Brief quick elevator pitches for startups in 2017 portfolio class of Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. in order of most likely to exit soonest to latest…

>  OrthodontiCell = Competitor Invisilign is worth $13.7 billion.  They straighten teeth in 18 months.  We can in 6 months.  They have no provision to freeze teeth straight > we do.  Current Status =  We are completing now final animal studies at Forysyth Institute in Boston and plan to enter clinical trials the 1st half of 2018 at Tufts University and UCSF in San Francisco.

>  VascuStim – Over 1 million diabetic related amputations are expected this year alone.  Over 23 million amputations are expected by 2030.   The diabetes population is exploding rising from 108 million in 1980 to 422 million in 2014 and expected to increase by 25 to 50% more by 2030.  Vascustim through collaborations has completed clinical studies in Czech Republic, Germany, Switzerland and Mexico in more than 70 patients utilizing bioelectric microcurrent stimulation and/or stem cells.  Over 30 papers have been published by a variety of teams from around the world documenting the benefits of bioelectric stimulation in improving wound healing  A separate study was completed independently by researchers in Czech Republic demonstrating the benefit of adding selected growth factors.  Our partners in Utah for amniotic fluid membranes have documented dozens of cases of diabetic leg and foot wound healing and numerous independent studies have been published documenting the same.   The VascuStim approach is to combine specific bioelectric stimulation signals for stem cell homing, blood vessel growth, healing and tissue regeneration with stem cells and selected growth factors for healing diabetic foot and leg ulcers and for limb salvage.   In some studies in some countries such as the USA we will utilize only bioelectric stimulation and amniotic fluid membranes to get started due to regulatory constraints.  Our bench top bioelectric stimulator via our manufacturing partner in California already has FDA 510K market clearance for improving blood circulation.  Amniotic fluid membranes are already marketed under the homologous exemption by our Utah based manufacturing partner.  Current Status =  We now are launching a worldwide paid registry clinical trial at more than 30 centers with us getting paid for the product during the studies under category B designation reimbursement.

>  Second Heart Assist = Competitor Abiomed is worth $7 billion.  Our pump is beating theirs so far in every performance parameter.   Our 2nd generation chronic implant is on track to be first wireless powered device with long term protection against thrombosis and hemolysis.  Current Status > We are completing now a series of large animal studies at Tufts Medical Center and plan to apply to the FDA to begin Early Feasibility Study clinical trial 1Q 2018.    We have recruited an all-star team to lead this initiative including Dr. Leslie Miller as CMO, Jeff Donofrio as President, Dr. Navin Kapur as CTO, Dr. Mark Kroll as Senior Advisor, Dr. Mark Cunninham as Chief CardioThoracic Surgery Advisor, Dr. Samer Banihani as Chief Nephrology Advisor and Dr. Nic Chronos and Dr. Jon Sherman as Cardiology Advisors.   Jane Reedy formerly from Thoratec and HeartWare has joined our team to lead Clinical and Regulatory Affairs with assistance from Larry Stevens, a former FDA reviewer, as our lead regulatory consultant and Todd Seiger as Chief Reimbursement Consultant.

>  Stem Cell Bra =  Our stem cell homing, proliferation and differentiation bioelectric bra can increase a woman’s breast fullness 30% in 4 to 6 weeks wearing the bra for only 1 hour every other day.   Over 1 billion women worldwide would be interested in acquiring a bra that increase their breast fullness safely by recruiting their own stem cells from their own fat and bone marrow with a homing signal.  Current Status > We completed one round of successful sheep studies in Argentina with histopathology examination to verify safety.  We are now are enrolling in second round of large animal studies.  We recruited Dr. Joel Aronowitz of Cedars Sinai UCLA as Chief Medical Advisor.  His team led the first ever case of stem cell repair of a cancer stricken breast in the USA with FDA clearance.

>  HairCell = Competitor Samumed using WnT signaling technology is worth $12 billion.  They get 10% hair growth.  We expect 30%.  Current Status = We are entering clinical trials in Canada and Argentina this quarter.

