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CLICK on image to see VIDEO of BioLeonhardt Heart Regeneration with Bioelectric Stimulator + Micro Infusion Pump
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2016 Progress Milestones
Heart and Cardiovascular
BioLeonhardt Heart Regeneration Video > https://vimeo.com/170229378
- Won $150,000 USTAR UTAG grant for BioLeonhardt for heart regeneration studies working with the University of Utah and Dr. Amit Patel.
- Developed protocol for progressive aggressive limb salvage for MyoStim Peripheral, EndoCell and Leonhardt-Wetling with use of the Cardiobridge or Second Heart aortic pump. Preparing to enter clinical trials OUS.
- Develop pre-clinical study plan with Harbor UCLA for AortaCell aorta regeneration studies.
- Recruited Dr. Juan Parodi, Dr. Barry Katzen, Dr. Harrison Lazarus and Dr. Jacob Cynamon to AortaCell aorta regeneration team.
- Filed CoroStim patent for utilizing vibrational energy to prevent clot, plaque, vegetation, and calcification formation on blood contact surfaces. Applying in particular to heart valves and LVADs.
- The Leonhardt's Launchpads team developed a full 80 page business plan for aorta positioned circulatory assist pump that won an engagement letter offer from WR Hambrecht & Co. to raise $50 million in stages.
- Leonhardt Launchpads Utah, Inc. has launched Second Heart focused on developing a pipeline of aorta positioned chronic circulatory assist pumps with wireless power. Firm has filed two patents and has lined up licensing of complimentary pioneering patents from inventors at CalTech, in Florida and in Israel.
- Led by Dr. Leslie Miller our Chief Medical Officer held investigator meetings at the American College of Cardiology and Heart Failure Society of America Annual Meetings attended by more than 20 U.S. leading center heart failure department chairs. The primary purpose was to design Phase I and II clinical trials for aorta positioned circulatory assist for acute de-compensating heart failure patients. This was followed by a pre-submission dialogue with the FDA on clinical trial planning.
- Prepared translational study protocol for BioPace biological pacemaker.
- The Leonhardt team led by Henk Abbink our EVP of Intl. Market Development and Howard Leonhardt had a number of meetings with Wetling Denmark and laid out a plan to introduce their wireless microcurrent product first into the North American market for treating diabetic foot ulcers via a joint venture Leonhardt-Wetling JV. In 2014 the team completed and published a 47 patient clinical trial for treating diabetic foot ulcers in Germany and Switzerland. Results = 95% healing a 8 weeks all 47 patients. CLICK HERE FOR LINK TO PUBLISHED STUDY > http://europepmc.org/abstract/med/24373098
- HeartScore developed precision care heart failure and stroke recovery programs based on genomics and high fidelity monitoring.
- HeartScore working with CerebraCell filed patents for 'brain saving" helmet a one button system helmet that is envisioned to be in all public places just like defibrillators are today to minimize brain damage from strokes.
- Valvublator filed patents for catheter based heart valve decalcification and regeneration and developed a translational study plan.
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CerebraCell 14 electrode brain regeneration and enhancement helmet.
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BRAIN
- CerebraCell filed an $80,000 grant application with the USTAR Technology Acceleration Program which is still pending.
- CerebraCell built and tested prototypes for brain regeneration including a 14 electrode brain helmet with highly sensitive and signal transmission accurate electrodes.
- CerebraCell presented at the Neuro Tech Leaders Forum in San Francisco October 24th and 25th.
- CerebraCell is preparing a grant application for the NIH Brain Initiative to be filed January 6th for stroke recovery. We have had two meetings with the NIH program director in charge of this area to gain guidance on the right submission.
- CerebraCell met with officials connected with the NFL to discuss use of our technology for concussion recovery. We have Dan Marino Hall of Fame NFL quarterback signed aboard as an advisor.
- CerebraCell has developed a product for brain function enhancement and memory improvement. We had a brief meeting with Bryan Johnson that provided $100 million in funding to Kernel for brain enhancement technology development at the Neuro Tech Leaders Forum and are working to establish a collaborative research collaboration forward.
- CerebraCell working with HeartScore developed and filed a patent for a "brain saving" helmet for minimizing brain damage following a stroke. The vision is that these simple to use helmets will be in every public place just like defibrillators are today ready for use by anyone with one button.
- Neuro Scientist Kelsie Fortner working out of Leonhardt's Launchpads Utah for CerebraCell developed research plan for traumatic brain injury recovery and is preparing to file USTAR, SBIR and NIH grant applications.
- CerebraCell held meetings with the brain research teams at UCLA and The Buck Institute in California and is exploring further research collaboration with both teams.
