Brief Elevator Pitches for Startups 2018 Portfolio Class Leonhardt’s Launchpads

HEART AND CARDIOVASCULAR

8 startups 3 at clinical stage.

Second Heart Assist

Second Heart Assist, Inc. www.secondheartinc.com – Developing both a temporary catheter based circulatory assist pump and a wireless powered chronic implant pump. One competitor is on the U.S.A. market with a catheter based pump and they peaked at $21 billion valuation this year with year to year sales growth exceeding 30%. There is no competitor yet on the market with a wireless powered chronic implant pump. The Second Heart Assist team has completed animal studies in Boston and Ohio as well as mock loop studies at the University of Louisville and Computational Fluid Dynamics studies in Berlin, Germany. The team has meet three times with the FDA as part of the interactive review process for an Early Feasibility Study. The team is finishing another round of pre-clinical studies with intention to enter clinical studies in Paraguay, Australia and the USA at Ohio State University within the next 90 days. IRB submissions have already been made. Second Heart Assist has numerous issued patents and dozens of new patent claims pending including those covering aortic stent cage design for greater stability, vibrational harmonic resonance to prevent blood clot formations, low RPM high flow design elements intended to reduce hemolysis and mechanical breakdown risks, unique impeller shape, pulsating stent graft in upper aorta and impeller aortic stent in lower aorta in timing optimization and more. The team expects to be in position to secure a strategic partner by spring of 2019 after clinical results from three centers. The Second Heart Assist conforming aortic stent used on both the tip of the temporary catheter based pump and the wireless powered chronic implant is modeled after the original Leonhardt patented aortic stent graft that has world market leadership today for non-surgical repair of aortic aneurysms.

BioLeonhardt

BioLeonhardt www.bioleonhardt.com – Developing a combination bioelectric stimulation, micro infusion pump and fifteen component composition intended to full regenerate ailing hearts. The Leonhardt team completed their first muscle stem cell repair of an infarcted large animal heart in 1988. Published first bioelectric regeneration paper in Circulation in 1999. Led team that completed landmark first ever non-surgical stem cell repair of a human heart in 2001. The BioLeonhardt technology platform represents the culmination of everything learned by more than 100 involved researchers since the 1980’s. Small animal feasibility studies were completed at the University of Utah last year and at the team is moving on to large animal studies at Texas Heart Institute with the team of Dr. Doris Taylor and Dr. Luis Sampaio now. In 2017 a separate independent team in Germany published a study confirming the ability of bioelectric signaling to improve cardiac function – https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5542736/. The team has hope to launch a first-in-man study for the combination therapy in late 2019 or 2020. If successful the BioLeonhardt technology has the potential to cut in half the more than $30 billion annual cost of caring for heart failure patients annually.

Aortacell

Aortacell – https://leonhardtventures.com/aortacell/ – In the 1990’s the Leonhardt team revolutionized the repair of aortic aneurysms without surgery with their patented endovascular aortic stent graft system that still holds market leadership today. The team completed the historic landmark first ever non-surgical repair of an aortic aneurysm in Australia in 1995. Today this same team is set to obsolete their previous market-leading technology with the development of AortaCell a bioelectric and biologics combination therapy to regrow and regenerate the aorta muscular wall instead of placing an artificial implant. The team is preparing to launch large animal studies at the University of Virginia in early 2019 with intention to move to first in man study late 2019 or 2020. The AortaCell technology has the potential to open up a whole new market segment as well in treating smaller aneurysms that are currently left into a watch and wait program today. AortaCell may also be used to strengthen aortic walls to improve sealing results with stent grafts in cases where they still may be used in very advanced large aortic aneurysms. The global market for aortic aneurysm repair is forecasted to soon exceed $3.8 billion annually without factoring in the new market of earlier repair non-invasively of smaller aneurysms.

