Q1 2024 Helius Medical Technologies Inc Earnings Call

Operator: Hey Dane, thank you for standing by. Welcome to Helius Medical Technology's 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 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would like to hand the conference over to your speaker today, Michelle Bilski. With Insight Communications, please go ahead.

Okay.

Speaker Change: Good day and thank you for standing by if you walk into the helix medical technologies first quarter 'twenty 'twenty four 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 need to press star one on your telephone you will then hear an automated message advising your hand is raised to withdraw your question. Please press star one again.

Speaker Change: Please be advised today's conference is being recorded I would now like to turn the conference would your speaker today, Michelle Bilsky with insight Communications. Please go ahead.

Michelle Gable Bilski: Thank you, Kevin. Welcome to the first quarter of 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 Gable Bilski: Thank you, Kevin and welcome to the first quarter of 'twenty 'twenty four earnings conference call for Helios Medical technologies. This is Michel scared of insight Communications Investor Relations for Helios, but you know today's call are Dave Andrey <unk>, Medical's, President and Chief Executive Officer, and Jeff Mathiesen, Chief Financial Officer.

Speaker Change: Participants have been placed in a listen only mode.

Michelle Gable 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, 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 can 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.

Speaker Change: Please note that this call is being recorded and access to the webcast can be obtained to the investors section of the heathman Ww.

Speaker Change: Www Dot Luis medical Dotcom.

Michelle Gable 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 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 Andreeff, President and Chief Executive Officer of Helius.

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 our current expectation for 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 factors section of our most.

Speaker Change: 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 13th 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'd like to turn the call over to Dale Andres, President and Chief Executive Officer of Helios.

Dane Carl Andreeff: Right. Thanks, Michelle. And thank you to everyone joining us today at Helius Medical's first quarter 2024 conference. In 2024, our focus remains on two things, securing widespread reimbursement for PONS and achieving FDA approval for stroke. We have 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.

Dane Carl Andreeff: Great. Thanks, Michelle.

Dane Carl Andreeff: Thank you to everyone joining us today on <unk> Medical's first quarter 2024 conference call.

Dane Carl Andreeff: In 2024, our focus remains on two things securing widespread reimbursement for ponds and achieving FDA approval for stroke.

We made progress on both fronts and are confident these milestones are just around the corner.

Dane Carl Andreeff: The $6 4 million dollar financing, we just announced last week, which extends our cash runway into 2025 will help get us there.

Dane Carl Andreeff: 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 HCPC 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 mouse.

Dane Carl Andreeff: I'll start with our pursuit of widespread reimbursement for ponds.

Dane Carl Andreeff: We are pleased that CMS Medicare understood. The benefits of this innovative treatment and establish codes for both the Pons mouthpiece and controller, which went into effect on April one.

Dane Carl Andreeff: This was a critical reimbursement and access milestone and the unique hikmet codes gave us the ability to begin negotiating reimbursement with third party payers.

Dane Carl Andreeff: As a reminder, the list price for the Pons device in North America, where it's indicated is $25700 comprised of $17800 for the controller and 70 904 the mouthpiece.

Dane Carl Andreeff: 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 Helius on the agenda for the public meeting with CMS on May 29. As the preliminary payment determination is subject to change, we are looking forward to presenting arguments at the meeting on May 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.

Dane Carl Andreeff: 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 heal is on the agenda for the public meeting with CMS on May 29.

Dane Carl Andreeff: For the mouthpiece, we will argue that it 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, gap filling should be done using the list price.

Dane Carl Andreeff: 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.

Dane Carl Andreeff: Pons is different from any neuro muscular peripheral stimulation therapy, and so for the controller will advocate using the GAAP Joey methodology based on our list price versus mapping it out to other not comparable neuromuscular stimuli.

Dane Carl Andreeff: Asian devices.

Dane Carl Andreeff: For the mouth piece, we will argue that is actually a supply that is applied to an individual's time and therefore, the lump sum payment structure is more appropriate than the cap rental structure set in the preliminary determination.

