POP Medical given FDA nod on pelvic device

medicine, healthcare

The company has developed a new method for treating pelvic floor prolapse.

POP Medical (formerly Pro Access) has obtained approval from the US Food and Drug Administration (FDA) for marketing of its medical device for treatment of pelvic floor prolapse. 20% of the women in the world suffer from this condition at any given moment, and 30% at some time in their lives. The condition causes internal organs to exert pressure on the pelvic floor, which can lead to repeat urinary tract infections, vaginal bleeding, pain, discomfort in sexual relations, etc. The accepted treatment was formerly a hysterectomy. In recent years, solutions involving anchoring through an alternative artificial pelvic floor have been developed, but these do not last, and feature bleeding and other side effects.

The newest methods for treating the problem are based on anchoring the existing pelvic floor tissue to the tendons above it. POP Medical's products is a new method of anchoring the pelvic floor to tendons that significantly shortens the duration of treatment (15 minutes, compared with an hour or more in the current methods), reduces pain, and simplifies the treatment, thereby substantially reducing the risk incurred.

The doctor fits the device on his finger like a thimble, inserts his finger into the vagina, identifies the precise location for treatment, and moves tissue liable to be damaged during the process away from the location. Only when the device is in the correct place does the doctor release the harpoon-shaped tacks, which become attached to the tendons. When the doctor removes the device and his finger, he leaves behind surgical stitching thread that completes the anchoring process.

The product was tested on 15 women in a clinical trial in Israel. In every case, a solution for pelvic floor prolapse was achieved, with no side effects recorded.

POP Medical was founded by medical director Prof. Menahem Neuman, and has raised only a few million dollars since it was founded. The company is managed by CEO Debbie Garner, who served in various marketing positions in drug company Eli Lilly, and as a health consultant for Avelere Healthcare, a heath consultant firm that, among other things, focuses on obtaining reimbursement from insurance companies. POP was founded in the Rad Biomed incubator, and received a follow-up investment from the Triventures fund.

Published by Globes [online], Israel business news - www.globes-online.com - on August 7, 2016

Copyright of Globes Publisher Itonut (1983) Ltd. 2016

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medicine, healthcare
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