Q4 2024 Spectral AI Inc Earnings Call
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I would now like to turn the conference over to Sarah Prendergast Assistant General excuse me Assistant General Counsel. Please go ahead.
Sarah Prendergast: Thank you Gary good afternoon, everyone and thank you for joining us.
2020.
Sarah Prendergast: And full year financial results conference call.
Speaker Change: For today will be Dr. Michael denial and the chairman of the board as backfill AI, and then say Capone, the Companys Chief Financial Officer.
Speaker Change: We also have Dr. Jeffrey Carter, Andy who is the principal investigator in our brain validation study and director of trauma and brands at the University Medical Center in New Orleans.
Speaker Change: And Dr. <unk>, the company's director of data science with us today.
Speaker Change: Before we begin I'd like to remind everyone that during this call certain statements made in this release are forward looking statements within the meaning of the safe Harbor provisions of the United States Private Securities Litigation Reform Act of 1995.
Speaker Change: John Vandermosten, John Vandermosten, John Vandermosten, John Vandermosten
Speaker Change: Including statements regarding the company's strategy plan objectives initiatives and financial outlook.
Speaker Change: When used in this press release, but was at the men's product dead, Xbox anticipates forecasts plans intends believes.
Speaker Change: May will should future propose and variations of these words or similar expressions or the negative versions of such words or expressions, alright, Dennis and are intended to identify forward looking statements.
Speaker Change: Good afternoon, and welcome to the Spectral AI fourth quarter and full year 2024 financial results conference call. All participants will be in listen only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.
Speaker Change: These forward looking statements are not guarantees of future performance condition or results and involve a number of known and unknown risks uncertainties assumptions and other important factors many of which are outside the company's control that could cause actual results or outcomes to differ materially from those discussed in the forward looking statements.
Speaker Change: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two.
Speaker Change: As such.
Speaker Change: Centers are cautioned not to place undue reliance on any forward looking statements.
Please note, this event is being recorded.
Speaker Change: I would now like to turn the conference over to Sarah Prendergast, Assistant General Counsel, please go ahead.
Speaker Change: Investors should carefully consider the foregoing factors and the other risks and uncertainties described in the risk factor section of the company's filings with the FCC, including the registration statement and the other documents filed by the company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from there.
Sarah Prendergast: Thank you, Gary. Good afternoon, everyone, and thank you for joining us for Spectral AI's 2024 Corp. Quarter in full year Financial Results Comfort Call.
Speaker Change: Our speakers for today will be Dr. Michael Demio, NC, Chairman of the Board of Spectral AI, and Vincent Capone, the company's Chief Financial Officer.
Speaker Change: As contained in the forward looking statements.
Speaker Change: Management will also be discussing non-GAAP financial metrics, a reconciliation of these non-GAAP financial measures to the most comparable GAAP measures can be found in the company's press release.
Speaker Change: We also have Dr. Jeffrey Carter and Steve, who is the principal investigator in our bird validation studies and director of trauma and burns at the University Medical Center in New Orleans and Dr. G. Hong Wang, the company's director of data science with us today.
Speaker Change: With that said I would now like to turn the call over to Dr. Denial. Dr to mild. Please go ahead.
Speaker Change: Thank you very much Sheryl and good afternoon, everyone.
Speaker Change: Before we begin, I'd like to remind everyone that during this call, certain statements made in this release are forward-looking statements within the meeting of the State Harvard Prohibitions of the United States Private Security's litigation reform act of 1995.
Speaker Change: We very much appreciate you joining today's call to discuss our fourth quarter and full year 2024 results and provide you an update on our progress.
Speaker Change: 2024 was a pivotal year spiritually as we continued advancing our <unk> technology to transform the assessment and potential treatment of wounds and burns our efforts over the last year have positioned us for long term success.
Speaker Change: including statements regarding the company's strategy, plans, objectives, initiatives, and financial outlook.
Speaker Change: When using this press release, the words estimate, projected, extracts, anticipates, forecasts, plans, intends, beliefs.
Speaker Change: Marked by key milestones in our regulatory pathway.
Speaker Change: Clinical validation and strategic partnerships.
Speaker Change: seeks may, will, should, future and propose and variations of these words for similar expressions or the negative versions of such words or expressions are intended to identify for looking statements.
For those of you, who don't know I am the founder of spectral AI.
Speaker Change: We found the company has special M D and 20, <unk> and I was especially eyes I am the second largest shareholder.
Speaker Change: I once served as CEO getting the BARDA contract and other matters and returned to the role of chairman of the Board last October.
Speaker Change: These forward-looking statements are not guaranteed the future performance, conditions, or results.
Speaker Change: and involved a number of known and unknown risks, uncertainties, assumptions, and other important factors, many of which are outside the company's control. That can cause actual results or outcomes to differ materially from those that have been discussed in the four years with these statements.
Speaker Change: In our third quarter earnings call I said, we would get back to basics and I said, we would focus on the three Fs <unk>.
Speaker Change: <unk> focus and finish.
Speaker Change: Our efforts R&D paying off and earlier this month, we announced positive topline results of our burn validation study, which was led by Dr. Jeff Carter.
Speaker Change: As such, listeners are cautioned not to place undue reliance on any forward-looking
Speaker Change: Investors should carefully consider the four-going factors and the other risks and uncertainties described in the risk factor of the company's filings with the SEC, including the registration statement and the other documents filed by the company.
Speaker Change: From New Orleans.
Speaker Change: Demonstrate the exceptional performance of our <unk> system and predicting burn healing potential.
Speaker Change: This study one of the largest burn trials ever conducted in the U S enrolled 164 patients for a potential de novo application across both adult and pediatric populations.
Speaker Change: Feeds, filings, identify and address other important risks and uncertainties that could cause actual events and revolts to differ materially from those contained in the war and looking statement.
Speaker Change: The findings confirm that debuted significantly outperforms performs a clinical judgment of burn positions in three key diagnostic metrics sensitivity nice core and specific specificity, which were all review with the FDA.
Speaker Change: Management will also be discussing non-GAAP financial metrics, a reconciliation of these non-GAAP financial measures to the most comparable GAAP measures can be found in the company's press release.
Speaker Change: With that said, I would now like to turn the call over to Dr. Demile. Dr. Demile, please go ahead.
Speaker Change: Sensitivity do you view identified non healing tissue with over twice the accuracy of burn physicians.
Dr. DeMille: Thank you very much Sarah, and good afternoon everyone. We very much appreciate you joining today's call to discuss our fourth quarter and full year 2024 results and provide you an update on our progress.
Speaker Change: Achieving 86, 6% at the image level.
Speaker Change: <unk> to 48%.
Speaker Change: From clinicians judgment.
