Saluda Medical has raised $40 million in a round led by a GlaxoSmithKline VC fund. The series D gives Saluda the means to take its spinal cord stimulation (SCS) device through a pivotal trial in the U.S. while commercializing it in Europe and its home country, Australia.
Sydney, Australia-based Saluda has built its nascent business on Evoke SCS. The device uses closed loop neuromodulation technology to both monitor signals travelling along the spine and stimulate the body itself. While other SCS systems make patients adjust the stimulation they emit, Saluda’s Evoke is designed to measure the body’s response to its output and automatically adjust the level in light of this feedback and its knowledge of the user’s preferences.
The potential of the technology has turned heads. New investor Action Potential Venture Capital (APVC) led the round. APVC was founded by GSK in 2013 to invest in bioelectronic medicines. This emerging class of medicines consists of devices that, like Evolve, monitor and correct the electrical signals that move through the body’s nervous system.
“Saluda has developed the first therapeutic device that is designed to both constantly read and modulate signals on the spinal cord to treat chronic pain,” APVC partner Juan-Pablo Mas said in a statement. “We are encouraged by the international clinical results to date, and believe Saluda's technology can potentially provide various clinical benefits to patients.”
APVC was joined in the round by existing investors including Medtronic. Saluda last disclosed a financing round in 2015 when Biosciences Managers led a $10 million series B investment.
Saluda will use the new money to complete the randomized, double-blind clinical trial it thinks will enable it to enter the U.S. market. The 11-site clinical trial is enrolling 134 people with chronic, intractable pain and randomizing them to receive either Evolve or a device that requires manual stimulation. Saluda is hoping Evolve will outperform the comparator against an endpoint that looks at pain scores and use in pain medication after three months.
In parallel, Saluda is working to bring the device to market in the European Union and Australia. Saluda thinks it already has the data it needs to win approval in those markets. If Saluda makes a success of Evolve, it will mark another step forward for the field of bioelectronic medicines.
Interest in the approach and belief in its potential to establish itself as a third treatment option alongside drugs and medical devices have grown in recent years, in part because of GSK’s interest in the field. APVC has now invested in seven companies. And GSK itself teamed up with Google’s Verily to create and invest around $700 million in a bioelectronics joint venture.
Saluda, working with the Pain Management Research Institute at the University of Sydney, has established itself at forefront of the sector. Now it has the financial clout to push Evolve past the final barriers between it and the market.