Diabetes is a growing concern worldwide. In the United States, approximately one in 10 adults is living with the disease. The Centers for Disease Control and Prevention (CDC) predicts that one in three Americans could be affected by 2050. The situation is equally alarming globally. Hundreds of millions of people are at risk of developing diabetes-related complications, with diabetic foot ulcers (DFUs) being one of the most severe. These can lead to amputation if not properly managed.
Amputations can be life-threatening. Studies show that lower-limb amputations reveal low survival rates. This reality highlights the need for effective foot care solutions, especially for those with diabetes. After all, diabetic foot ulcers are especially dangerous because they often go unnoticed until it's too late.
This is where Defender comes in. The Miami-based company aims to redefine DFU care by combining rigorous engineering with beautiful design in easy-to-use products. It specializes in products like the Smart Boot™ that protect feet and enhance the user's experience. The Smart Boot™ attests to the rapid advancements in wound care technology. They're equipped with sensors that monitor activity and compliance, pressure distribution, detect imbalances, and even provide feedback on adjusting walking patterns to reduce strain.
Dr. Jason Hanft, the visionary behind The Smart Boot™, is a renowned podiatrist with over four decades of experience in lower extremity medicine, surgery, and wound care. His extensive research and clinical trials have shown that traditional DFU care methods are inadequate in regard to healing times and complete wound healing.
"We interviewed 5,000 patients, asking them why they believed their wounds weren't healing. Over 90% of them said they were physically unable to follow the prescribed care. They can't wear the devices, apply the bandages, or stay off their feet. More than 85% shared that even when they received assistance, they felt stigmatized just because of how the medical products looked. As a physician, it was eye-opening to realize how a product's aesthetic could influence a patient's willingness to use it—even to the point where some were willing to risk amputation," Dr. Hanft shares.
Frustrated, the industry expert teamed up with former Nike designer Michael DiTullo to create a product that would truly make a difference. The result was the Foot Defender®, the company's flagship device. This innovative medical product is part of the world's first smart diabetic boot. It's the first of its kind to heal wounds faster than traditional non-removable devices. Engineered with advanced technology, it offers a unique blend of biomechanical engineering, modern footwear design, state-of-the-art textiles, and advanced remote data capture. These features provide superior protection, comfort, and engagement for those suffering from diabetic foot wounds.
The Defender Smart Boot™ is clinically proven to offload 50% more pressure from the foot than any other protective boots on the market. Patients are more likely to wear it consistently with its ultra-comfortable, easy-to-use design. The Foot Defender® redistributes weight away from vulnerable areas (e.g., the ball of the foot where most diabetic wounds occur), enhancing the healing process.
The properties of the Smart Boot™ and the Foot Defender® are even more important for those who spend eight to ten hours a day on their feet, such as construction workers, healthcare professionals, or anyone in a physically demanding job who requires prolonged periods of standing and moving around.
Clinical studies have shown that over 80% of patients using the Foot Defender® healed within an average of five and a half weeks. This is an exceptional improvement compared to the typical 38% healing over 12 weeks without such intervention.
The Defender Smart Boot™ further stands out for integrating remote patient monitoring technology. Powered by Sensoria, the smart boots combine microelectronics, a mobile app, and a clinician dashboard to monitor the healing process and ensure patient compliance. The Sensoria Core device connects to the mobile app via Bluetooth, tracking the patient's adherence to the prescribed offloading protocol and recording their activity. This data-driven interaction allows healthcare providers to engage with patients remotely as well as direct engagement with the patient while monitoring compliance.
Despite the impact of Foot Defender®, Dr. Hanft and his team encountered several challenges in positioning the product at the forefront. "We first focused solely on launching the Foot Defender® in the medical distribution channels. We quickly realized this was highly fragmented and patients were having difficulty obtaining the product. We received calls daily from people asking how they could procure our product. So, we expanded by enabling a direct-to-consumer sales channel," the Defender CEO and founder explains. Foot Defender® is now available directly through Amazon, Walmart, and the company website.
Defender is currently seeking additional funding to expand its capabilities and further develop the Defender Diabetic Foot Ulcer (DFU) Patient Platform, a comprehensive disease management solution for patients with DFUs. This platform operates through the Smart Boot™ and will be integrated with the Smart Sandal, Smart Shoes, and Smart Insoles while providing a robust backend system, enabling more advanced monitoring, compliance monitoring, and patient care.
The Smart Sandal is the next available device, a follow-up product to the Foot Defender® that patients can wear around the house after their wound has healed. This sandal will also feature monitoring technology to track patient activity and provide feedback to ensure they're not overexerting themselves. Defender plans to launch the Smart Sandal in the second quarter of 2025, with additional products to follow.
Ultimately, the Defender Smart Boot™ redefines DFU care. It improves healing outcomes and addresses long-standing challenges in healthcare accessibility, empowering patients to take control of their health.
