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

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.

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

CONTACT: Contact:

Media Contact:
Jacqueline Keller, Vice President of Marketing
(888) 287-9109 ext. 4
info@clearpointneuro.com

Investor Relations:
Danilo D’Alessandro, Chief Financial Officer
(888) 287-9109 ext. 3
ir@clearpointneuro.com