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March 8th

Don't miss out on the September/October 2020 issue of PRIME Journal! Read the new article about Hyaluronic Acid Threads for Skin Improvement. Alberto Diaspro, MD, MSc; Albina Kadjaya, MD; and George Sulamanidze, MD, PhD present the findings of their pilot split face study on the impact of HA threads on skin wrinkles ABSTRACT Background: stimulation of collagenesis, triggered by poly-Lactic acid (PLLA), allows practitioners to enhance the long-lasting performance ensured by poly-caprolactone (PCA); however, it takes months to develop. Given the anti-ageing effect of hyaluronic acid (HA), it has now been embedded in PLLA-PCA threads, making it possible to achieve skin amelioration. Objectives: this split-face pilot study highlights the differences between traditional and the new HA threads. It also aims at quantitatively assessing, using Quantificare Skin Analysis software (Quantificare S.A., Valbonne, France), wrinkles and skin texture on six subjects before, 1 and 3 months after thread insertion. Methods: 5 threads were implanted in the right cheek, and 5 HA threads in the left cheek. Patients were checked for the following 30 and 90 days. Results: HA threads show a better clinical outcome in skin microwrinkles. Skin texture appears to show the same outcome as normal threads. Conclusions: the presented results point out the positive outcome of these new HA threads: a less inflamed post-insertion period and a unique tool that obtains a simultaneous lifting effect and skin rejuvenation. Further studies on larger patient groups are indeed needed to confirm these preliminary results. Read the full issue here ???? ?https://prime-journal.online/magazine/International/Vol10/Issue5/12/index.html?idU=2?

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March 8th

Aptos threads are now FDA approved, which means that soon it will be available on the USA market. The whole Aptos team worked hard and consider this as a great achievement! We can`t wait to welcome more aesthetic medicine practitioners from the other side of the globe to our big Aptos community. 510(k) Premarket Notification Device Classification Name: Suture, Nonabsorbable, Synthetic, Polypropylene 510(K) Number: K192953 Device Name: APTOS Threads – Polypropylene Surgical Sutures Regulation Number: 878.5010 Classification Product Code: GAW Date Received: 10/21/2019 Decision Date: 08/27/2020 Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: General & Plastic Surgery 510k Review Panel: General & Plastic Surgery Type: Traditional Reviewed By Third Party: No Combination Product: No "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100)."

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April 22nd

Dear Aptos Partners, dear Colleagues, The unfolding coronavirus (COVID-19) crisis has significantly affected all industries. For safety reasons many countries declared state of emergency, and some of them even imposed a national quarantine, restricting the movement of the population except for necessity, work, and health circumstances. As numerous companies all around the world, Aptos also made remote working mandatory for all workers globally – now all of us are working from home and each of us are still on direct contact with our partners. You can still reach them out on their emails or contact our Executive office at hello@aptos.ge. We do not recommend calling our offices by telephone at this time. To keep our close contacts with doctors Aptos initiated online trainings. Starting from March 30th we began a cycle of free exclusive webinars hosted by our co-inventors and experts on Aptos Threads and Methods. Each seminar has a new, interesting topic and is announced on our official social media pages several days before we go live. So, don’t forget to follow us on Instagram and Facebook. We would like to thank you all for your cooperation. We wish you all health!

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April 22nd

EBRD Georgia supports innovation in the Aesthetic Medicine industry by signing the third Blue Ribbon project with Aptos Aptos, has become 2020 Blue Ribbon champion. EBRD First Vice President Jurgen Rigternik signed the agreement along with George Sulamanidze, General Director of Aptos, during his recent trip to Tbilisi on March 6. Georgia ASB team started working with Aptos in 2017, through advisory services to help the company improve its management effectiveness by developing appropriate business model, expanding product portfolio and implementing a franchise system for Aptos products and services. The successful implementation of the first stage of the advisory in 2018 led to the company signing up for the International Advisory project to improve the company’s strategic approach on regional and global level, and updating the organisational structure including the HR operations, as well as develop long-term sales plan while continuing to improve business processes and distribution management. Aptos is a family-owned business found by Mr. Marlen Sulamanidze, a famous Georgian plastic surgeon, and his two sons, also plastic surgeons Dr. George Sulamanidze who acts as the CEO of the company, and Dr. Konstantin Sulamanidze. The company is the leader in the beauty and aesthetics industry and is a manufacturer of a barbed thread and other unique materials used in plastic surgery and cosmetology. Aptos’s products and methods of treatment gained world recognition and are successfully used by the aesthetic physicians in 71 countries worldwide. The company sells its products directly and through distributors globally. The family ‘trio’ received many prestigious international awards and 18 patents for invention and innovation. Aptos is an international brand originated in Georgia, with production facilities based in Georgia, Russia, and Germany. The company's clinics operate in Russia, Georgia and Czech Republic. It now has an ambition to expand further in Europe, as well as in the US, Brazil and China. This is a true success story. EBRD is proud to support the development of the local brand set to become a global player. Following the successful implementation of the Advisory project, Georgia ASB team referred the company to the EBRD bankers which resulted in them signing the loan for Aptos via the Risk Sharing Facility with TBC Bank in and in December 2019. The loan is financing capital expenditures related to the construction of new energy efficient production facilities. Mr. George Sulamanidze emphasised during the signing ceremonial that the EBRD Advisory initiative brought to them wealth of knowledge in terms of management and structure and helped them overcome weaknesses. It has also helped the company identify its strengths and define its market position which allowed it to mitigate future risks better. When they thought it could not get better the EBRD approached the company to support the project not just with the know-how but also with financing. At this stage, he understood that his family managed to build a truly great brand and business that will never stop to innovate, expand, and strive to make humans beautiful, at least, from the ‘outside’.

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