FDA gives green light to Jointechlabs’ MiniTC point-of-care fat tissue processing device

BIOWORLD ARTICLE for NEW FDA Cleared MICROFAT device

FDA gives green light to Jointechlabs’ MiniTC device

By Meg Bryant

Regenerative therapies startup Jointechlabs Inc. has won the U.S. FDA’s nod for its MiniTC point-of-care fat tissue processing device. The 510(k)-cleared product is designed to extract microfat for use in grafts for a variety of indications, including medical aesthetics, plastic surgery, orthobiologics and wound healing.

MiniTC is Jointechlabs’ first product. The single-use, closed-loop medical device can be used in clinics with no specialized infrastructure, freeing clinicians from needing to manually process adipose (fat) tissue in a laboratory.

The device processes aspirated fat tissue into a fine, injectable or topically applied substance, without exposure to the external environment. When injected into a treatment site, the combination of high-integrity fat tissue and the stromal – or connective tissue – cells within it trigger regeneration of connective tissues, letting the patient’s own fat tissue support the healing and regrowth process.

Minimally invasive procedure

“The process of obtaining the fat sample is a minimally invasive outpatient procedure performed under local numbing,” Jonathan Schwartz, President at Jointechlabs, told BioWorld. “The process of harvesting fat sample takes 10 minutes, while the entire preparation of the fat graft is another 20-30 minutes before reinjecting back into the patient.”

Compared with other comparable fat processing devices, MiniTC is not just fast and easy – it’s also about half the price, he added.

Jointechlabs' MiniTC device

MiniTC’s performance has been validated both in vitro and in vivo, including in an observational orthopedic study in Israel and the United Arab Emirates, with 92% of the 47 patients reporting functional improvement with no complications. It has also been validated in studies with lymphoedema patients in the areas of facial aesthetics, and wound care, the company said.

“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 practitioners – in medical centers, hospitals and clinics – to provide safe, reliable and cost-effective cell-enriched fat grafts at the point of care.”

Schwartz said the company is currently in the process of launching the device and is focused on broadening awareness of its availability and usefulness among distributors and practitioners.

Active pipeline

San Francisco-based Jointechlabs is already looking beyond MiniTC to other regenerative medicine prospects. The company’s second product, Mini-Stem, is pending CE mark in Europe and is under investigation in other companies. Based on the MiniTC platform, the disposable, closed-loop device isolates stem cell fraction from fat, enabling nonsurgical stem cell treatments at the point of care.

Mini-Stem is not approved in the U.S., but Schwartz said preclinical studies are ongoing. “Jointechlabs is … looking to submit for FDA fast track the therapy utilizing the Mini-Stem system capabilities for bedside autologous cell application.”

Jointechlabs is also developing a stem cell-scaffold product for treating osteoarthritis. The company plans to seek FDA fast track approval of the biologic therapy, called JTL-T-01. A portion of the preclinical study for the product was funded by a $218,000 NIH Small Business Innovation Research grant, in collaboration with Rush University.

Founded in 2016, Jointechlabs’ technology was developed and patented by its founders Katz, COO Felix Pustilnik and Nishit Pancholi. The privately held company reached its current stage with little outside , preserving full control to its founders, Schwartz said.

“Currently, we are raising a series A equity round toward scaling up production and , as well as pipeline development,” he said.

Regenerative medicine field thriving

The regenerative medicine and advance therapies sector captured $10.7 billion in funding globally in the first half of 2020, despite the challenges posed by the COVID-19 pandemic, according to the Alliance for Regenerative Medicine. That’s 120% more than was raised in all of 2019

Moreover, the alliance reported that, for the first time since it began tracking the sector, the number of companies actively involved in cell and gene therapy, as well as tissue engineering, exceeds 1,000. Since the beginning of the year, the sector has growth about 2%. U.S. companies comprise more than half of the field, with 543 companies, followed by Europe and Israel with 238 and 184 in Asia.

For more information on this breakthrough technology, please contact

Jonathan Schwartz

President, Jointech Labs, Inc

[email protected]