Dr. DeMille: 2024 was a pivotal year of Spectral AI as we continued advancing our deep new technology to transform the assessment and potential treatment of wounds and burns.
Speaker Change: The second measurement di score.
Speaker Change: Abuses, some segmentation accuracy and AI algorithm reached 68, 5%.
Dr. DeMille: Our efforts for over the last year have positioned us for long-term success, marked by key milestones in a regulatory pathway, clinical validation, and strategic partnerships.
Speaker Change: Compared to 39, 2% for the part of physicians.
Speaker Change: Finally specificity the <unk> system surpass anticipated results and identifying non healing wound areas, achieving 61, 2% versus the expected 36%.
Dr. DeMille: So those of you who don't know, I am the Founder of Spectral AI.
Dr. DeMille: We found out the company has Spectral MD in 2009 and I was a Spectral AI's I AM the second largest shareholder. I once served as CEO , getting the Barton contract and other matters and returned to the role of Chairman of the Board last October .
Speaker Change: These results reinforce <unk> potential as a transformative tool in burn care our goals are to provide clinicians with an immediate objective assessment on day, one of an injury.
Dr. DeMille: And our third quarter earnings call, I said we would get back to basics and I said we would focus on the 3Fs. Finance, focus, and finish.
Speaker Change: Proving patient outcomes and potentially reducing health care costs.
Speaker Change: We plan to submit these results to the FDA by the end of Q2 2025 seeking to Novo classification in 2026.
Dr. DeMille: Our efforts are indeed paying off. In earlier this month, we announced positive top line results of our burn validation study, which is led by Dr. Jeff Carter from New Orleans. They demonstrate the exception performance of a deep view system in predicting burn healing potential.
Speaker Change: We are very proud of this milestone due to the focus that we've achieved the delivery of the items that we promised to BARDA.
Speaker Change: U S military and the population at large.
Speaker Change: We are now actively gathering real world clinical feedback across two continents further validating the systems impact.
Dr. DeMille: This study, one of the largest burn trials ever conducted in the US, enrolled 164 patients for a potential de novo application across both adult and pediatric populations.
Speaker Change: These global valuation will provide critical insights as we prepare for our upcoming FDA submission and eventual commercialization in the U S and beyond.
Dr. DeMille: The findings confirm that, debuting significantly our forms, our forms are clinical judgment of birth positions in three key diagnostic metrics, sensitivity, disqual and specificity, which were already due to the FDA.
Speaker Change: In the UK and Australia, the response or assistant has been exceptional burn specialists, there who express strong enthusiasm from the technology, recognizing its ability to improve patient care.
Dr. DeMille: Persensitivity, Deview identified non-healing tissue with over twice the accuracy of burn physicians, achieving 86.6% at the image level compared to 40.8% from clinician's judgment.
Speaker Change: We are committed to expanding our presence in the UK and further integrating deeper into standard burn care protocols.
At the end of our third quarter 2024 conference call I was asked if I could provide a timeline.
Speaker Change: Bringing deep beauty, Australia at the time I stated that we expected to have devices prepared and rolled out within the next few months with more details to share on this call.
Dr. DeMille: The second measurement, Dyscore, Deview System segmentation accuracy and AI algorithm reached 68.5% compared to 39.2% for the burn physicians.
Speaker Change: I am happy to report that we have delivered on that commitment.
Speaker Change: The momentum surrounding our technology has extended beyond the U K with partners in Australia actively integrating <unk> into their hospitals.
Speaker Change: We successfully deployed three <unk> systems in Australia at leading hospitals, including one Concord repatriation General Hospital in Sydney.
Dr. DeMille: These results reinforce deep use potential as a transformative tool in burn care. Our goals are to provide clinicians with an immediate, objective assessment on day one of an injury, improving patient outcomes, and potentially reducing health care costs.
Speaker Change: To the Royal Adelaide Hospital in Adelaide.
Speaker Change: Third Fiona Stanley Hospital, and Murdoch, which is a suburb of <unk>.
Speaker Change: These appointments were made possible through Australia's special access scheme in collaboration with Paulino Limited, a global leader and burn wound therapy.
Dr. DeMille: We plan to submit these results to the FDA by the end of Q2 2025 seeking the Nobel classification in 2026.
Speaker Change: By expanding into the UK and Australia, we are gathering valuable real world clinical data that will strengthen our case for our FDA submission and support global commercialization strategies across the U S and beyond.
Dr. DeMille: We are very proud as milestone due to the focus that we've achieved of delivering the item that we promise to Barda, the US military, and the population at large.
Speaker Change: In terms of debut snapshot him. This is a fully handheld portable and wireless diagnostic tool built on the same AI powered platform as regular GPU system. It is designed to provide rapid real time wound assessment in military and emergency care settings, including.
Dr. DeMille: We are now actively gathering real-world clinical feedback across two continents further validating the systems impact.
Dr. DeMille: These global valuations will provide critical insights as we prepare for upcoming FDA submission and eventual commercialization of the US and beyond.
Speaker Change: Battlefield triage.
Dr. DeMille: In the UK and Australia, the response or assistant has been exceptional. Byrnes Specialists there have expressed strong enthusiasm for the technology, recognizing its ability to improve patient care.
Speaker Change: We're deployed medical units ambulances and home health care environments.
Speaker Change: The development of snapshot and has been heavily supported by government funding with total rewards now exceeding $7 million.
Dr. DeMille: We are committed to expanding our presence in the UK and further integrating deep view into standard, current care protocols.
Speaker Change: These awards include multiple grants from the department of Defense.
Speaker Change: The defense Health agency and.
Dr. DeMille: At the end of our third quarter, 2024 conference call, I would ask if I could provide a timeline for bringing debut to Australia at the time I stated that we expected to have devices prepared and rolled out within the next few months with more details to share on this call.
Speaker Change: And amtech, the medical Technology Enterprise consortium, which most recently awarded an additional $850000 to further its development.
Speaker Change: We anticipate snapshot of them to be ready for military deployment at 2027 with potential applications beyond combat medicine, including wound size of measurement and expanded emergency and home health care use.
Dr. DeMille: I am happy to report that we have delivered on that commitment. The moments of surrounding our technology has extended beyond the UK with partisan Australia actively integrating deep view into their hospitals.
Speaker Change: These investments reinforce the broad potential of <unk> technology, allowing us to address critical needs across multiple sectors.
Dr. DeMille: We successfully deployed three defuse systems at Australia at leading hospitals, including one, Concord, Repatriation General Hospital at Sydney, two, the Royal Adelaide Hospital at Adelaide, and third, Fiona Stanley Hospital in Murdoch, which is a suburb of Perth.
Speaker Change: Discussing same IP.
