The ideal injector for stem cell therapies.
CLINICAL NEED
Stem cell therapies are an expanding market in regenerative medicine. The global stem cell industry has grown 13.6% annually from $5.6 billion in the year 2013. Currently, 4,681 clinical trials relating to stem cell therapies are being carried out in the United States with 3,000 in early phases of testing. As thousands of therapies advance past initial stages of testing, there will be an increased demand for a safe and effective way to deliver the stem cells to the patient.
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Today, physicians have difficulty delivering stem cells intradermally at consistent depths. Providers rely on tactile feedback and previous experience to deliver the cells to the desired location. Subjectivity and variance are inherent in the current treatment administration procedure. In order to generate useful clinical trial data, the stem cell delivery procedure needs to be optimized to be as consistent and repeatable as possible.
Another major concern is ensuring post-injection cell viability. If cells are injected too quickly, shearing forces in the needle can tear them apart. Furthermore, even just exposing the cells to air can be enough to cause an infection that renders the therapy useless. As a result of these complications, many existing dermal injectors cannot be adapted to this highly specialized application.