BioPace

BioPace – https://leonhardtventures.com/bio-pace/ – Over 3 million people worldwide have an implanted electronic pacemaker with a market about to exceed $6 billion annually. The related 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 is working to develop 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. BioPace is working with Electrophysiologists Dr. Alonso Moreno formerly of the University of Utah Cardiovascular Research and Training Institute, Dr. Nic Peters of Imperial Hospital London and Dr. Sergio Pinski of Cleveland Clinic Florida and we are filing multiple research grant applications as we are building and testing prototypes as well as filing new patent claims. BioPace hopes to complete animal studies in 2019 that lead to clinical studies in 2020. BioPace is dedicated to rebuilding the electrical conduction system of your own heart the same way it was built in the first place with living cells. The intention is to regenerate your natural pacemaker instead of getting an artificial steel can and battery device.

Valvublator

Valvublator – www.valvublator.com – Valvublator will significantly reduce the number of prosthetic heart valve implantations by decalcifying and rehabilitating existing heart valve tissue with an innovative and minimally invasive technique. The team that developed and patented the first percutaneous heart valve in the 1990’s intends to disrupt its own invention with this advanced innovation. This technology allows people to keep their own heart valve by cleaning, maintaining and regenerating their own heart valves, just as dental hygiene controls plaque formation on your teeth. The result is a healthier, longer-lasting natural heart. It is expected to have a major disruptive impact on the $20 billion prosthetic heart valve market. Led by medical device veteran Richard Henson and notable international experts in the field, the development team is creating and testing prototypes and additional patents. Valvublator hopes to complete pre-clinical studies in 2019 with intention to launch a first-in-man study in Italy with Dr. Antonio Colombo in 2020.

VibroCell Corostim

VibroCell Corostim – https://leonhardtventures.com/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 possibly 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 and heart valves. Current Status – Patents filed. Building prototypes for testing. Seeking out research collaborators. Working with Queensland University Brisbane, Australia and research collaborators in Pittsburgh and Utah to launch animal studies.

Vascustim

Vascustim – www.vascustim.com – 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. We partnered with Axolotl Biologics amniotic fluid compositions have documented dozens of cases of diabetic leg and foot wound healing and numerous independent studies have been published documenting the same. Their processing preserves exosomes for longer length growth factor expressions. We also developed and have patent pending bioelectric PRF platlet rich fibrin which has demonstrated incredible healing properties in multiple applications 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. Current Status = We now are launching a worldwide paid registry clinical trial at multiple centers with plans for us getting paid for the product during the studies under category B designation reimbursement.

Pressurestim

Pressurestim – www.pressurestim.com – In the USA alone over 80 million people have high blood pressure. 1 out of every 3 Americans. Many millions also have low blood pressure problems. Pressurestim is developing a bioelectric solution to high and low blood pressure with small bioelectric stimulators the size of nickel placed in strategic locations. A clinical study has been completed in China with positive results and studies are now moving to other OUS locations.

BioLeonhardt

heart regeneration

STAGE

PRE-CLINICAL

AortaCell

aorta regeneration

STAGE

PRE-CLINICAL

BioPace

biological pacemaker regeneration

STAGE

PRE-CLINICAL

Valvublator

heart valve regeneration

STAGE

R&D

VibroCell (includes CoroStim)

vibrational energy to prevent clots, plaque, calcification

STAGE

R&D

HeartScore

genomics and bioelectric based heart failure and stroke management

STAGE

PHASE I

VascuStim (formerly MyoStim Peripheral, includes EndoCell)

limb salvage regeneration, blood flow improvement for critical limb ischemia, diabetic leg and foot ulcer treatment, artery regeneration

STAGE

PHASE I

Second Heart Assist, Inc.

wireless powered chronic or temporary circulatory assist pump in aortic stent

STAGE

PRE-CLINICAL

PressureStim

bioelectric treatment of high blood pressure via improved arterial elasticity and bioelectric membrane potentials management.

