US Stem Cell Inc (USRM)

[TheHungryHippo]

The Connection to Johnson & Johnson and $USRM

MyoCELL® is a skeletal muscle myoblast cell therapy developed by BIOHEART [67] and is in Phase II/III trials in the US (MARVEL NCT00526253) in conjunction with the MyoCATH and MyoSTAR delivery catheters.




From Marvel Trial:
https://clinicaltrials.gov/ct2/show/NCT00526253?term=bioheart&rank=3

Official Title: A Multicenter Study to Assess the Safety and Cardiovascular Effects of Myocell™ Implantation by a Catheter Delivery System in Congestive Heart Failure Patients Post Myocardial Infarction(s)

Autologous myoblasts are harvested from a patient's skeletal muscle tissue. The myoblasts are isolated and expanded in culture in a closed system. When a sufficient number of cells are estimated they are taken from culture, packaged in a suspension and sent to the patient's interventionalist. The interventionalist uses an injection catheter via femoral artery to inject the myoblasts directly into the myocardium.

Do you recall that the Chairman of the Board: Dr. William P. Murphy;

Founded Cordis Corporation, that was sold to Johnson & Johnson for $1.9 Billion Dollars?

http://www.nytimes.com/1995/11/07/business/cordis-to-be-acquired-by-johnson-johnson.html

Three Months Ended September 30, 2016 as compared to the Three Months Ended September 30, 2015



USRM has been using NOGA mapping system, and MYOSTAR catheters by Cordis, in the Marvel trials.

They also have the ability to use MYOCATH:

The MyoCath was developed by Bioheart co-founder Robert Lashinski specifically for delivering new cells to damaged tissue. It is a deflecting tip needle injection catheter that has a larger needle which is 25 gauge for better flow rates and less leakage than systems that are 27 gauge. This larger needle allows for thicker compositions to be injected which helps with cell retention in the heart. Also, the MyoCath needle has more fluoroscopic brightness than the normally used nitinol needle, enabling superior visualization during the procedure. Seeing the needle well during injections enables the physician who is operating the catheter to pinpoint targeted areas more precisely, thus improving safety. The MyoCath competes well with other biological delivery systems on price and efficiency and allows the physician to utilize standard fluoroscopy and echo equipment found in every cath lab.

and they have been making sales on MYOCATH

We recognized revenues of $729,813 for the three months ended September 30, 2016. These revenues were generated from the sales of kits and equipment, services, MyoCath Catheters, AdipoCell, and laboratory services. We recognized revenues of $557,612 for the three months ended September 30, 2015 from the sale of MyoCath catheters, AdipoCell, physician training, patient studies and laboratory services. The differential in revenue reflected an increase based on the products and services provided.

MyoCell is a clinical therapy intended to improve cardiac function and designed to be utilized months or even years after a patient has suffered severe heart damage due to a heart attack or other cause. We believe that MyoCell has the potential to become a leading treatment for severe, chronic damage to the heart due to its perceived ability to satisfy, at least in part, what we believe to be an unmet demand for more effective and/or more affordable therapies for chronic heart damage. MyoCell uses myoblasts, cells that are precursors to muscle cells, from the patient’s own body. The myoblasts are removed from a patient’s thigh muscle, isolated, grown through our proprietary cell culturing process, and injected directly in the scar tissue of a patient’s heart. An interventional cardiologist performs this minimally invasive procedure using an endoventricular catheter. We have entered into an agreement with a Johnson & Johnson company to use its NOGA® Cardiac Navigation System along with its MyoStar tm injection catheter for the delivery of MyoCell in the MARVEL Trial.

MyoCell®, MyoCath®, MyoCell II with SDF-1tm, MyoCath IItm, BioPacetm and Allocelltm are trademarks of Bioheart, Inc. TGI 100tm and TGI 1200tm are trademarks of Tissue Genesis, Inc. MyoStar tm and NOGA® are trademarks of Cordis Corporation, a Johnson & Johnson company.

http://www.nature.com/nrcardio/journal/v3/n3s/fig_tab/ncpcardio0446_T1.html

Our MyoCath product candidate is protected by a patent, expiring in September 2017, in which we have an irrevocable co-exclusive license

The Myostar injection catheter is a NOGA percutaneous catheter with a deflectable tip and injection needle designed to inject directly into the myocardium.

(A) The MyoStar™ injection catheter allows precise delivery of stem cells based on the electromechanical map. (B) A magnified view of the distal tip. (C) Left ventricle illustrating direct stem cell delivery by the MyoStar™ injection catheter.

Biosense Webster, Inc., a Johnson & Johnson company,

The FDA recently approved the use of the Carto-3 mapping catheter from J&J’s Biosense Webster subsidiary for the intracardiac injection MPC-150-IM cells in the Phase III trial. The Carto-3 catheter is widely used to map the position of an RF ablation catheter used to treat patient s with cardiac arrhythmias, and is installed in around 2,000 major hospitals in the US. In contrast, only about 80 US hospitals have the NOGA Myostar mapping catheter used for injecting MPC-150-IM to date. The NOGA Myostar system is dedicated for transendocardial injection of biologicals for research and clinical trial purposes. Approval to use the Carto-3 catheter is expected to speed the opening of additional recruitment centres in the Phase III trial programme, including hospitals in Europe.

CARTO3 Fact Sheet:
https://www.biosensewebster.com/documents/carto3-fact-sheet.pdf?Cache=1%2F19%2F2015+3%3A56%3A28+PM

Earlier this year, the FDA approved the NAVISTAR(R) THERMOCOOL(R) Catheter, including its bidirectional EZ STEER(R) Catheter platform, as safe and effective for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation when used with the CARTO(R) System. The NAVISTAR(R) THERMOCOOL(R) Catheters are the first and the only ablation catheters approved by the FDA for the treatment of AFib.

Cardiac Mapping: Mentions Marvel here:
http://www.tandfonline.com/doi/full/10.1586/14779072.6.9.1181?scroll=top&needAccess=true