Speaker Change: In March 2024, we announced the formation of spectral IP, a dedicated intellectual property subsidiary focus on monetizing IP assets within the health care and AI driven technology sectors.
Dr. DeMille: These deployments remain possible through Australia's Special Access game and collaboration with Polly Novel Limited and Global Leader in Burrow Move Therapy.
Speaker Change: Shortly after its formation spiritual IP secured a $1 million investment with Erich Spangenberg, who is a leading figure in global IP investment is centrally is largest shareholders appointed as its chief Executive Officer.
Dr. DeMille: By expanding into the UK and Australia, we are gathering valuable, real-world clinical data that will strengthen our case for our FDA submission and support global commercialization strategies across the US and beyond.
Speaker Change: In November 2024, we took the next step by announcing our intention to spin off spectral IP into an independent publicly traded company through a transaction with <unk>. So our broader investment management. The following the spinoff semi Pea incorporated will focus on IP based financing and monetization.
Dr. DeMille: In terms of Deview Snapshot M, this is a fully handheld portable and wireless diagnostic tool built on the same AI-powered platform as regular Deview system.
Speaker Change: Strategies, including licensing litigation divestment structured financing royalty acquisitions and opportunistic transactions.
Dr. DeMille: It is designed to provide rapid real-time wound assessment in military and emergency care settings, including
Dr. DeMille: Battlefield triage, forward deployed medical units, ambulances, and home health care environments.
Speaker Change: While industry agnostic Sim IP will prioritize health care <unk>.
Speaker Change: The conductors.
Speaker Change: And Iot sectors, where intellectual property remains an underutilized.
Dr. DeMille: The development of snapshot M has been heavily supported by government funding with the tone the war is now exceeding $7 million.
Speaker Change: <unk> asset class.
Speaker Change: Spectral AI 30 patents in 35 pending patent applications will remain with spectral AI and not semi Pete the.
Dr. DeMille: These awards include multiple grants from the Department of Defense, the Defense Health Agency, and MTECH, the Medical Technology Enterprise Consortium, which most recently awarded an additional $850,000 to further its development.
Speaker Change: The spinoff is expected to be executed through a distribution of special IP stock to spectral AI shareholders subject to final board and regulatory approvals and other closing conditions.
Dr. DeMille: We anticipate snapshot have to be ready for military deployment in 2027, with potential applications beyond combat medicine including
Speaker Change: While we anticipate completing this transaction within the next 90 days there can be no assurance regarding the ultimate timing for completion of this transaction.
Dr. DeMille: These investments reinforce a broad potential of D2 technology, allowing us to address critical needs across multiple sectors.
Speaker Change: With that I will turn it over to our Chief Financial Officer, Vince Kebab.
Speaker Change: Yes.
Vince Kebab: Thanks, Dr Tomorrow, and thank you all for joining us today.
Dr. DeMille: Discussing SIM IP. In March 2024, we announced the formation of Spectral IP, a dedicated intellectual property subsidiary focused on monetizing IP assets within the health care and AI-driven technology sectors.
Speaker Change: I would like to remind everyone that our press release issued this afternoon contains additional details on our operating results we.
Vince Kebab: We expect to file our Form 10-K with the SEC later this week.
Vince Kebab: With that in mind I will focus my remarks on select financial highlights and key items.
Dr. DeMille: Shortly after its formation, Spectral IP secured a $1 million investment with Eric Spang and Burr, who is a leading figure in global IP investment, and Spectral AI's largest shareholder appointed as its chief executive officer.
Vince Kebab: Starting with our fourth quarter results research and development.
Vince Kebab: Search and development revenue was $7 6 million as compared to $5 3 million in the prior year period.
Dr. DeMille: In November 2024, we took the next step by announcing our intention to spin off special IT into an independent
Vince Kebab: This increase reflects the additional work we've done in the fourth quarter under the BARDA PBS contract.
Vince Kebab: As a reminder, especially for those of you who may be new to spectral R&D.
publicly traded company through a transaction with Saurolder, Investment Management.
Vince Kebab: R&D revenue is driven by our research and development activities, we invoice the U S government monthly to reflect our R&D expenditures with an added margin to cover expenses, such as labor and third party contractors and consultants.
Dr. DeMille: The following, the spin-off, SIMIP, Incorporative will focus on IP-based financing and monetization strategies, including licensing, litigation investment, structured financing, world-hack acquisitions, and opportunistic transactions.
Vince Kebab: We generally receive payment against these invoices from the U S government. Shortly after our invoice submission, which produces a positive and predictable effect on our P&L and our cash flow.
Dr. DeMille: Well, industry agnostics, SIMIP will prioritize healthcare, semiconductors, AI and IoT sectors for intellectual property remains and underutilize the valuable asset class.
Vince Kebab: Gross margin in the fourth quarter declined to 44% as compared to 46, 1% in the prior year period, due primarily to a smaller percentage of direct labor as a proportion of the total work on the BARDA PBS contract for the quarter.
Dr. DeMille: Spectral AI's 30 patents and 35 pending patent applications will remain with Spectral AI and not SIMIP. The spin-off is expected to be executed through a distribution of Spectral IP stock to Spectral AI shareholders, subject to final board and regulatory approvals and other closing conditions.
Vince Kebab: General and administrative expenses in the fourth quarter decreased to $4 6 million as compared to $5 4 million in the prior year period, driven by a decrease in our non BARDA related development activities from 2023.
Dr. DeMille: While we anticipate completing this transaction within the next 90 days, there can be no assurance regarding the ultimate timing or completion of this transaction.
Vince Kebab: Moving on to our full year results.
Dr. DeMille: With that, I will turn over to our Chief Financial Officer, Vincent Capone.
Vince Kebab: I am proud to announce that our research and development revenue in 2024 was $29 6 million a 63, 5% increase from the $18 $1 million. We recorded in 2023, representing the highest revenue reported in the company's history.
Vince.
Dr. DeMille: Thanks, Dr. Dimaio, and thank you all for joining us today.
Dr. DeMille: I would like to remind everyone that our press release issued this afternoon contains additional details on our operating results.
Dr. DeMille: We expect to file our Form 10K with the SEC later this week.
Vince Kebab: The year over year increase reflects the expanded work on the BARDA PBS contract for the full year 2024.
Dr. DeMille: With that in mind, I will focus my remarks on select financial highlights and key items.
Dr. DeMille: Starting with our fourth quarter results, research and development, Revenue was 7.6 million as compared to 5.3 million in the prior year period.
Vince Kebab: Gross margin rose to 44, 9% from 43, 6% in the prior year period, driven by the higher reimbursement rate under the current BARDA PBS contract as compared to the BARDA burn to contract which was in place for most of 2023, therefore, creating a positive impact on.
