Avi Fischer, M.D., joins as SVP, Medical Affairs and Innovation; J.C. Simeon assumes role of SVP, Quality
George Papandreou, Ph.D., promoted to General Manager and SVP, Focal Therapies; Kunal Faldu promoted to VP, Pharmaceutical Development
NEW HOPE, Pa., Feb. 07, 2023 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the addition of several highly accomplished industry veterans to its senior leadership team. Avi Fischer, M.D., joins as Senior Vice President (SVP), Medical Affairs and Innovation, and J.C. Simeon assumes the role of SVP, Quality. George Papandreou, Ph.D., has been promoted to General Manager and SVP of Focal Therapies (previously SVP, Quality) and Kunal Faldu has been promoted to Vice President (VP) of Pharmaceutical Development (previously Senior Director, Formulation Development).
“We are very pleased to have several outstanding industry leaders join and assume key roles on our leadership team. Avi and J.C. each bring significant domain expertise and a track record of accomplishment. George and Kunal have proven themselves as important leaders within our growing organization,” said Darren R. Sherman, President, Chief Operating Officer and Co-Founder of Orchestra BioMed. “We have worked hard to assemble a highly accomplished team that, combined, has contributed to more than 100 new product approvals or clearances and has authored over 600 patents. We believe this impressive depth of experience leaves us well positioned to successfully execute on the late-stage development of our BackBeat Cardiac Neuromodulation Therapy™ (CNT™) and Virtue® Sirolimus AngioInfusion™ Balloon (SAB) programs, as well as to identify and drive new potential opportunities based on our innovative partnership-enabled business model.”
Dr. Fischer brings to Orchestra BioMed extensive experience in procedural medicine and clinical research, particularly in the areas of electrophysiology and cardiac rhythm management. Most recently, he served as Chief Executive Officer of ElectroPhysiology Frontiers, S.p.A., a privately held medtech company developing a single-shot ablation system to treat atrial fibrillation. Previously, Dr. Fisher worked at St. Jude Medical and Abbott, where he held various leadership roles including Chief Medical Officer, Cardiac Rhythm Management, and Divisional Vice President, Medical Affairs. For 11 years prior to joining industry, Dr. Fisher was Medical Director, Pacemaker and Defibrillator Therapy, for Mount Sinai Medical Center in New York City. He earned his doctor of medicine degree from Tel Aviv University.
Mr. Simeon has more than two decades of experience in biopharmaceutical quality assurance and engineering as well as expertise in process development, characterization, scale-up, optimization, trouble shooting and technology transfer of manufacturing processes from the laboratory to commercial markets. He previously worked for Amring Pharmaceuticals as Head of Quality Assurance and Regulatory Affairs and was also Executive Director of Quality at Actinium Pharmaceuticals. He earned his bachelor’s degree in chemical engineering and his master of science degree in biomedical engineering from the New Jersey Institute of Technology.
Dr. Papandreou has over 25 years of management, R&D, quality and regulatory experience working with transformational drug/device combination products. Prior to joining Orchestra BioMed, he held senior roles at C.R. Bard/Becton Dickinson and Johnson & Johnson (Cordis Corporation).
Mr. Faldu has extensive experience in leading program management, product development and launch management for complex sterile drug products. Before joining Orchestra BioMed, Mr. Faldu worked for Solaris Pharma Corporation as Senior Director, Program Management and Manufacturing. Prior to Solaris Pharma, Mr. Faldu held technical and research positions at Pfizer and InnoPharma.
About Orchestra BioMed
Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s flagship product candidates include BackBeat Cardiac Neuromodulation Therapy™ (CNT™) for the treatment of hypertension, a significant risk factor for death worldwide, and Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of BackBeat CNT for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo Corporation, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. Orchestra BioMed has additional product candidates and plans to potentially expand its product pipeline through acquisitions, strategic collaborations, licensing, and organic development. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements relating to Orchestra BioMed’s ability to successfully execute on its late-stage development programs and identify new potential opportunities. These statements are often identified by the use of words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to be,” “will,” “would,” or the negative or plural of these words, or similar expressions or variations, although not all forward-looking statements contain these words. The Company cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those identified under the heading “Risk Factors—Risks Related to Orchestra’s Business and New Orchestra Following the Business Combination” in the definitive proxy statement/prospectus of Health Sciences Acquisitions Corporation 2 (Orchestra BioMed’s predecessor) filed with the U.S. Securities and Exchange Commission (the “SEC”) pursuant to Rule 424(b)(3) on December 16, 2022 and in the Company’s other filings with the SEC. These risks are not exhaustive. New risk factors emerge from time to time, and it is not possible for the Company’s management to predict all risk factors, nor can they assess the impact of all factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. In addition, statements that “the Company believes” and similar statements reflect the Company’s beliefs and opinions on the relevant subject. These statements are based upon information available to the Company as of the date hereof and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and the Company’s statements should not be read to indicate that it has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. Except as required by law, the Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.
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