Financial Data and Key Metrics Changes - ClearPoint Neuro reported total revenues of $12.8 million for the year ended December 31, 2020, a 14% increase from $11.2 million in 2019 [8] - The company achieved a gross margin of 71% in 2020, up from 65% in 2019, primarily due to a shift towards higher-margin service revenues [12] - Cash and cash equivalents increased to $20.1 million at the end of December 2020, compared to $5.7 million at the end of 2019, largely due to the issuance of senior secured convertible notes [18] Business Line Data and Key Metrics Changes - Functional neurosurgery navigation and therapy revenue decreased by 12% to $6.3 million in 2020 from $7.1 million in 2019, impacted by COVID-19 [9] - Biologics and drug delivery revenue surged by 109% to $5 million in 2020, up from $2.4 million in 2019, driven by a 302% increase in biologics and drug delivery services [10] - Capital equipment revenue fell by 10% to $1.5 million in 2020 compared to $1.7 million in 2019, as many hospitals postponed capital equipment acquisitions due to the pandemic [11] Market Data and Key Metrics Changes - The company expects to return to pre-COVID case volumes in the second half of 2021, as hospitals begin to reopen and schedule cases again [26] - Case volume for Q1 of 2021 is projected to be between 190 to 200 cases, an increase from 175 cases in Q4 2020 [26] Company Strategy and Development Direction - ClearPoint Neuro is focused on a four-pillar growth strategy, which includes expanding its biologics and drug delivery services, enhancing functional neurosurgery navigation, developing therapeutic programs, and pursuing global expansion [20][33] - The company aims to innovate with a cadence of annual product releases, including a next-generation SmartFrame Array and partnerships with Blackrock Microsystems and Philips [27][29] - ClearPoint is also looking to facilitate earlier engagement with pharma partners to enhance service revenue potential [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about returning to pre-COVID case volumes and highlighted the importance of the rapid deployment of vaccines [5] - The company noted that while COVID-19 has impacted case volumes, it has also provided opportunities to develop new partnerships and expand service offerings [6][21] - Management anticipates multiple new clinical trials to be initiated in 2021 as COVID-19 fears subside [22] Other Important Information - Research and development costs increased by 67% to $4.7 million in 2020, reflecting investments in personnel and collaborative research [12] - Sales and marketing expenses rose by 13% to $5.4 million in 2020, primarily due to increased compensation costs [13] Q&A Session Summary Question: Additional color on the move into the operating room and margin profile differences - Management clarified that not all procedures will migrate to the operating room, and the focus will be on simpler procedures where less troubleshooting is needed [37] Question: Insights on the Philips Maestro brain model partnership - The new system is expected to significantly reduce analysis time from 14-20 minutes to under 1 minute, enhancing peri-procedural applications [44] Question: Overhead expectations for expanding biologics and drug delivery segment - Management indicated that they will partner with existing companies for translational services rather than building in-house capabilities [48] Question: Potential for negotiating royalties in clinical trials - Management confirmed they are exploring opportunities for milestone payments and royalties in early-stage partnerships [71] Question: Barriers to increasing DBS market penetration - Management identified patient anxiety about awake procedures as a significant barrier and emphasized the need for education on advancements in technology [80]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_____to _____ Commission file number: 001-34822 ClearPoint Neuro, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 58-2394628 (State or ...