Dr. DeMille: This increase reflects the additional work we've done in the fourth quarter under the barred of PBS contract.
Dr. DeMille: As a reminder, especially for those of you who may be new to Spectral,
Vince Kebab: The company's gross margin.
R&D Revenue is driven by our research and development activities.
Vince Kebab: General and administrative expenses in 2024 was $19 9 million as compared to $20 9 million.
Dr. DeMille: We invoice the US government monthly to reflect our R&D expenditures with an added margin to cover expenses such as labor and third party contractors and consultants.
Vince Kebab: In 2023, primarily driven by a decrease in the non reimbursed work.
Dr. DeMille: We generally receive payment against these invoices from the U.S. government shortly after our invoice submission, which produces a positive and predictable effect on our P&L and
Vince Kebab: The higher legal and accounting spend that we incurred in 2023 relating to the company's financial transactions.
Vince Kebab: As a component of our general and administrative expenses R&D expenses in 2024 increased to $19 3 million from $15 1 million in 2023.
Dr. DeMille: Gross Margin in the 4th quarter declined to 44% as compared to 46.1% in the prior year period due primarily to a smaller percentage of direct labor as a proportion of the total work on the bar to PBS contract for the quarter.
Vince Kebab: It's important to note that total R&D activity is reflected both in our general and administrative expense and in our cost of revenue.
Vince Kebab: As a result, the increase in 2024 is primarily driven again by the increased work on our BARDA PBS contract.
Dr. DeMille: General and Administrative Expenses in the fourth quarter decreased to $4.6 million as compared to $5.4 million in the prior year period driven by a decrease in our non-barta-related development activities from 2023.
Vince Kebab: As of December 31, 2024, cash and cash equivalents totaled $5 2 million.
Vince Kebab: Following the completion of the long term debt financing with Avenue capital, which we announced earlier this week I am pleased to announce that our cash position currently exceeds over $14 million rigs.
Moving on to our full-year results.
Dr. DeMille: I am proud to announce that a research and development revenue in 2024 was $29.6 million, a 63.5% increase from the $18.1 million we recorded in 2023, representing the highest revenue reported in the company's history.
Vince Kebab: Regarding our liquidity I want to highlight the additional following items.
Vince Kebab: Total monthly operating losses were reduced from $4 6 million for the first half of 2024 to approximately $2 million in the second half of 2024, as we focused on improving our operating efficiencies and the concentration on the <unk> system as part of the BARDA PBS contract.
Dr. DeMille: The year-over-year increase reflects the expanded work on the BART of PBS contract for the full year 2024.
Dr. DeMille: Gross Margin Rose to 44.9% from 43.6% in the prior year period.
Vince Kebab: In 2024, we were also able to satisfy approximately $10 $1 million of our short term debt with an institutional lender, which was fully satisfied in February 2025.
Dr. DeMille: Driven by the higher reimbursement rate under the current bar to PBS contract, as compared to the bar to burn to contract, which was in place for most of 2023, therefore creating a positive impact on the company's gross margin.
Vince Kebab: We believe that our recent long term debt financing agreement and the smaller equity raise completed in connection therewith in combination with the multi year non dilutive funding provided by our U S government contracts with approximately $113 million left to utilize.
Dr. DeMille: General administrative expenses in 2024 was $19.9 million as compared to $20.9 million in 2023 primarily driven by a decrease in the non-reimbursed work.
Vince Kebab: <unk> provides us with a sound financial foundation to pursue our strategic objectives and.
Dr. DeMille: and the higher legal and accounting spend that we incurred in 2023 relating to the company's financial transactions.
Vince Kebab: And bring our deep UV system to commercialization.
Dr. DeMille: As a component of our general and administrative expenses, R&D expenses in 2024 increased to 19.3 million from 15.1 million in 2023.
Vince Kebab: The company is forecasting revenue of approximately $21 5 million for fiscal year 2025.
Vince Kebab: The financial guidance for fiscal year, 2025 does not reflect any contributions.
Dr. DeMille: It's important to note that total R&D activity is reflected both in our general and administrative expense and in our cost of revenue.
Vince Kebab: From the sale of the <unk> system for burn in the UK or in Australia, or any additional material financial contributions that may result from the commercialization of our <unk> system.
Dr. DeMille: As a result, the increase in 2024 is primarily driven again by the increased work on our bar at PBS contract.
Dr Tomorrow: With that I will turn it back over to Dr Tomorrow.
Dr. DeMille: As of December 31st, 2024, cash and cash equivalents totaled $5.2 million.
Dr Tomorrow: Thank you Vince.
Speaker Change: Before turning to your questions I want to thank our team for their focus and dedication and commitment to our promise to develop and commercialize our <unk> system.
Dr. DeMille: Following the completion of the long-term debt financing with Avenue Capital, which we announced earlier this week, I'm pleased to announce that our cash position currently exceeds over $14 million.
Speaker Change: As I said when I took over as chairman I wanted to focus on three as I mentioned earlier and the team has responded very well to that motivation their achievements to date and those on the horizon drive our success.
Dr. DeMille: Regarding our liquidity, I want to highlight the additional following items.
Dr. DeMille: Total monthly operating losses were reduced from 4.6 million for the first half of 2024 to approximately 2 million in the second half of 2024, as we focused on improving our operating efficiencies and the concentration on the deep-use system as part of the PBS contract.
Speaker Change: The management team has coalesced around these goals and are excited to leverage the sound financial Foundation that Vince described in supporting the team's efforts.
Speaker Change: Operator, let's open the call for questions from the analysts please.
Speaker Change: We will now begin the question and answer session.
Speaker Change: To ask a question you May press Star then one on your telephone keypad.
Dr. DeMille: In 2024, we were also able to satisfy approximately $10.1 million of our short-term debt with an institutional lender, which was fully satisfied in February 2025.
Speaker Change: If you are using a speakerphone please pick up your handset before pressing the keys.
Speaker Change: To withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble our roster.
Dr. DeMille: We believe that a recent long-term debt financing agreement and a smaller equity raise completed in connection therewith, in combination with the multi-year non-delutive funding provided by our U.S. government contracts with approximately $113 million left to utilize.
Speaker Change: Our first question today is from Carl Byrnes with Northland Capital markets. Please go ahead.
Carl Byrnes: Thanks, Congratulations on your progress.
Dr. DeMille: provides us with a sound financial foundation to pursue our strategic objectives.
Carl Byrnes: Wondering what your thoughts are for your plans with respect to commercial readiness.
and bring our deep use system to commercialization.
Carl Byrnes: And in the launch obviously around the corner with respect to staffing.
Dr. DeMille: The company is forecasting revenue of approximately 21.5 million for fiscal year 2025 and the financial guidance for fiscal year 2025 does not reflect any contributions.
