PLEXāā is Bringing the Heat with Preconditioning Solution Device Bloom43

Matthew Calleja
Written by Matthew Calleja

“My journey to medicine has been unconventional, but now is the moment for PLEXāā  and Bloom43 to transform the lives of patients, and we’re determined to seize this opportunity!”

– Saahil Mehta, Founder, PLEXāā

Each cancer journey is a unique battle, fraught with both unforeseen and unseen challenges. For breast cancer patients, grappling with issues like skin necrosis means enduring extended hospital stays, delayed treatments such as chemotherapy and radiotherapy, and prolonged separation from home and loved ones due to lingering healing times.

These challenges deeply affect patients, inspiring Saahil Mehta—a Consultant Plastic Surgeon, assistant TV producer, and medical graduate—to refocus his diverse career on a singular goal: enhancing patient outcomes. He launched PLEXāā—now part of the MedTech Innovator (MTI) 2024 Cohort—with a dedication to finding a patient-centric solution, which takes the form of their pioneering device, Bloom43.

Here’s the full picture. 

Late night novelty

The journey began in 2009 during Saahil Mehta’s tenure as a house officer in plastic surgery at St Thomas Hospital. Collaborating with a breast reconstruction team, they pioneered a new approach known as skin sparing mastectomy, leaving behind a favourable skin pocket for reconstruction. 

Yet, the thinness of this surgical skin pocket to remove the breast cancer posed a significant challenge: its poor blood supply often led to a troubling complication known as skin necrosis. This setback not only prolonged healing times and hospital stays but also jeopardised timely access to critical treatments like chemotherapy and radiotherapy.

During a night shift, immersed in research papers provided by his professor, Mehta stumbled upon a breakthrough concept: Supraphysiological preconditioning. 

This method, demonstrated in lab trials with mice, involved heating the skin to 43°C the day before surgery, enhancing blood flow through the release of heat shock proteins—natural protective agents in the body.

“The trials in mice yielded incredible results. When discussing this with my professor, we decided: why not try this in humans? And so, we did exactly that.”

Inspired by these promising findings, Mehta and his team devised a simple yet effective protocol: patients would use hot water bottles to heat their breasts the night before surgery, following a carefully crafted procedure.

Their randomised controlled trials, including a significant study involving 141 patients over nearly three years, yielded remarkable results. They discovered that this preoperative heat treatment not only reduced incidents of skin necrosis but also facilitated faster healing and enabled earlier discharge, even for patients experiencing minor complications.

Blooming beyond the lab

Bloom43

Despite these successes, the challenge remained: the hot water bottle method was neither scalable nor universally safe, especially for patients with a history of radiotherapy. 

Determined to translate these findings into tangible improvements for breast cancer patients, Mehta founded PLEXāā. The focus? Developing Bloom43, the world’s first sensor-controlled wearable device. 

Bloom43 allows all women to precondition their breasts the night before surgery, with the goal of reducing wound healing complications and safeguarding surgical outcomes.

In their mission to redefine cancer care, the creators of Bloom43 focused relentlessly on the patient’s needs. They engineered a medical device that prioritised simplicity and user-friendliness, making it ideal for home use while seamlessly integrating into surgical procedures. 

“This device is our way of bringing those positive results from our trials to everybody to benefit all patience.”

Advancing cancer treatment

Eschewing a clinical appearance, PLEXāā equipped Bloom43 with advanced sensor technology to precisely regulate skin preconditioning heat, ensuring safety for individuals with delicate skin due to prior reconstructions or radiotherapy.

In just 10 months, the team achieved major milestones: progressing towards manufacturing, obtaining ethical approval for a crucial pilot trial at Stanford Hospital, and being selected for the final Medtech Innovator cohort. Working closely with W L Gore on commercial strategies, they are currently managing regulatory challenges.

“Our primary takeaway on regulations is the need for simplified processes to accelerate innovation, ensuring devices like  Bloom43 reaches patients swiftly and makes a meaningful impact on their lives.”

Inspire MedTech Change in Malta this November 

When asked for a few inspirational takeaways, Saahil Mehta offered us this advice:

“Resilience is crucial. Trust your vision, pursue it relentlessly, stay motivated, and find joy in the journey. Be adaptable as necessary.”

In this spirit, MedTech World invites you to join us from November 6th to 8th in Valletta, following the momentum of MedTech Malta.

Connect with influential Key Opinion Leaders (KOLs), engage in strategic networking, and explore funding opportunities to tackle today’s healthcare challenges.

Set against the backdrop of Malta’s stunning scenery at the Mediterranean Conference Centre (MCC), MedTech Malta is poised to ignite your imagination towards advancing healthcare progress. 

Secure your tickets today!