Avita Medical (Seite 40)
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Great statistics were presented at the meeting. A few listed here:
Best of the Best Abstract – Pediatric Burn Care
Dr. Carter presented data showing that 98% of mixed-depth/full-thickness burn Injuries in pediatric patients treated using Spray-On Skin Cells in combination with widely spaced meshed autografts were healed within four weeks of treatment. The presentation, titled
“Evaluation of a Pediatric Population Treated for Burn Injuries Using an Autologous Skin Cell Suspension: Interim Analysis,”
described the interim outcomes for 23 pediatric patients with a median age of 6.7 years old (ranging from 0.8 to 16.0) treated under FDA-IDE approved Compassionate Use and Continued Access programs. In patients with extensive burn injuries, lack of available donor skin is a major limitation achieving permanent closure; and the longer a wound remains open, the more susceptible a patient is to infection. In the U.S., one-third of burn injuries occur in children, and the availability of donor skin for traditional meshed autografts is even more limited in pediatric patients with extensive injuries. The use of the RECELL System, a donor skin sparing technology that enables rapid definitive closure of burn wounds, has the potential to improve patient outcomes.
In this study of pediatric patients which included those with life-threatening thermal burn injuries, Spray-On Skin Cells prepared using the RECELL System were applied in combination with widely meshed split-thickness autografts to achieve definitive closure using minimal donor skin. A total of 107 burn injuries were treated in the study, and 98% achieved definitive healing within four weeks of treatment. Importantly, for patients with greater than 50% total body surface area (TBSA) burns, treatment with the combination of Spray-On Skin Cells and widely meshed split-thickness autografts achieved the same high rate of healing at week four as patients with smaller burns (burns equal to or less than 50% TBSA) treated with the same combination. In addition, in the study the donor sites on all patients were treated with Spray-On Skin Cells, and 62.5% of the donor sites were healed within a week of treatment, and 100% were completely healed within two weeks of treatment.
“This interim analysis supports the use of the RECELL System as a viable option for treatment in these deeper burn injuries in pediatric patients,”
said Dr. Carter.
“In this vulnerable patient population, we observed excellent clinical outcomes with 98% of wounds healing within four weeks of treatment, and with the majority of burn sites having cosmetic outcomes rated as satisfactory or equivalent compared to uninjured skin. The early healing of donor sites contributed to a decrease between harvest times for patients with limited donor skin availability.”
https://www.bioportfolio.com/news/article/3951694/AVITA-Medi…
Best of the Best Abstract – Pediatric Burn Care
Dr. Carter presented data showing that 98% of mixed-depth/full-thickness burn Injuries in pediatric patients treated using Spray-On Skin Cells in combination with widely spaced meshed autografts were healed within four weeks of treatment. The presentation, titled
“Evaluation of a Pediatric Population Treated for Burn Injuries Using an Autologous Skin Cell Suspension: Interim Analysis,”
described the interim outcomes for 23 pediatric patients with a median age of 6.7 years old (ranging from 0.8 to 16.0) treated under FDA-IDE approved Compassionate Use and Continued Access programs. In patients with extensive burn injuries, lack of available donor skin is a major limitation achieving permanent closure; and the longer a wound remains open, the more susceptible a patient is to infection. In the U.S., one-third of burn injuries occur in children, and the availability of donor skin for traditional meshed autografts is even more limited in pediatric patients with extensive injuries. The use of the RECELL System, a donor skin sparing technology that enables rapid definitive closure of burn wounds, has the potential to improve patient outcomes.
In this study of pediatric patients which included those with life-threatening thermal burn injuries, Spray-On Skin Cells prepared using the RECELL System were applied in combination with widely meshed split-thickness autografts to achieve definitive closure using minimal donor skin. A total of 107 burn injuries were treated in the study, and 98% achieved definitive healing within four weeks of treatment. Importantly, for patients with greater than 50% total body surface area (TBSA) burns, treatment with the combination of Spray-On Skin Cells and widely meshed split-thickness autografts achieved the same high rate of healing at week four as patients with smaller burns (burns equal to or less than 50% TBSA) treated with the same combination. In addition, in the study the donor sites on all patients were treated with Spray-On Skin Cells, and 62.5% of the donor sites were healed within a week of treatment, and 100% were completely healed within two weeks of treatment.