Financial Data and Key Metrics Changes - Total revenues for Q3 2020 were $3.5 million, an increase of 20% from $2.9 million in Q3 2019, reflecting a growth of $592,000 [5] - Gross margin improved to 80% in Q3 2020 from 66% in Q3 2019, primarily due to a higher contribution from service revenues [7] - Operating expenses rose by 43% to $4.1 million in Q3 2020 compared to $2.9 million in Q3 2019, driven by increased R&D and sales and marketing costs [8] Business Line Data and Key Metrics Changes - Functional neurosurgery navigation revenue decreased by 1% to $1.8 million in Q3 2020 from $1.9 million in Q3 2019, impacted by COVID-19 [6] - Biologics and drug delivery revenues surged by 162% to $1.5 million in Q3 2020 from $564,000 in Q3 2019, due to new relationships with biologic companies [6] - Capital equipment and software revenue fell by 48% to $200,000 in Q3 2020 from $400,000 in Q3 2019, attributed to postponed capital acquisitions [6] Market Data and Key Metrics Changes - The company reported a case volume rebound to 200 cases in the U.S. during Q3 2020, although still below pre-pandemic levels [3] - The company is currently operating at about 80% to 85% of expected case volumes had the pandemic not occurred [12] Company Strategy and Development Direction - The company is focused on four strategic growth pillars: neurosurgery navigation, biologics and drug delivery, in-house therapeutics, and achieving global scale [4] - The company aims to strengthen its position post-pandemic, believing it will exit in a stronger position [4] - The company has successfully hired clinical support team members in Europe to support biologics cases, marking a significant strategic investment [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the recovery of elective procedures, despite ongoing challenges from COVID-19 [4] - The company anticipates exiting 2020 with revenues between $12 million and $12.5 million, barring significant hospital shutdowns [19] - Management highlighted the importance of developing custom products and services for biologics and drug delivery, which are expected to grow despite clinical delays [16] Other Important Information - Cash and cash equivalents at September 30, 2020, were $14.7 million [9] - The company is actively working on new product evaluations and expects to re-enter the capital budgeting process in hospitals [15] Q&A Session Summary Question: Revenue breakdown by product and service categories - Management indicated that substantially all service revenue was represented by biologics and drug delivery, with minimal contributions from therapy revenue or capital equipment [25][26] Question: Clinical trials involvement and expected FDA approvals - Management noted that they have added five new partners since the pandemic began, with ongoing relationships fostering clinical trials, although specific trial details remain confidential [22][23] Question: R&D expenditure expectations - R&D expenditures are expected to remain above $1 million in Q4 2020, but the rate of increase will not be as high as in Q3 [36] Question: Impact of new laser solution on revenues and margins - The new laser solution is expected to follow a similar razor/razorblade model, potentially doubling revenue per case from current levels [39][40] Question: Expansion into other therapeutic areas - The company is primarily focused on neurosurgery but has done some work in spine and prostate areas, though these are not current strategic priorities [62]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_____to _____ Commission file number: 001-34822 ClearPoint Neuro, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 58-2394628 (State or Othe ...

ClearPoint Neuro, Inc. (NASDAQ:CLPT) Q2 2020 Results Conference Call August 12, 2020 4:30 PM ET Company Participants Joe Burnett - CEO Harold Hurwitz - CFO Conference Call Participants Sall Yanchus - Brookline Capital Markets Andrew D'Silva - B. Riley FBR Operator Greetings, and welcome to ClearPoint Neuro’s Second Quarter and Six Months 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Opera ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_____to _____ Commission file number: 001-34822 ClearPoint Neuro, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 58-2394628 (State or Oth ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________ FORM 10-K ___________________________ ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______. Commission File Number: 001-34822 CLEARPOINT NEURO, INC. (Exact name of registrant as specified in i ...

ClearPoint Neuro, Inc. (NASDAQ:CLPT) Q4 2019 Earnings Conference Call February 12, 2020 4:30 PM ET Company Participants Joseph Burnett - Chief Executive Officer Harold Hurwitz - Chief Financial Officer Conference Call Participants Brandon Hedgepath - RTM Capital Advisors Operator Greetings. Welcome to the ClearPoint Neuro Incorporated Fourth Quarter and Fiscal Year 2019 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the ...

Investor Presentati on PRECISE NEURO NAVIGATION & THERAPY Joe Burnett, President & CEO December 2019 FORWARD LOOKING STATEMENTS Statements herein concerning MRI Interventions, Inc. (the "Company") plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are fo ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_____to _____ Commission file number: 001-34822 MRI Interventions, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 58-2394628 (State o ...