We did it! This is such a huge day for Teal and women! The Teal Wand has been FDA approved!  Now women can screen for cervical cancer from home - no more stirrups or speculum. You can screen using the same test as is used in the doctors office, with the same accuracy, just collected comfortably from home with the Teal Wand!

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And we didn’t just do it….we did it the right way! Everything about Teal is designed for a women’s experience. From the Wand that is designed for a woman's confidence and comfort when collecting, to the amazing Teal Medical providers, the beautiful box that welcomes you to the at-home collection, results that are delivered with a personalized note from your provider. It’s truly awesome.

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Because experience matters. And the Teal team has created an exceptional one.

This wasn’t easy. It took a herculean effort from our tiny but mighty team to make it happen. I’m filled with pride—and gratitude.

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A Collective Victory

Like any great accomplishment, this was a team effort, both within our own team, our extended partners, our PIs, our trial patients, our investors, our friends, our families, and our champions and supporters tucked in all pockets of industry and life. Thank you all so much!

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But today, three teammates deserve special recognition: Trena Depel, Megan Fitzpatrick, and Alex Millie.

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At Teal, we don’t just aim to raise the bar in women’s health—we’re resetting it. Women deserve the best, and these three held that standard at every turn: in the product design, in the FDA clinical trial, and through the entire regulatory journey.

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Designed for Women, Proven by Research

Alex took our original IDEO prototype—designed to empower women to self-collect—and refined it tirelessly through multiple iterations, guided by patient data from our pilot phase. The result? A device that delivers both comfort and confidence, that women love.

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Clinical Trial Results:

• Comfort: 94% of participants preferred Teal to the standard of care‍
• Confidence: The Teal Wand matched clinician-collected accuracy at 96%
  
  

Turns out the FDA finds these numbers impressive as well! 

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Breaking Records, Raising Standards

Now, let’s talk about the clinical trial—and the powerhouse duo behind it.

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Trena and Megan led a 16-site study, the largest nationwide U.S. trial on self-collection, and completed enrollment in under five months, months ahead of plan. That speed and success reflect their talent, the dedication of our PIs, and the eagerness of participants to advance research and innovation in women’s health.

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At Teal, we each keep a candle on our desks that reads: “She believed she could, so she worked her ass off and she did.”  No one embodies that more than Trena and Megan.

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From managing communication with trial sites, to synthesizing mountains of data, to crafting a masterful submission—what these two have accomplished is almost unimaginable. And yet Trena wanted to go even faster, submitting and receiving FDA’s Breakthrough Device Designation, knowing it would put us on an accelerated path.

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Trena and the FDA were in near-daily contact these past few months, combing through every page of a 1,600-page submission. The goal? Ensure women have an at-home solution they can trust. FDA approval means women have this trust, they know that the Teal Wand is safe and effective. Women collecting a sample using the Teal Wand have the same accurate result as clinician-collected samples.

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Thanks to Trena and Megan, women now have the clarity and the product they deserve: Same test. Same accuracy. A more comfortable way to collect—from home.

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The Teal Wand is officially FDA approved. We launch in less than a month.

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Thank you for being part of this journey. Join the waitlist—this is just the beginning

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