>  CancerCell = Competitor Novocure reached $2 billion valuation this year.  They use bioelectric signals to jam cancer tumor communication.  Our CancerCell product has 7 part bioelectric therapy for cancer including early detection of tumors, reading tumors and custom jamming communication, cell division stop signal, blood supply starving signals, surface protein expression change so body attacks tumor – immunotherapy all followed by regeneration signals.  Current Status =  We have launched translational research studies at the Pacific Neurosciences Research Institute in Santa Monica, CA.

>  BioLeonhardt = A Leonhardt team achieved 95.7 meters improvement in exercise capacity 6 minute walk testing over placebo in a Phase II/III trial of muscle stem cells alone in treating advanced heart failure at 33 leading sites the USA.  We now are applying the combination of muscle stem cells with bioelectric stimulation, selected growth factors and other agents with repeat delivery via a micro infusion pump.  We expect now over 200 meters improvement.   CRT/ICD pacers are a $9 billion industry and they achieve only 16 to 20 meters improvement.   This technology has the potential to be the first to totally regenerate failing hearts.  Current status = we are completing animal studies at University of Utah and plan to enter clinical trials in 2018 OUS.

>  CerebraCell = Last year a Stanford team shocked the world reporting cerebracall stroke patients in wheelchairs got up and walked again after one time injections of modified stem cells to the damaged brain regions.  Our team working with the Pacific Neurosciences Institute in Santa Monica is embarking on translational research studies combining biolelectric stimulation controlled release of a stem cell homing protein with 14+ other brain regeneration promoting protein expression signals with a micro infusion pump and our CC-15 fifteen component brain regeneration composition comprised of stem cells, growth factors, amniotic fluid, selected alkaloids including tetraharmine, exosomes, Micro RNAs, nutrient hyrdogel and brain matrix.  Cerebracell has in its planned pipeline treatments not only for stroke but also for concussion, TBI, Alzheimer’s, Parkinson’s, Epilepsy and even for brain enhancement in healthy people with our Brain-N-Hance product.  Current Status > Developing a non-invasive bioelectric stimulation helmet.  Presented at Neuro Tech Leaders Forum and North Bay Innovation Summit.  Launching translational research studies at Pacific Neurosciences Institute Santa Monica.  Recruited Dr. Santosh Kesari as Chief Medical Advisor.  Developing bridges to UCLA’s Brain Institute for collaborative research.  Planning animal studies at Los Angeles Biomedical Institute and other locations.  Consulting with experts at Tufts University.   Recruited Dr. Warren Merrifield as an advisor with substantial brain diagnosis experience.   Working to file research grant applications.

> MyoStim ED – Over 322 million men worldwide suffer of erectile dysfunction.  Our bioelectric stimulation method is comprised of a simple conductive wrap connected to either a bench top or miniature bioelectric stimulator.  We believe our signals for expressing SDF-1, HGF, PDGF, VEGF, eNOS, HIF alpha, Follistatin and Tropoelastin will be more effective than other treatment options and less painful with less risk of infection the needle injections.   Current Status – We recently applied for an NIH research grant working with Dr. Nestor Gonzalez-Cadavid at Los Angeles Biomedical Research Institute that is intended to lead through translational studies in collaboration with Harbor UCLA Medical Center.

>  SkinCell Stimulator by MyoStim Skin – Well over 1 billion men and women worldwide use some product to attempt to improve the healthy youthful appearance of their facial and neck skin.   Our bioelectric stimulation method is comprised of a simple conductive mask connected to either a bench top or miniature bioelectric stimulator.  We believe our signals for expressing SDF-1, HGF, PDGF, VEGF, eNOS, HIF alpha, Follistatin and Tropoelastin will be more effective than other treatment options and less painful with less risk of infection the needle injections.   Current Status – We are in the process of launching an international clinical registry trial in multiple countries including Argentina, Canada, Mexico and Australia.

