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https://ir.avitamedical.com/news-releases/news-release-details/avita-medical-announces-achievement-co-primary-endpoints-updated
VALENCIA, Calif. and MELBOURNE, Australia, Nov. 09, 2022 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, today announced achievement of co-primary endpoints as a result of updated analysis of data from its clinical trial evaluating the safety and effectiveness of the RECELL® System for soft tissue repair.
The study design included two co-primary endpoints based on pairwise comparisons where each subject received both RECELL treatment and standard of care treatment (Control): one endpoint had a hypothesis of superiority for donor skin sparing and the other co-primary endpoint had a hypothesis of non-inferiority for healing.
Both co-primary endpoints have been met:
• RECELL achieved statistically significant donor sparing over Control (p<0.001).
• RECELL achieved statistical non-inferiority for healing versus Control (p<0.025).
“These results reinforce the potential for RECELL to become a new standard of care for soft tissue repair,” said Jim Corbett, AVITA Medical Chief Executive Officer. “We look forward to sharing the soft tissue repair outcomes with the FDA via our PMA submission expected in December 2022.”
Previously, the company announced that the donor sparing endpoint had achieved superiority and that the healing endpoint had just missed non-inferiority. Subsequently, further re-verification resulted in corrections to the healing data, ultimately leading to a conclusion of non-inferiority for healing.
AVITA Medical’s clinical trial in soft tissue repair has been funded in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201500028C.
Normally I would post the link but this story was behind a paywall. It's from The Australian. Someone posted the story on the HotCopper Avita board and I moved it here.
One of Australia’s best known and most successful medical breakthroughs has been the burns treatment process developed in Western Australia, which was highlighted after the 2002 Bali bombings.
But it is also one of the most tragic.
The US has now embraced the Australian technology as its burns standard treatment. It’s rare for the US to rank Australian technology first in an important medical treatment area like burns.
Australia’s next burns frontier will be Japan. And now the US has embraced the Australian burns technology the breakthrough looks set to revolutionise the US treatment of soft tissue injuries and vitiligo, which came into community prominence via the late Michael Jackson.
The tragedy arises because Australians not living in Perth who are badly burned must either fly to Perth or to the US to be treated with Australian technology.
How Australians lost at home but won abroad is one of the more remarkable stories involving. Australian technology.
Back in 2002 Professor Fiona Wood and colleague Marie Stoner at Royal Perth Hospital inspired Australians when they treated the badly burned victims of the Bali bombing with their unique “spray-on skin” technique.
Dr Fiona Wood at the Harry Perkins Institute South. Picture: Tony McDonough
Three years later Wood became Australian of the year and both Wood and Soner received our top science accolade, a Clunies Ross award. (I was on the judging panel).
Clunies Ross medals were given to scientists who took their invention to the development stage. Wood had led the formation of the public company Clinical Cell Culture to spread the Australian technology. It was listed on the ASX under the symbol “C3” which gave it a Star Wars image. It later changed its name to Avita Medical.
The Wood and Stoner skin culture technique (trademarked as RECELL) takes a small sample of the patient’s own skin, from which a “suspension” of skin cells is prepared, which is then sprayed onto areas of the patient requiring treatment.
The spray contains all of the cells necessary to promote healthy skin growth, including cells to promote healing and colour. Incredibly, the skin cells in the spray contain information to “know” what the person’s skin should look like – for example, facial skin cells “know” that they are facial skin cells – they can signal and recruit other cells, including nerve cells, to come in.
Australia’s world-class burns technology treatment process, which hails from Perth, has been embraced by the US, but sadly most locals are missing out. Picture: Ricardo Ceppi/Getty Images
What Wood and the directors of C3 did not fully appreciate was that they had developed not just a technology, but a whole system of treating burns.
For it to be used in markets outside Perth, the whole system had to be transposed, which was a major and time-consuming undertaking. C3/Avita began marketing the technology as a product rather than a system, and on the east coast of Australia there was considerable resistance in the medical profession to changing their methods of treating burns. Frustrated, C3/Avita went to London and Italy. They made the same mistake, and Australian style resistance was duplicated.
