Q2 2024 Helius Medical Technologies Inc Earnings Call

August 12, 2024

Speaker Change: Good day and thank you for standing by. Welcome to the Helios Medical Technologies second quarter 2024 earnings conference call. At this time, all participants are in a listen only mode.

Operator: 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 will need to press star one, one on your telephone. You will then hear an automated message advising your hand is raised.

Operator: 2024 Earnings Conference. At this time, all participants are in a listen-only mode.

Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is free. For all your questions, please press star 11 again. Please be advised that today's conference is being adjourned. I would now like to hand the conference over to your speaker today, Michelle Bilski.

Speaker Change: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised.

Operator: To ask your question, please press star 1 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.

Speaker Change: To withdraw your question, please press star 1 1 again

Speaker Change: Please be advised that today's conference is being recorded.

Michelle Bilski: Investor Relations for Helius Medical. Please go ahead. Thank you, operator. Welcome to the second quarter 2024 earnings conference call for Helius Medical Technologies. This is Michelle Bilski of Insight Communications, Investor Relations for Helius. With me on today's call are Dane Andreeff, Helius Medical's President and Chief Executive Officer.

Michelle Bilski: Investor Relations. Please go ahead. Thank you, operator. Welcome to the second quarter of 2024 earnings conference call for Helius Medical Technology. This is Michelle Bilski of Insight Communications, Investor Relations for Helius. With me on today's call are Dane Andreeff, Helius Medical's President and Chief Executive Officer, and Jeff Mathiesen, Chief Financial Officer. At this time, all participants have been placed in a listen-only mode.

Speaker Change: I would now like to hand the conference over to your speaker today.

Speaker Change: Michelle Bilski, Investor Relations for Helios Medical. Please go ahead.

Michelle Bilski: Thank you, operator. Welcome to the second quarter 2024 earnings conference call for Helius Medical Technologies. This is Michelle Bilski of Insight Communications, Investor Relations for Helius. With me on today's call are Dane Andreeff, Helius Medical's President and Chief Executive Officer, and Jeff Mathiesen, Chief Financial Officer. At this time, all participants have been placed in a listen-only mode.

Michelle Bilski: Thank you, Operator. Welcome to the second quarter of 2024 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 Andreeff, Helios Medical's President and Chief Executive Officer, and Jeff Mathiesen, Chief Financial Officer.

Michelle Bilski: Please note that this call is being recorded, and access to the webcast can be obtained through the investor section of the Helius website at www.heliusmedical.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 and our most recent quarterly report on Form 10-Q.

Michelle Bilski: Please note that this call is being recorded, and access to the webcast can be obtained through the investor section of the Helius website at www.heliusmedical.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 for the webinar. 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 and our most recent quarterly report on Form 10-Q.

Speaker Change: 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

Michelle Bilski: 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 August 12, 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.

Speaker Change: 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.

Speaker Change: These forward-looking statements, including statements regarding potential reimbursement pricing,

Speaker Change: 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 our most recent quarterly report on Form 10-Q.

Speaker Change: Sites 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 August 12, 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.

Speaker Change: I would now like to turn the call over to Mr. Andreeff.

Speaker Change: Dane, Dane, Dane,

Speaker Change: Dane Andreeff, Michelle Bilski, Michelle Bilski,

Speaker Change: Thank you for watching, see you in the next video!

Dane Andreeff: I would now like to turn the call over to Mr. Andreeff. Thanks, Michelle. And thank you, everyone, for joining us today on Helius Medical's second quarter 2024 earnings conference call. During 2024, our priority has been to get PONS therapy to as many people suffering from MS as possible. We've seen firsthand how our innovative technology makes a meaningful difference in a patient's fight against gait and balance deficit, a common but devastating symptom of MS. And I'm proud to say our efforts during the second quarter and recently have generated significant momentum toward greater access. Operator. All right. Yeah. Go ahead, Dane.

Dane Andreeff: Thanks, Michelle. And thank you, everyone, joining us today on Helius Medical's second quarter 2024 earnings conference call. During 2024, our priority has been to get PONS therapy to as many people suffering from MS as possible. We've seen firsthand how our innovative technology makes a meaningful difference in a patient's fight against gait and balance deficit, a common but devastating symptom of MS. And I'm proud to say our efforts during the second quarter and recently have generated significant momentum toward greater access. Operator. All right.

Speaker Change: Thanks for watching!

Dane Andreeff: I was going to step in. Go ahead. Yeah, I'm getting a lot of feedback. This line isn't working properly.

Michelle Bilski: Thanks, Michelle, and thank you, everyone, joining us today on Helios Medical's second quarter 2024 earnings conference call.

Michelle Bilski: During 2024, our priority has been to get PONS therapy to as many people suffering from MS as possible.

Speaker Change: We've seen first-hand how our innovative technology makes a meaningful difference in a patient's fight against gait and balance deficit, a common but devastating symptom of MS.

Speaker Change: And I'm proud to say our efforts during the second quarter and recently have generated significant momentum toward greater access.

Speaker Change: https://www.kenhub.com

Speaker Change: Thank you very much for watching this video and I'll see you in the next video.

Speaker Change: [inaudible]

Speaker Change: Operator. All right.

Operator: Go ahead, Dane. I was going to step in. Go ahead.

Dane Andreeff: Yeah, I'm getting a lot of feedback. This line isn't working properly. So, Jeff, do you want to step in, please? I'll, I'll keep going.

Speaker Change: Yeah.

Speaker Change: Go ahead, Dane. I was going to step in. Go ahead.

Jeff Mathiesen: So, Jeff, do you want to step in, please? I'll keep going, and why don't you dial back in and give another shot? Specifically, in April, we partnered with Lovell Government Services and SBA Certified Service Disabled Veteran Owned Small Business to make PONS therapy accessible to MS patients treated at the Veterans Administration and through our other federal agencies. The VA is the largest integrated health care system in the United States and home to a network of multiple sclerosis centers of excellence.

Speaker Change: Yeah, I'm getting a lot of feedback. This line isn't working properly. So, Jeff, do you want to step in, please?

Jeff Mathiesen: I'll keep going, and why don't you dial back in and give it another shot? Specifically, in April, we partnered with Lovell Government Services and SBA Certified Service Disabled Veteran Owned Small Business to make PONS therapy accessible to MS patients treated at the VA and to our other federal agents. The VA is the largest integrated health care system in the United States and home to a network of multiple sclerosis centers of excellence.

