ClearPoint Neuro, Inc. CLPT, a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, recently received FDA’s 510(k) clearance for its ClearPoint Navigation Software Version 3.0. ClearPoint Navigation Version 3.0 is 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.

Per management, the latest development will benefit its more than 50 global biopharma partners with the potential to standardize cell and gene therapy delivery in the United States.

CLPT Stock Likely to Gain From the Development

Since the announcement, CLPT stock edged 5.8% to $17.99 at yesterday’s after-market trading. 

In the coming years, new patients will be treated with cell and gene therapies. Therefore, it is crucial for key market players like ClearPoint to help healthcare providers with simplified workflows, offering solutions to increase surgical capacity and expanding access to its hardware and software. Henceforth, we expect the latest development to bolster investor confidence and maintain the upward momentum in CLPT's share price in the coming days.

ClearPoint has a market capitalization of $492.4 million. The Zacks Consensus Estimate for the company’s fiscal 2025 earnings indicates a 10.6% year-over-year increase on a 23.4% revenue improvement. In the trailing four quarters, it delivered an average earnings surprise of 9.84%. 

About ClearPoint Navigation Software Version 3.0

ClearPoint Navigation Software Version 3.0 introduces an intraoperative Computed Tomography (“CT”) workflow. While previous versions of ClearPoint software supported MRI-guided workflows exclusively, the latest release extends ClearPoint navigation capabilities to the operating room. 

ClaerPoint Navigation Version 3.0 is compatible with 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, will provide precise stereotactic guidance during neurosurgical procedures. These procedures include biopsies, catheter and electrode insertion, including deep brain stimulation (asleep or awake) lead placement.

The company anticipates a limited market release for ClearPoint Navigation Version 3.0 in the first quarter of 2025, with a planned full market release in the second half. 

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Industry Prospects Favor ClearPoint

Per a report by the Insight Partners, the intraoperative CT market is expected to register a compound annual growth rate (CAGR) of 7.3% from 2024 to 2031. Demand for precise surgery, technological advancements and increase in the prevalence of chronic disorders are key growth factors for the market.

Another Notable Development by ClearPoint

In November 2024, the company received FDA granted marketing authorization for the SmartFlow Neuro Cannula using the De Novo pathway. The SmartFlow Neuro Cannula is used for the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency. This signifies the first-ever FDA marketing authorization of a device used to deliver gene therapy directly to regions of interest within the brain. 

CLPT’s Price Performance

In the past year, CLPT’s shares have risen 135.1% compared with the industry’s 9% growth.

CLPT’s Zacks Rank and Key Picks

The company currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Veracyte VCYT, ResMed RMD and Omnicell OMCL.

Veracyte, carrying a Zacks Rank #1 (Strong Buy) at present, has an estimated earnings growth rate of 65.8% for 2025. You can see the complete list of today’s Zacks #1 Rank stocks here.

VCYT’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 520.58%. Veracyte’s shares have risen 49.2% in the past year compared with the industry’s 5.5% growth.

ResMed, carrying a Zacks Rank #2 (Buy) at present, has an estimated growth rate of 21.1% for 2025. RMD’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 6.41%. Its shares have risen 34.1% compared with the industry’s 7.7% growth in the past year. 

Omnicell, carrying a Zacks Rank #2 at present, has an estimated earnings growth rate of 72.7% for fourth-quarter 2024. Its earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 121.74%. OMCL’s shares have risen 26.4% against the industry’s 15.7% decline in the past year. 

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