News Release Details
Sharon Klugewicz Joins Bioventus as Senior Vice President, Quality and Regulatory Affairs
DURHAM, N.C., Nov. 01, 2021 (GLOBE NEWSWIRE) -- Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, has appointed Sharon Klugewicz as Senior Vice President, Quality and Regulatory Affairs. In this role, she will be responsible for all regulatory and quality functions globally, facilitating strong alignment across commercial, operations and R&D teams.
“We are very pleased to welcome Sharon to Bioventus as she helps us integrate Misonix into the Company and lead this important function,” said Ken Reali, CEO, Bioventus. “We will leverage her significant experience in quality assurance, regulatory affairs, product development, and manufacturing operations as we continue to grow our overall business and expand globally with our offerings for pain treatment, restorative therapies and surgical solutions.”
Since 2019, Klugewicz served as Chief Operating Officer of Misonix, a global ultrasonic surgical equipment and medical technology company recently acquired by Bioventus. During her tenure, Klugewicz played a key role in the launch of the company’s revolutionary ultrasonic surgical platform, the neXus® Ultrasonic Surgical System, in the US, EU and Canada.
Prior to that, she spent nearly seven years at Chembio Diagnostic Systems, joining first as its Vice President, QA/QC/Technical Operations, before being promoted to COO, then later President, Americas Region. She served as the company’s interim CEO for five months in 2017 and was later named Chief Quality & Regulatory Affairs Officer. Klugewicz began her career at Pall Corporation in 1991 serving in several progressive technical, marketing and quality roles during her 21 year tenure with the company’s Medical, Biopharmaceuticals, and Life Sciences Divisions. In 2009, she was promoted to Senior Vice President, Global Scientific & Laboratory Services and led that function until 2012.
Klugewicz received a Master of Science in Biochemistry from Adelphi University and a Bachelor of Science in Neurobiology from Stony Brook University.
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment, restorative therapies and surgical solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC. neXus is a trademark of Misonix, Inc.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements concerning Bioventus’s future growth, strategy and integration of Misonix. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated in this press release include, but are not limited to, the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; our ability to develop, acquire and commercialize new products, line extensions or expanded indications; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to differentiate the hyaluronic acid (“HA”) viscosupplementation therapies we own or distribute from alternative therapies for the treatment of osteoarthritic; the proposed down-classification of non-invasive bone growth stimulators, including our Exogen system, by the U.S. Food and Drug Administration (“FDA”); our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize; our ability to recognize the benefits of our investments; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner, including the Misonix acquisition; competition against other companies; the negative impact on our ability to market our HA products due to the reclassification of HA products from medical devices to drugs in the United States by the FDA; our ability to attract, retain and motivate our senior management and qualified personnel; our ability to continue to research, develop and manufacture our products if our facilities are damaged or become inoperable; failure to comply with the extensive government regulations related to our products and operations; enforcement actions if we engage in improper claims submission practices or in improper marketing or promotion of our products; the FDA regulatory process and our ability to obtain and maintain required regulatory clearances and approvals; failure to comply with the government regulations that apply to our human cells, tissues and cellular or tissue-based products; the clinical studies of any of our future products that do not product results necessary to support regulatory clearance or approval in the United States or elsewhere; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including Bioventus’s Annual Report on Form 10-K for the period ended December 31, 2020, as updated by Bioventus’s Quarterly Report on Form 10-Q for the period ended July 3, 2021 and as such factors may be updated from time to time in Bioventus’ other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Bioventus’ website at ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Company’s business.