SlideShare une entreprise Scribd logo
1  sur  37
[object Object],[object Object],[object Object]
Forward-Looking Statement ,[object Object],[object Object],[object Object]
Company Thesis ,[object Object],[object Object],[object Object],[object Object],[object Object]
Heart Disease is the Leading Cause of Death Worldwide ,[object Object],[object Object],[object Object],[object Object]
MyoCell ®  Cell Therapy Overview ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Myoblast Engraftment Post-Transplantation Contractile muscle tissue growing in the scarred portion of the heart following treatment with myoblast injections. Human Heart, Proof of Concept *  Hagege et al., Viability and Differentiation of Autologous Skeletal Myoblast Grafts in Ischemic Cardiomyopathy,  Lancet, Vol. 361, 2003: 491-492
MyoCell: Heart Failure Treatment Process Scar tissue following heart attack Injection of skeletal myoblasts into scar tissue using deflecting-tip catheter Cell manufacturing following thigh muscle biopsy 1 3 2
Bioheart Has Addressed CHF with Myocell Including third-party studies, myoblasts have been evaluated in at least 11 clinical trials involving more than 345 enrollees and more than  255 treated patients Trial # of Patients Status Primary Endpoints EU Phase I/II 5 Phase I 15 Phase I/II Completed Q2 2003 ,[object Object],[object Object],MYOHEART (US, Phase I) 20 Completed Final Patient Treated Q4 2006 ,[object Object],SEISMIC (EU, Phase II-a with Control) 40 (14 control) Completed Final Patient Treated Q3 2007 ,[object Object],[object Object],MARVEL Trial (N. Am./EU: Phase II/III, Double-blind, Placebo-controlled) 150 anticipated (50 controls) Stage 1 Results Announced First Patient Enrolled and Treated Q4 2007 ,[object Object],[object Object],[object Object]
Journal of the American College of Cardiology, Vol. 42, No. 12, 2003,  Serruys, Smits et al.  Study sponsored by Bioheart, Inc. LVEF Measured via LAO LV Angio.  3 month, p=0.009; 6 month, p=0.23.  N = 5. Percutaneous Intramyocardial Transplantation of Autologous Myoblasts: Bioheart First-In-Man Experience LVEF (%)
Percutaneous Intramyocardial Transplantation of Autologous Myoblasts – BIOHEART Phase I/II Trial Results for these trials were not statistically significant due, in part, to the limited number of patients treated. Baseline 6 Months 12 Months N = 13  N = 13  N = 13  LVEF: Mean Baseline = 34.4%  +  7.4   Mean 12-Month Follow-up = 36.6%  +  9.6 NYHA Class Improvement
Measurements via PV Loop, n=5. 33 41 190 150 4.6 5.6 Percutaneous Intramyocardial Transplantation of Autologous Myoblasts – BIOHEART Phase I/II Trial LVEF  CO  LVESV
Bioheart Percutaneously Delivered Myoblasts Clinical Trial Data Summary EU FIM, Phase I/II Adjudicated Data (n = 5+15)  Safety • 2 patient deaths (10%) Efficacy • 4/5 of patients improved one  heart failure class • 1/3 of patients improved two  heart failure classes • 1/3 of patients experience ~ 35%  relative improvement in LVEF • 15.3% improvement in Wall  Motion Score Index via stress echo • 13% reduction of LVED volume ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Bioheart Phase I/II Trial (005/006).
*  All 5 treated patients withdrew due to changes in German biopsy regulations. ** Both control patients withdrew after knowledge of randomization allocation. Bioheart Percutaneously Delivered  Myoblasts EU Phase II Trial (SEISMIC) 47 Patients Randomized:  ICD Patients: 31 MyoCell ® ,  16  Standard Medical Therapy Treatment Arm  ( MyoCell ® 150 - 800 x 10 6 ) 26 ICD Patients Control Arm (Standard Medical Therapy) 14 ICD Patients  Baseline Evaluation Screening:  62 ICD Patients 15 Screen Fails 5 Withdrawals* 2 Withdrawals**
SEISMIC   NYHA heart failure class Improvement Myoblast therapy Control therapy N=26 N=23 N=22 N=20 N=14 N=9 N=12 N=13 BL 1 mo 3 mo 6 mo BL 1 mo 3 mo 6 mo
SEISMIC  +60.3 m  +  54.1 -0.2 m ± 177.1 Treatment N=26 N=21 N=19 Control Control N=14 N=12 N=13 448 m 441 m 406 m 466 m 6-Minute Walk Test Improvement Difference Between Baseline and 6 Months
SEISMIC   Response to Treatment  NYHA HF / 6MWT / MLFQ / LVEF
MYOHEART US Phase I Study Flow Clinical Sites:   Columbia Presbyterian, Cleveland Clinic,   Mayo  Clinic,   Minneapolis Heart, St. Joseph ’ s / ACRI Core Lab:   Gentiae Clinical Research  2 injections (.25 cc) 6 injections (.25 cc) 18 injections (.25 cc) First Cohort (n=5) 25 x 10 6 cells 30 - Day Safety  Evaluation Second Cohort (n=5) 75 x 10 6 cells 30 - Day Safety  Evaluation Third Cohort (n=5) 225 x 10 6 cells 30 - Day Safety  Evaluation Fourth Cohort (n=5) 675 x 10 6 cells 27 injections (.50 cc)
MYOHEART  6MWT Average 6 Minute Walk Test – All Cohorts 6MWT (meters) N=20 422 474 471 N=18 N=15 47 36 N=15 6MWT (meters) N=18 All Patients Paired Analysis p = .0074 p = .2126 474 N=17 42 p = .1367 N=17
MYOHEART MLHFQ Average Minnesota Living with Heart Failure Score All Cohorts MLHF Score N=20 51 34 33 N=19 N=18 -14 -16 N=19 N=18 All Patients Paired Analysis p = .0016 p = .0004 MLHF Score 30 N=18 N=18 -18 p = .0006
Bioheart MARVEL Program Unique Features and Goals
MARVEL Program Study Objectives / End Points ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
p=0.50 MARVEL-1: Mean Change in 6-Minute Walk Distance (meters) n=6 n=7 n=6
MARVEL-1 Arrhythmia Analysis:  Myocell ®  Patients Amiodarone started  Amiodarone continued Myocell ®  Txt 14 Patients No  Amiodarone Txt n= 7 4 Patients 4 Episodes VT Amiodarone Started at Implant or Stopped n=3 Amiodarone Started at Bx n=4 2 Patients 2 Episodes VT 0 Patients 0 Episodes VT 0 Episodes VT 1 Patient 1 Episode VT
Competitive Advantage ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Competition – Congestive Heart Failure
Myoblast – Cell culture Process Development Manufacturing process is protected, scalable and reliable
Myoblasts vs. Bone Marrow Stem Cells for Cardiac ,[object Object],[object Object],[object Object],Combined Transplantation of Skeletal Myoblasts and Mesenchymal Cells (Cocultivation) in Ventricular Dysfunction After Myocardial Infarction.   Souza et al., Arg Bras Cardiol. 2004 Oct; 83(4):294-9; 288-93. ,[object Object]
Bone Marrow Mesenchymal Stem Cell Study ,[object Object],[object Object],[object Object],[object Object]
Bone Marrow Stem Cells Do Not Convert to Muscle ,[object Object],[object Object],[object Object],[object Object]
Bioheart:  The FDA Approved REGEN Trial Next Generation: MyoCell ®  SDF-1 Increased muscle formation  Increased blood vessel supply Endogenous circulating stem cells attracted to injury by chemokine proteins Damaged area secretes chemokine proteins Adult stem cells SDF-1 Cells Four years of sponsored animal studies have demonstrated that 2nd generation  MyoCell  ®   SDF-1 provides significantly higher levels of improvement than the first  generation MyoCell  ®  composition.
REGEN Trial – MyoCell SDF-1 ,[object Object],[object Object],[object Object],[object Object]
Manufacturing MyoCell ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 
 
