In the time it takes to read this sentence, somewhere in the world, a limb will be lost to a wound that refuses to heal. Globally, it’s estimated that every 30 seconds, a leg is amputated due to complications from diabetes, with 85% of these procedures preceded by a diabetic foot ulcer (DFU).

Chronic wounds, particularly diabetic foot ulcers, venous leg ulcers, and pressure sores, represent a perfect storm of biological dysfunction. They get stuck in a prolonged, destructive, inflammatory phase, where the body’s own enzymes break down new tissue faster than it can be formed. The wound becomes a battleground with no victor, leading to infection, necrosis, and, ultimately, amputation. The burden falls disproportionately on the elderly, the diabetic, and underserved communities where access to specialized care is limited.

Enter Kayla Rodriguez Graff, the Co-founder and CEO of SweetBio, a Memphis-based biotech company. The company’s flagship product, VERIS, is a bioengineered wound care dressing that masterfully combines a collagen derivative, medical-grade Manuka honey, and hydroxyapatite. This isn’t just another dressing; it is designed with materials known to tackle the biggest barriers that prevent chronic wounds from healing. Imagine a sophisticated therapeutic environment designed to actively reset the wound’s biology, calming the inflammatory chaos and coaxing the body into rebuilding itself.

In an exclusive and wide-ranging interview with the Drug and Device World, Graff shared the deeply personal story that fueled this innovation, the rigorous science that validates it, and her unwavering belief that high-performance wound care should be accessible to all.

A Personal Spark and a Preventable Tragedy

For Kayla Rodriguez Graff, the mission behind SweetBio is not abstract; it’s woven into her family’s history. “My great-grandfather passed away because he had an amputation, and he had diabetes,” she recounts, her tone reflecting a mix of professional resolve and personal remembrance. “What I didn’t know until I was older is that it started with a wound.”

This revelation came later, when her brother, Dr. Isaac Rodriguez, a biomedical PhD and tissue engineer, approached her with a novel biomaterial technology. He believed it had the potential to address complex, stalled wounds. The sibling connection sparked a powerful “what if” moment. “We thought, wow, could this have helped him?” Graff says. “And when we started to unpack this,we wondered who else is impacted by this type of wound? You hear about amputations, and then you hear about diabetes prevention. But in the interim, there are millions of people suffering with wounds that lead to these consequences.”

This personal connection fueled a professional crusade. They began to ask the fundamental question: “How can you avoid such catastrophic consequences that you hear about with diabetes? And many times, it’s catching a wound early enough to help turn it around and get it closed.”

But Graff and her brother quickly identified a second, equally formidable barrier: access. “We saw that there was a problem of access. products were being created, but they were really expensive. while the technology exists, if you can’t get it, then you can’t get better.” This dual focus, on both technological efficacy and systemic accessibility, became the cornerstone of SweetBio’s philosophy. They committed to taking “top technology and bringing it down to a lower price point that’s covered by insurance so that we can make that difference.”

The Biological Black Hole of Chronic Wounds

To understand the innovation of VERIS, one must first grasp why chronic wounds are so notoriously difficult to treat. Normal wound healing is a carefully orchestrated cascade of four stages: hemostasis (clotting), inflammation, proliferation (rebuilding), and remodeling (maturing). In a chronic wound, this process grinds to a halt, typically in the inflammatory phase.

The primary culprits are enzymes called matrix metalloproteinases (MMPs). In a healthy wound, MMPs are essential for clearing away damaged tissue. But in a chronic wound, their levels become wildly elevated, creating a destructive frenzy. They don’t just break down dead tissue; they devour the growth factors and new cell structures necessary for healing. Compounding the problem is a relative deficiency of their natural inhibitors, known as tissue inhibitors of metalloproteinases (TIMPs).

This imbalance creates a proteolytic environment, where tissue breakdown outstrips repair. Multiple clinical studies have confirmed that an elevated ratio of MMP-9 to TIMP-1 is a key biomarker for wound chronicity and failure to heal. The wound is essentially digesting itself.

Adding to this complexity are comorbidities like diabetes. Diabetic patients often suffer from neuropathy (loss of sensation) and poor blood circulation. “You may not even know that you have a wound,” Graff explains. A small cut or blister on a foot with reduced sensation can go unnoticed, festering until it becomes a gateway to infection and disaster.

