Announcement is made after profitable proof-of-concept trial in a preclinical mannequin of intravenous supply of enormous molecule tracers throughout the blood-brain barrier guided by prototype methods, together with each targeted ultrasound {hardware} and ClearPoint Navigation Software program and Robotics
SOLANA BEACH, CA / ACCESS Newswire / Might 27, 2026 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) (“Firm”), a world system, cell, and gene therapy-enabling firm providing exact navigation to the mind and backbone, at the moment introduced plans to enter the targeted ultrasound market, and demonstrated profitable intravenous supply of tracers throughout the blood-brain barrier in a preclinical mannequin utilizing the ClearPoint prototype system. This system was inbuilt partnership with the SONOCARELAB, at Sungkyunkwan College in Suwon, South Korea on the Pure Science Campus.
“This milestone has been practically 4 years within the making, and demonstrates our steady pursuit to be essentially the most full neuro navigation and remedy enabling firm on the planet”, commented Joe Burnett, President and CEO of the Firm. “Targeted Ultrasound has large potential, and has been studied throughout many functions together with drug supply, tissue ablation, liquid biopsy and even standalone therapies for neurological problems like Alzheimer’s Illness. By leveraging our 15 years of neuro navigation software program growth, and by deploying targeted ultrasound utilizing our deliberate robotic platform in a conventional OR setting, we consider the ClearPoint and SONOCARELAB resolution will match completely into our four-pillar progress technique.”
Notice: Picture exhibiting profitable supply of enormous molecule FITC Dextran Tracer and Evans Blue Tracers throughout the blood-brain barrier and in line with the deliberate focal acoustic beam trajectory in giant topic preclinical testing.
“Our objective is to supply essentially the most full portfolio potential to our biopharma companions to allow profitable, focused drug supply to the mind”, commented Jeremy Stigall, Chief Enterprise Officer & Normal Supervisor of Biologics and Drug Supply at ClearPoint Neuro, Inc. “Targeted ultrasound will likely be a device, and never the device, in our drug supply ecosystem, and will likely be deployed alongside our different routes-of-administration based mostly on drug sort, goal, and indication. Some biopharma companions will proceed to make use of our SmartFlow cannula with an infusion pump for convection enhanced gene remedy. Others will use our customized front-loading mechanized supply cannulas and pullback gadgets for transplantation in cell remedy sufferers. Nonetheless others will use our IRRAstream portfolio of versatile, indwelling gadgets for a number of, high-volume infusions to the ventricles. Targeted Ultrasound will likely be yet one more method within the ClearPoint Neuro ecosystem that’s effectively suited to extra complete drug dosing to widespread areas of the mind. We’ll uniquely present all of those choices to biopharma companions, alongside the power to find the right, drug particular method at our ClearPoint Superior Laboratories facility. Our translational science staff won’t solely have direct expertise but additionally actively play a job within the growth of all these options. Our objective is to work with our companions of their finest curiosity and letting the science select the best supply methodology for every particular drug.”
Notice: Picture exhibiting deployment of the ClearPoint / SONOCARELAB targeted ultrasound prototype utilizing the deliberate ClearPoint Robotic Navigation System within the working room setting with iCT Imaging.
“Our purpose-built Targeted Ultrasound prototype for drug supply is designed to quickly scale websites globally by means of just a few key mechanisms”, continued Mr. Stigall. “First, the system is designed for use outdoors of the MRI and within the working room, rising entry to extra websites world wide. Second, compatibility with the ClearPoint navigation software program and prototype robotic arm will allow constant and acquainted procedural planning throughout many alternative targets and indications, simplifying employees coaching on the hospital. By studying one ClearPoint software program and workflow, the hospital staff will have the ability to navigate within the MRI, the CT, with Robotics and with Targeted Ultrasound, all on the identical platform. Lastly, the self-contained system will likely be designed to allow quick, cheap set up into any working room suite with out difficult building or shielding. Our companions have requested for added, scalable routes-of-administration for biologics and medicines to the mind, and we’re working tirelessly to ship.”
“Our collaboration with ClearPoint Neuro has demonstrated the profitable integration of superior therapeutic ultrasound applied sciences with image-guided robotic neurointervention platforms in giant preclinical topics”, commented Professor Jinhyoung Park at Sungkyunkwan College. “We consider ClearPoint’s robust experience in translational neuroscience, navigation software program, and robotic steerage methods makes them an distinctive accomplice for advancing next-generation targeted ultrasound therapies towards future medical functions.”
“Our staff continues to execute towards our strategic plan of changing into the premier neuro navigation and remedy enabling firm on the planet”, continued Mr. Burnett. “Quick ahead into the longer term and our world ecosystem is on observe to be fairly spectacular. This may embrace 1) pre-commercial drug discovery companies together with customized system and software program creation for biopharma, 2) navigation software program that may be deployed within the MRI, CT or with our robotics, 3) MRI and working room drill options for extra environment friendly and constant mind entry, 4) laser and targeted ultrasound ablative therapies, 5) energetic CSF trade to deal with numerous sorts of hemorrhage within the mind, 6) a number of business routes-of-administration for focused drug supply utilizing cannulas, needles, catheters and now targeted ultrasound, and seven) distinctive modeling and affirmation software program to make sure the standard of supply is deliberate and quantified to raised make sure the profitable launch of those new-to-world cell and gene therapies. All of those product strains are supported by our increasing world infrastructure, and our staff of skilled medical specialists who’re best-in-class. Congratulations to the staff on this unbelievable milestone that has been practically 4 years within the making.”
