Product Line or Service

The goal of the company is to complete the development and market a biological-bioactive implant for the repair of articular cartilage defects in adult patients. These implants are composed of vital cartilage cells (chondrocytes), which within 1-2 months after the operation develop normal healthy cartilage.

The source of the cartilage cells is the patient’s bone marrow stem cells, which are obtained by aspiration of the patient’s hipbone under local anesthesia. These autologous cells (stem cells) are manipulated in vitro to become cartilage cells (chondrocytes). The implant is composed of a mix of these cells and a bio-degradable biological glue which serves as an adhesive biodegradable matrix for the implanted cells. The implantation procedure will be performed by the patient’s orthopedic surgeon in an arthroscopic method. Initially the Bioactive Implants will be perfected and marketed to the knee injuries (trauma, sport, and diseases) and replacement market. Published estimates indicate that the market for knee replacements currently stands at 200,000 replacements a year at a cost of $25,000 each. Over time, the same tissue engineering technology will be used to address other markets and opportunities. 

Technology/Proprietary Rights

The company distinguishes itself both in the revolutionary proprietary processing of the tissue cells and the innovative approach to the implantation method. A.M.T. Bio Tech’s tissue replacements will generate new healthy tissue that will last as long as the original cartilage. This solution is an excellent innovative option to the traditional artificial joint procedure, which is known to last only 10 - 15 years. The solution will eliminate the need for a total joint replacement in a significant amount of patients. This process is expected to be less expensive than current available solutions. The method of implantation is also simpler and less invasive.

Two U.S. patents (4,904,259 and 5,053,050) have been issued to the company. In addition patents have been issued in other countries based on the U.S. patents: 625913 – Australia, 893074 – South Africa, 5979188 – Canada, 90075 – Israel, 0339607 – E.P., 2858782 – Japan.

The company will continually expand its patent estate as it develops additional tissue engineered products derived from stem cells.

Market Opportunities

The pharmaceutical industry invests nearly 20% of sales in R&D, resulting in expenditures of $40 billion worldwide, while the biotechnology industry invests another $10 billion per year in R&D. Of this amount, approximately $10 billion is invested on early stage discovery, and $4.5 billion of development work is outsourced. Some of the larger pharmaceutical companies are out-sourcing up to 25% of their R&D budgets. The tissue engineering market is a fast growing market, and tissue engineered bioactive implants may well revolutionize medicine over the next ten to fifteen years, reshaping the $40 billion a year medical implant industry just as biotech is transforming the drug business. Epidemiological studies from both Europe and the United States, found that 15-20% of the population 55 years and older suffer from arthrosis of the hip or knee joint. 

Between 2.5-5% of this population will eventually need some form of joint replacement or joint reconstruction. Recent publications claim that close to 200,000 knee replacements are performed in the US on a yearly basis. These procedures represent a total yearly market for knee replacements of 5 Billion dollars. A.M.T. Bio-tech believes that its chondrogenic stem cell products could have, over time, a market of $1.4 billion worldwide.

Marketing/Sales and Distribution

There has been no major marketing effort to this date as the company has focused entirely on R&D. As the clinical in-vivo human studies progress, the company will explore one or all of the following sales and marketing options: 

1. Create corporate distribution, sales and marketing organizations that would:

   1. train physicians on how to collect the stem cells and administer the procedure, 

   2. create a central lab that will turn the autologous cells into chondrocytes, and 

   3. establish a sales and marketing organization 

2. Merge with one of the large pharmaceutical or biotech- nology companies and use their infrastructures for the items listed above.

3. Sell the product to a well-known international biomedical company.

Manufacturing

A.M.T. will initially use its own facilities to produce the Bio-Active Implant system. The company will seek GMP validated CRO’s to scale up its manufacturing abilities.
Competition

The A.M.T.’s Bio-Active Implants are a unique technology. The only known competitor with a product on the market is a company called Genzyme, which markets a product called Carticel. In place of the preferred Stem Cells used by AMT, Genzyme has based its product on the use of cartilage cells taken from the patient. This type of cartilage has documented limitations. Furthermore, the Carticel implantation process requires a major surgical procedure.

The Bio-Active Implant system has several advantages over Genzyme and over the widely used knee replacement:

1. Less invasive and less complicated procedure.

2. Patients are more willing to undergo procedure.

3. Longer-term benefits.

4. Unique cell source has significant Biological advantages.

5. Lower cost.