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BioLeonhardt MyoStim www.bioleonhardt.com – Implantable, programmable, re-fillable stem cell & growth factor pump combined with electrical stimulation for damaged heart muscle regeneration and limb salvage.
- Developed world’s smallest micro stimulator with longest battery life and most precise control of electrical signals working with QIG Greatbatch. Over $50 million invested into this development.
- Filed patents for IGF-1, Follistatin, Tropoelastin, eNOS, Activin, HGF signals to add to portfolio.
- Our micro pump partner secured over $2 million in SBIR research grants.
- Developed protocol for translational studies for heart regeneration.
- Met with FDA about Category B designation for $58,000 reimbursement per clinical case completed in the USA.
- Sourced infusion pacing leads with corkscrew tip.
- Began development of wireless energy transmission ver. 2.0.
Stem Cell Bra www.stemcellbra.com – World’s first women’s bra with built in electrical stimulation homing signal for stem cells with ability to differentiate them into breast tissue.
- Completed pilot large animal study in Argentina with positive results.
- Developed working prototypes.
- Filed two provisional patent applications.
- Solidified research alliance with Dr. Joel Aronowitz of Cedars Sinai UCLA.
- Initiated large animal study in Argentina with Dr. Jorge Genovese.
- Add dozens of supporting papers to web site.
Valvublator – https://leonhardtventures.com/valbulator.php + www.valvublator.com – first catheter based device for decalcifying, cell sodding, surface modifying and microcurrent regenerating heart valves so a patient may keep their own heart valve instead of getting an implant.
- Prepared a provisional patent application ready to be filed.
- Developed research collaboration with Dr. Mark Cunningham, Chief of Staff Cardiac Surgery at USC Keck Medical Center.
- Developed protocol for preserving a patients own heart valve without surgery.
- Presented Valvublator at 31st Annual Interventional Cardiology Meeting in Colorado.
- See www.valvublator.com for supporting science slide deck.
LV Sens – Left ventricle heart sensor placed via catheter
- Prepared provisional patent application for catheter based delivery.
- Developed disolvable cone design for percutaneous placement.
EndoCell – Endothelial progenitor cells delivered via adventia tissue micro needle catheter combined with microcurrrent stimulation for healing damaged arteries
- Developed research alliance with Dr. Warren Sherman, Director of Cardiovascular Stem Cell Research Columbia University and Dr. Dayu Teng University of California San Diego.
- Secured contract supplier for adventia needle catheter – Mercator Medical Systems.
- Secured manufacturing partner for micro stimulator.
- Developed pre-clinical and clinical study plan.
AortaCell – Non-invasive wireless energy device for healing aortic aneurysms, strengthening aortic necks in stent graft cases and sealing Type III endoleaks non-invasively.
- Developed manufacturing partner for micro stimulator.
- Recruited Dr. Juan Parodi to research team.
- Recruited Dr. Harrison Lazarus to research team.
- Designed catheter based system.
- Designed protocol for reinforcing aortic necks to improve stent graft performance.
- Designed protocol for creating a beating 2nd heart aorta.
- Granted 4% of seed stage equity to research and kids funds on behalf of co-Founder Dr. Roy Greenberg, former Chief of Vascular Surgery of Cleveland Clinic that passed away last year at age 49 of cancer.
DentaCell – – Microcurrent devices for healing dental gums, teeth and jaw bone.
- Secured manufacturing partner for micro stimulator.
- Established registered tooth pulp storage service partnership for future stem cell expansion in case of need.
OrthodontiCell – Tooth Movement Accelerator – designed to cut in half dental brace and aligner wearing time.
- Filed provisional patent application.
- Designed prototype.
- Recruited Dr. John Marchetto to serve as President.
CerebraCell – – Microcurrent device for helping patients recover from brain trauma and strokes.
- Discovered signal for controlled expression of IGF-1 and filed provisional patent.
- Secured manufacturing partners.
- Add dozens of supporting papers to web site.
- Prepared provisional patent application ready for filing.
