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Cardiology and cardiovascular cell therapy and tissue engineering

Healthcare Blogs - Healthcare Reflections Blogs

The amount of activity, both in development and in commercialized technology, in the field of cell therapy and tissue engineering has been enormous in the past few years, stemming from advances in stem cell therapy and cell biology in general.  One should not be surprised to see the number of active companies and products in this area.

If one were to examine a narrow niche in cell therapy and tissue engineering, such as in cardiology and cardiovasular applications, one might nonetheless be startled at the specific activity.  See below

CompanyDevelopmental/ PreclinicalClinicalsApproved / Marketed
3DM Inc.Orthopedic, cardio scaffolds
Aastrom Bioscience Inc.Cardio: IMPACT-DCM, Phase II; Vascular: RESTORE-CLI
Advanced Cell Technology, Inc.Myoblasts for heart failure, completed Phase I human
AdvanSource BiomaterialsCardioPass
Aldagen, Inc.Ischemic heart failure, 2013
Angioblast Systems, Inc.Adult stem cells for CHF, acute, MI, macular degeneration, and cord blood transplantation, 2012
Angiotech Pharmaceuticals, Inc.Working with Athersys to develop MultiStem for heart damageCollagraft, Neugraft bone graft matrices
Arteriocyte Medical Systems, Inc.ACY001 and ALO212 for lower extremity ischemiaACY001 for chronic cardiac ischemia (Phase I)
Athersys, Inc.MultiStem AMI
Baxter International Inc.Isolex stem cell therapy for chronic myocardial ischemia and critical limb ischemia; ACT34-CMI (adult autologous cellular therapy CD34+ stem cells for chronic myocardial ischemia); ACT34-CLI (injection of autologous CD34+ positive cells for critical limb ischemia)
BeFutur BiotechnologiesCellular implants for the regeneration of damaged heart tissue
Bio Nova InternationalCABG graftOmniflow II (biosynthetic vascular prosthesis for peripheral revascularization and arteriovenous access)
Bioheart Inc.BioPace biological "pacemaker"; Allocell allogenic cell therapy for severe chronic heart damageMyoCell for heart failure (MARVEL, SEISMIC, MYOHEART, REGEN; ASC Treatment (generate adipose-derived stem cells from patient's fat tissue, not FDA evaluated yet, for research only)Bioheart Acute Cell Therapy (TGI 1200) for acute MI
California Stem Cell Inc.Therapeutics for coronary heart disease
Capricor, Inc.Autologous cardiac stem cells for direct injection and matrix delivery treatment of myocardial infarctionAutologous cardiac stem cells for catheter infusion treatment of myocardial infarction and heart failure
Capstone TherapeuticsChrysalin (Rusalatide Acetate or TP508) for angiogenesis, revascularization, vascular endothelial dysfunction (AMI, chronic myocardial ischemia)
CellSeed, Inc.Regenerative cardiac patch (pulsating, living cardiomyocyte cardiac patch on the heart)
Cook GroupRegenerative tissue scaffolds
CryoLife, Inc.CryoValve SG pulmonary heart valve and the CryoPatch SG pulmonary cardiac patch (CryoPatch SG)
Cytograft Tissue EngineeringLifeLine TE blood vessel (TEBV), LifeJacket Stent Graft (AAA), LifeGuard soft tissue reinforcement patch
Cytori Therapeutics Inc.Adipose-derived stem and regenerative cells for AMI, chronic myocardial ischemia
ES Cell InternationalNeural progenitor cells (w/ CellCure); pancreatic progenitor cellsEmbryonic stem cell lines (cardiomyocytes)
Garnet BioTherapeuticsCell therapy for scar reduction, myocardial infarction
Genzyme CorporationBiopharm for cardiometabolic/renal diseasesBiopharm for genetic diseases, cardiometabolic/renal diseases
Geron CorporationRegenerative medicine (glial cells, cardiomyocytes, islets, chondrocytes, osteoblasts, hepatocytes)
HumacyteProof of concept for a Vascular replacement (also R&D for products for cardiovascular, cosmetic, soft tissue reconstruction, neurosurgical and orthopedic)
Kensey NashCollagen biomaterials for regeneration of cardiac tissue
MedtronicInvested in cardiovascular research efforts at MG Biotherapeutics, REMEDI, Scill Technology (dental implant)Cardio, ortho, neuro stem cell-based products
Mesoblast LimitedMesenchymal precursor cells for cardiovascular regeneration
MG Biotherapeutics, LLCAutologous cell therapies for damaged heart tissueMAGIC trial (myoblast autologous grafting in ischemic cardiomyopathy)
Miltenyi BiotecAdult, autologous stem cell therapy for myocardial regeneration
NellOne Therapeutics, Inc.Therapeutics to treat heart damage
OrganovoNovoGen 3-D bioprinter to create artificial arteries and tissueNovoGen 3-D bioprinter being distributed to researchers
Osiris Therapeutics Inc.Prochymal for heart tissue repair after heart attack
Pluristem Therapeutics, Inc.PLX-PAD therapeutic for critical limb ischemia
ReNeuron Ltd.ReN009 stem cell therapy for peripheral artery disease (uses CTX stem cell line)
Stem Cell Therapy International, Inc. / HistostemRegenerative stem cell transplantation
Targeted Genetics CorporationMYDICAR enzyme replacement therapy for heart failure
Tepha Inc.Intracardiac defect closure, absorbable cardiovascular stents
TriStem CorporationCreating stem cells from adult cells (retrodifferentiation technology) for cancer (leukemia), organ, neurology, cardiology

Source: MedMarket Diligence, LLC; Report #S520.

In the 2010 MedMarket Diligence report #S520, “Tissue Engineering, Cell Therapy and Transplantation Worldwide”, we detailed the technology, product, company and market activity of the spectrum of cell/tissue developments. Highlighting only cardiology/cardiovascular, above, gives evidence to the size of the broader market.

It seems that many stakeholders in companies at the early stages of development in this field generally do not recognize the extent to which this is a current, active market of available products, not some basic research (e.g., biotech “industry”) in which billions of dollars change hands (from VC to entrepreneurs) with little coming back in clinically approved product revenue.  An even larger volume of technology that, while it may not have been approved yet, is deep in the process of seeking approval. It was for this reason that we were able to definitively characterize this $6.9 billion global market, forecast to exceed $30 billion by 2018.

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