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KidneyCell

KidneyCell is a startup within the Leonhardt Ventures Cal-X Stars Business Accelerator and Leonhardt’s Launchpads Utah focused on kidney regeneration.

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(424) 291-2133

12130 Millennium Dr, Los Angeles, California, United States of America 90094

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/ – THE COMPANY

About this Venture

Discover our background, mission, and the world-class research driving our next-generation medical technology.

The Problem: Kidney Disease Statistics

  • 661,000 Americans are in kidney failure.
  • 30,000,000+ Americans have chronic kidney disease.
  • Patients have to wait up to 10 years for kidney transplant.
  • There are many side effects associated with kidney transplantations which cost up to $200,000. Side effects include tubular fibrosis. Anti-rejection drugs cost $75,000 to $100,000 annually.
  • There is no effective cure aside from kidney transplantation, too few donors, and a high morbidity and mortality associated with long-term dialysis. Approximately 5-7% of hospitalized patients experience acute kidney injury, a leading cause of mortality in institutionalized settings.

The Human Impact of Long-Term Dialysis & Transplant Waiting Lists

  • 12 Hours: A typical in-center hemodialysis patient spends 12 hours a week attached to a machine.
  • 93% Patients: Among patients ages 18-54 years old at the start of dialysis, 93% were classified as disabled.
  • 100,000: Each year, more than 100,000 Americans begin hemodialysis as a result of kidney failure.
  • 40 Million: 40 Million adult Americans are currently classified as having chronic kidney disease.
  • 13 Patients: Every day 13 patients die waiting for a kidney transplant.
  • 48%: Of Stage 4 CKD patients, 48% were unaware of their severe CKD.
  • 3.5 Times: African-Americans are 3.5x more likely to develop kidney failure.
  • 1.5 Times: Hispanics are 1.5x more likely to develop kidney failure.

Expert Leadership: Decades of Experience in Regenerative Medicine

The core founders of KidneyCell have been working on regeneration therapies since the 1980s and bring deep experience into this development. KidneyCell has assembled an all-star team of scientists, bioengineers, clinicians and advisors to advance this development forward.

/ A - Our Team

Our Team

  • Portrait Placeholder

    Howard Leonhardt

    Executive Chairman and CEO

    Inventor with 22+ U.S. Patents, Founder 30+ startups, Developed Leading Stent Graft System

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    Phil Patton

    President

    21 years medical device innovation experience,...
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    Dr., 

    Leslie Miller

    Chief Medical Officer

    Former Chairman Cardiovascular Medicine University of Minnesota, 80+ clinical trials, 241 publications, Co-Editor leading Text Book Stem Cell Therapies

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    Jeff Donofrio

    Vice President of Marketing

    30 years medical device sales and marketing experience, formerly with Cardiac Assist, Inc.

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    Brian Hardy

    Director of Marketing

    20 years startup marketing experience

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    Dr., 

    Jorge Genovese

    Vice President Bioelectric Regeneration Research

    30 years experience organ regeneration, former Director Cardiac Regeneration Lab University of Utah

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    Dr., 

    Stuart Williams

    Vice President Biologics Research

    35 years experience biologics research, Director Cardiovascular Innovation Institute Regeneration Lab

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    Jeremy Koff

    Vice President Business Development

    30 years medical device development experience primarily with Alfred Mann Companies- Alfred Mann’s nephew

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    Kapil Sharma

    Senior Bioengineer

    MS Bioengineering and Entrepreneurship University of Utah

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  • Portrait Placeholder

    Dr., 

    Samer Banihani

    Chief Nephrology Advisor Nick Kearley

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    Nick Kearley

    Research Assistant

    UCLA Extension Pre-Med, B.S. Degree Operations Management (Boston College, experience with 3 startups)

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/ – THE TECHNOLOGY

The Technology behind it

Discover the science and innovation driving our advanced solutions, designed to deliver safe, effective, and transformative results.

