October 21, 2016 3:10 PM ET


Company Overview of SetPoint Medical Corporation

Company Overview

SetPoint Medical Corporation, a biomedical technology company, develops neuromodulation therapies for patients with inflammatory autoimmune diseases, such as rheumatoid arthritis and Crohn's disease. SetPoint Medical Corporation was formerly known as Innovative Metabolics Inc. and changed its name to SetPoint Medical Corporation in July 2008. The company was incorporated in 2006 and is based in Valencia, California.

Mann Biomedical Park

Santa Clarita

Valencia, CA 91355

United States

Founded in 2006

Key Executives for SetPoint Medical Corporation

Chief Executive Officer, President and Director
Scientific Co-Founder
Scientific Co-Founder
Chief Medical Officer
Chief Technical Officer
Compensation as of Fiscal Year 2016.

SetPoint Medical Corporation Key Developments

SetPoint Medical Announces Positive Clinical Results in Crohn’S Disease

SetPoint Medical announced positive results from an ongoing study modulating the inflammatory reflex to treat Crohn’s Disease (CD), a debilitating disease caused by inflammation in the digestive tract. The open-label pilot study is being conducted at five centers in Europe, including patients with moderately-to-severely active Crohn’s despite treatment with a tumor necrosis factor (TNF) antagonist drug. The trial uses an implanted device to deliver digital doses of electricity, stimulating the vagus nerve with timed electrical pulses, activating the body’s natural Inflammatory Reflex to produce a systemic anti-inflammatory effect. In this study, eight patients with severe Crohn’s Disease not responsive to TNF antagonists received an implant on the vagus nerve in their neck to deliver digital doses to the vagus nerve. Improvement was assessed at the sixteen-week mark using the primary endpoint for the study a change from baseline to week 16 in the Crohn's Disease Activity Index (CDAI), a tool used to quantify the symptoms of patients with the disease. Severe Crohn’s is defined by a CDAI greater than 450, and remission is defined as a CDAI below 150. At the primary end point, the CDAI scores of six of the eight patients in the study were reduced by 70 points or more, and CDAI remission and endoscopic remission was achieved in three patients. The data also show a direct correlation between vagus nerve stimulation and the suppression of pro-inflammatory cytokines, including TNF, which plays a key role in inflammation, a finding consistent with the results from the company’s earlier study in patients with rheumatoid arthritis. The company is developing a novel proprietary bioelectronic medicine platform to treat a variety of inflammation-mediated autoimmune diseases by 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 utilizing digital dose delivery to modulate disease pathways historically treated with drugs.

SetPoint Medical Announces Relocation of Corporate Headquarters to Mann Biomedical Park in Valencia, California

SetPoint Medical announced the relocation of its corporate headquarters to Mann Biomedical Park in Valencia, California. The move equips the company with additional offices and creates dedicated space for their maturing R&D, clinical and operational capabilities. The company’s new headquarters provides more than 14,000 square feet for the company’s 25 full-time employees, doubling the size of the company’s previous location, also in Valencia.

SetPoint Medical Announces Management Changes

SetPoint Medical announced 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 the company as Vice President, Clinical Affairs. As Vice President, Lusin Markaryan has primary responsibility for planning and coordinating company's regulatory submissions to the U.S. Food and Drug Administration and other regulatory authorities. She previously held the position of Senior Director, Regulatory Affairs at the company. Raju Joshi, who joined the company from Amgen, will be responsible for developing and executing the clinical development strategy and clinical trials of the company technology platform as Vice President, Clinical Affairs. Both serve on company's management team and report to Anthony Arnold, Chief Executive Officer of the company. Ms. Markaryan brings 16 years of regulatory and clinical experience with leading global medical device companies. Prior to joining the company, 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. Raju Joshi Joshi brings more than 25 years of healthcare experience in multiple sectors including: medical devices, biotechnology, pharmaceuticals, payor and management consulting. Prior to joining the company, 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.

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