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AVITA (RCEL) Gets FDA Nod for Expanded Use of RECELL System

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AVITA Medical (RCEL - Free Report) announced that the FDA approved its RECELL System for the treatment of full-thickness skin defects. Shares of the company were up almost 7.34% on Jun 7, after market hours on the news.

The expanded indication covers various types of full-thickness skin defects resulting from traumatic avulsion, surgical excision or resection. The approval of the expanded indication significantly increases RCEL's market opportunity, which is estimated to be at least five times greater than before. 

The RECELL System was initially approved by the FDA in 2018 for the treatment of severe burns. It is an autologous cell harvesting device that uses a small amount of a patient's skin to prepare and deliver a regenerative cell suspension called Spray-On Skin Cells. This suspension contains living cells that promote healing and re-pigmentation throughout the infected wound.

AVITA submitted a premarket approval supplement for soft tissue repair to the FDA in December 2022. The company increased its field sales organization to ensure a successful commercial launch of the RECELL System’s expanded use. The sales team has undergone comprehensive training and will be ready for the launch on Jul 1, 2023.

Shares of AVITA have risen 123% year to date against the industry’s 0.5% decline.

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The company is leveraging its expertise to develop innovative cellular therapies for various indications, including the re-pigmentation of stable vitiligo lesions.

In December 2022, it submitted a PMA application to the FDA for the use of RECELL System to treat vitiligo. The potential approval from the regulatory body is expected to be a huge boost for RCEL.

Zacks Rank and Stocks to Consider

AVITA currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Akero Therapeutics (AKRO - Free Report) and ADMA Biologics, Inc. (ADMA - Free Report) , and Omega Therapeutics (OMGA - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Loss per share estimate for Akero Therapeutics has narrowed from $3.46 to $2.78 for 2023 in the past 90 days. Shares of Akero Therapeutics have nosedived 7.1% year to date.

AKRO’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 7.96%. 

Loss per share estimate for ADMA Biologics has narrowed from 19 cents to 9 cents for 2023 in the past 90 days. In the year so far, shares of ADMA Biologics have risen 4.7%.

ADMA’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.13%. 

Loss per share estimate for Omega Therapeutics has narrowed from $2.51 to $2.05 for 2023 in the past 90 days. Shares of the company have risen 46.9% year to date.

OMGA’s earnings beat estimates in two of the trailing four quarters, met the mark in one and missed in another, delivering an average surprise of 8.24%.

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