>Regenerative Medicine

15.Regenerative Medicine

The concept of regenerative medicine inspires visions of futuristic clinical scenarios where damaged or diseased tissues and organs are not treated with therapeutics, but surgically replaced! Such an approach would ideally suit the global phenomenon of increased life expectancies where significantly large
patient populations are suffering from age-related “wear and tear” conditions,such as arthritis, osteoporosis, and cardiovascular disease. The role of regenerative medicine, also referred to as tissue engineering, in the medical device industry is somewhat confusing. The FDA classifies medical products as either biological, drug, or medical device; regenerative medicine products fall within the gray area between biologics and devices. For clarification, the FDA has designated commercially available Carticel ? (autologous cultured chondrocytes) as “biological” since the cartilage repair product comprising living cells. With that being said, Apligraf? (living, bi-layered skin substitute) is classified as a “device” due to the perception that it functions as a type of “bandage” despite also being composed of living tissue. Most artificial organ strategies will be categorized as devices based upon their construction around ynthetically engineered tissue scaffolds. For clarification, the prospect of stem cells will not be considered in this prospectus since the technology intuitively falls under the biological category, although future cross-over products that will function as devices is highly probable. The clinical and economic impact of stem cell research has yet to be elucidated due to the ethical and political implications that are inherent to this controversial technology.

The promise of regenerative medicine offers the potential to provide engineered organs and tissue that mimic natural biological systems without prejudice or with minimal response from a patient’s immune system; obvious areas of interest include: organ transplants, improved joint and limb replacements,
revascularization of veins and arteries, and cosmetic repair surgeries. More than 89,000 US patients are on the organ transplant waiting list; 17 of those die perday while waiting for available vital organs: hearts, livers, kidneys,pancreas,lung, or bone marrow.

The emergence and growth of the industry in recent years serve as positive indications for the future outlook. Between 1985 and 2002, the number of regenerative medicine companies globally peaked at 90-plus with a cumulative revenue of $100 million to $150 million (USD).

Since then, the number of companies has risen to 150-plus, generating a cumulative revenue of $300 million to $400 million.Although these figures do not provide great evidence of an explosive new sector of the medical device industry,one must consider the implications of developing products regulated under such extremely strict efficacy and safety guidelines.

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