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ClearPoint Neuro Announces Installation and First Procedure Using the ClearPoint Prism® Neuro Laser Therapy System and Navigation System at Kaleida Health in Buffalo

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ClearPoint Neuro, Inc. (CLPT) announced the successful installation and completion of an initial procedure with the ClearPoint Prism Neuro Laser Therapy System and the ClearPoint Neuro Navigation System at Kaleida Health in Buffalo, New York. Dr. Jonathan Riley and team performed the procedure, marking the first successful case with combined MRI targeting and laser ablation solutions. The company looks forward to expanding into full market release later this year. The Prism laser is currently in limited market release at select academic medical centers across the United States.
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The recent announcement by ClearPoint Neuro, Inc. regarding the successful installation and initial procedure using their ClearPoint Prism Neuro Laser Therapy System and the ClearPoint Neuro Navigation System represents a significant milestone in the field of medical device technology, particularly in neurosurgery. The integration of MRI targeting with laser ablation solutions is a noteworthy advancement, as it enhances the precision and minimizes the invasiveness of neurosurgical procedures. This technology eliminates the need for external cooling during laser application, which is a unique feature compared to other products in the market. By reducing setup complexity and ablation time, it potentially improves patient outcomes and increases the efficiency of medical workflows.

From a business perspective, the limited market release at select academic medical centers indicates a strategic approach to market penetration, allowing ClearPoint Neuro to gather data and refine their technology with input from leading medical professionals before a full market release. The success of this initial procedure could serve as a proof of concept, thereby increasing credibility and potentially accelerating the adoption rate post full market release. However, the long-term impact on the company's financials will depend on the rate of adoption, scalability of production and the ability to maintain a competitive edge in technology.

The healthcare industry is seeing a growing trend towards minimally invasive surgery, with a focus on reducing patient recovery time and improving surgical outcomes. ClearPoint Neuro's recent development fits well within this trend, suggesting potential market demand for their integrated neurosurgical systems. The non-cooled laser applicator technology may offer a competitive advantage, as it simplifies the surgical process and reduces the potential for complications associated with cooling mechanisms.

As this technology is currently in limited release, the company's stock could be influenced by the market's perception of its potential. Positive feedback from the initial procedures and the anticipation of a full market release later in the year could have a bullish effect on investor sentiment. However, investors will be looking for evidence of sustainable demand, the ability to scale up production and the maintenance of a strong intellectual property position to protect against competitors.

ClearPoint Neuro's announcement may have implications for the company's financial performance. The successful initial procedure could signal future revenue growth from sales of the new system. The medical device sector is highly competitive and innovations that offer improved outcomes and efficiency can command premium pricing. The market will be closely monitoring the adoption rate of ClearPoint's technology, as it could significantly impact the company's market share in the neurosurgery device sector.

Investors will also be interested in the cost implications of the new technology. The removal of the need for external cooling could suggest a reduction in operational costs for healthcare providers, which could incentivize adoption. However, the cost of the technology to providers and the reimbursement landscape will be crucial factors in determining the financial viability of the system. ClearPoint Neuro's stock performance in the short term could reflect the market's assessment of these factors, with long-term performance hinging on the system's clinical success and market penetration.

SOLANA BEACH, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- 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 installation and completion of an initial procedure with both the ClearPoint Prism Neuro Laser Therapy System and the ClearPoint Neuro Navigation System by Dr. Jonathan Riley and team at Kaleida Health in Buffalo, New York.

“We are ecstatic to have completed our first successful case with combined ClearPoint Neuro MRI targeting and laser ablation solutions,” stated Dr. Jonathan Riley, Assistant Professor of Neurosurgery at the University of Buffalo, and Medical Director of Functional Neurosurgery at Kaleida Health. “This is a world leading suite of technologies that allows us to offer selected minimally invasive neurosurgical procedures to patients in our region.”

“Our successful first case with Dr. Riley and the team at Kaleida Health is emblematic of the excellent collaboration we have both with our customers and within our organization,” said Chris Osswald, Segment Leader for Laser Therapy at ClearPoint Neuro. “Our limited market release has been such a positive experience, mainly because of our team’s dedication. We look forward to continued success together with the team at Kaleida Health and as we look to expand into full market release later this year.”

The ClearPoint Prism Neuro Laser Therapy System features the only non-cooled laser applicator on the market. ClearPoint’s next-generation laser applicator technology eliminates the need for external cooling, simplifying setup, reducing power and ablation time, lessening imaging artifact, and enabling more efficient workflows. The Prism laser is currently in limited market release at select academic medical centers across the United States. For more information about the ClearPoint Neuro Laser Therapy System please visit: https://www.clearpointneuro.com/clearpoint-prism-neuro-laser-system/

The ClearPoint Prism™ Neuro Laser Therapy System

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, 2022, and the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2023, 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, 2023, which the Company intends to file with the Securities and Exchange Commission on or before March 31, 2024. The Company does not assume any obligation to update these forward-looking statements.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/66f919ac-c17e-402e-a88e-1211e8044e7c


FAQ

What did ClearPoint Neuro announce recently?

ClearPoint Neuro announced the installation and completion of an initial procedure with the ClearPoint Prism Neuro Laser Therapy System and the ClearPoint Neuro Navigation System at Kaleida Health in Buffalo, New York.

Where was the initial procedure with the ClearPoint Prism Neuro Laser Therapy System and the ClearPoint Neuro Navigation System completed?

The initial procedure was completed at Kaleida Health in Buffalo, New York.

Who performed the initial procedure?

Dr. Jonathan Riley and team at Kaleida Health performed the initial procedure.

What is the unique feature of the ClearPoint Prism Neuro Laser Therapy System?

The ClearPoint Prism Neuro Laser Therapy System features the only non-cooled laser applicator on the market.

Where is the Prism laser currently in limited market release?

The Prism laser is currently in limited market release at select academic medical centers across the United States.

ClearPoint Neuro, Inc.

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