The VERIS Solution: Engineering Support for a Healing Microenvironment

VERIS is a solid, biodegradable sheet that synthesizes three key components:

• Collagen Derivative: A natural extracellular matrix protein that provides a scaffold for cell migration and acts as a “sacrificial substrate” for excess MMPs, luring them away from the patient’s vulnerable new tissue.
• Manuka Honey: Renowned for its potent antibacterial and anti-inflammatory properties, it also helps modulate the immune response and has been shown to support growth factor activity.
• Hydroxyapatite: A naturally occurring mineral that can bind proteins and ions, triggering cell adhesion and proliferation, and promoting re-epithelialization.

“Collagen works extraordinarily well on inflammation,” Graff notes. “And Manuka honey is this extraordinary material that helps in each stage, from inhibiting bacteria growth to reducing inflammation, and it has the potential to help in regeneration with growth factors.”

Graff adds that the problem with the Manuka honey use is: “It’s just messy, sticky and uncontrolled. Too much of it can actually be harmful to the wound. But we right-sized it, if you will, combining the two materials to incorporate their benefits and reduce their limitations.”

The result is what Graff calls a “comprehensive solution to support the wound  across the healing cascade.” These claims are backed by rigorous laboratory evidence.

In Vitro Evidence

A 2021 study provided the first deep dive into the biological mechanism of SweetBio products. Researchers investigated how the product influenced human macrophages (key immune cells) and fibroblasts (cells crucial for building new tissue).

The findings were striking. When macrophages were cultured on the SweetBio products, secretion of the destructive MMP-9 enzyme plummeted to negligible levels. Consequently, the critical MMP-9/TIMP-1 ratio was reduced by 5 times compared to negative controls and a remarkable 16 times compared to LPS-stimulated (highly inflamed) controls.

This demonstrated a powerful ability to calm the inflammatory storm. But the product didn’t just suppress the negative; it actively promoted the positive. In fibroblasts, SweetBio products triggered a significant release of pro-healing growth factors, including basic fibroblast growth factor (FGFb) and vascular endothelial growth factor (VEGF), which are essential for angiogenesis (new blood vessel formation) and cell proliferation.

This dual-action—simultaneously reducing destructive inflammation and stimulating the secretion of regenerative growth factors—suggested that SweetBio products could comprehensively unstick a stalled wound and propel it forward.

A Head-to-Head Comparison

A follow-up study in 2022 put SweetBio products to a direct test against two other commercially available wound products: a 100% collagen sheet (COL) and a 95% Manuka Honey Calcium Alginate sheet (MH).

The results were even more definitive. After 24 hours, the MMP-9/TIMP-1 ratio in the SweetBio product (referred to as BCMH in the study) group was 0.006. To put this in context:

• It was 11 times lower than the collagen sheet (0.065).
• It was 3 times lower than the Manuka honey sheet (0.018).
• It was 16 times lower than the tissue culture plate control (0.098).

This was a clear indication that the synergistic combination of materials in the SweetBio product was far more effective at controlling inflammation than any of its individual components alone.

The growth factor data was equally telling. While the high-concentration Manuka honey sheet (MH) showed cytotoxic effects and the lowest levels of growth factor expression, both the collagen sheet and the SweetBio product promoted a favorable growth factor environment. However, SweetBio products uniquely stimulated high levels of specific factors like BMP-5 and TGF-β1, which play vital roles in tissue development and regeneration. The study concluded that while both collagen and SweetBio products APIS offered a “comprehensive approach,” the significantly lower inflammatory marker ratio of SweetBio products suggested “a superior comprehensive approach to wound healing”.

Real-World Clinical Impact

Laboratory promise is one thing; healing real patients in challenging clinical settings is another. A 2023 retrospective clinical evaluation assessed the performance of SweetBio products in a real-world setting.

The study reviewed 47 chronic wounds, with 27 treated with SweetBio products and 20 receiving a varied standard of care (SOC), which included silver foams, iodine, and other collagen sheets. The results were compelling. For the wounds that did achieve closure, the average time to closure was 7.4 weeks in the SweetBio product  group, compared to 14.8 weeks in the SOC group. This represented a two-fold faster healing rate that was statistically significant.

