ClearPoint Neuro Announces FDA Clearance for ClearPoint Navigation Software Version 3.0
SOLANA BEACH, Calif., January 27, 2025 (Newswire.com)
–
ClearPoint Neuro, Inc. (Nasdaq:CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced it has received 510(k) clearance for its ClearPoint Navigation Software Version 3.0.
“As we prepare for the wave of new patients that will be treated with cell and gene therapies in the years ahead, it is crucial that ClearPoint helps healthcare providers be ready by providing simplified workflows, offering solutions to increase surgical capacity and expanding access to our hardware and software,” commented Joe Burnett, President and CEO at ClearPoint Neuro. “The newest ClearPoint 3.0 platform is designed to do exactly that by offering one of the fastest and most accurate navigation systems available while enabling the flexibility to be used in both the MRI suite and the operating room. Today, more than nighty-five percent of all stereotactic procedures in the United States take place in the operating room using Computed Tomography (CT) as the imaging modality. Using CT, the ClearPoint Software now supports the entire operating room procedure, eliminating the need for additional third-party navigation systems. Hospitals can use ClearPoint in either or both settings, benefiting from a consistent workflow that streamlines procedures and builds proficiency. We believe that this single, flexible solution will benefit our 50+ global biopharma partners with the potential to standardize cell and gene therapy delivery around the world, starting here in the United States.”
ClearPoint Navigation Software Version 3.0 introduces an intraoperative CT workflow that builds on over a decade of experience in enabling MRI-guided stereotactic procedures. While previous versions of ClearPoint software supported MRI-guided workflows exclusively, the latest release extends ClearPoint navigation capabilities to the operating room. With compatibility for intraoperative CT and Conebeam CT imaging, this enhancement broadens access to precision-guided neurosurgery for facilities without intraoperative MRI capabilities. The ClearPoint Navigation Software Version 3.0 when used in conjunction with the SmartFrame® XG stereotactic frame, is intended to provide precise stereotactic guidance when placing instruments or devices during neurosurgical procedures. These procedures include biopsies, catheter and electrode insertion including deep brain stimulation (asleep or awake) lead placement.
The Company plans to initiate a limited market release for ClearPoint Navigation Version 3.0 in Q1 2025, with a planned full market release in the second half of 2025.
About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as pre-clinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
This press release contains forward-looking statements within the context of the federal securities laws, including the Company’s expectation for the future market of its products and services, and other performance and results. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which may cause the Company’s actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: global and political instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2024, both of which have been filed with the Securities and Exchange Commission, and the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which the Company intends to file with the Securities and Exchange Commission on or before March 31, 2025. The Company does not assume any obligation to update these forward-looking statements.
Source: ClearPoint Neuro, Inc.
| Inventory NSN Marketplace, Aviation Marketplace, Electronic Parts Marketplace at Valley of Parts |
|---|
| 2888633-1 Double Angle Bracket Part of FSC 5340 Hardware, Commercial By Navair And Navsea Managed |
| 1154M82P001A Angle Bracket Part of FSC 5340 Hardware, Commercial By General Electric Company |
| E-3962 Pump Wall Bracket Part of FSC 5340 Hardware, Commercial By Dover Fluid Management Inc. |
| ST9M581-1N Angle Bracket Part of FSC 5340 Hardware, Commercial By Fastener Specialty Inc. |
| 2B1007M1 Bumper Part of FSC 5340 Hardware, Commercial By Minor Rubber Co. Inc. |
| G080143-001 Manual Control Handle Part of FSC 5340 Hardware, Commercial By Dings Co |
| T212 Loop Clamp Part of FSC 5340 Hardware, Commercial By Ap Parts Co |
| 80-7486 Doorstop Part of FSC 5340 Hardware, Commercial By Department Of Defense Project |
| ST9M558C20 Retaining Strap Part of FSC 5340 Hardware, Commercial By Boeing Company The |
| 1586262-103 Hinge Part of FSC 5340 Hardware, Commercial By Lockheed Martin Corporation |
| 9290491 Synchro Clamp Part of FSC 5340 Hardware, Commercial By U S Army Armament Research & |
| 12325463 Rim Latch Part of FSC 5340 Hardware, Commercial By U S Army Tank Automotive Command |
| 7-217223113 Access Cover Part of FSC 5340 Hardware, Commercial By Rotair Industries Inc. |
| DYN56-B Spacing Threaded Standoff Part of FSC 5340 Hardware, Commercial By Electrical Instrument Service Inc |
| 9762-SS-0632-7 Spacing Threaded Standoff Part of FSC 5340 Hardware, Commercial By New Haven Mfg Corp |
| 36719425 Butt Hinge Part of FSC 5340 Hardware, Commercial By Clark Equipment Company |
