Tivic Health CEO Jennifer Ernst thinks the bioelectronic medicine space is ready to explode.
When serial inventor John Claude showed Jennifer Ernst an early prototype of what would become Tivic Health’s ClearUp device, she thought the 9-in.-long black wand looked like a rectal thermometer for a cow. But Claude said his wife agreed that running it over her face to deliver ultra-low current electrical waves cleared up sinus congestion.
Ernst — a Xerox veteran who went on to grow the U.S. business of flexible electronics company Thinfilm (now Ensurge Micropower) — was intrigued. It was her introduction to bioelectronic medicine. She compares the field to semiconductors, personal computers or online retail in their early days.
“This has all the markings of an industry that is going from the esoteric science to being ready to explode in the practical sense,” Ernst told Medical Design & Outsourcing in a recent interview.
Fast forward to 2022, and San Francisco–based Tivic Health (Nasdaq:TIVC) is among a group of companies such as Cala Health, FemPulse, ReliefBand and more that are pioneering noninvasive neurostimulation devices to treat various health symptoms.
“The use of a noninvasive technology versus an implantable technology is what opens up bioelectronic medicine as a first-line therapeutic,” Ernst said.Tivic Health is selling its small, handheld ClearUp device directly to consumers through its website and through online retailers including Amazon, Best Buy and Walmart. It is FDA-cleared to treat allergy-related sinus pain as well as congestion from allergies, cold and flu.
Tivic Health’s revenue was up by a third to nearly $1.3 million last year, and Q1 2022 revenue was up by another third year-over-year to $428,000.
The company is simplifying its manufacturing process, moving locations and seeking more suppliers to boost production even more to meet demand. A double-blind randomized controlled trial based at the Icahn School of Medicine at Mount Sinai in New York is examining use of a version of the ClearUp with a slight variance in programming to treat post-operative sinus pain. And there is work to use the technology to treat migraines.
I’m a year-round allergy sufferer myself, so I was intrigued enough by the ClearUp device myself that I asked a PR person for Tivic Health to send me one. I finally broke it out of the box when I had a bad head cold and tested negative for COVID-19. The device easily fit in my hand. I followed the instruction and gently ran the electrode tip along my cheek, nose, and brow bone, stopping whenever the device vibrated.
Within a minute of finishing the treatment, a huge amount of snot came out of my nose. I felt better.
Ernst later told me that a set of nerves in the sinuses radiate out to the skin. The ClearUp device uses a tiny bit of current to electronically identify nerves. When it hits upon an optimal treatment area, it vibrates to alert the user to stop moving the device and then delivers a therapeutic pulsed electron wave — still an order of magnitude less than a facial massager — that release norepinephrine to reduce pain. The signal detection and the system’s real-time adjusting based on proprietary algorithms meant that it didn’t need to be pre-tailored to my physiology to produce the results.
I was curious whether regular use of the ClearUp device could enable me to reduce my overall allergy symptoms. But remembering to regularly use the ClearUp was not easy. Between work and little kids, it’s tough to make time for much these days.
Ernst suggested I carry the ClearUp in my pocket and use it when needed. She said it’s been especially popular with people working jobs such as construction — or surgery — where getting groggy from allergy or cold medication isn’t a good option. CPAP users are another use group because the ClearUp provides a way to reduce congestion before bedtime.
“Any place you just want to be able to breathe a little better, it’s where you want to have a ClearUp around,” Ernst said.
There were a few rare times where I felt a slight pin-pricking sensation. Ernst said that sensation can happen if the ClearUp goes across a hair follicle, and turning the device’s therapy level down should help if that happens.
Getting the ClearUp device to this point involved years of miniaturization and device simplification. Ernst’s team came up with vibration as haptic feedback versus noises or lights.
“It’s a pretty nice, tight getting that feedback loop with the haptic,” Ernst said. “It’s a nice discreet, elegant solution.
The sham-controlled clinical trials behind the 510(k) retained haptic vibration for the control group.
“People with the active treatment ended up knowing they had the active because they got results,” Ernst said.
For Ernst, ClearUp as a device — a direct-to-consumer bioelectronic product that treats a common condition and raises awareness about the technology — is only the beginning. “This is a product that is valuable to people in their homes. It’s a way for people to get comfortable with electronic medicine.”
Device developers have so far only hit the tip of the iceberg when it comes to bioelectronic medicine’s potential, according to Ernst. “There is a host of things that can be done around the immune system, around the brain science. … When there is a cure from Alzheimer’s, I am convinced it will come from this field, from the bioelectronic field. … I’m starting with the small-scale stuff, but I believe that this is the field that will develop cures for some of the most significant conditions that don’t have ways to address them today.”