Regions, if youre contemplating any co promotion partners and alike.
Speaker Change: Thank you great question Mary So if I heard you say that what our plans for commercialization. So let me call. It half step back of course, we're going to anticipate the FDA clearance with them to develop a submission that should yield a commercially viable product that we will begin to commercialize.
Dr. DeMille: from the sale of the Debut system for burn in the UK or in Australia or any additional material financial contributions that may result from the commercialization of our Debut system.
Dr. DeMille: With that, I will turn it back over to Dr. Demayo.
Speaker Change: We're going to pre condition the market with a number of ways. There are a number of studies that we're going to be utilizing in.
Thank you, Benz.
Dr. DeMille: Before turning to your questions, I want to thank our team for their focus and dedication and commitment to our promise to develop and commercialize our debut system.
Speaker Change: In that time period between the submission and the clearance, but at Novo submission.
Speaker Change: We have presentations papers publications et cetera, and addition of mobilizing a sales force that will begin to accumulate as well, but as I mentioned in the discussion with the interest with the devices in the UK and Australia, beginning <unk> real world evidence to support the devices in those countries can support.
Dr. DeMille: As I said, when I took over his chairman, I wanted to focus on the three aspects I mentioned earlier and the team that responded very well to that motivation.
Dr. DeMille: The management team has coalesced around these goals and are excited to leverage the Sound Financial Foundation that Vincent described in supporting the team's efforts.
Speaker Change: <unk> and be in health care of the patients in those countries. Therefore, we.
Dr. DeMille: Operator, let's open the call of questions from the analyst, please.
Speaker Change: We plan on abstracts in writing and other matters to be able to discuss that to be able to have that could be excitement around commercializing it more broadly.
We will now begin the question and answer session.
Dr. DeMille: To ask a question, you may press star then one on your telephone keypad. If you are using a speaker phone, please pick up your handset before pressing the keys.
Speaker Change: As you asked as well about other matters and co products and all that that's currently being discussed but I cant report anything at this time that would be material to disclose.
Dr. DeMille: To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster.
Speaker Change: Got it. Thanks, that's helpful I'm wondering kind of going back.
Speaker Change: Sure.
Speaker Change: <unk>.
Speaker Change: Please go alone strategy, what would you envision in terms of how many sales reps would you need in harmony medical specialists would you need or liaisons.
Speaker Change: Our first question today is from Carl Byrnes with Northland Capital Markets. Please go ahead.
Speaker Change: And regions. Thanks.
Carl Burns: Thanks, and congratulations on your progress. I'm wondering what your thoughts are, or your plans with respect to commercial readiness and in the launch, obviously, around the corner with respect to staffing, regions, if you're contemplating any co-promotion partners and the like. Thanks.
Speaker Change: Good another good question, we already have a number of.
Speaker Change: Service people out there taking care of the devices that are out there for research purposes. The validation study.
Speaker Change: I would be I don't want to stretch out and say exactly how many I would have at this time it would be premature, but we're looking at approximately 170 more units being rolled out by the federal government contract.
Thank you. It's a great question, Mary.
Speaker Change: So, if I heard you said, what are our plans for commercialization? So, let me go have a step back of course. We're going to anticipate the FDA clearance with the Dundadova Submission, that should yield a commercially viable product. Thank you.
Speaker Change: And the PBS contract.
Speaker Change: Sure.
Speaker Change: So we would need the appropriate number at this time, which I would refer you to give at this time.
Speaker Change: No salesforce necessarily.
Speaker Change: that we will begin to commercialize. We've got a precondition to market with a number of ways. There are a number of studies that we're going to be utilizing.
Speaker Change: Because the BARDA the device that bar clients rollout will not need a sales force of roll those out so it will be beginning small sales force necessary to get those initial 170 units to the U S.
Speaker Change: in that time period between the submission and the clearance that had over-submission.
Speaker Change: We have presentations, papers, publications, etc., in addition to mobilizing a sales force that will begin to accumulate as well.
Speaker Change: Yeah.
Speaker Change: Got it thanks.
Speaker Change: Thank you thanks Carl.
Speaker Change: But as I mentioned in the discussion with the devices in the UK and Australia, we're getting RWE or real-world evidence to support the devices in those countries can support and be in that it helps the care of the patients in those countries, therefore...
Speaker Change: The next question is from Ryan Zimmerman with <unk>. Please go ahead.
Ryan Zimmerman: Hey, guys can you hear me okay.
Speaker Change: We can hear you great.
Speaker Change: Sorry for the background noise set of airport.
Vince Kebab: Maybe on the $21 million in BARDA R&D revenue. This year for 25, I think before we thought about it kind of similar to $2000 for Vince.
Speaker Change: We plan on abstracts and writing and other matters to be able to discuss that, to be able to have the excitement around commercializing it more broadly.
Vince Kebab: Vince just kind of bridge us from what was $28 million guidance in 2004 to the 'twenty one.
Speaker Change: You asked as well about other matters and co-products and all that that's currently being discussed but I can't report anything at this time that would be material to disclose. Thank you very much.
Speaker Change: In 2025, and then with that and not including any commercial revenue within the comment that you made that you do expect commercial revenue potentially this year just want to understand kind of how you're thinking about your commercial launch in terms of contribution.
Speaker Change: Got it, thanks, that's helpful. I'm wondering, kind of going back, if you were to, you know, a complete go-alone strategy, what would you envision in terms of how many sales reps would you need and how many medical specialists would you need for liaisons and regions, thanks.
Vince Kebab: Yes, Ryan.
Vince Kebab: Good question here I mean, we have always seen in 2025 is a little step back in revenue as we position for the FDA submission.
Speaker Change: And another good question. We already have a number of service people out there taking care of the devices that are out there for the research purposes of the validation study.
Vince Kebab: And obviously, we cant rollout in the U S until we get the de Novo clearance. So 2025 will be a step back in revenue.
Speaker Change: I would be I don't want to stretch out and say exactly how many I would have at this time I'd be premature but we're looking out approximately 170 more units being rolled out by the federal government contract in the in the PBS contract.
Vince Kebab: But.
Vince Kebab: We're really going to be in the process of providing additional developments to the device. So that when we get clearance from the FDA.
Vince Kebab: We'll be in a position to really reach commercialization very quickly.
Vince Kebab: For the BARDA contract first and then for other indications throughout.
Speaker Change: So, we would need the appropriate number at this time, which I wouldn't be free to give at this time. There's no sales force necessarily, because the barna...
Vince Kebab: Again, we talked about this in earlier calls.
Vince Kebab: Revenue generating from the UK and Australia.
