ClearPoint Neuro Announces Full Market Release of SmartFrame OR™ and ClearPoint PRISM® 3T Laser Therapy System

Rhea-AI Summary

ClearPoint Neuro announced the full market release of its SmartFrame OR platform and ClearPoint Prism Neuro Laser Therapy System at the 2024 ASSFN meeting in Nashville from June 1-4.

The SmartFrame OR aims to expand Deep Brain Stimulation (DBS) to more hospitals, making it accessible to more patients. Dr. Kim Burchiel noted that DBS is effective for Parkinson's Disease, Essential Tremor, and Dystonia, but only 5% of eligible patients receive treatment due to access.

ClearPoint's new platform promises precision and efficiency in DBS procedures, according to Dr. Andrew Conner. CEO Joe Burnett highlighted the company's innovation, emphasizing the benefits for surgical customers and patients.

The new products will be featured in various sessions during the ASSFN meeting, showcasing their potential to improve neurosurgical practices.

Positive

• Full market release of SmartFrame OR and ClearPoint Prism Neuro Laser Therapy System.
• SmartFrame OR expected to make Deep Brain Stimulation (DBS) more accessible.
• SmartFrame OR supports precision, efficiency, and reliability in DBS procedures.
• Showcase at 2024 ASSFN meeting provides visibility and credibility.
• Potential to treat more patients with Parkinson's Disease, Essential Tremor, and Dystonia.
• ClearPoint Neuro's innovation acknowledged by industry experts.
• Comprehensive product portfolio demonstrated, including laser therapy and brain modeling software.
• Engagement with healthcare and research centers across multiple continents.
• Collaborations with pharmaceutical and biotech companies for CNS therapeutics delivery.

Negative

• Only 5% of eligible patients currently receive DBS treatment, indicating market penetration challenges.
• Unclear if the new products will significantly change existing clinical practices and outcomes.
• Potential high costs associated with adopting new technology in more hospitals.
• Risk of uptake if hospitals are not equipped or trained adequately for new systems.
• Dependence on the success of pre-clinical and clinical trials for broader market acceptance.

Medical Research Analyst

The release of the SmartFrame OR and ClearPoint PRISM Neuro Laser Therapy System represents significant progress in the field of neurosurgery, particularly for the treatment of conditions such as Parkinson's Disease, Essential Tremor and Dystonia. Deep Brain Stimulation (DBS) has a robust clinical history, but its application has been mostly limited to specialized centers. The SmartFrame OR platform aims to broaden the availability and accessibility of these procedures by simplifying and standardizing the process, potentially enabling more hospitals to perform DBS effectively.

The SmartFrame OR's focus on precision and ease of use can lead to more consistent outcomes, which is important for conditions requiring exact placement of electrodes in the brain. This could also translate to lower overall costs for the healthcare system, as more widespread adoption might reduce the need for highly specialized centers. However, the long-term success of this technology will depend on its adoption rate and the training provided to neurosurgeons in general hospitals.

The ClearPoint PRISM Neuro Laser Therapy System also holds potential, particularly in providing a less invasive treatment option for patients. Laser therapy can offer targeted treatment with minimal damage to surrounding tissues, which is critical in neurosurgery. The potential for usage in various neurological conditions could expand the market reach of ClearPoint Neuro's offerings.

Financial Analyst

From a financial perspective, the full market release of the SmartFrame OR and ClearPoint PRISM Neuro Laser Therapy System could positively influence ClearPoint Neuro's revenue streams. The products target a niche but growing market of neurological treatments, which could attract significant interest from hospitals and clinics seeking cutting-edge tools to enhance their offerings.

Revenue diversification is a critical factor here. ClearPoint Neuro is not only providing devices but also pre-clinical development services. This diversification can stabilize revenues by mitigating risks associated with reliance on a single product line or market segment. The company's partnership with pharmaceutical and biotech companies further strengthens its market position.

Investors should watch for the company's upcoming earnings releases to gauge market adoption and sales performance. The initial adoption rates, feedback from neurosurgical centers and patient outcomes will be pivotal data points. Additionally, any regulatory updates or further FDA approvals could serve as catalysts for stock performance.