 
 
[object Object],[object Object],[object Object]

Contenu connexe

Tendances

IGX Investor Presentation
IGX Investor PresentationIGX Investor Presentation
IGX Investor PresentationItelGenx
 
26 jack h. mendelson - 5552406 - method for treating pain and brain perfusi...
26   jack h. mendelson - 5552406 - method for treating pain and brain perfusi...26   jack h. mendelson - 5552406 - method for treating pain and brain perfusi...
26 jack h. mendelson - 5552406 - method for treating pain and brain perfusi...Mello_Patent_Registry
 
autohémothérapie en anglais
autohémothérapie en anglaisautohémothérapie en anglais
autohémothérapie en anglaisYahya Al Ansari
 
Galena presentation 11 jan 17
Galena presentation   11 jan 17Galena presentation   11 jan 17
Galena presentation 11 jan 17Galenabio
 
10 the importance of audit to monitor applications of procedures and improve ...
10 the importance of audit to monitor applications of procedures and improve ...10 the importance of audit to monitor applications of procedures and improve ...
10 the importance of audit to monitor applications of procedures and improve ...NPSAIC
 
IntelGenx Presentation Apr 2018
IntelGenx Presentation Apr 2018IntelGenx Presentation Apr 2018
IntelGenx Presentation Apr 2018ItelGenx
 
Sawc Carman Brown Op Poster Orlando, Fl 04.10
Sawc Carman Brown Op Poster Orlando, Fl 04.10Sawc Carman Brown Op Poster Orlando, Fl 04.10
Sawc Carman Brown Op Poster Orlando, Fl 04.10Bradley Ford
 
Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent Endeavor...
Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent 	 Endeavor...Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent 	 Endeavor...
Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent Endeavor...MedicineAndFamily
 
Galena presentation 9 feb 17
Galena presentation   9 feb 17Galena presentation   9 feb 17
Galena presentation 9 feb 17Galenabio
 
Transplant Nephrectomy Improves Survival following a Failed Renal Allograft (...
Transplant Nephrectomy Improves Survival following a Failed Renal Allograft (...Transplant Nephrectomy Improves Survival following a Failed Renal Allograft (...
Transplant Nephrectomy Improves Survival following a Failed Renal Allograft (...Raj Kiran Medapalli
 
Recro vs Actavis Case 1:14-cv-01118-GMS Appendix of Trial Evidence
Recro vs Actavis Case 1:14-cv-01118-GMS Appendix of Trial EvidenceRecro vs Actavis Case 1:14-cv-01118-GMS Appendix of Trial Evidence
Recro vs Actavis Case 1:14-cv-01118-GMS Appendix of Trial EvidenceAndrew Cunningham
 
Chmis20161143c chiesi haemophilia b gene therapy advisory board
Chmis20161143c chiesi haemophilia b gene therapy advisory boardChmis20161143c chiesi haemophilia b gene therapy advisory board
Chmis20161143c chiesi haemophilia b gene therapy advisory boardTim Robinson
 

Tendances (20)

JSM2012-HybridPMS-Liao-v3
JSM2012-HybridPMS-Liao-v3JSM2012-HybridPMS-Liao-v3
JSM2012-HybridPMS-Liao-v3
 
IGX Investor Presentation
IGX Investor PresentationIGX Investor Presentation
IGX Investor Presentation
 
26 jack h. mendelson - 5552406 - method for treating pain and brain perfusi...
26   jack h. mendelson - 5552406 - method for treating pain and brain perfusi...26   jack h. mendelson - 5552406 - method for treating pain and brain perfusi...
26 jack h. mendelson - 5552406 - method for treating pain and brain perfusi...
 
autohémothérapie en anglais
autohémothérapie en anglaisautohémothérapie en anglais
autohémothérapie en anglais
 
Mast apr13pres
Mast apr13presMast apr13pres
Mast apr13pres
 
Galena presentation 11 jan 17
Galena presentation   11 jan 17Galena presentation   11 jan 17
Galena presentation 11 jan 17
 
Writing Sample
Writing SampleWriting Sample
Writing Sample
 
Trius mar13presentation
Trius mar13presentationTrius mar13presentation
Trius mar13presentation
 
10 the importance of audit to monitor applications of procedures and improve ...
10 the importance of audit to monitor applications of procedures and improve ...10 the importance of audit to monitor applications of procedures and improve ...
10 the importance of audit to monitor applications of procedures and improve ...
 
