Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $9.2 million, representing a 17% increase from $7.9 million in Q2 2024 [8][10] - Gross margin decreased to 60% in Q2 2025 from 63% in Q2 2024, primarily due to higher inventory reserves [10] - Operating expenses increased by 16% to $11.2 million in Q2 2025 from $9.7 million in Q2 2024 [10][11] - Cash and cash equivalents rose to $41.5 million as of June 30, 2025, compared to $20.1 million at the end of 2024 [11] Business Line Data and Key Metrics Changes - Biologics and Drug Delivery revenue increased by 10% to $4.7 million in Q2 2025, driven by a 12% rise in product revenue and an 8% increase in service revenue [8][9] - Neurosurgery Navigation revenue grew by 33% to $3.4 million, attributed to new product offerings and additional placements [9] - Capital Equipment and Software revenue rose by 11% to $1 million, primarily due to increased service revenue [9] Market Data and Key Metrics Changes - ClearPoint technology is now available at over 100 centers globally, with regulatory clearance in 36 countries [6][24] - The company has activated two new sites in Q2 2025 and expects to activate between 15 and 20 new sites by the end of the year [24] Company Strategy and Development Direction - The company is focused on extending its lead in cell and gene therapy through a comprehensive drug delivery ecosystem [4][5] - Plans to evolve the product portfolio to enhance hospital efficiency and throughput [5] - Aiming to expand the global installed base and generate scale for wider access to ClearPoint technology [6][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth across all business pillars, supported by a strong cash position [13][14] - The company is preparing for significant demand as new restorative therapies become available [5][14] - Management highlighted the importance of regulatory approvals and collaborations with biopharma partners for future growth [16][18] Other Important Information - The company has secured foundational funding from Oberlin Capital to support its strategic initiatives [6] - ClearPoint has submitted applications for new ICD-10 codes to assist in tracking commercial use of its technologies [18] Q&A Session Summary Question: Can you provide more details on the biologic partner opportunity and revenue contribution from Cabildy? - Management indicated that while early opportunities are significant, they are not expected to be massive revenue drivers in the near term, serving more as milestones for larger market opportunities [31][32] Question: What is the status of the ClearPoint 3.0 rollout and its impact on margins? - Management confirmed that there is currently no margin impact from ClearPoint 3.0, and the deployment has been the fastest in the company's history, with 35 sites now using the software [36][40] Question: How will MRI suite availability impact the launch of therapies? - Management discussed strategies to improve efficiency in both MRI and operating room settings to mitigate bottlenecks and enhance capacity for procedures [51][53]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $8.5 million, an 11% increase from $7.6 million in Q1 2024 [7] - Gross margin improved to 60%, up from 59% in Q1 2024 [9] - Cash and cash equivalents decreased to $12.4 million from $20.1 million at the end of 2024 [10] Business Line Data and Key Metrics Changes - Biologics and Drug Delivery revenue increased by 9% to $4.7 million, driven by a $1.2 million increase in product revenue [7][8] - Neurosurgery Navigation revenue grew 70% to $3.3 million, attributed to higher sales of new product offerings [8] - Capital Equipment and Software revenue decreased 63% to $500,000 due to fewer new placements of navigation and laser units [9] Market Data and Key Metrics Changes - The company activated two new sites in Q1 2025, expanding its installed base [51] - The single-use consumables business saw a growth rate of 104%, driven by increased orders from biopharma partners [13] Company Strategy and Development Direction - The company aims to extend its lead in cell and gene therapy through a comprehensive drug delivery ecosystem [4] - Plans to evolve the product portfolio to enhance hospital efficiency and throughput [5] - The company is focused on expanding its global installed base and generating scale for novel treatments [5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for additional cell and gene therapy platforms to gain approvals in the next two years [15] - The recent partnership with Overland Capital provides the company with foundational funding to execute its strategy [6][12] - Management anticipates that revenue growth will outpace expense growth for the full year [11][57] Other Important Information - The company has implemented a new subscription program called Pathfinder, allowing hospitals to access technology through annual fees [21] - The company expects to achieve GLP certification by the end of the year, which will enable larger studies and increased demand [42][47] Q&A Session Summary Question: What initiatives can be prioritized now that capital is available? - Management indicated opportunities to accelerate hiring for field support and preclinical resources to meet partner demands [29] Question: How does the new capital runway relate to achieving sustained breakeven? - Management believes the new debt facility can support cash breakeven, with expectations of generating meaningful cash flow in the coming years [31] Question: How is the neuro franchise tracking relative to expectations? - Management stated that the neuro franchise is on plan and expects significant growth throughout the year [34] Question: What is the expected mix of MRI versus OR procedures in the future? - Management anticipates a shift towards more OR procedures, but expects MRI procedures to remain crucial for drug delivery therapies [40][41] Question: What is the status of GLP certification and customer interest? - Management confirmed that they are on track for GLP certification and have received interest from pharma partners for studies once certified [42][46] Question: How are the new sites