Shots:
- May Health has received CE Mark for its Anavi System to treat PCOS-related infertility based on EU & US ULTRA studies in anovulatory or oligo-ovulatory women with PCOS who failed, declined, or were contraindicated to 1L therapy
- At 12mos. (26 evaluable pts/32), 77% (20/26) ovulated (13 spontaneously & 7 after restarting 1L therapy), with a 46% pregnancy rate incl. 10 spontaneous pregnancies (7 with & 3 without restarted therapy) & 2 via ART, resulting in 6 live births
- Also, May Health is conducting the US REBALANCE IDE trial to support FDA approval, enrolling women (18-40yrs.) with PCOS who have failed, are contraindicated to, or decline 1L ovulation-induction therapies
Ref: Business Wire | Image: May Health | Press Release
Related News: Zenflow Receives the US FDA Approval for Zenflow Spring Implant and Delivery System for Benign Prostatic Hyperplasia (BPH)
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