The KidneyCell Solution: A Triple-Therapy Approach to Renal Repair

Focused on total kidney regeneration utilizing:

  1. Bioelectric stimulator
  2. Micro infusion pump
  3. Fifteen component KC-15 kidney regeneration composition for kidney regeneration.

Repairing kidneys the way they are built in the first place with bioelectric signaling, stem cells, growth factors, exosomes, micro RNAS and matrix!

Kidneycell image

Harnessing Biological Potential: Bioelectric Signaling & Stem Cell Integration

The KidneyCell team is developing a product intended for total kidney regeneration utilizing a combination of bioelectric signaling controlled release or regeneration promoting proteins, including a stem cell homing signal, and a re-fillable micro infusion pump that is re-filled daily or weekly with a fifteen component composition comprised of stem cells, growth factors, exosomes, micro RNAs, selected alkaloids, amniotic fluid, PRF, nutrient engineering hydrogel and kidney matrix.

Bioelectric Signaling & Stem Cell Integration

The Bioelectric Protocol: Targeted Sequential Protein Release

The company utilizes bioelectric stimulation to control release of specific proteins on demand for specific regenerative purposes in sequence:

  1. SDF-1 (stem cell homing factor – recruits a persons own stem cells to stimulated tissues)
  2. VEGF (for new blood vessel growth).
  3. IGF-1 (for DNA repair at the nucleus level).
  4. Follistatin (for muscle and tissue regeneration).
  5. RANKL (for demineralization and tissue loosening when needed).
  6. Hepatocyte Growth Factor (tissue regeneration)

Micro Infusion Pump Dual Chamber
Wearable Bioelectric Stimulator
KidneyCell Device
KidneyCell

Regenerative Signaling & Advanced Treatment

  • eNOS (for dilating blood vessels for increasing flow).
  • Tropoelastin (increases elasticity of any tissues such as skin, arteries, aorta, heart and promotes healing of wounds).
  • Activin A + B
  • EGF Epidermal Growth Factor (regeneration)
  • Klotho (kidney regeneration, hypertension treatment)

In extreme cases we combine our regeneration microstimulator with an implantable, programmable, re-fillable stem cell/growth factor micro pump. In cases of kidney cancer we have special signals to stop tumor cell division and blood supply followed by the above regeneration protocol.

Scientific Foundations: The Role of Klotho & FGF in Endocrine Health

  • The Klotho proteins αKlotho and βKlotho are essential components of endocrine fibroblast growth factor (FGF) receptor complexes, as they are required for the high-affinity binding of FGF19, FGF21 and FGF23 to their cognate FGF receptors.
  • FGF21 is a starvation hormone that induces stress responses by activating the sympathetic nervous system and the hypothalamus–pituitary–adrenal axis.
  • FGF19 is a satiety hormone that promotes metabolic responses to feeding.
  • Klotho has been shown to exert pleiotropic actions, including cytoprotection, anti-oxidation, anti-apoptosis, protection of vasculature, promotion of angiogenesis and vascularization, inhibition of fibrogenesis and preservation of stem cells. The exact diagnostic and therapeutic role of Klotho in humans is not fully known yet.
  • Klotho works as a circulating hormone or local autocrine/paracrine factor to exert pleiotropic actions. As in the case of regulation of TRPV5 channels, sKl may target sialic acids to exert its action in different contexts. Other potential mechanisms also exist.

Klotho
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Klotho Signaling & Cardiovascular Protection

  • Inflammation is characterized by an activation of NFκB. Klotho suppresses nuclear factor NFκB activation and the subsequent transcription of proinflammatory genes.
  • Mounting evidence indicates that Klotho is a multifunctional protein that regulates several pivotal signaling pathways, and therefore, its cardioprotective actions in CKD in vivo might be much more complex than targeting ROS/MAPK alone. In addition to interacting with FGF-23, recent studies show that secreted Klotho is able to bind to Wnt ligands, TGF-β type II receptor and FGF receptor-1, respectively, thereby modulating these pathogenic signaling.3,13,14 Because Wnt/β-catenin is a master regulator that controls the expression of multiple RAAS components,15 loss of Klotho in CKD would lead to hyperactivation of RAAS through derepressing Wnt/β-catenin. This will lead to salt and water retention, thereby promoting pressure and volume overload and hypertension, all of which could contribute to LVH.
  • Although distant from each other, the kidney and the heart constantly engage in cross-talk through circulating factors. This study by Yang et al.6 shows that Klotho deficiency in the uremic state is a key factor mediating aberrant kidney and heart interactions. Such insights, as provided by this interesting study by Yang et al.,6 may lead to translational studies aimed at lowering CVD events and mortality in patients with CKD.

