Saluda Medical Inc., an Australia-based global medical device company, has announced the closing of a $150 million equity financing round led by new investor Wellington Management.
Saluda Medical said in a statement that the round also saw strong support from current investor Fidelity Management and 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.
According to the statement, 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 Chiefr Executive Officer 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,” he added.
Saluda Medical also announced that it has redomiciled as Saluda Medical Inc., a Delaware company.
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® SmartSCS™ System, is the only evoked compound action potentials (ECAP)-controlled closed-loop 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 automatically reads, records, and responds to the nerves’ response to stimulation 4+ million times a day 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.
Furthermore, unprecedented 36-month data from the EVOKE Study demonstrated enduring and consistent pain relief with the Evoke System.
Saluda Medical’s first Food and Drug Administration (FDA) indication is in chronic pain, a debilitating condition that affects quality of life and drives patients to opioid use.
According to Saluda Medical, 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, it said 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.
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