PNV - Banter and General Comments, page-12070

AVH have a distribution agreement with the same company PNV use for Europe (Germany, Austria and Switzerland) PolyMedics Innovations GmbH as per below. So maybe DW was just alerting to this PNV Recell link but you would assume PNV management will have a good look at the case study results using BTM under Recell Go now it's FDA approved.

Last post on this thread for AVH links but have a listen to the next quarterly update on August 9Th, or the previous 22/05/2024 on the benefits of Recell Go over Recell, the new tech is easier to use, less staff needed and you can make as much spray on skin as needed with multiple machines working in tandem to complete the treatment. Hence sales forecast to explode, i think i'll buy more tomorrow as it's on the move.

As part of our strategic growth plans, we plan to expand our global presence within the European Union and Australiathrough the exclusive use of third-party distributors. In November 2023, we entered into our first European distribution partnershipwith PolyMedics Innovations GmbH. PolyMedics Innovations will lead our expansion into Germany, Austria, and Switzerland.We plan to actively identify new distribution partners in our focused markets over the next 6 to 12 months.

INTERNATIONAL STRATEGY

In international markets, the RECELL System has received various approvals and registrations to promote skin healing in awide range of applications including, burns, full-thickness skin defects, and vitiligo. These endorsements includeTGA registration in Australia, CE mark approval in Europe, and PMDA approval in Japan under the Pharmaceuticals and MedicalDevices Act for burns. Our global commercialization strategy is focused on Australia, the European Union, and Japan.Table of Contents7In February 2019, we entered into a partnership with COSMOTEC, an M3 Group company, to market and distribute theRECELL System in Japan. Following the approval of reimbursement pricing by the Japanese Ministry of Health, Labor, and Welfare,COSMOTEC began the commercial launch of RECELL in September 2022.
As part of our strategic growth plans, we plan to expand our global presence within the European Union and Australiathrough the exclusive use of third-party distributors. In November 2023, we entered into our first European distribution partnershipwith PolyMedics Innovations GmbH. PolyMedics Innovations will lead our expansion into Germany, Austria, and Switzerland.We plan to actively identify new distribution partners in our focused markets over the next 6 to 12 months.

From the latest Annual report

RESEARCH & DEVELOPMENTOur research and development activities are focused on advancing our innovative products and building a comprehensiveportfolio of solutions, as well as developing clinical applications to advance the management of wound care. Additionally, wecontinue to conduct clinical studies to provide further efficacy and health economic evidence.

We continue to commit resources to product development to ensure the RECELL system continues to evolve and that wemaintain robust patent protection. In June 2023, we submitted a PMA supplement to the FDA for RECELL GO™. RECELL GO iscomprised of a reusable durable base unit and a single-use sterile cartridge. The RECELL GO system aims to control the currentmanual process of cell disaggregation and filtration, as well as soak time, reducing variability across medical providers compared tothe current device. This revolutionary design will also reduce training requirements, allowing us to leverage our sales team moreeffectively. In turn, we believe the reduction in training medical professionals will lead to increased adoption across our indicationsand the broader market. Additionally, RECELL GO offers us an opportunity to expand our intellectual property portfolio. With eachiteration of our RECELL System, we anticipate preservation of the therapeutic power of Spray-on Skin Cells, deployed in devices thatbecome appropriate for use in an increasing range of clinical settings. This is particularly important as we aim to enter thedermatology space, where there is a shift toward an emphasis on the volume of patients treated in a day.

RECELL GO maintains the FDA Breakthrough Device designation from predecessor devices. On September 29, 2023, wereceived notice from the FDA that additional information regarding the PMA supplement is required for the continuation of asubstantive review for RECELL GO. This request, which is not unique to the Breakthrough Device Program, placed the applicationfile on hold while we address the FDA's questions. A category of questions posed by the FDA requires additional in-house testing.The testing is already underway and we expect to submit a response to the FDA no later than February 28, 2024. Upon submitting aresponse to the FDA, the application will reenter the 180-day cycle, with 90 days remaining in the review period. This timing wouldimply a product launch on May 31, 2024.

TONE will evaluate repigmentation using the RECELL device and will also seek to measure the improvement in the qualityoflife following treatment of stable vitiligo with RECELL. TONE, including publication, is expected to be complete by the end of2024. The second step is to initiate a health economics study to capture the longitudinal healthcare costs for a vitiligo patient, which isexpected to be completed by the end of 2024. The purpose of these studies is to demonstrate how treating vitiligo with RECELL cansignificantly reduce the lifetime healthcare cost of patients. As a result, commercial payors will stand to benefit economically byproviding coverage of RECELL for the repigmentation of stable depigmented vitiligo lesions. Following publication of these studies,we expect conversations with commercial payors to begin during the second quarter of 2025. Commercial coverage will be rolled outon a tiered basis based on state and geographic factors. The Company anticipates that the initial phase of reimbursement coverage willlikely begin in the fourth quarter of 2025, with appropriately sized commercial support as coverage is established.