placed in terms of sales agreements? - Management clarified that the two new sites activated were capital placements, with additional systems placed under the Pathfinder agreements [51][52]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $8.5 million, an 11% increase from $7.6 million in Q1 2024 [7] - Gross margin improved to 60%, up from 59% in Q1 2024 [9] - Cash and cash equivalents decreased to $12.4 million from $20.1 million at the end of 2024 [10] Business Line Data and Key Metrics Changes - Biologics and Drug Delivery revenue increased by 9% to $4.7 million, driven by a $1.2 million increase in product revenue [7][8] - Neurosurgery Navigation revenue grew 70% to $3.3 million, attributed to higher sales of new product offerings [8] - Capital Equipment and Software revenue decreased 63% to $500,000 due to fewer new placements of navigation and laser units [9] Market Data and Key Metrics Changes - The company activated two new sites in Q1 2025, expanding its installed base [19][50] - The single-use consumables business saw a growth rate of 104%, driven by increased orders from biopharma partners [13] Company Strategy and Development Direction - The company aims to extend its lead in cell and gene therapy through a comprehensive drug delivery ecosystem [4] - Plans to evolve the product portfolio to enhance hospital efficiency and throughput [5] - The company is focused on expanding its global installed base and generating scale for novel treatments [5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for additional cell and gene therapy platforms to gain regulatory approval within two years [15] - The recent partnership with Overland Capital provides the company with foundational funding to execute its strategy [6][12] - Management anticipates that revenue growth will outpace expense growth for the full year [11][56] Other Important Information - The company has implemented a new subscription program called Pathfinder, allowing hospitals to access technology through an annual fee [21] - The Pathfinder program will smooth out capital revenue recognition over time [22] Q&A Session Summary Question: Opportunities with Incremental Capital - Management sees opportunities to accelerate hiring and expand preclinical resources in response to pharma partners' requests [29] Question: Neuro Franchise Growth Expectations - Management believes the neuro franchise can grow significantly more than 20% throughout the year, with potential upside based on product adoption [33] Question: MRI vs. OR Procedure Mix - Management anticipates a shift towards more procedures being performed in the operating room, especially as new drug therapies are introduced [39] Question: GLP Certification Timeline - Management expects to achieve GLP certification by the end of the year, with pent-up demand from pharma partners for studies once certified [42][44]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $8.5 million, an 11% increase from $7.6 million in Q1 2024 [7] - Gross margin improved to 60%, up from 59% in Q1 2024 [10] - Cash and cash equivalents decreased to $12.4 million from $20.1 million at the end of 2024 [11] Business Line Data and Key Metrics Changes - Biologics and Drug Delivery revenue increased by 9% to $4.7 million, driven by a $1.2 million increase in product revenue [8] - Neurosurgery Navigation revenue surged 70% to $3.3 million, attributed to higher sales of new product offerings [9] - Capital Equipment and Software revenue fell 63% to $500,000 due to fewer new placements of navigation and laser units [10] Market Data and Key Metrics Changes - The company activated two new sites in Q1 2025, which were both capital placements [51] - The introduction of the three point zero navigation software has allowed expansion into operating rooms, enhancing market reach [14] Company Strategy and Development Direction - The company aims to extend its lead in cell and gene therapy through a comprehensive drug delivery ecosystem [4] - Plans to evolve the product portfolio to focus on fast, simple, and predictable workflows to increase hospital efficiency [5] - The company is pursuing global scale by expanding its installed base and generating more access to its ecosystem [5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for additional cell and gene therapy platforms to gain approvals in the next two years [16] - The recent partnership with Overland Capital provides the company with the necessary funding to execute its strategy [6] - Management anticipates that operational cash burn will continue to increase but expects to generate meaningful cash flow as new drugs come online [31] Other Important Information - The company has implemented a Pathfinder subscription program to smooth capital revenue recognition over time [22] - The three point zero navigation software has been well received, with positive feedback from surgeons regarding efficiency and accuracy [18] Q&A Session Questions and Answers Question: Are there initiatives that can be prioritized now with access to incremental capital? - Management confirmed that there are opportunities to accelerate hiring and expand preclinical resources in response to partner requests [29] Question: How does the new capital runway relate to achieving sustained breakeven? - Management believes the new debt facility can support the company towards cash breakeven, especially with the flexibility of an interest-only period [31] Question: How is the neuro franchise tracking relative to expectations? - Management stated that the neuro franchise is on plan and expects significant growth throughout the year, with potential upside from new product launches [34] Question: What is the expected mix of MRI versus OR procedures in the future? - Management indicated that while MRI procedures currently dominate, there is potential for OR procedures to grow faster as new therapies are introduced [40] Question: What is the status of GLP certification and customer interest? - Management confirmed that they are on track for GLP certification by the end of the year and noted strong interest from pharma partners for studies once certified [42][46]