Issue No. 173: Prescription Wearables

Illustration: Courtney Powell

With each new iteration, fitness trackers are looking more and more like medical devices.

As the wrist wars intensify, and the market for medical wearables outpaces wellness-focused smartwatches, a growing number of companies are vying for FDA approval.

Digital Doc

As of 2020, one in five Americans wears a smartwatch or fitness tracker. In addition to wrist-worn devices, chest straps, rings, and smart apparel contribute to a category expected to reach $138B by 2028.

Beyond step counting, wearable makers are eyeing lucrative pieces of the trillion-dollar healthcare market.

  • The global remote patient monitoring (RPM) market is projected to be worth north of $1.7B by 2027.
  • The “global wearable healthcare” market will nearly double between 2021 and 2026, from $16.2B to $30.1B.
  • The internet of medical things (IoMT) market will hit $158.1B in 2022.

Today’s wearables provide always-on, passive remote monitoring, making early detection and patient management a reality. But, because most devices lack clinical validation, there’s a missing link between your data and your doctor.

Trying to bridge the gap, Apple offers a host of medically focused developer tools, including ResearchKit, HealthKit, and CareKit. A step further, last year, Apple launched a feature for sharing health data with doctors or family.

Similarly, Samsung’s Together function enables sharing of select health and fitness data with friends or trainers, making healthcare a gray area.

With security concerns and HIPAA rules looming, developing approved hardware can help mitigate risks. The holy grail, while fitness trackers get recommended, medical-grade devices get prescribed — and that’s piqued the interest of wearable makers.

Pending Approval

Moving in, companies from Fitbit to Apple to Withings are conducting clinical studies and courting the FDA for sign-off on ECGs, pulse oximeters, and more.

  • In the past four years, Apple, Samsung, and Fitbit have all gained FDA approval for ECG (electrocardiogram) sensors that read heart rhythm and can detect AFib.
  • WHOOP was used to monitor patients in phase-III COVID-19 vaccine trials, and last year, the company hired a “Director of Quality Medical Systems.”
  • Oura partnered with UCSF on clinical trials that showed its ring could detect early signs of fever three days before flu or COVID symptoms began.
  • Launching in 2022, Oura competitor Movano has voiced its intentions for a medical-grade smart ring capable of detecting chronic diseases.

Doubling down, last October, French wearable maker Withings landed dual FDA approval for two features of its new ScanWatch tracker: ECG and pulse oximeter (measuring blood oxygen levels and detecting sleep apnea).

Now, the ScanWatch is classified as a class-II medical device. Meanwhile, Apple abandoned its filing for an FDA-approved pulse oximeter ahead of launching its Series 6 Watch.

Pressure test. Heart disease remains the leading cause of death in the US. While Withings offers a connected blood pressure monitor, it’s not worn all the time. Instead, continuous blood pressure-tracking wearables hope to curb the crisis.

Here, Omron’s HeartGuide watch relies on a small inflatable cuff lining the band. This FDA-approved device tracks blood pressure, steps, and sleep activity.

Swiss healthtech firm Aktiia, which raised a $17.5M Series A in late 2021, aims to do the same with optical sensor technology. And last April, Fitbit began trials to test approximating blood pressure by measuring pulse arrival time (PAT) with its tracker.

Multi-use CGMs. Apple has been long-rumored to be developing a noninvasive continuous glucose monitor for Watch, and as metabolic health goes mainstream, countless others are pursuing the technology.

Outside general wellness applications, there’s a growing need for noninvasive glucose-monitoring solutions.

  • In 2021, US diabetes deaths topped 100K for the second year in a row.
  • By 2030, diabetes-related medical costs and productivity loss will exceed $600B.

CGM startups like Levels and Supersapiens show promise, but they rely heavily on medical device manufacturers Abbott and Dexcom, who share a “duopoly” over the available tech.

Meanwhile, these healthcare mainstays are backing into the fitness market.

Entering consumer biowerables, Abbott’s forthcoming Lingo series will track glucose, ketones, lactate, and possibly alcohol levels — targeting athletic performance and metabolic health.