Speaker Change: I'll keep going and why don't you dial back in and give it another shot.

Speaker Change: Specifically, in April, we partnered with Lovell Government Services and SBA Certified Service Disabled Veterans Owned Small Business.

Speaker Change: to make PONS therapy accessible to MS patients treated at the VA and through our other federal agencies.

Speaker Change: The VA is the largest integrated health care system in the United States and home to a network of multiple sclerosis centers of excellence.

Jeff Mathiesen: The VA estimates that between 55,000 and 70,000 veterans in the U.S. live with MS. As the only portable and readily accessible therapy that may lead to neuroplasticity, PONS is a potential game changer for these veterans and their families, and we're happy to be a preferred provider and help more service members access this treatment. Shortly thereafter, in May, PONS was approved for inclusion and levels via a federal supply schedule and the General Services Administration Advantage contracts at prices of $23,843.72, and $7,344.97 for the PONS device and the PONS mouthpiece, respectively.

Speaker Change: The VA estimates that between 55,000 and 70,000 veterans in the U.S. live with MS.

Speaker Change: as the only portable and readily accessible therapy that may lead to neuroplasticity.

Speaker Change: PONS is a potential game-changer.

Speaker Change: to these veterans and their families, and we're happy to be a preferred provider and help more service members access this treatment.

Speaker Change: Shortly thereafter, in May, PONS was approved for inclusion and levels via Federal Supply Schedule.

Speaker Change: and the General Services Administration Advantage contracts at pricing of $23,843.72.

Jeff Mathiesen: $7,344.97 for the PONS device and the PONS mouthpiece, respectively. Also, in May, we received the first third-party reimbursement of $23,900 from a major insurance carrier for a PONS device. Then, in July, PONS was approved for inclusion in Lovell's DAPA contract for the Department of Defense, at $23,724.57 for the PONS device and $7,308.25 for the PONS mouthpiece, respectively. These were all important accomplishments in establishing market pricing for PONS as we pursue reimbursement at CMS and third-party payers. Last quarter.

Speaker Change: and $7,344.97 for the PONS device and the PONS mouthpiece, respectively.

Jeff Mathiesen: Also in May, we received the first third-party reimbursement of $23,900 from a major insurance carrier for Ponce de Valle. Then, in July, PONS was approved for inclusion in Lovell's DAPA contract for the Department of Defense, at $23,724.50 and $7,308.25 for the PONS device and the PONS mouthpiece, respectively. These were all important accomplishments in establishing market pricing for PONS as we pursue reimbursement at CMS and third-party payers. Last quarter.

Speaker Change: Also in May, we received the first third-party reimbursement of $23,900 from a major insurance carrier for a PONS device.

Speaker Change: Then in July, PONS was approved for inclusion in Lovell's DAPA contract for the Department of Defense at $23,724.50.

Speaker Change: and $7,308.25 for the PONS device and the PONS mouthpiece, respectively.

Speaker Change: These were all important accomplishments in establishing market pricing for PONDS as we pursue reimbursement at CMS and third-party payers.

Jeff Mathiesen: CMS assigned HCPCS codes covering the PONS controller and mouthpiece and in May released its preliminary Medicare payment determinations for both. This was a significant reimbursement and access milestone for Helius, and we were gratified to know that CMS understood the benefits of this innovative treatment.

Jeff Mathiesen: CMS-assigned HCPCS codes covering the PONS controller and mouthpiece and in May released its preliminary Medicare payment determinations for both. This was a significant reimbursement and access milestone for Helius. And we were gratified to know that CMS understood the benefits of this innovative treatment. We were pleased with this development, but believe there is a strong argument for higher reimbursement rates for both the mouthpiece and the controller, which we presented at the CMS public meeting on May 29th, as well as in subsequent written communication.

Speaker Change: Last quarter

Speaker Change: CMS-assigned HCPCS codes covering the PONS controller and mouthpiece.

Speaker Change: and in May released its preliminary Medicare payment determinations for both.

Speaker Change: This was a significant reimbursement and access milestone for Helios.

Speaker Change: And we were gratified to know that CMS understood the benefits of this innovative treatment.

Jeff Mathiesen: We were pleased with this development, but believe there is a strong argument for higher reimbursement rates for both the mouthpiece and the controller, which we presented at the CMS public meeting on May 29th, as well as in subsequent written communication. First, we argued that it was appropriate to categorize the mouthpiece as a supply item to be reimbursed on a lump sum payment structure. As a reminder, the mouthpiece has a 14-week life and involves application to a patient's tongue.

Speaker Change: We were pleased with this development, but believe there is a strong argument for higher reimbursement rates for both the mouthpiece and controller, which we presented at the CMS public meeting on May 29th.

Jeff Mathiesen: First, we argued that it was appropriate to categorize the mouthpiece as a supply item to be reimbursed at a lump sum payment structure. As a reminder, the mouthpiece has a 14-week life and involves application to a patient's tongue. Therefore, we believe a 13-month cap rental structure is not appropriate.

Speaker Change: as well as in subsequent written communications.

Speaker Change: First, we argued that it was appropriate to categorize the mouthpiece as a supply item.

Speaker Change: to be reimbursed on a lump sum payment structure.

Speaker Change: As a reminder, the mouthpiece has a 14-week life and involves application to a patient's tongue.

Jeff Mathiesen: So, therefore, we believe a 13-month cap rental structure is not appropriate. Additionally, we provided recent contract pricing and invoices to support the market pricing at pricing levels I previously discussed. Abuse for Setting String of the reimbursement using the gap filling method. We also articulated how PONS is not a neuromuscular peripheral stimulation therapy. And therefore, it is not appropriate to map pricing to such devices.

Speaker Change: So therefore, we believe a 13-month cap rental structure is not appropriate.

Jeff Mathiesen: Additionally, we provided recent contract pricing and invoices to support the market pricing at pricing levels I previously discussed. Abuse for Setting in of reimbursement using the GAP billing method. We also articulated how PONS is not a neuromuscular peripheral stimulation therapy. And therefore, it is not appropriate to map pricing to such devices.

Speaker Change: Additionally, we provided recent contract pricing and invoices to support the market pricing at pricing levels I previously discussed.

Speaker Change: to be used for setting...

Speaker Change: of the reimbursement using the gap filling method.

Speaker Change: We also articulated how ponds

Speaker Change: is not a neuromuscular peripheral stimulation therapy and therefore it is not appropriate to map pricing to such devices.