Aha 2 mr lipid
Aha 2 mr lipidAha 2 mr lipid
Aha 2 mr lipid
 
Atherothrombosis
AtherothrombosisAtherothrombosis
Atherothrombosis
 
IntelGenx Presentation Apr 2018
IntelGenx Presentation Apr 2018IntelGenx Presentation Apr 2018
IntelGenx Presentation Apr 2018
 
Sawc Carman Brown Op Poster Orlando, Fl 04.10
Sawc Carman Brown Op Poster Orlando, Fl 04.10Sawc Carman Brown Op Poster Orlando, Fl 04.10
Sawc Carman Brown Op Poster Orlando, Fl 04.10
 
Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent Endeavor...
Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent 	 Endeavor...Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent 	 Endeavor...
Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent Endeavor...
 
Effortles Trial
Effortles TrialEffortles Trial
Effortles Trial
 
Galena presentation 9 feb 17
Galena presentation   9 feb 17Galena presentation   9 feb 17
Galena presentation 9 feb 17
 
Transplant Nephrectomy Improves Survival following a Failed Renal Allograft (...
Transplant Nephrectomy Improves Survival following a Failed Renal Allograft (...Transplant Nephrectomy Improves Survival following a Failed Renal Allograft (...
Transplant Nephrectomy Improves Survival following a Failed Renal Allograft (...
 
Recro vs Actavis Case 1:14-cv-01118-GMS Appendix of Trial Evidence
Recro vs Actavis Case 1:14-cv-01118-GMS Appendix of Trial EvidenceRecro vs Actavis Case 1:14-cv-01118-GMS Appendix of Trial Evidence
Recro vs Actavis Case 1:14-cv-01118-GMS Appendix of Trial Evidence
 
Chmis20161143c chiesi haemophilia b gene therapy advisory board
Chmis20161143c chiesi haemophilia b gene therapy advisory boardChmis20161143c chiesi haemophilia b gene therapy advisory board
Chmis20161143c chiesi haemophilia b gene therapy advisory board
 
Bhnt
BhntBhnt
Bhnt
 

En vedette

Mariëtte Hoitink, HTNK: Creatief Leiderschap 28 april 2011
Mariëtte Hoitink, HTNK: Creatief Leiderschap 28 april 2011Mariëtte Hoitink, HTNK: Creatief Leiderschap 28 april 2011
Mariëtte Hoitink, HTNK: Creatief Leiderschap 28 april 2011KennisKring Amsterdam
 
Innovation and entrepreneurship for agro, food and the environment van joep koen
Innovation and entrepreneurship for agro, food and the environment van joep koenInnovation and entrepreneurship for agro, food and the environment van joep koen
Innovation and entrepreneurship for agro, food and the environment van joep koenKennisKring Amsterdam
 
Griffin Securities reiterates Unilife Corp ($UNIS) target with $10.50 target
Griffin Securities reiterates Unilife Corp ($UNIS) target with $10.50 targetGriffin Securities reiterates Unilife Corp ($UNIS) target with $10.50 target
Griffin Securities reiterates Unilife Corp ($UNIS) target with $10.50 targetProActive Capital Resources Group
 
Russell Hancock about Silicon Valley 10-10-2011 at AIM event
Russell Hancock about Silicon Valley 10-10-2011 at AIM eventRussell Hancock about Silicon Valley 10-10-2011 at AIM event
Russell Hancock about Silicon Valley 10-10-2011 at AIM eventKennisKring Amsterdam
 
Garispanduan penggredan premis_makanan
Garispanduan penggredan premis_makananGarispanduan penggredan premis_makanan
Garispanduan penggredan premis_makananRoiamah Basri
 
Double page spread
Double page spreadDouble page spread
Double page spreadEDPRICE93
 
Soal bahasa indonesia
Soal bahasa indonesiaSoal bahasa indonesia
Soal bahasa indonesiaNaya Ti
 
Building the Ultimate Human Organisation (ArabNet, Beirut, 2016)
Building the Ultimate Human Organisation (ArabNet, Beirut, 2016)Building the Ultimate Human Organisation (ArabNet, Beirut, 2016)
Building the Ultimate Human Organisation (ArabNet, Beirut, 2016)John Peebles
 
Fitting facilities for today's library users
Fitting facilities for today's library usersFitting facilities for today's library users
Fitting facilities for today's library usersPin Pin Yeo
 
Job Witteman, directeur Amsterdam Internet Exchange
Job Witteman, directeur Amsterdam Internet ExchangeJob Witteman, directeur Amsterdam Internet Exchange
Job Witteman, directeur Amsterdam Internet ExchangeKennisKring Amsterdam
 

En vedette (20)

Intellipharmaceutics Corporate Presentation, February 2012
Intellipharmaceutics Corporate Presentation, February 2012Intellipharmaceutics Corporate Presentation, February 2012
Intellipharmaceutics Corporate Presentation, February 2012
 
Debt Resolve (OTCBB: DRSV) - White Paper - July 2011
Debt Resolve (OTCBB: DRSV) - White Paper - July 2011Debt Resolve (OTCBB: DRSV) - White Paper - July 2011
Debt Resolve (OTCBB: DRSV) - White Paper - July 2011
 
Products & Services
Products & ServicesProducts & Services
Products & Services
 
Mariëtte Hoitink, HTNK: Creatief Leiderschap 28 april 2011
Mariëtte Hoitink, HTNK: Creatief Leiderschap 28 april 2011Mariëtte Hoitink, HTNK: Creatief Leiderschap 28 april 2011
Mariëtte Hoitink, HTNK: Creatief Leiderschap 28 april 2011
 
Innovation and entrepreneurship for agro, food and the environment van joep koen
Innovation and entrepreneurship for agro, food and the environment van joep koenInnovation and entrepreneurship for agro, food and the environment van joep koen
Innovation and entrepreneurship for agro, food and the environment van joep koen
 
Griffin Securities reiterates Unilife Corp ($UNIS) target with $10.50 target
Griffin Securities reiterates Unilife Corp ($UNIS) target with $10.50 targetGriffin Securities reiterates Unilife Corp ($UNIS) target with $10.50 target
Griffin Securities reiterates Unilife Corp ($UNIS) target with $10.50 target
 