STAGE

R&D

BRAIN

Cerebracell

Cerebracell – www.cerebracell.com – utilizes bioelectrics and biologics for brain regeneration. Entering studies now at McGowan Regenerative Medicine Institute in Pittsburgh. Team has developed a “brain saving helmet” for non-invasive reduction of brain injury following strokes and traumatic brain injuries. The group is developing treatments for Parkinson’s, Alzheimer’s and epilepsy as well. The Pittsburgh team previously published positive results in animal studies with their ECM matrix biologics solution. The new study combines bioelectrics with biologics to attempt to improve upon results. A separate Stanford independent clinical study recently showed the ability to get wheelchair bound post stroke patients to get up and walk again with a single treatment with injected modified stem cells. The CerebraCell team is working to improve upon their results.

CerebraCell (includes CerebraCell Brain-N-Hance and CerebraCell Concussion)

brain regeneration, cognitive function improvement, concussion recovery

STAGE

PRE-CLINICAL

COSMETIC AND PERSONAL CARE

All 7 products at clinical stage of development

SkinStim

SkinStim – www.skin-stim.com – Entering clinical studies now in Los Angeles, Pittsburgh and South Africa. Face and neck skin regeneration. Product features controlled stem cell homing and tropoelastin release for increasing elasticity.

HairCell

HairCell – www.haircellstim.com – Launched clinical study in South Africa and about to launch in other locations. Targeting 30% hair density growth.

MyoStim ED

MyoStim ED – www.erectistim.com – Completed and published first clinical study with 85% success results over placebo with one signal tested. Launching new study with multiple signals targeting 100% success of ED recovery.

TestiStim

TestiStim – www.testistim.com – Issued patented for bioelectric underwear for testosterone management. Pilot clinical evaluation completed with successful results. Moving to larger scale pilot studies.

OrthodontiCell

OrthodontiCell – www.orthodonticell.com – Targeting to reduce time to straighten teeth by 2/3rds and to freeze stabilized teeth straight after straightening. Market leader Align Technology peaked at $30.9 billion valuation this year and was no. 1 S&P 500 stock of 2017. They charge > $4000 and take > 18 months to straighten teeth and have no technology to keep them straight. We believe we can straighten teeth in 6 months and keep them straight. Entering clinical trials now at multiple sites. Research collaborators published positive animal study.

DentaCell

DentaCell – www.dentacellaccelerator.com – Multiple dentistry products in development utilizing combination of bioelectrics and biologics.

Stem Cell Bra

Stem Cell Bra – www.stemcellbra.com – Sheep studies demonstrate up to 30% increase in breast fullness volume with only one hour of wear of the Stem Cell Bra every other day for 4 weeks. Now moving to clinical studies in South Africa and other locations.

Stem Cell Bra

breast regeneration

STAGE

PRE-CLINICAL

DentaCell

dental gum regeneration + tooth pulp storage

STAGE

PHASE I

OrthodontiCell

bioelectric stimulator for accelerated tooth movement and freezing teeth positions straight

STAGE

PRE-CLINICAL

SkinStim

skin regeneration

STAGE

COMMERCIAL

MyoStim ED

bioelectric erectile dysfunction treatment

STAGE

PHASE II

HairCell

hair regeneration

STAGE

PHASE I

TestiStim

Bioelectric treatment of Low Testosterone

STAGE

PHASE I

MAJOR ORGAN REGENERATION

Up to 4 products entering clinical stage of development of 12 in group.

BladderCell

BladderCell – www.bladdercell.com – bladder regeneration for incontinence treatment – entering clinical trials in Brazil.

OrthoStim

OrthoStim – www.ortho-stim.com knee regeneration – entering clinical trials in Los Angeles area.

EyeCell

EyeCell – https://leonhardtventures.com/eyecell/ – eye regeneration – completed grant supported study at U of Utah in small animals. Now moving to large animal studies.

PancreaCell

PancreaCell – https://leonhardtventures.com/pancreacell/ -pancreas regeneration – preparing for large animal studies at University of Miami. Finalist last year in ADA Innovation Awards.

