ClearPoint Neuro Archives - Medical Design Sourcing

ClearPoint Neuro wins FDA clearance for neuro laser therapy accessory

The ClearPoint Prism neuro laser therapy system. [Image courtesy of ClearPoint Neuro]ClearPoint Neuro (Nasdaq:CLPT) announced today that the FDA granted 510(k) clearance for its Prism bone anchor accessory.

It marks the second new product introduction in 2024 for the company, with its stereotactic guidance system garnering clearance in January.

The Prism system features the only non-cooled laser applicator on the market, the company said. Its next-generation laser applicator technology eliminates the need for external cooling. This simplifies setup, reduces power and ablation time and lessens imaging artifact for more efficient workflows.

ClearPoint Neuro designed its Prism bone anchor accessory for use with commercially available stereotactic systems. These systems work for intracranial and neurosurgical procedures. Such procedures require accurate positioning of compatible small surgical instruments or accessories in the cranium, brain or nervous systems.…

ClearPoint Neuro reports positive laser therapy results

The ClearPoint Prism neuro laser therapy system. [Image courtesy of ClearPoint Neuro]ClearPoint Neuro (Nasdaq:CLPT) today announced preclinical results highlighting the accuracy of its Prism neuro laser therapy system.

The Prism system features the only non-cooled laser applicator on the market, the company said. Its next-generation laser applicator technology eliminates the need for external cooling. This simplifies setup, reduces power and ablation time and lessens imaging artifact for more efficient workflows.

ClearPoint Neuro currently has the Prism laser in a limited market release at select academic medical centers in the U.S. The company also recently used Prism with its recently FDA-cleared Array software version 1.2 to improve the practicality of neurolaser therapy.

Investigators published their latest results from evaluations of Prism in the Journal of Neurosurgery. Data demonstrated accurate, near-real-time brain tissue temperature readings with …

ClearPoint Neuro prices $15M offering

ClearPoint Neuro (Nasdaq:CLPT) announced today that it priced an underwritten public offering worth approximately $15 million.

The company is offering 2,307,694 shares of its common stock at a price to the public of $6.50 per share. It also granted the underwriter a 30-day option to purchase up to an additional 346,154 shares of common stock at that offering price. ClearPoint Neuro is offering all shares in this case.

According to a news release, the company expects the offering to close on March 4, 2024, subject to customary closing conditions.

Solana Beach, California-based ClearPoint Neuro plans to use proceeds from the offering for general corporate purposes. That may include R&D, potential acquisitions or investments or repayment of debt. Lake Street Capital Markets serves as the sole book-running manager for the proposed offering.

This marks the latest boost for ClearPoint Neuro, which kicked off 2024 with a series of milestones. In Janu…

New ClearPoint Neuro software wins FDA clearance, used in first cases

The Maestro Brain Model as part of the ClearPoint 2.2 software. [Image courtesy of ClearPoint Neuro]ClearPoint Neuro (Nasdaq:CLPT) announced that the FDA cleared its ClearPoint 2.2 software with integrated Maestro Brain Modeling.

The Solana Beach, California-based company also reported the first-in-human cases following the FDA clearance.

ClearPoint Neuro President and CEO Joe Burnett said the system now offers fast, peri-procedural segmentation of the cortical structures of the brain. This helps to identify targets and safety zones for cell and gene therapy delivery, laser ablation, biopsy and deep brain stimulation.

According to the company, MRI-guided neuro interventions need rapid, accurate and reproducible segmentation of brain structures. Maestro demonstrates superior performance compared to both manual expert segmentation and FreeSurfer, according to quantitative analysis.

The company expects a full market release of ClearPoint 2.2 in the seco…

ClearPoint Neuro reports first procedures with laser therapy system

The ClearPoint Prism neuro laser therapy system. [Image courtesy of ClearPoint Neuro]ClearPoint Neuro (Nasdaq:CLPT) announced that it completed the first procedures with its laser therapy and navigation systems.

In September 2022, the FDA cleared the company’s Swedish partner Clinical Laserthermia Systems’ neuro laser therapy system. The Solana Beach, California-based company planned from then to commercialize the system as the Prism.

ClearPoint Neuro holds exclusive global rights to commercialize the CLS magnetic resonance (MR) guided laser interstitial thermal therapy (MRgLITT) system for neuro applications.

Dr. Jonathan Riley and a team at Kaleida Health in Buffalo, New York, completed the procedure.

“We are ecstatic to have completed our first successful case with combined ClearPoint Neuro MRI targeting and laser ablation solutions,” Riley said. “This is a world-leading suite of technologies that allows us to offer selected minimally invasi…

FDA clears stereotactic guidance system from ClearPoint Neuro

ClearPoint Neuro (Nasdaq:CLPT) announced today that it received FDA 510(k) clearance for its SmartFrame OR stereotactic system.

Solana Beach, California-based ClearPoint Neuro developed its SmartFrame OR system with two main components. It features the SmartFrame OR technology with the ClearPointer optical navigation wand.

SmartFrame OR offers stereotactic guidance for the placement and operation of instruments or devices in neurological procedures. It helps during the planning and operation processes of these procedures, performed in conjunction with the use of a compatible optical stereotaxic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placements and electrode introduction.

