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SetPoint Medical Raises $64M in Preferred Stock Financing to Support Pivotal Trial for its Novel Bioelectronic Platform

VALENCIA, Calif., January 27, 2021-- SetPoint Medical Corporation today announced raising $64M in a Preferred Stock Financing to support its RESET-RA pivotal trial in patients with rheumatoid arthritis (RA). The company is developing its platform for the treatment of chronic, inflammation-mediated autoimmune diseases and is initially focused on a potentially efficacious, yet less immunosuppressive option for the treatment of RA.

This financing was led by New Enterprise Associates (NEA) and included returning investors Action Potential Venture Capital, Boston Scientific, Topspin Fund, Morgenthaler, Euclidean Capital and an undisclosed strategic investor. New investors including ShangBay Capital, Richard King Mellon Foundation, Ascendum Capital, Asahi Kasei, Catalio Capital Management, BPC Fund, Midas Capital, Revelation Partners, Aethan Capital, Citta Capital and SVE Capital also participated in this round. William Dai, Founding Managing Partner at ShangBay Capital, has joined SetPoint Medical’s Board of Directors in conjunction with this financing. The financing included the conversion of approximately $21M in outstanding convertible debt.

The proceeds from the financing will be used to support the RESET-RA multicenter, double-blind, randomized, sham controlled pivotal trial that will enroll up to 250 patients at 40 clinical trial sites across the U.S. The trial will evaluate the safety and effectiveness of the SetPoint bioelectronic platform in patients with moderate-to-severe RA who are incomplete responders or are intolerant to biologic or targeted synthetic disease modifying anti-rheumatic drugs (DMARDs). The company has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for the use of its device in patients with RA who have incomplete response to, or are intolerant to multiple biologic drugs.

There are approximately 1.5 million Americans diagnosed with RA. Despite the effectiveness of biologic and targeted agents for the treatment of RA, many patients either do not respond, lose therapeutic response or are intolerant to these agents. SetPoint’s investigational bioelectronic medicine platform stimulates the vagus nerve to activate the endogenous inflammatory reflex and thereby reduce inflammation.

“We are encouraged by the rigorous science and clinical results to date and are excited to continue our support of SetPoint to bring its breakthrough technology to patients with RA,” said Josh Makower, MD, General Partner, NEA. “SetPoint’s technology has the potential to revolutionize the treatment of patients with autoimmune diseases.”

“We’re incredibly pleased to have the support of an experienced and strong group of investors who see the disruptive potential of our therapeutic platform,” said Murthy V. Simhambhatla, PhD, President and CEO of SetPoint Medical. “We look forward to initiating our pivotal trial in RA and working collaboratively with the FDA to bring our novel therapeutic platform to patients.”

About SetPoint Medical

SetPoint Medical is a privately held clinical-stage bioelectronic medicine company dedicated to treating patients with chronic autoimmune diseases. SetPoint Medical’s bioelectronic medicine platform is intended to offer patients and providers a treatment alternative for rheumatoid arthritis, inflammatory bowel disease and other chronic autoimmune conditions with potentially less risk and cost than drug therapy. The company is developing a novel bioelectronic medicine platform that stimulates the vagus nerve to activate the inflammatory reflex to produce a systemic immune-restorative effect. For more information, visit www.setpointmedical.com.

Contact:
Media Contact:
Annika Parrish
The Ruth Group
720-412-9042
media@setpointmedical.com

Investor Relation Contact:
Carol Ruth
The Ruth Group
917-859-0214
setpointmedical@theruthgroup.com


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