Dane Carl Andreeff: And therefore, the gap drilling should be done using the less price.

Dane Carl Andreeff: We believe 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 on October 1st, 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.

Speaker Change: We believe in it.

Speaker Change: We are in a good position to secure higher rates than those established in the preliminary determination.

Speaker Change: Once finalized the payment rates are expected to be effective October one 2024.

Speaker Change: We believe the final determination of these rates will make it easier to expand reimbursement across third party payors, creating a pathway to positive cash flow as we continue working to secure FDA authorization under Pons breakthrough designation for stroke.

Speaker Change: Yeah.

Speaker Change: We look forward to keeping you updated on our evolving discussions with CMS.

Dane Carl Andreeff: 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 survival since gait and balance deficit is a medical condition that almost inevitably leads to falling and increases the health care cost burden for these patients.

Speaker Change: 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.

Speaker Change: 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.

Speaker Change: Clinical program aims at establishing the effects of cranial nerve noninvasive neuromodulation using pons therapy on gate and dynamic balance in chronic stroke survivors.

Speaker Change: Since gate imbalanced after sick is a medical condition that almost inevitably leads to falling and increases the health care cost burden for these patients the stroke Registrational program.

Dane Carl Andreeff: The Stroke Registrational Program also aims to confirm our real-world evidence that PONS therapy significantly reduces the risk of falling in at least 28% of stroke patients with gait and balance deficit as compared to the average one to three percent 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 start 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 registration program. Recruitment for the single-arm study begins this month, with the goal of enrolling 8 to 10 participants by the end of the year.

Speaker Change: Also aimed at confirming our real world evidence that pons therapy significantly reduces the risk of falling in at least 28% are stroke patients.

Speaker Change: With gait and balance deficit as compared to the average one 3% from physical therapy alone.

Speaker Change: In January we announced the addition of Brooks rehabilitation hospital to our stroke clinical program and it is the first state site to have started enrolling patients in the open label study, which is an integral part of our stroke Registrational program because it brings the pond.

Speaker Change: Clinical experience two additional sites in the United States.

Speaker Change: Last month, we announced the participation of Shepherd Center in our Registrational program.

Speaker Change: Recruitment for the single arm study begins this month with the goal of enrolling eight to 10 participants by the end of the year.

Dane Carl Andreeff: Shepherd Center has already been a valuable partner for Helius 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 cost of the registration of programs. We are targeting regulatory submission by early 2025 with the goal of receiving marketing authorization utilizing PON's breakthrough designation for stroke later in the year. Well over 5 million stroke survivors in the United States are affected by walking and balance disability.

Speaker Change: 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.

Speaker Change: Subject adherence to pons therapy in people with multiple sclerosis M S.

Speaker Change: In addition to adding more sites to our stroke pathway during during the quarter, we aligned with the FDA on our development plan to significantly streamline the size timeline and the cost of the registered Registrational program.

Speaker Change: We are targeting regulatory submission by early 2025 with the goal of receiving marketing authorization utilizing ponds breakthrough designation in stroke later in the year.

Speaker Change: Well over 5 million stroke survivors in the United States are affected by walking and balanced disability and we are excited for this ground breaking treatment to reach those who need it.

Dane Carl Andreeff: 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 and balance impairment due to MS. Those efforts include ongoing engagement with the physical therapist community, and we now have PONS-trained therapists located nationwide. We recently attended the American Physical Therapy Association Combined Sections meeting, where we had the opportunity to further highlight POND's therapeutic benefits.

Speaker Change: Yeah.

As we continue to pursue stroke approval, we remain committed to getting pons therapy into the hands of more people suffering gait and balance impairment due to en masse.

Speaker Change: These efforts include ongoing engagement with the physical therapists community and we now have ponds trained therapists located nationwide.

Speaker Change: We attended recently the American physical therapy Association combined sections meeting, where we had the opportunity to further highlight ponds therapeutic benefits P. Ts are critical to patient success with ponds, and we're always eager to engage with.

