Thursday, May 24, 2018 7:58:30 AM
Phase II/III
The encouraging results led to the design of a multicenter, randomized, double-blind, placebo-controlled phase II/III clinical trial (MARVEL, NCT00526253) in patients (expected n = 390) with class II or III heart failure who had previously experienced MI. Patients were recruited at the time of publication and were to receive MyoCell autologous SkMs (400 or 800 × 106 cells) via injection catheter together with the NOGA XP Cardiac Navigation System [872586], [954700]. The primary endpoints were patient wellbeing and distance they can walk [954700].
Myocell:
Comella states "Patients with treatment did about 100 METERS further in their exercise capacity or 6 min walk test"
"Bi ventricular pacing was APPROVED by the FDA with a 20 METER differential."
"Flag ship product is something that is showing a 5 TIMES greater improvement for what is considered the gold standard for heart failure patients".
95.7 TO 52 BIOHEART MYOCELL BEATS MESOBLAST MPCS IN SIDE BY SIDE PHASE II/III CLINICAL TRIAL PERFORMANCE IN THE PRIMARY END POINT MEASURE OF EXERCISE CAPACITY IMPROVEMENT IN HEART FAILURE PATIENTS VIA 6 MIN. WALK TESTING.
CRT Bi-V pacers sold by Medtronic, St. Jude and Boston Scientific-Guidant, Biotronik and Sorin Biomedica provide on average about 20 meters improvement in exercise capacity testing. Sales of CRT Bi-V pacers are expected to exceed $6 billion this year. Bioheart MyoCell beats their performance by nearly 500%.
95.7 TO 53 BIOHEART MYOCELL BEATS CARDIO3 C-CURE CARDIAC STEM CELLS IN SIDE BY SIDE COMPARISON – 6 MIN. WALK.
95.7 TO 53 BIOHEART MYOCELL BEATS CAPRICOR CARDIAC STEM CELLS IN SIMILAR CLINICAL STUDIES – 6 MIN. WALK.
95.7 TO 10 BIOHEART MYOCELL BEAT OSIRIS/HARE ALLOGENEIC BONE MARROW DERIVED STEM CELLS IN SIMILAR CLINICAL STUDIES – 6 MIN. WALK.
ECGI Holdings Announces LOI to Acquire Pacific Saddlery to Capitalize on $12.72 Billion Market Potential • ECGI • Jun 13, 2024 9:50 AM
Fifty 1 Labs, Inc. Announces Major Strategic Advancements and Shareholder Updates • CAFI • Jun 13, 2024 8:45 AM
Snakes & Lattes Opens Pop-Up Location at The Wellington Market in Toronto: A New Destination for Fun and Games - Thanks 'The Well', PepsiCo, Indie Pale House & All Sponsors & Partners for Their Commitment & Assistance Throughout The Process • FUNN • Jun 13, 2024 8:18 AM
HealthLynked Introduces Innovative Online Medical Record Request Form Using DocuSign • HLYK • Jun 12, 2024 8:00 AM
Ubiquitech Software Corp (OTC:UBQU) Posts $624,585 Quarterly Revenue - Largest Quarter Since 2018 • UBQU • Jun 11, 2024 10:13 AM
Element79 Gold Corp Files for OTCQB Uplisting, Provides Financial Update • ELEM • Jun 11, 2024 9:25 AM