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ClearPoint Neuro (CLPT) Gets FDA's Nod for SmartFrame OR System
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ClearPoint Neuro, Inc. (CLPT - Free Report) recently 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.
The company is currently planning to commence a limited market release in the first half of 2024, with a planned full market release in the second half of 2024.
The latest regulatory approval is likely to significantly boost ClearPoint Neuro’s Neuromodulation business.
Significance of the Approval
Per management, the company expects to expand its portfolio beyond the magnetic resonance imaging (MRI) into the operating room. Management believes that the SmartFrame OR Stereotactic System is the first product in its portfolio that does not require the use of MRI during the stereotactic neuro-navigation procedures, the majority of which takes place in the OR. This will likely allow ClearPoint Neuro to access more hospitals and support more patients than its legacy portfolio.
Management also feels that as the SmartFrame OR is compatible with capital hardware and software already present in many neurosurgical operating rooms, it would not require approval by hospital capital committees for surgeons to try the new product.
Industry Prospects
Per a report by MarketsandMarkets, the global neuromodulation market was estimated at $6 billion in 2022 and is anticipated to reach $10.4 billion by 2027 at a CAGR of 11.8%. 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.
Recent Development
This month, 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.
During the to-be-reported quarter, ClearPoint Neuro launched the full market release of the ClearPoint PRISM Neuro Laser Therapy System. It also launched and deployed ClearPoint 2.2 Software with embedded ClearPoint Maestro and 1.2 Array Software with parallel trajectory tumor planning application to the installed base. The company also won the first purchase orders for GLP-ready pre-clinical services.
Price Performance
Shares of the company have lost 22.9% in the past year against the industry’s 0.5% rise and the S&P 500's 22% 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) , Merit Medical Systems, Inc. (MMSI - Free Report) and Integer Holdings Corporation (ITGR - Free Report) .
DaVita, presently carrying a Zacks Rank #2 (Buy), has an estimated long-term growth rate of 17.3%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 36.6%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
DaVita’s shares have gained 31.9% compared with the industry’s 9% rise in the past year.
Merit Medical, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 11.5%. MMSI’s earnings surpassed estimates in each of the trailing four quarters, with the average being 14.4%.
Merit Medical has gained 11.7% compared with the industry’s 9.6% rise in the past year.
Integer Holdings, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 15.8%. ITGR’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 11.9%.
Integer Holdings’ shares have rallied 44.3% compared with the industry’s 0.5% rise in the past year.
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ClearPoint Neuro (CLPT) Gets FDA's Nod for SmartFrame OR System
ClearPoint Neuro, Inc. (CLPT - Free Report) recently 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.
The company is currently planning to commence a limited market release in the first half of 2024, with a planned full market release in the second half of 2024.
The latest regulatory approval is likely to significantly boost ClearPoint Neuro’s Neuromodulation business.
Significance of the Approval
Per management, the company expects to expand its portfolio beyond the magnetic resonance imaging (MRI) into the operating room. Management believes that the SmartFrame OR Stereotactic System is the first product in its portfolio that does not require the use of MRI during the stereotactic neuro-navigation procedures, the majority of which takes place in the OR. This will likely allow ClearPoint Neuro to access more hospitals and support more patients than its legacy portfolio.
Management also feels that as the SmartFrame OR is compatible with capital hardware and software already present in many neurosurgical operating rooms, it would not require approval by hospital capital committees for surgeons to try the new product.
Industry Prospects
Per a report by MarketsandMarkets, the global neuromodulation market was estimated at $6 billion in 2022 and is anticipated to reach $10.4 billion by 2027 at a CAGR of 11.8%. 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.
Recent Development
This month, 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.
During the to-be-reported quarter, ClearPoint Neuro launched the full market release of the ClearPoint PRISM Neuro Laser Therapy System. It also launched and deployed ClearPoint 2.2 Software with embedded ClearPoint Maestro and 1.2 Array Software with parallel trajectory tumor planning application to the installed base. The company also won the first purchase orders for GLP-ready pre-clinical services.
Price Performance
Shares of the company have lost 22.9% in the past year against the industry’s 0.5% rise and the S&P 500's 22% 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) , Merit Medical Systems, Inc. (MMSI - Free Report) and Integer Holdings Corporation (ITGR - Free Report) .
DaVita, presently carrying a Zacks Rank #2 (Buy), has an estimated long-term growth rate of 17.3%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 36.6%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
DaVita’s shares have gained 31.9% compared with the industry’s 9% rise in the past year.
Merit Medical, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 11.5%. MMSI’s earnings surpassed estimates in each of the trailing four quarters, with the average being 14.4%.
Merit Medical has gained 11.7% compared with the industry’s 9.6% rise in the past year.
Integer Holdings, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 15.8%. ITGR’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 11.9%.
Integer Holdings’ shares have rallied 44.3% compared with the industry’s 0.5% rise in the past year.