Dane Carl Andreeff: Physical therapists are critical to patient success with POND, 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 Global Government Services and an approved supplier to the VA and DOD to make ponds available to federal health care 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 activist.

Speaker Change: This important group.

Speaker Change: Last quarter I mentioned, our efforts to target the department of Veterans affair.

Speaker Change: Which is the largest integrated healthcare system in the United States and sees more than 28000 cases of M. S annually.

Speaker Change: I'm pleased to report that we're officially partner with global government services.

Speaker Change: And an approved supplier to the V. A N D O D to make pons available to federal health care systems.

Speaker Change: We've seen firsthand how parnes therapy has improved the lives of veterans suffering from Matt en masse and we're thrilled that more service members will have access to this treatment.

Dane Carl Andreeff: In Canada, where PONS is already authorized for stroke, we are currently working to establish sites in five separate administration regions as part of a government-funded initiative designed to further validate the effectiveness of PONS therapy when used by patients suffering from the effects of stroke. We believe this initiative will 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.

Speaker Change: Turning now to our Canadian activities.

Speaker Change: In Canada. We're pond is already authorized for stroke. We are currently working to establish sites in five separate administration regions as parts of our government funded initiatives designed to further validate the effectiveness of pons therapy when used by patients.

Speaker Change: Suffering the effects of stroke.

Speaker Change: 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.

Speaker Change: Moving into the rest of 'twenty, 'twenty, four achieving reimbursement and making progress on our stroke.

Dane Carl Andreeff: Registration or program remain are 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 cashflow as we pursue authorization. With that, let me turn the call over to Jeff to discuss our first quarter financial results in more detail.

Speaker Change: Registered Registrational program remain are.

Speaker Change: Our top priorities and both sides both go order insight.

Speaker Change: We could achieve CMS reimbursement as early as October 1st which would enable us to expand reimbursement across 33rd Party payors.

Speaker Change: Significantly boosting our revenues and given us a pathway to positive cash flow as we pursue operation for stroke.

Speaker Change: With that let me turn the call over to Jeff to discuss our first quarter financial resorts in more detail.

Jeffrey S. Mathiesen: It is a pleasure to be with you today. Total revenue for the first quarter of 2024 was $135,000, an increase of $24,000 compared to $111,000 in the first quarter of 2023, reflecting increased product sales in both the US and Canada. But the first quarter of 2024 cost of revenue was $123,000 compared to $122,000 for the prior year period, remaining relatively flat due to fixed overhead costs. Selling general and administrative expenses for the first quarter of 2024 decreased to $2.6 million compared to $2.9 million in the first quarter of 2023, due primarily to a decrease in professional fees and payroll-related expenses, partially offset by an increase in contract manufacturer expenses associated with the transition to the new contract manufacturer during the current year period.

Jeffrey S. Mathiesen: Thanks, Dan.

Jeffrey S. Mathiesen: A pleasure to be with you today.

Jeffrey S. Mathiesen: Total revenue for the first quarter of 'twenty 'twenty four it was $135000 an increase of $24000 compared to $111000 in the first quarter of 2023.

Jeffrey S. Mathiesen: <unk> increased product sales in both the U S and Canada.

Jeffrey S. Mathiesen: For the first quarter of 2020 for cost of revenue was $123000 compared to $122000.

Jeffrey S. Mathiesen: For the prior year period remaining relatively flat due to the fixed overhead costs.

Jeffrey S. Mathiesen: Selling general and administrative expenses for the fourth quarter of 2024 decreased to $2.6 million compared to $2 $9 million in the first quarter of 2023.

Jeffrey S. Mathiesen: Due primarily to a decrease in professional fees and payroll related expenses, partially offset by an increase in contract manufacturer expense associated with the transition to the new contract manufacturer during the current year period.

