Solana Company

Good day, and thank you for standing by. Welcome to the Helios Medical Technologies fourth quarter and year-end 2022 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. Instructions will be given at that time. As a reminder, today's conference may be recorded. I would like to hand the call over to your speaker, Michelle Bilski, Investor Relations.

Please go ahead. Thank you, Operator. Welcome to the fourth quarter and year-end 2022 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 Andreef, Helios Medical's President and Chief Executive Officer, and Jeff Bateson, Chief Financial Officer. Also on the call today is Dr. Antonella Favit-Van Telt, Helios Medical's Chief Medical Officer, who will be available as needed during Q&A. 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 attained through the investor section of the Healius website at www.healiusmedicals.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 factor section of our most recent annual report on Form 10-K and quarterly reports on Form 10-Q. 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 9, 2023. 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.

Thank you, Michelle, and welcome, everyone. It was another strong quarter for Helios and our portable neuromodulation stimulator, or PONS device, which is indicated in North America for treatment of gait deficit due to mild to moderate symptoms of MS when used in conjunction with a supervised therapeutic exercise program. PONDS is also authorized in Canada for the treatment of chronic balance deficit due to mild to moderate traumatic brain injury, or TBI, and just announced this morning for stroke. In the US, PONDS also has an FDA breakthrough designation for stroke in addition to the breakthrough designation for MS, which we believe will be a significant benefit as we seek reimbursement in the United States. During the fourth quarter, the benefits of PONS therapy continued to resonate with healthcare providers, physical therapists, and patients in the US as we added prescribers and trained PTs. Because PONS is the only available portable and readily accessible neurostimulation therapy with the potential to generate neuroplasticity, essentially rewiring parts of the brain. It is a potential game changer for people suffering from gait imbalance impairment. Our mission is to make this important and innovative technology available to as many qualified patients as possible, and we are working to improve access on multiple fronts. Physical therapists, play a key role in PONS treatment, and training them quickly enough to meet demand was a bottleneck we faced early in the U.S. launch. To standardize the process and reduce training time, we introduced an online training module, which allows practitioners who wish to treat MS-related balance and gait deficit to learn remotely at their own pace in three hours or less. instead of through an in-person multi-day course. It has quickly become the primary method for training therapists, which means faster relief for patients. Another way we've improved access is through our recent partnership with Upscript, a leading telehealth company focused on providing medications and devices direct to the consumer. Through PonsTherapy.com, Americans with gait and balance deficits can now access online health evaluations to fill PONS therapy prescriptions through a network of fully licensed providers with e-prescribing capabilities and obtain PONS through home delivery. The initial response has been overwhelmingly positive, and the first devices were shipped in January 2023. patients who are motivated to improve their walking can now take the fight against ms into their own hands sales of pawns devices are currently on a cash pay basis but we don't want cost to be an impediment to use in june 2022 we launched our patient therapy access program or ptap which provides patients access to on label pawns therapy at an early 85% discount to list price. PTAP was scheduled to expire at the end of 2022, but we're pleased to announce that we're extending this program through June of 2023. The vast majority of U.S. Ponds device prescriptions in the fourth quarter were through the PTAP program. The Neurology Center of New England has been an important contributor to our PTAP program. And we were thrilled to add the institution to our PONS therapeutic experience program. PONS-STEP is an open-label observational trial that allows us to partner with some of the nation's premier academic medical centers to observe PONS therapy in a real-world setting while enabling the key opinion leaders in MS management to build their knowledge, and advise the broader medical community. During the fourth quarter, we also added MGH, Institute of Health Professions, and Oregon Health and Science University to the program, bringing the total number of PONSTEP centers of excellence to five as of today. To most effectively help those suffering from balance and gait impairment, it's critical that we engage not only the patients, but also the two other PONS therapy stakeholders, the neurologists who prescribe PONS and the physical therapists who oversee the treatment. You've already heard how we've improved and streamlined the training process for physical therapists, and we continue to maintain an active dialogue with the group in order to best serve them and their patients. We just returned from the American Physical Therapy Association's conference for physical therapists, national and regional PT clinics and neural rehab specialists, and have well over 200 leads to follow up on. Interacting with the broader neurology community, as we have with PONCEP, is another key to properly educating patients and providers about the mechanism of action and benefits of PONCE. In April, we will be attending the American Academy of Neurology annual meeting in Boston, and at the end of May, we'll be at the Consortium of Multiple Sclerosis Centers annual meeting in Denver, which is attended by the MS Centers of Excellence focused on MS neurologists. Turning to our Canadian activities, at the end of 2022, PONS was authorized for sale in Canada for chronic balance deficit due to mild to moderate traumatic brain injury. as well as mild to moderate symptoms of MS. Yesterday, we learned that Health Canada extended PONS indication to include use as a short-term treatment of gait deficit to mild to moderate symptoms from stroke. An estimated 870,000, 78,000 Canadians are currently living with stroke, with more than 89,000 new strokes occurring every year and gait impairment is a major source of post-stroke disability. A real-world evidence database analysis showed that mild and moderate stroke patients using PONS therapy experienced an average six to seven point improvement in their functional gait assessment score over the 14-week treatment period. which far exceeds the 4.2 minimal detectable change usually seen in stroke patients. Before starting treatment, most patients were considered at risk of falling. But after 14 weeks of PON therapy, 28% of the patients were no longer at risk of falling. Routine rehabilitation physical therapy does not usually provide a meaningful reduction in this risk, usually in the 1 to 3% range. So this is a significant improvement. PONS has been commercially available in Canada since 2019 for MS and TBI, and we're happy that Health Canada authorized PONS for stroke, enabling Helios to deliver clinically meaningful benefits for stroke patients as well. This was a huge win for Helios and for Canadians suffering balancing gait impairment as it's become evidence that PONS therapy employs a shared mechanism of action and provides a significant and clinically meaningful improvement in balancing gait, regardless of the underlying medical condition. We also recently extended our partnership agreement with Canada's Health Tech Connect a leading health technology company specializing in neurotechnology innovation. This agreement grants HTC the exclusive right to purchase, market, and sell and distribute ponds through the metropolitan Vancouver area, subject to certain minimums. The initial term is for five years, with the possibility to extend it to 10 years. HTC has been an instrumental partner for Helios, and we're excited to strengthen our relationship and expand our presence across Vancouver through HTC's network of leading-edge neural rehabilitation clinics. Other exciting developments are underway in Canada, and we hope to share them very soon. Though it is currently a smaller market for us, we believe Canada's growth potential parallels the U.S. market in the near term due to the multiple indications, in particular, TBI and now stroke. With that, let me turn the call over to Jeff to discuss our fourth quarter financial results in detail.