Solana Company

Good day and thank you for standing by. Welcome to the Helios Medical Technologies first quarter 2024 earnings conference call. At this time, all participants are in 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 need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised today's conference is being recorded. I would like to have the conference review speaker today, Michelle Bilski, with Insight Communications. Please go ahead.

Thank you, Kevin. Welcome to the first quarter 2024 earnings conference call for Helios Medical Technologies. This is Michelle Dilski 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, including statements regarding potential reimbursement pricing, involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including those identified in the risk factor 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 May 13, 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.

Great. Thanks, Michelle. And thank you to everyone joining us today on Helios Medical's first quarter 2024 conference call. In 2024, our focus remains on two things, securing widespread reimbursement for PONs and achieving FDA approval for stroke. We've made progress on both fronts and are confident these milestones are just around the corner. The $6.4 million financing we just announced last week, which extends our cash runway into 2025, will help get us there. I'll start with our pursuit of widespread reimbursement for PONS. We are pleased that CMS Medicare understood the benefits of this innovative treatment and established HCPCS codes for both the PONS mouthpiece and controller, which went into effect on April 1st. This was a critical reimbursement and access milestone, and the unique HCPCS codes give us the ability to begin negotiating reimbursement with third-party payers. As a reminder, the list price for the PONS device in North America, where it's indicated, is $25,700, comprised of $17,800 for the controller and $7,900 for the the mouthpiece. Earlier this month, we were pleased to learn that CMS had released its preliminary Medicare payment determinations for the PONS controller and mouthpiece and placed Helios on the agenda for the public meeting with CMS on May 29th. As the preliminary payment determination is subject to change, we are looking forward to presenting arguments at the meeting on the 29th to support higher reimbursement rates. PONS is different from any neuromuscular peripheral stimulation therapy, and so for the controller, we'll advocate using the gap-filling methodology based on our list price versus mapping it out to other not comparable neuromuscular stimulation devices. For the mouthpiece, we will argue that is actually a supply that is applied to an individual's tongue. And therefore, the lump sum payment structure is more appropriate than the cap rental structure set in the preliminary determination. And therefore, the gap filling should be done using the list price. We believe in a we are in a good position to secure higher rates than those established in the preliminary determination. Once finalized, the payment rates are expected to be effective October 1, 2024. We believe the final determination of these rates will make it easier to expand reimbursement across third-party payers, creating a pathway to positive cash flow as we continue working to secure FDA authorization under PON's breakthrough designation for stroke. We look forward to keeping you updated on our evolving discussions with CMS. Turning now toward our pursuit of stroke authorization in the United States, We made several important strides towards this objective during the quarter by adding six more sites to the stroke pathway in both the U.S. and Canada. Based on encouraging results from an earlier trial, as well as real-world evidence from Canada where PONS is already authorized for treatment of stroke, The clinical program aims at establishing the effects of cranial nerve non-invasive neuromodulation using PONS therapy on gait and dynamic balance in chronic stroke survivors. Since gait and balance deficit is a medical condition that almost inevitably leads to falling and increases the healthcare cost burden for these patients, The stroke registrational program also aims at confirming our real-world evidence that PUNS therapy significantly reduces the risk of falling in at least 28% of stroke patients with gait and balance deficits as compared to the average 1% to 3% from physical therapy alone. In January, we announced the addition of Brooks Rehabilitation Hospital to our stroke clinical program, and it is the first site to have started enrolling patients in the open label study, which is an integral part of our stroke registration program because it brings the PONS clinical experience to additional sites in the United States. Last month, we announced the participation of Shepherd Center, in our registrational program. Recruitment for the single-arm study begins this month with a goal of enrolling eight to 10 participants by the end of the year. Shepherd Center has already been a valuable partner for Helios as part of our PONS Therapeutic Experience Program, which was designed to evaluate the impact of subject adherence to PONS therapy in people with multiple sclerosis MS. In addition to adding more sites to our stroke pathway during the quarter, we aligned with the FDA on our development plan to significantly streamline the size, timeline, and the cost of the registrational program. We are targeting regulatory submission by early 2025 with the goal of receiving marketing authorization utilizing PON's breakthrough designation in stroke later in the year. Well over 5 million stroke survivors in the United States are affected by walking and balance disability, and we are excited for this groundbreaking treatment to reach those who need it. As we continue to pursue stroke approval, we remain committed to getting PONS therapy into the hands of more people suffering gait imbalance impairment due to MS. Those efforts include ongoing engagement with the physical therapist community. And we now have PONS-trained therapists located nationwide. We attended recently the American Physical Therapy Association combined sections meeting, where we had the opportunity to further highlight PONS therapeutic benefits. PTs are critical to patient success with PONS, and we're always eager to engage with this important group. Last quarter, I mentioned our efforts to target the Department of Veterans Affairs, which is the largest integrated healthcare system in the United States and sees more than 28,000 cases of MS annually. I'm pleased to report that we're officially partnered with Lovell Government Services, an approved supplier to the VA and DOD, to make PONS available to federal healthcare systems. We've seen firsthand how PONS therapy has improved the lives of veterans suffering from MS, and we're thrilled that more service members will have access to this treatment. Turning now to our Canadian activities. In Canada, where PONS is already authorized for stroke, we are currently working to establish sites in five separate administration regions as parts 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 initiative will not only accelerate adoption in Canada, but also benefit our pursuit of market access and third-party coverage here in the United States. Moving into the rest of 2024, achieving reimbursement and making progress on our stroke registrational program remain our top priorities, and both sites, both goals are in sight. We could achieve CMS reimbursement as early as October 1st, which would enable us to expand reimbursement across third-party payers, significantly boosting our revenues and giving us a pathway to positive cash flow as we pursue authorization for stroke. With that, let me turn the call over to Jeff to discuss our first quarter financial resorts in more detail.