Jeffrey S. Mathiesen: Research and development expense for the first quarter of 2024 decreased to $0.8 million compared to $0.9 million in the first quarter of 2023, driven primarily by a decrease in product development expenses and clinical trial activities as we transitioned our focus to U.S. commercialization. Operating loss for the first quarter of 2024 was $3.4 million, compared to a loss of $3.8 million in the prior year period. We reported a net loss for the first quarter of 2024 of $2.5 million, or a loss of $3.08 per basic and diluted common share. We also had a net loss of $2.5 million in the prior year period, or a loss of $4.42 per basic and diluted common sugar.

Jeffrey S. Mathiesen: Research and development expense for the first quarter of 2024 decreased to zero point $8 million compared to zero point $9 million in the first quarter of 2023.

Jeffrey S. Mathiesen: Driven primarily by a decrease in product development expenses and clinical trial activities as we transitioned our focus to U S commercialization activities.

Jeffrey S. Mathiesen: Operating loss for the first quarter of 2024 was $3 $4 million compared to a loss of $3 $8 million in the prior year period.

We reported a net loss for the first quarter of 2024 of two and a half million dollars or a loss of $3.08 per basic and diluted common share.

Jeffrey S. Mathiesen: We also had a net loss of $2 $5 million in the prior year period, or a loss of $4.42 per basic and diluted common share.

Jeffrey S. Mathiesen: Our cash burn from operations for the first quarter of 2024 decreased to $3 million compared to $3.2 million in the first quarter of 2023. As of March 30, 2024, we had $3.6 million in cash and no debt. Last Thursday, we closed on a $6.4 million public offering and received net proceeds of approximately $5.6 million, which will extend our cash runway into 2025. Importantly, 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 first, excuse me, the final reimbursement determination for the PONS controller and the mouthpiece by CMS if the stock price at that time is at or We expect the final determination to be announced in late summer to be effective October 1st of this year.

Jeffrey S. Mathiesen: Our cash burn from operations for the first quarter of 'twenty 'twenty four decreased to $3 million compared to $3 $2 million in the first quarter of 2023.

Jeffrey S. Mathiesen: As of March 30th 'twenty, 'twenty, four we had $3 $6 million in cash and no debt.

Jeffrey S. Mathiesen: Last Thursday, we closed on.

Jeffrey S. Mathiesen: A $6 $4 million public offering and received net proceeds of approximately $5 $6 million.

Jeffrey S. Mathiesen: Which will extend our cash runway into 2025.

Jeffrey S. Mathiesen: Importantly, 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 first excuse me the final reimbursement determination for the Pons controller in the marketplace by CMS.

Jeffrey S. Mathiesen: If the stock price at that time at or about $2 25 per share.

Jeffrey S. Mathiesen: We expect final determination to be announced in late summer could be effective October one of this year.

Jeffrey S. Mathiesen: If exercised the additional proceeds from the exercise of these warrants will fund our operations well into the second half of next year.

Jeffrey S. Mathiesen: And helps to keep.

Jeffrey S. Mathiesen: Take financing risk off the table.

Jeffrey S. Mathiesen: If exercised, the additional proceeds from the exercise of these warrants will fund our operation well into the second half of next year and help to take financing risks off the table. Turning now to our outside... While POM sales remain on a cash-pay basis, and at a price point that is not feasible for the vast majority of patients in our addressable markets, we will expect revenues will continue to be muted.

Jeffrey S. Mathiesen: Turning now to our outlook.

Jeffrey S. Mathiesen: While our pawn sales remain on a cash pay basis.

Jeffrey S. Mathiesen: As a price point that is not feasible for the vast majority of patients in our addressable markets.

Jeffrey S. Mathiesen: We will expect revenues will continue to be muted.

Jeffrey S. Mathiesen: However, as we have discussed, our recent access to VA patients through leveled government services and the expectation of CMS reimbursement by October 1st, which will facilitate our efforts to expand reimbursement across third-party payers, which we believe will position us to significantly boost our revenues beginning later this year and provide us a pathway to positive cash flow. With that, Kevin, let's now turn the call over to questions. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please

Jeffrey S. Mathiesen: However, as we have discussed our recent access to VA patients through level government surfaces.