RegenaLung

RegenaLung – https://leonhardtventures.com/regenalung/ – lung regeneration – preparing to enter animal studies.

LiverCell

LiverCell – https://leonhardtventures.com/livercell/ – liver regeneration – preparing to enter animal studies in Pittsburgh.

KidneyCell

KidneyCell – www.kidney-cell.com – kidney regeneration – preparing to enter animal studies in Pittsburgh.

EarCell

EarCell – www.ear-cell.com – ear hearing regeneration – searching for research collaborators.

InStim

InStim – www.instimcell.com – bioelectric inflammation management – planning clinical trials in China. Real time read and customized bioelectric inflammation management via anti-inflammatory cytokine expressions.

PolypStim

PolypStim – www.polypstim.com – bioelectric polyp, cyst or fibroid treatment – preparing for animal studies that lead into clinical studies.

Wave

Wave – www.wave-stim.com – bioelectric endometriosis treatment – preparing for clinical studies in Brazil.

BioLeonhardt Whole Body Regeneration

BioLeonhardt Whole Body Regeneration – https://leonhardtventures.com/bioleonhardt-whole-body/ – whole body regeneration chamber – filing National Science Foundation SBIR grant application. Developing a “womb” for adults. Intended to reduce age by 30 years and extend life by 30 years.

EyeCell

eye regeneration

STAGE

PRE-CLINICAL

PancreaCell

pancreas regeneration

STAGE

PRE-CLINICAL

OrthoStim

bioelectric and composition joint regeneration

STAGE

PHASE I

LiverCell

liver regeneration

STAGE

PRE-CLINICAL

KidneyCell

kidney regeneration

STAGE

R&D

EarCell

ear hearing regeneration

STAGE

R&D

BladderCell

bladder regeneration

STAGE

R&D

PolypStim-MucosaCell

sub-mucosa regeneration

STAGE

R&D

InStim

bioelectric real time inflammation management

STAGE

R&D

RegenaLung (includes ECMO-Cath)

lung regeneration (includes 50% owned subsidiary RegenaLung COPD) cannula for infusing oxygen directly into the blood using an oxygenator, a medical device that acts as an artificial lung

STAGE

R&D

BioLeonhardt Whole Body Regeneration

whole body regeneration and Bod-Stim bioelectric yoga and athletic pants

STAGE

R&D

CANCER TREATMENT

CancerCell

CancerCell – www.cancercellinc.com – bioelectric cancer therapy – entering animal studies at UCLA. Multiple issued patents and many pending. Read cancer tumor and custom deliver bioelectric signaling sequence designed to jam communication, trigger immune response, starve blood supply, halt cell division, rupture cancer cells, manage inflammation, re-program cancer cells and after tumor is eradicated regenerate the organ. Two competitors Novocure and Pulsed Biosciences both published recently successful clinic results with bioelectric therapies for cancer. They reached $2 billion and $550 million valuations after pilot study results. Novocure only jams communication. Pulsed Biosciences slightly triggers a partial immune response. We believe our multi-modality CancerCell approach which is customized based on reading tumors will prove out to provide superior results in upcoming studies.

CancerCell

bioelectric cancer tumor treatment + regeneration

STAGE

PRE-CLINICAL

“These are forward looking projections. As we are a startup the only thing we can guarantee is that we will miss them over and over again, until we survive our own mistakes”

– Rachid Sefrioui, Professional Investor, Venture Capitalist @ Finaventures, Entrepreneur

GENERAL

By nature of being extremely short in scope elevator pitches leave out relevant risks and can be misleading in portraying a technology or company to be better than it may appear if a more lengthy and comprehensive presentation is made. The conciseness of the language by nature is slanted to the positive and de-emphasizes risks and obstacles.