Vince Kebab: While it would be nice to see it's not going to be dispositive for us as far as a significant portion of our overall revenue but.
Speaker Change: The device that borrow plants will roll out will not need a sales force to roll those out so it will be beginning small sales force necessary to get those initial 170 units to the US.
Vince Kebab: We've already seen in 2025 is kind of a little retreat from 2024, as we as we pause to get commercialization and FDA clearance.
Damn it. Thanks.
Thank you. Thanks, Carl.
Speaker Change: The next question is from Ryan Zimmerman with BTIG, please go ahead.
Vince Kebab: We look to see that ramp up in 2026.
Vince Kebab: Okay.
Hey guys, can you hear me okay?
Speaker Change: And then Dr de Mayo, what's left to submit to FDA.
We can hear you great.
Okay, good start for the background noise
Speaker Change: The results were really good there really encourage you in a few weeks ago. What are you got to do with what are you got one other boxes that would happen.
and an airport.
Maybe on the 21 million dollars.
Speaker Change: Jack just to get that final submission.
Speaker Change: in Barda R&D revenue this year for 25. I think before we thought about it kind of similar to 20.4.
Speaker Change: It's all the things you might expect.
Speaker Change: The SAP the statistical plan.
Speaker Change: then just kind of bridge us from what was, you know, the 28 million.
Speaker Change: <unk>.
Speaker Change: All the hardware and software requirements the validation of <unk> that goes along with all of that the clear result of the clinical trial that I described the results too is an entire package of how many sections would that be teen 14 sections for the FDA application.
guidance in 24 to the 21.
Speaker Change: in 2025, and then, you know, with that and not including any commercial revenue, but then the comment that you made that you do expect commercial revenue potentially this year, just want to understand kind of how you're thinking about your commercial launch in terms of contributions.
Speaker Change: I'd also add to that because of our BARDA relationship and other U S. Government agency all of the sections will be previewed and reviewed by BARDA first and then go to the FDA. So we'll have another set of eyes, if you will and brains reviewing everything before it goes into the FTA.
Speaker Change: Yeah, Ryan, that's a good question here. I mean, we have always...
Speaker Change: Scene 2025 is a little step back in revenue as we position for the FDA submission and you know obviously we can't roll out in the US until we get the DeNovo clearance.
Speaker Change: Thank you.
So, 2025 will be a step back in revenue, but…
Speaker Change: The next question is from John <unk> with Zacks. Please go ahead.
Speaker Change: We're really going to be in the process of providing additional developments to the device, so that when we get clearance from the FDA, we'll be in a position to really reach commercialization very quickly for the bar to contract first and then for other indications throughout. Thank you very much.
Speaker Change: Great. Thank you and Hello docs to myelin Vince.
Speaker Change: You released that.
Speaker Change: The data short time ago, and there was the dice score mentioned and I wanted to see if you could give us some additional context in terms of what that means and how the FDA looks at it and then also the importance and measuring at the image level versus the pixel level.
Again, and we talked about this in earlier calls.
Speaker Change: John that is a fantastic question and anticipating that coming I have two of our estimates here Dr. Wong Jehan Wong who is our data science chief Dr. Jeffrey Carter, who has run the pie trials, so I'm going to turn over to Dr. Wong to give us a couple of answers on your questions, which are excellent. Thanks.
Speaker Change: <unk> mile. So.
Speaker Change: John This is a good question. So <unk> basically is a widely used metrics being data science field for evaluating the segmentation path, including non healing wounds segmentation our case.
Speaker Change: Basically it measures the overlap between the DDI models segmentation.
Speaker Change: And with versus the ground trues up the non heating region.
Speaker Change: The benefits I feel that.
Speaker Change: FDA requires tight series because.
Speaker Change: FDA and not only wants to understand.
Speaker Change: With sensitivity, but it also wants to understand the ties score, which is kind of like a balanced which will provide some balance results for <unk>.
Speaker Change: Does the precision and recall because <unk> basically it will provide to you how good you actually segmenting a target but.
Speaker Change: It won't panelized if you.
Speaker Change: We are we can make some mistakes I'll have some force posture, while diets actually trying to balancing both seeds precision and recall, which actually keep see more.
Speaker Change: The next question is from Jon Vander motion with Zacks. Please go ahead.
Speaker Change: A comprehensive view of the models performance, especially in the cases of the imbalanced data centers.
Speaker Change: Great. Thank you and Hello docs to myelin Vince.
Speaker Change: You released the data a short time ago and there was the dice score mentioned and I wanted to see if you could give us some additional context in terms of what that means and how the FDA looks at it and then also the importance and measuring at the image level versus the pixel level.
Speaker Change: And regarding your next question here.
Speaker Change: During the discussion with FDA.
Speaker Change: Do you think.
Speaker Change: When we actually report our segmentation performance. It's also a natural reporting about this detection performance because if you think about segmentation. It is a more advanced.
Speaker Change: John that is a fantastic question and anticipating that coming I have two of our assets here Dr. Wong Dr. Wong Who's our data science Chief Dr. Jeffrey Carter, who is running the trials, so I'm going to turn over to Dr. Wong and it gives us a couple of answers all your questions which are excellent.
Speaker Change: Way to report the results when you get a com core of the firm, but I think the first step FDA wants to understand is whether you keep your device is able to actually identify the now heating area in the image So thats why.
Speaker Change: So John this is a good question so <unk> basically is.
Speaker Change: So FDA has just shown we have the two paths of the validation process why is focused on the detection performance and another <unk> focus on the segmentation.
Speaker Change: Widely used metrics in data science field evaluating the segmentation past, including non healing wounds segmentation our case.
Speaker Change: Okay.
Speaker Change: Basically it measures the overlap between the <unk> models segmentation.
Speaker Change: Great.
Speaker Change: Another question is on additional deployments in Australia, and the U K you mentioned there were three.
Speaker Change: And with versus the ground truth after not heating region.
Speaker Change: The benefits.
Speaker Change: And in Australia, what what's on tap for 2025 for the rest for the rest of the year there.
Speaker Change: The.
Speaker Change: FDA required sties here because.
Speaker Change: FDA not only wants to understand how algorithms sensitivity.
Speaker Change: Do we think we're going to keep up that pace or is that a yes, I'm just wondering what the pace might be for the rest of the year.
Speaker Change: It also wants to understand that ties school, which is kind of like a balanced which will provide some balance resolves.
Speaker Change: Well, we don't plan on putting in any more units. If that's your question in terms of pace.
Speaker Change: The precision and recall because you know if you know our sensitivity basically it will provide to you how good you actually segmenting a target but it.
Speaker Change: Add those three centers that pace would be that they would.
Speaker Change: They've been trained and begin to utilize it just like the U K physicians begin to understand how to utilize it when to utilize it.
