This article first appeared on GuruFocus .
Release Date: August 13, 2026
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
Positive Points
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HIFU revenue grew 39% year-over-year to $13.2 million in Q2 2026, with 13 Focal One capital system sales, a 44% increase.
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U.S. Focal 1 procedure volumes increased 47% year-over-year, demonstrating strong recurring revenue growth.
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Gross margin improved to 55.6% from 51.1% in the prior year, driven by lower system costs and disciplined pricing.
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CMS proposed a 12% increase in HIFU facility payment for 2027, marking the fifth consecutive annual increase, supporting reimbursement predictability.
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Expansion into new indications (BPH and endometriosis) is progressing, with 14 BPH patients treated and the first commercial endometriosis program launched in Europe.
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The company raised $40 million in an equity offering, strengthening its balance sheet to fund growth initiatives.
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The install base grew to 184 systems, with 15 U.S. hospital networks owning two or more systems, including repeat placements at Cleveland Clinic and Kaiser Permanente.
Negative Points
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Operating expenses increased to $15.4 million from $11.5 million, driven by higher investment in growth initiatives.
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Net loss widened due to a $6.3 million non-cash charge from changes in fair value of EIB warrants and interest expense.
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Shareholders' equity was negative $3.2 million at quarter-end, though the recent equity raise is expected to improve it.
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Discontinued operations (ESWL and distribution) saw a 34% revenue decline, reflecting ongoing termination of distribution agreements.
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The company faces foreign exchange headwinds, with a $400,000 unfavorable impact in the quarter.
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Tariff impacts totaled approximately $500,000 on the quarter's results.
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BPH and endometriosis contributions to revenue are expected to be minimal in the near term, with material impact not anticipated until 2027.
Q & A Highlights
Q: Can you speak to the upcoming clinical data that we need to watch out for, particularly the HIFUSI study? When can we see a readout, and how important could it be? A: Ryan Rhodes (CEO): The HIFUSI study patients have been treated and are in the follow-up period. We expect a readout potentially at the very end of this year or the beginning of next year. This is an important study because it looks at active surveillance, and we believe it will be favorable to the story of using focal therapy for low to intermediate-risk patients.
Q: With the recent equity raise in hand, can you talk about the pushes and pulls of future cash use to build out Focal One as a platform across multiple indications and the resourcing necessary to accomplish this as you aim for that 40% growth profile? A: Ryan Rhodes (CEO): The equity raise supports three buckets of growth. First, accelerated commercial growth through investments in sales structure and marketing. Second, investment in expanded indications like BPH and endometriosis, potentially including U.S. clinical studies. Third, new innovative technologies, including our work in histotripsy, where we've already filed important patents and want to accelerate development. Ken Mobick (CFO) added that they are also looking to optimize current infrastructure to be responsible about additional spending.
Q: Can you speak to the upcoming clinical data that we need to watch out for, particularly the HIFUSI study? When can we see a readout, and how important could it be? A: Ryan Rhodes (CEO): The HIFUSI study patients have been treated and are in the follow-up period. We expect a readout potentially at the very end of this year or the beginning of next year. This is an important study because it looks at active surveillance, and we believe it will be favorable to the story of using focal therapy for low to intermediate-risk patients.
Q: With the recent equity raise in hand, can you talk about the pushes and pulls of future cash use to build out Focal One as a platform across multiple indications and the resourcing necessary to accomplish this as you aim for that 40% growth profile? A: Ryan Rhodes (CEO): The equity raise supports three buckets of growth. First, accelerated commercial growth through investments in sales structure and marketing. Second, investment in expanded indications like BPH and endometriosis, potentially including U.S. clinical studies. Third, new innovative technologies, including our work in histotripsy, where we've already filed important patents and want to accelerate development. Ken Mobick (CFO) added that they are also looking to optimize current infrastructure to be responsible about additional spending.
Q: Can you speak to the upcoming clinical data that we need to watch out for, particularly the HIFUSI study? When can we see a readout, and how important could it be? A: Ryan Rhodes (CEO): The HIFUSI study patients have been treated and are in the follow-up period. We expect a readout potentially at the very end of this year or the beginning of next year. This is an important study because it looks at active surveillance, and we believe it will be favorable to the story of using focal therapy for low to intermediate-risk patients.
Q: With the recent equity raise in hand, can you talk about the pushes and pulls of future cash use to build out Focal One as a platform across multiple indications and the resourcing necessary to accomplish this as you aim for that 40% growth profile? A: Ryan Rhodes (CEO): The equity raise supports three buckets of growth. First, accelerated commercial growth through investments in sales structure and marketing. Second, investment in expanded indications like BPH and endometriosis, potentially including U.S. clinical studies. Third, new innovative technologies, including our work in histotripsy, where we've already filed important patents and want to accelerate development. Ken Mobick (CFO) added that they are also looking to optimize current infrastructure to be responsible about additional spending.
Q: Can you speak to the upcoming clinical data that we need to watch out for, particularly the HIFUSI study? When can we see a readout, and how important could it be? A: Ryan Rhodes (CEO): The HIFUSI study patients have been treated and are in the follow-up period. We expect a readout potentially at the very end of this year or the beginning of next year. This is an important study because it looks at active surveillance, and we believe it will be favorable to the story of using focal therapy for low to intermediate-risk patients.
Q: With the recent equity raise in hand, can you talk about the pushes and pulls of future cash use to build out Focal One as a platform across multiple indications and the resourcing necessary to accomplish this as you aim for that 40% growth profile? A: Ryan Rhodes (CEO): The equity raise supports three buckets of growth. First, accelerated commercial growth through investments in sales structure and marketing. Second, investment in expanded indications like BPH and endometriosis, potentially including U.S. clinical studies. Third, new innovative technologies, including our work in histotripsy, where we've already filed important patents and want to accelerate development. Ken Mobick (CFO) added that they are also looking to optimize current infrastructure to be responsible about additional spending.
Q: Can you speak to the upcoming clinical data that we need to watch out for, particularly the HIFUSI study? When can we see a readout, and how important could it be? A: Ryan Rhodes (CEO): The HIFUSI study patients have been treated and are in the follow-up period. We expect a readout potentially at the very end of this year or the beginning of next year. This is an important study because it looks at active surveillance, and we believe it will be favorable to the story of using focal therapy for low to intermediate-risk patients.
Q: With the recent equity raise in hand, can you talk about the pushes and pulls of future cash use to build out Focal One as a platform across multiple indications and the resourcing necessary to accomplish this as you aim for that 40% growth profile? A: Ryan Rhodes (CEO): The equity raise supports three buckets of growth. First, accelerated commercial growth through investments in sales structure and marketing. Second, investment in expanded indications like BPH and endometriosis, potentially including U.S. clinical studies. Third, new innovative technologies, including our work in histotripsy, where we've already filed important patents and want to
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
