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Market Opportunity

Spinal Cord Injury

As explained on the site, Spinal cord injury (SCI) is a devastating and life changing medical condition. Spinal cord injury is categorized by damage to any part of the spinal cord or nerves in the Cortical Spinal Tract (CST). When these nerves are damaged, this causes permanent changes in strength, sensation and other body functions from below the site of the injury. Vertebrae are grouped into sections. The higher the injury on the spinal cord, the more dysfunction can occur. The reason that people remain paralyzed after spinal cord injury is that the CST cannot regenerate.

Market Opportunity for SCI:
Spinal Cord Injuries in Major Pharmaceutical Markets

Geographic Area New Cases Annually Chronic Cases Total Population Estimated Total Cases Source of Information
U.S.A. 78,000 1,462,725 318,900,000 1,540,725 Christopher and Dana Reeve Foundation
Canada 8,614 161,033 35,160,000 169,647 Numbers inferred based on American data
Western Europe 97,225 1,820,552 397,500,000 1,917,777 Numbers inferred based on American data
Total: 183,839 3,444,310 751,560,000 3,628,149

Market Opportunity for Other Conditions

The Promise of Axonis’s Science

Although spinal cord injury, peripheral nerve injury, optic nerve conditions, Parkinson’s, Alzheimer’s, ALS and other traumatic injury and neurodegenerative diseases are all quite different and represent different segments of the market, the type of regeneration needed to promote recovery in each of these conditions is similar. The treatment proposed by Axonis causes growth as if the nervous system was developing for the first time. Since this is the most fundamental growth in the nervous system, the Company’s technology may be applicable to all of the above listed segments and more.

Stroke

A stroke occurs when blood flow to an area of the brain is cut off. When this happens, brain cells are deprived of oxygen and begin to die. There are two types of stroke: Ischemic strokes and Hemorrhagic strokes. Ischemic strokes happen when clots form in the brain’s blood vessels or in blood vessels elsewhere in the body, and then travel to the brain and block blood flow to the brain’s cells. Hemorrhagic strokes occur when a blood vessel in the brain breaks or ruptures. Symptoms of a stroke are weakness, numbness of the face, arm or leg on one side of the body, loss of vison or dimming, loss of speech, difficulty speaking or understanding what other are saying, sudden severe headache and or loss of balance. After a stroke, the process of thinking, remembering and recognizing things called (cognition) can become challenging. The types and degrees of disability that follow a stroke depend upon which area of the brain is damaged and the severity of the damage. Generally, stroke can cause five types of disabilities: paralysis or problems controlling movement; sensory disturbances including pain; problems using or understanding language; problems with thinking and memory; and emotional disturbances. There is a stoke every 40 seconds in the United States.

Market Opportunity for Stroke:
Stroke in Major Pharmaceutical Markets

Geographic Area New Cases Annually Chronic Cases Total Population Estimated Total Cases Source of Information
U.S.A. 795,000 5,800,000 318,900,000 6,595,000 CDC
Canada 50,000 426,000 35,160,000 476,000 Ontario Stroke Network
Western Europe 990,945 7,229,539 397,500,000 8,220,484 Antonio Di Carlo, Human Economic Burdan of a Stoke / Numbers inferred based on American data
Total: 6,595,000 6,595,000 751,560,000 15,291,484

Optic Nerve Damage

The small photoreceptor cells of the retina (the inner surface at the back of the eye) sense light and transmit impulses to the optic nerve. The optic nerve from each eye carries impulses to the brain, where visual information is interpreted. Damage to an optic nerve or damage to its pathways to the brain results in loss of vision. The optic nerve can be damaged by shock, toxins, radiation, disease and trauma. Most cases of optic neuritis are caused by an autoimmune reaction to the optic nerve and the surrounding myelin. Some auto immune conditions that can cause Optic Neuritis are Multiple Sclerosis (MS), Neuromyelitis optica (NMO), Sarcoidosis, Lupus, Syphilis, and Lyme Disease. Some Optic Nerve Disorders are: Hereditary Optic Nerve Disorders (Hereditary Optic Neuropathies), Ischemic Optic Neuropathy, Papilledema, Glaucoma and Toxic Amblyopia.

