SAN FRANCISCO, CA, October 21, 2024 – Teal Health, the woman-led company behind the Teal Wand^TM at-home cervical cancer screening, today announced their submission to the FDA. This screening will address barriers to cervical cancer screening and give millions of women and people with a cervix an alternative method for screening, one that is convenient, comfortable, and private. This submission, which received FDA Breakthrough Device Designation in May of this year, is the final step before making the Teal Wand commercially available. Teal Health’s SELF-CERV clinical trial, which completed enrollment earlier this year, has demonstrated strong clinical performance and an overwhelming preference for the Teal Wand. While pending approval, Teal Health has compiled a report to share a glimpse into their study’s diverse demographic profile and the participants’ experiences with the Teal Wand.

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“Our goal has always been to design for women, listening to their needs and building a solution that fits into their lives. This submission is our final step in being able to deliver that solution,” said Kara Egan, CEO of Teal Health.

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“Cervical cancer is almost entirely preventable when caught early, yet 1 in 4 women in the U.S. are behind on their screenings. Women want to be up-to-date, but the universal truth is that we are just too busy: too busy with our jobs, caring for our kids, helping our aging parents, you name it, we’re doing it. The Teal Wand is designed to fit into her schedule, offering a convenient at-home alternative that can allow women to feel supported when taking control of their health.”

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The Case for At-Home Screening: Why Women Are Choosing the Teal Wand™

The numbers speak for themselves. Teal Health’s SELF-CERV study, which included over 600 participants at 16 clinical sites across the U.S., highlights the growing demand for an at-home cervical cancer screening. 

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The study revealed the following:

• 94% of participants said they’d prefer to self-collect at home if they knew it was just as accurate as an in-office exam.
• 93% found the Teal Wand easy or very easy to use
• 86% would be more likely to stay up-to-date with routine cervical cancer screening if an at-home self-collecting option was available

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These findings aren’t just statistics—they’re a call to action. Teal Health's study revealed that women and people with a cervix across various demographics—including race, ethnicity, income, and gender identity—reported similar reasons for delaying screening. Thirty-two percent of participants cited lack of time, discomfort with the current in-office screening, and cost as top concerns. Today, nearly half of the US counties don’t have an OBGYN, and one-third of Americans can’t access preventive care. It is also important to address discomfort with the current exam and provide additional options for women to stay current on this screening.

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Inclusive Innovation: A Device and Study Designed for Diversity

The Teal Wand is designed for women and people with a cervix to easily collect their own vaginal sample from the comfort of their homes. All study participants were able to collect a sample, 92% of study participants collected in under two minutes and 90% reported it was as comfortable or more comfortable than the current experience. The SELF-CERV study validated the performance of the Teal Wand by comparing results to a clinician-collected sample with a speculum and brush. Performance exceeded study goals. “Our study was designed with a commitment to enroll participants who reflect the diversity of the U.S. population and ensure a safe and easy experience,” states Trena Depel, Vice President of Clinical and Regulatory at Teal Health, “We credit our clinical study partners for helping support that commitment.” 

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Teal Health prioritized diversity in the study, ensuring representation across various demographic groups. Over 25% of SELF-CERV participants were Black or African American—nearly double the representation in similar trials. Additionally, 20% identified as Hispanic or Latinx, mirroring national demographics, and 1.2% as American Indian/Alaska Native or Native Hawaiian/ Pacific Islander. The majority of participants identified as heterosexual females, with 13% identifying as bisexual, pansexual, or gay/lesbian and 2% identifying as genderqueer/non-conforming, transgender/male, or other gender identities. Most participants had household incomes close to the U.S. median, with 40% earning below $50,000 annually. 

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Age distribution spanned the 25-65 range recommended for cervical cancer screening by the American Cancer Society guidelines, and notably, 18% were in perimenopause or menopause, a group who can often experience discomfort with traditional speculum exams. Another group who can experience increased difficulty with traditional screening is women with a higher BMI or a retroverted cervix, which can impact sample collection. Study participants represented a wide range of body types and were successful in self-collecting adequate samples. This device empowers both patients and providers by offering a more accessible and comfortable alternative for cervical cancer screening.

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“The diverse representation in this trial is critical, as cervical cancer disproportionately affects women of color, women who have challenges with today’s screening due to physical or emotional challenges with a speculum exam, along with other marginalized groups," said Liz Swenson, MD, OBGYN and Medical Director at Teal Health. “This study reflects our commitment to addressing the challenges faced by patients from all walks of life."

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Teal Health’s Momentum to Eradicate Cervical Cancer Continues

Teal Health’s FDA submission comes on the heels of another major milestone. The company announced last week that they have been awarded a $1.68 million SBIR grant from the National Cancer Institute, which will further accelerate the development of the Teal Wand. This funding, along with their submission, marks a major step toward Teal Health’s mission to make cervical cancer screening more accessible, ultimately contributing to the eradication of cervical cancer in the U.S. Since its launch, the company has stayed focused on this bold vision. With the overwhelming support of women nationwide, strong clinical data, and this grant, the company is confident that the Teal Wand will play a pivotal role in achieving that goal.

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This news release was first announced earlier today by CEO, Kara Egan, on stage at the HLTH conference in Las Vegas. You can see a visualization of this data and more on getteal.com. 

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About Teal Health

Teal Health is on a mission to design a better healthcare experience for women - starting with cervical cancer screenings. By creating the option for a woman to screen for cervical cancer from the comfort of home and providing telehealth follow-up, Teal can increase access to this life-saving cancer screening. Teal Health is a member of the Cervical Cancer Roundtable, a joint collaboration between the American Cancer Society and the Biden Cancer Moonshot, a coalition of industry leaders with the goal of eliminating cervical cancer as a public health concern in the US. To learn more, visit www.getteal.com.

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CONTACT INFORMATION

Mallory Walsh
mallory@tealhealth.co  
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