Freeguide
FreeguideFreeguide
Freeguide
 
Arnold Smeulders, directeur COMMIT
Arnold Smeulders, directeur COMMITArnold Smeulders, directeur COMMIT
Arnold Smeulders, directeur COMMIT
 
Russell Hancock about Silicon Valley 10-10-2011 at AIM event
Russell Hancock about Silicon Valley 10-10-2011 at AIM eventRussell Hancock about Silicon Valley 10-10-2011 at AIM event
Russell Hancock about Silicon Valley 10-10-2011 at AIM event
 
Garispanduan penggredan premis_makanan
Garispanduan penggredan premis_makananGarispanduan penggredan premis_makanan
Garispanduan penggredan premis_makanan
 
Double page spread
Double page spreadDouble page spread
Double page spread
 
Procesi ligjvenes pjesa 1
Procesi ligjvenes pjesa 1Procesi ligjvenes pjesa 1
Procesi ligjvenes pjesa 1
 
Amsterdam Smart City
Amsterdam Smart CityAmsterdam Smart City
Amsterdam Smart City
 
Daily Dose Equities - Exosomes from human cd34
Daily Dose Equities - Exosomes from human cd34Daily Dose Equities - Exosomes from human cd34
Daily Dose Equities - Exosomes from human cd34
 
3 reports
3 reports3 reports
3 reports
 
Soal bahasa indonesia
Soal bahasa indonesiaSoal bahasa indonesia
Soal bahasa indonesia
 
No1
No1No1
No1
 
Building the Ultimate Human Organisation (ArabNet, Beirut, 2016)
Building the Ultimate Human Organisation (ArabNet, Beirut, 2016)Building the Ultimate Human Organisation (ArabNet, Beirut, 2016)
Building the Ultimate Human Organisation (ArabNet, Beirut, 2016)
 
Fitting facilities for today's library users
Fitting facilities for today's library usersFitting facilities for today's library users
Fitting facilities for today's library users
 
Job Witteman, directeur Amsterdam Internet Exchange
Job Witteman, directeur Amsterdam Internet ExchangeJob Witteman, directeur Amsterdam Internet Exchange
Job Witteman, directeur Amsterdam Internet Exchange
 

Similaire à Bioheart (OTC: BHRT; Twitter: $BHRT)

Cardiology Journal club
Cardiology Journal clubCardiology Journal club
Cardiology Journal clubPRAVEEN GUPTA
 
Steroid Withdrawal after kidney transplantation
Steroid Withdrawal after kidney transplantationSteroid Withdrawal after kidney transplantation
Steroid Withdrawal after kidney transplantationChristos Argyropoulos
 
Novel medical therapy
Novel medical therapyNovel medical therapy
Novel medical therapydrucsamal
 
Trevor Pickersgill, looking to the future, treatments
Trevor Pickersgill, looking to the future, treatmentsTrevor Pickersgill, looking to the future, treatments
Trevor Pickersgill, looking to the future, treatmentsMS Trust
 
Galena presentation 8 feb 16
Galena presentation  8 feb 16Galena presentation  8 feb 16
Galena presentation 8 feb 16Galenabio
 
Autologous Bone Marrow Cell Therapy for Autism: An Open Label Uncontrolled C...
Autologous Bone Marrow Cell Therapy for Autism: An  Open Label Uncontrolled C...Autologous Bone Marrow Cell Therapy for Autism: An  Open Label Uncontrolled C...
Autologous Bone Marrow Cell Therapy for Autism: An Open Label Uncontrolled C...remedypublications2
 
ClinicalOutcomesFollowingCoronary BifurcationPCITechniques.pdf
ClinicalOutcomesFollowingCoronary BifurcationPCITechniques.pdfClinicalOutcomesFollowingCoronary BifurcationPCITechniques.pdf
ClinicalOutcomesFollowingCoronary BifurcationPCITechniques.pdfIrving Torres Lopez
 
CLBS Corporate Slide Presentation March 2018
CLBS Corporate Slide Presentation March 2018CLBS Corporate Slide Presentation March 2018
CLBS Corporate Slide Presentation March 2018Steve Sizer
 
2010.05.20 clinicians view on regeneration
2010.05.20 clinicians view on regeneration2010.05.20 clinicians view on regeneration
2010.05.20 clinicians view on regenerationneithan
 
Newer management techniques for glioblastoma
Newer management techniques for glioblastomaNewer management techniques for glioblastoma
Newer management techniques for glioblastomaabhitux
 
Trustfusion Presentation
Trustfusion PresentationTrustfusion Presentation
Trustfusion PresentationDaniil Pavlenko
 
YM BioSciences CorpPres ASH2012 Dec 10 12
YM BioSciences CorpPres ASH2012 Dec 10 12YM BioSciences CorpPres ASH2012 Dec 10 12
YM BioSciences CorpPres ASH2012 Dec 10 12YMBioSciences
 
DANISH trial (Cardiology)
 DANISH trial (Cardiology) DANISH trial (Cardiology)
DANISH trial (Cardiology)PRAVEEN GUPTA
 

Similaire à Bioheart (OTC: BHRT; Twitter: $BHRT) (20)

Clinimacs Newsletter 2010
Clinimacs Newsletter 2010Clinimacs Newsletter 2010
Clinimacs Newsletter 2010
 
Cardiology Journal club
Cardiology Journal clubCardiology Journal club
Cardiology Journal club
 
Steroid Withdrawal after kidney transplantation
Steroid Withdrawal after kidney transplantationSteroid Withdrawal after kidney transplantation
Steroid Withdrawal after kidney transplantation
 
Dietrich, Dalton
Dietrich, DaltonDietrich, Dalton
Dietrich, Dalton
 
Novel medical therapy
Novel medical therapyNovel medical therapy
Novel medical therapy
 
Trevor Pickersgill, looking to the future, treatments
Trevor Pickersgill, looking to the future, treatmentsTrevor Pickersgill, looking to the future, treatments
Trevor Pickersgill, looking to the future, treatments
 
Galena presentation 8 feb 16
Galena presentation  8 feb 16Galena presentation  8 feb 16
Galena presentation 8 feb 16
 
Slideshare Demo
Slideshare DemoSlideshare Demo
Slideshare Demo
 
Autologous Bone Marrow Cell Therapy for Autism: An Open Label Uncontrolled C...
Autologous Bone Marrow Cell Therapy for Autism: An  Open Label Uncontrolled C...Autologous Bone Marrow Cell Therapy for Autism: An  Open Label Uncontrolled C...
Autologous Bone Marrow Cell Therapy for Autism: An Open Label Uncontrolled C...
 
