Saluda Medical Pty Ltd. is spreading its roots in both the neuromodulation space and the developing bioelectronics medicine market with its latest funding round. The Artarmon, Australia-based company has secured $40 million in an all-equity financing series D round led by new investor, Action Potential Venture Capital, a Glaxosmithkline plc (GSK) fund that invests in companies developing bioelectronic medicines. Existing investors, including Medtronic plc, also participated in the round.
Artarmon, Australia-based Saluda Medical is developing the Evoke Spinal Cord Stimulator (SCS) system. The device is designed to use the patient's own neural fingerprint to monitor and adapt the dose of electrical stimulation automatically and tailor the therapy to meet each individual patient's needs in real-time.
The company said this latest round of funding will support the current U.S. pivotal randomized, double-blinded clinical trial now enrolling patients at 11 sites across the country. In addition the company will use the funding to help commercialize the device in both Europe and in Australia.
"With support from our engaged investors, we remain committed to developing new approaches to bring relief to patients suffering from chronic pain and other disorders that may be treated with our technology," said John Parker, CEO of Saluda Medical.
The firm has also had supporting data for Evoke.
Long-term clinical data from the first chronic implant study of closed-loop SCS conducted in Australia was recently presented at the International Neuromodulation Society 13th Annual World Congress in Edinburgh.
Results at six months show subjects with axial back pain experienced an average sustained improvement of 80 percent relief. In addition, the 32-patient cohort showed clinically meaningful improvements in function, disability, and sleep. The data from the Australia clinical study was presented in the morning plenary session on May 29 as part of a larger program on evoked compound action potentials in neuromodulation.
PAIN REDUCTION MARKET
The neuromodulation space - especially the segment that treats chronic pain has several players. Menlo Park, Calif.-based Nevro Corp. has had its Senza (SCS) system on the market since 2015. However, the Menlo Park, Calif.-based company hit a hiccup last quarter when it its OUS revenues of $15.3 million were lower than analysts' estimates of $16.5 million. The company said it needed to bolster its sales force to more adequately ramp up adoption.
"This story is quickly becoming an expectations game - how many reps can be hired and how quickly can they come up to speed," said Suraj Kalia, an analyst with Northland Capital Markets.
The neuromodulation space is projected to reach $6.20 billion by 2020, at a CAGR of 11.2 percent during the forecast period, according to a report from Research and Markets. Firms in the space have developed a number of technologies to tackle various disease states.
Baltimore-based Eneura Inc. has developed the SpringTMS (transcranial magnetic stimulation) migraine treatment device, which received FDA clearance about three years. (See Medical Device Daily, May 28, 2014). The technology is prescription-only and uses single-pulse transcranial magnetic stimulation to induce very mild electrical currents that can depolarize neurons in the brain.
Stimrelieve LLC is developing a similar technology, the Halo Migraine System, which is implantable. In Dec. of 2015, The Fort Lauderdale, Fla.-based company received approval from the FDA to conduct a clinical trial of a stimulation device to treat chronic migraine (See Medical Device Daily, Dec. 29, 2015.)
Other companies in the space include, Boston Scientific Corp., Abbott Laboratories Inc., Synapse Biomedical Inc., Neurosigma Inc., Neuropace Inc., Neuronetics Inc., Cyberonics Inc. and Biocontrol Medical Inc.
Medtronic and GSK's participation in the funding round isn't surprising. However both companies' reasons are different. For Medtronic, the appeal is to continue raising its profile and reach into the neuromodulation market. The Dublin-based company has achieved significant milestones in neuromodulation.
About two years ago, Medtronic formed a partnership with Ridgefield, N.J.-based Samsung Electronics America Inc. to develop digital health solutions for neuromodulation patients including those with chronic pain, movement disorders, incontinence and other conditions. (See Medical Device Daily, Dec. 14, 2015.) The partnership followed a similar model both companies had adhered to in the diabetes space. (See Medical Device Daily, June 9, 2015.)
GSK reasoning for funding revolves around the field of biolectric medicine, a disease treatment path where devices are used to record, stimulate, and block neural signals, which the Evolve device squarely falls into.
The London-based company has been extremely busy investing in the biolectric medicine market. Last year, GSK took a huge step in commitment to the burgeoning space by forming a joint venture with Google's Verily Lifesciences, called Galvani Bioelectronic. (See Medical Device Daily, Aug. 2, 2016.) Both organizations have agreed to invest up to $712 million over seven years, subject to successful completion of various discovery and development milestones.
Galvani Bioelectronic will evaluate bioelectronics medicine to combat chronic conditions, with type 2 diabetes expected as a potential focus of initial research.