Speaker Change: And give us the feedback that we look forward to with the real world application.
Speaker Change: Ooh Panelized if you.
Speaker Change: I believe we can make some mistakes I'll have some food cost while times actually trying to balancing both the precision and recall, which actually keep see more.
Speaker Change: So we don't expect to expand the number of sites, we just expect to be able to pursue.
Speaker Change: Through a deeper dive and each of them to understand better how it's used and as we make serial improvements, which we expect to make us with their feedback how we.
Speaker Change: A comprehensive view of the models performance, especially in the cases of the imbalanced data.
Speaker Change: <unk> looked at back in.
Speaker Change: Okay. So we have the the expected number of units both in the U K and Australia right now.
Speaker Change: And regarding your next question here.
Speaker Change: During discussion with FDA.
Speaker Change: Yes, Sir that is correct it for future okay. Thank you.
Speaker Change: Do you think.
Speaker Change: Well when we actually report our segmentation performance. It's also a natural reporting about detection performance because if you think about segmentation as a more advanced.
Speaker Change: Thank you thanks John.
Speaker Change: The next question is from Rama <unk> swam paciello with H C. Wainwright. Please go ahead.
Speaker Change: Thank you good afternoon, Michael and then a couple of quick questions.
Speaker Change: Way to report the results when you get a comscore.
<unk>.
Speaker Change: So.
Speaker Change: But I think the first step FDA wants to understand is whether you keep your device is able to actually identify the now heating area in the image So thats why.
Speaker Change: In terms of the pediatric study that got initiated recently.
Speaker Change: The timeline and a four four data from that study.
Speaker Change: Howard you.
Speaker Change: The FDA has just shown we have.
Speaker Change: Use that data to expand your label.
Speaker Change: The two paths of the validation process why is focused on the detection performance and another wise folks on the segmentation.
Speaker Change: Hey, RK, thank you very much.
Speaker Change: The data I.
Speaker Change: Okay.
Speaker Change: The study has been discussing in this call and we also issued a press release, a week or so ago two weeks ago with the top line numbers.
Speaker Change: Great. Another question is on additional deployments in Australia, and the U K you mentioned that there were three.
Speaker Change: We hit the performance metrics that were asked and cleared by the FDA. So the answer to your question as the data has been preliminarily processed in truth and that's what we have planned to release.
Speaker Change: And in Australia, what what's on tap for 2025 for the rest for the rest of the year there.
Speaker Change: Do we think we're going to keep up that pace or is that a yes, I'm just wondering what the pace might be for the rest of the year.
Speaker Change: Thats locked down I can repeat the numbers if you want.
Speaker Change: Well, we don't plan on putting in any more units. If that's your question in terms of pace.
Speaker Change: No I'm talking about the pediatric study.
Speaker Change: Add those three centers that pace would be that they would.
Speaker Change: So RK ASO emerge into one there is no separate studies, both the burn centers and emergency department centers emerge as well as the pediatric and adult populations is all merge into one big dataset.
Speaker Change: They've been trained and begin to utilize it just like the U K physicians begin to understand how to utilize it when to utilize it.
Speaker Change: And give us the feedback that we look forward to with the real world application.
Speaker Change: So we don't expect to expand the number of sites. We just expect to build a deeper dive in each of them to understand better how it's used.
Speaker Change: Does that answer RK I mean, we made yourself analyses is not a requirement.
Speaker Change: And as we make serial improvements, which we expect to make us with their feedback how we.
Speaker Change: The FCA.
Speaker Change: I'd have to say that press release okay.
Speaker Change: Look that back in.
Speaker Change: Yes, I'm sorry, yes, and then this is a good question no because that we did I'm sorry in <unk>, we did enroll a 115 adult and 49 pediatric patients for a total of $1 64.
Speaker Change: Okay. So we have the the the expected number of units both in the U K and Australia right now, yes, Sir that is correct. It will future. Okay. Thank you.
Speaker Change: So we feel we have a representative sample to again merge all this data.
John: Thank you thanks John.
Speaker Change: The next question is from Rama <unk> swam paciello with H C. Wainwright. Please go ahead.
Speaker Change: And to repeat what I said, we will be doing sub analysis, but that is not a requirement that we anticipate for the FDA submission that.
Speaker Change: Thank you good afternoon, Michael and then a couple of quick questions.
Speaker Change: With that we will submit.
Speaker Change: Hum.
Speaker Change: Okay.
Speaker Change: So.
Speaker Change: And then in terms of the debut snapshot am.
Speaker Change: In terms of the pediatric study that got initiated recently, what's the timeline and a four four data from that study.
Speaker Change: So is there any.
Speaker Change: Any milestones that we can expect in terms of the how the development is growing.
Speaker Change: And Hollywood U.
Speaker Change: Use that data to expand your label.
Speaker Change: During 'twenty five.
Speaker Change: Oh, Hey, RK, Thank you very much.
Speaker Change: So there are some soft milestones they actually the team went down too.
Speaker Change: The data from the study has been discussed in this call and we also have issued a press release, a week or so ago two weeks ago with a topline numbers. We hit the performance metrics that were asked and cleared by the FDA. So the answer to your question as the data has.
Speaker Change: The San Antonio Burn center of the military disciplinary received some preliminary feedback from the military down there those are being incorporated right now will.
Speaker Change: We will be submitting some of those plans for the remainder of 2025. So this is kind of a completion I would say in 2025, we get that to the point of.
Speaker Change: Been preliminarily processed in truth, and that's what we have planned to release.
Speaker Change: For more formal.
Speaker Change: That's locked down I can repeat the numbers if you want.
Speaker Change: I won't call it a clearance, but we're looking at ruggedness testing.
Speaker Change: No I'm talking about the pediatric study.
Speaker Change: What other changes we need to make based upon the military or using it in a preliminary assessment in 2026 I believe it is I can't recall that date right now will be sending in another application I think it's in March 2026 through September of next year getting the next tranche of money from the federal government or the military to be able to.
Speaker Change: So RK, it's all emerge into one there is no separate studies, both the burn centers and emergency department centers emerge as well as the pediatric and adult populations. It's all merge into one big dataset.
Speaker Change: Complete.
Speaker Change: Does that answer RK I mean, we made yourself analyses is not a requirement.
Speaker Change: The processing of course with the military wants is for us to be able to design and develop it to be able to use and more austere settings again as we know the world is a very difficult place and so higher altitudes in temperature extremes all of that will be further developed with the device.
Speaker Change: The FCA.
Speaker Change: I did see that press release okay.
Speaker Change: Yeah, I'm, sorry, yes, and then that's a good question no because that we did I'm sorry in <unk>, we did enroll 115 adult and 49th pediatric patients for a total of $1 64.