Enabling real-time integration, Dexcom’s new API connects its FDA-approved hardware to fitness tracking software. It launched its first partnership with Garmin in October 2021.

Smart House

Transcending wearables, medical monitoring is colliding with consumer health.

Withings debuted its Body Scan smart scale in 2022, capable of detecting body composition, heart rate, and vascular age. FDA approval is pending.

Elsewhere in the bathroom, Casana raised a $30M Series B and is seeking agency approval for its toilet seat that measures blood oxygen level, blood pressure, and heart rate. Another approach, the BBalance bath mat—which measures weight, stability, and posture—is currently being tested in hospitals.

Moving to the bedroom, smart mattress maker Eight Sleep monitors key health metrics to optimize sleep fitness. Expanding its platform, co-founder Alexandra Zatarain is eyeing opportunities in preventative health and diagnostics, musing: “What else can we do while you’re sleeping to save your life?”

Looking Ahead

The glaring issue with health and fitness wearables is that, despite greater adoption, we don’t appear to be getting any healthier.

Knowing metrics is one thing. But acting on them, or sharing them with your doctor, could have a far greater impact on health outcomes.

More than a trendy watch, the most impactful solutions will likely be tied into a comprehensive health ecosystem.


💛 Soul Searching

A key player in the boutique fitness boom, SoulCycle came to define the indoor cycling experience. But, after the pandemic and some public stumbles, the brand is retooling its playbook.

On the Fitt Insider Podcast: Evelyn Webster, CEO of SoulCycle, joined us to discuss the company’s omnichannel plan of attack in the shifting brick-and-mortar landscape.

We also cover: SoulCycle’s at-home bike, retaining top instructors, and charting a new path forward.

Listen to today’s episode here.


👟 Shoe-lulemon

Activewear retailer lululemon is making its long-awaited foray into footwear.

Kicking off its entrance into the category, lululemon is releasing a women’s running shoe dubbed Blissfeel.

The $148 runner will hit shelves March 22, rolling out across North America, China, and the UK.

Ladies first. According to lululemon chief product officer Sun Choe, the company set out to fill a void in women’s footwear:

“We intentionally started with women first because we saw an opportunity to solve for the fact that, more often than not, performance shoes are designed for men and then adapted for women. That didn’t sit well with us.”

On the heels of its debut runner, the company will also release women’s cross-trainers and post-workout slide-ons this summer, followed by another training shoe in the fall.

Be on the lookout: lulu said its men’s footwear line will arrive in 2023.

Lace ’em Up. lululemon joins a growing number of brands challenging Nike’s top spot in athletic footwear.

  • NOBULL reached a $500M valuation last year on 80% YoY growth and just launched its first performance running shoe.
  • Brooks Running unseated Nike in the women’s performance category in Q1 2021, increasing sales by 88%.
  • Touting comfort, HOKA has posted 96% YoY growth and grew its DTC channel by almost 15%.
  • Both Allbirds and On Running IPO’d last year at billion-dollar valuations, boasting sustainability as a differentiating factor.

Punchline: With the global athletic footwear market set to reach $66B by 2027, brands are finding whitespace among runners who value performance, inclusivity, and authenticity.

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👀 Market Watch

As COVID restrictions are lifted, gym operators are seeing memberships rebound while at-home fitness brands try to pinpoint demand.

For context: Correcting course, equipment makers Peloton and iFIT suffered steep losses in recent weeks. On the flipside, Planet Fitness saw its member base top pre-pandemic levels.

The latest: Xponential Fitness and Beachbody reported Q4 and full 2021 earnings, providing more insight into an industry in flux.

$XPOF

  • The boutique studio operator increased revenue 45% YoY, to $155M, for FY2021.
  • Paying members grew 70% and gym visits were up 50% in Q4 compared to Q4 2020.
  • Revenue and adjusted EBITDA surpassed pre-COVID totals, up 20% and 66%, respectively, in 2021 vs. 2019.

All-access. Of note, Xponential launched XPASS nationwide. This ClassPass-like offering unlocks access to its 2,000 US locations across 10 studio concepts, plus its digital platform, through one subscription.

