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."
Microfat Isolation
MiniTC allows for processing of adipose (fat) tissue without exposure to the external environment. The final product of the processing is a fine washed fractured fat tissue known as fat graft or microfat. When implanted by injection, the essential effect can be attributed to the preservation of the integrity of fat tissue and the stromal cells within its natural niche. Together it constitutes structural factors that trigger the reconstruction, regeneration and healing of connective tissues. It's a gentle process that uses an individual's own fat tissue to cushion and support areas of injury or damage as the body heals itself.
Pipeline Products
Jointechlabs has an extensive development program. In addition to MiniTC, the company's Mini-Stem – a patented, disposable, closed loop medical device – is pending approval in Europe (and under investigation in other countries) for isolation of stem cell fraction (SVF) from fat. Mini-Stem will enable doctors to provide safe, reliable, cost-effective non-surgical stem cell treatments at the point-of-care. Mini-Stem will serve as a platform for cell therapies and is well poised to target the developing regenerative medicine market, unlike any of the current devices. Additionally, Jointechlabs is developing proprietary stem cell-scaffold product as a biologic therapy for osteoarthritis, for approval under the FDA's fast-track program. A portion of the pre-clinical study for JTL-T-01 is funded by NIH's small business grant (SBIR grant) in collaboration with Rush University.
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/.
Media Contact:
Betsy Levy | Phone: (415) 377-3112 | Email: [email protected]
SOURCE Jointechlabs
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