Our Approach

Hearing and Beyond

Hearing and Beyond

Reversing degenerative damage to cure hearing loss

Frequency is developing progenitor cell activation (PCA™) therapies, innovative disease-modifying products that temporarily activate cellular regeneration at specific sites in the body for unprecedented healing benefits. Frequency’s initial focus is on chronic noise induced hearing loss.

 

Hearing Function

Humans develop their sense of hearing in utero and it is one of the first senses that babies engage to learn about the world around them. Hearing occurs when sound waves enter the ear canal and displace the tympanic membrane (ear drum). This energy is transferred to the three tiny bones within the middle ear, called the ossicular chain. The last bone in the chain, called the stapes, presses on the oval window membrane then transfers energy to the cochlea.

The cochlea (Greek for snail) is the specialized portion of the inner ear that detects sound. Within the cochlea lies a sensory epithelium, called the organ of Corti, which sits atop the basilar membrane that vibrates in response to sound. The organ of Corti is arranged in a precise manner to detect high frequencies in the base all the way to low frequencies in the apex.

The organ of Corti contains tiny sensory cells that are commonly called “hair cells” because they bear microvilli bundles that bend in response to sound pressure. These hair cells come in two highly specialized types:

    • OHCs, or outer hair cells, that appear as three distinct rows and act as acoustical pre-amplifiers. Any loss of these cells results in approximately 50dB of hearing loss

  • IHCs, or inner hair cells, which are organized in a single row and are responsible for converting the detected sound signal into an electrical impulse. Neurotransmitters are then released from the IHCs to relay this message to the auditory nerve.

In adult mammals, the hearing organ is incapable of spontaneously restoring lost or damaged hair cells, making hearing loss a permanent effect.

Anatomy of the Ear



Organ of the Corti within the Cochlea

 

Chronic Noise Induced Hearing Loss

The industrial revolution was an era that brought many life-changing innovations to our world, but it also introduced an ever-growing level of noise pollution that has had a detrimental effect on our hearing. According to the World Health Organization, over 5% of the world’s population suffers from disabling hearing loss, and not just the elderly. Untreated hearing loss in working-age adults costs the U.S. more than $56 billion in annual productivity. Chronic noise induced hearing loss, the focus of our lead program, affects around 48 million people in the U.S. alone. Hearing loss affects these working age adults in multiple ways, within both personal and professional situations. Since we correlate hearing loss with aging, many younger people who suffer from hearing loss go undiagnosed and untreated due to the stigma associated with the condition.

Hearing loss caused by prolonged exposure to excessive noise can be attributed to many professional environments, such as heavy construction sites or military training. However, every day loud noises such as a busy subway or weekend concert can have a large impact on hearing as well, with noticeable differences the further away one goes from busy urban areas. These situations affect people of all ages, indicating hearing loss as a wide-spread issue.

Most hearing loss results from the loss of key cells in the inner ear, called hair cells, which are necessary to convert sound waves into nerve impulses. In adult mammals, unlike birds or reptiles, these cells do not spontaneously regenerate, although progenitor cells capable of regenerating hair cells remain present in the ear.

Our breakthrough therapy uses a proprietary combination of small-molecule drugs to cause inner ear progenitor cells to multiply and create new hair cells. Because we are utilizing small molecules, our therapy can be easily administered by direct injection into the middle ear where it crosses the round window membrane to enter the cochlea, a common delivery method for other inner ear medicines. Unlike hearing aids or cochlear implants, our therapy should restore natural hearing function. And unlike cochlear implants, our therapy does not require an invasive surgery.

Hearing Loss Affects Nearly 1 Billion People Worldwide

 

Frequency targets and activates dormant progenitor cells to regrow human hair cells

 

Clinically Established Injection Procedure

Frequency will use a clinically established procedure to inject small molecules in a slow-release gel into the middle ear during a three minute office procedure. Intra-tympanic injections are widely used for steroids in a high volume ENT procedure under an existing CPT code.

Frequency’s non-invasive, simple injection could have a profound effect on the people who suffer from chronic hearing loss.

 

 

Other Potential Indications

Frequency is focused on a very lucrative and large unmet clinical need: regenerating hearing in humans, a feat that has yet to be conquered during human history. But we’re not stopping there. By validating the hearing functional improvements our platform accomplishes, we’re also validating a whole new therapeutic approach: employing small molecules targeted to specific sites in the body to heal numerous cellular maladies and deficiencies. While our initial focus is on chronic hearing loss, a potential $20 billion market with no effective therapeutic solution currently in existence, our Progenitor Cell Activation platform has widespread potential for other applications ranging from skin-related diseases, muscle regeneration and gastrointestinal diseases.