Also critical to achieving market access is our ongoing investigator initiated placebo-controlled study by Dr. Steven Couch at the Medical University of South Carolina, which evaluates the effects of cranial nerve non-invasive neuromodulation delivered using PONS therapy on gated dynamic balance in chronic stroke survivors. We also began an open-label study as part of our registrational program, raising the total number of participants between the two studies to approximately 100. In January, Brooks Rehabilitation Hospital joined the program as a second site to Dr. Couch's study and is now also the first site to have start enrolling patients in the open-label study. We believe that bringing POND's clinical experience to additional sites in the U.S., through the open label study will further support our stroke authorization efforts. We also recently aligned with the FDA on our stroke development plan. Through this plan, we could leverage the randomized control study at MUSC as part of the registration program along with the open label study and real-world evidence from Canada to significantly streamline the size, timeline, and the cost of the registrational program. A more efficient path to approval is great news not only for Helios, but also for the millions of stroke survivors in the U.S. who could benefit from PONS therapies. We are targeting regulatory submission by early 2025 with a goal of receiving marketing authorization utilizing PONS breakthrough designation in stroke later in the same year. If authorized to treat stroke in the US, PONS would be eligible for the proposed transitional coverage of emerging technologies or TSET pathway, which would expedite Medicare coverage