SetPoint Medical Announces Data Supporting Continued Clinical Development of its Bioelectronic Device for T...Read Press Release from
October 23, 2018
– Appoints Lusin Markaryan as Vice President of Regulatory Affairs and Raju Joshi as Vice President of Clinical Affairs –
Valencia, CA – September 12, 2016 – SetPoint Medical, a clinical-stage biomedical technology company developing a bioelectronic therapy for inflammatory diseases, announced today that it has expanded its senior management team with the appointment of executives in regulatory and clinical affairs to serve in leadership roles as the company advances its bioelectronic medicine platform. Lusin Markaryan has been promoted to Vice President, Regulatory Affairs, and Raju Joshi has joined SetPoint as Vice President, Clinical Affairs.
As Vice President, Lusin Markaryan has primary responsibility for planning and coordinating SetPoint’s regulatory submissions to the U.S. Food and Drug Administration (FDA) and other regulatory authorities. She previously held the position of Senior Director, Regulatory Affairs at the company. Raju Joshi, who joined SetPoint from Amgen, will be responsible for developing and executing the clinical development strategy and clinical trials of the SetPoint technology platform as Vice President, Clinical Affairs. Both serve on SetPoint’s management team and report to Anthony Arnold, Chief Executive Officer of SetPoint Medical.
“Lusin Markaryan and Raju Joshi bring vital expertise to SetPoint at this exciting time for the company, as we recently published the results from our first-in-human study in rheumatoid arthritis and prepare for clinical trials with our new proprietary device,” said Anthony Arnold, Chief Executive Officer of SetPoint
Medical. “Both of these leaders will play key roles in further advancing the clinical development of our bioelectronic medicine platform and position our company for continued growth.”
SetPoint is developing a novel proprietary bioelectronic medicine platform to treat a variety of inflammation- mediated autoimmune diseases, using an implanted device to stimulate the vagus nerve, activating the body’s natural Inflammatory Reflex to produce a systemic anti-inflammatory effect. The emerging field of bioelectronic medicine aims to address unmet patient needs by utilizing neural conduction and modulation to impact disease pathways. Through advanced technology, it targets disorders historically treated with drugs.
Lusin Markaryan, Vice President, Regulatory Affairs
Ms. Markaryan brings 16 years of regulatory and clinical experience with leading global medical device companies. Prior to joining SetPoint, she served as Director, Regulatory Affairs for Non-Intensive Diabetes Therapies at Medtronic, where she also held several other regulatory posts. She also held positions with Boston Scientific’s Neuromodulation division, Cedar Sinai IRB and AlleCure Corporation. Ms. Markaryan earned a BA in English from the University of California, Irvine and has completed courses in the Regulatory Science program at the University of Southern California. She also has earned the Regulatory Affairs Certificate (RAC) for both the U.S. and the European Union.
Raju Joshi, Vice President, Clinical Affairs
Ms. Joshi brings more than 25 years of healthcare experience in multiple sectors including: medical devices, biotechnology, pharmaceuticals, payor and management consulting. Prior to joining SetPoint Medical, she was Medical Sciences Director and Director of Clinical Development at Amgen, preceded by her role as Senior Manager of Clinical Research, Regulatory and Reimbursement at Medtronic. Additionally, she held several positions at Deloitte Consulting and WellPoint Health Inc. Ms. Joshi holds a Bachelor of Science degree in Biomedical Sciences from the University of California, Irvine, a Master’s degree in Healthcare Administration from the University of Southern California and SOCRA CCRP certification as a Clinical Research Professional.
About SetPoint Medical
SetPoint Medical is a privately held biomedical technology company dedicated to treating patients with debilitating inflammatory diseases using bioelectronic therapy. SetPoint’s approach is intended to offer patients and providers an alternative for the treatment of RA and other chronic inflammatory diseases with less risk and cost than drug therapy. SetPoint’s therapy is also being evaluated in an open-label clinical study for Crohn’s Disease.
SetPoint is developing a novel bioelectronic medicine platform consisting of an implantable miniature neuromodulation device and iPad prescription pad application. The implantable device stimulates the vagus nerve to activate the body’s natural inflammatory reflex, which is intended to produce a potent systemic anti- inflammatory effect. The company has published positive results from a first-in-human open-label proof-of- concept trial in rheumatoid arthritis in Proceedings of the National Academy of Sciences (PNAS) and presented positive results at the American College of Rheumatology meeting. Current investors in the company include Morgenthaler Ventures, Flare Capital Partners, Topspin Partners, Medtronic, GlaxoSmithKline’s Action Potential Venture Capital Limited and Boston Scientific. For more information, visit www.setpointmedical.com.