Mosie Baby becomes first company to secure FDA clearance for at-home intravaginal insemination
Mosie Baby becomes first company to secure FDA clearance for at-home intravaginal insemination
Follows significant increase in demand for at-home insemination
The Mosie Baby at-home fertility kit has received FDA Class II Clearance for use in intravaginal insemination (IVI).
It is now the first and only company to secure this level of approval since the FDA publicly warned in late 2021 that all at-home insemination devices needed more than Class I.
Maureen Brown, CEO and co-founder told FutureFemHealth that:
“Securing FDA clearance for the Mosie Baby Kit is a significant achievement, highlighting our dedication to safe at-home insemination.
“It sets new safety standards that others must follow in the market. As pioneers in the space, we have seen the demand for at-home insemination grow significantly since our launch in 2015. We welcome the need for strict oversight to keep people safe as they seek out low-intervention fertility tools at home to avoid high-cost, high-intervention options in-clinics.”
Fertility support needed to be easier and more accessible
Mosie Baby was originally borne out of personal experience. Maureen and partner Marc Brown were struggling to conceive.
“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 Maureen.
“Since inventing the Mosie Baby Kit in 2014, we realised we weren’t alone in our fertility journey as it’s reported that one in six people experience infertility.”
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 allows for an easy transfer and minimises 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.
Growing demand for at-home support
As more people become aware of at-home fertility support as an option, the demand for solutions is growing. Just last week we reported the news that here in the UK, Béa Fertility (an ICI at-home kit) had secured additional funding to expand and is planning a US launch.
Both of these options can be an alternative to, or a step before attempting fertility treatment, such as IVF, in a clinic setting. Home insemination kits are typically a fraction of the cost of IVF, help avoid lengthy waiting lists for treatment, and allow people to inseminate in the comfort of their own home.
Expanding to more retailers
Mosie’s FDA Clearance follows on from news in September that it had secured a $1million bridge round to help it expand into more mass retailers in the US. It’s currently available for purchase at mosiebaby.com, CVS.com or at select CVS stores nationwide, Walmart.com and optumstore.com.
Posting about the achievements of Mosie Baby on LinkedIn, Chief Growth Officer Jaime Rooney acknowledged the barriers for small start-ups as well as large organisations:
"Consumerization of healthcare" is a fun idea to talk about, but working in this industry, it is incredibly challenging to deliver upon. Traditional healthcare companies lack the flexibility and capabilities to really connect with busy, overwhelmed consumers. And companies that are consumer-centric can quickly grow disillusioned by the web of regulations and complexities in healthcare and medical devices.
Yet Mosie Baby has persisted and are already making a difference. Maureen continued:
“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.”