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Text Box: Injectable
Tissue
Bethany Nichols

Introduction

Market Issues

Triggers and Barriers

Data and Research

Future for Injectable Tissue

Competitive Environment

Surgery Comparisons

Conclusion

Appendix

References

Introduction:

Breakthroughs in the regeneration of basic human cells now make it possible to repair cartilage and bone without intrusive surgery. Injectable Tissue (Appendix A), a new development by Genzyme soon to hit the market, can repair damaged cartilage in the knee. This procedure will swap knee replacement and arthroscopic surgery with a new-fangled process that injects new tissue and growth hormones into the knee in order for the body to then repair itself. It has a great potential to cut down on costs, recovery time, and risk to patients.

Today’s current market is dominated by insufficient technologies that do not permanently repair the knee. The market for knee surgeries in the U.S. is currently around 300,000 cases per year, and worldwide the number rises to around 850,000 (http://www.arthroscopy.com/sp13008.htm). With Genzyme’s current position in the technological market, it is poised to capture a majority of this market once the product reaches mainstream adoption in 2-3 years. Total Knee Replacement has an average cost of $26,000 and only provides a temporary solution in which the procedure must be re-administered every 5-8 years. Arthroscopic surgery costs around $15,000, but is only useful on minor problems or injuries (http://www.arthroscopy.com/sp08001.htm). It can also be administered to the same area only a limited number of times. This means that if you get re-injured an alternate, more extensive method must be used to re-correct the problem. However, Injectable Tissue will run around $15,000 to $35,000, with the bulk of this cost coming from producing the regenerated cells. As the market leader and innovator for Injectable Tissue, Genzyme would be able to hold on to a majority of this portion of the market, causing other companies to stay out of the market and therefore keeping the cost low.

Market Issues:

Injectable Tissue has many factors boosting it over the alternatives, but there are still some hurdles to overcome. Since it is far less complicated than other procedures it is very appealing to doctors. It also has a very short recovery time, appealing to patients and physical therapists, a one-time 3 month recovery compared to an often repeated 8 month recovery period. But, due to strict FDA regulations in the U.S., Genzyme will have to be sure that when Injectable Tissue reaches the market it is prepared to perform. Genzyme’s Carticel procedure uses many of the same concepts and principles as Injectable Tissue meaning that the FDA has very little investigating to do in order to approve this new process, thus FDA approval at this point seems likely (http://www.arthroscopy.com/sp08001.htm). Due to the fact that Carticel has proven its effectiveness, its track record will push injectable tissue into the spotlight. Another risk could be that there are people that oppose the ideas that Genzyme and injectable tissue stand for, such as stem cells, research on animals, and many other issues that the community may disagree with. Due to the fact that Genzyme is in the medical industry they are certainly at the mercy of FDA approval, as well as dependence upon insurance coverage since most medical procedures are very expensive.

Triggers and Barriers:

Injectable tissue has some trigger and barriers that should definitely be noted. FDA approval is going to drastically affect the rate of adoption. If the federal drug administration slows the development of injectable tissue it could force the entire project to facilities in Europe. This would slow the approval process for healthcare, and thus on to the majority of the market. Although, this does not appear likely, Carticel, a procedure that Genzyme currently patented, uses many of the same principles that require FDA approval. The difference between injectable tissue and Carticel is that Carticel is an intrusive surgery and does provide any of the smaller recovery times. Since many of the same concepts are used that have already been approved through Carticel, a quick approval for injectable tissue is expected.

Data and Research:

Due to the fact that Injectable Tissue has yet to reach the market, no data is available about the effectiveness of the treatment. Genzyme plans to thoroughly test the procedure innumerous amounts of times to make sure each specific detail is correct. However, it will be many years until they can determine the long term affects of the surgery due to the fact that they have not had testing patients results. Therefore, many studies will be done to get this procedure to perfection. When it first enters the market, it will be performed by leading doctors in the major cities medical hospitals. Since all doctors and nurses will have to have special training to administer the injectable tissue, it will take a few years before all hospitals can conduct the procedure. After the procedure has been implemented for an extended amount of time, the results that patients get can help Genzyme to improve on the process. Since the biggest problem with current solutions is that there are no long-term solutions to a knee injury, by making injectable tissue outlast the alternatives it will dominate the market and achieve the dominant design. In addition, the feedback from the doctors, both therapists and surgeons, will allow Genzyme to make the process easier. The reduction of complications and the amount of time and staff required to perform operation will most certainly lower cost associated with most projects. The development of this project will take an extensive amount of time due to the amount of quality research that will need to be done in many various areas.

To get this feedback from the patients and doctors, a survey/analysis company will be used. This process will take a long time since much research and information will need to be gained. However, by doing just so, injectable tissue will far outweigh the other options for a knee surgery. Genzyme will want to know about recovery, the speed, quality, or any pain felt from the patients. From the hospitals they will want to know how this surgery compared to others, or how successful it was compared to the other surgeries. Genzyme would like to know how the surgery process itself compared to others, if it was quicker, more complex, less time consuming. The largest piece of information would not be attainable until some time in the future. The ultimate selling point will be the long run effectiveness, since the knee replacement is only temporary and arthroscopic surgery simply removes pain and can often not be performed multiple times a permanent solution would make those two alternatives obsolete.

Future for Injectable Tissue:

Genzyme is also looking forward to FDA approval of embryonic stem cell research. Though injectable tissue does not depend entirely on this advancement, it will greatly benefit from the work done in that area. It is projected that any advancement in that area would speed up the maturation process for injectable tissue, and pushes it even closer to its ultimate goal for soft tissue regeneration (Goho, 2003). Future projected plans for injectable tissue are to involve cartilage and bone repair, cosmetic surgeries, genetic disorders, then on to soft tissue regeneration (Appendix B) and (Appendix C).