Jeff Mathiesen: Instead, we argued reimbursement for the controller should be established using the gap-filling methodology based on market price. CMS is expected to publish final reimbursement rates in the coming week. Once finalized, the payment rates will be effective on October 1st, 2024. We are also actively assisting several MS patients as they submit claims with other third-party payers on a one-off basis in attempts to secure reimbursement. Beginning in June, we began building out a sales rep organization to service the VA sites throughout the U.S. To date, we have established sales representatives in 13 states, including Texas and Florida, plus Puerto Rico.

Jeff Mathiesen: Instead, we argued reimbursement for the controller should be established using the gap-filling methodology based on market prices. CMS is expected to publish final reimbursement rates in the coming week. Once finalized, the payment rates will be effective on October 1st, 2024.

Speaker Change: Instead, we argued reimbursement for the controller should be established using the gap-filling methodology based on market pricing.

Speaker Change: CMS is expected to publish final reimbursement rates in the coming weeks.

Speaker Change: Once finalized, the payment rates will be effective October 1, 2024.

Jeff Mathiesen: We are also actively assisting several MS patients as they submit claims with other third-party payers on a one-off basis in attempts to secure reimbursement. Beginning in June, we began building out a sales rep organization. Service, the VA sites throughout the U.S. To date, we have established sales representatives covering 13 states, including Texas and Florida, plus Puerto Rico. We believe having boots on the ground representatives focused on neurological disorders and that have established relationships with the individual VA sites will be critical to building out sales across the VA facilities in the U.S. I'll pause for a second and just see if Dane has rejoined.

Speaker Change: We are also actively assisting several MS patients as they submit claims with other third-party payers on a one-off basis in attempts to secure reimbursement.

Speaker Change: and Dane Andreeff. Thank you. Bye bye.

Speaker Change: Beginning in June, we began building out a sales rep organization.

Speaker Change: the service of VA sites throughout the U.S.

Speaker Change: To date, we have established sales representatives covering 13 states including Texas and Florida plus Puerto Rico.

Jeff Mathiesen: We believe having boots on the ground representatives focused on neurological disorders and that have established relationships with the individual VA sites will be critical to building out sales across the VA facilities in the U.S. I'll pause for a second and just see if Dane has rejoined. He has.

Speaker Change: We believe having boots-on-the-ground representatives focused on neurological disorders and that have established relationships with the individual VA sites will be critical to building out sales across the VA facilities in the U.S.

Dane Andreeff: I have. Jeff, thank you. Let me continue. Um...

Dane Andreeff: Jeff, thank you. Let me continue. While much of our focus during the quarter was on removing barriers to access and secure reimbursement, we also made meaningful progress toward our pursuit of stroke authorization in the US, where over 5 million stroke survivors are affected by walking and balance disability. The registration program, which includes an investigator-initiated placebo-controlled study at the Medical University of South Carolina and Brook Rehabilitation and a company-sponsored open-label trial, has been fully enrolled.

Speaker Change: I'll pause for a second and just see if Dane has rejoined.

Dane Andreeff: I have. Jeff, thank you. Let me continue.

Dane Andreeff: While much of our focus during the quarter was on removing barriers to access and secure reimbursement, we also made meaningful progress toward our pursuit of stroke authorization in the US, where over 5 million stroke survivors are affected by walking and balance disability. The registration program, which includes an investigator-initiated placebo-controlled study at the Medical University of South Carolina and Brook Rehabilitation and a company-sponsored open-label trial, has been fully enrolled. In June, site participation enrollment in the open-label study, with the addition of top neurorehabilitation centers, such as Rehabilitiam, The Neurology Center of New England, and MGH Institute of Health Professions, started enrolling.

Dane Andreeff: Um...

Speaker Change: While much much of our focus during the quarter was on removing barriers

Speaker Change: to access and secure and reimbursement. We also made meaningful progress toward our pursuit of stroke authorization in the US where over 5 million stroke survivors are affected by walking and balance disability.

Speaker Change: The registration program, which includes an investigator-initiated placebo-controlled study at the Medical University of South Carolina and Brook Rehabilitation, and a company-sponsored open-label trial, has been fully enrolled.

Dane Andreeff: In June, site participation enrollment in the open-label study began, with the addition of top neurorehabilitation centers, such as RehabilitGM, the Neurology Center of New England, and MGH Institute of Health Professions, starting to enroll. This groundbreaking registrational program, which also has the participation of Brooks Rehabilitation and Shepard Center in the Open Label Study, is designed to establish the effects of cranial nerve non-invasive neuromodulation delivered using PONS therapy on gait and balance in chronic stroke survivors. It will also establish POND's therapeutic impact on the risk of falling in US patients.

Speaker Change: In June, site participation enrollment of the Open Label Study with the addition of top neurorehabilitation centers, such as Rehabilit- Rehabili-GYM,

Speaker Change: The Neurology Center of New England and MGH Institute of Health Professions have started enrolling.

Dane Andreeff: This groundbreaking registrational program, which also has the participation of Brooks Rehabilitation and Shepherd Center in the Open Label Study, is designed to establish the effects of cranial nerve, non-invasive neuromodulation delivered using PONS therapy on gain and balance in chronic stroke survivors. It will also establish PON's therapeutic impact on the risk of falling in U.S. patients.

Speaker Change: This groundbreaking registrational program, which also has the participation of Brooks Rehabilitation and Shepherd Center to the Open Label Study, is designed to establish the effects of cranial nerve non-invasive neuromodulation.

Speaker Change: delivered using PONS therapy on gain and balance in chronic stroke survivors.

Speaker Change: It will also establish PARN's therapeutic impact on the risk of falling in U.S. patients.

Dane Andreeff: In addition to enrolling 60 participants in the MUSC study, we anticipate enrolling approximately 30 patients into the open-label study across all sites. By the end of the third quarter, we expect that the results will significantly bolster our FDA submission when we submit for regulatory approval in 2025. The Stroke Registrational Program was established in part based on real world evidence from Canada, where POND is already authorized for the treatment of stroke. To further strengthen the data package for FDA authorization and support national reimbursement in Canada, we've begun an additional Canadian study on the use of PONS therapy to treat stroke with the goal of enrolling 40 to 60 subjects by the end of 2024 at three Centers of Excellence for Stroke Rehabilitation.

Speaker Change: In addition to enrolling 60 participants to the MUSC study, we anticipate enrolling approximately 30 patients into the Open Label Study across all sites.

