BioScience Managers has welcomed the US FDA’s approval of Saluda Medical’s Evoke Spinal Cord Stimulation (SCS) System.
It has also welcomed the finalisation of US$125 million in new Saluda equity financing to operationalise and scale the commercialisation of its Australian developed technology.
BioScience Managers said it has invested in Saluda since 2015 when the company was performing early-stage clinical work.
“Completing such a significant financing and gaining FDA approval is fantastic news for Saluda, which is leading the world in SCS,” said Dr Geoff Brooke, BioScience Managers’ representative on the company's board.
Saluda is an Australian-founded global medical device company focused on neuromodulation therapies. The Evoke System treats chronic intractable pain of the trunk and limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
“This Australian healthcare innovation may soon contribute large scale human life improvement through safe and effective pain relief,” said Dr Brooke.
“FDA approval for the Evoke System is a major milestone for Saluda, which resulted from over a decade of advanced research and development and years of patient-centric determination to transform the standard of care. Evoke’s innovations are borne from Dr John Parker’s vision and pioneering research, and Saluda’s strong and lasting partnerships with the clinical community and mutual dedication to patients,” said Jim Schuermann, Saluda President and CEO.
The Evoke System received CE mark approval in Europe in 2019, with initial sales underway. Saluda Medical plans to implement a controlled, limited release of the Evoke System in the second half of 2022 among select trial sites before initiating a full commercial release in 2023.