The
"Brain Saving Helmet"

Revolutionary Combined Modality Therapeutic Approach
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Neuroinflammation in traumatic brain injury: A chronic response to an acute injury

Traumatic brain injury is a great unmet medical need.  The primary phase of TBI causes significant necrotic death but due to the acute timeline, treatment options during this phase is very limited. However, significant damage occurs during secondary cell death due to neuroinflammation. Secondary cell death is instigated by excitotoxicity, blood-brain barrier breakdown, oxidative stress, and inflammation. Inflammation is a major contributor to secondary cell death and a likely therapeutic target through anti-inflammatory mechanisms. Targeting specific factors, proteins, genes via targeted specific bioelectric stimulation signaling and utilizing stem cell therapy, such as MSC, growth factors and selected alkaloids treatments, to target anti-inflammatory responses could produce better therapeutic outcomes.  CerebraCell believes real time monitoring of TBI neuroinflammation and real time customized bioelectric, stem cell and growth factors therapy is necessary to improve clinical anti-inflammatory treatments and thus TBI recovery outcomes.

Sequenced approach to treatment…

For Stroke, TBI and Concussion…

Time is brain.

CerebraCell In the Field

1. Rapid portable diagnosis.
2. CerebraCell portable one button easy to use non-invasive “Brain Saving Helmet”

Unlocking the Power of Precise Bioelectric Signaling, Stem Cells and Selected Support Agents to Regenerate and Improve Brain Function

Focused on Reversing Damage from Stroke, Traumatic Brain Injury and Concussion and Improving Brain Cognitive Function
Revolutionary Combined Modality Therapeutic Approach

1. Comprehensive accurate portable EEG.
2. Bioelectric stimulation control of stem cell homing, proliferation and differentiation as well as new blood vessel growth and controlled expression of dozens of brain regeneration promoting proteins.
3. Re-fillable micro infusion pump.
4. Fifteen component proprietary CC-15 brain regeneration composition – stem cells, growth factors, exosomes, micro RNAs, selected alkaloids, engineered hydrogels and matrix.
5. Implantable micro implants that communicate with external stimulator generators and EEG analysis.
6. Customized real time bioelectric inflammation modulation and management.

CerebraCell in The Clinic

If the non-invasive “Brain Saving Helmet” after repeat treatments has not restored complete cognitive function then…

1. Micro implants or implantable pacing infusion leads are implanted into target brain regions identified from comprehensive digital analysis.
2. Implants are connected to micro stimulator and micro pump.
3. Micro stimulator sequences protein expressions SDF-1, IGF-1, HGF, EGF, PDGF, VEGF, eNOS, HIF 1 alpha, Activin A+B, Follistatin, Tropoelastin, GDF-10, GDF-11, stem cell proliferation, stem cell differentiation to brain tissue control and Neurogen 3 to affect brain regeneration.
4. Micro infusion pump is refilled and periodic intervals with stem cell based cocktail mix composition comprised of stem cells, growth factors, amniotic fluid, selected exosomes, selected micro RNAs, selected alkaloids such as harmine, tumeric, engineered hyrogels and brain matrix.

SDF-1 and PDGF are powerful stem cell homing cytokines that are produced on demand by our patented bioelectric stimulation signaling. These signals can be delivered to target brain tissue regions either non-invasively, invasively via a pacing lead or via micro implants.

1963

The first to use chronic depth stimulation as a therapy in motor disorders was Natalia Petrovna Bekthereva, neuroscientist at the Institute of Experimental Medicine and the Academy of Medical Sciences in Leningrad. In 1963 she published a work on the use of multiple electrodes implanted in sub-cortical structures for the treatment of hyperkinetic disorders (Bekthereva et al., 1963). However, since her papers were written in Russian, her works were not well known around the world. In her “therapeutic electro-stimulation,” as she named this method, she used “electric stimulation with high-rate pulses of suprathreshold current,” achieving excellent results (Bekthereva et al., 1975).

1999

Leonhardt research team collaborator Dr. Shinichi Kanno publishes in CIRCULATION the Journal of American Heart Association first paper on bioelectric limb regeneration via controlled expression of proteins such as VEGF.

2001

Leonhardt leads team that completes first ever non-surgical stem cell repair of human heart in The Netherlands with Dr. Patrick Serruys.   Team went on to complete, publish and present Pilot, Phase I, Phase II and Phase II/III study results working with 33 centers in the USA and 6 centers OUS.   84% of treated patients improved or did not decline.  Only 16% of treated patients declined.  69% of control or placebo patients in these same studies worsened in heart function.