Speaker Change: And by the end of the third quarter, expect that the results will significantly bolster our FDA submission when we submit for regulatory approval in 2025.

Speaker Change: The Stroke Registrational Program was established in part based on real-world evidence from Canada where PONDS is already authorized for the treatment of stroke.

Speaker Change: to further strengthen the data package submission for FDA authorization.

Speaker Change: and support national reimbursement in Canada.

Speaker Change: We've begun an additional Canadian study on the use of POND therapy.

Speaker Change: to treat stroke with the goal of enrolling 40 to 60 subjects by the end of 2024 at three Centers of Excellence for Stroke Rehabilitation.

Dane Andreeff: The study, which has received approval by the Institutional Review Board in June, has already begun enrolling participants. A new research program to extend established evidence of the effect of on-label primes on risk of falling and stroke patients with gait and balance deficits in Canada has also begun enrolling patients with TBI and MS at three top Canadian neurorehabilitation sites in May.

Speaker Change: The study

Speaker Change: which has received approval by the institutional review boards in June has already started participants enrollment.

Speaker Change: a new research program to extend established evidence.

Speaker Change: Thank you.

Speaker Change: The Effect of Unlabeled Primes on Risk of Falling in Stroke Patients

Speaker Change: with GAIT and Balanced Abstinence in Canada.

Speaker Change: has also begun enrolling patients with TBI and MS at three top Canadian neurorehabilitation sites in May.

Dane Andreeff: We're excited about where we stand at the mid-year of the year. We secured reimbursement with a major third-party insurer, and the expected Medicare price determination to be effective on October 1st will enable us to further expand reimbursement across third-party payers. The number of PONS-trained therapists in the field is growing, and our FDA submission for stroke remains on track. Given all that we've put into place, we see a clear path ahead toward achieving our main goal of removing barriers and helping more people benefit from POND.

Dane Andreeff: We secured reimbursement with a major third-party insurer, and the expected Medicare price determination to be effective October 1st will enable us to further expand reimbursement across third-party payers. The number of PONS-trained therapists in the field is growing, and our FDA submission for stroke remains on track. Given all that we've put in place, we see a clear path ahead toward achieving our main goal of removing barriers and helping more people benefit from POND.

Speaker Change: We're excited about where we stand at the mid-year of the year.

Speaker Change: We secured reimbursement with a major third-party insurer and the expected Medicare price determination to be effective October 1st will enable us to further expand reimbursement across third-party payers.

Speaker Change: The number of PONS-trained therapists in the field is growing, and our FDA submission for stroke remains on track.

Speaker Change: Given all that we've put into place, we see a clear path ahead toward achieving our main goal of removing barriers and helping more people benefit from POND.

Jeff Mathiesen: And with the $6.4 million of financing we announced in May, we extended our runway to cover the key 2024 miles. I'll now turn the call over to Jeff to discuss our second quarter financial results in more detail. Thanks, Dane.

Dane Andreeff: And with the $6.4 million of financing we announced in May, we extended our runway to cover the key 2024 miles. I'll now turn the call over to Jeff to discuss our second quarter financial results in more detail.

Speaker Change: And with the $6.4 million of financing we announced in May, we extended our runway to cover the key 2024 milestones.

Speaker Change: I'll now turn the call over to Jeff to discuss our second quarter financial results in more detail. Thank you.

Jeff Mathiesen: Again, it's a pleasure to be with you today. Total revenue for the second quarter of 2024 was $182,000, a decrease of $74,000 compared to $256,000 in the second quarter of 2023, as a result of the termination of our patient therapy access program on June 30, 2023, and the termination of temporary cash pay pricing in May of 2024. Revenue for the quarter was up 35% compared to the first quarter of 2024 as a result of increased sales in both the U.S. and Canada.

Dane Andreeff: Thanks, Dane.

Jeff: Again, it's a pleasure to be with you today.

Jeff: Total revenue for the second quarter of 2024 was $182,000, a decrease of $74,000 compared to $256,000 in the second quarter of 2023.

Jeff: As a result of the termination of our patient therapy access program on June 30, 2023, and the termination of temporary cash pay pricing in May of 2024.

Jeff: Revenue for the quarter was up 35% compared to the first quarter of 2024 as a result of increased sales in both the US and Canada.

Jeff Mathiesen: For the second quarter of 2024, cost of revenue was $118,000 compared to $184,000 for the prior year period, primarily attributable to lower sales compared to the same period in the prior year. Selling, general, and administrative expenses for the second quarter of 2024 were $2.5 million, remaining relatively flat when compared to the $2.6 million reported in the second quarter of 2020. Research and development expenses for the second quarter of 2024 were $0.9 million compared to $0.7 million in the second quarter of 2023, driven primarily by an increase in clinical trial activities for stroke and riscopolco.

Jeff Mathiesen: For the second quarter of 2024, cost of revenue was $118,000 compared to $184,000 for the prior year period, primarily attributable to lower sales compared to the same period in the prior year. Selling, general, and administrative expenses for the second quarter of 2024 were $2.5 million, remaining relatively flat when compared to the $2.6 million reported in the second quarter of 2024. Research and development expenses for the second quarter of 2024 were $0.9 million compared to $0.7 million in the second quarter of 2023, driven primarily by an increase in clinical trial activities for stroke and the risk of polio. Total expenses for the second quarter of 2024 were $3.3 million. Flatland compared to 3.3 million in the second quarter of 2020.

Jeff: For the second quarter of 2024, cost of revenue was $118,000, compared to $184,000.

Jeff: For the prior year period, primarily attributable to lower sales compared to the same period in the prior year.

Jeff: selling general and administrative expenses for the second quarter of 2024 were 2.5 million dollars compared to remaining relatively flat when compared to the 2.6 million dollars reported in the second quarter of 2023.

Jeff: Research and development expenses for the second quarter of 2024 were $0.9 million compared to $0.7 million in the second quarter of 2023.

Jeff: driven primarily by an increase in clinical trial activities for stroke and risk of fall programs.

Jeff Mathiesen: Total expenses for the second quarter of 2024 were $3.3 million, flatland compared to $3.3 million in the second quarter of 2020. Operating loss for the second quarter of 2024 was $3.2 million, compared to a loss of $3.2 million for the prior year period. We reported a net loss for the second quarter of 2024 of $1.6 million, or a loss of 64 cents per basic and diluted common share. We also had a net loss of $1.6 million in the prior year period, or a loss of $2.92 per basic and diluted time and share due to a higher number of weighted average shares. However, our cash burn from operations was flat at $5.9 million.