| 8680208-1 Spacing Threaded Standoff Part of FSC 5340 Hardware, Commercial By Northrop Grumman Guidance And |
| ST9M621-1375 Plug Button Part of FSC 5340 Hardware, Commercial By Boeing Company The |
| NAS1715C24A Loop Clamp Part of FSC 5340 Hardware, Commercial By National Aerospace Standards |
| 4C27106-117A Access Cover Part of FSC 5340 Hardware, Commercial By Triumph Fabrications – Fort Worth |
| 55649 Dust And Moi Protective Cap-Plug Part of FSC 5340 Hardware, Commercial By Braden Carco Gearmatic |
| 74A110965-2062 Access Cover Part of FSC 5340 Hardware, Commercial By Boeing Company The |
| SSB-46P Quick Release Plunger Part of FSC 5340 Hardware, Commercial By Barry Wright Corporation |
| 1153M23G03 Tube Clamp Bracket Part of FSC 5340 Hardware, Commercial By General Electric Company |
| 1392690 Angle Bracket Part of FSC 5340 Hardware, Commercial By Oshkosh Corporation |
| 2HE997 Loop Clamp Part of FSC 5340 Hardware, Commercial By Oshkosh Corporation |
| LA94640-3 Electrical-Mechanical Equip Post Part of FSC 5340 Hardware, Commercial By Turbodyne |
| 16B1751-7 Access Cover Part of FSC 5340 Hardware, Commercial By Lockheed Martin Corporation |
| 330033P01 Plain Solid Disk Part of FSC 5340 Hardware, Commercial By Whittaker Controls Inc. |
| 1523809 PIECE 25 Bumper Part of FSC 5340 Hardware, Commercial By Mare Island Naval Shipyard |
| 1501805R Extension Drawer Slide Section Part of FSC 5340 Hardware, Commercial By Jonathan Engineered Solutions Corp. |
| BACC10DW24D Loop Clamp Part of FSC 5340 Hardware, Commercial By The Boeing Company |
| 8928 Yoke Flange Part of FSC 5340 Hardware, Commercial By Koehring Cranes Inc |
| NAS1714D2-13NW Loop Clamp Part of FSC 5340 Hardware, Commercial By National Aerospace Standards |
| 4K5563 Rod End Clevis Part of FSC 5340 Hardware, Commercial By Caterpillar Inc. |
| NO.1-DS Flush Catch Part of FSC 5340 Hardware, Commercial By A L Hansen Manufacturing Company |
| 751401-1-1 Access Cover Part of FSC 5340 Hardware, Commercial By Hamilton Sundstrand Corporation |
| 145978-1 Bracket Part of FSC 5340 Hardware, Commercial By Itt Corporation |
| 0N295389 Spring Clip Part of FSC 5340 Hardware, Commercial By National Security Agency |
| 65C18226-638 Access Cover Part of FSC 5340 Hardware, Commercial By The Boeing Company |
| 540-9493-003 Spacing Threaded Standoff Part of FSC 5340 Hardware, Commercial By Rockwell Collins Inc. |
| 8267773 Access Cover Part of FSC 5340 Hardware, Commercial By U S Army Armament Research & |
| 12304143 Launcher Gren Plate Part of FSC 5340 Hardware, Commercial By U S Army Tank Automotive Command |
| 75651-41X2-5 Access Cover Part of FSC 5340 Hardware, Commercial By Electric Boat Corporation |
| 10505111 Webbing Strap Part of FSC 5340 Hardware, Commercial By General Dynamics Land Systems Canada |
| 66-20258-1 Angle Bracket Part of FSC 5340 Hardware, Commercial By The Boeing Company |
| 7-311111070-17 Angle Bracket Part of FSC 5340 Hardware, Commercial By Mcdonnell Douglas Helicopter Co Inc |
| A29132-001 Rod End Clevis Part of FSC 5340 Hardware, Commercial By Teleflex Inc |
| 754CS-6-2-8 Loop Clamp Part of FSC 5340 Hardware, Commercial By Hydro-Aire Inc. |
| 37-10-131-20 Lock-Release Lever Part of FSC 5340 Hardware, Commercial By Southco Inc. |
| SM-B-561831-1 Plain Solid Disk Part of FSC 5340 Hardware, Commercial By Us Army Communications & |
| BACS38A288A8N Webbing Strap Part of FSC 5340 Hardware, Commercial By Pioneer Aerofab Company Inc. |
| 66701-1 Loop Clamp Part of FSC 5340 Hardware, Commercial By Edo Corporation |
| 5051707-1 Access Cover Part of FSC 5340 Hardware, Commercial By Signals Warfare Project Manager |
| M44204 Loop Clamp Part of FSC 5340 Hardware, Commercial By Deere & Co |
| 5068970-001 Expansion Shield Part of FSC 5340 Hardware, Commercial By Signals Warfare Project Manager |
| 204-89258-16 Angle Bracket Part of FSC 5340 Hardware, Commercial By The Boeing Company |
| J29S0032-1 Loop Clamp Part of FSC 5340 Hardware, Commercial By Mcdonnell Douglas Corp |
| 127-0657-007 Loop Clamp Part of FSC 5340 Hardware, Commercial By Boeing Company The |
| 1557037 Dust And Moisture Protective Cap Part of FSC 5340 Hardware, Commercial By Navair And Navsea Managed |
| H75WB Pipe Hanger Part of FSC 5340 Hardware, Commercial By Egs Electrical Group |
| GB11F1-2 Angle Bracket Part of FSC 5340 Hardware, Commercial By Northrop Grumman Systems Corporation |
| 70-75353-200 Detent Plunger Part of FSC 5340 Hardware, Commercial By Gardner Denver Water Jetting Systems |
| 93015-2 General Purpose Resilient Mount Part of FSC 5340 Hardware, Commercial By Barry Wright Corporation |
| SS50726K2220 Plug Button Part of FSC 5340 Hardware, Commercial By Trw Assemblies And Fasteners Group |
| 4400C0310 Stay Part of FSC 5340 Hardware, Commercial By Northrop Grumman Systems Corporation |
| 81-1214-1 Lock-Release Lever Part of FSC 5340 Hardware, Commercial By Grimes Aerospace Company |
| PD12323551 General Purpose Access Door Part of FSC 5340 Hardware, Commercial By U S Army Tank Automotive Command |
| 10319-SS-1032 Bow Handle Part of FSC 5340 Hardware, Commercial By New Haven Mfg Corp |
| 12268225 Access Cover Part of FSC 5340 Hardware, Commercial By U S Army Tank Automotive Command |