“We are thrilled to welcome Mary to our team as we fully expect her leadership and experience in Regulatory Affairs will contribute immediately to our partners and to patients globally,” commented
Ms. McNamara-Cullinane brings to the Company over 25 years of experience in the healthcare and life sciences field. Her global regulatory and clinical affairs expertise includes regulation of radiology, urology, physical medicine, orthopedic, neurological wound care, digital health, IVDs, dental medical devices, and combination products. She has authored over 200 submissions including 510(k)s, RFDs, Breakthrough Device Designations, 513(g)s, IDEs, and PMAs. Mary is also a frequent podium speaker and panelist on a range of topics including
“ClearPoint’s growth hinges on new product introductions and geographic expansion, both of which require a strong regulatory strategy and team,” stated
About
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
Forward-Looking Statements
Statements herein 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, 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 and the measures adopted to contain its spread; future revenue from sales of the Company’s ClearPoint Neuro Navigation System products; the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s ClearPoint Neuro Navigation System products; 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 and development 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
Contact:Jacqueline Keller , Vice President, Marketing (949) 900-6833 info@clearpointneuro.comCaroline Corner , Investor Relations ir@clearpointneuro.com
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