Jeff: Total expenses for the second quarter of 2024 were $3.3 million.

Jeff Mathiesen: Operating loss for the second quarter of 2024 was $3.2 million, compared to a loss of $3.2 million for the prior year period. We reported a net loss for the second quarter of 2024 of $1.6 million, or a loss of $0.64 per basic and diluted common share. We also had a net loss of $1.6 million in the prior year period, or a loss of $2.92 per basic and diluted time and share due to a higher number of weighted average shares. Our cash burn from operations was flat at $5.9 million.

Jeff: Flatland compared to 3.3 million in the second quarter of 2023.

Jeff: Operating loss for the second quarter of 2024 was $3.2 million, compared to a loss of $3.2 million for the prior year period.

Jeff: We reported a net loss for the second quarter of 2024 of 1.6 million dollars or a loss of 64 cents per basic and diluted common share.

Jeff: We also had a net loss of 1.6 million dollars in the prior year period or a loss of two dollars and ninety two cents per basic and diluted time and share.

Jeff: due to a higher number of weighted average shares outstanding.

Jeff Mathiesen: So for the six months ended June 30, 2024 and June 30, 2020. As of June 30, 2024, we had $6.4 million in cash and no debt. In May, we closed on a $6.4 million public offering and received net proceeds of $5.5 million, which will extend our cash flow and way into 2025. This financing also includes one-year warrants for an additional $6.4 million of gross proceeds that are callable by the company within 30 days of announcing the final reimbursement determination per PONS controller and mouthpiece by CMS if the stock price trades at or above $2.25 per share for five consecutive days during that

Jeff Mathiesen: So for the six months ended June 30, 2024 and June 30, 2023. As of June 30, 2024, we had $6.4 million in cash and no debt. In May, we closed on a $6.4 million public offering and received net proceeds of $5.5 million, which will extend our cash flow on the way into 2025. This financing also includes one-year warrants for an additional $6.4 million of gross proceeds that are callable by the company within 30 days of announcing the final reimbursement determination for PONS controller and mouthpiece by CMS if the stock price trades at or above $2.25 per share for five consecutive days during

Jeff: Our cash burn from operations was flat at $5.9 million, so the six months ended June 30, 2024 and June 30, 2023.

Jeff: As of June 30, 2024, we had $6.4 million in cash and no debt.

Jeff: In May, we closed on $6.4 million.

Jeff: public offering and received net proceeds of 5.5 million dollars which will extend our cash flow on way into 2025

Jeff: This financing also includes one-year warrants.

Speaker Change: for an additional $6.4 million of gross proceeds that are callable by the company within 30 days of announcing the final reimbursement determination for PONS controller and mouthpiece by CMS.

Speaker Change: if the stock price trades at or above $2.25 per share for five consecutive days during that period.

Jeff Mathiesen: We expect a final determination will be announced in late summer and effective October 1st of this year. If exercised, the additional proceeds from these warrants will fund our operations well into the second half of next year. Turning now to our. To date, POM sales have been muted due to the fact that they have primarily been on a cash pay basis. And as a price point, that is not feasible for the vast majority of patients and our addressable Mark.

Jeff Mathiesen: We expect a final determination will be announced in late summer and effective October 1st of this year. If exercised, the additional proceeds from these warrants will fund our operations well into the second half of next year. Turning now to our outlet. To date, POM sales have been muted due to the fact that they have primarily been on a cash-pay basis.

Speaker Change: We expect a final determination will be announced in late summer and effective October 1st of this year.

Speaker Change: If exercised, the additional proceeds from these warrants will fund our operations well into the second half of next year.

Speaker Change: Turning now to our Outlook.

Speaker Change: To date, POM sales have been muted due to the fact that they have primarily been on a cash pay basis.

Speaker Change: And as a price point, that is not feasible for the vast majority of the patients in our addressable markets.

Speaker Change: However, with our recent inroads into the VA and the expected Medicare reimbursement to be effective October 1st of this year, we believe we are positioned to significantly boost our revenues beginning later this year, providing us a pathway to positive cash flow.

Operator: And as a price point, that is not feasible for the vast majority of patients and our addressable market. However, with our recent inroads into the VA and the expected Medicare reimbursement to be effective October 1st of this year, we believe we are positioned to significantly boost our revenues beginning later this year, providing us a pathway to positive cash. With that, Daniel, let's now open the call for questions. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced.

Jeff Mathiesen: However, with our recent inroads into the VA and the expected Medicare reimbursement to be effective October 1st of this year, we believe we are positioned to significantly boost our revenues beginning later this year, providing us a pathway to positive cash. With that, Daniel, let's now open the call to questions.

Speaker Change: With that, Daniel, let's now open the call for questions.

Operator: As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. In the interest of time, we ask that you please limit yourself to one question and one follow-up. Our first question comes from Anthony Vendetti with Maxim Group. Your line is open.

Operator: To withdraw your question, please press star 11 again. In the interest of time, we ask that you please limit yourself to one question and one follow-up. Our first question comes from Anthony Vendetti with Maxim Group. Your line is open.

Speaker Change: As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.

Speaker Change: In the interest of time, we ask that you please limit yourself to one question and one follow-up.

Speaker Change: Our first question comes from

Anthony Vendetti: Thanks. So, once the final price determination is received from CMS, do you have a pipeline of patients? And, you know, how do you think that will affect initial sales?

Dane Andreeff: So, once the final price determination is received from CMS, do you have a pipeline of patients? And, you know, how do you think that will impact initial sales? And then I have a follow-up question.

Speaker Change: Anthony Venditti with Maxim Group. Your line is open.

Anthony Venditti: Thanks. So, once the final price determination is received from CMS,

Speaker Change: And how do you think that will, what would that impact be on initial sales? And then I have a follow-up on stroke.

Dane Andreeff: And then I have a follow-up on. Yeah. Hi Anthony. It's Dane.

Dane Andreeff: Yeah, hi Anthony, it's Dane. Thanks for your question. We keep a long list of Medicare patients with their prescribers, of course, their insurance, which is Medicare, because we cannot file one-off claims right now, waiting for CMS and Medicare to reimburse us. So we do have a very strong list of built-up demand regarding Medicare.

Dane Andreeff: Thanks for your question. We have been keeping a long list of Medicare patients with their prescribers, and, of course, their insurance, which is Medicare, because we cannot file one-off claims right now, waiting for CMS and Medicare to reimburse us. So we do have a very strong list of built-up demand regarding Medicaid.

