Khosla-backed Thync dodges FDA, heads to market with $299 mood-shifting consumer wearable

The pieces of Thync Vibes

Startup Thync has started to sell its forehead-adhesive consumer device intended to make users feel "more calm or energized" after the FDA exempted the system from any regulation as a medical device. The startup said it is the first consumer wearable device that's marketed to improve a person's mood.

The device, dubbed Thync Vibes, uses low levels of pulsed electrical energy to signal specific neural pathways. The company claims this allows users to "dial up or dial down their stress responses and energy levels."

"Today's fast-paced life requires us to switch situations and change mindsets at increasing speed," said Thync CSO Jamie Tyler in a statement. "Thync helps people find calm and focus throughout your day. Thync is the result of groundbreaking research at some of the best academic institutions, combined with cutting-edge engineering that leverages patented algorithms. This has culminated in today's launch of a device that, for the first time, lets you safely tap into the power of your own mind."

The device came out of research at Harvard University, Massachusetts Institute of Technology, Stanford University and Arizona State University.

Thync Vibes measures one inch by two inches by one-half inch. For $299 on the company site, a device can be purchased that includes "10 Calm Strips" and "10 Energy Strips." It also includes a charging cable and works with an accompanying smartphone app to select treatment and otherwise control the device.

On the regulatory front the company said, "The FDA exempted the Thync System from medical device regulations requiring pre-market notification (clearance) or approval." It added that electrical stimulation products have been widely used for more than 40 years and that the Thync device was tested by an independent lab.

The company does cite a study showing that the device results in a "significant reduction of physiological and psychological stress," with 97% of study participants stating that the relaxation effect of the Thync device is greater than placebo treatment.

The startup released a series of user testimonial and describes the effects of the device as like a shot of espresso or a glass of wine. Its use is described as helpful during transition times from one kind of activity to another. It's said to have an immediate effect that lasts from 30 minutes to an hour with a "carry-over impact" that lasts several hours.

On the energy-boosting aspects, one user described that, "While using Thync, I was able to get a steady amount of work done and keep my mind really lasered in on what I needed to do, which lowered my frustration and made me more productive," said Christian Hoffman, a creative director and senior designer in a statement.

As for the calming properties, "Thync helped me fall asleep and calm down from the high stress levels I have to deal with at work," said Kristin Cole, an emergency room technician, in a statement. "Typically I wake up quite often in the middle of the night, but after using the Calm Vibe, I woke up less, felt like a better person, was in a better mood, and had much more energy during the day."

Thync CEO Isy Goldwasser

The lead investor in Thync is Khosla Ventures, which along with a Vinod Khosla's nonprofit Khosla Impact, is very focused on med tech. Khosla is a co-founder of Sun Microsystems and a partner at Kleiner Perkins Caufield & Byers. Other investors in the Silicon Valley, CA-based startup include Formation 8 and Velos Partners.

Consumer-oriented med tech players in the Khosla Ventures portfolio include activity tracker company Misfit Wearables; Adamant Technologies, which has a device that enables users to track health and fitness through an analysis of chemicals in their breath; Cellscope, which does at-home disease diagnostics via a smartphone optical assessment; wearable clinical monitoring company Quanttus; and Consumer Physics, which is creating a pocket spectrometer for smartphones intended for consumer apps.

"Our mission at Thync is to 'unlimit' people," summed up Thync co-founder and CEO Isy Goldwasser in a statement. "Thync brings together innovations in neuroscience and engineering so you can access your own abilities."

- here is the release