About ClearPoint Neuro
ClearPoint Neuro is a tool, cell, and gene therapy-enabling firm providing exact navigation to the mind and backbone. The Firm uniquely offers each established medical merchandise in addition to preclinical growth companies for managed drug and system supply. The Firm’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and analysis facilities in North America, Europe, Asia, and South America. The Firm can be partnered with essentially the most progressive pharmaceutical/biotech corporations, educational facilities, and contract analysis organizations, offering options for direct central nervous system supply of therapeutics in preclinical research and medical trials worldwide. Thus far, hundreds of procedures have been carried out and supported by the Firm’s field-based medical specialist staff, which presents help and companies to our prospects and companions worldwide. For extra data, please go towww.clearpointneuro.com.
Ahead Trying Statements
This press launch comprises forward-looking statements throughout the context of the federal securities legal guidelines. Statements concerning the Firm’s future occasions, developments and future efficiency; the Firm’s entry into the targeted ultrasound market and the event and business potential of its prototype targeted ultrasound system; the Firm’s expectations for the event partnership with Sungkyunkwan College, together with the anticipated scope, length and outcomes of such partnership; the Firm’s perception concerning the potential functions of targeted ultrasound expertise, together with for drug supply, tissue ablation, liquid biopsy and coverings for neurological problems; the continued growth and business potential of the Firm’s proprietary Robotic Neuro-Navigation platform and its compatibility with the targeted ultrasound system; the Firm’s expectations concerning the power to deploy its targeted ultrasound resolution within the working room setting; the Firm’s expectations concerning the scalability, set up necessities, and world web site adoption of the targeted ultrasound system; the Firm’s expectations concerning its four-pillar progress technique, together with the combination of targeted ultrasound into its drug supply ecosystem; the Firm’s skill to supply a number of routes-of-administration for focused drug supply; the Firm’s expectations concerning preclinical drug discovery companies and the ClearPoint Superior Laboratories facility; the Firm’s expectations concerning navigation software program deployment throughout MRI, CT and robotic platforms; the Firm’s expectations concerning drill options, laser and targeted ultrasound ablative therapies; the Firm’s expectations concerning energetic CSF trade merchandise; the Firm’s expectations concerning modeling and affirmation software program for drug supply; the dimensions of complete addressable markets or the market alternative for the Firm’s services and products; and the Firm’s expectations, beliefs, plans, estimates or projections regarding the longer term, are forward-looking statements throughout the that means of those legal guidelines. These forward-looking statements are based mostly on administration’s present expectations and are topic to the dangers inherent within the enterprise, which can trigger the Firm’s precise outcomes to vary materially from these expressed in or implied by forward-looking statements. Specific uncertainties and dangers embrace these regarding: dangers inherent within the analysis, growth, and regulatory approval of the Firm’s new merchandise, together with its prototype targeted ultrasound system and prototype robotic navigation system; the danger that the Firm’s targeted ultrasound expertise could not advance from prototype to business product on the anticipated timeline or in any respect; the Firm’s dependence on the event partnership with Sungkyunkwan College and the danger that such partnership could not obtain its anticipated targets; the danger that preclinical outcomes will not be predictive of leads to human medical trials; the Firm’s biotech Companions’ dangers associated to the continued conduct of their medical research, together with the danger that such trials will likely be unable to display information ample to help additional medical growth or regulatory approval; the commercialization and acceptance of gene and cell therapies; the Firm’s skill to take care of its present relationships with its biotech Companions or enter into relationships with new companions; the Firm’s skill to proceed to construct and keep the infrastructure and personnel wanted to permit for widespread adoption of its services and products; the longer term marketplace for preclinical companies and merchandise and the funding and timeline required to increase such companies, which might divert sources from the Firm’s different enterprise operations; the danger that the Firm’s four-pillar progress technique could not obtain the anticipated outcomes as a consequence of market, aggressive, or operational components; macroeconomic and inflationary situations; regulatory and coverage uncertainty; the introduction of or adjustments in tariffs, sanctions, or commerce limitations; geopolitical developments, equivalent to instability, protectionism and financial nationalism; the Firm’s skill to market, commercialize and obtain broader market acceptance for brand spanking new services and products provided by the Firm; the provision of further funding to help the Firm’s enterprise exercise, together with its analysis and growth packages and the growth of its business group; the power of the Firm to handle the expansion of its enterprise; and the Firm’s skill to draw and retain its key workers. For an in depth description of the Firm’s dangers and uncertainties, you’re inspired to assessment its paperwork filed with the SEC together with the Firm’s current filings on Kind 8-Okay, Kind 10-Okay and Kind 10-Q. You might be cautioned to not place undue reliance on forward-looking statements, which communicate solely as of the date on which they had been made. The Firm undertakes no obligation to replace such statements to mirror occasions that happen or circumstances that exist after the date on which they had been made, besides as required by regulation.
Contact:
Investor Relations:
Danilo D’Alessandro, Chief Monetary Officer
(888) 287-9109 ext. 3
ir@clearpointneuro.com
SOURCE: ClearPoint Neuro, Inc.
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