Jeffrey S. Mathiesen: And the expectation of CMS reimbursement.

Jeffrey S. Mathiesen: By October one, which will facilitate our efforts to expand reimbursement across third party payers we.

Jeffrey S. Mathiesen: We believe will position us to significantly boost our revenues beginning later this year and provides us a pathway to positive cash flow.

Kevin: With that Kevin let's.

Kevin: Now I'll turn the call over for questions.

Operator: Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to remove yourself from the queue, please press star 11 again. We will pause for a moment while we compile our Q&A list. Our first question comes from Nicholas Sherwood with Maxim Group. Your line is open.

Kevin: Thank you ladies and gentlemen, if you have a question or a comment at this time. Please press star one on your telephone. If your question has been answered or you wish to move yourself from the queue. Please press star one again, we will pause for a month or compile the Q&A roster.

Kevin: Our first question comes from Nicolas Sherwood with Maxim Group. Your line is open.

Nicholas Sherwood: All right, congrats on the quarter. Can you just go into a little bit more on the timeline with the local government services agreement that you signed, kind of like where you are at with that agreement and build out a sales team with them or just kind of get some more color on it?

Kevin: Hi.

Nicholas Sherwood: Congrats on the quarter.

Nicholas Sherwood: Can you just go into a little bit more on the timeline, but.

Nicholas Sherwood: While both government services agreement that you signed kind of like where are you at with that agreement.

Nicholas Sherwood: Gently build out a sales team with them or just kind of get some more color on it.

Dane Carl Andreeff: Yeah. Hey, Nick, thanks for your question and your comment. So, we're in the process right now of having our PONS therapy be on contract with the FSS and the GSA contracts, the General Service Administration. This should go public very soon, in the next few days or weeks. And then by January 1st, our team and their team will be all trained up internally, and we could start receiving prescriptions, invoices, and training VA rehab experts on PONS therapy so that they can start treating.

Nicholas Sherwood: Yes.

Nicholas Sherwood: Nick.

Nick: Thanks for your question.

Speaker Change: Your comment.

Speaker Change: So we're in the process right now of having our ponds therapy be on contract.

With E F SaaS and the GSA contracts the General services administration.

Dane Carl Andreeff: So, Dane, I think you misspoke. You said January 1st. Oh, I'm sorry.

Speaker Change: This should go public very soon.

Speaker Change: And the next days and weeks.

Speaker Change: And then by January 1st.

Speaker Change: Our our team and their team will be all trained up internally.

Speaker Change: And we could start receiving prescriptions invoices and training VA rehab.

Speaker Change: Experts on points therapy, so that they can start treating their patients.

So Dave I think you Misspoke, you said January one.

Dane Carl Andreeff: When you'd be trained. I mean, June 1st. June 1st. Yes. Sorry. Thank you. June 1st.

Dane Carl Andreeff: Oh, I'm, sorry, when they have to be trained.

Speaker Change: June 1st Yes, sorry.

Speaker Change: First bank.

Dane Carl Andreeff: Okay, so June 1st, you'll start, you expect to start receiving prescriptions.

Speaker Change: Okay. So June 1st.

Speaker Change: Yeah, I'll start and you expect to start receiving prescriptions.

Dane Carl Andreeff: At some time in early June, hopefully, there will be some training on both sides, but we do have, you know, a couple of the VAs looking at PONS therapy for their MS patients right now. So, it's very exciting. They've already targeted at least one VA with 25% of their MS population.

Speaker Change: At some time in hopefully early June there are some training on both sides, but we do have.

Speaker Change: A couple of the V A's.

Speaker Change: Looking at.

Speaker Change: PON therapy for their Ms patients right now so.

Speaker Change: So it is very exciting they are already targeted at least.

Speaker Change: No one VA of of 25% of their M S.

Speaker Change: [noise] population at that VA.

