Heliuk Medical (HMT) introduces patient therapy access program
Mar 9th 2023, 9:40 pm
Analysis: Part 1: Performance of the Company during the Period Heliuk Medical Technologies (HMT) is a neurotechnology company that is primarily focused on neurological wellness. The company’s neurotechnology product, Portable Neuromodulation Stimulator (PoNS), is used for non-implantable neurological treatments. The company has commercialized its product in Canada, the US, and Australia. In terms of revenue, HMT witnessed growth in FY 2021, with revenue increasing from $0.5 million in FY 2020 to $3.6 million in FY 2021. This increase can be attributed to multiple factors, including HMT’s expansion in Canada and the launch of its product in the US market. However, the company’s net losses have been increasing from $12.4 million in FY 2020 to $20.6 million in FY 2021, which can be attributed to the company’s investments in research and development and expansion of its commercial reach. HMT’s product, PoNS, received clearance for short-term treatments of gait and balance deficits due to mild-to-moderate symptoms of neurological conditions like multiple sclerosis, traumatic brain injury, and stroke. The company launched its Patient Therapy Access Program (PTAP) in June 2022, to provide qualifying patients access to PoNS therapy at a significantly reduced price. Furthermore, HMT launched an e-commerce website in December 2022 in the US to make it easier for patients to obtain PoNS systems. Additionally, HMT contracted with an industry consultant to conduct a health economic study of PoNS, which established a U.S. list price for the PoNS device of $25,700, comprised of $17,800 for the controller and $7,900 for the mouthpiece. Part 2: Forward-Looking Analysis HMT’s expansion into the US market is an important milestone for the company but also represents a significant challenge. The company will face stiff competition from established players operating in the US market. HMT’s success will depend on various factors such as the effectiveness of its product, cost competitiveness, and strategic partnerships to reach a wider customer base. The company is bullish on commercial insurance coverage and Medicare reimbursement for PoNS within the Durable Medical Equipment, or DME, benefit category. However, the company currently does not have any applicable Healthcare Common Procedure Coding System, or HCPCS, codes to describe the PoNS device or mouthpiece, which may limit the company’s ability to pursue DME reimbursement. The company has initially applied for unique HCPCS codes during the third quarter of 2021, and the company's plans to collect additional clinical and real-world data to address CMS's questions. The company expects to meet again with CMS in June 2023. Looking ahead, the company will continue to monitor the development of CMS’s new pathway for coverage of innovative new devices, Transitional Coverage of Emerging Technology (“TCET”), which is replacing the repealed Medicare Coverage of Innovative Technologies (“MCIT”) rule to gain CMS reimbursement benefits as a result of its Breakthrough designation in MS. HMT also intends to provide broad access and reimbursement for PoNS therapy over time through commercial insurers. However, the company acknowledges that its primary source of sales is expected to be self-pay patients, and the company plans to support the cost of the PoNS therapy by offering a cash pay discount, collaborating with third parties to provide self-pay patients with financing options, and working with advocacy groups and charitable organizations to help self-pay patients access its technology. Conclusion: HMT’s focus on neurological wellness can be seen as a relevant and innovative strategy. However, the company faces competition from established players in the US market. HMT’s success will primarily depend on the effectiveness of its product, cost competitiveness, and strategic partnerships to reach a wider customer base. The company expects to gain CMS reimbursement benefits as a result of its Breakthrough designation in MS by following the evolution of CMS’s new pathway for coverage of innovative new devices, Transitional Coverage of Emerging Technology (“TCET”), which is replacing the repealed Medicare Coverage of Innovative Technologies (“MCIT”) rule. The company acknowledges its primary source of sales is expected to be self-pay patients, and therefore, the company plans to provide self-pay patients with financing options and also collaborate with advocacy groups and charitable organizations to help self-pay patients access its technology. Overall, while HMT currently faces challenges, the company's innovative strategy and focus on neurological wellness could potentially aid HMT’s growth in the future if the company successfully executes its strategy.