ClinicalOutcomesFollowingCoronary BifurcationPCITechniques.pdf
ClinicalOutcomesFollowingCoronary BifurcationPCITechniques.pdfClinicalOutcomesFollowingCoronary BifurcationPCITechniques.pdf
ClinicalOutcomesFollowingCoronary BifurcationPCITechniques.pdf
 
CLBS Corporate Slide Presentation March 2018
CLBS Corporate Slide Presentation March 2018CLBS Corporate Slide Presentation March 2018
CLBS Corporate Slide Presentation March 2018
 
2010.05.20 clinicians view on regeneration
2010.05.20 clinicians view on regeneration2010.05.20 clinicians view on regeneration
2010.05.20 clinicians view on regeneration
 
Newer management techniques for glioblastoma
Newer management techniques for glioblastomaNewer management techniques for glioblastoma
Newer management techniques for glioblastoma
 
CYTX Corporate Presentation, Biotech Showcase
CYTX Corporate Presentation, Biotech ShowcaseCYTX Corporate Presentation, Biotech Showcase
CYTX Corporate Presentation, Biotech Showcase
 
LD Micro Conference
LD Micro ConferenceLD Micro Conference
LD Micro Conference
 
Jefferies 2012 Global Healthcare Conference
Jefferies 2012 Global Healthcare ConferenceJefferies 2012 Global Healthcare Conference
Jefferies 2012 Global Healthcare Conference
 
Trustfusion Presentation
Trustfusion PresentationTrustfusion Presentation
Trustfusion Presentation
 
YM BioSciences CorpPres ASH2012 Dec 10 12
YM BioSciences CorpPres ASH2012 Dec 10 12YM BioSciences CorpPres ASH2012 Dec 10 12
YM BioSciences CorpPres ASH2012 Dec 10 12
 
DANISH trial (Cardiology)
 DANISH trial (Cardiology) DANISH trial (Cardiology)
DANISH trial (Cardiology)
 
Maor Presentation 2016
Maor Presentation 2016Maor Presentation 2016
Maor Presentation 2016
 

Plus de ProActive Capital Resources Group

Plus de ProActive Capital Resources Group (20)

Pegasi Energy Research Note July 18, 2012
Pegasi Energy Research Note July 18, 2012Pegasi Energy Research Note July 18, 2012
Pegasi Energy Research Note July 18, 2012
 
Islet defense in bio century week of 5 28-12
Islet defense in bio century week of 5 28-12Islet defense in bio century week of 5 28-12
Islet defense in bio century week of 5 28-12
 
Insider transaction detail for Isa Odidi (IPCI)
Insider transaction detail for Isa Odidi (IPCI)Insider transaction detail for Isa Odidi (IPCI)
Insider transaction detail for Isa Odidi (IPCI)
 
Caprock risk management, llc
Caprock risk management, llcCaprock risk management, llc
Caprock risk management, llc
 
VTUS SEC Filing Form 8-K
VTUS SEC Filing Form 8-KVTUS SEC Filing Form 8-K
VTUS SEC Filing Form 8-K
 
TNXP Fact Sheet May 2012
TNXP Fact Sheet May 2012TNXP Fact Sheet May 2012
TNXP Fact Sheet May 2012
 
Arcis Exec Summary
Arcis Exec Summary Arcis Exec Summary
Arcis Exec Summary
 
SSIE 4.20.12
SSIE 4.20.12 SSIE 4.20.12
SSIE 4.20.12
 
Kerx zerenex phase3
Kerx zerenex phase3Kerx zerenex phase3
Kerx zerenex phase3
 
ARM Stroke
ARM StrokeARM Stroke
ARM Stroke
 
ARM Parkinsons
ARM ParkinsonsARM Parkinsons
ARM Parkinsons
 
ARM Heart Disease
ARM Heart DiseaseARM Heart Disease
ARM Heart Disease
 
ARM Diabetes
ARM DiabetesARM Diabetes
ARM Diabetes
 
Arm ALS
Arm ALSArm ALS
Arm ALS
 
Tonix12 ceocfo-article-clean newphoto
Tonix12 ceocfo-article-clean newphotoTonix12 ceocfo-article-clean newphoto
Tonix12 ceocfo-article-clean newphoto
 
Applied DNA Sciences (OTCBB: APDN)
Applied DNA Sciences (OTCBB: APDN)Applied DNA Sciences (OTCBB: APDN)
Applied DNA Sciences (OTCBB: APDN)
 
Daily Dose Equities - Intracoronary Bone Marrow
Daily Dose Equities - Intracoronary Bone MarrowDaily Dose Equities - Intracoronary Bone Marrow
Daily Dose Equities - Intracoronary Bone Marrow
 
Daily Dose Equities - Effect of Transendocardial Delivery
Daily Dose Equities - Effect of Transendocardial Delivery Daily Dose Equities - Effect of Transendocardial Delivery
Daily Dose Equities - Effect of Transendocardial Delivery
 
2012 MHCC Web resentation proposal-3-19-2012-published
2012 MHCC Web resentation proposal-3-19-2012-published2012 MHCC Web resentation proposal-3-19-2012-published
2012 MHCC Web resentation proposal-3-19-2012-published
 
PolyMedix ($PYMX) Cowan Research
PolyMedix ($PYMX) Cowan Research PolyMedix ($PYMX) Cowan Research
PolyMedix ($PYMX) Cowan Research
 

Dernier

Teekay Corporation Q1-24 Earnings Results
Teekay Corporation Q1-24 Earnings ResultsTeekay Corporation Q1-24 Earnings Results
Teekay Corporation Q1-24 Earnings ResultsTeekay Corporation
 
High Profile Call Girls in Pune (Adult Only) 8005736733 Escort Service 24x7 ...
High Profile Call Girls in Pune  (Adult Only) 8005736733 Escort Service 24x7 ...High Profile Call Girls in Pune  (Adult Only) 8005736733 Escort Service 24x7 ...
High Profile Call Girls in Pune (Adult Only) 8005736733 Escort Service 24x7 ...SUHANI PANDEY
 
