For its fourth acquisition in as many years, Laborie Medical Technologies has opted to build out its gastroenterology offerings, snapping up Pelvalon and its patient-controlled device for women experiencing fecal incontinence.
Pelvalon was founded about a decade ago out of Stanford University’s biodesign program. In that time, it has racked up two back-to-back FDA clearances for its Eclipse system, which is indicated for use by women between the ages of 18 and 75 to give them more control over their own bowel movements.
The system will join the host of other devices and tools spanning gastroenterology, urology, OB-GYN and neonatal health that make up New Hampshire-based Laborie’s portfolio. Its new ownership by Laborie will help scale up the Eclipse system and bring it to more physicians and their patients across the U.S., Pelvalon CEO Miles Rosen said in a statement.
“Laborie’s mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity,” said Michael Frazzette, Laborie’s president and CEO. “Our mission is well served by the addition of Eclipse to help patients who suffer from this difficult condition.”
The financial terms of the acquisition were not disclosed.
RELATED: Pelvalon launches vaginal insert for nonsurgical treatment of fecal incontinence
The Eclipse system includes a vaginal insert that is fitted to each patient by their physician and is attached to a small inflatable balloon. Patients insert the device like a tampon or diaphragm, then use a detachable pump to inflate the balloon. The fully inflated balloon essentially blocks off the rectum, preventing stool leakage, and can be deflated at any time to allow for bowel movements, giving patients full control over their bowels.
In a clinical study that fitted 61 women with the device, 86% of participants reported improvement in their bowel control after one month of use. The same number said they’d seen a reduction in their number of unintended bowel movements during that time, with more than 40% saying that number had been slashed to zero thanks to the Eclipse system.
Additionally, the device caused no adverse events during the study period, and nearly every participant said it was comfortable and something they’d recommend to a friend.
Those study results led to the FDA’s de novo clearance of the original Eclipse system in early 2015. Less than a year later, the agency issued a follow-up 510(k) clearance for the second generation of the device, which featured new sizing tools for physicians and a trial version of the system that made it easier for patients to try it out.
RELATED: Laborie pens $239M Cogentix buyout to boost urology unit
Medtech acquisitions have become practically an annual tradition for Laborie in recent years. The most recent of these saw it purchase specialty endoscopy devicemaker GI Supply for an undisclosed amount in a deal that closed last fall.
Prior to that, in early 2020, it dropped $525 million to scoop up Clinical Innovations—which develops devices used in the neonatal ICU and labor and delivery departments—and another $239 million in 2018 to buy Cogentix Medical—maker of a neuromodulation device to treat overactive bladder and a soft-tissue bulking agent to manage stress urinary incontinence.