- Secured investment from the University of Northern California Foundation.
- Placed CerebraCell in Leonhardt’s Launchpads @ UNC STIC Incubator near Santa Rosa, CA.
- Recruited Dr. Santosh Kesari noted Cerobrovascular Researcher and Brain Surgeon to team.
EyeCell – https://leonhardtventures.com/eyecell.php – Microcurrent device for reversing macular Degeneration and for treating other eye disorders.
- Lined up manufacturing partners.
- Partnered with renowned eye surgeon Dr. Patrick Johnson of Minneapolis.
- Recruited Dr. Edward Kondrot renowned expert of microcurrent eye related therapies to research team.
- Placed EyeCell duly in Cal-X Stars and Leonhardt’s Launchpads at UNC STIC incubators in Santa Monica and Santa Rosa.
CoroStim – Vibrational energy device for preventing plaque, calcification and clot formation in human bodies and blood contact devices.
- Prepared provisional patent application for filing.
- Lined up manufacturing partners.
- Conducted market research.
- Found and posted dozens of supporting papers.
BioPace – https://leonhardtventures.com/biopace.php – Biological pacemaker made of living cells placed via a percutaneous needle tipped catheter.
- 2 patents issued.
- Held research collaboration discussions with European investigators.
HeartScore www.heartscore.co – Full lineup of cardiovascular diagnostics including genetic tests and @ home and point of care monitoring for developing individualized care for heart failure and cardiovascular patients.
- Developed Heart Failure Management Program.
Cardiobridge – www.cardiobridge.com – circulatory assist pump on catheter.
- Held experts panel meeting @ ACC Chicago to design clinical plan.
- Developed animation video.
- Prepared regulatory plan
- Developed reimbursement strategy.
- Recruited Dr. Leslie Miller to team.
- Filed for CE Mark approval.
- Presented data on 35 patients at EuroPCR and other meetings.
PancreaCell – pancreas regeneration
- Developed manufacturing partnership for micro stimulator.
- Developed manufacturing partnership for micro pump.
- Met with University of Georgia Incubator based potential collaborators.
- Recruited Dr. Camillo Ricordi of Miami Diabetes Research Institute as an advisor.
- Assembled large number of supporting scientific articles.
- Recruited Dr. Nicholas Chronos as an advisor
BladderCell
- Developed manufacturing partnership for micro stimulator.
- Developed manufacturing partnership for micro pump
- Recruited Laurelle Johson as an advisor.
RegenaLun
- Developed manufacturing partnership for micro stimulator.
- Developed manufacturing partnership for micro pump.
KidneyCell
- Developed manufacturing partnership for micro stimulator.
- Developed manufacturing partnership for micro pump
LiverCell
- Developed manufacturing partnership for micro stimulator.
- Developed manufacturing partnership for micro pump.
EarCell
- Developed manufacturing partnership for micro stimulator.
- Developed manufacturing partnership for micro pump
HairCell
- Developed manufacturing partnership for micro stimulator.
- Developed manufacturing partnership for micro pump.
- Secured manufacturing partner for head helmets.
- Recruited Derek Kahn to serve as President.
- Designed clinical protocol and pre-clinical plan.
- Files provisional patent applications for follistatin and IGF-1.
- Building and testing prototypes in Utah @ Leonhardt’s Launchpads Utah.
- Developing working relationship with the University of Northern California.
MyoStim ED
- Developed manufacturing partnership for micro stimulator.
- Developed manufacturing partnership for micro pump.
- Lauched beta web site.
MyoStim Skin
- Developed manufacturing partnership for micro stimulator.
- Developed manufacturing partnership for micro pump.
- Developed relationship with Dr. Leif Rogers in Beverly Hills, CA for clinical studies.
Regenerative Economy Portfolio Updates
The California Stock Exchange – www.calstockexchange.com – Aspirations to become 1st U.S. social good impact stock exchange – under development.
- Secured registered Trademark for The California Stock Exchange TM.