>  PancreaCell – Over 420 million worldwide suffers of diabetes.  The primary cause of diabetes is a malfunctioning pancreas exasperated by chronic inflammation.  Our PancreaCell product is designed to address both these underlying causes with a bioelectric treatment stand alone option in mild cases and a combination bioelectric + micro infusion pump + fifteen component PC-15 pancreas regeneration composition with repeat deliveries.  Current Status – We are applying to NIH in January for grant funding working with the Diabetes Research Institute at the University of Miami with Dr. Camillo Ricordi.   November of 2017 we made it to the finals of the nationwide American Diabetes Association National Innovation Pitch Contest.  We recruited Dr. Harish Kapoor as President.

>  PressureStim – Over 1.2 billion people worldwide suffer of high blood pressure.  Some estimates indicate up to 50% of all Americans suffer some form of blood pressure abnormality.  High blood pressure increases the risk of many disease states that lead to premature death.   Our team has developed a bioelectric stimulation modulation system to manage blood pressure in patients.  Current Status – Patents filed.  Searching for potential collaborative research partners in California and Utah.

>  Valvublator – Our team patented and developed the first percutaneous heart valve which today is the standard of care for hundreds for thousands of patients.   Today we have obsoleted our own invention with an even better invention.  The Valvublator helps people keep their own heart valve instead of getting an artificial or animal based implant.  The current artificial heart valve market is nearly $9 billion annually.  Cleaning, maintaining, regenerating your own heart valve is expected to open up a much larger market valued at over $15 billion annually.  The concept is to clean up and regenerate heart valves early with a catheter based procedure before the disease is so progressed that malfunction occurs.  We clean our teeth to stop plaque formation.  We need to start doing the same with our heart valves.  Our team is leading the way.   Current Status – Patents filed.  Working to build and testing first working prototypes.  Set up to do first in man studies after pre-clinical studies in Italy with Dr. Antonio Colombo.

>  LiverCell – About 50 million people worldwide suffer of liver disease.  Our bioelectric stimulation + micro infusion pump + LC-15 fifteen component liver regeneration composition we believe can be more effective than other treatment options for liver function and health recovery.  Current Status – We recruited Ben Boytor as President.  We are working now to file research grant applications and have held some meetings with the liver regeneration team at Duke University to attempt to initiate translational research studies.

> BioPace – Over 3 million people worldwide have an implanted electronic pacemaker.  The A-Fib market is estimated to be nearly $14 billion annually.   Over 400,000 deaths annually in the USA alone are attributed to electrical heart abnormalities.   All healthy people function well with a natural biological pacemaker made up of living cells and healthy conduction cells within their heart.  BioPace has developed and has patent and patent pending a pipeline of products that utilize bioelectric signaling + stem cells + growth factors + optogenetics to restore normal pacing and electrical conduction within an ailing heart.  We believe restoring your own natural heart pacing function with living cells, the way it is built in the first place, is a far better alternative to getting a steel can with an electronic circuit board, battery and steel leads in your heart.   Current Status – Working with Dr. Alonso Moreno at the University of Utah Cardiovascular Research and Training Institute we are filing multiple research grant applications and we are building and testing prototypes as well as filing new patent claims.

>  AortaCell – Our team in the 1990’s developed and patented the first and leading endovascular stent graft system for repairing aortic aneurysms without surgery.  There are over $1 billion of annual sales of these products now worldwide.   We are not obsoleting our previous invention with AortaCell.  AortaCell utilizes bioelectric stem cell homing, proliferation and differentiation signals to repair an aortic aneurysm with living cells and living smooth muscle instead of an artificial fabric and metal implant.   Current Status – We have recruited Dr. Barry Katzen, Dr. Jacob Cynamon, Dr. Sam Ahn, Dr. Leslie Miller, Dr. Juan Parodi and Dr. Harrison Lazarus to the AortaCell team.  They are leaders in the field of aortic aneurysm repair.  We are currently building and testing prototypes and plan to begin pre-clinical animal studies soon.

>  DentaCell Accelerator – Our team is leading an innovation accelerator focused on applying our core technology platform of bioelectric stimulation + micro infusion pumps + stem cell and growth factor based compositions to dentistry.  We are combining this with a commitment to personalized, functional and holistic medicine approaches in dentistry.   Current Status – We are developing products for controlling infections, inflammation, pain and accelerated healing related to dental procedures.   We have recruited Tom Newman as President and Dr. Val Kanter as Chief Medical & Scientific Advisor.  We expect to be initiating clinical trials soon.  We have established tooth pulp banking services as our first commercial product.

