“Expanding ClearPoint’s portfolio beyond the MRI into the operating room is of key strategic significance to the Company in 2024 and beyond,” stated
The SmartFrame OR Stereotactic System is composed of two main components: the SmartFrame OR, and the ClearPointer™ Optical Navigation Wand. The SmartFrame OR is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of a compatible optical stereotactic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction. The ClearPointer is intended to be used in conjunction with the SmartFrame OR and a compatible stereotactic optical navigation system for patient registration and navigation. SmartFrame OR may be used with or without available bone screw fiducials. The Company has initiated limited market release, with a planned full market release in the second half of 2024.
“Importantly, the SmartFrame OR is compatible with capital hardware and software already present in many neurosurgical operating rooms,” continued Burnett. “As a result, we expect this to be the fastest product launch in our history. The SmartFrame OR can ‘plug-and-play’ into already existing commonly used hospital imaging equipment. Given our initial experience, we now expect to enter full market release by the end of Q2 generating meaningful product revenue in the second half of the year.”
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Forward-Looking Statements
This press release contains forward-looking statements within the context of the federal securities laws, which include the Company’s expectations for the future performance, market, and revenue of its products. 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
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Contact: Media Contact:Jacqueline Keller , Vice President of Marketing (888) 287-9109 ext. 4 info@clearpointneuro.com Investor Relations: Danilo D’Alessandro, Chief Financial Officer (888) 287-9109 ext. 3 ir@clearpointneuro.com
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