Revolutionising Breast Surgeries with Preconditioning: The Journey from Hot Water Bottles to BLOOM43

In this case study, Plexaa, an alumnus company of the Accelerating FemTech programme, shares how their patented supraphysiological preconditioning device, BLOOM43, will ensure positive wound healing outcomes for patients undergoing breast cancer surgery. 

Overview 

Out of the 100,000 breast cancer surgeries conducted each year in the UK, one in three patients will suffer from wound complications, while one in five will require additional surgical intervention. These mean increased costs for the NHS, prolonged hospitalisation for patients, complications in their wound healing process and delays in subsequent treatments.  

A potential solution to these challenges lies in pre-operative supraphysiological preconditioning, a proactive approach that involves heating skin at the surgical site to improve blood supply. This mitigates potential wound complications such as skin necrosis, ultimately improving overall surgical outcomes. 

Plexaa is revolutionising the surgical experience for patients by addressing their holistic well-being — both mentally and physically. At the forefront of this is BLOOM⁴³, their patented wearable device designed for at-home use. This ultra-precise tool preconditions breasts before surgery by gently warming the skin and causing the release of a special group of naturally occurring proteins within the body’s cells called Heat Shock Proteins (HSPs). HSPs trigger the natural release of carbon monoxide into the surrounding tissue, increasing blood flow and preparing the site for surgery.  

The whole act of preconditioning helped me feel empowered. I felt active, like I was doing something active to improve my [surgical] outcome, and I was less of a passenger. 

Study Trial Participant

Journey 

Plexaa was founded by Dr Saahil Mehta, a Consultant Plastic Surgeon at Chelsea and Westminster NHS Foundation Trust, after discussions with colleagues regarding skin sparing mastectomies. While this procedure yields favourable aesthetic outcomes, it leaves behind delicate skin prone to necrosis, requiring patients to undergo additional surgeries that can adversely affect outcomes and survival rates. Upon discovering promising results from preoperative preconditioning trials in animals, they began similar trials with human patients. 

Initial trials focused on women undergoing immediate breast reconstruction after skin-sparing mastectomies. Patients were instructed to heat water at home to 43 degrees Celsius and use hot water bottles to heat their breasts, following protocols aligned with the animal trials. Pre-surgery assessments using laser dopplers revealed increased blood flow to the skin. At the same time, analysis of post-surgery outcomes showed a decrease in skin necrosis rates, re-operation needs, and outpatient follow-ups. 

Recognising the limitations and risks associated with using hot water bottles, Saahil set out to create a device capable of delivering preconditioning benefits effectively, consistently, and safely, which led to the creation of Plexaa and the development of BLOOM⁴³. 

Support from Accelerating FemTech 

Through the Accelerating FemTech programme, Plexaa has benefitted from invaluable expert insights, mutual learning and networking opportunities from the health innovation networks and fellow companies in the programme.  

From the value proposition workshop, they have also realised that they are further along in their business development than initially anticipated, helping to validate their achievements thus far and highlighting the areas for further growth. 

While navigating the entrepreneurial journey has been challenging, the “excellent” and “unwavering support” from Accelerating FemTech and the programme’s delivery team has been particularly rewarding for Plexaa. This has helped reaffirm that the company is on the right path and can contribute to the NHS. 

Impact/Outcomes 

• Two trials were completed, including a randomised control trial with 141 patients sponsored by the National Institute for Health and Care Research (NIHR) 
• 50% reduction in reoperation rates 
• 70% reduction in outpatient follow-up 
• 13% reduction in healing complications (e.g., skin necrosis) 
• An average of two-day reduction in hospital stays 
• Improvement in overall patient outcomes and survival rates 
• Frees up time for NHS staff and improves delivery of care  

I wish BLOOM43 was available when I had my surgery, as I would have absolutely used it.

Carly Moosah
Patient Champion

Next Steps 

In the next 12 months, Plexaa hopes to use the funds from both Innovate UK’s Biomedical Catalyst and the NIHR’s Invention for Innovation (i4i) Awards to support further clinical trials. The team is also considering post-surgery usage for BLOOM⁴³ and how the device can be further customised based on clinician and patient feedback.  

As the principle of preconditioning extends beyond specific conditions or surgeries, Plexaa is also developing an app that complements BLOOM⁴³. The platform will cater specifically to the unique needs of women undergoing surgery. They ultimately aim to create an app that comprehensively addresses surgery-related concerns across various health conditions, ultimately bridging the Gender Data Gap. 

To find out more about Plexaa and Bloom43, please visit their website. 

Accelerating FemTech helps early-stage companies, university spinouts and academic entrepreneurs focused on women’s health to gain the commercial and funding momentum they need for long-term success. The 10-week programme supports innovators to prepare for a special closed-call funding opportunity through Innovate UK’s Biomedical Catalyst, delivered alongside a collaborative learning programme and facilitated networking with key NHS and health sector stakeholders. 

Accelerating FemTech is delivered by the Health Innovation Network (HIN) South London and its partners. It utilises Innovate UK funding as part of the Biomedical Catalyst, in collaboration with the Medical Research Council. The programme builds upon the experience of running the award-winning DigitalHealth.London Accelerator, Propel and other innovator support programmes from the health innovation networks. The first cohort ran from May 2023, where alumni were awarded more than £1m in funding through the Biomedical Catalyst. The second cohort will run between 2024 and 2025. Register your interest now and learn more about Accelerating FemTech via our website.