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ClearPoint Neuro, Inc. (CLPT) is a commercial-stage medical device company specializing in developing and commercializing platforms for minimally invasive brain surgery. The company offers integrated systems and solutions for neurosurgical procedures, including navigation, therapy, and biologics delivery. Its products are used globally in clinical and research settings to enhance precision and outcomes in brain interventions.
- Biologics and Drug Delivery - Provides disposable products and services for preclinical and clinical trials, supporting pharmaceutical and biotech companies in delivering therapies to the central nervous system.
- Neurosurgery Navigation and Therapy - Offers disposable products for procedures utilizing the ClearPoint system, including deep brain stimulation and laser catheter placement.
- Capital Equipment and Software - Sells reusable hardware, software, and related services for neurosurgical applications, including the ClearPoint system and SmartFrame OR Stereotactic System.
| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
Joseph M. Burnett ExecutiveBoard | President, Chief Executive Officer, and Director | Joseph M. Burnett has been the President and CEO of ClearPoint Neuro, Inc. since November 2017 and serves as a member of its Board of Directors. He brings extensive executive experience from roles at Royal Philips, Volcano Corporation, and Guidant Corporation. | View Report → | |
Danilo D’Alessandro Executive | Chief Financial Officer | Danilo D’Alessandro is the Chief Financial Officer (CFO) at ClearPoint Neuro since January 1, 2021. He initially joined as Vice President of Finance in September 2020 and brought extensive experience from his previous roles at Royal Philips. | ||
Jeremy L. Stigall Executive | Chief Business Officer | Jeremy L. Stigall is a seasoned leader with over 20 years of experience in the medical device industry, currently serving as Chief Business Officer at CLPT since February 2024. He previously served as Executive Vice President and General Manager of Biologics & Drug Delivery from December 2022 and joined CLPT as Vice President, Biologics and Drug Delivery in July 2020. | ||
Mazin Sabra Executive | Chief Operating Officer | Mazin Sabra is the Chief Operating Officer at CLPT since October 10, 2022. He has an extensive background in leadership roles, having served in senior positions at Stryker Corporation and Philips. |
- Your 2025 revenue guidance ranges widely from 15% to 31% growth; can you detail the specific factors that could drive you to the higher end of this range and what might limit you to the lower end?
- With over 60 biopharma partners critical to your future growth, how are you mitigating the risks associated with potential delays or failures in their clinical trials and regulatory approvals?
- As you expand into the operating room with new product introductions, how do you plan to manage the anticipated increase in operating expenses and cash burn to maintain a path toward profitability?
- Given the potential approval of cell and gene therapies in the next two years, what specific steps are you taking now to ensure you have the capacity and infrastructure to meet a possible surge in demand?
- Considering competitors are also developing technologies for cell and gene therapy delivery, how do you intend to maintain and enhance your competitive advantage and protect your market position?
Competitors mentioned in the company's latest 10K filing.
| Company | Description |
|---|---|
Monteris Medical, Inc. | Offers devices for laser ablation under direct MRI guidance, which are competitive with the company's ClearPoint system. |
Provides devices for laser ablation under direct MRI guidance and systems for conventional stereotactic neurosurgical procedures, competing with the company's ClearPoint system. | |
Brainlab | Offers systems such as navigational platforms and cannulas useful for drug delivery under MRI, competing with the company's products. |
Elekta | Provides devices and systems for conventional stereotactic neurosurgical procedures, competing with the company's ClearPoint system. |
FHC Inc. | Offers devices and systems for conventional stereotactic neurosurgical procedures, competing with the company's ClearPoint system. |
Provides devices and systems for conventional stereotactic neurosurgical procedures, competing with the company's ClearPoint system. | |
Neurologica Corporation | A subsidiary of Samsung Electronics Co., offers devices and systems for conventional stereotactic neurosurgical procedures, competing with the company's ClearPoint system. |
Its ROSA® robot serves as an operating room alternative to the company's ClearPoint system. | |
Renishaw plc | Offers systems such as navigational platforms and cannulas useful for drug delivery under MRI, competing with the company's products. |
A large, well-known company in the medical device industry that competes in the neurosurgical market. |
| Customer | Relationship | Segment | Details |
|---|---|---|---|
PTC Therapeutics, Inc. | Related party (significant stockholder, CEO on board) | All | Accounts for 9% of total revenue in 2024 (~$2.83M) , 17% of biologics & drug delivery revenue in 2024 , and 12% of total revenue in 2023. No outstanding AR as of Dec 31, 2024 or 2023. |
Recent press releases and 8-K filings for CLPT.
- Annual Meeting held on May 21, 2025: Stockholders approved several key proposals, including the election of eight directors to serve until the 2026 meeting.
- Auditor ratification: The appointment of Cherry Bekaert LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2025, was approved.
- Executive compensation matters: Advisory votes on executive compensation and approval of both the Employee Stock Purchase Plan and the Sixth Amended Incentive Compensation Plan were confirmed.
- Q1 2025 revenue reached $8.5M, marking an 11% year-over-year increase with Neurosurgery Navigation up 70% to $3.3M, Biologics and Drug Delivery increasing 9% to $4.7M, and Capital Equipment revenue declining 63% to $0.5M; gross margin improved to 60%.
- The company reported strategic progress with the launch of 3.0 navigation software and the full market rollout of its PRISM laser therapy system, contributing to a significant boost in its single-use consumables segment.
- ClearPoint Neuro secured foundational funding from Oberland Capital, including a new credit facility and equity investment, to support accelerated hiring, expanded preclinical capacity, and progress towards GLP certification.