Approach to regenerate inner ear sensory hair cells lays the groundwork for EarCell’s lead program for treating chronic noise-induced hearing loss
Developed by a research team that has brought numerous breakthrough innovations from concept to market leadership positions with over 400,000 patients treated to date
Consistent bioelectric protein expression, blood vessel growth and organ healing results achieved in tissue studies in multiple mammalian species and in pilot clinical studies for various applications of use of the core platform technology are now being applied for the first time in translational research studies to restore hearing.
Press Release – Playa Vista, CA & Salt Lake City, Utah –(PRBUZZ)— EarCell, a startup focused on harnessing the regenerative potential of progenitor cells in the body to restore lost hearing, announced today the launch of translational research studies at its associated laboratories in California and Utah. EarCell is incubating at Leonhardt’s Launchpads facilities in both California and Utah including research labs at BioInnovations Gateway in Salt Lake City, Utah. See the newly launched EarCell web site at www.ear-cell.comfor more information.
The EarCell technology platform designed to restore hearing is comprised of these components:
- Bioelectric stimulator with 15+ patented and patent pending signals for hearing regeneration.
- Micro infusion pump – refillable and programmable for repeat deliveries of hearing regeneration composition.
- EC-15 fifteen component hearing regeneration composition comprised of stem cells, growth factors, amniotic fluid, exosomes, Micro RNAs, nutrient hydrogel, alkaloids and matrix.
The sensory hair cells in the hearing portion of the inner ear, or cochlea, detect sound and transmit their signal to neurons that ultimately communicate with the brain. These cells are susceptible to damage, and because these cells do not regenerate spontaneously, the number of hair cells in the ear only decreases with age. Per the World Health Organization (WHO), 360 million people worldwide have moderate or worse hearing loss, with an additional 1.1 billion people at risk for hearing loss from recreational noise alone.
“The ability to regenerate hair cells within the inner ear already exists in nature. The EarCell team is harnessing the natural bioelectric trigger signals involved which include stem cell homing, proliferation, differentiation and healing to apply them in a targeted manner to hearing regeneration,” said Leslie Miller, M.D. Chief Medical Officer, Leonhardt’s Launchpads, Leonhardt Ventures and EarCell.
“Hundreds of studies have been published documenting the healing power of bioelectricity, especially specific signals, stem cells, growth factors, exosomes, micro RNAs, hydrogel, alkaloids and matrix. What is unique about this platform is combining more than 15 bioelectric regeneration signals with repeat deliveries of a mixed hearing regeneration composition with a re-fillable and programmable micro infusion pump.” states Brett Burton, Director of R&D and Startup Launches at Leonhardt’s Launchpads Utah, Inc. and EarCell. “We believe this much more comprehensive and full systems based approach to hearing regeneration will be proven out through studies to be more effective than any single gene, cell, molecule, drug or signal with single time delivery.”
“In 1985 we began collaborative research discussions with Dr. Robert Becker the author of The Body Electric. Our team completed our first stem cell organ regeneration study working with Dr. Race Kao in 1988 (published in 1989 in The Physiologist) and published our first bioelectric regeneration paper in Circulation with Dr. Shinichi Kanno in 1999. Starting in 2000 we began studies combining bioelectric stimulation with injections/infusions of stem cells and growth factors. We believe no other team has developed as much experience and cumulative knowledge in this combination therapy for organ regeneration as we have. We are now embarking on applying this core platform to hearing regeneration with the strong confidence coming from more than 33 years experience.” states Howard J. Leonhardt, Lead Inventor, Executive Chairman & CEO
“We have assembled an all-star team to advance this technology forward. We soon will announce some research study collaborations with major universities. We look forward to sharing soon data from well controlled studies designed to prove out the safety and efficacy of this technology platform for hearing regeneration,” states Ken Evans, President EarCell
EarCell was founded in 2016 to translate the breakthrough work in the combination bioelectric stimulation and repeat deliveries of a mixed stem cell and growth factors based organ regeneration composition developed by its scientific founders, Howard Leonhardt and Dr. Jorge Genovese into new treatments, where controlled tissue regeneration with locally delivered bioelectric stimulation signals, stem cells and growth factors could have profound therapeutic potential. The company has licensed foundational patents from inventors Howard J. Leonhardt and Dr. Jorge Genovese.
What Is Does Bioelectric Stimulation Do?
Our patented and patent pending bioelectric stimulation signals do the following:
- SDF-1 = stem cell homing signal, promotes blood vessel maturation
- IGF-1 = promotes DNA repair and regeneration.
- EGF = promotes regeneration.
- HGF = promotes blood vessel growth and regeneration.
- PDGF = stem cell homing signal, promotes blood vessel formation, promotes regeneration.
- VEGF = promotes blood vessel formation.
- HIF 1 Alpha = promotes blood vessel formation.
- eNOS = dilates blood vessels.
- Tropoelastin = promotes improved elasticity of tissues.
- Follistatin = promotes regeneration particularly of muscle.
- GDF-10 + 11 = promotes regeneration particularly of neuronal cells and nerves.
- IL-1, 3, 6, 9 = helps manage healing and inflammation.
- Proliferation = multiples recruited and injected stem cells.
- Differentiation = converts recruited stem cells to useful local tissue.
EarCell is developing a combination bioelectric, stem cells and growth factors therapy designed to activate progenitor cells within the body to restore healthy full hearing. Our lead program is designed to re-create sensory cells in the inner ear to treat chronic noise induced hearing loss, which affects over 30 million people in the U.S. alone. www.ear-cell.com ;
ABOUT LEONHARDT’S LAUNCHPADS:
Leonhardt’s Launchpads was founded in 2008 in Santa Rosa and expanded to Santa Monica in 2013, Salt Lake City in 2015 and Playa Vista in 2017 serving as a innovation and startup accelerator focused primarily on organ regeneration and recovery technology breakthroughs. It is the accelerator unit of Leonhardt Ventures (Leonhardt Vineyards LLC DBA Leonhardt Ventures) founded in 1982 and formed into a California LLC in 2005 which is the commercialization outlet for founder and inventor Howard J. Leonhardt’s inventions. Howard Leonhardt has 21 issued U.S. patents and dozens more patent claims pending currently at the USPTO. Leonhardt inventions have been used to treat more than 400,000 patients to date. Leonhardt is most well noted for the invention of predictably compliant cardiovascular balloon catheters in the 1980s, stent grafts and percutaneous heart valves in the 1990’s and bioelectric and stem cell organ regeneration devices and therapies since 2000. The Leonhardt’s Launchpads business is to accelerate each organ specific startup through first-in-man studies and then seek a strategic partner.
Please click here for answers to Frequently Asked Questions related to EarCell https://ear-cell.com/faq/