Sinus pain is just the start for the CEO of Tivic Health

Jennifer Ernst, CEO of Tivic Health [Image courtesy of Tivic Health]

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-inch-long black wand looked like a rectal thermometer for a cow. But Claude said his wife agreed that passing it over her face to deliver ultra-low current electrical waves relieved sinus congestion.

Ernst – a Xerox veteran who later expanded the US operations of flexible electronics company Thinfilm (now Ensurge Micropower) – was intrigued. It was his introduction to bioelectronic medicine. She likens the field to semiconductors, personal computers, or early online retail.

“It has all the hallmarks of an industry going from arcane science to being ready to explode in a practical sense,” Ernst said. Medical design and outsourcing in a recent interview.

Fast forward to 2022, and San Francisco-based Tivic Health (Nasdaq:TIVC) is part of a group of companies like Cala Health, FemPulse, ReliefBand and many others that are leading the way. maintains non-invasive neurostimulation devices to treat various health symptoms.

“The use of non-invasive technology versus implantable technology is what opens up bioelectronic medicine as a first-line therapeutic,” Ernst said.

Marketing image of the Tivic Health ClearUp device for the non-invasive treatment of sinus congestion

A marketing image of the ClearUp device [Image courtesy of Tivic Health]

Tivic Health sells its small, portable ClearUp device directly to consumers through its website and through online retailers such as Amazon, Best Buy, Walgreens and Walmart. It is FDA-cleared to treat allergy-related sinus pain as well as congestion due to allergies, colds, and flu.

Tivic Health revenue increased by one-third to nearly $1.3 million last year, and first-quarter 2022 revenue increased by another third year-over-year to $428,000.

The company simplifies its manufacturing process, relocates and seeks more suppliers to increase 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 investigating the use of a version of the ClearUp with a slight variation in programming to treat postoperative sinus pain. And there is work to use technology to treat migraines.

I’m a year-round allergy sufferer myself, so I was intrigued enough by the ClearUp device myself to ask a Tivic Health PR guy to send me one. I finally took it out of the box when I had a bad head cold and tested negative for COVID-19. The device easily fits in my hand. I followed the instructions and gently ran the electrode tip along my cheek, nose and brow bone, stopping each time 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 radiated to the skin. The ClearUp device uses a tiny bit of current to electronically identify nerves. When it reaches an optimal treatment area, it vibrates to alert the user to stop moving the device, then delivers a therapeutic pulsating electronic wave – still an order of magnitude smaller than a facial massager – which releases norepinephrine to reduce pain. Signal detection and real-time adjustment of the system based on proprietary algorithms meant it didn’t need to be pre-tuned to my physiology to produce the results.

I was curious if regular use of the ClearUp device could help reduce all of my allergy symptoms. But remembering to use the ClearUp regularly wasn’t easy. Between work and small children, it’s hard to find time for many these days.

Ernst suggested I carry the ClearUp in my pocket and use it when needed. She said it was particularly popular with people working in jobs such as construction – or surgery – where becoming groggy from allergies or cold medicine is not a good option. CPAP users are another user group as the ClearUp provides a way to reduce congestion before bedtime.

“Any place where you just want to be able to breathe a little easier is where you want to have a ClearUp,” Ernst said.

There were a few rare times when I felt a slight pinprick sensation. Ernst said the sensation can occur if the ClearUp crosses a hair follicle, and lowering the therapy level of the device should help if that happens.

Getting the ClearUp device to this point required years of miniaturization and simplification of the device. Ernst’s team proposed vibrations as haptic feedback to noises or lights.

“It’s a pretty nice, tight feedback loop with the haptics,” Ernst said. “It’s a nice discreet and elegant solution.

Simulation-controlled clinical trials behind the 510(k) retained haptic vibrations for the control group.

“People with the active treatment came to know they had the active because they got results,” Ernst said.

For Ernst, ClearUp as a device — a direct-to-consumer bioelectronics product that treats a common condition and raises awareness of technology — is just the beginning. “It’s a valuable product for people at home. It’s a way for people to learn about electronic medicine.

According to Ernst, device developers have so far only touched the tip of the iceberg when it comes to the potential of bioelectronic medicine. “There’s a whole host of things that can be done around the immune system, around brain science. … When there is a cure for Alzheimer’s disease, I am convinced that it will come from this field, from the field of bioelectronics. …I’m starting with the small scale stuff, but I believe this is the area that will develop cures for some of the most important conditions that have no way to treat them today.

Leave a Comment