2020 December-January Analysis Featured

Georgian aesthetic medicine firm Aptos receives U.S. FDA green light

The Aptos thread lifting method offers a third option between surgical intervention and chemical injections. Already well-established across the world in more than 70 countries, Aptos is now setting its eye on the U.S. market.

Though many may have heard of Georgia through what are becoming household words such as khachapuri and Saperavi, the Georgian sciences in recent years have been doing their part to get the word out about Georgia as well.

Georgian aesthetic-medicine firm Aptos is continuing the trend by having recently received permission from the U.S. Food and Drug Administration (FDA) to begin distribution of its unique surgical sutures that offer an alternative to invasive cosmetic surgeries to tighten and lift the face and to chemical methods of rejuvenation.

“The idea to use surgical sutures has been around in the medical literature since around the late 1950s,” Aptos Director George Sulamanidze told Investor.ge, “but the potential was only harvested when my father, Marlen Sulmanidze, was able to create a reliable, effective application for them in aesthetic plastic surgery, by producing a thread in the 1990s with tiny embedded hooks which lightly snag the skin just below the surface, lifting it up.”

The application process generally takes less than half an hour, does not require anaesthesia nor does it significantly alter the skin below, allowing for a drastic decrease in recovery time as compared to traditional surgical methods.

Sulmanidze’s technique addressed two big problems in the aesthetic medicine industry: “One was that classic aesthetic medicine, up until that point, had offered just two main approaches—one surgical, one chemical. Both [are] rather drastic, and left open a niche for a more natural approach,” Sulmanidze explains.

Another pain point to be addressed was that many cosmetic procedures are only appropriate for certain age groups, which left some patients without a suitable solution.

The first successful application of the thread was used by George Sulmanidze’s father in 1996, in Russia, where the company’s first factory was set up. Later, manufacturing plants were established in the U.S. (in 2001, in Anaheim, California), and in Italy as well.

Aptos is now building a factory in Georgia with European Bank for Reconstruction and Development (EBRD) financing and help from Enterprise Georgia, and is on track to be completed by February 2021. Quality control for all Aptos products produced globally is already carried out in Georgia.

A thread apart

Today, Aptos is the leader in its field, selling in 75 countries “despite a number of copycat companies that have sprouted up across the world,” Sulamanidze notes, stressing that it is the “breadth and depth of our expertise, and the diversity of our product line that sets Aptos apart from competitors.”

Aptos has two groups of products: absorbable, which disintegrate after 2 years, and nonabsorbable, which last four or five, but are unsuitable for repeat operations.

“Our competitors have been unable to replicate the strength and durability of our absorbable products, [for] which 1.5 years post-operation, more than 60% of the [suture’s] diameter remains in the tissue. Compared to our Chinese competitors, their products disintegrate to a similar extent within just six months, while others within a year,” Sulamanidze says.

FDA approval

Aptos got the green light from the FDA this past September after five years of hard work.

“Being an American company would have made it easier. As a foreign company, it took us much investment, documentation and attention to our manufacturing process. We’ve been interested in the American market since 2001. My father and I flew there every three months, presenting all the time. Now that we have approval, we are debating whether to open our own office, or to go through a local partner.”

After having brought Aptos through the process, George Sulamanidze recommends that Georgian companies looking to export to the U.S. find local partners and come up with an airtight business plan, for the importance of which he points to the fact that the EBRD has decided to sponsor Aptos and finance a nearly $100,000 market-entry strategy for the company—only the third in Georgia for which the EBRD has ever done so.

____________________________ ADVERTISEMENT ____________________________