Financing Further Propels Commercial and Research & Development Initiatives
Artarmon, NSW & Bloomington, MN – April 13, 2023, Link here – Saluda Medical Inc. (“Saluda Medical”), a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies designed to treat debilitating neurological disorders, today announced the closing of a US $150 million equity financing round led by new investor Wellington Management, with strong support from current investor Fidelity Management & Research Company and new investor TPG. Current investors Redmile Group, LLC, Action Potential Venture Capital and funds and accounts advised by T. Rowe Price Associates, Inc. also participated.
Net proceeds from the financing will be used to advance the commercial release of the Evoke® Spinal Cord Simulation (SCS) System while also helping to further advance the Company’s mission and technology platform.
“We are very excited to add two elite healthcare investors to our shareholder base while existing investors continue to support our mission to transform patients’ lives with neural sensing technology and revolutionize the field of neuromodulation”, said Jim Schuermann, President and CEO of Saluda Medical. “With this financing, which follows the recent presentation of our 36-month data, the decision by CMS to grant Evoke TPT payment, and our initial limited commercial release, we are more prepared than ever to fundamentally transform the neuromodulation space with our clinically proven, technologically unrivaled platform.”
The Company also announced that it has redomiciled as Saluda Medical Inc., a Delaware company.
Saluda’s first FDA indication is in chronic pain, a debilitating condition that affects quality of life and drives patients to opioid use. Studies have shown that over 19 million Americans have chronic pain that limits their ability to work. Although spinal cord stimulation has been used as a treatment option for chronic pain since 1967, Evoke is the first system designed to automatically self-adjust with millisecond precision to optimize therapy based on a patient’s unique spinal cord activation.
BofA Securities acted as sole placement agent for this transaction.
About Saluda Medical
Saluda Medical is a global company transforming patients’ lives with disruptive neural sensing technologies designed to revolutionize the field of neuromodulation. The company’s first product, the Evoke® System, is the only smart spinal cord stimulation (SCS) system and is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. The Evoke® System instantaneously reads, records, and responds to each patient’s neural signature to provide continually optimized therapy and is proven to be superior to open-loop SCS for the treatment of overall trunk and/or limb pain. 12-month results from the EVOKE study, the first double-blind randomized controlled trial (RCT) used in support of Premarket Approval (PMA) in spinal cord stimulation history, were published in The Lancet Neurology and 24-month results have since been published in JAMA Neurology. Both publications are poised to set new clinical standards for long-term pain relief and improvements in physical and emotional functioning, sleep quality and health-related quality of life. Furthermore, there is promising data to show the Evoke® System demonstrated a reduction in re-programming visits over time as well as an elimination of explants due to loss of efficacy out to 24-months – which are significant challenges with current SCS therapies. To learn more, including risks & important safety information, visit www.saludamedical.com/us/safety/.
Saluda Medical and Evoke are registered trademarks owned by Saluda Medical Pty Ltd.