Plexāā’s BLOOM43 platform for breast surgery launches in the U.S.

Plexāā, a MedTech company focused on improving surgical outcomes through devices and digital products, has announced the U.S. launch of its BLOOM⁴³ platform, a combination of a wearable preconditioning medical device and app developed to prepare patients for breast surgery.

The BLOOM⁴³ device, worn at home prior to surgery, uses a technique called Supraphysiological Preconditioning to boost skin resilience. Clinical trials have shown that this technique can support wound healing and help prevent post-operative complications associated with breast procedures.

“Patients always ask what they can do to ready themselves for breast surgery, and, in fact, a recent survey of 141 patients showed that the majority feel both physically and mentally underprepared, at 61% and 71% respectively,” said plastic surgeon Saahil Mehta, MD, FRCS (Plast), CEO and founder of Plexāā. “With BLOOM⁴³, women now have a way to make critical improvements to tissue health before the first incision. We designed our device, as well as its novel companion app, to empower and support patients at every step of the journey.”

According to a study published in Annals of Translational Medicine, in December 2023, wound complications can occur in up to 30% of reconstruction or implant procedures, often requiring antibiotics, hospitalisation, or reoperation.

Skin necrosis (tissue death) due to compromised blood flow remains a critical concern, and can necessitate additional procedures to remove damaged tissue, delaying healing and additional treatment, and requiring further surgeries. Together, these issues increase the likelihood of longer recoveries, higher costs, and distress for patients.

Plexāā says the BLOOM⁴³ device is the first-ever wearable to deliver Supraphysiological Preconditioning, a novel, evidence-based technique in which the device precisely heats the skin at the intended surgical site.

This preoperative procedure stimulates the release of heat shock proteins, enhancing blood flow. The Plexāā team has combined this with a thorough and evidenced-based Prehab program delivered through the companion app, which provides advice on areas such as pre-op nutrition and physical health to help patients holistically prepare themselves for surgery.

“The hardest part about having cancer is losing control. As a nine-year breast cancer survivor, my journey has included eight breast surgeries. Three of those surgeries resulted in healing complications, including skin necrosis,” said Nichole W. Owens, the first patient in the U.S. to incorporate BLOOM⁴³ prior to surgery. “By using the BLOOM⁴³ device before my most recent surgery, I felt empowered and prepared because I had done everything I could to have a successful outcome.”

BLOOM⁴³ is a fully wearable, non-invasive, drug-free device that patients place over the breast in the hours before surgery, typically the night prior.

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