By John Brosky
PARIS If insurers like surgically implanted devices for pain relief, they are going to love minimally invasive surgery (MIS) for implanting a better performing device.
That is the vision being pursued by a German-Italian startup, Wise (Milan, Italy), that in June, 2015 raised €3 million ($3.25 million) to develop a novel, flexible electrode that can be folded and introduced into the spinal column using a catheter.
This approach aims to replace the current procedure of cutting open a patient's spinal column to grind bones in order to fit stiff electrode arrays.
The spinal cord stimulation (SCS) market is estimated to be $1.3 billion, according to a February, 2015 report from iData Research (Vancouver, British Columbia) and is dominated by Boston Scientific (Natick, Mass.), Medtronic (Dublin) and St. Jude Medical (St. Paul, Minn.), in that order.
And the market is growing fast thanks to favorable reimbursement for the implantation of electrodes that jam pain signals among patients suffering from back surgery syndrome. Insurers prefer this device-centered solution to chronic pain rather than paying for patients to become dependent on opium-based medications.
SCS devices have been shown to produce overall cost savings in the treatment of chronic pain patients over opioid medications that can carry substantial health risks.
In its report, iData also notes that the market is far from saturated with less than 10% of the potential patient population being treated with an SCS device, a low penetration that its believes indicates the number of units sold will continue growing without significant slowing over time.
Wise has substantial competition
Wise is not the only company bringing forward a new technology for this burgeoning market opportunity.
"We are entering a field which is quite crowded," Wise CEO Luca Ravagnan told Medical Device Daily.
"But the technology currently in this market has not changed for many years and this is the great opportunity that we have, and this is what our investors see in our vision," he said.
"Electrodes that are thinner, foldable and highly conformable to sensitive nerve tissue that can be implanted through minimally invasive surgery is a game-changer," said Ravagnan.
Using a proprietary process called supersonic cluster beam implantation (SCBI) technology, Wise engineers have found a way to embed nanoparticles of platinum and iridium into a silicon-based substrate, creating a composite layer below the surface that becomes an electro-conductive skin.
Compared to the metal-based arrays currently used in surgery, the Wise electrodes are stretchable, flexible and super-thin. Instead of pushing and forcing metal bands to assure a contact, Wise electrodes are sticky and adhere directly to nerves, maintaining contact and providing a more precise stimulation or recording of signals.
The Wise electrodes hold a potential for a wide range of biomedical applications beyond SCS for paddle lead electrodes, such as muscle or cardio stimulation.
The Series A financing for Wise seems miserably miserly compared to the market opportunity, and Ravagnan acknowledged he will need a more significant Series B round within the next two years to bring forward the SCS device.
Because the SCS device needs another four years of development to design and demonstrate an effective and safe MIS delivery system, Wise created for investors an intermediate milestone that targets a completely different procedure, cranial electrocorticography using the Wise electrodes for cortical grids.
Used primarily for intraoperative recording of brain signals during cancer surgery to identify areas of brain function, Ravagnan believes this application of Wise's novel electrode can be brought to market with CE mark regulatory approval in less than two years.
"When we have this first product on the market, this will be a powerful value inflection point for the company, a demonstration of the safety and effectiveness of the electrode, even if it is a more narrow market opportunity than spinal cord stimulation," he said.
Asked if this step-wise approach aims at an early sale of the company and its technology, Ravagnan admitted, "There is always the possibility. We would not be the first company that, having demonstrated a first-in-man success, goes for an exit. We are in touch with the big players in this field. They know what we are doing."
"Yet this is not our objective, to work toward an exit for the company. With the cortical grid electrode product we have the opportunity for a faster go-to-market strategy that will give us an approval by the beginning of 2017," he said.
"In just two years we will be able to show to regulators that this Class III device is safe and feasible, and we will show surgeons a class of electrodes that no one else can make. Cortical grids is not a huge market, though it is a considerable one, and it may also encourage partnerships with other players," he said.
Reaching an early value inflection point with a CE mark for the electrode has other benefits for the company, such as encouraging investors as the company moves to a Series B round to fund development of the spinal stimulation device.
Ultimately, he added, the electrodes used as a cortical grid and as a SCS device, "are not very different from a technical point of view. This first step of investment in a sense also advances the development of the spinal device with research and development for connection systems and optimization of the electrode."
"Final development of the device itself does not pose a great technical hurdle, nor will it be difficult proving that the electrode works as well as the current standards," he said. "Demonstrating the safety and effectiveness of the implantation technique is what is new and innovative, and here is where we will find challenges, how the surgeon creates a space, opens the catheter and unfolds the electrode."
Published July 22, 2015