ClearPoint Neuro’s ClearPointer works in conjunction with SmartFrame OR and a compatible stereotactic optical navigation system. It helps with patient registration and navigation.

SmartFrame OR can be used with …

ClearPoint Neuro enters drug delivery licensing deal with UCB

ClearPoint Neuro (Nasdaq:CLPT) announced today that it entered into a multi-year license agreement with UCB over gene therapy delivery.

Solana Beach, California-based ClearPoint Neuro develops a therapy-enabling platform providing navigation and delivery to the brain. The licensing agreement with UCB establishes a partnership on delivery platforms for UCB’s gene therapy portfolio.

Get the full story at our sister site, Drug Delivery Business News.

‘ClearPoint Neuro expects at least 22% revenue growth in 2023’

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ClearPoint Neuro (Nasdaq:CLPT) today announced preliminary fourth-quarter revenues that come up short of Wall Street projections.

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Solana Beach, California-based ClearPoint Neuro expects $5.2 million in sales for the quarter ended Dec. 31, 2022. While that comes in 21% ahead of totals from the same quarter last year, it falls short of analysts’ projections of $5.8 million.

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The company, which develops technology for both navigation and delivery to the brain, also increased its biologics and drug delivery revenue. The $2.3 million in sales represented a 37% year-over-year increase. Neurosurgery products produced $2.3 million in revenues for a 7% uptick from 2021.

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Full-year revenue came in at $20.6 million for a 26% year-over-year increase. It also came in well ahead of ClearPoint Neuro’s guidance for between $21 million and $22 million.

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ClearPoint Neuro expects 2023 revenues to fall between $25 million and $27 million for between 22%…

ClearPoint Neuro expects at least 22% revenue growth in 2023

ClearPoint Neuro (Nasdaq:CLPT) today announced preliminary fourth-quarter revenues that came up short of Wall Street projections.

Solana Beach, California-based ClearPoint Neuro expects $5.2 million in sales for the quarter ended Dec. 31, 2022. While that comes in 21% ahead of totals from the same quarter last year, it falls short of analysts’ projections of $5.8 million.

The company, which develops technology for both navigation and delivery to the brain, also increased its biologics and drug delivery revenue. The $2.3 million in sales represented a 37% year-over-year increase. Neurosurgery products produced $2.3 million in revenues for a 7% uptick from 2021.

Full-year revenue came in at $20.6 million for a 26% year-over-year increase. It also came in well ahead of ClearPoint Neuro’s guidance for between $21 million and $22 million.

ClearPoint Neuro expects 2023 revenues to fall between $25 million and $27 million for between 22% and …

ClearPoint Neuro to commercialize FDA-cleared neuro laser

The ClearPoint Prism neuro laser therapy system [Image courtesy of ClearPoint Neuro]ClearPoint Neuro (Nasdaq: CLPT) announced today that FDA has cleared its Swedish partner Clinical Laserthermia Systems’ neuro laser therapy system.

The plan is for ClearPoint Neuro to commercialize the system as the ClearPoint Prism. The company has exclusive global rights to commercialize the CLS magnetic resonance (MR) guided laser interstitial thermal therapy (MRgLITT) system. The system is for neuro applications.

The ClearPoint Neuro navigation system has FDA clearance and a CE mark. The company has it installed in over 60 active sites in the United States, Canada, and Europe. In addition, the company has partnerships with more than 45 pharmaceutical and biotech companies. Applications it’s pursuing include drug delivery to the brain. Also, ClearPoint Neuro is active in the hot brain-computer interface space. It is working with Blackrock Neurotech to automate BCI im…

7 brain-computer interface companies you need to know

[Image from Milad Fakurian on Unsplash] Blackrock Neurotech, BrainGate, ClearPoint Neuro, Neuralink, Synchron and more race to bring brain-computer interface (BCI) tech to market.

They’re using a multitude of methods — and developing their own systems that would allow patients to control a computer with their brain.

Such technology could potentially enable countless immobile people someday to control a mouse cursor, keyboard, mobile device/tablet, wheelchair or prosthetic device by only thinking.

The FDA last year issued leapfrog guidance for nonclinical testing and study design related to implanted brain-computer interface (BCI) devices. Leapfrog guidance allows the agency to share its initial thoughts on emerging technologies that are early in development but appear likely to be of importance to public health.

Companies have faced a number of challenges as they try to bring brain-computer interface technology to the market, but they continue to …

Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials

Blackrock Neurotech’s Utah array is used in its brain-computer interface implant to sense brain signals [Photo courtesy of Blackrock]

Blackrock Neurotech and the University of Pittsburgh’s Rehab Neural Engineering Labs (Pitt RNEL) are working together on the first portable brain-computer interface (BCI) to allow patients to participate in research trials from home.

A Blackrock representative said it’s the final step as the company prepares to launch its first commercial product early next year.

Salt Lake City-based Blackrock plans to submit its first commercial BCI device, called MoveAgain, to the FDA this year.

Blackrock wants its BCI platform to be the first one that’s commercially available to people with paralysis. Its implant has been used in patients since 2004 through research studies, with zero FDA-reported serious adverse events since then.

“Through this expansion…