ClearPoint Neuro Announces FDA Clearance of Prism Bone Anchor Accessory

Rhea-AI Summary

ClearPoint Neuro, Inc. announced FDA clearance for its Prism Bone Anchor Accessory, supporting the ClearPoint Prism Neuro Laser Therapy System, expanding into the operating room. The accessory will enable precise navigation for laser therapy in the brain and spine, with a market release in Q2 2024 and full market release in the second half of the year.

Positive

• Expansion beyond MRI into the operating room for laser applicators placement.

• Received FDA clearance for Prism Bone Anchor Accessory.

• Second new product introduction within the first four months of 2024.

• Supports accurate positioning of surgical instruments in cranium, brain, or nervous systems.

Negative

• None.

Insights

Medical Device Analyst

The FDA clearance of the Prism Bone Anchor Accessory by ClearPoint Neuro represents an extension of the company's product portfolio into the operational toolkit used in neurosurgery. This regulatory milestone will likely bolster the company's presence in the operating room segment, a space traditionally dominated by MRI-guided procedures. From a medical device standpoint, the integration with stereotactic systems signals toward a strategic alignment with existing surgical workflows, which could facilitate adoption in clinical settings. For healthcare investors, the crux lies in the accessory's potential to drive sales growth, especially given this product's fit within an expanding suite of neurosurgical devices. ClearPoint's strategy to commence with a limited market release allows for real-world feedback, which is important to refine product deployment ahead of the broader market release. Investors should monitor the uptake of the Prism System and any reported improvements in surgical outcomes or operational efficiencies as these factors will influence long-term revenue trajectories.

Healthcare Industry Analyst

ClearPoint Neuro's recent FDA clearance is indicative of the company's aggressive innovation pipeline and commitment to expanding its footprint in the neurosurgical space. The introduction of the Prism Bone Anchor Accessory also reflects the broader industry trend of incorporating precision navigation technologies in complex medical procedures. From an industry perspective, companies that successfully secure FDA clearances tend to gain a competitive advantage and can be attractive for partnerships, especially with healthcare facilities looking to minimize MRI constraints. The company's established relationships with global healthcare and research centers, as well as partnerships within the pharmaceutical and biotech sectors, could be leveraged to expedite the commercialization process. Investors should consider the broader implications of this clearance as a sign of ClearPoint's potential to capture market share from traditional imaging and navigation modalities, which can ultimately contribute to top-line growth and enhance shareholder value over time.

Key Accessory to the ClearPoint Prism® Neuro Laser Therapy Will Enable Operating Room Placement of Laser Fibers

SOLANA BEACH, Calif., April 29, 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 it has received 510(k) clearance for its Prism Bone Anchor Accessory. This clearance marks the Company’s second new product introduction within the first four months of 2024.

“Similar to the recent launch of our SmartFrame OR platform, the introduction of the Prism Bone Anchor Accessory for use with the ClearPoint Prism Neuro Laser Therapy System supports our continued expansion beyond the MRI into the operating room. This is where most laser applicators are placed today,” stated Chris Osswald, PhD, Director, Global Segment Leader for Laser Therapy at ClearPoint Neuro. “We are pleased to round out our laser portfolio and look forward to working with hospitals in the United States interested in the Prism System that may have challenges with MRI access. We plan to begin our limited market release on schedule here in the second quarter, with a full market release in the second half of 2024.”

The Prism Bone Anchor Accessory is intended to be used with commercially available stereotactic systems for intracranial and neurosurgical procedures which require accurate positioning of compatible small surgical instruments or accessories in the cranium, brain or nervous systems. It is designed to provide short-term fixation and positioning of compatible neurosurgical instruments or accessories under image-guidance.

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, which may 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 December 31, 2023, which has been filed with the Securities and Exchange Commission, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2024, which the Company intends to file with the Securities and Exchange Commission on or before May 15, 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?

ClearPoint Neuro announced FDA clearance for its Prism Bone Anchor Accessory.

What is the purpose of the Prism Bone Anchor Accessory?

The Prism Bone Anchor Accessory is intended for use with stereotactic systems for intracranial and neurosurgical procedures, providing fixation and positioning of compatible neurosurgical instruments under image-guidance.

When will the Prism Bone Anchor Accessory be released to the market?

A market release is scheduled for the second quarter of 2024, with a full market release planned for the second half of the year.

What is ClearPoint Neuro's main product?

ClearPoint Neuro's flagship product is the ClearPoint Neuro Navigation System, which has FDA clearance and is CE-marked.

Where can more information about ClearPoint Neuro be found?

More information about ClearPoint Neuro can be found on their website at www.clearpointneuro.com.