Newly Launched Technology Will Be on Display at ASSFN in Nashville from June 1 - 4

SOLANA BEACH, Calif., June 01, 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 announces full market release of its SmartFrame OR platform and ClearPoint Prism Neuro Laser Therapy System at the 2024 Biennial Meeting of the American Society of Stereotactic and Functional Neurosurgery from Saturday, June 1^st – Tuesday, June 4^th in Nashville.

“Deep Brain Stimulation (DBS) has been proven to be a safe and effective strategy to manage patients with medically intractable Parkinson’s Disease, Essential Tremor, and Dystonia,¹” said Dr. Kim Burchiel, Professor of Neurological Surgery at the Oregon Health & Science University. “In its more than 30-year history in the US, this highly effective therapy has been mostly performed in highly specialized neurosurgical centers, which, because of their relative rarity, has resulted in only about 5% of eligible patients being treated.¹ The development of the SmartFrame OR is anticipated to be a significant step towards accomplishing the triple aim of achieving excellent outcomes in an accessible and appropriate clinical setting, with broad patient acceptance, because it is expected to allow DBS procedures to be performed in a much larger spectrum of hospitals, by a larger contingent of well-trained neurosurgeons.”  

“ClearPoint Neuro’s new SmartFrame OR solution supports stereotactic precision packaged in an efficient, intuitive, and reliable platform,” stated Dr. Andrew Conner, Assistant Professor of Neurosurgery at Oklahoma University. “It has completely changed my DBS practice for the better since its release.”

“This is a truly exciting milestone for ClearPoint, and one that has been years in the making,” commented Joe Burnett, President and CEO at ClearPoint Neuro. “We set out to prove that we are one of the most innovative and focused companies in the Neurosurgery space. We are now walking into the premier stereotactic neurosurgical conference able to demonstrate new laser therapy, new operating room navigation, new brain modeling software, new access products and new drug delivery preclinical and clinical trial services. This is meaningful innovation that will ultimately benefit our surgical customers and most importantly, many new patients around the world.”

At ASSFN, the SmartFrame OR and ClearPoint Prism Neuro Laser Therapy System will be showcased at:

• Special Course 1: Epilepsy Surgery Fundamentals and Challenges on Saturday, June 1^st
• Special Course 2: Movement Disorder Surgery Fundamentals and Challenges on Saturday, June 1^st
• Meet the Expert Session: Initial Experience with the SmartFrame OR Platform
  

About ClearPoint Neuro

ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as pre-clinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.

Forward-Looking Statements

This press release contains forward-looking statements within the context of the federal securities laws, which may include the Company’s expectations for the future performance, market, and revenue of its products and services. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which 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: global and political instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2024, both of which have been filed with the Securities and Exchange Commission. The Company does not assume any obligation to update these forward-looking statements.

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¹ Data on file at ClearPoint Neuro

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ef08f4c6-fb7a-4470-b834-6589a0a3adfd

A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/dc00d91c-8a9a-410b-a41a-c435136a10b5

FAQ

What is the SmartFrame OR announced by ClearPoint Neuro?

The SmartFrame OR is a newly released platform designed to expand Deep Brain Stimulation (DBS) procedures to a larger spectrum of hospitals.

When will the SmartFrame OR and ClearPoint Prism Neuro Laser Therapy System be showcased?

They will be showcased at the 2024 Biennial Meeting of the American Society of Stereotactic and Functional Neurosurgery (ASSFN) from June 1-4.

What is the significance of the SmartFrame OR platform?

The SmartFrame OR is expected to make DBS procedures more accessible and efficient, potentially benefiting more patients with conditions like Parkinson's Disease, Essential Tremor, and Dystonia.

Who praised the new SmartFrame OR platform for its impact on DBS practice?

Dr. Andrew Conner, Assistant Professor of Neurosurgery at Oklahoma University, praised the SmartFrame OR for enhancing his DBS practice.

What events will feature ClearPoint Neuro's new products at the ASSFN meeting?

Events include Special Course 1 on Epilepsy Surgery and Special Course 2 on Movement Disorder Surgery, both on June 1st, as well as a Meet the Expert Session.