These risks include…
1. Startups may not have or secure resources to brings it products to market.
2. None of these startups have tested their products sufficiently enough to make any definitive product or company performance claims.
3. The startups patents pending may not be issued. Patent license agreements may not hold up.
4. All the company agreements, including patent licenses, supply and research agreements are subject to conditions which may not be met or may not have already been met to keep them active and enforceable.
5. The company with a small staff undertaking so many activities is bound to have mistakes in information and outdated information on selected web sites and other documents.
6. Any early stage investment is high risk but these startups are even higher risk since they attempt to take on very large medical problems where other firms with much more substantial resources have failed.
7. No other firm has been highly successful financially in stem cell or bioelectric based organ regeneration. Most of the startups in these accelerators are attempting to do something which has never been done before.
8. Traditionally it costs hundreds of millions of dollars just to bring one of these products to market and many years of development by a focused team of professionals. This accelerator business model attempts to bring up to 30 innovations through first-in-man studies with a substantially smaller staff with dramatically substantially less resources than our traditionally required for even one startup of this type. This in and of itself is and indicator of associated extremely high investment risk.
9. Personnel highlighted as being involved in the projects and startups are nearly all part time and are not compensated most often by cash. Many consultants and advisors listed limit their help to a few hours annually. A number do not have signed agreements in place and are working with the companies in a less formal capacity.
10. Research projects started may not be finished for a variety of reasons.
These elevator pitches do not purport to be all-inclusive or necessarily to contain all the information that a prospective investor may desire in investigating the Company, and may be subject to updating, withdrawal, revision or amendment. No representation or warranty, express or implied, is or will be given by Leonhardt’s Launchpads, the Company, their advisers or any of their respective directors, shareholders, partners or employees as to the accuracy or completeness of the pitches or the information or opinions contained therein.
Any financial projections given are illustrative only and none of the projections or assumptions should be taken as promises on the part of the Company nor should they be taken as implying any indication, assurance or guarantee that those assumptions are correct or exhaustive.

These pitches contain forward-looking statements. These statements relate to, amongst other things, the Company’s future prospects, developments and business strategies. Forward-looking statements are identified by their use of terms and phrases such as “believe”, “could”, “envisage”, “estimate”, “intend”, “may”, “plan”, “will” or the negative of those, variations or comparable expressions, including references to assumptions.

The forward-looking statements in this Pitch are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by those statements. If one or more of these risks or uncertainties materialises, or if underlying assumptions prove incorrect, the Company’s actual results may vary materially from those expected, estimated or projected. Given these risks and uncertainties, potential investors should not place any reliance on forward looking statements. These forward-looking statements are made only as at the date of the Pitch.

Each recipient of these Pitches must make their own independent assessment of the information provided by the Company and is recommended to seek independent advice on the contents hereof from an authorized person specializing in advising on investments of the kind in question. Neither the Company, Leonhardt’s Launchpads, nor any of their advisers, nor their respective directors, partners, representatives, agents, consultants or employees shall be liable for any direct, indirect or consequential loss or damage suffered by any person relying on statements or omissions from the Pitch and to the maximum extent permitted by law, all conditions, warranties and other terms which might be implied by statute, common law or the law of equity and any such liability are expressly excluded. The Pitch should not be construed as a recommendation to prospective investors by the Company or Leonhardt’s Launchpads, Cal-X Stars Business Accelerator, Inc., or any of their respective officers to invest in the Company, and does not form any commitment by the Company to proceed with an investment. The Company and Leonhardt’s Launchpads, Leonhardt Ventures or Cal-X Stars Business Accelerator, Inc. reserve the right to terminate the procedure at any time and to terminate any discussions and negotiations with any prospective investors at any time and without giving any reason.