- Launched Cal-X 30 Social Good Impact Index Fund/Exchange Traded Fund powered by Motif Investing a registered broker dealer.
The Lions Den TV Show Cal-X – http://www.calstockexchange.com/the-lions-den/ – Launched online crowdfunding TV show airingon The Kindheart Lionheart INSPIRATIONAL WORKS TV Network – www.kindheartlionhearttv.com ;
Cal-X Crowdfund Connect – www.calxcrowdfund.com – Crowdfunding campaign building services firm launched.
Cal-X Stars Business Accelerator, Inc. – www.calxstars.com – 5 year business accelerator specializing in cardiovascular and social good media innovations.
- Accelerated progress of 26 regenerative medtech and 4 regenerative economy startups.
- Secured 80 business advisors with substantial experience.
- Secured 37 scientific and clinical advisors with substantial experience.
Cal-Xelerator www.calxelerator.com – 108 day startup launch accelerator.
- Developed and published comprehensive 15 1/2 week program for startup launch
Leonhardt’s Launchpads NorCal www.leonhardtslaunchpads.com – Incubator for select few life science companies at University of Northern California Science & Technology Innovation Center.
- Sapheon Medical that incubated at UNC STIC sold for $238 million to Medtronic Covidien.
- Enrolled EyeCell and CerebraCell in Leonhardt’s Launchpads @ UNC STIC at the University of Northern California in Rohnert Park, California (near Santa Rosa 45 minutes north of San Francisco)
Food Trikes and Scooters www.foodtrikesandscooters.com – Solar powered mini food trucks supported by full array of services.
- Built out and sold first unit.
- Developed sales brochure and web site.
- Secured manufacturing partnerships.
Wine Country Baseball www.winecountrybaseball.com + https://leonhardtventures.com/wine-country-baseball.php – Development league for showcasing players hoping to get signed to MLB contracts.
- Preparing for 7th Annual Wine Country Baseball Classic.
Cal-Xport – http://cal-xport.com/ – The “Alibaba” site for California exporters.
- Launched web site.
- Promoted UCLA export education programs.
- Developed TRIP MATCHING SERVICE to help exporting companies make overseas export sales calls at less expense. Working on developing easy to use APP.
- Posted dozens of helpful resource links.
Kindheart Lionheart Media & Publishing www.kindheartlionheart.com – Online book store – inspirational works. Publisher, creator and producer of inspirational content.
- Advanced forward Dolphin Smiles: The Legend of Kindheart LIonheart via UCLA Writing Program.
Kindheart Lionheart TV Network – www.kindheartlionhearttv.com – Inspirational works TV network.
- Selected programs have more than 2 billion views.
- Created 4 original in-house original programs.
Kindheart Lionheart Startup Media Support Services http://kindheartlionheart.com/startup-media-support-services/ – Media marketing and ad team to help launching startups. We take part cash and part equity for pay for services. Primarily producer of company videos.
- Developed full service studio for producing TV shows, ads, music videos, company videos and short films.
Radio Veronica USA – www.radioveronicausa.com – Online radio station set up to crowdfund the publishing rights of songs with one tap of your phone.
- Launched first Facebook based radio station that allows listeners to crowdfund purchase publishing rights of songs.
The Kindheart Lionheart Radio Show – https://leonhardtventures.com/khlh-radio.php – Radio show focused on stories of compassion and courage in the marketplace in the era of conscious capitalism.
- Aired 14 episodes covering stories of compassion and courage in the marketplace, innovators and creators.
Kindheart Lionheart Adventures – www.lionheartadventures.com – Charitable giving travel company and set of products to help foundations raise funds.
- Arranged over 24 exciting charitable giving and foundation fund raising adventure pacakages.
Startup California www.startupcalifornia.org – Startup support services.
- Over 100 interns signed up into summer startup internship program.
- Upgraded the Startup Jobs site.
- Managed 8 state regions.
- Posted over 4000 posts of information helpful to startups.
LA BioHub – www.labiohub.org – Life science information hub with plans for a physical incubator in near future for the Los Angeles area.