Market Opportunity for Optic Nerve Damage:
Top 3 Optic Nerve Conditions in Major Pharmaceutical Markets

Geographic Area

 

Cause Cases

Annually

Total Population Estimated Total Cases Source of Information
U.S.A.

 

Optic Neuritis 2,040,960 318,900,000

 

2,623,640

 

World Health Organization & World Glaucoma Association, “Optic neuritis: Pathophysiology, clinical features, and diagnosis” – B. Osborne & L. Balcer, rightdiagnosis.com/p/papilledema

 

Glaucoma 382,680
Papilledema 200,000
Canada Optic Neuritis 225,024 35,160,000 289,266

 

Case numbers were inferred based on American Data
Glaucoma 42,192
Papilledema 22,050
Western Europe Optic Neuritis 2,544,000 397,500,000 3,270,294

 

Case numbers were inferred based on American Data
Glaucoma 477,000
Papilledema 249,294
Total: 6,183,200 751,560,000 6,183,200

Alzheimer’s Disease

Alzheimer’s disease is the most common cause of dementia. The word dementia describes a set of symptoms that can include memory loss and difficulties with thinking, problem-solving or language. Alzheimer’s is a progressive disease, which means that gradually, over time, more parts of the brain are damaged. As this happens more and more symptoms develop, becoming more sever over time. Two abnormal structures called plaques and tangles are prime suspects in damaging and killing nerve cells. Alzheimer’s has no current cure, but treatments for symptoms are available and research continues.

Cost of Care in the U.S. Annually – $259 billion
Cost of Care in Canada Annually – $10.4 billion
Cost of Care in Europe Annually – €250 billion

Market Opportunity for Alzheimer Disease:
Alzheimer Disease in Major Pharmaceutical Markets

Geographic Area New Cases Annually Chronic Cases Total Population Estimated Total Cases Source of Information
U.S.A. 471,000 5,500,000 318,900,000 5,971,000 Alzheimer’s Association.org, alzheimers.net
Canada 25,000 564,000 35,160,000 589,000 Alzheimer Society Canada
Western Europe 587,088 6,855,597 397,500,000 7,442,685 Niu H1Álvarez-Álvarez I, Et Al.  / Case numbers were inferred based on American Data
Total: 1,083,088 12,919,597 751,560,000 14,002,685

Peripheral Neuropathy

Peripheral neuropathy is a disorder that occurs when peripheral nerves malfunction because they’re damaged or destroyed. This disrupts the nerves’ normal functioning. They might send signals of pain when there’s nothing causing pain, or they might not send a pain signal even if something is harming you. This can be due to: an injury, systemic illness, an infection or an inherited disorder. Although peripheral neuropathy has many causes, one of the leading causes is diabetes, a disease that is growing in epidemic proportions in the United States.  It is estimated that 60-70% of diabetics suffer from peripheral neuropathy. Unlike other tissues in the body, peripheral nerve regeneration is slow and usually incomplete.  Other conditions that cause Peripheral Neuropathy that are not accounted for are: Chemotherapy, Lyme Disease, Charcot-Marie-Tooth disease, Guillain, Barre syndrome, varicella-zoster virus, botulism, and poliomyelitis.

Market Opportunity for Neuropathy:
Peripheral Neuropathy in Major Pharmaceutical Markets

Geographic Area

 

Cause New Cases Annually Chronic Cases Total Population Estimated Total Cases Source of Information
U.S.A.