The study’s authors were transparent about the challenges. The overall closure rates were low in both groups (26% for SweetBio product , 40% for SOC), a finding consistent with other real-world data from complex patient populations. The primary reasons for non-closure were not product failure, but systemic issues: non-adherence (missed appointments, not offloading), comorbidities, and wounds worsening beyond the study’s scope. This highlights a critical point: even the most advanced technology cannot overcome profound social determinants of health without a supportive system.

However, one case study from this evaluation powerfully illustrates the technology’s potential. A patient presented with a diabetic foot ulcer on each foot, both non-healing for over six months. The patient, who enjoyed an active life with grandchildren, was not fully compliant with offloading instructions. In a perfect within-patient control scenario, the clinicians treated the left foot with the SweetBio product and the right foot with standard of care.

Within six weeks, the SweetBio-treated wound on the left foot was fully closed, while the SOC-treated wound on the right remained open. At that point, the clinicians switched the right foot to the SweetBio treatment. After just two weeks of the new treatment, the right foot wound also closed.

Bridging the Innovation Chasm

Graff speaks as passionately about reimbursement codes as she does about cellular biology. For her, creating a brilliant product is only half the battle. “Our goal was to make this low to no cost for patients, no cost for clinics to prescribe, and save the healthcare system up and downstream expenses,” she states.

This focus on access dictated their entire market entry strategy. The most advanced wound care products are often incredibly expensive and reserved for the most severe cases, typically applied in a clinical setting. SweetBio deliberately pursued a different path. “The best path for opening access is as a wound supply,” Graff explains, “and the way that works is wound care is applied by the patients at home.”

This decision to create a product for at-home use required a relentless focus on usability. “We took a lot of notes from the pandemic when everyone learned how to do a COVID-19 test. We said, ‘OK, our products are just as simple to administer.’ We wrote our instructions and drew the pictures.” This user-centric design was then submitted to and cleared by the FDA, proving the product was safe for at-home application.

Yet, this creates a paradox. What about patients who cannot treat their own wounds due to mobility issues, cognitive decline, or simply the wound’s location? Graff identifies this as a key policy change she would love to see. “I would love to see it reimbursed to be used in the office. As of right now, you could use a high-cost product in the office or a low-cost product at home. To be able to have products like ours reimbursed for a clinician to put it on, that would make an extraordinary difference.”

The Future of Wound Care

Looking forward, Graff sees a landscape ripe for disruption. “Unfortunately, we are going to see more and more wounds with the rise in the numbers of diabetes cases and the correlation to our aging loved ones,” she acknowledges. The solution, she believes, lies in smarter, more decentralized care.

She is particularly excited about the convergence of advanced biomaterials with digital health tools. “What I’m most excited about are self-assessment and self-treatment plans where possible.” She envisions a future where affordable handheld devices using thermal imaging or other technologies can quickly assess a wound’s bacterial load and inflammatory status at a clinic or even at home.

“It would be so exciting to see those tools get in patients’ hands so that they can self-assess, work with their clinician virtually, and self-apply based on the mutually agreed treatment plan,” she says, painting a picture of a more personalized, efficient, and patient-empowered model of care. Artificial intelligence (AI) analytics could help interpret the vast amount of data from these assessments, guiding treatment decisions more precisely.

For public awareness, she advocates for a centralized, trusted source of information. “I would love to see one centralized body be the spearhead of the source of truth, whether that is the CDC or the American Diabetes Association, that says ‘we know this disease, we understand not just the physical burden, but the emotional burden that it costs.’”

And for SweetBio itself? The mission is expanding. “Our goal is that we want everyone to have access to a healthier tomorrow.” While their current product, VERIS, has unlocked significant access, Graff is already looking to the next frontier. “I get really excited to think about in 2026 and 2027 how we bring access to a better bandage that’s between that Urgent Care visit and a Band-Aid at home. So, we are thinking over-the-counter therapy.”

Furthermore, with patents across the globe, international partnerships are firmly in scope. “Since the beginning, our vision was not just to help millions, it’s to impact billions.”