ClearPoint Neuro, Inc. Announces Appointment of Mary McNamara-Cullinane as Vice President of Regulatory Affairs


ClearPoint Neuro, Inc.

SOLANA BEACH, Calif., Aug. 08, 2022 (GLOBE NEWSWIRE) — ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy platform company enabling navigation and delivery to the brain, today hui announced that Mary McNamara-Cullinane has joined the company as Vice President of Regulatory Affairs. Ms. McNamara-Cullinane will report directly to Joe Burnett, CEO of ClearPoint Neuro, and will be part of the company’s management team.

“We are thrilled to welcome Mary to our team, as we expect her leadership and regulatory affairs experience to immediately benefit our partners and patients around the world,” commented Joe Burnett, President and Chief management of ClearPoint Neuro. “Our mission at ClearPoint continues to attract talented professionals who can build teams and achieve scale, not for where we are today, but where we are headed tomorrow. Mary is the perfect example an experienced functional leader who can define regulatory strategy and put in place the people and processes to execute it.The regulatory affairs function will be one of our greatest strengths as we support our growing portfolio of partners pharmaceutical and device products and our global installed base.

Ms. McNamara-Cullinane brings to the Company more than 25 years of experience in healthcare and life sciences. His global regulatory and clinical affairs expertise includes the regulation of radiology, urology, physical medicine, orthopedics, neurological wound care, digital health, IVDs, dental medical devices and combined products. She has authored over 200 submissions, including 510(k), RFD, Breakthrough Device Designations, 513(g)s, IDE and PMA. Mary is also a frequent speaker and panelist on a range of topics including MedTech, regulatory affairs and women in healthcare. Prior to joining the company, she was Senior Vice President of Regulatory Affairs at Alira Health. Previously, Ms. McNamara-Cullinane was Principal of MMC Regulatory Consulting and held leadership positions at Intrinsic Therapeutics and Echo Therapeutics. Ms. McNamara-Cullinane holds a Bachelor of Arts from the Massachusetts College of Liberal Arts, a graduate degree in Cardiovascular Health and Biochemistry from Northeastern University, and a Masters in Public Health from Southern New Hampshire University. .

“ClearPoint’s growth is driven by new product introductions and geographic expansion, both of which require a strong regulatory strategy and team,” said Mary McNamara-Cullinane. “I am thrilled to support the company’s impactful mission and help bring meaningful neurosurgical innovation to patients around the world.”

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® The 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 pharmaceutical and biotechnology companies, academic institutions, and contract research organizations that provide solutions for the direct delivery of therapeutics to the CNS in preclinical studies and trials. clinics around the world. 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

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 such 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; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of our products and services in the delivery of therapies; 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, and the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2022, which the company intends to file with the Securities and Exchange Commission on or before August 15, 2022.

CONTACT: Contact: Jacqueline Keller, Vice President, Marketing (949) 900-6833 Caroline Corner, Investor Relations

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