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Clearance of the closed-loop device helps to legitimize the growing field of regenerative medicine.
Jointechlabs recently announced that the MiniTC™ fat grafting device has received FDA clearance.
MiniTC is a disposable, closed-loop medical device that allows physicians to process fat in the clinical setting for fat grafting applications in medical aesthetics, plastic surgery, wound healing, and orthobiologics.
The clearance helps to legitimize the growing field of regenerative medicine, according to the company.
"The FDA clearance of MiniTC represents an important step forward in the regenerative medicine market," says Nathan Katz, Jointechlabs' CEO in the press release.
"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 makes it possible to process fat gently and in isolation from the external environment, which, says the company, helps to maintain its structural integrity and ability to support, heal, and regenerate connective tissues.
Additionally, they report, MiniTC is more affordable and easier to use compared with other fat processing devices.
The device has been validated in vitro and in vivo, according to the release, in an observational orthopedic study of 47 patients in Israel and the UAE in which 92% had functional improvement and zero complications. It has also been validated in clinical studies with lymphoedema patients and in facial aesthetics, hair regrowth, and wound healing, they say, though the release does not provide specific references to published studies.
"Jointechlabs' MiniTC device is easy to use and effective," says Joseph Purita, MD, orthopedic surgeon and director of the Institute of Regenerative Medicine in Boca Raton, Fla., in the release. "It is encouraging to see the continuing development of new technology for regenerative medicine that is compliant with FDA guidelines."
The company also has the Mini-Stem device in development for isolating stem cell fraction from fat. The patented, disposable, closed-loop device, is currently pending approval in Europe and being investigated in other countries. Jointechlabs believes the Mini-Stem will be a platform for cell therapies and instrumental in the evolution of the regenerative medicine market. Notably, Jointechlabs is currently developing a proprietary stem cell-scaffold biologic therapy product for osteoarthritis under the FDA's fast-track program. The pre-clinical study for the JTL-T-01 product is partially funded by NIH's small business grant and in collaboration with Rush University.