Competitive Environment:

Injectable Tissue will be entering the market as a competitor rather than creating a new market; however once it reaches the market in 2-3 years it will skyrocket above the incumbent technologies: knee replacement and arthroscopic knee surgery. The fact that this procedure will be drastically less complex will make its adoption very attractive to prospective orthopedic hospitals and surgeons. The benefits of a non-intrusive surgery, less recovery time, eventual lower costs certainly make it desirable for other patients. The current estimated cost is anywhere from $15,000 to $35,000, depending on the extent of the injury and the number of required injections (http://www.technologyreview.com/articles/emerging0203.asp?p=0). Knee replacement and arthroscopic surgery have been tapped out and saturated into the market. Knee replacement lasts for only a few years with a price range of around $26,000. The operation requires 8-12 months of recovery time and then must be performed again 5-8 years later, the best case scenarios last up to 15 years. Arthroscopic surgery usually runs on the low end when compared to Total Knee Replacement. It averages around $15,000, but can become expensive when complications arise. The problem with this surgery is that it cannot fix major problems, it deals primarily with tears in the cartilage and can only be preformed a certain number of times before it cannot be done again. Injectable tissue has the potential to solve all these problems as well as move into other areas as well.

Surgery Comparisons:

Total Knee Replacement

Total knee replacement is a procedure in which injured parts of the knee are replaced with artificial parts. The procedure is administered by separating the muscles and ligaments around the knee to expose the knee capsule (Appendix D). It is then opened to expose the inside of the joint. The ends of the thigh bone and shin bone are removed, and occasionally the kneecap in order for the artificial parts to be cemented into place (http://www.vh.org/adult/patient/orthopaedics/kneereplacement/). This causes a large incision in the knee which could lead to scars and possible infection. The longest possible amount of time for an artificial knee to last is 10 years, thus making it not a permanent fixture. It also does not guarantee full recovery back to normal physical activities. Physical therapy after a total knee replacement is very time consuming, painful, and not always fully successful. Recovery time with a physical therapist can last up to eight months, three times a week, with numerous exercises to be done in the office and at home.

Arthroscopic Surgery

Arthroscopic Surgery treats knee problems by making a small incision inside of the knee, utilizing a pencil-sized instrument called an arthroscope (Appendix E). The scope contains optic fibers that transmit the image of your knee to a television monitor. From this the surgeon can examine the interior of your knee and determine the problem. The surgeon then inserts surgical instruments through other incisions in the knee to remove or repair the damaged tissue (http://orthoinfo.aaos.org/booklet/thr_report.cfm?thread_id=8&topcategory=knee). Once again, this causes incisions in the knee which could lead to scars and possible infection. This surgery can only fix minor problems and usually can only be administered a limited number of times to the knee. Like total knee replacement, recovery time with a physical therapist can last up to eight months, three times a week, with many exercises to complete not only with the physical therapist, but also at home.

Injectable Tissue

Injectable Tissue, as it can be seen, certain takes precedence over the other alternatives. It not only is non-intrusive, it also has speedy recovery and is a permanent fix. The process begins by taking a healthy piece of tissue from the injured knee in order to be sent to the lab to grow for the injection. A needle is then inserted into the knee and the damaged piece of cartilage or tissue is removed (Appendix A). The newly formed is then inserted, with only one needle incision. The recovery time expected for injectable tissue is less than 3 months. This certainly could be crucial as compared to 8 months due to the fact that many of us have lives to carry out, families to take care of, and jobs to tend to; however, if not able to return to normal daily functions certain types of depression and a sense of helplessness could be felt. The physical therapy will be much less intense and regular daily activities will be able to be resumed. This certainly will help those in the work force or athletes to whom a quick recovery time is crucial. It will also be more beneficial to elders so that they are not inhibited too long by the extensive surgery that could be very harmful to their overall well-being.

Conclusion:

As it can be seen, Genzyme’s Injectable Tissue certainly has the advantage over the other options in its low cost, small recovery time, non-intrusiveness, and as a permanent fix to the problem. Although it is in the making and will not reach the market for 2-3 more years, it will certainly sky rocket above the rest. With the studies to come in the future, it will be able to be proven to be the most effective and longest lasting procedure for knee surgery. Injectable Tissue does not end here, but will have a future in many aspects of the medical field and each of our lives.

Appendix:

Appendix A:

Step 1: Biopsy

Your surgeon takes a tiny piece of healthy cartilage during an arthroscopic procedure.

Step 2: Biopsy Processing and Cell Culturing

The biopsy is sent to Genzyme Biosurgery in Cambridge, Massachusetts, for processing and culturing. Processing releases the chondrocytes which are then cultured or grown for about 5 weeks. The chondrocytes multiply significantly, yielding about 12 million cells. These cells, Carticel, are returned to your surgeon for implantation.

Step 3: Incision

An incision is made to expose the injury and damaged cartilage is removed.

Step 4: Periosteum Harvest and Suture

Periosteum, a tissue that covers the bone, is harvested from the shin bone and sutured over the injury site to create a water tight compartment ("patch").

Step 5: Implantation

After ensuring that the injury site is water tight, Carticel is implanted beneath the periosteum. Here the cells may continue to multiply, forming the building blocks of healthy cartilage and integrating with surrounding cartilage. With time, the cells will mature and fill in the injury site with a firm, durable tissue.