ClearPoint Neuro Announces First Patient Enrolled in Glioblastoma Trial Using ClearPoint Prism™ Neuro Laser Therapy System at Skåne University Hospital in Sweden
ClearPoint Neuro, Inc. (Nasdaq: CLPT) has initiated a clinical trial for Glioblastoma, enrolling its first patient at Skåne University Hospital in Lund, Sweden. This trial assesses the safety and feasibility of the ClearPoint Prism™ Neuro Laser Therapy System for tumor ablation in five patients. The system combines navigation and laser technology for minimally invasive procedures. Following FDA clearance received in September, data from this trial will also assist in obtaining CE Mark in Europe. ClearPoint aims to improve treatment options for neurological disorders.
- Initiation of a clinical trial for Glioblastoma at Skåne University Hospital.
- First patient enrolled and treated with the ClearPoint Prism Neuro Laser Therapy System.
- FDA clearance obtained for the ClearPoint Prism system in September.
- Exclusive global rights to commercialize the ClearPoint Prism system for neuro applications.
- None.
SOLANA BEACH, Calif., Dec. 12, 2022 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced enrollment of the first patient in a Glioblastoma clinical trial using the ClearPoint Prism™ Neuro Laser Therapy System at Skåne University Hospital in Lund, Sweden (SUS Lund).
The Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions study, sponsored by Clinical Laserthermia Systems AB (CLS – Lund, Sweden), is a single-center, single-arm, prospective clinical trial evaluating the safety and feasibility of using the minimally invasive MR-guided laser therapy system to ablate tumor in up to five Glioblastoma patients. The SUS Lund team is also currently utilizing the ClearPoint Neuro Navigation platform for standard of care procedures, including tumor biopsy and guiding implantation of deep brain stimulation (DBS) electrodes to target.
ClearPoint Neuro has exclusive global rights to commercialize the ClearPoint Prism Neuro Laser Therapy System from CLS for neuro applications. The system comprises a clinical solution combining the ClearPoint navigation platform, the laser technology from CLS, and a thermal ablation monitoring software called Thermoguide™ from Image Guided Therapy (IGT - Bordeaux, France). In September of this year, CLS received FDA clearance for the ClearPoint Prism Neuro Laser Therapy System. Data from this trial will be utilized by CLS to secure CE Mark (Conformité Européenne) in Europe.
“The clinical trial with minimally invasive laser thermal treatment of patients with recurrent malignant brain tumors, glioblastoma, has now started at Skåne University Hospital and the treatment of the first patient could be carried out as planned. The treatment was performed, for the first time in Sweden, in a magnetic resonance imaging (MRI) suite in order to avoid transporting the patient between surgery and the MRI suite,” stated Dr. Peter Siesjö, Neurosurgeon and Principal Investigator of the study at Skåne University Hospital in Lund, Sweden.
“Skåne University Hospital has a long history of engaging in world-class research and education,” commented Joe Burnett, President and CEO of ClearPoint Neuro. “We are proud to support SUS Lund and CLS on this pilot study using the innovative laser therapy system to treat glioblastoma lesions. The ClearPoint Neuro Navigation System offers an efficient one-room solution that helps neurosurgeons in the United States to accurately place laser fibers and help treat brain tumors, radiation necrosis and epileptic foci in thousands of patients. Expanding brain and spine laser therapy treatment options for patients and neurosurgeons in the EU, and beyond, is a key priority in the years ahead.”
About ClearPoint Neuro
ClearPoint Neuro’s mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, neuro-aspiration, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint Neuro Navigation System has FDA clearance, is CE-marked, and is installed in over 60 active sites in the United States, Canada, and Europe. ClearPoint Neuro is partnered with approximately 50 pharmaceutical and biotech companies, academic institutions, and contract research organizations providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, more than 5,000 cases 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
Statements in this press release concerning the Company’s plans, growth, and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, the size of total addressable markets or the market opportunity for the Company’s products and services, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks 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 impact of the COVID-19 pandemic, global instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s ClearPoint Neuro Navigation System and other new products offered by the Company; the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s ClearPoint Neuro Navigation System and other new products offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of our products and services in their delivery of therapies; 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, 2021, and the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2022, both of which have been filed with the Securities and Exchange Commission.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/66f919ac-c17e-402e-a88e-1211e8044e7c
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