/ ? — FAQ

Common questions

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  1. KidneyCell = non-invasive bioelectric stimulation for kidney recovery
  2. KidneyCell Plus Lite Biologics = bioelectric stimulation + PRF and regenerative fluid (exosomes OR amniot fluid) therapy for kidney recovery
  3. KidneyCell Plus Full Biologics = bioelectric stimulation + stem cells + 14 support factors for kidney regeneration delivered via implantable bioelectric stimulator and re-fillable infusion pump with pacing infusion catheter directed to kidneys.
  4. KidneyCell Plus Second Heart Assist = bioelectric stimulation + full biologics + Second Heart Assist circulatory assist wireless powered aortic stent pump placed in aorta just above renal arteries.

Bioelectric

Bioelectric produced SDF1 and PDGF for stem cell homing and proliferation and kidney regeneration
Bioelectric produced klotho for kidney regeneration
Bioelectric produced EGF for kidney regeneration
Bioelectric produced Follistatin for kidney regeneration
Bioelectric produced COL17A1 for kidney regeneration
Bioelectric produced HGF for kidney regeneration
Bioelectric produced Tropoelastin for kidney regeneration
Bioelectric produced HIF1a for kidney regeneration

Biologics

Stem cells (any or all from list) for kidney regeneration including hypoxia treated MSCs, adipose derived cells, urine derived kidney stem cells, placenta, amniotic membrane and umbilical cord cells, endothelial progenitor cells

Growth factor cocktail gel for kidney regeneration – https://www.sciencedaily.com/releases/2019/05/190531085406.htm

Selected alkaloids for kidney regeneration

  • Klotho soluble for kidney regeneration
  • Exosomes for kidney regeneration

Micro RNA gel for kidney regeneration

  • Amniotic fluid for kidney regeneration
  • Oxygenated nanoparticles
  • Stromal fraction from adipose tissue for kidney regeneration
  • Bioelectric treated PRF for kidney regeneration
  • Matrix for kidney regeneration
  • Nutrient hydrogel for kidney regeneration
  • Wharton’s Jelly for kidney regeneration
/ – KNOWLEDGE BASE

Related resources

Want to learn more? Browse our clinical resources and scientific publications on our comprehensive suite of targeted treatments.

KidneyCell Internal Clinical Data & Protocols

This group contains core proprietary documents, executive summaries, and preliminary data results specific to the KidneyCell regeneration system.

Executive Summary

A strategic overview of KidneyCell’s mission, its role within Leonhardt Ventures, and the market need for regenerative renal solutions.

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Proposed Clinical Study Protocol

Detailed roadmap and methodology for upcoming clinical trials focused on total kidney regeneration.

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KidneyCell II Clinical Study Results Table

A data repository containing preliminary results and outcome tables from the second phase of clinical testing.

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KidneyCell Pilot Study

Formal report on the initial pilot testing phase, demonstrating early proof-of-concept for bioelectric renal therapy.

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Clinical Trials Overview

Comprehensive documentation of the clinical trial landscape for Bioelectric Stimulation (BES) in renal failure.

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Leonhardt MicroStimulator II / Implantable Option

Technical specifications for the implantable micro-stimulator hardware designed for targeted regenerative signaling.

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Electric Stimulation for Kidney Study

A technical white paper and study details provided by Leonhardt Ventures, exploring the specific mechanisms and efficacy of bioelectric stimulation in renal tissue repair.