Speaker Change: Okay, and then in terms of.
Speaker Change: So we feel we have a representative sample too again merge all this data.
And are the product that has been placed in U K.
Speaker Change: And to repeat what I said well be doing sub analyses, but that is not the requirement that we anticipate for the FDA submission.
Speaker Change: Ben.
Speaker Change: I think it's been a little bit little over a year now so what are the learnings from that.
Speaker Change: With that we will submit.
Speaker Change: Hum.
Speaker Change: Okay.
Speaker Change: From what Youre learning from there do you think there has to be any protocol changes or any.
Speaker Change: And then in terms of the deep you a snapshot am.
Speaker Change: So is there any.
Speaker Change: Development on this software or hardware side.
Speaker Change: Any milestones that we can expect in terms of the how the development is going.
Speaker Change: RK, let me turnover Dr. Carter, who is our burn expert has been watching all of that data.
Speaker Change: During 'twenty five.
Speaker Change: Europe Youre asking a very prudent question more about implementation science.
Speaker Change: So there are some salt milestones he actually the team went down too.
Speaker Change: The San Antonio Burn center of the military disciplinary received some preliminary feedback from the military down there those are being incorporated right now will.
Speaker Change: Our users in the UK are giving us a lot of very helpful. Input. This is the first time they've had a diagnostic tool for burn of this quality in caliber they've historically used laser Doppler imaging in the UK and they are comparing this to that tool.
Speaker Change: We will be submitting some of those plans for the remainder of 2025. So this is kind of a completion I would say in 2025, we get that to the point of.
Speaker Change: That technology has not taken off in the United States due to many limitations with that.
Speaker Change: A more formal.
Speaker Change: Well I won't call it a clearance, but we're looking at ruggedness testing.
Speaker Change: Our device was designed to.
Speaker Change: Not have those limitations and so it'll be interesting how it compares in the U S. But a lot of what we're learning right now is how the device performs relative to their previous experiences. We've had very positive feedback or anticipate that there will be data shared at several of the upcoming scientific meetings as early as one in April from our colleagues.
Speaker Change: What other changes we need to make based upon the military are using it and our preliminary assessment in 2026 I believe it is I can't recall the date right now will be sending in another application I think it's in March 2026 through September of next year getting the next tranche of money from the federal government or the military to be able to.
Speaker Change: In the U K as for guidelines, yes, there is a lot of work that will need to be done for guidelines and usage.
Speaker Change: Complete the.
Speaker Change: The processing of course with the military wants is for us to be able to design and develop it to be able to use and more austere settings again as we know the world is a very difficult place and so higher altitudes in temperature extremes all of that will be further developed with the device.
Speaker Change: There there's already been some.
Speaker Change: Work done to establish coding for this are a product of this caliber theres going to be a lot of work is going to be needed to change care.
Speaker Change: Paradigms, because we've never had a tool like this you can imagine is north of <unk> <unk>, we had a broken arm you never had mix rate it would be very different than once you've got an X-ray. So we anticipate that this is going to have.
Speaker Change: Okay, and then in terms of.
Speaker Change: The product that has been placed in U K.
Speaker Change: Ben.
Speaker Change: A beautiful adoption, but theres going to be a need to really study the implementation and do it in a constructive well educated way.
Speaker Change: I think it's been a little bit little over a year now so what are the learnings from that and.
Speaker Change: You know from what you're learning from there do you think there has to be any protocol changes or any.
Speaker Change: Thank you all thank you for taking my questions.
Speaker Change: Thank you.
Speaker Change: This concludes our question and answer session I would like to turn the conference back over to Dr. <unk> for any closing remarks.
Speaker Change: Development on this software or hardware side.
Speaker Change: Yeah.
RK: RK, let me turnover Dr. Carter, who is our burn expert has been watching all this data.
Speaker Change: Thank you very much.
Speaker Change: So thank you again for your participation and continued interest in special AI. We are very pleased with the progress we've made and remain optimistic about our prospects for growth.
Speaker Change: Sure.
Speaker Change: Youre asking a very prudent question more about implementation science.
Speaker Change: Our users in the UK are giving us a lot of very helpful. Input. This is the first time they've had a diagnostic tool for burn of this quality in caliber they've historically used laser Doppler imaging in the UK and they are comparing this to that tool that technology is not taken.
Speaker Change: We hope to speak with some of you in the future events, including upcoming meetings that are coming both locally and abroad as well as the annual American Burn Association meeting I really want to thank Dr. Carter and Dr. Wong, who at the time with us today as well.
Speaker Change: I, thank everyone and I wish you a very good evening.
Speaker Change: In the United States too many limitations with that.
Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Speaker Change: Our devices designed to.
Speaker Change: Not have those limitations and so it'll be interesting how it compares in the U S. But a lot of what we're learning right now is how the device performs relative to their previous experiences. We've had very positive feedback I anticipate that there will be data shared at several of the upcoming scientific meetings as early as one in April from our colleagues.
Speaker Change: In the U K as for guidelines, yes, there is a lot of work that will need to be done for guidelines and usage.
Speaker Change: There there's already been some.
Speaker Change: Work done to establish coding for this or a product of this caliber theres going to be a lot of work that's going to be needed to change care.
Speaker Change: Paradigms, because we've never had a tool like this you can imagine there's north predicts surgeon. If you have a broken arm you never had mix rate it would be very different and then once you've got an X-ray. So we anticipate that this is going to have.
Speaker Change: A beautiful adoption, but theres going to be a need to really study the implementation and do it in a constructive well educated way.
Speaker Change: Thank you all and thank you for taking my questions.
Speaker Change: Thank you our starting today.
Doctor Tomorrow: This concludes our question and answer session I would like to turn the conference back over to the Doctor Tomorrow for any closing remarks.
Speaker Change: Thank you very much.
Doctor Tomorrow: Well. Thank you again for your participation and continued interest in specialty I. We are very pleased with the progress we've made and remain optimistic about our prospects for growth.
Doctor Tomorrow: We hope to speak with some of you in the future events, including upcoming meetings that are coming both locally and abroad as well as the annual American Burn Association meeting I really want to thank Dr. Carter and Dr. Wong, who at the time with us today as well.
Doctor Tomorrow: I, thank everyone and I wish you a very good evening.
Doctor Tomorrow: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Doctor Tomorrow: Yeah.
Doctor Tomorrow: [music].
Doctor Tomorrow: Yeah.
Doctor Tomorrow: Yeah.
Doctor Tomorrow: [music].
Doctor Tomorrow: Yeah.
Doctor Tomorrow: [music].
Doctor Tomorrow: Yeah.
Doctor Tomorrow: Yeah.