Any and all discussions, negotiations and communications, including through any online forums, between any recipient of the Pitches and the Company and their respective directors, shareholders, employees, advisers and/or representatives will remain subject to contract. Any person who invests in the Company at any time must comply with all applicable laws and regulations in force in any jurisdiction in which they acquire, offer or sell shares and must obtain any consent, approval or permission required in respect of any such transaction under the laws and regulations in force in any jurisdiction to which they are subject or in which any such transaction takes place or in which they possess the Pitch. Neither the Company, Leonhardt’s Launchpads, nor any of their respective directors, partners, representatives, agents, consultants or employees shall have any responsibility for any such matters.

The distribution of the Pitches in certain jurisdictions other than California may be restricted by law and therefore persons accessing the Pitch into whose possession the Pitch documents come should inform themselves about and observe any such restrictions. Any failure to comply with these restrictions may constitute a violation of securities laws of any such jurisdiction. Recipients represent and warrant to the Company and Leonhardt’s Launchpads, that they are able to receive the Pitches without contravention of applicable legal or regulatory restrictions in the jurisdiction in which they reside, conduct business or receive the Pitches, including in particular the requirements of the Act.

The individual startups accept highlighted in this listing of elevator pitches accept responsibility for the information contained in each Pitch. The Pitches are meant to only reflect the most positive and optimistic personal opinion of the company founders and nothing more or less. To the best of the knowledge and belief of the Company (who has taken all reasonable care to ensure that such is the case) the information contained in this Pitch is in accordance with the facts and there are by the extreme brief nature of the few line elevator pitches there are indeed facts the omission of which would affect the validity of such information. This information may be obtained elsewhere such as our private placement memorandum, our annual report or the risk and warnings disclaimers proceeding and following the elevator pitches on this page or on the individual startup web sites. These risks include in brief – patents cited may not protect us, patent license agreements may not hold up, patents pending may not be issued, company lacks resources to complete research, early data is not enough to determine definitively if technology works, all agreements are subject to conditions being met and due to lack of financial resources the likelihood and risk of not meeting such conditions is high, many agreements may not be properly ratified or signed, company is underfunded and understaffed and personnel aboard have diverted attention with other jobs and many projects.
The information contained in the Updates section and the Q&A section and any downloaded documents do not form part of the Pitch and have not been reviewed or approved by Leonhardt’s Launchpads Board of Directors or Legal Counsel. Similarly, any information published outside of the Leonhardt’s Launchpads web sites, including on social media platforms (e.g. Facebook, Twitter) or the Company’s news blog, does not form part of the Pitches. Leonhardt’s Launchpads, Leonhardt Ventures and Cal-X Stars Business Accelerator, Inc. assumes no responsibility for information contained in the Q&A or Updates section, downloads or in any form of media outside the Leonhardt’s Launchpads accelerator and such information should not be deemed an offer or invitation to invest or be relied on to invest.

RISK WARNING
Potential investors should be aware of the risks associated with an investment in the Company especially at an early stage in its development and should ensure that they have read and understood the Risk Warning on the Leonhardt’s Launchpads, Cal-X Stars Business Accelerator, or Leonhardt’s Launchpads websites before continuing. If any potential investors are in any doubt regarding the contents of any Pitches, they must consult their own professional financial advisers.
Investment in the Company carries substantial risk and may involve special risks that could lead to a loss of all or a substantial amount of such investment. Unless prospective applicants for shares fully understand and accept the nature of the Company and the potential risks inherent in the Company they should not invest in the Company. A prospective investor should consider carefully whether an investment in the Company is suitable for themselves in the light of their personal circumstances, the economic climate and the financial resources available to them. There can be no assurance that the Company’s objectives in respect to any of its funds will be achieved and investment results may vary substantially over time. As such, an investor’s capital may be at risk.

ANY INVESTMENT IN PRIVATE LIMITED COMPANIES, ESPECIALLY AT AN EARLY STAGE IN THEIR DEVELOPMENT, IS AN INHERENTLY RISKY INVESTMENT. IF YOU ARE IN ANY DOUBT ABOUT INVESTING, LEONHARDT’S LAUNCHPADS RECOMMENDS YOU CONSULT WITH YOUR FINANCIAL ADVISOR.