ClearPoint Neuro (CLPT) Company Overview

ClearPoint achieves FDA 510(k) clearance for its Navigation Software Version 3.0, designed to standardize cell and gene therapy delivery in the United States.

ClearPoint Neuro (CLPT) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.

Only Device Approved to Deliver First Disease-Modifying Treatment for AADC Deficiency in the United States SOLANA BEACH, CA / ACCESSWIRE / November 13, 2024 / ClearPoint Neuro, Inc. (Nasdaq:CLPT) (the "Company"), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the SmartFlow Neuro Cannula using the De Novo pathway. The SmartFlow Neuro Cannula is intended for intraputaminal administration of PTC Therapeutics' gene therapy KEBILIDI™ (eladocagene exuparvovec-tneq) for the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.

ClearPoint Neuro reported strong YoY growth in Q3, but the stock reacted negatively, probably due to its high valuation and weak sequential growth. Volatile performance should be expected in the near term due to the company's size and the immaturity of growth initiatives. ClearPoint's margins are improving, and cash burn is minimal, which should ease concerns about dilution.

SOLANA BEACH, Calif., Oct. 17, 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 that it will release financial results for its 2024 third quarter on Thursday, November 7th, after the market close.

ClearPoint Neuro (CLPT) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.

ClearPoint Neuro clears all debt from balance sheet after early repayment of principal & interest on $10 million convertible note held by PTC Therapeutics

ClearPoint's business is gaining momentum, with recent growth investments starting to pay off. Growth in system placements is an early indication of the potential boost that the OR system and laser therapy will provide. ClearPoint's biologics business also continues to progress. This was highlighted recently by uniQure's solid clinical trial data.

ClearPoint Neuro, Inc. (CLPT) came out with a quarterly loss of $0.16 per share versus the Zacks Consensus Estimate of a loss of $0.19. This compares to loss of $0.29 per share a year ago.