Balaji Nagar ( Call Girls ) Pune 6297143586 Hot Model With Sexy Bhabi Ready...
Balaji Nagar ( Call Girls ) Pune  6297143586  Hot Model With Sexy Bhabi Ready...Balaji Nagar ( Call Girls ) Pune  6297143586  Hot Model With Sexy Bhabi Ready...
Balaji Nagar ( Call Girls ) Pune 6297143586 Hot Model With Sexy Bhabi Ready...tanu pandey
 
Corporate Presentation Probe Canaccord Conference 2024.pdf
Corporate Presentation Probe Canaccord Conference 2024.pdfCorporate Presentation Probe Canaccord Conference 2024.pdf
Corporate Presentation Probe Canaccord Conference 2024.pdfProbe Gold
 
Best investment platform in india-Falcon Invoice Discounting
Best investment platform in india-Falcon Invoice DiscountingBest investment platform in india-Falcon Invoice Discounting
Best investment platform in india-Falcon Invoice DiscountingFalcon Invoice Discounting
 
Teekay Tankers Q1-24 Earnings Presentation
Teekay Tankers Q1-24 Earnings PresentationTeekay Tankers Q1-24 Earnings Presentation
Teekay Tankers Q1-24 Earnings PresentationTeekay Tankers Ltd
 
VVIP Pune Call Girls Handewadi WhatSapp Number 8005736733 With Elite Staff An...
VVIP Pune Call Girls Handewadi WhatSapp Number 8005736733 With Elite Staff An...VVIP Pune Call Girls Handewadi WhatSapp Number 8005736733 With Elite Staff An...
VVIP Pune Call Girls Handewadi WhatSapp Number 8005736733 With Elite Staff An...SUHANI PANDEY
 
The Leonardo 1Q 2024 Results Presentation
The Leonardo 1Q 2024 Results PresentationThe Leonardo 1Q 2024 Results Presentation
The Leonardo 1Q 2024 Results PresentationLeonardo
 
Top Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts Podanur
Top Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts PodanurTop Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts Podanur
Top Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts Podanurdharasingh5698
 
VVIP Pune Call Girls Sopan Baug WhatSapp Number 8005736733 With Elite Staff A...
VVIP Pune Call Girls Sopan Baug WhatSapp Number 8005736733 With Elite Staff A...VVIP Pune Call Girls Sopan Baug WhatSapp Number 8005736733 With Elite Staff A...
VVIP Pune Call Girls Sopan Baug WhatSapp Number 8005736733 With Elite Staff A...SUHANI PANDEY
 
Teck Supplemental Information, May 2, 2024
Teck Supplemental Information, May 2, 2024Teck Supplemental Information, May 2, 2024
Teck Supplemental Information, May 2, 2024TeckResourcesLtd
 
Call Girls Marunji Call Me 7737669865 Budget Friendly No Advance Booking
Call Girls Marunji Call Me 7737669865 Budget Friendly No Advance BookingCall Girls Marunji Call Me 7737669865 Budget Friendly No Advance Booking
Call Girls Marunji Call Me 7737669865 Budget Friendly No Advance Bookingroncy bisnoi
 
Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)
Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)
Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)kojalkojal131
 
Vijayawada ( Call Girls ) Pune 6297143586 Hot Model With Sexy Bhabi Ready F...
Vijayawada ( Call Girls ) Pune  6297143586  Hot Model With Sexy Bhabi Ready F...Vijayawada ( Call Girls ) Pune  6297143586  Hot Model With Sexy Bhabi Ready F...
Vijayawada ( Call Girls ) Pune 6297143586 Hot Model With Sexy Bhabi Ready F...tanu pandey
 
Collective Mining | Corporate Presentation - May 2024
Collective Mining | Corporate Presentation - May 2024Collective Mining | Corporate Presentation - May 2024
Collective Mining | Corporate Presentation - May 2024CollectiveMining1
 
Nicola Mining Inc. Corporate Presentation May 2024
Nicola Mining Inc. Corporate Presentation May 2024Nicola Mining Inc. Corporate Presentation May 2024
Nicola Mining Inc. Corporate Presentation May 2024nicola_mining
 
VIP Call Girls Mehsana 7001035870 Whatsapp Number, 24/07 Booking
VIP Call Girls Mehsana 7001035870 Whatsapp Number, 24/07 BookingVIP Call Girls Mehsana 7001035870 Whatsapp Number, 24/07 Booking
VIP Call Girls Mehsana 7001035870 Whatsapp Number, 24/07 Bookingdharasingh5698
 
Collective Mining | Corporate Presentation - May 2024
Collective Mining | Corporate Presentation - May 2024Collective Mining | Corporate Presentation - May 2024
Collective Mining | Corporate Presentation - May 2024CollectiveMining1
 
Indapur - Virgin Call Girls Pune | Whatsapp No 8005736733 VIP Escorts Service...
Indapur - Virgin Call Girls Pune | Whatsapp No 8005736733 VIP Escorts Service...Indapur - Virgin Call Girls Pune | Whatsapp No 8005736733 VIP Escorts Service...
Indapur - Virgin Call Girls Pune | Whatsapp No 8005736733 VIP Escorts Service...SUHANI PANDEY
 

Dernier (20)

Teekay Corporation Q1-24 Earnings Results
Teekay Corporation Q1-24 Earnings ResultsTeekay Corporation Q1-24 Earnings Results
Teekay Corporation Q1-24 Earnings Results
 
High Profile Call Girls in Pune (Adult Only) 8005736733 Escort Service 24x7 ...
High Profile Call Girls in Pune  (Adult Only) 8005736733 Escort Service 24x7 ...High Profile Call Girls in Pune  (Adult Only) 8005736733 Escort Service 24x7 ...
High Profile Call Girls in Pune (Adult Only) 8005736733 Escort Service 24x7 ...
 
Balaji Nagar ( Call Girls ) Pune 6297143586 Hot Model With Sexy Bhabi Ready...
Balaji Nagar ( Call Girls ) Pune  6297143586  Hot Model With Sexy Bhabi Ready...Balaji Nagar ( Call Girls ) Pune  6297143586  Hot Model With Sexy Bhabi Ready...
Balaji Nagar ( Call Girls ) Pune 6297143586 Hot Model With Sexy Bhabi Ready...
 