Dane Carl Andreeff: Understood. And then, kind of, and just to clarify, I'm sorry. I was just going to say, so there's a little bit of an order process. So as they are looking to write a prescription, they would need to make sure that they've got someone trained there before the order could get placed with us. So there's a little bit of an order process that plays out as we're developing these new relationships. Yeah, and if you remember, we gave me the PT.

Speaker Change: Understood and then just to clarify.

Speaker Change: I was just going to say, so theres a little bit of an order process. So as they are looking to to write a prescription.

Speaker Change: We would need to make sure that they've got someone trained there before the order can get placed with us so there's a little bit of a order process.

Speaker Change: Lays out.

Speaker Change: Developing these new relationships.

Dane Carl Andreeff: Correct. Yes. The physical therapist. That would be the one to administer the treatment.

Speaker Change: Yes.

Speaker Change: If you remember we do you mean the PT.

Speaker Change: Correct, yes, physical therapist that would be the one to administer that help with the treatment.

Dane Carl Andreeff: And just to follow on that, yes, so if you remember, we modulized our PT training, so once they got access to the modulized software, they could do it within three hours or longer.

Speaker Change: And just to follow on that yes. So if you remember we modularized our P. T training. So once they receive access to the modular software they can do it within three hours or less.

Dane Carl Andreeff: Okay, that kind of leads into my next question. How much demand have you seen from new physical therapists taking the training program for POMS therapy?

Speaker Change: Okay that kind of leads into my next question.

Speaker Change: How what.

Speaker Change: Demand have you seen from new physical therapists, taking down.

Speaker Change: The training program for advanced therapy.

Dane Carl Andreeff: Yeah, it's been steady and upwards, Nick, on both sides of the border. What we're seeing, let's start in Canada. We're seeing this because commercial payers want to see more of the map filled in. So, we've really pushed, you know, into British Columbia because of what we're doing there. If you remember the Pacific Blue Cross study in back to work for traumatic brain injury, we had a very successful study that was performed by Pacific Blue Cross. Eight out of the nine had no longer an issue with balancing gait and returning back to work. And, of course, they closed out five of their long-term disability claims to save $1.6 million.

Speaker Change: Yes, it's been steady and upwards.

Speaker Change: Nick on both sides of the border.

Speaker Change: What we're seeing let's start in Canada.

Speaker Change: Where we're seeing this because.

Speaker Change: The commercial payers want to see more of the map filled then so we've really pushed.

Speaker Change: And to British Columbia.

Speaker Change: Because of what we're doing there are if you remember the Pacific Blue Cross study.

Speaker Change: And back to work for traumatic brain injury.

Speaker Change: We had a very.

Speaker Change: Successful study that was performed by Pacific Blue Cross.

Speaker Change: <unk> had no longer an issue with balance and gait.

Speaker Change: Returning back to work and of course, we are they closed out five of their long term disability claims to save $1 6 million.

Dane Carl Andreeff: So, that is really an exciting time for us. The payers do want to see us fill in the map with registered PONS trainers in Canada. And in the United States, we believe that will be part of the process as well. And remember, you know, most patients don't want to be driving more than 30 minutes to and from their PT because the first two weeks of PONS are performed in clinic. So the closer we can get registered PONS trainers to the patients, it makes it much easier for the patient to meet their PT. Are you targeting specific uh, Physical Therapists to make sure that you have that geographic coverage.

Speaker Change: So that is really an exciting time for us.

Speaker Change: The payers do you want to see us filling in the map with registered clients trainers in Canada and in the United States, We believe that.

Speaker Change: That is what will be.

Speaker Change: Part of the process as well and remember.

Speaker Change: Most patients don't want to be driving more than 30 minutes to and from.

Speaker Change: P T. Because the first two weeks are at Ponzis performed in clinic. So the closer we can get registered pons trainer.

Speaker Change: Trainers to that patients are it makes it much easier for the patient to <unk>.

Speaker Change: To.

Speaker Change: Meet their P T.

Speaker Change: Okay.

Speaker Change: Are you so with that said Martin Fraser steps at all.

Speaker Change: Are you targeting specific.

