Announcement is made after successful proof-of-concept trial in a preclinical model of intravenous delivery of large molecule tracers across the blood-brain barrier guided by prototype systems, including both focused ultrasound hardware and ClearPoint Navigation Software and Robotics
SOLANA BEACH, CA / ACCESS Newswire / May 27, 2026 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) ("Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced plans to enter the focused ultrasound market, and demonstrated successful intravenous delivery of tracers across the blood-brain barrier in a preclinical model using the ClearPoint prototype system. This device was built in partnership with the SONOCARELAB, at Sungkyunkwan University in Suwon, South Korea on the Natural Science Campus.
"This milestone has been nearly four years in the making, and demonstrates our continuous pursuit to be the most complete neuro navigation and therapy enabling company in the world", commented Joe Burnett, President and CEO of the Company. "Focused Ultrasound has tremendous potential, and has been studied across many applications including drug delivery, tissue ablation, liquid biopsy and even standalone treatments for neurological disorders like Alzheimer's Disease. By leveraging our 15 years of neuro navigation software development, and by deploying focused ultrasound using our planned robotic platform in a traditional OR setting, we believe the ClearPoint and SONOCARELAB solution will fit perfectly into our four-pillar growth strategy."
Note: Image showing successful delivery of large molecule FITC Dextran Tracer and Evans Blue Tracers across the blood-brain barrier and consistent with the planned focal acoustic beam trajectory in large subject preclinical testing.
"Our goal is to offer the most complete portfolio possible to our biopharma partners to enable successful, targeted drug delivery to the brain", commented Jeremy Stigall, Chief Business Officer & General Manager of Biologics and Drug Delivery at ClearPoint Neuro, Inc. "Focused ultrasound will be a tool, and not the tool, in our drug delivery ecosystem, and will be deployed alongside our other routes-of-administration based on drug type, target, and indication. Some biopharma partners will continue to use our SmartFlow cannula with an infusion pump for convection enhanced gene therapy. Others will use our custom front-loading mechanized delivery cannulas and pullback devices for transplantation in cell therapy patients. Still others will use our IRRAflow portfolio of flexible, indwelling devices for multiple, high-volume infusions to the ventricles. Focused Ultrasound will be yet another approach in the ClearPoint Neuro ecosystem that is well suited for more comprehensive drug dosing to widespread regions of the brain. We will uniquely provide all of these options to biopharma partners, alongside the ability to discover the correct, drug specific approach at our ClearPoint Advanced Laboratories facility. Our translational science team will not only have direct experience but also actively play a role in the development of all these solutions. Our goal is to work with our partners in their best interest and letting the science choose the most effective delivery method for each specific drug."
Note: Image showing deployment of the ClearPoint / SONOCARELAB focused ultrasound prototype using the planned ClearPoint Robotic Navigation System in the operating room setting with iCT Imaging.
"Our purpose-built Focused Ultrasound prototype for drug delivery is designed to rapidly scale sites globally through a few key mechanisms", continued Mr. Stigall. "First, the system is designed to be used outside of the MRI and in the operating room, increasing access to more sites around the world. Second, compatibility with the ClearPoint navigation software and prototype robotic arm will enable consistent and familiar procedural planning across many different targets and indications, simplifying staff training at the hospital. By learning one ClearPoint software and workflow, the hospital team will be able to navigate in the MRI, the CT, with Robotics and with Focused Ultrasound, all on the same platform. Finally, the self-contained system will be designed to enable fast, inexpensive installation into any operating room suite without complicated construction or shielding. Our partners have asked for additional, scalable routes-of-administration for biologics and drugs to the brain, and we are working tirelessly to deliver."
"Our collaboration with ClearPoint Neuro has demonstrated the successful integration of advanced therapeutic ultrasound technologies with image-guided robotic neurointervention platforms in large preclinical subjects", commented Professor Jinhyoung Park at Sungkyunkwan University. "We believe ClearPoint's strong expertise in translational neuroscience, navigation software, and robotic guidance systems makes them an exceptional partner for advancing next-generation focused ultrasound therapies toward future clinical applications."
