Plexฤฤ has launched its BLOOM43 platform in the U.S., a wearable and app designed to improve surgical outcomes for breast surgery patients through preconditioning.
Plexฤฤ, a medtech company focused on surgical outcomes, announced the U.S. launch of its BLOOM43 platform. BLOOM43 is a combination of a wearable medical device and digital app designed to prepare patients for breast surgery by improving skin resilience before the procedure.
Clinical Background and Intended Use
The BLOOM43 device is worn at home and uses a method called Supraphysiological Preconditioning to heat the surgical site, which, the company says, stimulates the release of heat shock proteins and enhances blood flow. Clinical trials have shown the technique supports wound healing and may help prevent complications such as skin necrosis and the need for reoperation.
Scope of Surgical Risk and Device Design
According to the company, breast surgeries, whether reconstructive, oncological, or cosmetic, carry risk of complications in up to 30% of cases. Issues such as skin necrosis can lead to delayed recovery, extended hospital stays, and additional surgical procedures. The BLOOM43 device is the first wearable to deliver this specific preconditioning method. It is non-invasive and drug-free, and is typically worn the night before surgery.
App-Based Support and Additional Features
The device pairs with the BLOOM43 app, which is DHAF- and ORCHA-certified and offers a range of support including pre-op nutrition guidance, personalized programs, and a community platform. The app is available globally, and the device can be prescribed in the U.S. and ordered with an HSA or FSA account.
Clinical Use and Early Adoption
Surgeons are currently prescribing BLOOM43 at San Francisco Plastic Surgery & Laser Center and Illuminate Surgery in Los Gatos, Calif. According to the company, clinical data shows the device may decrease skin necrosis risk by 24%, reduce follow-up surgeries by 50%, shorten hospital stays by 2 days, and cut outpatient follow-ups by 70%.
Patient Perspective
โThe 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,โ said Nichole W. Owens, the first U.S. patient to use BLOOM43 prior to surgery. โBy 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.โ
Company Overview
Plexฤฤ is also researching applications of Supraphysiological Preconditioning for other surgical procedures, including C-sections, orthopedic surgeries, and general and vascular operations.
Photo: Plexฤฤ