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The Klotho Protein & FGF23 Axis

This group focuses on the “anti-aging” Klotho protein, which is a central signaling component of the KidneyCell bioelectric protocol.

Patent Filing for Bioelectric Controlled Klotho Expression

News regarding Leonhardt’s patent for using specific electrical signals to trigger the body’s endogenous Klotho production.

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Renal and Extrarenal Actions of Klotho

A study on how Klotho functions as a hormone affecting both the kidney and overall systemic health.

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Secreted Klotho and Chronic Kidney Disease (Europe PMC)

Research detailing how low levels of secreted Klotho serve as a marker and driver of CKD progression.

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Secreted Klotho and Chronic Kidney Disease (PMC Archive)

An in-depth look at Klotho deficiency in the uremic state and its systemic complications.

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Klotho/FGF23 Axis in Chronic Kidney and Cardiovascular Disease

Exploring the vital relationship between mineral metabolism, heart health, and kidney function via Klotho.

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Association between Soluble Klotho and Change in Kidney Function

A longitudinal study linking levels of soluble Klotho to the rate of decline in renal capacity.

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Treating Systemic Klotho Deficiency (Karger)

A study on the therapeutic potential of restoring Klotho to treat systemic organ decline.

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Treating Systemic Klotho Deficiency (AJN)

Clinical insights into Klotho replacement as a strategy for managing chronic renal conditions.

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Correlation between Soluble α-Klotho and Renal Function (Meta-Analysis)

A systematic review confirming the statistical link between Klotho levels and kidney health stages.

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The Klotho Proteins in Health and Disease (Nature)

High-level scientific review of Klotho’s role in cytoprotection and anti-fibrosis.

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The Role of Klotho Protein in CKD: Animal and Human Studies

Research showing the regenerative impact of Klotho across various biological models.

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The Role of Klotho in Chronic Kidney Disease (Review)

A comprehensive analysis of how Klotho modulates signaling pathways in CKD.

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Klotho Protein: An Overview

Foundational science regarding Klotho’s function as a multifunctional protein.

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Loss of Klotho in CKD Breaks One’s Heart

Critical research on the cardiorenal syndrome and how kidney health directly impacts the heart.

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Klotho Supplementation and Diabetic Kidney Health

Study on reducing renal hypertrophy and blood pressure in Type 2 Diabetes models using Klotho.

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Urinary Extracellular Vesicles Carrying Klotho

Investigating how Klotho-enriched vesicles can improve the recovery of renal function.

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Klotho to Treat Kidney Fibrosis

Clinical study on using Klotho to inhibit and reverse the scarring of kidney tissue.

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Renal Klotho Expression in Acute Kidney Injury (AKI)

Proving the correlation between Klotho loss and the severity of acute renal damage.

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Significance of the Anti-Aging Protein Klotho

An overview of the systemic benefits and anti-aging potential of this regenerative protein.

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Klotho Deficiency Aggravates Sepsis-Related Dysfunction

Exploring the protective role of Klotho during severe systemic inflammation and organ failure.

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New Insights into the Mechanism of Soluble Klotho

Frontiers in Endocrinology article on the molecular pathways used by soluble Klotho.

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Klotho: A Major Shareholder in Vascular Aging

Investigating Klotho’s role in preventing the calcification and aging of the vascular system.

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Fibroblast Growth Factor-23 and Klotho in CKD

Analysis of how FGF-23 and Klotho work together to regulate mineral balance in the blood.

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Klotho and Kidney Function Decline (AJKD)

An Important Step Forward in Understanding the Link Between Mineral Metabolism and Progression.

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Klotho Supplementation and Oxidative Stress in Diabetes

Clinical study showing how Klotho can mitigate hypertension and stress in diabetic renal models.

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Klotho Ameliorates Medullary Fibrosis in Hypertensive Kidneys

Research on improving the kidney’s response to high blood pressure through Klotho restoration.

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Klotho Gene Deficiency and Salt-Sensitive Hypertension

Identifying Klotho loss as a primary driver of inflammation-mediated high blood pressure.