- Signed aboard Dr. Santosh Kesari renowned Neuro Surgeon from Southern California as Chief Medical Officer for CerebraCell and CancerCell.
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OrthodontiCell Prototype
Design Candidate
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COSMETIC AND PERSONAL CARE
- Completed pilot study in sheep in Argentina with Dr. Jorge Genovese for Stem Cell Bra. 20% breast tissue growth with only 1 hour of stimulation every other day for 4 weeks. Only 3 of our 12 patented signals used.
- Launched HairCell hair regeneration clinical trial in Mexico. Expect results by year end.
- HairCell recruited Derek Kahn to serve as President.
- HairCell was featured in Follicle for Thought - http://www.folliclethought.com/haircell-interview-exclusive/
- Developed protocol and sourced face interfaces for SkinCell Stimulator by MyoStim Skin for skin regeneration. Completing pre-clinical safety studies. Lined up a number of pilot clinical trial sites.
- Developed collaboration with Dr. Nestor Cadavid-Gonzalez at LABioMed Harbor UCLA for development and testing of MYOSTIM ED erectile dysfunction product. Developed translational research plan.
- Filed two patents for OrthodontiCell for accelerated tooth movement and stabilization.
- Recruited Dr. John Marchetto renowned orthodontist surgeon to help lead OrthodontiCell as President and Chief Medical Officer.
- Developed research collaboration with Tufts University for OrthdontiCell translational studies and recruited Dr. Susan Baloul as Chief Orthodontist Advisor.
- Filed $100,000 TCIP grant for OrthodontiCell studies on October 31, 2016.
- Developed stimulator for DentaCell and OrthodontiCell and we are building and testing prototypes in our Utah lab this fall.
- Arranged FDA certified lab to handle dental tooth pulp storage (stem cell storage) for DentaCell and we are preparing for market launch as soon as the DentaCell mouth stimulator has FDA clearance.
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CLICK ON IMAGE ABOVE or here for VIDEO > https://vimeo.com/176658874 EyeCell incubating in Leonhardt's Launchpads Utah, Inc. won a $125,000 Technology Acceleration Program grant to for eye regeneration studies.
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Dr. Camillo Ricordi - Chief Advisor PancreaCell
Director Diabetes Research Institute
Pancreas Regeneration Research Discussions
with Howard Leonhardt Executive Chairman
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MAJOR ORGAN REGENERATION
- Won $125,000 USTAR Technology Acceleration Program grant for EyeCell for eye regeneration studies.
- Recruited Dr. Patrick Johnson, Dr. Y. King Liu, Dr. Dinesh Patel and Dr. Edward Kondrot to join EyeCell research team.
- With introductions made by Dr. Dinesh Patel our advisor we reached out to a number of University of Utah eye regeneration researchers for EyeCell and met with Dr. Brian Jones and learned of his rabbit model for retinal degeneration that we may use in upcoming studies.
- We reached out and met withg Dr. M. Gharib at CalTech for collaborative research on EyeCell. He holds a number of related patents and has built and testing numerous micro eye pumps.
- We recruited Tuan Hoang CEO of Fluid Synchrony, our primary micro pump supplier, to join the EyeCell team as an engineering and product development advisor.
- We filed patents for pancreas cancer tumor stoppage and pancreas regeneration for PancreaCell.
- We recruited Dr. Camillo Ricordi Director of the Diabetes Research Institute as Chief Scientific and Medical Advisor to PancreaCell and met with him and his team twice this year so far in Miami to advance forward a clear translational research plan that starts with studies using cadaver pancreas tissue.
- We recruited Dr. Nicholas Chronos as Vice President of R&D for PancreaCell.
- PancreaCell presented at PANCREAS 2016 in Chicago in October.
- We presented PancreaCell technology in person to the Health & Wellness Director at Apple Computer Corp. in Cupertino, CA. Steve Jobs their founder died of pancreas failure.
- RegenaLung met with the lung regeneration research team at Cedars Sinai UCLA and laid out a plan to file new grant applications together.
- RegenaLung recruited Richard Koffler to serve as President.
- BladderCell launched for bladder regeneration and recruited Laurelle Johnson to serve as President.
- LiverCell launched for liver regeneration and recruited Ben Boytor to serve as President.
- EarCell launched for hearing regeneration and developed a product development plan.
- KidneyCell launched for kidney regeneration and developed a product development plan.
- We filed patents for BioLeonhardt Whole Body regeneration and developed a product development plan. A video was created to show the vision for this technology platform.
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Renowned Neuro Surgeon Dr. Santosh Kesari Chief Medical Officer CerebraCell and CancereCell. Chief of Neuro Oncology John Wayne Cancer Institute Providence St. Johns Hospital Santa Monica, CA. Former Chief Neuro Surgery UC San Diego.
