Regenerative Medicine is the process of engineering living, functional cell and tissue-based therapies and administering these to patients to repair or replace tissue or organ function lost due to age, disease, damage, or congenital defects. Target diseases include cancers, diabetes, heart disease, ALS and target disorders include spinal/movement, hearing loss, vision loss, and neurological (i.e., stroke).
Nearly all currently available and development stage regenerative medicine products and therapies utilize biopreservation processes and products in the acquisition of source material, isolation and manipulation of specific cells, and storage and shipment of a final product dose to a patient location. System optimization is critical and biopreservation economics greatly impact product commercialization potential through shelf life impact on distribution, and clinical dose efficacy following preservation.
This market is comprised of nearly 700 commercial companies and numerous other hospital-based transplant centers developing and delivering cellular therapies such as stem cells isolated from bone marrow, peripheral and umbilical cord blood as well as engineered tissue-based products. MedMarket Diligence, LLC, estimates that the current worldwide market for regenerative medicine products and services is growing at 20 percent annually. We expect pre-formulated biopreservation media products such as our HypoThermosol and CryoStor to continue to displace “home-brew” cocktails, creating demand for clinical grade preservation reagents that will grow at greater than the overall end market rate.
We have shipped our proprietary biopreservation media products to over 200 regenerative medicine customers. We estimate that our products are now incorporated into 30 to 40 regenerative medicine cell- or tissue-based products in pre-clinical and clinical trial stages of development. While this market is still in an early stage, we have secured a valuable position as a supplier of critical reagents to numerous regenerative medicine companies and university based centers.
HypoThermosol Clinical Trial Use in Regenerative Medicine