“This interim analysis supports the use of the RECELL System as a viable option for treatment in these deeper burn injuries in pediatric patients,”
said Dr. Carter.
“In this vulnerable patient population, we observed excellent clinical outcomes with 98% of wounds healing within four weeks of treatment, and with the majority of burn sites having cosmetic outcomes rated as satisfactory or equivalent compared to uninjured skin. The early healing of donor sites contributed to a decrease between harvest times for patients with limited donor skin availability.”
https://www.bioportfolio.com/news/article/3951694/AVITA-Medi…
Trading Spotlight
Due Diligence on Avita Medical the Company and ReCell
Company Site
https://www.avitamedical.com/
Avita Medical Wikipedia
https://en.wikipedia.org/wiki/Avita_Medical
Some background on some officers and directors at Avita there is a reason they chose these people
Chairman of the Board
Louis James Panaccio
Also Executive Director of ASX50 company and one of the world’s largest medical diagnostics companies, Sonic Healthcare Limited, where he has served since 2005
https://en.wikipedia.org/wiki/S%26P/ASX_50
https://en.wikipedia.org/wiki/Sonic_Healthcare
https://www.bloomberg.com/research/stocks/people/person.asp?…
Non Executive Director
Jeremy L. Curnock Cook
Also Founder and Chairman at International Bioscience Managers Ltd
https://biosciencemanagers.com/
https://www.bloomberg.com/research/stocks/private/person.asp…
Damien McDonald
Non Executive Director
Also Chief Executive Officer and an Executive Director of LivaNova PLC NASDAQ:LIVN
https://en.wikipedia.org/wiki/LivaNova
https://www.bloomberg.com/research/stocks/private/person.asp…
Louis Drapeau
Non Eexcutive Director
Also Independent Director at AmphliPhi Biosciences Corp.(NYSE:APHB) and Independent Director at Surface Pharmaceuticals Inc
Professor Suzanne Crowe AM
https://www.bloomberg.com/research/stocks/people/person.asp?…
Michael S. Perry
CEO of Avita Medical
Also prior to joining AVITA, Dr. Perry was the Chief Scientific Officer of Novartis (NYSE:NVS) Cell and Gene Therapy Unit
https://www.bloomberg.com/research/stocks/people/person.asp?…
Other officers in Avita come with leadership experience in other multi-national companies. Just pointed out those top ones as it shows just who is involved and why they were chosen.
$AVMXY $AVH.AX Milestones..............................
September 20, 2018
Received FDA PMA approval of ReCell
October 2018
AVITA Medical Announced First U.S. Sales of RECELL® System and Commencement of Commercial Shipping
Multiple U.S. burn centers incorporating RECELL System into their practices in advance of national U.S. market launch
AVITA Medical Announced Commencement of Randomized Controlled Clinical Study of RECELL® System in Treatment of Children with Burn Injuries
November 2018
AVITA Medical Announced Hiring of Full U.S. Sales Team of Experienced Burn Professionals to Support National Launch of RECELL® System. Also incorporated in the sales team are Clinical Training Specialists (CTS) who will train surgeons and nurses and assist burn centers in their use of the RECELL System.
Announced strong market response to the RECELL System approval in advance of U.S. launch with 32 burn centers actively reviewing the product or placing commercial orders
Of the 134 burn centers in the U.S., 32 have already commenced an evaluation of RECELL or have proceeded to the formal purchasing approval process required to order the product. Seven of these burn centers have completed their internal processes, ordered the RECELL System, and have received commercial shipments.
January 2019
AVITA Medical Announced U.S. National Market Launch of RECELL® System. The U.S. sales team of Regenerative Tissue Specialists and Clinical Training Specialists that joined AVITA Medical in November 2018 has been trained and fully deployed across the U.S. in support of the nationwide launch of the RECELL System.
AVITA’s new commercial team was in active discussions with nearly half of the total number of burn centers across the U.S.
36 burns centers have begun the purchase authorization process with their hospital administration.
25 burn centers have been trained and certified in the use of the RECELL System.
12 accounts have already placed orders and have received commercial shipments.
