FDA Clears Jointechlabs' MiniTC for Point-of-Care Fat Tissue Processing and its Broad Range of Applications
SAN FRANCISCO, Aug. 26, 2020 /PRNewswire/ -- Jointechlabs – a leader in point-of-care regenerative medicine therapies – today announced that the U.S. Food and Drug Administration (FDA) cleared the company's MiniTC™ for point-of-care fat tissue processing designed to obtain microfat (or fat grafts), for multiple indications. Jointechlabs plans to focus on a range of therapeutic areas including medical aesthetics, plastic surgery, orthobiologics and wound healing.
"The FDA clearance of MiniTC represents an important step forward in the regenerative medicine market," said Nathan Katz, Jointechlabs' CEO. "The company's comprehensive and proprietary technology provides a variety of tissue reconstruction and regeneration options, enabling healthcare practitioners – in medical centers, hospitals and clinics – to provide safe, reliable and cost-effective cell enriched fat grafts at the point-of-care."
MiniTC is a disposable, closed loop medical device that can be used in the clinic setting, with no change in infrastructure, eliminating the need for manual processing of fat tissue in the lab. Also, the device is less costly, cumbersome and labor intensive compared to what currently exists. MiniTC's performance has been validated in vitro and in vivo, including an observational orthopedic study in Israel and the UAE, involving 47 patients – with 92% reporting functional improvement and no complications. Additionally, it was validated in clinical studies with lymphoedema patients as well as in the areas of facial aesthetics, hair regrowth and wound care.
"Jointechlabs' MiniTC device is easy to use and effective," said Joseph Purita, M.D., orthopedic surgeon and director of the Institute of Regenerative Medicine in Boca Raton, Florida. "It is encouraging to see the continuing development of new technology for regenerative medicine that is compliant with FDA guidelines."
Headquartered in San Francisco, Jointechlabs is recognized as an experienced and respected emerging world leader in point-of-care regenerative medicine therapies. With its devices and technology, Jointechlabs enables healthcare practitioners to provide safe, reliable, cost-effective non-surgical regenerative medicine treatments at the point-of-care. For more information, please visit: http://jointechlabs.com/.
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