Evolution Devices was founded in July 2017 after Pier Mantovani’s father was diagnosed with multiple sclerosis. Seeing his father struggle to walk thereafter, Mantovani was inspired to create a company dedicated to producing neuro-rehabilitative technology.
More than four years later, Evolution Devices has designed a muscle stimulation wearable named EvoWalk that will be paired with a digital physical therapy platform.
The AI-powered EvoWalk is a muscle stimulator that uses motion tracking and machine learning to treat a range of walking impairments for people who suffer from things such as Parkinson’s disease, strokes or multiple sclerosis. The device works by timing where users are in their walk, then triggering muscle activation to compensate for whatever walking impairment the user has.
One video on the company’s YouTube channel shows Mantovani’s father using the device to combat the foot drop caused by his multiple sclerosis.
Mantovani, the company’s chief executive, said that he and his co-founders’ vision was to help people move better. “It’s not just people that have specific problems because of their neurological impairments,” Mantovani said. “Our dream is to help all types of impairments.”
Mantovani and company are no longer performing any more research and development changes to the EvoWalk and are now eyeing an FDA clearance submission.
“We really think that we can get the FDA clearance around second quarter of next year, that’s our goal,” Mantovani said. “Once we launch, we’ll be able to get some traction and then probably go into a series A round for growth (between fourth quarter of 2022 and first quarter of 2023).”
Price sensitivity
Mantovani said that Evolution Devices is hoping to release the EvoWalk with a $2,000 price point.
If that price is viable, it would be cheaper than similar stimulation tech products offered by Valencia-based Bioness Inc. and Michigan-based AxioBionics. Bioness’ product, the L300 Go, costs about $6,000 while AxioBionics’ Walkaide is around $4,500.
Gerald Loeb is a professor of biomedical engineering and the director of the Medical Device Development Facility at the USC Viterbi School of Engineering in Los Angeles. Loeb said that questions about Evolution Devices will revolve around what new advantage the company can bring to the market of electrical stimulation products and where the price of the EvoWalk device will actually fall.
“In my experience, a lot of startups in this field look at the competing product and they say, ‘We’ll compete on price.’ The question is whether there’s any price sensitivity, because once insurers say this is what we’ll reimburse for or not, you’re kind of stuck with it,” Loeb said. “The other (thing) is that most people underestimate the cost of sales.”
Loeb added that if the EvoWalk is cheap enough that patients could pay for it themselves, then Evolution Devices could manage to finesse the insurance reimbursement path and compete on cost. “If there is a substantial market for that, they might have something they could compete on,” Loeb said.
However, Mantovani said the company’s goal is “to be able to hopefully bundle everything to be insurance reimbursed, so that we can provide the therapy with the device, and to have it be reimbursed for people.”
Therapy platform
The company plans to pair the EvoWalk with a physical therapy platform that recently started its pilot program.
The platform matches patients with a certified neurologic physical trainer who assesses patients through a HIPAA-compliant video platform. The patients are trained and have a customized therapy program developed that is supplemented by mobility data and changes as their rehab progresses.
“We thought that (the platform) was a really key feature of what we’re building to help improve someone’s health. A device can only do so much,” Mantovani said.
The COVID-19 pandemic gave the company an opportunity to build out a remote physical therapy platform, because the pandemic made person-to-person therapy sessions difficult.
“People that were at high risk didn’t want to go to physical therapy, they wanted to be home,” he explained.
EvoWalk’s digital physical therapy study recently received approval from the Institutional Review Board, an organization designated by the FDA to review medical research involving human subjects.
“Providing a therapeutic paired with physical therapy is something that’s pretty novel,” Mantovani said. “And I think that’s something we really want to kind of double down on.”
Because Evolution Devices doesn’t have a product, it has depended on investments. In 2019 and 2020, the company received $727,490 worth of grants. This year, the company received $70,000 more in grants. The 2021 grants were acquired from the LyfeBulb & Bristol Myers-Squib MS Challenge, National Science Foundation I-Corps, and the final installment of Evolution Device’s phase 1 grant. The company has raised more than $1 million.
Evolution Devices was also one of five finalists that received a grant from the Toyota Mobility Foundation. According to the foundation’s website, it “aims to support strong mobility systems while eliminating disparities in mobility.”
Evolution Devices also recently launched a crowdfunding campaign that as of October 20, has garnered more than $155,000 from 299 investors with 72 days remaining.
“It’s exciting to see something that you started and was breaking constantly to getting to a point where it’s very reliable and paired with physical therapy that people are getting results from,” Mantovani said. “It’s really exciting to be this close.”