Chronic wounds are a major challenge for patients, caregivers, clinicians, and health systems. They can cause pain, infection, disability, repeated procedures, hospitalization, amputation, social isolation, and loss of independence. Yet chronic wounds are often treated as complications of other diseases rather than as a major health problem in their own right.

The cost and inefficiency of chronic wound care

The result is a field with many products but relatively few therapies approved to treat the underlying failure to heal. Meaningful progress requires more than another variation of an existing dressing. It requires patient-centered research, better clinical-development tools, and investment in treatments intended to move wounds toward durable closure.

The problem of chronic wounds

An estimated 2.5% of the U.S. population is affected by chronic wounds, including diabetic foot ulcers, pressure injuries, venous and arterial ulcers, and other hard-to-heal wounds. A 2023 Medicare analysis estimated that 10.5 million beneficiaries had a chronic wound in 2019 and placed annual wound-care spending between $22.5 billion and $67.0 billion, depending on the services included.

The burden is not distributed equally. Age, diabetes, vascular disease, immobility, access to care, and social conditions affect both risk and outcomes. Published research has also documented racial disparities in diabetic foot ulcers and lower-extremity amputation. Better wound care therefore requires attention to who can reach treatment, where treatment can be delivered, and whether study populations reflect the people most affected.

The original paper also called attention to the imbalance between the scale and mortality of chronic wounds and the resources devoted to research. It cited 2022 NIH cancer-research funding of approximately $7.6 billion and an estimate that wound-healing research received roughly one dollar for every 150 dollars directed to cancer research. Funding categories and disease comparisons are imperfect, but the disparity illustrates why chronic wounds can remain underrecognized despite their human and economic burden.

Listen to patients

Patients living with serious chronic wounds

At FDA’s 2022 Wound Healing Scientific Workshop, patients and caregivers described chronic wounds as painful, burdensome, and sometimes limb- or life-threatening. Their testimony emphasized needs that conventional product descriptions can overlook:

  • Treatments that help wounds heal and prevent complications
  • Care that is affordable and covered
  • Options that can reach patients in skilled nursing, home, rural, and other community settings
  • Treatment plans that account for individual circumstances and preferences
  • Outcomes that include pain, mobility, function, independence, and quality of life—not only wound measurements

These priorities should influence product design, clinical endpoints, study operations, and decisions about where care can occur.

Management remains essential—but it is not the endpoint

Pressure redistribution, compression when indicated, perfusion assessment, infection management, debridement, moisture balance, nutrition, and management of underlying disease are foundational. They should not be displaced by a new therapy.

The innovation gap is different: many products support or protect the wound while relying on the patient’s own impaired biology to complete repair. FDA reported in 2022 that more than 800 products, including dressings, were cleared for wound management, while no small-molecule drug was approved for a non-healing chronic-wound subtype. The agency identified only one biologic, approved in 1997, together with a small number of cell-based therapies and devices authorized for treatment.

The opportunity is to pair strong wound-management fundamentals with therapies designed and tested to address biological barriers to healing.

Why nitric oxide is relevant

Nitric oxide as a research strategy for chronic wounds

Nitric oxide is a naturally occurring signaling molecule involved in vascular tone, inflammatory and immune response, antimicrobial activity, cell proliferation, collagen formation, angiogenesis, and remodeling. Chronic wound conditions such as hypoxia, oxidative stress, infection, and impaired cellular signaling may disrupt NO production or availability.

This makes local NO delivery a scientifically plausible therapeutic strategy. It does not mean that every NO product will produce the same result or that biological plausibility establishes clinical benefit. Each formulation must be characterized, dosed, and evaluated on its own evidence.

What responsible innovation should look like

For chronic wound innovation to matter, it should be:

  • Patient centered, with outcomes that reflect healing, complications, function, and quality of life
  • Scientifically disciplined, with prespecified methods and clear separation of laboratory, observational, and clinical evidence
  • Practical, so treatment can fit the realities of wound-care settings and the lives of patients and caregivers
  • Accessible, with development plans that consider skilled nursing, home, community, and specialist care
  • Additive to good care, not a substitute for pressure relief, perfusion management, infection control, and other essentials

NOxy’s topical platform is designed to generate nitric oxide at the point of care from components combined as a foam. The company’s lead program, NOX1416, is investigational. Its safety and effectiveness have not been established, and it has not been approved by FDA.

A call for change

The field should be judged by whether more people heal, avoid complications, preserve mobility and independence, and regain quality of life. Achieving that standard will require better therapies, stronger evidence, modern trial designs, and care models that recognize the human burden of a wound.

The shift from wound management to wound healing is not a rejection of existing care. It is a commitment to build on that care with treatments capable of changing outcomes.

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