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MOSIE BABY BECOMES THE FIRST COMPANY TO RECEIVE FDA CLEARANCE FOR AT-HOME INTRAVAGINAL INSEMINATION
AUSTIN, Texas, Dec. 6, 2023 /PRNewswire/ -- Mosie Baby, a pioneering at-home fertility care company, has secured FDA Class II clearance for its Mosie Baby Kit making it the first and only FDA-cleared over-the-counter kit for use in intravaginal insemination (IVI). The kit was created to support those who are unable to conceive with intercourse or for whom intercourse is not an option. Following its FDA 510k Class II clearance, Mosie Baby looks forward to expanding access to its Mosie Baby Kit which was determined to be "substantially equivalent" to a predicate device used in clinically administered intrauterine insemination (IUI).
Designed to be used with either a fresh or cryogenically frozen donor semen sample, each Mosie Baby Kit includes two patented syringes, which are specifically designed for at-home insemination, and two proprietary collection cups that were created for semen collection. Mosie Baby's syringe features a patented barrel-free tip and slit opening which optimizes transfer while minimizing waste, while its collection cup has a proprietary design that supports maximum collection. As part of Mosie Baby's FDA Class II clearance, the Mosie Baby Kit was put through rigorous clinical and technical testing, including Human Sperm Survival Assay, vaginal irritation testing, and biocompatibility testing. Through these tests, Mosie Baby validated that the device is non-cytotoxic, non-irritating, non-sensitizing, and free from microbial contamination.
"Nearly 10 years ago, my husband and I were devastated by a diagnosis of unexplained infertility and were desperate for options that were safe, financially accessible and easy to use at home," said co-founder and CEO Maureen Brown. "Since inventing the Mosie Baby Kit in 2014, we realized we weren't alone in our fertility journey as it's reported that one in six people experience infertility. To date, we're very proud to share that Mosie Baby has helped more than 100,000 families inseminate from the comfort of their own home. We are now thrilled to offer our device as an FDA reviewed option for families looking to inseminate at home."
"The recent Mosie Baby clearance means hundreds of thousands of underserved people now benefit from an at home option. The technology adheres to the highest FDA recognized test standards and is supported by robust clinical performance testing. The team took the time and care to manufacture a quality product. I am delighted to see it become accessible to countless future parents on their fertility journey. The team at Mosie Baby is on a path to becoming the at home gold standard fertility option." - Kwame Ulmer, Managing Partner at MedTech Impact Partners and former Deputy Director at FDA.
The Mosie Baby At-Home Insemination Kit (MSRP: $129.99) is available for purchase at mosiebaby.com, CVS.com or at select CVS stores nationwide, Walmart.com and optumstore.com. The kit will launch with additional retailers and healthcare partners in 2024. For more information, please visit mosiebaby.com.
About Mosie Baby
Mosie Baby is the developer and inventor of The Mosie Baby Kit, a groundbreaking at-home insemination kit featuring the patented Mosie syringe. Mosie is the first syringe designed, patented and now FDA-cleared specifically for at-home intravaginal insemination.
Mosie Baby is on a mission to empower people with the tools they need to grow their family on their own terms. Their vision is to create a safe and inclusive community for those looking to conceive by opening up conversations around conception while bringing dignity, accessibility and confidence to the process of inseminating at home.
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SOURCE Mosie Baby