Introduction
Our mission at Atraxon Biotech is to offer a surgical solution for the treatment and prevention of painful neuromas. Neuromas represent one of the most painful neurological conditions worldwide.
Patients develop neuromas after nerve injury or amputation, which can have a big impact on their quality of life. It leads to overuse of pain medication, disrupted rehabilitation, loss of productive years, and high healthcare consumption with high costs involved.
Frequently Asked Questions
Neuroma’s can be a complex topic. For us, they’re our bread and butter. We selected a couple of the most frequently asked questions that we have heard along the way, and answered them for you.
A painful neuroma is a condition where damaged nerves form a tangled, hypersensitive mass. It occurs often after surgery, trauma or amputation, without the possibility to resolve spontaneously.
A neuroma develops when a nerve is partially or completely damaged, often due to injury or amputation. The formation process involves:
Initial Nerve Damage: When a nerve is severed or injured, the nerve fibers (axons) lose their original target connections. The body naturally attempts to repair the damage by encouraging axon regrowth (Fig. B + E).
Pathway Obstruction: In cases where the ends of the damaged nerve are too far apart or one end is removed (e.g., in an amputation), the axons cannot reconnect with their original target (Fig. D +E).
Uncontrolled Growth: Without a clear pathway, the axons grow randomly in an attempt to find a connection. This uncontrolled growth results in a mass of nerve tissue, known as a neuroma, forming at the injured nerve end (Fig. F).
Pain Signal Formation: The neuroma sends abnormal, confusing signals to the brain, often interpreted as pain, tingling, or burning sensations.
Chronic Nature: Once formed, the neuroma may stop growing, but the nerve tissue remains highly sensitive, causing persistent pain and discomfort.
© Atraxon Biotech 2024 - Image illustrates nerve damage, repair and neuroma formation.
Patients typically report an intense, localized pain at the site of the amputation or trauma. Also mentioned are burning, tingling, or electrical shock-like sensations.
The area has an increased sensitivity, often triggered by touch or pressure. Also, phantom limb pain, where pain is perceived in a limb that has been amputated is related to neuroma formation.
Chronic pain from neuromas severely impacts patients' daily activities, professional life, and overall well-being. A large group of amputees have a high dependency on pain medication, including opioids, with significant side effects and potential for misuse
Usually, it involves smaller nerves that are more superficial and less protected (hand and feet). About 20 - 35% of patients experiencing a nerve trauma develop a painful neuroma and 30% of these patients develop chronic pain, and subsequently creating a higher risk of disability, depression and social isolation.
Worldwide there are at least 1.000.000 new amputees/year. This number is provided by WHO/US Center Disease Control/ International Diabetes Federation. More specific there are 111.000 traumatic and vascular lower limb amputations/year in USA and 150.000 traumatic and vascular lower limb amputations/year in Europe.
Of the lower-limb amputees, 19% develop symptomatic neuromas. That’s about 1 in every 5 patients with an amputation of their lower-limb. For the upper extremity amputees, this number is about 13%, or 1 in 8 patients. 75% of amputees with painful neuroma report significant reduction in daily activities and an increased use of pain medication.
The risk increases with the number of amputations globally, particularly due to rising diabetes rates leading to diabetic-related amputations. Unfortunately, current surgical treatments have high failure rates with over 30% recurrence.
Treatment depends on the severity of the neuroma:
A) Non-Surgical Treatments:
Pain management with medications (NSAIDs, nerve stabilizers like gabapentin).
Steroid injections to reduce inflammation and nerve activity.
Physical therapy and desensitization techniques.
B) Surgical Interventions:
Excise neuroma and relocate the nerve end to reduce regrowth.
Nerve Cap (implant): Removal of the neuroma followed by capping with an implant.
Targeted Muscle Reinnervation (TMR): Redirecting severed nerve endings into nearby muscles to provide a functional target.
Regenerative Peripheral Nerve Interface (RPNI)
Centro-central Anastomosis (CCA): The axons grow in the autograft and are prevented from creating a neuroma. See figure.
The pitfalls of the current treatments are that they are time-consuming and costly, they require the involvement of a neuro- or plastic surgeon and have unpredictable outcomes. However, proper nerve management during the initial amputation can reduce neuroma formation.
© Atraxon Biotech 2024 - Image illustrates the workings of Centro-Central Anastomosis
Without treatment, neuromas can lead to chronic, ebilitating pain that affects mobility and quality of life. Patients develop a dependency on pain medications, including opioids, with potential for misuse.
Also, the rehabilitation is impaired after amputation. This delays prosthetic use or recovery, which consequently leads to diminished return to work or social activities.
Neuroma pain leads to increased healthcare costs, prolonged rehabilitation times, and lost productive years for patients.
Reducing Nontraumatic Lower-Extremity Amputations by 20% by 2030: Time to Get to Our Feet: A Policy Statement From the American Heart Association Mark A. Creager, MD, FAHA, Chair, et al. On behalf of the American Heart Association Advocacy Coordinating Committee
Molina CS, Faulk JB. Lower Extremity Amputation. [Updated 2022 Aug 22]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.