Speaker Change: Hi Anthony, it's Dane. Thanks for your question.

Speaker Change: Keeping a long list of Medicare patients with their prescribers.

Speaker Change: Of course, their insurance, which is Medicare, because we cannot file one-off claims right now waiting for CMS and Medicare reimbursement. So we do have a very strong list of built-up demand regarding Medicare.

Dane Andreeff: Okay, great. And then just wondering, where are you with patient enrollment for the stroke trial? And are you still on target for completing it and then submitting it to the FDA in the first half of 2025? We are on track, enrollment's on track, as well as submitting in the first half of 2025.

Speaker Change: Okay, great. And then, just wondering, where are you with patient enrollment for the stroke trial? And are you still on target for a?

Dane Andreeff: We are on track. Enrollment's on track as well as the submission in the first half of 2020.

Speaker Change: Completing it and then submitting to the FDA in the first half of 2025.

Speaker Change: We are on track, enrollment's on track, as well as submitting in first half of 2025.

Dane Andreeff: Anthony, if you remember, we'll be using, on top of that, our second FDA breakthrough designation, which truly gives us a wonderful pathway forward with a 150-day notice period. Okay, great. No, that's helpful. And then I guess one last question: Where are you with potential studies or expansion for TBI?

Dane Andreeff: Okay, great. Anthony, if you remember, we'll be using, on top of that, our second FDA breakthrough designation, which truly gives us a wonderful pathway forward with a 150-day notice period. Okay, great. No, that's helpful. And then I guess one last question. Where are you with them? Potential studies or expansion for TBI. Right now, we're still investigating. That expansion into TDI, as you are aware, we had Pacific Blue Cross do their own study for Back to Work, which came out with a white paper late last year, where eight of the nine of their long-term disability claims stated that Balance and Gait, after using PONS therapy for 14 weeks, that eight of the nine of their long-term disability patients and claimants had no longer balance and gait issues to go back to work.

Speaker Change: Okay, great.

Speaker Change: Anthony, if you remember, we'll be using, on top of that, our second FDA breakthrough designation, which truly gives us a wonderful pathway forward with 150-day notice period.

Speaker Change: Okay, great. No, that's helpful. And then I guess one last question.

Speaker Change: Where are you with...

Dane Andreeff: Right now, we're still investigating that expansion into TDI. As you are aware, we had Pacific Blue Cross do their own study for Back to Work, which came out with a white paper late last year, where eight of the nine of their long-term disability claims stated that Balance and Gait, after using PONDS therapy for 14 weeks, eight of the nine of their long-term disability patients and claimants had no longer Balance and Gait issues to go back to work. Five of the nine went back to work in PONDS therapy, saving Pacific Blue Cross approximately $1.6 million. So a significant cost-benefit analysis that is heavily weighted towards using PONS therapy for traumatic brain injury.

Speaker Change: potential studies or expansion for for TTI.

Dane Andreeff: Five out of the nine went back to work after PONS therapy, saving Pacific Blue Cross approximately 1.6 million dollars. Thus, a significant cost-benefit analysis that is heavily weighted towards using PONS therapy for traumatic brain injury.

Speaker Change: Right now, we're still investigating.

Speaker Change: that expansion into TDI. As you are aware, we had Pacific Blue Cross do their own study for back to work, which came up with the white paper.

Speaker Change: late last year where eight of the nine of their long-term disability claims

Speaker Change: stated that balance and gait, after using PONS therapy for 14 weeks, that eight of the nine of their long-term disability patients and claimants had no longer balance and gait issues to go back to work.

Speaker Change: Five out of the nine went back to work in Pond's therapy

Speaker Change: saved Pacific Blue Cross approximately 1.6 million dollars.

Speaker Change: So, a significant cost-benefit analysis that is heavily weighted towards in using PONS therapy for traumatic brain injury.

Dane Andreeff: Okay, you know, that's helpful. Thanks for that color, Dane. I'll hop back in the queue. I appreciate it.

Dane Andreeff: Okay, you know, that's helpful. Thanks for that color, Dane. I'll hop back in the queue. Great. Thanks, Anthony. Thank you. As a reminder, to ask a question, please press star 11. Again, that is star 11 to ask a question.

Operator: I'm showing no further questions at this time. I would now like to turn it back to Dane Andreeff for closing remarks. Great. Thank you. Thank you, Daniel. My apologies again for the technical difficulties, but just thank you for following Helius Medical Technologies. As you've heard today, we're excited about where we stand at this point in the year and truly look forward to keeping you updated as we pursue coverage in reimbursement and authorization for stroke. So, thank you very much. This concludes today's conference. Thank you for participating. You may do so now.

Speaker Change: Patient.

Operator: Great. Thanks, Anthony. Thank you. As a reminder, to ask a question, please use the Q&A function. Thank you.

Speaker Change: Okay, you know, that's that's helpful. Thanks for that color, Dane. I'll hop back in the queue. Appreciate it.

Operator: Thank you. As a reminder, to ask a question, please press star 1-1. Again, that is star 1-1 to ask a question. I'm showing no further questions at this time. I'd now like to turn it back to Dane Andreeff for closing remarks.

Anthony Venditti: Thanks, Anthony.

Speaker Change: Thank you. As a reminder, to ask a question, please press star 1 1. Again, that is star 1 1 to ask a question.

Operator: Robert, 2024 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. To ask a question during the session, you will 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 that today's conference is being recorded.

Speaker Change: I'm showing no further questions at this time. I would now like to turn it back to Dane Andreeff for closing remarks.

Dane Andreeff: Great. Thank you. Thank you, Daniel. My apologies again for the technical difficulties, but just thank you for following Helius Medical Technologies. As you've heard today, we're excited about where we stand at this point in the year and truly look forward to keeping you updated as we pursue coverage in reimbursement and authorization for stroke. So, thank you very much.

Speaker Change: Great.

Dane Andreeff: Thank you. Thank you, Daniel. My apologies again for the technical difficulties, but just thank you for following Helios Medical Technologies.

Dane Andreeff: As you've heard today, we're excited about where we stand at this point in the year and truly look forward to keeping you updated as we pursue coverage in reimbursement and authorization for stroke. So thank you very much.

Michelle Bilski: I would now like to hand a comments over to your speaker today.

Michelle Bilski: Michelle Bilski, Investor Relations for Helius Medical. Please go ahead. Thank you, operator.

