ClearPoint Neuro Announces Rec – GuruFocus.com


SOLANA BEACH, Calif., June 02, 2022 (GLOBE NEWSWIRE) — ClearPoint Neuro, Inc. (CLPT) (the “Company”), a global therapeutic platform company enabling navigation and delivery to the brain, announced today today received certification for the Medical Device Single Audit Program (MDSAP).

The MDSAP allows for a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple jurisdictions or regulatory authorities allowing for appropriate regulatory oversight of medical device manufacturers’ quality management systems. medical devices while minimizing the regulatory burden on industry. The program currently represents the Therapeutic Goods Administration of Australia, the Agência Nacional de Vigilância Sanitária of Brazil, Health Canada, the Japanese Ministry of Health, Labor and Welfare and the Pharmaceutical and Medical Devices Agency, and the Center for Devices and Radiological Health of the United States Food and Drug Administration.

“The fourth pillar of ClearPoint’s growth strategy is global expansion for which MDSAP certification is essential. This certification validates our continued commitment to maintaining the highest quality assurance standards within the medical device industry, as required by regulatory authorities around the world,” said Megan Faulkenberry, Vice President of Quality and regulation at ClearPoint Neuro. “While many medical device companies find it difficult to expand into key geographies due to the many requirements at play in various regulations, our team was able to achieve this significant achievement. This milestone demonstrates the high level of quality and regulatory compliance we maintain as we continue to move forward globally. We have invested in making our quality system a force our biologics and drug delivery partners can rely on as they navigate regulatory and commercial approvals for their drug platforms.

About ClearPoint Neuro

ClearPoint Neuro’s mission is to improve and restore the quality of life for patients and their families by enabling therapies for the most complex neurological disorders with pinpoint precision. Applications of the company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, neuroaspiration, and delivery of drugs, biologics, and gene therapy to the brain. The clear point® Neuro Navigation System is FDA cleared, CE marked, and installed at over 60 active sites in the United States, Canada, and Europe. ClearPoint Neuro partners with approximately 45 biologic/pharmaceutical companies and academic centers, providing solutions for the direct delivery of therapeutics to the CNS in preclinical studies and clinical trials worldwide. To date, more than 5,000 cases have been treated and supported by the company’s team of field clinical specialists, who provide support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com

Forward-looking statements

The statements herein regarding the Company’s plans, growth and strategies may include forward-looking statements within the context of federal securities laws. Statements regarding future events, developments and future performance of the Company, as well as management’s expectations, beliefs, plans, estimates or projections regarding 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 or implied by the forward-looking statements. Particular risks and uncertainties include those related to: the impact of the COVID-19 pandemic and the measures adopted to contain its spread; future revenues from sales of the company’s ClearPoint Neuro navigation system products; the Company’s ability to market, market and achieve broader market acceptance for the Company’s ClearPoint Neuro navigation system products; and the risks inherent in the research and development of new products. More detailed information about these and other factors that could affect the Company’s actual results is described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021. , and in the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2022, both of which have been filed with the Securities and Exchange Commission.

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