Lucille’s Cafes Franchising & Licensing Co. –https://leonhardtventures.com/lucilles-cafe.php + www.lucillescafes.com – Holding company that holds trademark, franchising, SOPs and recipe rights for the highly successful Lucille’s Cafes.
- Completed franchise package for restaurant.
- Designed Lucille’s on Wheels Food Truck.
- Developed Lucille’s on Wheels full menu.
- Developed Lucille’s on Wheel’s Mini Food Truck design.
- Developed Lucille’s on Wheel’s Food Trike design.
Entrepreneurship Party Public Policy Institute – www.entrepreneurshipparty.com – Public policy institute to support entrepreneurs.
2016 Priority List – Goals
HEART AND CARDIOVASCULAR
> BioLeonhardt – heart regeneration.
1. Finish large animal studies in Spain.
2. Prepare to launch clinical trials in 2017.
3. Continue to build patent estate.
> AortaCell – aorta regeneration.
1. Finish large animal studies at LABioMed Harbor UCLA.
2. Initiate pilot OUS clinical studies.
> BioPace – biological pacemaker regeneration.
1. Initiate animal studies with University of Rostock.
> Valvublator – heart valve regeneration.
1. Finalize prototypes at University of Utah.
2. Complete large animal studies.
3. Prepare to launch clinical studies in 2017.
> CoroStim – vibrational energy to prevent clots, plaque, calcification.
1. Finalize prototypes and lab testing.
2. Complete large animal studies.
3. Build patent estate.
> HeartScore – genomics based heart failure management.
1. Launch in North American market.
> EndoCell – artery regeneration.
1. Complete translational studies in Italy with Dr. Antonio Colombo with guidance from Dr. Warren Sherman and Dr. Dayu Teng.
> MyoStim Peripheral – limb blood flow improvement.
> Initiated progressive aggressive limb salvage trial in Czech Republic.
> LVSens – heart sensors.
> Build and lab test prototypes in Los Angeles and Utah.
> Cardiobridge – circulating assist pump (note – not LV controlled)
> File for 510K for high risk PCI in USA.
> File for CE Mark in Europe.
> File to begin heart failure clinical trials in the USA.
> Leonhardt-Wetling Peripheral – wireless diabetic foot ulcer treatment.
> File for 510K in USA.
> Initiated Phase II/III controlled study in the USA.
Brain
> CerebraCell – brain regeneration.
> Complete tumorgenecity animal studies in Cleveland, Ohio.
> Launch OUS pilot clinical trial for stroke recovery.
> Launch OUS pilot clinical trial for cancer tumor stoppage.
> Launch OUS pilot clinical trial for cerebral aneurysm repair.
Cosmetic
> Stem Cell Bra – breast regeneration.
> Finalize sheep study in Argentina.
> Prepare for pilot OUS clinical trials.
> DentaCell – dental gum regeneration + tooth pulp storage.
> Launch tooth pulp storage program in USA.
> Complete study for pain relief in healing.
> OrthodontiCell – cuts in half dental brace wearing time
> Complete large animal studies in Argentina.
> Launch pilot clinical trial OUS.
> MyoStim Skin – skin regeneration.
> Launch pilot clinical trial with Dr. Leif Rogers in Los Angeles.
> MyoStim ED – erectile dysfunction treatment.
> Complete pre-clinical studies with Dr. Nestor Ca-David Gonzalez at LABioMed Harbor UCLA.
> HairCell – hair regeneration
> Complete tumorgencity studies.
> Launch pilot OUS clinical trial.
Major Organ Regeneration
> EyeCell – eye regeneration.
> Complete registry study for microcurrent macular degeneration recovery.
> Launch OUS cornea regeneration study.
> PancreaCell – pancreas regeneration.
> Complete cadaver studies at U of Miami with Dr. Camillo Ricordi.
> Complete large animal studies at U of Georgia with Dr. Nic Chronos.
> Launch OUS pilot clinical trial in China, Italy and Canada.