Announced company update which included Pre-launch U.S. product sales of A$1.1 million in second quarter (Oct-Dec).
Announced AVITA Medical Announces Nine RECELL® System Abstracts Accepted for Presentation at American Burn Association (ABA) 51st Annual Meeting. One of the abstracts being presented by Dr. Wood herself. (Was later updated to include 1 more abstract for a total of 10)
• Pediatric patients (selected as a Top-Five Abstract to be presented in plenary session)
• Extensive burn injuries in an adult population (life threatening burns greater than 50 percent total body surface area or TBSA)
• Burn injuries of the hands
• Burn injuries of joints and rehabilitation considerations
• Budget impact of use of the RECELL System versus standard of care in treatment of severe burns at Arizona Burn Center
• Post-operative wound management following treatment with the RECELL System
• Treatment and healing of donor sites with the RECELL System in patient with large TBSA burns
• Case study of 60% TBSA patient with life-threatening burn injuries and limited donor skin
• A summary of ten years of clinical experience using RECELL System in the point-of-care treatment of burn injuries
The first one is the most relevant, because as can be seen it is one of the steps for FDA PMA approval for the pediatric use of ReCell in the US as can be seen from this quote from the PR from the approval of ReCell for adults last September.
"FDA Approval Supported by the Results from Two Randomized, Controlled Clinical Trials"
The results have also been presented at multiple scientific conferences, including the Top Five Abstract plenary session of the American Burn Association (ABA) 50th Annual Meeting held in April 2018.
https://www.businesswire.com/news/home/20180920006001/en/AVI…
February 2019
Announced 41 of the 134 burn centers in the U.S. have been
trained and certified in the use of the RECELL System, and 19 of these centers have already purchased the product. This is an increase of 16 hospitals trained and certified in the use and the addition of 7 hospitals now purchasing in 4 weeks.
March 2019
Avita Medical Announced Collaboration with COSMOTEC, an M3 Group Company, to Commercialize the RECELL® System in Japan
COSMOTEC filed a JPMDA application for approval to market the RECELL System in Japan
The JPMDA has accepted the application and review is expected to take nine months to a year. Japan is the second largest healthcare market in the world.
Now, due to FDA PMA approval from what I have read on JPMDA approval times/processes Avita is at an advantage with ReCell, which could push it closer to 9 months.
From the PR released by Cosmotec "The number of patients suffering from chronic wounds and decubitus ulcers is increasing in Japan due to aging. Japan is also planning for the Tokyo Olympic Games in 2020"
AVITA Medical to Present at Cowen and Company Health Care Conference
Avitas first conference in front of the big players, many say this is one of the things that kicked off $AVMXY's increased interest as well being added to the ASX500 about the same time.
In Australia $AVH.AX (AVMXY) has long had institutional investors they are more than 50% of the outstanding shares, some are HSBC, USB, JP Morgan, Merrill Lynch and Citicorp who have been in Avita years.
Milestones for $AVMXY going forward for the rest of 2019
Q3 results which will give an idea of growth, doing sales of A$1.1 million in the US in Q2 with no sales/training team set in place is outstanding.
BARDA has contract to purchase 5000 units with option for 20,000, the 20,000 is no doubt for a serious emergency but the 5000 is rather significant when that is announced I do not completely understand the process for this, I thought I did, but, it's confusing as is anything to do with the government. Just who will warehouse them etc, but none the less when it is announced that will be a rather large deal.
The one thing that is clear it has been announced to happen in the 2019 calendar year. I personally do not expect it to be granted until the juvenile approval happens which is expected Sept/Oct of 2019.
Uplisting to the Nasdaq, $AVMXY was hoping this would be completed by the end of March but it got pushed ahead for whatever reason but is still going to happen in 2019.
Military contracts, now Avita first got into bed with the government by way of the Army as the military has long been looking for a solution to the problem of burns received in battles, they are looking at many different solutions due to the many different types and the differing severity of burn wounds. The military to date by the Medical Command (DOD - Army) has purchased twice which were sent to the Brooke Army Medical Center at Ft. Sam Houston in Texas October and January.
https://govtribe.com/opportunity/federal-contract-opportunit…
5 units per, I believe this is more than likely so that they may do their own studies, now the company has not released the information on the purchases publicly, it was found by accipiterr on of our long time poster to the board.