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In Vivo Klotho Gene Transfer to Ameliorate Renal Damage

Landmark study on using gene transfer to heal damaged renal structures.

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Bioelectric Stimulation & Bioelectronic Medicine

This group highlights the use of electrical stimulation to trigger DNA repair and biological responses for kidney healing.

Bioelectric Stimulation and DNA Damage Reduction

First-time clinical evidence that bioelectric signals can reduce cellular DNA damage in kidney failure patients.

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Neuromuscular Electrical Stimulation in Chronic Kidney Failure

A Systematic Review and Meta-analysis confirming the benefits of electrical stimulation for CKF.

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Neuromuscular Electrical Stimulation (KidneyCell Hosted PDF)

A review of the physiological impacts of electrical stimulation on renal function and muscle health.

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Bioelectronic Approaches to Neuroimmune Interactions in AKI

Research on using bioelectronics to control the immune response during acute kidney injury.

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Electrically Stimulated Acupuncture and Renal Blood Flow

Study showing how specific stimulation increases renal blood flow via micro-RNA carrying exosomes.

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Regenerative Medicine & Stem Cell Therapy

This group explores the use of stem cells, organoids, and bio-scaffolds in rebuilding functional kidney tissue.

Mesenchymal Stem Cell (MSC) Therapy for Renal Failure

Recent updates and publications regarding stem cell treatment for acute and chronic renal failure.

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Stem Cells Help Reduce Kidney Transplant Rejection

A video resource explaining the role of stem cells in improving transplant success and reducing rejection.

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Making New Kidneys: Insights into Regeneration

A Bangor Daily News feature on the future of bio-engineering kidneys.

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Renal SDF-1 Signals and Stem Cell Homing

Research into how SDF-1 signals (used in KidneyCell protocols) recruit repair cells to damaged kidneys.

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SDF1 Induction and Kidney Cell Subtype Distribution

Study on how SDF1 signals regulate cellular distribution within the kidney after injury.

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Mini Kidneys Grown from Stem Cells

News on laboratory-grown “organoids” and their potential for testing regenerative therapies.

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Kidney Cells Generated From Stem Cells

MedPage Today feature on breakthroughs in renal tissue engineering.

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Gel-Based Delivery System for Stem Cell Factors

Scientists develop specialized delivery gels (hydrogels) for the precise release of growth factors.

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IKKα in Kidney Recovery and Regeneration

Molecular research on the role of specific proteins in healing renal tissue after ischemic injury.

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De Novo Kidney Regeneration with Stem Cells

Research on rebuilding renal function from scratch using cellular scaffolding.

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Regenerative Medicine in Kidney Disease (Nature Reviews)

Comprehensive overview of the future prospects and current progress in renal regeneration.

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Regenerative Medicine: Stem Cell Prospects & Challenges

Discussion on the hurdles and potential of clinical-grade stem cell applications for kidneys.

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Extracellular Vesicles in Renal Disease

Analysis of the clinical potential of extracellular vesicles as a therapy for kidney conditions.

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/ – INSIGHTS & PERSPECTIVES

Related posts

Want to learn more? Browse our clinical resources and scientific publications on our latest updates and insights.

CAUTION Disclaimer and Warning: Products described on this web site are in early stage development and are not yet proven safe or effective in statistically significant controlled clinical studies. Any statement or phrases implying efficacy or safety in any form are considered modified by “intended to” or “designed to”. Investigational use only in countries where investigation is permitted by law and proper filings have been made and appropriate regulatory clearances have been granted. Any use of the product(s) must be in an authorized clinical study with institutional review board (ethics committee) approval and proper patient consent procedures followed. For other countries product is only available for laboratory investigation by credentialed institutions and investigators with proper clearances with a research agreement in place with a study sponsor. NOT AVAILABLE FOR SALE.

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The KidneyCell team is pioneering a triple-therapy approach combining bioelectric signaling, a programmable micro infusion pump, and our proprietary KC-15 regeneration composition. Our mission is to provide a viable alternative to dialysis and long-term transplant waiting lists through advanced regenerative medicine.

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