> RegenaLung – lung regeneration
> Complete pre-clinical studies.
> Prepare for OUS pilot clinical trial.
> LiverCell – liver regeneration.
> Design final protocol and product.
> KidneyCell – kidney regeneration.
> Design final protocol and product.
> EarCell – ear hearing regeneration.
> Deisgn final protocol and producdt.
> BladderCell – bladder regeneration
> Design final protocol and product.
> BioLeonhardt Whole Body Regeneration – Whole body regeneration.
> Find a development partner for this project.
Cancer Treatment
> CancerCell – bioelectric cancer tumor treatment + regeneration.
Note – CerebraCell, RegenaLung, BladderCell, LiverCell, KidneyCell and PancreaCell have the cancer tumor stoppage signals built into their organ specific technology platforms.
> Complete lab studies.
> Launch pre-clinical studies.
> Prepare for 2017 pilot clinical trials.
Regenerative Economy
> The California Stock Exchange TM
> Get more press coverage.
> Recruit big names to join us.
> Increase promotion of iDISCLOSE PPM product sold on commission basis.
> Increase promotion of WorthWorm pre-money valuation software on commission basis.
> Fine tune the Cal-X 30 Social Good Impact Fund after 1 full year of experience.
> Prepare for stock exchange regulatory filings with a partner.
> Cal-X Crowdfund Connect
> Focus on $15K paid crowdfunding marketing assistance campaigns.
> Food Trikes and Scooters
> Hire a sales manager to boost sales.
> Wine Country Baseball
> Hold 7th Annual Wine Country Baseball Classic September 29th.
> Cal-Xport
> Upgrade web site tools for exporters.
> Kindheart Lionheart Media & Publishing
> Get Dolphin Smiles: The Legend of Kindheart Lionheart published or self publish it. Send screenplay out to all major studios.
> Kindheart Lionheart TV Network
> Film new episodes of Love Roller Coaster.
> Film California Love series.
> Film Covers of Great Speeches series.
> Film Lions Den Startup Pitch Crowdfunding Show.
> Film Love Dialogues series.
> Surpass 3.5 billion views across all programs.
> Hire advertising sales manager.
> Radio Veronica USA
> Promote crowdfund purchase of portion of publishing rights of songs product.
> Kindheart Lionheart Adventures
> Develop a poster and online ad that travel agencies can display.
> Partner with a major travel agency.
> Lucilles’ Cafe’s of America
> Sell franchises.
> Leonhardt’s Launchpads Utah
> Get lab set up at BioInnovations Gateway.
> Hire 3 biomedical engineers.
> Integrate with U of Utah researchers.
> File for multiple SBIR grants.
Leonhardt’s Launchpads NorCal
> Support CerebraCell.
> Support EyeCell.
> Reorganize Tisugen Therapeutics.
> Reach out to recruit more local startups.
> Develop certificate programs in bioengineering modeled after UCLA Extension programs.
Leonhardt’s Launchpads Georgia
> Get small office set up at U of Georgia Innovations Gateway supported by a local intern and Dr. Nic Chronos to start at low cost.
Cal-Xelerator
> Recruit 4 exciting outside startups to join 108 day startup launch bootcamp.
LABioHub
> Hold a Santa Monica based Life Science startup pitch contest. Enter our own companies and use truly independent judges.
Startup California
> Hold crowdfunding and startup finance seminars in San Diego, OC, LA, Santa Barbara, San Jose, San Francisco, Santa Rosa, Sacramento and Lake Tahoe. Sell iDISCLOSE, Cal-X Crowdfund Connect and WorthWorm as sponsors.
Cal-X Stars Business Accelerator, Inc.
> Focus on advancing the current 2016 portfolio with patents, supporting data, opinion leader endorsements and positive press. Build excitement in financial community.
> Work on getting blog coverage for our startups.
> Recruit Chief Medical Advisors and CEOs for each startup not yet staffed.
> Help all incubating/accelerating startups pursue SBIR grants.
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