Michelle Bilski: Welcome to the second quarter of 2024 Earnings Conference Call for Helius Medical Technologies. This is Michelle Bilski of Insight Communications, Investor Relations for Helius.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.

Speaker Change: This concludes today's conference call. Thank you for participating. You may now disconnect.

Michelle Bilski: With me on today's call are Dane Andreeff, Helius Medical's President and Chief Executive Officer, and Jess Mathiesen, Chief Financial Officer. At this time, all participants have been placed in listen-only mode. Please note that this call is being recorded and access to a webcast can be obtained to the investor section of the Helius website at www.heliusmedical.com.

Michelle Bilski: 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 a form 10K, and almost recent quarterly report on form 10Q. Select factors may be updated from time to time in our other filings with the SEC, which are available on our website.

Michelle Bilski: All statements made during this call are as of August 12, 2024. We undertake new obligations to publicly update or revise our forward-looking statements over the results of new information, future events, or otherwise, except as required by law.

Speaker Change: Thanks for watching!

Dane Andreeff: I would now like to turn the call over to Mr. Andreeff. Thank you, Michelle. And thank you, everyone, joining us today on Helius Medical's second quarter, 2024 earnings conference call. During 2024, our priority has been to get pawn therapy to as many people suffering from NNASAs possible. We've seen firsthand how our innovative technology makes a meaningful difference in a patient's fight against gay and bound steppes. It's a common but devastating symptom of MS. And I'm proud to say our efforts during the second quarter and recently have generated significant momentum toward greater access.

Speaker Change: Are You Looking for Someone? Many Awards Are Awaiting for The Best Actress in TV Or Cast Granny Maybe this one will do

Dane Andreeff: Operator. Yeah. Go ahead, Dane. Now I was going to step in. Go ahead. Yeah. I'm getting a lot of feedback. This line isn't working properly.

Dane Andreeff: So Jeff, do you want to step in please? I'll keep going and want you to dial back in and give them a shot. Specifically in April, we partnered with level government services and SBA certified service disabled veterans owned small business to make ponds therapy accessible to MS patients treated at the VA and to our other federal agencies. The VA is the largest integrated healthcare system in the United States and home to a network of multiple sclerosis centers of excellence.

Dane Andreeff: The VA estimates that between 55,000 and 70,000 veterans in the US live with MS as the only portable and readily accessible therapy that may lead to neuroplasticity. Ponds is a potential game changer for these veterans and their families and we're happy to be a preferred provider and help more service members access this treatment. Shortly thereafter in May, Ponds was approved for inclusion in levels VA federal supply schedule and the general services administration advantage contracts at pricing of $23,843.72 and $7,344.97 for the Ponds device and the Ponds.

Dane Andreeff: Ponds, small piece respectively. Also in May, we received the first third party reimbursement of $23,900 from a major insurance carrier for a Ponds device. Then in July, Ponds was approved for inclusion in levels DAPA contract for the Department of Defense at $23,724.50 and $7,308.25 for the Ponds device and the Ponds, small piece respectively. These were all important accomplishments in establishing market pricing for Ponds as we pursue reimbursement at CMS and third party payers.

Dane Andreeff: Last quarter, CMS assigned HICS-PICS codes covering the Ponds controller and mouthpiece and in May released its preliminary Medicare payment to terminations for both. This was a significant reimbursement and access milestone for healers and we were gratified to know that CMS understood the benefits of this innovative treatment. We were pleased with this development but believe there is a strong argument for higher reimbursement rates for both the mouthpiece and controller which we presented at the CMS public meeting on May 29th, as well as in subsequent written communications.

Dane Andreeff: First, we argued that it was appropriate to categorize the mouthpiece as a supply item to be reimbursed on lump sum payment structure. As a reminder, the mouthpiece has a 14 week life and involves application to a patient's tongue. So, therefore, we believe a 13 month cap rental structure is not appropriate. Additionally, we provided recent contract pricing and invoices to support the market pricing at pricing levels I previously discussed to be used for setting of the reimbursement using the gap-filling method.

Dane Andreeff: We also articulated how ponds is not a neuromuscular peripheral stimulation therapy, and therefore, it is not appropriate to map pricing to such devices. Instead, we argued reimbursement for the controller should be established using the gap-filling methodology based on market pricing. GMS is expected to publish final reimbursement rates in the coming weeks. Once finalized, the payment rates will be effective October 1, 2024. We are also actively assisting several MS patients as they submit claims with other third-party payers on a one-off basis in attempts to secure the reimbursement.

Dane Andreeff: Beginning in June, we began building out a sales rep polarization to service the VA sites throughout the U.S. Today, we have established sales representatives covering 13 states including Texas and Florida plus Puerto Rico. We believe having boots on the ground representatives focused on neurological disorders and that have established relationships with the individual VA sites will be critical to building out sales across the VA facilities in the U.S. I'll pause for a second and just see if Dan has rejoined. I have. Jeff, thank you. Let me continue.

Dane Andreeff: While much of our focus during the quarter was on removing barriers to access and securing reimbursement, we also made meaningful progress toward our pursuit of stroke authorization in the U.S, where over 5 million stroke survivors are affected by walking and bounce disabilities. The registration program, which includes an investigator initiated placebo control study at the Medical University of South Carolina and Brooke rehabilitation and a company sponsored Open Label Trial has been fully enrolled.

Dane Andreeff: In June, site participation enrollment of the Open Label study with the addition of top neuro rehabilitation centers such as re-evologium. The Neurology Center of New England, and MGH Institute of Health Professions, had started enrolling. This ground-breaking, Registration Program, which also has the participation of Brooks Rehabilitation and Shepard Center to the Open Label Study, is designed to establish the effect of cranial nerve non-invasive neuromodulation delivered using pond therapy on gain imbalance in chronic stroke survivors.

Dane Andreeff: It will also establish pond therapeutic impact on the risk of falling in U.S, patients. In addition to enrolling 60 participants to the MUSC study, we anticipate enrolling approximately 30 patients into the Open Label Study across all sites, by the end of the third quarter, expect that the results will significantly bolster our FDA submission when we submit for regulatory approval in 2025. The stroke registrational program was established in part based on real-world evidence from Canada where pond is already authorized for the treatment of stroke.