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CANCER
- CancerCell filed patent application for a bioelectric signal to stop cell division.
- CancerCell filed a patent application for a bioelectric signal to stop blood supply to cancer tumors.
- We recruited Dr. Santosh Kesari Chief of Neuro at the John Wayne Cancer Institute at Providence St. Johns Hospital in Santa Monica (former UCSD) as Chief Scientific and Medical Advisor for CancerCell and CerebraCell.
- We filed a specific patent for pancreatic cancer treatment followed by pancreas regeneration.
- CancerCell, PancreaCell, Regenalung and CerebraCell entered a 90 day option to acquire the pioneering patents of inventor Eleanor Schuler for series of inventions that detects the electrical activity in tumors and then adjusts the electrical signaling to customize and transmit back a tumor growth stoppage bioelectric signal or set of signals.
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GENERAL
- Working with Gas Money Productions in Los Angeles we completed 18 animation videos demonstrating our innovations.
- We signed aboard to our team as an advisor/consultant Dr. Micheal Levin the premier leading scientist in the field of bioelectric organ regeneration from Tufts University in Boston.
- Brian Hardy of Fizzpopmedia our Director of Marketing completed 26 new web sites including a full re-do or our Leonhardt Ventures home base master web site and Leonhardt's Launchpads Utah, Inc.
- Alternate Health, Inc. has provided offer to finance a number of our clinical trials for our organ regeneration platform technology especially for eye, lungs, brain and pancreas in combination with their anti-inflammation platform technology.
- Won estimated value $250,000 USTAR BioInnovations Gateway R&D lab, equipment, personnel support grant in Utah.
- Filed new bioelectric stimulation patent applications for controlled expression of IGF-1, HGF, EGF, eNOS, Activin A+B, Follistatin, Tropoelastin, Neurogenin 3, RANKL/TNF A, GDF-10, GDF-11 in addition to our already patent issued SDF-1 (stem cell homing) and VEGF (blood vessel growth) signals.
- Received term sheet from Fluid Synchrony, Inc, of Pasadena, CA for $500,000 investment in exchange for micro pump supply and micro pump + stimulator engineering services.
- Hired Dr. Leslie Miller a leading cardiologist, circulatory assist pump investigator and stem cell scientist to serve as Chief Medical Officer for Leonhardt Ventures and Leonhardt's Launchpads operated by Cal-X Stars Business Accelerator, Inc. including Leonhardt's Launchpads Utah, Inc.
- Established agreement with Trask Britt law firm in Salt Lake City, UT to handle filing all patent applications for a stock plus cash compensation plan.
- Launched Leonhardt's Launchpads Pasadena to work more closely in research collaboration with CalTech, WeWork Pasadena Startups, Cross Campus Pasadena Startups Pasadena Bioscience Incubator, Fluid Synchrony, IdeaLab, Huntington Research Institute, Keck Institute for Biomedical Engineering and other entities located in that area.
- Launched and staffed Leonhardt's Launchpads Utah, Inc. to work more closely in research collaboration with the University of Utah, USTAR, Technology Commercial Venture, BioInnovations Gateway, Center for Medical Innovation, Utah State, Weber State.
- Leonhardt's Launchpads Utah, Inc. recruited a local advisory board of local Salt Lake City industry leaders - Dr. Dinesh Patel founder of Theratech, Dr. Harrison Lazarus, Devin Thorpe, Dr. Amit Patel, with Jeremy Koff and David Robinson of nearby Park City, Utah
- Paul Norman an accomplished successful entrepreneur from Napa Valley, California has invested $225,000 with us so far over two years (much paid directly to our animation video development team Gas Money Productions and other contract vendors) and joined our team as a Managing Partner of our innovation accelerator - Leonhardt's Launchpads operated by Cal-X Stars Business Accelerator, Inc. , Leonhardt's Launchpads Utah, Inc. and Leonhardt's Launchpads NorCal. Paul has 30+ years of strategic partner contract negotiation and has been our lead in establishing agreements with a number of our partners. His son Nick Norman has jumped in to join our Leonhardts Launchpads NorCal office as well helping on many fronts.
- Leonhardt's Launchpads was featured in FORBES online Magazine - When Boundless Optimism Meets Medtech Anything Seems Possible via @forbes http://www.forbes.com/sites/devinthorpe/2016/08/10/when-boundless-optimism-meets-medtech-anything-seems-possible/#72c7789c1389
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Dr. Stuart Williams VP of R&D BioLeonhardt presenting at Technology Showcase at Heart Rhythm Society Annual Meeting
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MAJOR CONFERENCES, SHOWCASES AND PRESENTATIONS
- Presented Organ Regeneration Technologies at Academy of Regenerative Practices Annual Meeting in Fort Lauderdale, Florida in January.
