American Marconi Wireless News - ClearPoint Neuro Announces FDA Clearance of the Velocity Alpha(R) MR High Speed Surgical Drill System and First Clinical Use, Further Expanding Our Drug Delivery Ecosystem and Global Footprint

The Velocity Alpha MR High Speed Surgical Drill is manufactured by a German-based surgical equipment leader, adeor medical AG, and it is a versatile pneumatic drill system designed to streamline ClearPoint procedures and improve case efficiency in both MR and Operating Room environments. The new drill is purpose-built to uniquely integrate with ClearPoint Neuro's SmartFrame navigation platform, featuring specialized drill bits and cutters - further differentiating it from conventional surgical drills. Designed primarily to support multi-trajectory procedures, including investigational cell- and gene-therapy cases, it integrates into procedural workflows for complex neurosurgical applications.

The addition of the new drill reflects the Company's strategy to broaden its product portfolio with complimentary technologies designed to function cohesively across ClearPoint Neuro procedures, supporting a more connected ecosystem and long-term growth. In the future, the Company expects the drill to be compatible with its robotic navigation platform, which is currently in development.

"The design of the drill bits provides tactile feedback during bone access, and facilitates consistent, predictable opening of the skull even during minimally invasive procedures where the bone is not fully visualized," said Dr. Paul Larson, Professor of Neurosurgery at University of Arizona/Banner University Medical Center-Tucson and the Company's Chief Medical Officer. "For my cases that involve multiple trajectories, its integration with the SmartFrame platform has the potential to reduce my procedure times by an hour or more."

"This new drill will expand our ability to support complex therapeutic workflows such as advanced clinical trials, as well as established workflows like DBS and LITT," said Nate Williams, Director of Research and Development at ClearPoint Neuro. "We believe solutions like this can help our neurosurgeon customers perform cases more efficiently today and provides a clear pathway to scale across surgical environments and toward broader commercial adoption of therapies."

"High-speed surgical drilling and cranial access have been at the core of what we do at adeor medical AG for decades. The Velocity Alpha MR high-speed system is a product that truly reflects this experience - built by a team that knows the neurosurgical environment inside out. We deeply value our partnership with ClearPoint Neuro and are genuinely proud to play a role in contributing to further streamline the surgical workflow for their SmartFrame navigation platform. Seeing this newly developed drill achieve FDA clearance and perform well in the first clinical use is exactly the kind of outcome we work towards," said Dominic Hasbach, Chief Executive Officer of adeor medical AG.

About the Velocity Alpha^® MR High Speed Surgical Drill System

The Velocity Alpha MR High Speed Surgical Drill System is 510(k) cleared by the FDA for use in the United States for trephination, incision, cutting, removal, shaping, and sawing of soft and hard tissue, bone and biomaterials in or near a magnetic field of 3.0 Tesla or less for use in Neurosurgery. A universal cutter system with one-click coupling and integrated telescoping functionality is designed to support the needs of today's OR personnel. The system is designed for ease of handling and operates at up to 80,000 rpm with a low noise profile.

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 preclinical 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 central nervous system delivery of therapeutics in preclinical 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.

Disclosure Statement: Dr. Paul Larson is the Chief Medical Officer at ClearPoint Neuro.

Forward Looking Statements

This press release contains forward-looking statements within the context of the federal securities laws, including the Company's expectation for the future market of the Velocity Alpha MR High Speed Surgical Drill System, and the product's other performance and results, including the product's ability to reduce procedural time, streamline complex workflows, enhance overall case efficiency, and advance commercial adoption of therapies. 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: 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 ability to maintain its current relationships with biologics and drug delivery partners or enter into new relationships with such partners; 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 the Company's new products. For a detailed description of the Company's risks and uncertainties, you are encouraged to review its documents filed with the SEC including the Company's recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Contact Information

Investor Relations:
Danilo D'Alessandro, Chief Financial Officer
(888) 287-9109 ext. 3
[email protected]

SOURCE: ClearPoint Neuro, Inc.

View the original press release on ACCESS Newswire

P.Mathewson--AMWN