"Our team continues to execute toward our strategic plan of becoming the premier neuro navigation and therapy enabling company in the world", continued Mr. Burnett. "Fast forward into the future and our global ecosystem is on track to be quite impressive. This will include 1) pre-commercial drug discovery services including custom device and software creation for biopharma, 2) navigation software that can be deployed in the MRI, CT or with our robotics, 3) MRI and operating room drill solutions for more efficient and consistent brain access, 4) laser and focused ultrasound ablative treatments, 5) active CSF exchange to treat various types of hemorrhage in the brain, 6) multiple commercial routes-of-administration for targeted drug delivery using cannulas, needles, catheters and now focused ultrasound, and 7) unique modeling and confirmation software to ensure the quality of delivery is planned and quantified to better ensure the successful launch of these new-to-world cell and gene therapies. All of these product lines are supported by our expanding global infrastructure, and our team of expert clinical specialists who are best-in-class. Congratulations to the team on this incredible milestone that has been nearly four years in the making."
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 visitwww.clearpointneuro.com.
Forward Looking Statements
This press release contains forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance; the Company's entry into the focused ultrasound market and the development and commercial potential of its prototype focused ultrasound system; the Company's expectations for the development partnership with Sungkyunkwan University, including the anticipated scope, duration and outcomes of such partnership; the Company's belief regarding the potential applications of focused ultrasound technology, including for drug delivery, tissue ablation, liquid biopsy and treatments for neurological disorders; the continued development and commercial potential of the Company's proprietary Robotic Neuro-Navigation platform and its compatibility with the focused ultrasound system; the Company's expectations regarding the ability to deploy its focused ultrasound solution in the operating room setting; the Company's expectations regarding the scalability, installation requirements, and global site adoption of the focused ultrasound system; the Company's expectations regarding its four-pillar growth strategy, including the integration of focused ultrasound into its drug delivery ecosystem; the Company's ability to offer multiple routes-of-administration for targeted drug delivery; the Company's expectations regarding preclinical drug discovery services and the ClearPoint Advanced Laboratories facility; the Company's expectations regarding navigation software deployment across MRI, CT and robotic platforms; the Company's expectations regarding drill solutions, laser and focused ultrasound ablative treatments; the Company's expectations regarding active CSF exchange products; the Company's expectations regarding modeling and confirmation software for drug delivery; the size of total addressable markets or the market opportunity for the Company's products and services; and the Company's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. 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: risks inherent in the research, development, and regulatory approval of the Company's new products, including its prototype focused ultrasound system and prototype robotic navigation system; the risk that the Company's focused ultrasound technology may not advance from prototype to commercial product on the anticipated timeline or at all; the Company's dependence on the development partnership with Sungkyunkwan University and the risk that such partnership may not achieve its anticipated objectives; the risk that preclinical results may not be predictive of results in human clinical trials; the Company's biotech Partners' risks related to the ongoing conduct of their clinical studies, including the risk that such trials will be unable to demonstrate data sufficient to support further clinical development or regulatory approval; the commercialization and acceptance of gene and cell therapies; the Company's ability to maintain its current relationships with its biotech Partners or enter into relationships with new partners; the Company's ability to continue to build and maintain the infrastructure and personnel needed to allow for widespread adoption of its products and services; the future market for preclinical services and products and the investment and timeline required to expand such services, which could divert resources from the Company's other business operations; the risk that the Company's four-pillar growth strategy may not achieve the anticipated results due to market, competitive, or operational factors; macroeconomic and inflationary conditions; regulatory and policy uncertainty; the introduction of or changes in tariffs, sanctions, or trade barriers; geopolitical trends, such as instability, protectionism and economic nationalism; the Company's ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the availability of additional funding to support the Company's business activity, including its research and development programs and the expansion of its commercial organization; the ability of the Company to manage the growth of its business; and the Company's ability to attract and retain its key employees. 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:
Investor Relations:
Danilo D'Alessandro, Chief Financial Officer
(888) 287-9109 ext. 3
ir@clearpointneuro.com
SOURCE: ClearPoint Neuro, Inc.
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/clearpoint-neuro-enters-into-10-year-focused-ultrasound-development-partnership-with-1171172
