US Stem Cell Inc (USRM)

[TheHungryHippo]

The treatment with MyoCell® involves taking a biopsy from the patient’s leg muscle, transporting that biopsy to Bioheart’s cell manufacturing facility, expanding the number of cells from the biopsy, and inducing the cells to regress to produce precursors to muscle cells called myoblasts. These cells know that they are muscle cells, but do not know which muscle. Once those precursor cells, or myoblasts, are present, they are segregated from the muscle cells and grown until they number over 1 billion cells. The myoblasts are then transported back to the patient’s treatment centre. Some are then injected into the patient’s heart with a needle tipped injection catheter. The modified cells are injected in the same manner into the patient’s heart. The modified myoblasts are created using an adenovirus vector or a non-viral vector. The myoblasts will release increased levels of the SDF-1 protein, which stimulates angiogenesis and regeneration of tissue.

Method of providing a dynamic cellular cardiac support
US 20020124855 A1

"The present invention provides a method for repairing damaged myocardium. The method comprises using a combination of cellular cardiomyoplasty and electrostimulation to synchronize the contractions of the transplanted cells with the cardiac cells. The method comprises the steps of obtaining myogenic cells from a donor and implanting the myogenic cells into the damaged myocardium. Electrical stimulation can be applied to the cells in vitro during culturing of the cells, after implantation of the cells into the myocardium or both."

10 May 2016 AS Assignment
Owner name: NORTHSTAR BIOTECH GROUP, LLC, MINNESOTA
Free format text: SECURITY INTEREST;ASSIGNOR:BIOHEART, INC.;REEL/FRAME:038531/0932
Effective date: 20121010

https://www.google.es/patents/US20020124855?dq=assignee+northstar+biotech+group+llc&hl=en&sa=X&ved=0ahUKEwjSpZKG2-vSAhXC6oMKHcyeCfMQ6AEIKDAC

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. A qualified physician performs this minimally invasive procedure using an endoventricular catheter. We entered into an agreement with Biosense Webster (a Johnson & Johnson company) to use its NOGA® Cardiac Navigation System along with its MyoStar™ injection catheter for the delivery of MyoCell in the MARVEL Trial.

When injected into scar tissue within the heart wall, myoblasts have been shown to be capable of engrafting in the damaged tissue and differentiating into mature skeletal muscle cells. In a number of clinical and animal studies, the engrafted skeletal muscle cells have been shown to express various proteins that are important components of contractile function. By using myoblasts obtained from a patient’s own body, we believe MyoCell is able to avoid certain challenges currently faced by other types of cell-based clinical therapies including tissue rejection and instances of the cells differentiating into cells other than muscle. Although a number of therapies have proven to improve the cardiac function of a damaged heart, no currently available competing treatment, to our knowledge, has demonstrated an ability to generate new muscle tissue within the scarred regions of a heart as MyoCell has demonstrated.

MyoCell is a regenerative, cellular therapy intended to improve cardiac function for those with congestive heart failure and is designed to be utilized months or even years after a patient has suffered severe heart damage due to a heart attack or other cause.

Our cardiovascular and vascular product candidates have been streamlined, putting our best opportunities at the forefront of our efforts. The MYOCELL and MYOCELL SDF-1 candidates will, in our opinion, advance forward in the treatment of chronic heart failure (CHF). We are in active prospective partnering discussion for the MYOCELL SDF-1 program. Partnering, we contend, will enhance our capabilities, reduce our development cost through cost sharing and potentially accelerate our time to approval and commercialization. We will continue to apply our ADIPOCELL technology to the treatment of patients in clinic at the point of care. We believe that updating and diversifying our clinical development programs increases the probability of our success, brings operational and fiscal clarity to our Company, and will ultimately enhance shareholder value.

We will continue to evaluate and act upon opportunities to increase our top line revenue position and that correspondingly increase cash in-flows. These opportunities include but are not limited to the development and marketing of new products and services, mergers and acquisitions, joint ventures, licensing deals and more.

MyoCell therapy "$35,000 to $45,000 range" per patient

The cost of MyoCell therapy is projected to be in the $35,000 to $45,000 range and includes the harvesting of the muscle cells, the laboratory processing of the cells, and the consumable delivery technology (MyoCath). Additional therapy costs will include one hour of cath lab time and a two to six day inpatient stay for post- therapy monitoring. Not including professional fees, these costs add $2,200 to $3,500 to the procedure. Additionally, initial costs would include diagnostic testing, such as stress tests, ultrasounds, and EP studies, to determine the extent of the cardiac tissue damage and to determine if the patient is a candidate for MyoCell therapy.

Reimbursement for a unique technology is difficult to determine. Currently, there are no existing CPT, DRG, or APC codes that reflect autologous cell therapy for the treatment of damaged myocardium because it is still an investigational therapy. When approved, BioHeart can apply for a new technology add-on payment. If the application is accepted, Medicare would pay a marginal cost factor of 50% of the costs for the new technology in excess of the full DRG payment. Considering ICDs (implantable cardioverter defibrillator) cost $23,000 or more and have to be replaced every four to seven years, Myocell therapy will be a primary candidate for additional reimbursement.
External Cardiac Basal Annuloplasty

Vendors:
• Mardil, Inc. – BACE (Basal Annuloplasty of the Cardia Externally)
• Myocor, Inc. (Edwards Lifesciences) – Coapsys and iCoapsys devices • Acorn Cardiovascular – CorCap Cardiac Support Device
• Paracor Medical Inc. – HeartNet

Each year, approximately 100,000 surgical procedures are performed to replace or repair a defective heart valve. Unfortunately, heart valves only last 10 to 15 years and there’s a surgical mortality rate of 2% to 5%. In addition, patients are required to take anticoagulants for the rest of their lives.
As a result of these dilemmas regarding cardiac surgical procedures, external cardiac basal annuloplasty devices were developed to support and reshape the heart muscle into its normal state to allow the heart valves to open and close properly. The system uses mechanical/mesh systems applied to the base of the heart to prevent leakage and regurgitation of heart valves in a simpler and safer procedure without the need for replacement or cardiac bypass support during surgery. This method should render improved outcomes and allow for a wider range of surgery candidates.

Competing Technologies:
• Heart Value Replacement and Repair Surgery
Costs:
• Device – $10,000 to $20,000
• Implantation – $15,000 to $20,000

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