FDA PMA approval for use in children under 18 is expected August/September
Japanese JPMMDA approval for commercial use in Japan expected Dec 2019-Feb 2020
That's about it for what's important, numerous articles, independent video news story's available but for the important things I believe that about covers it.
Anything particular about ReCell itself can be found on the company website.
Company Site
https://www.avitamedical.com/
Avita Medical Wikipedia
https://en.wikipedia.org/wiki/Avita_Medical
Some background on some officers and directors at Avita there is a reason they chose these people
Chairman of the Board
Louis James Panaccio
Also Executive Director of ASX50 company and one of the world’s largest medical diagnostics companies, Sonic Healthcare Limited, where he has served since 2005
https://en.wikipedia.org/wiki/S%26P/ASX_50
https://en.wikipedia.org/wiki/Sonic_Healthcare
https://www.bloomberg.com/research/stocks/people/person.asp?…
Non Executive Director
Jeremy L. Curnock Cook
Also Founder and Chairman at International Bioscience Managers Ltd
https://biosciencemanagers.com/
https://www.bloomberg.com/research/stocks/private/person.asp…
Damien McDonald
Non Executive Director
Also Chief Executive Officer and an Executive Director of LivaNova PLC NASDAQ:LIVN
https://en.wikipedia.org/wiki/LivaNova
https://www.bloomberg.com/research/stocks/private/person.asp…
Louis Drapeau
Non Eexcutive Director
Also Independent Director at AmphliPhi Biosciences Corp.(NYSE:APHB) and Independent Director at Surface Pharmaceuticals Inc
Professor Suzanne Crowe AM
https://www.bloomberg.com/research/stocks/people/person.asp?…
Michael S. Perry
CEO of Avita Medical
Also prior to joining AVITA, Dr. Perry was the Chief Scientific Officer of Novartis (NYSE:NVS) Cell and Gene Therapy Unit
https://www.bloomberg.com/research/stocks/people/person.asp?…
Other officers in Avita come with leadership experience in other multi-national companies. Just pointed out those top ones as it shows just who is involved and why they were chosen.
$AVMXY $AVH.AX Milestones..............................
September 20, 2018
Received FDA PMA approval of ReCell
October 2018
AVITA Medical Announced First U.S. Sales of RECELL® System and Commencement of Commercial Shipping
Multiple U.S. burn centers incorporating RECELL System into their practices in advance of national U.S. market launch
AVITA Medical Announced Commencement of Randomized Controlled Clinical Study of RECELL® System in Treatment of Children with Burn Injuries
November 2018
AVITA Medical Announced Hiring of Full U.S. Sales Team of Experienced Burn Professionals to Support National Launch of RECELL® System. Also incorporated in the sales team are Clinical Training Specialists (CTS) who will train surgeons and nurses and assist burn centers in their use of the RECELL System.
Announced strong market response to the RECELL System approval in advance of U.S. launch with 32 burn centers actively reviewing the product or placing commercial orders
Of the 134 burn centers in the U.S., 32 have already commenced an evaluation of RECELL or have proceeded to the formal purchasing approval process required to order the product. Seven of these burn centers have completed their internal processes, ordered the RECELL System, and have received commercial shipments.
January 2019
AVITA Medical Announced U.S. National Market Launch of RECELL® System. The U.S. sales team of Regenerative Tissue Specialists and Clinical Training Specialists that joined AVITA Medical in November 2018 has been trained and fully deployed across the U.S. in support of the nationwide launch of the RECELL System.
AVITA’s new commercial team was in active discussions with nearly half of the total number of burn centers across the U.S.
36 burns centers have begun the purchase authorization process with their hospital administration.
25 burn centers have been trained and certified in the use of the RECELL System.
12 accounts have already placed orders and have received commercial shipments.
Announced company update which included Pre-launch U.S. product sales of A$1.1 million in second quarter (Oct-Dec).
