SAN FRANCISCO — Patricia Allen vividly remembers the “glorious moment” last summer when she strolled on a North Beach sidewalk without having to focus on the laborious process of lifting, swinging and lowering her left leg, which has suffered from hemiparesis, or weakness, since a stroke in 2019.

“It was a Tinkerbell feeling; surreal, as if the sun was shining just for me,” she said. “It was a feeling of freedom and independence. It was something wow.”

Allen was able to walk with fluidity thanks to the Cionic Neural Sleeve, a leg sleeve embedded with sensors that monitored her movements and electrodes that stimulated her muscles to activate as needed.

Essentially it is bionic clothing.

Now the device is close to public release early this year, as its maker, San Francisco startup Cionic, has gained Food and Drug Administration approval and state licensing as a medical device manufacturer. (Allen was among a few dozen early testers.)

Cionic hopes that the sleeve will prove transformative for some of the 35 million Americans with mobility impairments.

The mission is personal for Cionic founder and CEO Jeremiah Robison, who worked on handwriting recognition at Apple, wearable health sensors at Jawbone and the first web browser for mobile phones at Openwave.

His daughter Sofia, 13, was born prematurely and has cerebral palsy, which affects her walking.

“I’d spent most of my career at the intersection of data and the human body, building wearables to track aspects of human health,” Robison said. “I had enough knowledge and a huge motivation to say, ‘Since nothing is available for my daughter, if not me, who? If not now, when?'”

He started the company in his San Francisco garage in 2018 aiming to build clothing to augment movement, and had a working prototype that year, using a pair of Sofia’s tights.

“I was test pilot zero in the early stage,” said Sofia, a seventh grader who loves music and science and hopes to be an engineer. “I got to try the very first iteration. Now I have a sleeve in my size, which is pretty cool.”

(The device will not initially be available to the public for pediatric use, however.)

One of Robison’s inspirations was watching Sofia receive physical therapy that incorporated functional electrical stimulation, or FES, to fire up her muscles. It was a clunky process: A physical therapist would place electrode pads on her leg muscles with long wires connecting them to a control device that the therapist manipulated while walking with Sofia. Robison had also seen how movement analysis performed at a gait lab had helped Sofia walk in a straight line.

His eureka moment was to combine “the diagnostic power of a gait lab with the therapeutic power of FES into a garment that could be worn … anywhere in the world,” as he explained on the company’s website.

The 19-person company, which has $23 million in venture backing, coined its name from a mashup of “cybernetics, the science of communications and automatic control systems in machines and living things, and bionics, the study of mechanical systems that function like living organisms or parts of living organisms,” Robison said in a follow-up email.

Cionic is offering the sleeve at an introductory price of $200 a month for 12 months, after which users own it outright. Users also can cancel their subscription at any time without penalty. It’s still considered experimental technology, Robison said, which is likely to prevent most insurers from covering it.

The sleeve comes with a small control device, slightly larger than a deck of cards, that slips into a pocket on the upper thigh. That device communicates with an app on the wearer’s smartphone that allows the user to customize stimulation settings, and offers exercises to help increase strength and reinforce motor learning, Robison said.

The battery-powered device runs for 8 to 12 hours and can be recharged with a supplied USB-C charger.

Cionic’s mobility specialists will do remote training and fine tuning for each user, said Rebecca Webster, Cionic director of clinical operations.

“Everyone has very different impairments,” she said. “The system can do four quadrants of the leg: the shin, calf, quad and hamstrings. Not everyone needs all of those muscle groups to be turned on.”

The sleeve is most appropriate for people with gait impairments due to neurological disorders such as stroke, multiple sclerosis, cerebral palsy and spinal cord injuries (short of full paralysis), she said.

“Many patients with these conditions have to think with every step about where they are stepping,” she said. “It takes a lot of mental energy. The sleeve decreases that mental load.”

Stephen Kanter, a physical therapist who works with MS patients in New York, and adjunct professor of anatomy and biomedical ethics at Seton Hall University in New Jersey, said the main alternatives for home-based functional electrical stimulation are leg cuffs from WalkAide and Bioness, which cost a few thousand dollars each.

“What’s exciting about Cionic is that it has the potential to offer things that the other FES devices don’t,” such as stimulating multiple muscle groups, rather than just one at a time, and the app’s ability to adjust the stimulation based on changes in the how the user is walking, he said.

While he hasn’t used the device in the clinic and has no involvement with the company, he’s seen demos of it. “It creates a synchronicity in movement, which can potentially allow for better walking or better fluidity of walking,” he said.

Still, in his opinion, it would be better for patients to use the device under guidance of a physical therapist. Robison said Cionic focused on home use deliberately because only about a fifth of people who need physical therapy actually receive it.

Allen, 57, who lives in Novato, said the gait assist removes one source of anxiety as she job hunts.

“It enables me to walk securely,” she said. “When I wear the sleeve, the electrical stimulation helps ensure that I have proper foot placement on the ground. I can carry on with confidence. This is invaluable especially when you’re going to interviews. Bottom line is it gives me peace of mind — one less thing I have to concern myself with.”

For the Robisons, mobility issues are a family affair. Sofia’s mother Jacquie Robison started a nonprofit called WAWOS (we’re all working on something) to support children with cerebral palsy and related neuromuscular delays, while Sofia herself offers wellness tips on the WAWOS Instagram account.

“My main thing I’ve been steadfast about is that (the tips are) not just disability-related; they must be applicable to anybody,” Sofia said. “I don’t want to make it disability specific. We’re preaching: Disability isn’t the important thing about people.”

Sofia said the sleeve was helpful psychologically as well as physically.

“For me, just being the one left behind (because she’s slower than friends) can be mentally really difficult,” she said. “Helping people not be the one left behind can be really important. I just want to say nice job, Dad,” she added affectionately.

Still, she hopes to prod her father to invent more Iron Man-type devices.

“I was promised rocket socks when we started this,” she said. “I’m still waiting on those, Dad.”

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