> EyeCell – A number of reports have come out this year demonstrating the ability of stem cell injections to recover some forms of blindness.  We believe our product which comprises a combination of a bioelectric stimulator, which includes stem cell homing capability, a micro infusion pump and our EC-15 fifteen component eye regeneration composition can be more effective than other treatment options.  Current Status – We have completed two phases of pre-clinical studies of EyeCell in human cadaver eyes and we are now moving into animal studies at the University of Utah.  We recently received animal ethics committee approval to begin the study.

> InStim – Noncommunicable chronic diseases such as inflammatory bowel diseases, cancer, diabetes, obesity, and pulmonary, cardiovascular, and neurodegenerative diseases are becoming the leading cause of death throughout the world. Most of these risk factors are closely linked to chronic inflammation, which leads to the development of these various chronic diseases.  Over 2 billion people worldwide suffer of some form of inflammation.  The market for anti-inflammatory drugs is expected to reach $106 billion by 2020.  InStim is the first therapy known that reads inflammation and custom delivers the precise bioelectric signals to express the precise correct anti-inflammatory or inflammatory cytokines in the proper sequence to promote optimal recovery, health and function.  The InStim microprocessor holds information on the ideal healing responses in people that recover well from an event that may trigger inflammation.  This is a baseline for custom bioelectric inflammation modulation.  Current Status – Patents filed.  Seeking out research partners to begin studies.

> CoroStim VibroCell – Blood clot, calcification and plaque formation on blood contact surfaces is a leading cause of death.   Thrombosis alone contributes to more than 52.8 million deaths annually according to the GBD.  The CoroStim VibroCell team has developed a vibrational harmonic resonance energy technology that it believes can stop blood clots, calcification and plaque from forming on both natural and artificial blood contact surfaces.  Blood clots have been the Achille’s Heel of long term circulatory assist support devices.   Current Status – Patents filed.  Building prototypes for testing.  Seeking out research collaborators.

> KidneyCell – Over 2 million people worldwide receive treatment for chronic kidney disease or failure.  1 in 10 people in the USA will afflicted with kidney disease.  Chronic kidney disease often triggers chronic inflammation which leads to multiple organ failure including heart failure.  Our team has developed a combination bioelectric stimulator + micro infusion pump + KC-15 fifteen component kidney regeneration composition for kidney regeneration and chronic inflammation treatment and management.  We believe that this therapy can be more effective than other treatment options.  Current Status – Filed patents.  Building and testing prototypes in our lab.  Seeking research collaborators to initiate translational research studies.

> BladderCell – Nearly 300 million people worldwide suffer of some sort of bladder control problem.  Our team has developed a combination bioelectric stimulator + micro infusion pump + BC-15 fifteen component bladder regeneration composition to regenerate failing bladders back to their original health and function.  Numerous independent studies have confirmed the ability for electrical stimulation and stem cell injections to improve bladder function.   Current Status – We recruited Laurelle Johnson as President.  We are building and testing prototypes in our lab.  We filed patent claims.  We are seeking out research collaborators.

> RegenaLung – Over 3 million people die each year from chronic respiratory diseases.  Recent studies have shown the strong potential for stem cell therapy to improve lung recovery including reducing chronic inflammation.  Our team has developed the first combination bioelectric stimulator + micro infusion pump + RL-15 fifteen component stem cell based lung regeneration composition therapy for lung regeneration.   Current Status – Filed patents.  Held potential research collaboration meetings with Cedars Sinai UCLA Dr. Barry Stripp, Mayo Clinic and University of Utah researchers.   Recruited Dr. Richard Koffler of Greenwings Biomedical as President.  Preparing to launch translational research studies.

• 3% royalty on sales of MilkStim bioelectric milk stimulation products.
• 3% royalty on sales of StimVet  veterinary products accelerator products.