Like physical therapists to make sure that you have that geographic.

Dane Carl Andreeff: Coverage in the United States, if and when the CMS, codes, and stuff like that, reimburse for it. So, actually, what we're seeing, Nick, is a lot of patients wanting to file claims that are coming from existing registered PONS trainers, which is a good thing. And these are one-off claims for MS, for their gait deficit, and we could be helpful there. We're excited to help them with commercial payers and start their PONS therapy as soon as possible.

Speaker Change: Coverage in the United States, it's personnel.

Speaker Change: The CNS.

Speaker Change: Yes.

Speaker Change: That reimbursement levels.

Speaker Change: Okay. So so actually what were seeing Nick is we're seeing a lot of patients wanting to file.

Speaker Change: Claims that are coming from existing.

Speaker Change: Registered Pons trainers.

Speaker Change: Which is a good thing.

Speaker Change: And these are one off claims.

Speaker Change: For M S.

Speaker Change: For their gait deficit.

Speaker Change: We could be helpful. There, we're excited to help them.

Speaker Change: With the commercial payers and <unk>.

Speaker Change: And start their parents therapy as soon as possible, but our goal with reimbursement is also.

Dane Carl Andreeff: But, you know, our goal with reimbursement is also to be able to sit down with some of the regional, super regional physical therapy chains. We'd like to partner with them to quickly fill in the map once reimbursement goes effective, hopefully on October 1st of this year.

Speaker Change: Be able to sit down with some of the regional Super regional physical therapy chains.

Speaker Change: We'd like to partner with them to quickly.

Speaker Change: Fill in the map once reimbursement goes effective hopefully on October <unk> of this year.

Nicholas Sherwood: Understood. That takes care of all my questions. Thank you for providing all that detail, and I'll hop back into the queue.

Speaker Change: Understood.

Speaker Change: Takes care of all my question. Thank you for providing all that detail and I'll hop back into the queue. Okay great.

Dane Carl Andreeff: Great. Thanks, Nick. Again, ladies and gentlemen, if you have a question or a comment at this time, please

Speaker Change: Great. Thanks, Thanks, Nick.

Operator: Thank you. Again, ladies and gentlemen, if you have a question or a comment at this time, please press star 1 and 1 on your telephone. And I'm not taking any further questions at this time. I'd like to turn the call back over to Dane for any closing remarks.

Speaker Change: Thank you.

Speaker Change: Again, ladies and gentlemen, if you have a question or comment at this time. Please press star one on your telephone.

Speaker Change: And I'm not showing any further questions at this time I'd like to turn the call back over to Dave <unk> for any closing remarks.

Dane Carl Andreeff: Great. Thanks, Kevin. And thank you, everyone, for following Helius Medical Technologies. Before we go, I just want to thank the team at Helius for their hard work and dedication to bringing PONS therapy to the millions who need it. We're right on the cusp. We're excited about our upcoming milestones and look forward to keeping you updated as we pursue coverage and reimbursement and authorization for stroke. Thank you again.

Dane Carl Andreeff: Great. Thanks, Kevin.

Dane Carl Andreeff: Thank you everyone for phoning Heelys medical technologies.

Dane Carl Andreeff: Before we go I just want to thank the team at <unk> for their hard work and dedication to bringing pons therapy to.

Dane Carl Andreeff: To the millions who need it we're right on the cusp.

Dane Carl Andreeff: We're excited about our upcoming milestones and look forward to keeping you updated as we pursue coverage and reimbursement and authorization in stroke. Thank you again.

Operator: Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.

Speaker Change: Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.

Speaker Change: Okay.

Speaker Change: [music].

Q1 2024 Helius Medical Technologies Inc Earnings Call

Demo

Solana

Earnings

Q1 2024 Helius Medical Technologies Inc Earnings Call

HSDT

Monday, May 13th, 2024 at 8:30 PM

Transcript

No Transcript Available

No transcript data is available for this event yet. Transcripts typically become available shortly after an earnings call ends.

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