Corporate Presentation Probe Canaccord Conference 2024.pdf
Corporate Presentation Probe Canaccord Conference 2024.pdfCorporate Presentation Probe Canaccord Conference 2024.pdf
Corporate Presentation Probe Canaccord Conference 2024.pdf
 
Best investment platform in india-Falcon Invoice Discounting
Best investment platform in india-Falcon Invoice DiscountingBest investment platform in india-Falcon Invoice Discounting
Best investment platform in india-Falcon Invoice Discounting
 
Teekay Tankers Q1-24 Earnings Presentation
Teekay Tankers Q1-24 Earnings PresentationTeekay Tankers Q1-24 Earnings Presentation
Teekay Tankers Q1-24 Earnings Presentation
 
VVIP Pune Call Girls Handewadi WhatSapp Number 8005736733 With Elite Staff An...
VVIP Pune Call Girls Handewadi WhatSapp Number 8005736733 With Elite Staff An...VVIP Pune Call Girls Handewadi WhatSapp Number 8005736733 With Elite Staff An...
VVIP Pune Call Girls Handewadi WhatSapp Number 8005736733 With Elite Staff An...
 
Call Girls in Panjabi Bagh, Delhi 💯 Call Us 🔝9953056974 🔝 Escort Service
Call Girls in Panjabi Bagh, Delhi 💯 Call Us 🔝9953056974 🔝 Escort ServiceCall Girls in Panjabi Bagh, Delhi 💯 Call Us 🔝9953056974 🔝 Escort Service
Call Girls in Panjabi Bagh, Delhi 💯 Call Us 🔝9953056974 🔝 Escort Service
 
The Leonardo 1Q 2024 Results Presentation
The Leonardo 1Q 2024 Results PresentationThe Leonardo 1Q 2024 Results Presentation
The Leonardo 1Q 2024 Results Presentation
 
Top Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts Podanur
Top Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts PodanurTop Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts Podanur
Top Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts Podanur
 
VVIP Pune Call Girls Sopan Baug WhatSapp Number 8005736733 With Elite Staff A...
VVIP Pune Call Girls Sopan Baug WhatSapp Number 8005736733 With Elite Staff A...VVIP Pune Call Girls Sopan Baug WhatSapp Number 8005736733 With Elite Staff A...
VVIP Pune Call Girls Sopan Baug WhatSapp Number 8005736733 With Elite Staff A...
 
Teck Supplemental Information, May 2, 2024
Teck Supplemental Information, May 2, 2024Teck Supplemental Information, May 2, 2024
Teck Supplemental Information, May 2, 2024
 
Call Girls Marunji Call Me 7737669865 Budget Friendly No Advance Booking
Call Girls Marunji Call Me 7737669865 Budget Friendly No Advance BookingCall Girls Marunji Call Me 7737669865 Budget Friendly No Advance Booking
Call Girls Marunji Call Me 7737669865 Budget Friendly No Advance Booking
 
Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)
Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)
Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)
 
Vijayawada ( Call Girls ) Pune 6297143586 Hot Model With Sexy Bhabi Ready F...
Vijayawada ( Call Girls ) Pune  6297143586  Hot Model With Sexy Bhabi Ready F...Vijayawada ( Call Girls ) Pune  6297143586  Hot Model With Sexy Bhabi Ready F...
Vijayawada ( Call Girls ) Pune 6297143586 Hot Model With Sexy Bhabi Ready F...
 
Collective Mining | Corporate Presentation - May 2024
Collective Mining | Corporate Presentation - May 2024Collective Mining | Corporate Presentation - May 2024
Collective Mining | Corporate Presentation - May 2024
 
Nicola Mining Inc. Corporate Presentation May 2024
Nicola Mining Inc. Corporate Presentation May 2024Nicola Mining Inc. Corporate Presentation May 2024
Nicola Mining Inc. Corporate Presentation May 2024
 
VIP Call Girls Mehsana 7001035870 Whatsapp Number, 24/07 Booking
VIP Call Girls Mehsana 7001035870 Whatsapp Number, 24/07 BookingVIP Call Girls Mehsana 7001035870 Whatsapp Number, 24/07 Booking
VIP Call Girls Mehsana 7001035870 Whatsapp Number, 24/07 Booking
 
Collective Mining | Corporate Presentation - May 2024
Collective Mining | Corporate Presentation - May 2024Collective Mining | Corporate Presentation - May 2024
Collective Mining | Corporate Presentation - May 2024
 
Indapur - Virgin Call Girls Pune | Whatsapp No 8005736733 VIP Escorts Service...
Indapur - Virgin Call Girls Pune | Whatsapp No 8005736733 VIP Escorts Service...Indapur - Virgin Call Girls Pune | Whatsapp No 8005736733 VIP Escorts Service...
Indapur - Virgin Call Girls Pune | Whatsapp No 8005736733 VIP Escorts Service...
 

Bioheart (OTC: BHRT; Twitter: $BHRT)