Dane Andreeff: To further strengthen the data package submission for FDA authorization and support national reimbursement in Canada, we've begun an additional Canadian study on the use of pond therapy to treat stroke with the goal of enrolling 40 to 60 subjects by the end of 2024 at three centers of excellence for stroke rehabilitation. The study, which has received approval by the institutional review boards in June, has already started participants enrollment. A new research program to extend establish evidence of the effect of unlabeled pond on risk of falling in stroke patients with gait and bound steps to think Canada has also begun in rolling patients with TBI and MAP at three top Canadian neuro rehabilitation sites in May.

Dane Andreeff: We're excited about where we stand at the mid-year of the year. We secured reimbursement with a major third party insurer and the expected Medicare price determination to be effective October 1st will enable us to further expand reimbursement across third party payers. The number of ponds trained therapists in the field is growing and our FDA submission for stroke remains on track. Given all that we've put into place, we see a clear path ahead toward achieving our main goal of removing barriers and helping more people benefit from ponds. And with the $6.4 million of financing we announced in May, we extended our runway to cover the key 2024 milestones.

Jeffrey Mathiesen: I'll now turn the call over to Jeff to discuss our second quarter financial results in more detail. Thanks, Jane. Again, it's a pleasure to be with you today.

Jeffrey Mathiesen: Total revenue for the second quarter of 2024 was 182,000, a decrease of 74,000 compared to 256,000 in the second quarter of 2023. As a result of the termination of our patient therapy access program on June 30, 2023 and the termination of temporary cash pay pricing in May of 2024. Revenue for the quarter was up 35% compared to the first quarter of 2024, as a result of increased sales in both the U.S, and Canada.

Jeffrey Mathiesen: For the second quarter of 2024, cost of revenue was $118,000 compared to $184,000, but for the prior year period, primarily attributable to lower sales compared to the same period in the prior year. Selling general administrative expenses for the second quarter of 2024 were $2.5 million compared to remaining relatively flat when compared to the $2.6 million reported in the second quarter of 2023. Research and development expenses for the second quarter of 2024 was $0.9 million compared to $0.7 million in the second quarter of 2023, driven primarily by an increase in clinical trial activities for stroke and risk of fall programs.

Jeffrey Mathiesen: For the expenses for the second quarter of 2024 were $3.3 million flat when compared to $3.39 in the second quarter of 2023. Operating loss for the second quarter of 2024 was $3.2 million compared to the loss of $3.2 million for the prior year period. We reported a net loss for the second quarter of 2024 of $1.6 million or a loss of 64 cents per basic and diluted common share. We also had a net loss of $1.6 million in the prior year period or a loss of $2.92 per basic and diluted common share due to a higher number of weighted average shares outstanding.

Jeffrey Mathiesen: Our cash burn from operations was flat at $5.9 million for the sixth month ended June 30, 2024 and June 30, 2023. As of June 30, 2024, we had $6.4 million in cash and no debt. In May, we closed on $6.4 million public offering and received net proceeds of $5.5 million which will extend our cash long way in 2025. This financing also includes one-year warrants for an additional $6.4 million of gross proceeds that are callable by the company within 30 days of announcing the final reimbursement determination for a pounce controller and mouthpiece by CNS.

Jeffrey Mathiesen: Yet the stock price trades at or above $2.25 per share for prior consecutive days during that period. The expected final determination will be announced in late summer and effective October 1st of this year. If exercise, the additional proceeds from these warrants will fund our operations well into the second half of next year.

Jeffrey Mathiesen: Turning now to our outlook, today, Pond sales have been muted due to the fact that they have primarily been on a cash pay basis. And as a price point, that is not feasible for the vast majority of the patients in our addressable markets. However, with our recent inroads into the VA and the expected Medicare reimbursement to be effective October 1st of this year, we believe we are positioned to significantly boost our revenues beginning later this year, providing us a pathway to positive cash flow.

Operator: With that, Daniel, let's now open the call for questions. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. In the interest of time, we ask that you please let yourself to one question and one follow-up.

Anthony Vendetti: Our first question comes from Anthony Vendetti with maximum group. Your line is open. Thanks.

Dane Andreeff: So once the final price determination is received from CMS, do you have like a pipeline of patient? And how do you think that will, what will that impact the initial sales? And then I have a follow-up on stroke? Yeah, I am. Thanks for your question. We have been keeping a long list of Medicare patients with their prescribers. Of course, their insurance, which is Medicare because we cannot follow one off claims right now, waiting for CMS and Medicare reimbursement. So we do have a very strong list of those up to man regarding Medicare. Okay, great.

Dane Andreeff: And then just wondering where are you with patient enrollment for the stroke trial? And are you still on target for completing it and then submitting to the FDA in the first half of 25? We are on track and enrollment on track as well as the submitting in first half of 2025.

Dane Andreeff: Okay, great. Anthony, if you remember, we'll be using on top of that our second FDA breakthrough designation, which truly gives us a wonderful pathway forward with 150 day notice period. Okay, great. Now that's helpful.

Dane Andreeff: And then I guess one last question. Where are you with and potential studies or expansion for TDI. Right now, we're still investigating that expansion into TDI as you are aware. We had Pacific Blue Cross do their own study for back to work, which came up with the white paper late last year, where eight of the nine of their long-term disability claims stated that balance and gait after using pond therapy for 14 weeks, that eight of the nine of their long-term disability patients and claimants had no longer balanced and gait issues to go back to work.

Dane Andreeff: Five of the nine went back to work in pond therapy, saved Pacific Blue Cross approximately $1.6 million. So a significant cost benefit analysis that is heavily weighted towards in using pond therapy for traumatic brain injury patients. Okay, you know, that's helpful. Thanks for that color, Dane. I'll hop back in to you. Appreciate it. Great. Thanks, Anthony. Thank you.

Operator: As a reminder, to ask a question, please press store 11. Again, let us store 11 to ask a question. I'm showing you no further questions at this time.

Dane Andreeff: I'll now like to turn it back to Dane.

Dane Andreeff: Andrew, for closing remarks. Great. Thank you. Thank you, Daniel. My apologies again for the technical difficulties, but just thank you for following Helius Medical Technologies. As you've heard today, we're excited about where we stand at this point in the year and truly look forward to keeping you updated as we pursue coverage in reimbursement and authorization and for stroke.

Dane Andreeff: So thank you very much.

Operator: This concludes the day's conference call. Thank you for participating.

Dane Andreeff: You may now disconnect. Andreeff, Dane Andreeff, Dane Andreeff, Dane Andreeff, Andreeff, Dane Andreeff, Dane Andreeff, Dane

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