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ClearPoint Neuro (CLPT) Gets FDA's Nod for New Software
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ClearPoint Neuro, Inc. (CLPT - Free Report) recently announced its receipt of the FDA’s clearance and first-in-human cases using the ClearPoint 2.2 Software with integrated Maestro Brain Modeling. The company also announced the publication of a key validation study for its ClearPoint Maestro Brain Model in the peer-reviewed journal NeuroImage.
The first clinical cases using ClearPoint 2.2 were completed successfully in the current quarter. The company expects a full market release in the second half of 2024.
The latest regulatory approval is likely to be a significant stepping stone for ClearPoint Neuro and boost its business.
Significance of the Approval
Management believes that the Maestro Brain Model and its integration into the recently FDA-cleared ClearPoint 2.2 navigation software is expected to now offer fast, peri-procedural segmentation of the cortical structures of the brain to identify both targets and safety zones for cell and gene therapy delivery, laser ablation, biopsy and deep brain stimulation.
Per management, the announcement that one of many planned validation studies has been published in NeuroImage will likely give surgeons confidence in the performance and accuracy of the Maestro Tool.
Industry Prospects
Per a report by MarketsandMarkets, the global neuromodulation market was estimated at $6.2 billion in 2023 and is anticipated to reach $11 billion by 2028 at a CAGR of 12%. Factors like the rising prevalence of neurological disorders and the increasing adoption of innovative neuromodulation devices are likely to drive the market.
Given the market potential, the latest regulatory clearance will likely provide a significant impetus to ClearPoint Neuro’s business.
Notable Developments
Last month, ClearPoint Neuro announced the installation and completion of an initial procedure with both the ClearPoint Prism Neuro Laser Therapy System and the ClearPoint Neuro Navigation System.
The same month, ClearPoint Neuro announced its receipt of the FDA’s 510(k) clearance for its SmartFrame OR Stereotactic System. The system is expected to offer flexible workflows to surgeons (including iCT forward projection), thereby enabling precise image-based corrections to achieve sub-millimetric accuracy.
Also, in January, ClearPoint Neuro announced its preliminary results for the fourth quarter and full year 2023. Per the results, the company expects its fourth-quarter 2023 revenues to be approximately $6.8 million, up 32% year over year. Biologics and drug delivery revenues are likely to be $4.1 million, up 76% year over year.
Price Performance
Shares of the company have lost 12.7% in the past year against the industry’s 11% rise and the S&P 500's 28.7% growth.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, ClearPoint Neuro carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , Cardinal Health, Inc. (CAH - Free Report) and DexCom, Inc. (DXCM - Free Report) .
DaVita, sporting a Zacks Rank #1 (Strong Buy), has an estimated long-term growth rate of 12.1%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 35.6%. You can see the complete list of today’s Zacks #1 Rank stocks here.
DaVita’s shares have gained 51.2% compared with the industry’s 12.6% rise in the past year.
Cardinal Health, flaunting a Zacks Rank of 1 at present, has an estimated long-term growth rate of 15.9%. CAH’s earnings surpassed estimates in each of the trailing four quarters, with the average being 15.6%.
Cardinal Health has gained 39.6% compared with the industry’s 14.9% rise in the past year.
DexCom, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 33.1%. DXCM’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 32.8%.
DexCom’s shares have rallied 5.1% compared with the industry’s 11% rise in the past year.
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ClearPoint Neuro (CLPT) Gets FDA's Nod for New Software
ClearPoint Neuro, Inc. (CLPT - Free Report) recently announced its receipt of the FDA’s clearance and first-in-human cases using the ClearPoint 2.2 Software with integrated Maestro Brain Modeling. The company also announced the publication of a key validation study for its ClearPoint Maestro Brain Model in the peer-reviewed journal NeuroImage.
The first clinical cases using ClearPoint 2.2 were completed successfully in the current quarter. The company expects a full market release in the second half of 2024.
The latest regulatory approval is likely to be a significant stepping stone for ClearPoint Neuro and boost its business.
Significance of the Approval
Management believes that the Maestro Brain Model and its integration into the recently FDA-cleared ClearPoint 2.2 navigation software is expected to now offer fast, peri-procedural segmentation of the cortical structures of the brain to identify both targets and safety zones for cell and gene therapy delivery, laser ablation, biopsy and deep brain stimulation.
Per management, the announcement that one of many planned validation studies has been published in NeuroImage will likely give surgeons confidence in the performance and accuracy of the Maestro Tool.
Industry Prospects
Per a report by MarketsandMarkets, the global neuromodulation market was estimated at $6.2 billion in 2023 and is anticipated to reach $11 billion by 2028 at a CAGR of 12%. Factors like the rising prevalence of neurological disorders and the increasing adoption of innovative neuromodulation devices are likely to drive the market.
Given the market potential, the latest regulatory clearance will likely provide a significant impetus to ClearPoint Neuro’s business.
Notable Developments
Last month, ClearPoint Neuro announced the installation and completion of an initial procedure with both the ClearPoint Prism Neuro Laser Therapy System and the ClearPoint Neuro Navigation System.
The same month, ClearPoint Neuro announced its receipt of the FDA’s 510(k) clearance for its SmartFrame OR Stereotactic System. The system is expected to offer flexible workflows to surgeons (including iCT forward projection), thereby enabling precise image-based corrections to achieve sub-millimetric accuracy.
Also, in January, ClearPoint Neuro announced its preliminary results for the fourth quarter and full year 2023. Per the results, the company expects its fourth-quarter 2023 revenues to be approximately $6.8 million, up 32% year over year. Biologics and drug delivery revenues are likely to be $4.1 million, up 76% year over year.
Price Performance
Shares of the company have lost 12.7% in the past year against the industry’s 11% rise and the S&P 500's 28.7% growth.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, ClearPoint Neuro carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , Cardinal Health, Inc. (CAH - Free Report) and DexCom, Inc. (DXCM - Free Report) .
DaVita, sporting a Zacks Rank #1 (Strong Buy), has an estimated long-term growth rate of 12.1%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 35.6%. You can see the complete list of today’s Zacks #1 Rank stocks here.
DaVita’s shares have gained 51.2% compared with the industry’s 12.6% rise in the past year.
Cardinal Health, flaunting a Zacks Rank of 1 at present, has an estimated long-term growth rate of 15.9%. CAH’s earnings surpassed estimates in each of the trailing four quarters, with the average being 15.6%.
Cardinal Health has gained 39.6% compared with the industry’s 14.9% rise in the past year.
DexCom, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 33.1%. DXCM’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 32.8%.
DexCom’s shares have rallied 5.1% compared with the industry’s 11% rise in the past year.