2022 outlook. The company plans to open more than 500 studios this year with a revenue target north of $200M.

$BODY

  • The digital fitness brand saw Q4 revenue decline 4% YoY, with year-end revenue up 1% compared to 2020 and 16% over 2019.
  • Net loss was $228.4M for FY2021, compared to $21.4M in 2020 and net income of $32.3M in 2019.
  • The company’s subscriber base totaled 2.54M, down 3% compared to 2020, but a 50% increase compared to 2019.

Reorg. Like Peloton and iFIT, Beachbody is restructuring to lower expenses — the company laid off 10% of its workforce in Q1’22. Additionally, after its SPAC merger with smart bike maker MYXfitness, hardware sales have slowed, presenting new challenges going forward.

Further streamlining the business, Beachbody will implement a “One Brand” strategy, unifying its digital and connected fitness efforts under the Beachbody namesake.

2022 outlook. The company is forecasting Q1 2022 revenue of $170–180M. Still, it has a long road ahead to hit the $1.47B in 2022 revenue it pitched investors ahead of going public last year.


📰 News & Notes

  • Eight Sleep puts smart mattresses in Airbnbs.
  • 30-day retention of mental health apps is 3.3%.
  • Join the team: We’re hiring a social media manager.
  • Fitt Jobs: 900+ career opportunities in health & fitness.
  • Fitbit immediately recalls 1.7M smartwatches over burn risk.
  • Tom Brady’s TB12 enters physical therapy in Philly and Florida.
  • The rise of AI fitness trainers: computer vision and real-time feedback.
  • Startup Q&A: Speede co-founder Dan Mooney on building stronger athletes.
  • Report: One hour of strength training per week reduces all-cause mortality 10–17%.

💰 Money Moves

  • Peloton co-founder and ex-CEO John Foley sold $50M in stock to MSD Partners.
  • Daybreak Health, a digital mental and behavioral health platform for schools, raised $10M in a Series A round led by Lightspeed Venture Partners.
    More from Fitt Insider: The Kids Aren’t Alright
  • Global fitness company Virgin Active raised £88.4M ($115.8M) and acquired Real Foods Group, owner of South African healthy restaurant chains Kauai and Nü, for £28.6M ($37.5M).
  • Nonalcoholic beer maker Partake Brewing raised $16.5M in a Series B round led by PowerPlant Partners and Amberstone.
    More from Fitt Insider: Nonalcoholic is the New Cool
  • Consumer wellness company Thorne HealthTech acquired Nutrativa, manufacturer of 2D nutritional supplement discs.
    More from Fitt Insider: Thorne’s Well-care Roadmap
  • Canada-based Wellness Natural Inc., owner of plant-based protein snack brand SimplyProtein, secured $8.5M in Series B funding to expand North American operations.
  • Barnfox, developer of wellness-focused remote work and retreat centers, raised $1M from undisclosed investors.
  • Private equity firm L Catterton acquired Taxa Outdoors, creators of multifunctional camping trailers, for an undisclosed sum. RX3 Growth Partners also invested.
    More from Fitt Insider: The New Camping
  • Digital digestive health platform Vivante Health secured $16M in a Series A round led by 7wireVentures.
    More from Fitt Insider: Gut Check
  • CAY SKIN, maker of a mineral- and antioxidant-packed sunscreen for all skin types, launched after raising $4.1M in seed funding.
  • Wildflower, a maternity care startup, closed $26M in a funding round led by TT Capital Partners.
  • Kintsugi, a mental health platform using AI to detect anxiety and depression in speech patterns, added $20M in a Series A round led by Insight Partners.
  • UK-based women’s bladder care startup Jude raised €2.4M ($2.6M) in pre-seed funding.
  • juli, an AI-assisted digital health platform for managing chronic conditions, raised $3.8M in seed funding.
  • Health Gorilla, an interoperability platform for health data, raised $50M in Series C funding.

Today’s newsletter was brought to you by Anthony and Joe Vennare, Ryan Deer, Melody Song, and Wesley Yen.

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