  • 1.
  • 2.
  • 3.
  • 4.
  • 5.
  • 6. Myoblast Engraftment Post-Transplantation Contractile muscle tissue growing in the scarred portion of the heart following treatment with myoblast injections. Human Heart, Proof of Concept * Hagege et al., Viability and Differentiation of Autologous Skeletal Myoblast Grafts in Ischemic Cardiomyopathy, Lancet, Vol. 361, 2003: 491-492
  • 7. MyoCell: Heart Failure Treatment Process Scar tissue following heart attack Injection of skeletal myoblasts into scar tissue using deflecting-tip catheter Cell manufacturing following thigh muscle biopsy 1 3 2
  • 8.
  • 9. Journal of the American College of Cardiology, Vol. 42, No. 12, 2003, Serruys, Smits et al. Study sponsored by Bioheart, Inc. LVEF Measured via LAO LV Angio. 3 month, p=0.009; 6 month, p=0.23. N = 5. Percutaneous Intramyocardial Transplantation of Autologous Myoblasts: Bioheart First-In-Man Experience LVEF (%)
  • 10. Percutaneous Intramyocardial Transplantation of Autologous Myoblasts – BIOHEART Phase I/II Trial Results for these trials were not statistically significant due, in part, to the limited number of patients treated. Baseline 6 Months 12 Months N = 13 N = 13 N = 13 LVEF: Mean Baseline = 34.4% + 7.4 Mean 12-Month Follow-up = 36.6% + 9.6 NYHA Class Improvement
  • 11. Measurements via PV Loop, n=5. 33 41 190 150 4.6 5.6 Percutaneous Intramyocardial Transplantation of Autologous Myoblasts – BIOHEART Phase I/II Trial LVEF CO LVESV
  • 12.
  • 13. * All 5 treated patients withdrew due to changes in German biopsy regulations. ** Both control patients withdrew after knowledge of randomization allocation. Bioheart Percutaneously Delivered Myoblasts EU Phase II Trial (SEISMIC) 47 Patients Randomized: ICD Patients: 31 MyoCell ® , 16 Standard Medical Therapy Treatment Arm ( MyoCell ® 150 - 800 x 10 6 ) 26 ICD Patients Control Arm (Standard Medical Therapy) 14 ICD Patients Baseline Evaluation Screening: 62 ICD Patients 15 Screen Fails 5 Withdrawals* 2 Withdrawals**
  • 14. SEISMIC NYHA heart failure class Improvement Myoblast therapy Control therapy N=26 N=23 N=22 N=20 N=14 N=9 N=12 N=13 BL 1 mo 3 mo 6 mo BL 1 mo 3 mo 6 mo
  • 15. SEISMIC +60.3 m + 54.1 -0.2 m ± 177.1 Treatment N=26 N=21 N=19 Control Control N=14 N=12 N=13 448 m 441 m 406 m 466 m 6-Minute Walk Test Improvement Difference Between Baseline and 6 Months
  • 16. SEISMIC Response to Treatment NYHA HF / 6MWT / MLFQ / LVEF
  • 17. MYOHEART US Phase I Study Flow Clinical Sites: Columbia Presbyterian, Cleveland Clinic, Mayo Clinic, Minneapolis Heart, St. Joseph ’ s / ACRI Core Lab: Gentiae Clinical Research 2 injections (.25 cc) 6 injections (.25 cc) 18 injections (.25 cc) First Cohort (n=5) 25 x 10 6 cells 30 - Day Safety Evaluation Second Cohort (n=5) 75 x 10 6 cells 30 - Day Safety Evaluation Third Cohort (n=5) 225 x 10 6 cells 30 - Day Safety Evaluation Fourth Cohort (n=5) 675 x 10 6 cells 27 injections (.50 cc)
  • 18. MYOHEART 6MWT Average 6 Minute Walk Test – All Cohorts 6MWT (meters) N=20 422 474 471 N=18 N=15 47 36 N=15 6MWT (meters) N=18 All Patients Paired Analysis p = .0074 p = .2126 474 N=17 42 p = .1367 N=17
  • 19. MYOHEART MLHFQ Average Minnesota Living with Heart Failure Score All Cohorts MLHF Score N=20 51 34 33 N=19 N=18 -14 -16 N=19 N=18 All Patients Paired Analysis p = .0016 p = .0004 MLHF Score 30 N=18 N=18 -18 p = .0006
  • 20. Bioheart MARVEL Program Unique Features and Goals
  • 21.
  • 22. p=0.50 MARVEL-1: Mean Change in 6-Minute Walk Distance (meters) n=6 n=7 n=6
  • 23. MARVEL-1 Arrhythmia Analysis: Myocell ® Patients Amiodarone started Amiodarone continued Myocell ® Txt 14 Patients No Amiodarone Txt n= 7 4 Patients 4 Episodes VT Amiodarone Started at Implant or Stopped n=3 Amiodarone Started at Bx n=4 2 Patients 2 Episodes VT 0 Patients 0 Episodes VT 0 Episodes VT 1 Patient 1 Episode VT
  • 24.
  • 25. Competition – Congestive Heart Failure
  • 26. Myoblast – Cell culture Process Development Manufacturing process is protected, scalable and reliable
  • 27.
  • 28.
  • 29.
  • 30. Bioheart: The FDA Approved REGEN Trial Next Generation: MyoCell ® SDF-1 Increased muscle formation Increased blood vessel supply Endogenous circulating stem cells attracted to injury by chemokine proteins Damaged area secretes chemokine proteins Adult stem cells SDF-1 Cells Four years of sponsored animal studies have demonstrated that 2nd generation MyoCell ® SDF-1 provides significantly higher levels of improvement than the first generation MyoCell ® composition.
  • 31.
  • 32.
  • 33.  
  • 34.  
  • 35.  
  • 36.  
  • 37.

Notes de l'éditeur

  1. Used Bioheart cells with MyoStar / Noga system No patient deaths or SAEs reported 1 patient was hospitalized at 6 weeks after the procedure due to progressive heart failure and long asymptomatic runs of non-sustained VT on Holter monitoring. After recompensation, telemetry still showed NSVT, and an ICD was placed prophylactically. Other 4 patients experienced no AEs or ventricular arrhythmias.
  2. Summary of data from FIM, 005-006 trials. Data adjudicated by Cardialysis (CRO, Rotterdam, the Netherlands) and Cleveland Clinic (independent core lab)
  3. Note dose is patient and infarct size dependent.
  4. 5 sites: Mayo Clinic, Cleveland Clinic, Mt. Sinai (NYC), Minneapolis Heart, ACRI / St. Joseph ’s (Atlanta) Interim data expected at TCT in October 2005.
  5. Mean Values Left graph represents all data available at each time point Right graph is paired analysis – i.e. matched data from BL to 3 mos. and BL to 6 mos. for only those patients available at these timepoints Trends for all patients treated from BL through 6-Months look compelling and are partially statistically significant Consistent with p-values to what Dr. Dib saw in his study (n=23) P values computed using paired t test
  6. Median Values Left graph represents all data available at each time point Right graph is paired analysis – i.e. matched data from BL to 3 mos. and BL to 6 mos. for only those patients available at these timepoints Statistical significance attained at both 3 and 6 months Consistent with p-values to what Dr. Dib saw in his study (n=23) P values computed using paired t test