Avita Medical Ltd (RCEL)

[inversor86]

Here's a nice article that highlights the main facets from Q2. Progress is moving along. I picked up more shares this past week @ $3 to lower my cost basis to around $4.

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Avita Reports Strong Sales Growth & Clinical Trial Progress for ReCell Spray-On-Skin
Jeff Ramson Thu, Aug 09, 2012 @ 09:43 AM


Avita Medical (AVH.AX) (AVMXY) is a global med-tech company that develops and distributes highly innovative products in Regenerative and Respiratory Medicine. The Company's regenerative and tissue-engineered products provide revolutionary solutions utilizing a patient's own skin and the regenerative capability of the human body to treat a wide range of wounds, scars and skin defects.



ReCell® Spray-On Skin™ is a stand-alone, rapid cell harvesting device that enables surgeons to treat wounds and skin defects using a very small sample of the patient's own cells. Using a postage stamp-sized tissue sample (as opposed to a large skin graft), the surgeon can prepare a stem cell rich suspension within 30 minutes at the point of care. This spray-on skin can treat a burn 80 times the size of the tissue sample, a significant improvement over skin grafting, which has much more limited expansion in wound coverage and is often extremely painful, disfiguring and infection-prone. As early as 5-7 days post ReCell treatment, new skin typically emerges with minimal to no scarring and proper texture and pliancy. ReCell has enormous market potential because it is applicable in multiple indications, including burns, chronic wounds (such as venous leg ulcers and diabetic foot ulcers), and plastic, reconstructive and cosmetic procedures. ReCell is generating early revenues in several key geographical regions. ReCell® Spray-On Skin™ is patented, CE marked for the EU and TGA registered in Australia. Most recently, it received sFDA approval in China. In the US, ReCell is in late stage clinical studies with funding from two grants from the US Dept. of Defense. Below is a summary of ongoing US (FDA) clinical trials.

ReCell® Spray-On Skin™ is in pivotal studies for treatment of burns with FDA submission targeted for the second half of 2013. ReCell is also being evaluated in a pilot clinical study for scar remodeling for cosmetic medicine/scar aesthetics that is expected to be completed in late 2012-early 2013 and used as the basis for a pivotal FDA study of ReCell for scar remodeling.

Avita Medical also commercializes med-tech devices for respiratory disease, including spacers (used in conjunction with inhalers to aid in the delivery of medications directly to the lungs). Avita’s Breath-A-Tech product is one of Australia’s leading hospital-grade spacers designed to aid in the delivery of inhaled medications.

In late July, Avita provided a financial and operational update for the end of Fiscal Year 2012 (FY12) on 6/30/12, including the following highlights:

- total revenue increased 13% during FY12 ($5.2 million vs. $4.5 million) including an 88% increase in ReCell Spray-On Skin

- increased gross margins from 72% to 76% from Q1 to Q4 with 73% margins for full-year FY12

- gross profit increased by 17% to $4.2 million with a ($5 million) operating loss during FY12 reflecting an expansion phase for the Company focused on ReCell clinical development and sales/marketing initiatives focused on regenerative medicine as a key growth driver

- received additional regulatory approvals for ReCell in Russia, Mid-East and China while progressing US (FDA) clinical development as outlined above

- obtained full ownership of ReCell in addition to being granted key European patent covering broad claims and trademark protection for “Spray-On Skin” along with the submission of three new patent applications in the US

ReCell is the key growth driver for Avita.