A PARTIAL LIST OF MASSACHUSETTS BIOTEC FIRMS WITH AN ESTIMATED 1,500 R&D JOBS ANNUAL SALES POTENTIAL OF $ 1.2 BILLION

Tri-Point Medical L.P.

Sharpoint Development Corp., General Partner

February 15, 1994

Honorable Tim Valentine
Chairman,

Technology, Environmental, and Aviation Subcommittee

c/o Ms. Sherri Stone

House of Representatives

B374 Rayburn Building
Washington, DC 20515

Honorable Tim Valentine:

As Chairman of the Technology subcommittee, I thought that our company's experience during the last twelve to fifteen months might be of interest to you.

Specifically, the proposed Healthcare plan as proposed by the Executive Office and the related jitters that have resulted in the financial community have slowed the development of our company'■ technology and therefore our company.

Tri-Point Medical is a biomaterials firm that two years ago discovered an innovative and proprietary composition that can be used as an adhesive to close surgical wounds or tramatic wounds. Based on this discovery, Tri-Point decided to go to the financial markets, to raise funds to accelerate the development of the surgical adhesive. Since Tri-Point is a typical biomaterials startup company, we must go to the venture capital market. What we found was a healthy dose of fear regarding the future of healthcare products. Most firms that might invest in our situation were holding back funds to protect previous investments.

When the venture capitalist looks at healthcare reform and then combines his risk assessment with the FDA turmoil, they back away. We started our process over a year ago. We have made progress but still have not finalized the funds needed to accelerate our plans. Please feel free to call me if I may answer further questions. Sincerely,

Tri-Point Medical L.P. 5265 Capital Boulevard Raleigh, NC 27604 (919) 876-7800 Fax (919) 790-1041

I wish to testify on behalf of myself and those who are concerned about the rapid development of gene therapy. On September 14, 1990, I administered the first human gene therapy treatment. This was an infusion of genetically corrected white blood cells that was given to a 4-year-old girl with a fatal Immune deficiency disorder called Adenosine Deaminase Deficiency or ADA deficiency. The results of this first gene therapy experiment have been quite dramatic with a marked decrease of infections and an improved quality of life that now allows that child to be a fully functional second grader in a public school classroom in Cleveland, Ohio.

The field of gene therapy has the greatest potential for prevention and treatment
of disease high cost in human suffering or in healthcare dollars. For instance, I
conceived of an idea on how one might treat brain tumors with gene therapy.
We have now treated eight patients at the National Institutes of Health. The
early results are encouraging with five of the eight patients having had clear
evidence of an anti tumor effect. This has been accomplished with no evidence
of toxicity. While these studies are preliminary, this confirms for me that the
promise of gene therapy as an effective and non toxic therapy is real.

As a physician, my first concern is that all people have access to health care
and I fully support the efforts by the administration to guarantee that for all
United States citizens. The second priority is the prevention of disease. With
more than 4,000 known genetic disorders and for a host of other disorders such
as, cancer, auto-immune disease and infectious diseases, gene therapy holds a
tremendous opportunity. For disorders such as Tay-Sachs Disease where the
neurologic devastation begins before birth, we have the opportunity to intervene
so that child will be neurologically normal from birth. For women with breast
cancer we have the opportunity to identify those at risk and insert normal genes
into the mammary tissue before they get cancer so no woman ever has to
struggle with the decision of having her breasts removed prophylactically.

Will gene therapy be expensive? As a single, clinical therapy, gene therapy may well be expensive. But the overall cost savings whether it be in prevention or in treatment should be substantial. For instance, our 4-year-old patient with ADA deficiency is receiving injections of a drug that costs $200,000 per year. Even if gene therapy, as a one-shot cure, costa as much as $10,000 or more, millions of dollars in savings will be realized over the course of that child's life, just on the savings on the drug therapy alone. There would be additional savings from preventing this child's repeated illnesses.

In July, 1993 the lowa Methodist Medical Center in Des Moines, Iowa established the Human Gene Therapy Research Institute. As Executive Director of that Institution, I am working with a staff of 30 people to transform this new knowledge in genetics and molecular biology to effective new treatments for patients.

I am fully confident that over the next five to ten years we will see the
emergence of dramatic new curative therapies for diseases for which there
have been no satisfactory therapy. I want to encourage congress to consider
continued vigorous support for gene therapy development and invite you to visit
our facility and our patients. We have a remarkably bright future ahead of us in
helping all mankind.

Sincerely,

Kamithila. And

Kenneth W. Culver, M.D.
Executive Director

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