ClearPoint Neuro, Inc. Announces First-in-Human Cases of the SmartFrame Array™ Neuro Navigation System and Software

Rhea-AI Summary

ClearPoint Neuro has announced the first human cases using its SmartFrame Array Neuro Navigation System, aiming to enhance neurosurgery workflows by reducing procedure times in MRI and Operating Room settings. The Array system's flexibility is expected to increase accessibility for hospitals and surgeons. Initial procedures were conducted by prominent neurosurgeons at renowned institutions, showcasing the system's efficiency. Full market release of the Array is anticipated in early 2022, following a phase of limited market release to gather training materials and case studies.

Positive

• Successful human cases performed using the SmartFrame Array Neuro Navigation System.
• Demonstrated ability to complete multiple neurosurgical procedures in one day.
• Expected increase in accessibility for hospitals and surgeons leveraging the Array's flexibility.
• Plans for a full market release in early 2022 indicate positive growth trajectory.

Negative

• None.

SOLANA BEACH, Calif., May 18, 2021 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling company providing navigation and delivery to the brain, today announced the first human cases of the SmartFrame Array Neuro Navigation System and Software. The ‘Array’ system is designed to streamline workflows and reduce procedure time in both the MRI Suite and in the Operating Room. The Company believes the added flexibility of a potential Operating Room placement will allow more hospital sites and surgeons to access ClearPoint’s technology and clinical support.

The first cases were performed by Dr. Clark Chen¹, Professor, Lyle French Chair in Neurosurgery and Department Head at the University of Minnesota Medical School.

Additional early users of the Array system include Dr. Veronica Chiang, Professor of Neurosurgery and Director of Stereotactic Radiosurgery at Yale School of Medicine, and Dr. Sanjeet Grewal, Neurosurgeon at Mayo Clinic in Florida. “As a surgeon, having the ability to obtain that final confirmatory scan before passing through brain tissue is an important step for both patient safety and trajectory accuracy,” stated Dr. Grewal. “ClearPoint shows continued focus on workflow improvements with Array, which has the potential to speed up procedures without giving up the accuracy gained from real-time MRI guidance.”

The Array system helped surgeons to complete three neurosurgical procedures using ClearPoint in a single day, further demonstrating the potential of Array to shorten procedure times and increase clinical confidence.

“We are thrilled to introduce this important and pivotal product for the ClearPoint team,” commented Joe Burnett, President and CEO of ClearPoint Neuro. “Array highlights the execution of our strategy to expand beyond the MRI suite, and become a more comprehensive neurosurgery platform – with technology that is effective and valuable in the Operating Room, as well. Our goal in the future is to offer a suite of both MRI and OR Navigation tools that leverage our common software, workflow, and clinical specialist team to support many diverse procedures and indications. Array is not intended to replace the prior SmartFrame platform, but will rather complement it, allowing surgeons to choose which technology is most appropriate for an individual patient’s presentation. A great example of this is how, for the first time, three procedures were completed using ClearPoint in a single day, two of which used Array and one with our traditional SmartFrame.”

The SmartFrame Array System is expected to remain in a limited market release throughout 2021 as training materials and case studies are collected in support of education across multiple sites, indications, and languages. The Company expects a full market release of the Array product in early 2022.

About ClearPoint Neuro

ClearPoint Neuro’s mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, neuro-aspiration, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint Neuro Navigation System has FDA clearance, is CE-marked, and is installed in over 60 active sites in the United States, Canada, and Europe. ClearPoint Neuro is partnered with over 30 biologics/pharmaceutical companies and academic centers, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, more than 4,500 cases have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services for our partners. For more information, please visit www.clearpointneuro.com.

Forward-Looking Statements

Statements herein concerning the Company’s plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the impact of COVID-19 and the measures adopted to contain its spread; future revenues from sales of the Company’s ClearPoint Neuro Navigation System products; and the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s ClearPoint Neuro Navigation System products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2021, both of which have been filed with the Securities and Exchange Commission.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/7fadb65d-e2ce-4e66-8b05-11b9a1637a92

¹ Dr. Clark Chen has a consulting relationship with ClearPoint Neuro.

FAQ

What is the SmartFrame Array Neuro Navigation System from ClearPoint Neuro (CLPT)?

The SmartFrame Array Neuro Navigation System is a product designed to streamline neurosurgical workflows and reduce procedure time in MRI and operating room settings.

When will ClearPoint Neuro (CLPT) fully release the SmartFrame Array system?

ClearPoint Neuro plans for a full market release of the SmartFrame Array system in early 2022.

Who performed the first human procedures using the SmartFrame Array Neuro Navigation System?

The first human procedures were performed by Dr. Clark Chen from the University of Minnesota Medical School.

What potential benefits does the SmartFrame Array provide to neurosurgeons?

The Array is expected to speed up procedures while maintaining accuracy through real-time MRI guidance.

How does ClearPoint Neuro (CLPT) plan to expand its neurosurgery platform?

The company aims to become a comprehensive neurosurgery platform by offering both MRI and operating room navigation tools.