AVH.AX - Burns Treatment Device (the next PNV)


DECISION

ABOUT

  • AVH owns the patents and produces a medical device called RECELL, which produces a “suspension” of spray-on skin cells using a small sample of the patient’s own skin to help treat burn patients and skin defects. The primary purpose of RECELL initially will be to treat patients with acute and severe burns.

  • The device was invented by Australian of the Year Dr Fiona Wood and has been used to treat victims of the Bali bombings in 2002.

  • The current standard of care for severe burn patients is based on skin grafting techniques; the RECELL device significantly reduces the donor skin requirement with no compromising impacts on efficacy. For larger burn areas, the skin requirement is reduced in combination with traditional grafting, where surgeons have used “spray-on” skin between gaps on wider areas for successful surgical outcomes.

FINANCIAL

  • Sale of goods: Up 543% (A$7,705,398 vs A$1,198,861)

  • Total comprehensive loss attributable to owners of the parent: A$ (32,819,919) vs A$ (15,955,876)

  • TOTAL EQUITY: A$ 30,400,095 vs A$ 18,999,559

  • Cash and cash equivalents at end of period: A$ 28,983,491 vs A$ 14,825,532 (FY18)

WHY

  • In 2015, where AVH was able to secure significant funding from the US Biomedical Advanced Research and Development Authority (BARDA) to help fund development efforts to secure Pre-Market approval for RECELL by the Food and Drugs Administration (FDA) in the US.

  • In September 2018, the company received FDA approval for use of RECELL to treat patients with acute and severe burns for patients over 18, paving the way to commence commercial activities in the largest burns market.

  • RECELL trials have demonstrated improved patient outcomes including shorter length of stay, reduced pain and improved cosmetic outcomes (less scarring), while hospitals have benefited from lower treatment costs and improved productivity.

  • In April-2019, RECELL was showcased in numerous presentations at the major ABA Burns Conference in the US, which featured analysis on significant cost-saving outcomes for AVH’s target patient market (i.e. patients with a total burns surface area more than 10 per cent). The increased awareness of the product should help drive adoption in a market that is relatively concentrated (134 burn centres, 300 burn surgeons) over the next few years.

Source: https://rogermontgomery.com

OPPORTUNITIES

  • NASDAQ listing

  • 19 September 2019 - New Data Published in Aesthetic Plastic Surgery Explores the Use of the RECELL System in Combination with Dermabrasion to Treat Acne Scars. Data published in Aesthetic Plastic Surgery by the Department of Plastic Surgery at Peking Union Medical College Hospital exploring the use of the RECELL® Autologous Cell Harvesting Device (RECELL® System) in combination with dermabrasion to treat facial acne scars.

  • Other recent publications investigating the use of the RECELL System in the treatment of dermatological conditions, include:

  • “The use of noncultured regenerative epithelial suspension for improving skin color and scars: A report of 8 cases and review of the literature”

  • “The clinical efficacy of treatment using the autologous non-cultured epidermal cell suspension technique for stable vitiligo in 41 patients”

  • 17 September 2019 — U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) application to conduct a pivotal trial evaluating the safety and effectiveness of the RECELL® Autologous Cell Harvesting Device (RECELL® System) in combination with meshed autografting for the treatment of acute full-thickness skin defects, such as degloving (a type of injury where the skin is ripped from the underlying tissue), crush wounds (a break in the external surface of the body), abrasions, lacerations, and surgical wounds. The pivotal studies leading to the RECELL System’s FDA premarket approval (PMA) for the treatment of acute thermal burns demonstrated that the RECELL System treated burns using 97.5ii percent less donor skin when used alone in second-degree burns, and 32 percent less donor skin when used with autograft for third-degree burns.iii Despite the statistically significant reduction in donor skin required to treat burn patients with the RECELL System, burn wounds treated with the RECELL System achieved healing comparable to the burn wounds treated with standard of care. Donor site outcomes from the clinical trial for second-degree burns also revealed a statistically significant reduction in patient-reported pain, increased patient satisfaction and improved scar outcomes.ii

  • There appears to be additional opportunities for application of the RECELL technology. There are various stages of trials and development including:

  • Approval for use for Paediatrics – where trials have commenced in late 2018. AVH has already used the device on paediatrics in previous trials for compassionate use

  • Chronic wounds – including venous leg and diabetic foot ulcers

  • Hypopigmentation – vitiligo and scars

  • Trauma wounds

  • There is also the opportunity to partner with other companies to penetrate new geographies (as evidenced by its recent deal with COSMOTEC in Japan).

Technical


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