LiverCell Technology

4.5 million Americans have diagnosed liver disease

patent pending bioelectrical signaling sequences

liver regeneration

Instead of a donor liver treating one patient, LiverCell is designed to enable a patient to regenerate their own liver.

Instead of major surgery, LiverCell uses a small endovascular infusion catheter with bioelectric stimulation leads built in connected to a small re-fillable infusion pump and bioelectric stimulator placed just under the skin which are designed to regenerate back to full function a patent’s own liver.

THE FUTURE IS 100% NON-INVASIVE THERAPY FOR LIVER REGENERATION AND LIVERCELL PLANS TO LEAD THE WAY!

Instead of a using a minimally invasive infusion catheter and stimulation leads as we are in our first generation product our second generation LiverCell product is designed to regenerate livers with a 100% non-invasive approach. This is done getting our bioelectric signaling sequence signals to the right places to affect the right protein releases to enable liver regeneration without any invasive procedure required. The bioelectric signals will be delivered from outside of the patient’s body! Non-invasive bioelecdtric therapy has already demonstrated successful results in a number of studies for other organs including kidneys with success and our LiverCell team is adapting that core technology now for liver regeneration.

OUR PIPELINE

LiverCell Endo-Bioelectric

Pre-clinical

LiverCell Endo-Bioelectric+Biologics

Pre-clinical

LiverCell Non-Invasive

Clinical studies expected to launch 2H 2019

LiverCell Team

Howard Leonhardt

Executive Chairman & CEO

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Ben Boytor

President

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Dr. Leslie Miller

Chief Medical Officer

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Dr. Jorge Genovese

Vice President Bioelectric Regeneration Research

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Dr. Stuart K. Williams

Vice President Biologics Research

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LiverCell History

In the late 1980’s shortly after the publication of the book The Body Electric, Howard Leonhardt LiverCell co-founder, contacted author Dr. Robert Becker to discuss collaboration in research in organ regeneration with a first research project on limb salvage for patients with severe lower limb ischemia. That eventually led to a paper published in 1999 in Circulation the Journal of the American Heart Association working with Dr. Shinichi Kanno and a first patent for bioelectric based limb salvage, new blood vessel growth and ischemia treatment. In 1988 Leonhardt collaborators and advisors Dr. Race Kao and Dr. George Magovern that completed the first case of muscle stem cell repair of a damage heart in large animals which was published in The Physiologist in 1989.

In 1994 Leonhardt teamed up with Dr. Stuart Williams and Dr. Robert Kellar, then both at the University of Arizona, whom are pioneers in biologics research and product development. Dr. Williams secured the first patent for harvesting endothelial cells and stem cells from adipose tissue. Dr. Kellar is a leading developer of regenerative fluids derived from amniotic sources. Both Dr. Wiliams and Dr. Kellar remains key advisors to our innovation accelerator and LiverCell today. That same year Leonhardt began organ recovery research at LABiomed in Torrance, CA in animal labs where he still continues pre-clinical research today.

In 1995 Howard Leonhardt filed the first patent on a stem cell delivery system for internal organs – ProCell. That same year Leonhardt led a team in Australia with Dr. Ken Thomson and Dr. Peter Field that completed the historic first non-surgical repair of an aortic aneurysm (this later led to a 1998 acquisition of this technology by Medtronic AVE as well as a percutaneous heart valve, the stem cell delivery catheter PROCELL and an intravascular lung). That led to meeting Dr. Doris Taylor whom in 1998 published a landmark paper in Nature Medicine on myoblast based regeneration of damaged hearts.

In early 2001 a team led by Leonhardt in The Netherlands working with Professor Patrick Serruys, Dr. Warren Sherman, Dr. Kumar Ravi and Dr Pieter Smits completed the historic first ever non-surgical muscle stem cell base repair of a human heart. This was later published as part of a study in the Journal of American College in 2002 Smits et al. That same year Howard Leonhardt filed the first of his series of bioelectric and/or stem based composition organ regeneration patents. The first one focused on myogenesis (regenerating heart, smooth or skeletal muscle). Around that time Ben Boytor, President of LiverCell, joined the Leonhardt led team and he helped spearhead the effort to get into 35 clinics in the USA and 5 centers in Europe with FDA cleared Phase I, then Phase II, then Phase II/III double blinded, randomized, placebo controlled studies.

He also helped the team achieve the very first FDA clearance for a combination cell and gene therapy product for organ regeneration MyoCell II with SDF1. In 2008 Leonhardt moved from Florida to California and formed an innovation accelerator lab at first headquartered on the campus of the University of Northern California in Santa Rosa, California in their UNC Foundation Science and Technology Innovation Center (UNC STIC). The work in this lab, named Leonhardt’s Launchpads @ UNC STIC, focused on applying everything learned since the 1980’s on bioelectric and biologics based organ regeneration, which had mostly focused on heart and limb regeneration up to that point, to see if it could be improved upon and applied to other organs such as kidneys, liver, pancreas, eyes, lungs, skin, and aortas. Leonhardt has served on the UNC Foundation and University Board of Directors since 1999 and was co-founder of their UNC STIC life science incubator.

In 2012 the Leonhardt’s Launchpads headquarters moved to Los Angeles where it remains today. In late 2015 a branch lab and accelerator was opened in Utah, in 2016 a branch location in Minneapolis opened and in late 2018 in Pittsburgh and Australia. The Leonhardt’s Launchpads accelerator(s) now have 30 startups www.leonhardtventures.com all focused on organ regeneration and recovery and all but one based on same core IP platform of bioelectrics and biologics. 13 products are at clinical stage of development as of May 2019 and another 17 are in pre-clinical studies. Data has been gathered on 220 bioelectric therapy patients as of May 2019 coverage a variety of organs and the team has a goal to have data or enrollment towards data gathering on 500 patients by the end of 2019. Thus far about 83% of patients treated have had successful results and no serious adverse events have been reported. Due to the early stage nature of these pilot studies the company does not make any claims that safety of efficacy has bee proven yet.

The LiverCell team is supported by over 100 innovation accelerator mentors and advisors with decades of experience in organ regeneration, startup and medical device development. We believe no other team brings to the table the bioelectric and biologics based organ regeneration experience that our team has dating back to the 1980’s.