 

Trauma 4,464,600 22,323,000 318,900,000

 

49,128,347 American journal of physical medicine & rehabilitation, foundationforpn.org,  ihpavepn.com, Neuropathy in Pre Diabetes Study, CDC
Diabetes 255,000 21,500,000
HIV 10,747 575,000
Canada Trauma 492,240 2,461,200 35,160,000 5,594,015 CDC, Case numbers were inferred based on American Data
Diabetes 28,115 2,370,460
HIV 38,000 204,000
Western Europe Trauma 5,565,000 27,825,000 397,500,000 61,237,120 Case numbers were inferred based on American Data
Diabetes 317,850 26,799,153
HIV 13,396 716,721
Total: 11,184,948 104,774,534 751,560,000 115,959,482

Parkinson Disease

Parkinson’s disease (PD) is a long-term degenerative disorder of the central nervous system that mainly affects the motor system. The symptoms generally come on slowly over time. Early in the disease, the most obvious are shaking, rigidity, slowness of movement, and difficulty with walking. Thinking and behavioral problems may also occur. Nearly one million people in the US are living with Parkinson’s disease. The cause is unknown, and although there is presently no cure, there are treatment options such as medication and surgery to manage its symptoms.

Cost of Care in the U.S. Annually – $25 billion
Cost of Care in Canada Annually – $120.4 million

Market Opportunity for Parkinson Disease:
Parkinson Disease in Major Pharmaceutical Markets

Geographic Area New Cases Annually Chronic Cases Total Population Estimated Total Cases Source of Information
U.S.A. 60,000 630,000

 

318,900,000 690,000 Parkinson’s Disease Foundation
Canada 6,600 100,000 35,160,000 106,600 UCB Canada Inc.
Western Europe 75,000

 

800,000

 

397,500,000 875,000 efpia.eu

 

Total: 141,600 1,530,000 751,560,000 1,671,600

Multiple Sclerosis

Multiple Sclerosis is a chronic, typically progressive disease involving damage to the sheaths of nerve cells in the brain and spinal cord. This damage disrupts the ability of parts of the nervous system to communicate, resulting in a range of signs and symptoms, including physical, mental, and sometimes psychiatric problems. Genetic and environmental factors are known to contribute to MS, but a specific cause for this disease has yet to be identified. Early symptoms may include numbness and/or paresthesia, mono- or paraparesis, double vision, optic neuritis, ataxia, and bladder control problems. Subsequent symptoms also include more prominent upper motor neuron signs, such as increased spasticity, increasing para- or quardriparesis, vertigo, incoordination and other cerebellar problems, depression, emotional lability, abnormalities in gait, dysarthria, fatigue and pain are also commonly seen. There is no curative treatment available for the MS at this time.

Market Opportunity for Multiple Sclerosis:
Multiple Sclerosis in Major Pharmaceutical Markets

Geographic Area New Cases Annually Chronic Cases Total Population Estimated Total Cases Source of Information
U.S.A. 104,000 400,000 318,900,000 504,000 healthline.com
Canada 26,000 100,000 35,160,000 126,000 Multiple Sclerosis Society of Canada
Western Europe 129,633 498,589 397,500,000 628,222 Underpressureproject.eu / Case numbers were inferred based on American Data
Total: 259,633 998,589 751,560,000 1,258,222

Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic lateral sclerosis (ALS) is a rare group of neurological diseases that mainly involve the nerve cells (neurons) responsible for controlling voluntary muscle movement. Voluntary muscles produce movements like chewing, walking, breathing and talking. The disease is progressive, meaning the symptoms get worse over time. Currently, there is no cure for ALS and no effective treatment to halt, or reverse, the progression of the disease.

Market Opportunity for Amyotrophic Lateral Sclerosis (ALS):
Amyotrophic Lateral Sclerosis (ALS) in Major Pharmaceutical Markets

Geographic Area New Cases Annually Chronic Cases Total Population Estimated Total Cases Source of Information
U.S.A. 5,000 30,000 318,900,000 35,000 CDC, John Hopkins Medicine
Canada 551 3,300 35,160,000 3,851 ALS Society Canada, Case numbers were inferred based on American Data
Western Europe 6,232 37,394 397,500,000 43,626 Case numbers were inferred based on American Data
Total: 11,783 70,694 751,560,000 82,477
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