A Schaumburg firm offers a possibly life-saving service that few people would look for but that none would likely reject.
While most consumers would hope to never require the assistance of Vascular Transplant Services in their lifetime, to an aging diabetic population in need of limb-salvage procedures, the Schaumburg firm represents a new lease on life.
Opening an operation like VTS is a painstaking, lengthy process that requires dedication, patience and substantial capital.
It’s probably why no other vascular tissue supplier has attempted to do so in the last decade, said Tim Stevens, director of operations for VTS.
However, Stevens and his colleagues saw an underserved market that will only be expanding in the coming years as the population ages and diabetics begin to require more treatments.
The lengthy process took three years of development and hundreds of thousands of dollars of investment before the firm could officially open its doors last July with full approval from the Food and Drug Administration.
No longer in the business of starting a business, the principals of the firm can now focus on the mission of providing valuable tissue transplants to those in need.
“One person (donor) can enhance or save the lives of 25 others,” said Anita Jordan, president of VTS.
VTS focuses mainly on vascular tissue transplants for the saphenous vein, which runs down the leg from the groin to the ankle. Recent technological advancements have made this procedure more popular as a method for diabetics to save their limbs.
Typically, diabetics will pull tissue from their own bodies and reposition it before appealing to a donor, but once they have exhausted their own supply, a matching donor is the only option, said Stevens.
Jordan and Stevens both have extensive experience in the pharmaceutical industry, mainly working with FDA regulations of anti-infectives.
Through family connections, Jordan recruited Dr. Edmond Owen Jr., a Memphis-based cardiovascular surgeon, who functions as the medical director for the firm while Stevens and Jordan work on FDA approvals, mainly with the packaging process.
To round out the group the firm hired James Byrd as technical director. Byrd has performed more than 6,000 vascular tissue recoveries.
With the team set in place the search for donors was underway. The firm acquires its tissue from the Midwest region and a few surrounding states.
“We work with three recovery groups right now,” said Jordan. “They locate potential donors, approach the families and discuss the options of organ donation with them.”
After a match is found VTS completes the entire process from retrieval to distribution. The tissue is recovered by the medical professionals on staff and then it is examined and evaluated by the lab technicians in Schaumburg. If it passes all of the requirements it is then stored in cryopreservation, which freezes the tissue at a controlled rate.
“Industry standard for storage is about 10 years,” said Stevens. “We already have about 50 samples in storage right now.”
One of the unique aspects of VTS is that its technicians have developed the firm’s own proprietary broad-spectrum antibiotic solution that is used in the packaging and cleansing process of the donated tissue.
The solution has met FDA approvals and may represent yet another business venture for VTS in the future.
“Our manufacturer told us to be ready for other firms inquiring about the solution,” said Stevens. “There is a possibility that it may be purchased by others in the future.”
The firm also has an online tool for physicians to examine available samples and locate matches for their patients. It is a secure log-in system viewable only by member doctors. Once they find a possible match, they then can call one of the medical staff at VTS and discuss the tissue further.
VTS works with distributors to find physicians who may be in need of vascular tissues for limb salvage procedures. The firm has not expanded its services nationwide yet, but that is eventually the goal.
Jordan and Stevens declined to discuss the actual cost of donated tissue, but stated that the overhead and startup costs of the business were very high, hinting that the price of tissue is somewhat high.
“There is a huge expense to do this,” said Stevens. “In the beginning, just one validation process for the FDA can cost $100,000.”
Stevens said that the firm underwent multiple validation processes.
On Nov. 8, for example, VTS sent out two tissue transplants to be used in two separate procedures in Memphis the following day. They were the first deliveries made by the firm.
Stevens and Jordan expressed a satisfied sense of accomplishment when discussing this event.
However, for VTS this could be just the tip of the iceberg, as part of its mission is to distribute and use as much tissue as possible.
“We are very stringent in our analysis and we do reject tissue if it is not up to standard,” said Stevens. “But a lot of companies reject tissue that could be used in this process. We want to use as much as we can. It is out of respect to the donor and their families. We take in the fact that this is a gift.”