Allergens are a problem. Grass and weed pollen, mold spores, dust mites, and cockroaches are all things that cause allergic reactions that people deal with. The majority of sinus sufferers treat their painful allergies with pills.
Since most Americans have a small cadre of sinus treatments like pills, nose sprays, and nasal flushes in their bathrooms already, another pill hardly makes a difference. In fact, because it’s drug-free and works with the body’s natural electricity, that’s why consumers are very interested in using a new, modern piece of healthtech called ClearUP. Since it’s drug-free that means it has no pharmaceutical side effects or chance of addiction. It’s a logical place to start if you’re marketing a device that addresses allergies without having to reach for another pill.
An Allergy Problem You Can’t See
When you buy a new car – a Honda Accord perhaps – you’re suddenly stricken by how many Honda Accords you see on the road. That’s called the Baader-Meinhof phenomenon, and it explains why if you’re someone who doesn’t have allergies, the problem flies under your radar. For the 45 million adult Americans who have allergies, they all know that treatment options haven’t changed much recently.
The majority of sinus sufferers are already popping pills even though they can have side effects on your kidneys. However, for 90% of allergy sufferers out there, there is a desire to take fewer sinus medications. Not to mention there are those for whom current treatments don’t work well on sinus pain especially. That’s where Co-Founder and CEO of Tivic Health, Jennifer Ernst, spotted an opportunity. We sat down to talk with her about why she’s so excited about consumer neuromodulation for chronic conditions like allergies and beyond.
About Tivic Health
Founded in 2016, San Francisco startup Tivic Health has raised $11 million in funding and has already brought an FDA-cleared device to market. It’s something we wrote about in our recent piece on 8 Companies Developing Bioelectronic Devices. The human body actually generates electricity – enough to power a light bulb – so it’s no surprise that electricity itself can act as a therapeutic. What Tivic Health developed is a small handheld device called ClearUP that emits microcurrent waveform, or low-level electrical stimulation, which calms the sinus nerves and shrinks swollen sinus tissues to alleviate congestion.
In order to establish the scientific and medical proof for ClearUP, Tivic Health led a series of studies that can be found on their website. The results are telling. ClearUP was proven to reduce sinus pain in almost three out of four participants. Over 80% preferred ClearUP to other allergy treatments. It was also shown to reduce congestion in 88% of study participants after regular use. Numbers like these are quite compelling for the powers that be, and Tivic Health – in September 2019 – was granted FDA clearance for an over-the-counter neuromodulation device for sinus pain which is now stocked at leading online retailers such as Amazon, BestBuy.com, Sharper Image, Walgreens.com, and Walmart.com, among others.
Two clinical studies resulted in FDA over-the-counter clearance because the device is extremely safe and effective. The over-the-counter approval came about because it addresses an application that allows any adult allergy sufferer to self-diagnose and self-administer without seeing a doctor or getting a prescription. You know when you have sinus pain or congestion, and you know when to start treating it. You simply go out and purchase whatever solutions you think you need in order to manage and control it at all times.
In March, the FDA expanded the indication for use of ClearUP® Sinus Pain Relief to include congestion from not only allergies, but the flu, and the common cold. This allows the company to begin marketing to a whole lot more consumers with congestion versus those with just allergies. The cough-cold-allergy market is worth over $120 billion globally, and Tivic Health is now able to address the pain and congestion segments of that market. But what we’re wondering is just how effective it’s been for the first indication – sinus pain relief.
The Sinus Pain Relief Use Case
We’re born skeptics who take a risk-averse approach to investing. We’re also overworked and underpaid, so allergies haven’t found their way onto our hierarchy of needs unless you are one of the 45 million who suffer from allergies. So, we perused through the hundreds of verified reviews for the ClearUP device. We saw lots of happy customers and took special note of the people who said they went into the whole thing as skeptics. “If this is just a placebo effect then it’s the best placebo effect ever,” said one reviewer. Others mentioned suffering for years with no treatment and finally coming across one that worked. Less frequent were people who said it just didn’t work for them. We were impressed by how Tivic Health interacted with those who didn’t receive relief from the device. Customer satisfaction is critically important part of gaining adoption for a device whose success is now solely determined by consumer adoption.
In speaking with the company, they said 74% of first-time ClearUP users see an immediate effect according to a clinical study. If one uses it regularly over a sustained period of four weeks, the effect improves over time. You can be sure that those who benefited from the device will be very vocal about it since everyone approaches new therapies with a certain degree of skepticism. You can build the best consumer medical device in the world, but it will only be adopted if people perceive it as beneficial to use.
At a list price of $149, ClearUP isn’t cheap up front, but it’s fairly priced when you consider the pill or nasal spray alternatives over time which can cost several hundred dollars a year collectively.
A successful consumer medical device also opens the door to sell other devices through the same channels since now people see – in the words of Gertrude Stein – some “there there.” With the expanded indication from the FDA, the total addressable market grows to the 200+ million adults who get colds every year. It’s that bigger picture where Ms. Ernst seems built for the job.
The Future of Electroceuticals
Today’s heavy social media user passing themselves off as a “tech worker” could be excused for not knowing the significance of the acronym PARC which stands for Palo Alto Research Center. Previously known as Xerox PARC, this Vatican City of innovation has been responsible for such developments as laser printing, Ethernet, the modern personal computer, graphical user interface (GUI), and object-oriented programming. That’s where Tivic Health’s CEO, Jennifer Ernst, spent 20 years of her career establishing a business development approach that spanned the entire enterprise. Reading her CV makes you wonder why you’ve squandered half your life so far, and it also provides a great deal of credibility behind her aspirations to bring neuromodulation to the consumer masses.
Ms. Ernst explained why her company was able to bring a medical device to market – along with an expanded indication for use – in just three years’ time. It’s not just the experienced team on board, it’s also because of something that makes electroceuticals so enticing to investors – safety. While a pharma startup may need to spend $2-3 billion bringing a product to market, an electroceutical may cost a fraction of that – $100 million perhaps or in the case of Tivic Health approximately $9 million. Not to mention duration. Tivic Health went from zero to FDA-cleared device in three years’ time. Contrast that to the eight years or so it takes a drug to reach the market.
Tivic Health is using consumer feedback to improve their initial device after shipping product to every single U.S. state and territory. Having achieved a CE mark, they’re eyeballing international sales too, and also considering expanding their indications even further. The human face is a target-rich area with 12 branches of the cranial nerve. Microcurrents are very effective for inflammatory conditions, and since clinical studies don’t cost a fortune, it’s easy enough to start exploring other application areas. The focus is on consumer devices that put the consumer in charge.
Over time, Tivic Health’s success means that they may look outward for expansion as well. Investor interest in electroceuticals has been strong, and acquisitions will likely play a part in helping the company grow. Perhaps most telling is when Ms. Ernest talked about her investor base includes institutions that are focused on researching therapies for sinus pain. When they saw how well ClearUP worked, they wanted a piece of that. There’s every reason to believe that their investment is on track to show some superior returns, especially when you take into account the global market for pain and congestion resulting from colds, flus, or allergies.
People wonder why their great idea and $3 won’t get them a cup of coffee at Starbucks, much less an appointment with a venture capital firm. What matters more than ideas is the ability to take a vision and execute on it. A proven ability to build businesses consistently over decades is a great prerequisite to running your own company. Tivic Health has the caliber of leadership on board that leads you to believe they’re doing something big in the area of consumer neuromodulation devices.