News
Innovative menstrual cup secures FDA clearance
The US menstrual care brand Sunny has received FDA clearance for its reusable menstrual cup.
Sunny’s innovation, a reusable period cup that comes with a tampon-style applicator, has become the only menstrual cup and applicator to receive FDA 510(k) clearance.
The product is made of medical-grade silicone, as well as other reusable medical-grade materials.
The Class II Medical Device removes the barriers keeping tampon users from switching to a more sustainable period care option that is free of potentially harmful materials.
“I’m incredibly proud of our team that earned this 510k Clearance,” Cindy Belardo, co-founder and CEO of Sunny, told Femtech World.
“We know it’s a major win for female health. I hope that in seeing our journey, we validate the urgency for attention to the femtech space.”
Drew Jarvis, co-founder and CMO of Sunny, who first began innovating in period care after trying a menstrual cup in high school, said: “Menstrual cups have historically been exempt from the 510(k) process due to substantial equivalence.
“Because we invented the very first menstrual cup applicator, we had to reprove that substantial equivalence so, we had to go through the 510(k) process, which speaks to the innovative nature of our device.”
The Sunny Cup + Applicator inserts like a tampon, holds two to five times the amount of tampons and can be used for up to 12 hours at a time.
Since their launch in 2022, Sunny has sold 20,000 units, raised US$2.5m, and secured US$850k in pre-sale orders.
Looking ahead, the next big goal for Sunny is to establish a sustainable manufacturing process to keep up with the demand and orders.
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Diagnosis
Lung cancer drug shows breast cancer potential
Ovarian cancer cells quickly activate survival responses after PARP inhibitor treatment, and a lung cancer drug could help block this, research suggests.
PARP inhibitors are a common treatment for ovarian cancer, particularly in tumours with faulty DNA repair. They stop cancer cells fixing DNA damage, which leads to cell death, but many tumours later stop responding.
Researchers identified a way cancer cells may survive PARP inhibitor treatment from the outset, pointing to a potential way to block that response. A Mayo Clinic team found ovarian cancer cells rapidly switch on a pro-survival programme after exposure to PARP inhibitors. A key driver is FRA1, a transcription factor (a protein that turns genes on and off) that helps cancer cells adapt and avoid death.
The team then tested whether brigatinib, a drug approved for certain lung cancers, could block this response and boost the effect of PARP inhibitors. Brigatinib was chosen because it inhibits multiple signalling pathways involved in cancer cell survival.
In laboratory studies, combining brigatinib with a PARP inhibitor was more effective than either treatment alone. Notably, the effect was seen in cancer cells but not normal cells, suggesting a more targeted approach.
Brigatinib also appeared to act in an unexpected way. Rather than working through the usual DNA repair routes, it shut down two signalling molecules, FAK and EPHA2, that aggressive ovarian cancer cells rely on. FAK and EPHA2 are proteins that relay survival signals inside cells. Blocking both at once weakened the cells’ ability to adapt and resist treatment, making them more vulnerable to PARP inhibitors.
Tumours with higher levels of FAK and EPHA2 responded better to the drug combination. Other data link high levels of these molecules to more aggressive disease, pointing to potential benefit in harder-to-treat cases.
Arun Kanakkanthara, an oncology investigator at Mayo Clinic and a senior author of the study, said: “This work shows that drug resistance does not always emerge slowly over time; cancer cells can activate survival programmes very early after treatment begins.”
John Weroha, a medical oncologist at Mayo Clinic and a senior author of the study, said: “From a clinical perspective, resistance remains one of the biggest challenges in treating ovarian cancer. By combining mechanistic insights from Dr Kanakkanthara’s laboratory with my clinical experience, this preclinical work supports the strategy of targeting resistance early, before it has a chance to take hold. This strategy could improve patient outcomes.”
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