- Held Technology Showcase at NANS North American Neuromodulation Society Annual Meeting in Las Vegas, NV in January. Met with QIG Greatbatch about stimulator OEM supply.
- Held Technology Showcase at JP Morgan Healthcare Conference at Parasoma highlighting BioLeonhardt and Cardiobridge in San Francisco in January.
- Presented BioLeonhardt and circulatory assist pump technology at UCARS Cardiac Recovery Symposia at the University of Utah in February.
- Presented Technology Showcase at BioUtah's Entrepreneur and Investor Summit February in Utah.
- Held showcase for AortaCell, MyoStim Peripheral, EndoCell, CerebraCell, Valvublator, Cardiobridge, Second Heart and BioLeonhardt at the 28th Annual ISET International Society of Endovascular Therapy Meeting in Miami in February. Had meetings with Dr. Katzen, Dr. Margolis, Dr. Abrams, Dr. Juan Parodi, Dr. John Marchetto and others.
- We presented BioLeonhardt, Valvublator and circulatory assist pump platform at the 31st Annual Interventional Cardiology Meeting at Snowmass, Colorado in March.
- Held an investigators meeting at the American College of Cardiology Meeting in Chicago in March for heart failure clinical trial design attended by 20 leading heart failure department chairs.
- We held a showcase at LA Heart Failure in April in Los Angeles.
- Technology Showcase and Angel Investor Meeting University of Minnesota April 23d, 2016.
- Held startup showcase at Annual Shareholders Meeting and Board Meeting at ROC Santa Monica in Santa Monica, CA in April.
- We presented all of our heart and cardiovascular technologies at EuroPCR in May and met with a number of potential strategic partners and distributors. We also met with the Wetling wireless microcurrent device team, Utrecht University researchers and others.
- We held a showcase at the 22nd Annual Heart Failure Symposia in San Diego on June 18th.
- Presented PancreaCell at UCLA First Look LA Conference at CNSI sponsored by the Los Angeles Venture Association on June 22nd.
- Showcase for Organ Regeneration Technologies International Society of Stem Cell Therapy June 23rd San Francisco.
- Held Technology Showcase at Stanford University June 24th. Meeting with advisor Suresh Gurunathan co-founder of NanoStim.
- Held Regenerative Medtech showcase at USTAR Sorenson Building University of Utah September 8th.
- Presented CerebraCell at North Bay Innovation Summit in Rohnert Park, CA in September 16th.
- Technology Showcase, Angel Investor Meetings, Biomedical Innovation Center meetings BioPace, Talk at Carlson Business School University of Minnesota for Minnesota Cup September 21st to 24th, 2016. Met with Stemonix "organs in a dish" supplier.
- Presented PancreaCell at PANCREAS 2016 in Chicago October 19th.
- Presented CerebraCell at Neuro Tech Leaders Forum October 24th and 25th.
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20 Leading U.S. Heart Failure Department Chairs gathered for our private meeting @ the Heart Failure Society of America Annual Mtg. Orlando, FL For Clinical Trial Design Advice. A similar sized group gathered for us at the American College of Cardiology Mtg. in Chicago.
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CLICK ON IMAGE ABOVE TO WATCH VIDEO
BioLeonhardt Whole Body pulls together all our organ regeneration technologies into
one product. Our most ambitious development. Patents pending.
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BioLeonhardt Whole Body Regeneration Chamber
Patent Pending - Under Development
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Photo from our "Saving Steve Jobs" PancreaCell presentation day at Apple Computer headquarters.
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Dr. Leslie Miller our Chief Medical Officer at our Utah Lab at BioInnovations Gateway
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CLICK ON IMAGE ABOVE or here > https://vimeo.com/183574529 for video. Prototype development Second Heart LLC wireless aortic circulatory assist pump with a stent graft. That is our 1991 invented TALENT stent graft in the photo that has about 50% of the world market share today.
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Dr. Amit Patel of the Heart Stem Cell Therapy team at University of Utah and Principal Investigator of the BioLeonhardt heart regeneration study with $150,00 USTAR University Technology Acceleration Grant with $150,000 in matching funds. Advisor to Leonhardt's Launchpads Utah, Inc.
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Howard Leonhardt Executive Chairman at EuroPCR for meetings with potential strategic partners and investigators.
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Leonhardt's Launchpads Utah, Inc. team working in lab on bioelectric micro stimulator testing. Front to back Mariano Lopez, Michael R. Angerbauer, Thomas Wallace
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Howard Leonhardt and Dr. Jorge Genovese
Co-Inventors of our lineup of bioelectric stimulators
for controlled protein expression and organ regeneration.
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