2007

Howard Leonhardt and noted bioelectric regeneration research Dr. Jorge Genovese formerly from the University of Utah join forces as co-inventors and begin filing numerous patent application claims together for bioelectric based organ regeneration and recovery.

2015

Dr. Giorgio Lofrese and colleagues in Italy publish on the importance of IGF-1 in brain injury recovery – https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4568328/

2016

Leonhardt and Genovese filed provisional patent application for bioelectric stimulation controlled release of IGF-1.

Leonhardt’s Launchpads Utah, Inc. with CerebraCell are accepted into the BioInnovations Gateway USTAR laboratory in Utah with access to over $30 million of research lab equipment and resources and subsidized research lab space.

CerebraCell Utah lab team lead by Michael Angerbauer tests out various brain helmet designs for brain stimulation.

Leonhardt and Genovese filed provisional patent application for CerebraCell “Brain Saving Helmet”.

Stanford team (not associated with CerebraCell) led by Dr. Gary Steinberg published landmark study demonstrating remarkable recovery of some brain stroke patients treated with modified stem cells.

CerebraCell announces collaboration with HeartScore to develop a total stroke management program.

CerebraCell presents at Neuro Tech Leaders Forum San Francisco.

Leonhardt team creates new CerebraCell unit focused on this area called CerebraCell Brain-N-Hance.

2017

Leonhardt and Genovese file new series of patents focused on organ regeneration with combination therapies including brain regeneration.

Dr. Santosh Kesari Director of Research at the Pacific NeuroSciences Institute in Santa Monica, CA joins CerebraCell as Chief Medical & Scientific Advisor.

MIT team reports wireless deep brain stimulation – “Traditional deep brain stimulation requires opening the skull and implanting an electrode, which can have complications. Secondly, only a small number of people can do this kind of neurosurgery,” says Ed Boyden, an associate professor of biological engineering and brain and cognitive sciences at MIT, and the senior author of the study, which appears in the June 1 issue of Cell. CerebraCell team reaches out to them to try to initiate research collaboration.

CerebraCell creates subsidiary CerebraCell Concussion focused on concussion recovery.

Leonhardt files series of patent claims for bioelectric inflammation management including brain inflammation.

CerebraCell Team

Howard J. Leonhardt
Executive Chairman & CEO

Dr. Santosh Kesari
Chief Medical Advisor

Dr. Leslie Miller
Chief Medical Officer

Dr. John Langell
Chief Innovation Advisor Utah Lab

Tuan Hoang
Chief MicroPump Engineer

Dr. Thomas Ichim
Chief Stem Cell Scientist

Dr. Stuart K. Williams
VP Biologics Research

Dr. Jorge Genovese
VP Bioelectrics Research

Brittany Brown, CPA
Interim Chief Financial Officer

 

Alex Richardson
VP Engineering and Product Development

Dr. Brett Burton
Director of R&D Utah Lab

Brian Hardy
Director of Marketing

Stephan Kann
CFO

Kelsie Fortner
Staff Neuro Scientist/Grant Writer

Michael Angerbauer
Chief BioEngineer Utah Lab

Dr. Scott Marland
Engineering Consultant Utah Lab

Jeremy Koff
VP Business Development and Strategy

 

Michael Williams
Chief Science & Technology Research Advisor

Kevin Arnal
Catheter Pacing Infusion Lead Engineering Consultant

David Robinson
Business Development Advisor

Paul Norman
Business Development Advisor

Dr. Dinesh Patel
Board Director and Senior Advisor

Kapil Sharma
Staff BioEngineer/Grant Writer

Christian Oveson
Staff BioEngineer

Sejal Choudhouri
Staff BioEngineer/Grant Writer

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CAUTION Disclaimer and Warning: Products described on this web site are in early stage development and are not yet proven safe or effective in statistically significant controlled clinical studies. Any statement or phrases implying efficacy or safety in any form are considered modified by “intended to” or “designed to”. Investigational use only in countries where investigation is permitted by law and proper filings have been made and appropriate regulatory clearances have been granted. Any use of the product(s) must be in an authorized clinical study with institutional review board (ethics committee) approval and proper patient consent procedures followed. For other countries product is only available for laboratory investigation by credentialed institutions and investigators with proper clearances with a research agreement in place with a study sponsor. NOT AVAILABLE FOR SALE.