Solana Company

Thank you all for standing by, and welcome to the Helios Medical Technologies Q3 2021 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. I'll now turn the call over to your host, Judy DiClemente. Ma'am, you may now begin.

Thank you, Jesse. Welcome to the Q3 2021 Earnings Conference Call for Helios Medical Technologies. This is Judy DiClemente of Insight Communications, Investor Relations for Helios. With me on today's call are Dan Andrews, Helios Medical's President and Chief Executive Officer, and Jeff Matthiessen, 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 indicated, including those identified in the risk factors section of our most recent annual report on Form 10-K and quarterly report on Form 10-Q. Such factors may be updated from time to time in our other filings with the FCC, which are available on our website. All statements made during this call are as of November 10, 2021. 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. Dane?

Thanks, Judy. And welcome, everyone, to the Helios Medical's third quarter 2021 earnings conference calls. It's an exciting time for the company as we head toward Q1 2022 commercial launch of our PONS therapy for gait deficit due to mild to moderate symptoms of multiple sclerosis. With approximately 1 million Americans suffering with MS, there is a high unmet need, and PONS is the only medical device for this indication approved in the United States. A few days ago, we received market authorization from the Australian Therapeutic Goods Administration, or the TGA, for the sale of PONS as a Class 2A medical device. We have since confirmed the authorization is for short-term use by healthcare professionals as an adjunct to therapeutic exercise programs to improve balance and gait. And this is the broadest possible scope. We are thrilled that we will be able to introduce this groundbreaking therapy to patients in Australia who need to improve their balance and gait. We'll now begin pursuing the pathway toward commercialization in Australia with the objective of leveraging it to help fund our US commercialization launch. Earlier this week, we announced the launch of our Therapeutic Experience Program, or TEP, with NYU Langone Health as the first of 10 to 12 planned centers of excellence. The TEP study is designed to assess adherence to the portable neuromodulation stimulator, PONS, therapy in patients with multiple sclerosis and will go a long way toward helping Helios and clinicians assess patients' adherence to the PONS therapy in advance of commercialization. We also expect these centers to be among the first commercial sites to offer PONS. For those who may be new to HeLaS, let me provide some background on this innovative therapy that we believe has the potential to improve dynamic gait and balance deficits across a variety of indications. First, PONS stands for portable neuromodulation stimulator. It is the first and only patented therapy combining trigeminal nerve neurostimulation via the tongue with physical therapy to reduce symptoms of neurological disease or trauma. The pond's mouthpiece electrodes stimulate the tongue's surface, sending signals to the brain. This stimulation is believed to help strengthen the neural connections associated with balance and walking when combined with physical rehabilitation. The mechanism of action works through neuromodulation or the modification of the nervous system by targeted stimuli. PONS is designed to induce translingual neurostimulation, that is, trigeminal nerve neuromodulation via the tongue. The device delivers 25 million pulses per 20-minute session. To the patient, it feels like champagne or carbonated water bottles, water bubbles. Another advantage is that there's no procedure or implant involved with PONS. it simply sits on your tongue. Gait deficit is a disabling condition impacting the function, independence, and quality of life for people with MS. And until now, non-pharmaceutical interventions have had limitations. In subjects with gait deficit due to mild to moderate symptoms of MS, 14 weeks of PONS therapy has shown significant gait improvement, compared to physical therapy alone, meaning it's both safe and effective. You can see why we're excited about this groundbreaking therapy. I'll provide more color about our prelaunch strategy, including TEP in a moment, but first I wanted to share another piece of exciting news. In August, PONS was granted a second FDA breakthrough designation, this time for the treatment of dynamic gait and balance deficits resulting from a stroke. This is a significant milestone for Helios, as an estimated 7 million Americans suffer from stroke complications, and that's seven times the number afflicted with MS. Let's take a minute to cover these highlights in more detail. As I mentioned, we plan to bring PONS therapy for treatment of MS-related gait deficits to the market during first quarter 2022. Our commercial efforts in the U.S. will focus on raising awareness upon therapy by engaging three primary audiences. First, neurologists and other physicians who may prescribe our therapy. Second, personnel at key neurorehabilitation centers where likely patients will be treated. And third, MS patients themselves through information campaigns and social media. An important launching pad for commercialization is our therapeutic experience program, or TEP, which I mentioned at the start of this call. TEP is an open-label, interventional, observational, outcome research study, which will be conducted at 10 to 12 centers of excellence, beginning with NYU Langone Health, one of the nation's premier academic medical centers, and Dr. Lee Chevret. In addition to NYU, we plan to partner with neurologists and neurorehab centers, which identified as having the greatest potential to be early adopters of our technology, and initial efforts will focus on the 10 states that comprise more than 50% of the targeted MS patients. Through TEPP, we can establish the relationship between patient's adherence to PONS therapy program, which combines the PONS device with a 14-week physical therapy program and functional improvement. In addition to informing the commercial launch, TEP will enable key opinion leaders in the management of MS to build their knowledge of PONS therapy. We expect to treat 50 to 60 patients in our study. Our other pre-commercial activities, including building inventory, finalizing our distribution model, identifying and onboarding neuro-rehab clinics currently treating MS patients, creating patient access programs, and engaging with KOLs and potential strategic partners. During the quarter, we introduced U.S. PONS treatment website, ponstreatment.com, to expand our online resources for U.S.-based clinicians and patients. We'll also be presenting at several conferences, including ACTRIM, which is the America's Committee for Treatment and Research in Multiple Sclerosis in February 2022, and which is the American Academy of Neurology in April, and then finally the CMSC, the consortium of multiple sclerosis centers in March. We will launch in the U.S. with cash pay customers first while actively pursuing coverage under commercial and government reimbursement programs. Last quarter, we mentioned that we hope to obtain Medicare coverage for our PONS therapy in the United States through the proposed Medicare coverage of the innovative technology or the MSIT rule. which was due to go into effect in December and had the potential to provide FDA-designated breakthrough medical devices and expedited pathway to obtaining nationwide Medicare coverage. On September 15th, CMS published a proposal that would repeal the MSIP pathway. A 30-day comment period was part of the proposal, and while we will continue to monitor this We also remain focused on building out our reimbursement strategy for both commercial and government payers. We are also engaging with commercial payers to establish PONS pricing in line with pricing for comparable devices used in the neurorehabilitation space. Turning now to a brief update on our commercial activities in Canada. Following a period of increased restrictions due to a spike in COVID cases, we are pleased to see Canada making progress toward recovery. An important market in its own right, commercial activities in Canada greatly inform our U.S. commercial launch, providing valuable insight about the PONS therapy. In Canada, PONS is authorized for the treatment of gait deficit due to symptoms of MS, and chronic balance deficit due to traumatic brain injury. We have now established 36 clinics throughout the country of Canada. As excited as we are about the commercialization of ponds for MS in the U.S. and Canadian markets, we see an even bigger opportunity for stroke patients. Of the estimated 7 million Americans who suffer from the physical effects of stroke, 80% experience gait impairment. With breakthrough designation now granted, a pivotal trial of PONS therapy in stroke patients is planned for second quarter 2022 with the aim of obtaining clearance and a second indication. If approved, we are targeting launch commercially during the first half of 2024. With that, let me turn the call over to Jeff to discuss our third quarter financial results.