Announced AVITA Medical Announces Nine RECELL® System Abstracts Accepted for Presentation at American Burn Association (ABA) 51st Annual Meeting. One of the abstracts being presented by Dr. Wood herself. (Was later updated to include 1 more abstract for a total of 10)
• Pediatric patients (selected as a Top-Five Abstract to be presented in plenary session)
• Extensive burn injuries in an adult population (life threatening burns greater than 50 percent total body surface area or TBSA)
• Burn injuries of the hands
• Burn injuries of joints and rehabilitation considerations
• Budget impact of use of the RECELL System versus standard of care in treatment of severe burns at Arizona Burn Center
• Post-operative wound management following treatment with the RECELL System
• Treatment and healing of donor sites with the RECELL System in patient with large TBSA burns
• Case study of 60% TBSA patient with life-threatening burn injuries and limited donor skin
• A summary of ten years of clinical experience using RECELL System in the point-of-care treatment of burn injuries
The first one is the most relevant, because as can be seen it is one of the steps for FDA PMA approval for the pediatric use of ReCell in the US as can be seen from this quote from the PR from the approval of ReCell for adults last September.
"FDA Approval Supported by the Results from Two Randomized, Controlled Clinical Trials"
The results have also been presented at multiple scientific conferences, including the Top Five Abstract plenary session of the American Burn Association (ABA) 50th Annual Meeting held in April 2018.
https://www.businesswire.com/news/home/20180920006001/en/AVI…
February 2019
Announced 41 of the 134 burn centers in the U.S. have been
trained and certified in the use of the RECELL System, and 19 of these centers have already purchased the product. This is an increase of 16 hospitals trained and certified in the use and the addition of 7 hospitals now purchasing in 4 weeks.
March 2019
Avita Medical Announced Collaboration with COSMOTEC, an M3 Group Company, to Commercialize the RECELL® System in Japan
COSMOTEC filed a JPMDA application for approval to market the RECELL System in Japan
The JPMDA has accepted the application and review is expected to take nine months to a year. Japan is the second largest healthcare market in the world.
Now, due to FDA PMA approval from what I have read on JPMDA approval times/processes Avita is at an advantage with ReCell, which could push it closer to 9 months.
From the PR released by Cosmotec "The number of patients suffering from chronic wounds and decubitus ulcers is increasing in Japan due to aging. Japan is also planning for the Tokyo Olympic Games in 2020"
AVITA Medical to Present at Cowen and Company Health Care Conference
Avitas first conference in front of the big players, many say this is one of the things that kicked off $AVMXY's increased interest as well being added to the ASX500 about the same time.
In Australia $AVH.AX (AVMXY) has long had institutional investors they are more than 50% of the outstanding shares, some are HSBC, USB, JP Morgan, Merrill Lynch and Citicorp who have been in Avita years.
Milestones for $AVMXY going forward for the rest of 2019
Q3 results which will give an idea of growth, doing sales of A$1.1 million in the US in Q2 with no sales/training team set in place is outstanding.
BARDA has contract to purchase 5000 units with option for 20,000, the 20,000 is no doubt for a serious emergency but the 5000 is rather significant when that is announced I do not completely understand the process for this, I thought I did, but, it's confusing as is anything to do with the government. Just who will warehouse them etc, but none the less when it is announced that will be a rather large deal.
The one thing that is clear it has been announced to happen in the 2019 calendar year. I personally do not expect it to be granted until the juvenile approval happens which is expected Sept/Oct of 2019.
Uplisting to the Nasdaq, $AVMXY was hoping this would be completed by the end of March but it got pushed ahead for whatever reason but is still going to happen in 2019.
Military contracts, now Avita first got into bed with the government by way of the Army as the military has long been looking for a solution to the problem of burns received in battles, they are looking at many different solutions due to the many different types and the differing severity of burn wounds. The military to date by the Medical Command (DOD - Army) has purchased twice which were sent to the Brooke Army Medical Center at Ft. Sam Houston in Texas October and January.
https://govtribe.com/opportunity/federal-contract-opportunit…
5 units per, I believe this is more than likely so that they may do their own studies, now the company has not released the information on the purchases publicly, it was found by accipiterr on of our long time poster to the board.
FDA PMA approval for use in children under 18 is expected August/September
Japanese JPMMDA approval for commercial use in Japan expected Dec 2019-Feb 2020
That's about it for what's important, numerous articles, independent video news story's available but for the important things I believe that about covers it.
Anything particular about ReCell itself can be found on the company website.
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