The end of the road looked near for the Avita public company when Jeremy Curnock Cook, founder and managing partner of Melbourne and London based health care investment group BioScience Managers, became a major shareholder.
Cook and other investors were excited that, unlike other medical investments, RECELL was a proven system to treat burns. Rather than fight the prejudices that had been developed in eastern Australia and to a lesser extent in London and Italy, Cook and the new board chose to market in the US.
Avita sought US Food & Drug Administration (FDA) approval not just for the product but for the whole RECELL the system. It was granted in 2018.
But along the way, the US Army’s medical research establishment was so impressed with RECELL that it helped Avita by sponsoring clinical trials and described the system as offering a possible “paradigm shift” in skin injury treatment.
The US Department of Defence signed-on for purchase contracts years before RECELL was approved by FDA. Badly burned US soldiers in Afghanistan received the treatment. The Australian defence people did not follow their American counterparts.
Avita raised substantial capital in the US, where it is now listed and where its top management is based. Once Avita obtained FDA approval, it began rolling its systems out across the US, careful not to make the Australian mistakes. However, with the approval of FDA and the U S Department of Defence made the process was much easier.
But there was still one hazard to come. By 2019-20, Avita had spent large sums rolling out its system, but then Covid-19 struck the US population and the number of burns victims plummeted. Avita expensed the rollout and when the burns victims did not arrive as expected the share price slumped.
But with normality returning turnover is now rising, and the company has $90m in cash preparing for the day when its systems will be approved in soft tissues and vitiligo – both much bigger markets than burns.
BrainStorm Cell Therapeutics Presents New Analyses from NurOwn's Phase 3 ALS Trial at the 21st Annual NEALS Meeting
https://seekingalpha.com/pr/19008031-brainstorm-cell-therapeutics-presents-new-analyses-from-nurowns-phase-3-als-trial-21st-annual
AVITA Medical Announces FDA Breakthrough Device Designations for the RECELL® System
https://seekingalpha.com/pr/19006459-avita-medical-announces-fda-breakthrough-device-designations-for-recell-system
AVITA Medical to Announce Third Quarter 2022 Financial Results
https://seekingalpha.com/pr/18985268-avita-medical-to-announce-third-quarter-2022-financial-results
This is from a post on the No More Excuses facebook page:
At 26:07, Lindborg mentions,
This too:
Yup...it seems like everything was in the red today.
I think it has more to do with everything being in the red too. Maybe we will see a bump when the other half of the trial is finished and we get the news on that.
Any idea when we can expect those Cohort B results?
Ryan Zimmerman, a medtech analyst at BTIG, admitted in a report earlier this week that the CEO change at Avita caught him off guard at first, as investors had no warning that this change was coming. A conversation with Corbett provided the analyst with more clarity on the board's thinking, however.
"Regardless of where shares are trading today (albeit inexpensive, in our view), Mr. Perry was a clinically-oriented leader who successfully took [Avita] through a number of trials and indication expansions," Zimmerman wrote. "As [Avita] enters a new commercial phase, with the data from both the Soft Tissue trial and Vitiligo trial complete (and successful), [Avita] is focused on adopting a more commercially oriented strategy to drive revenue growth and requires leadership with more experience commercializing medical devices in larger markets. Admittedly, while the change caught us off guard initially, we don't disagree with this assessment and think that this may be the necessary medicine to get shares in a stronger position longer-term."
Quick question:
I was listening to this interview with Fiona Wood and she talked about some new products that she's been working on (the iKnife, a 3D skin printer, & scarless healing cream.) Will Avita Medical be getting these products eventually to expand their portfolio?
AMLX stock is in red territory today on yesterday's news. I would have expected it to shoot up like a rocket. I assumed that the positive AMLX news would provide a halo effect for other companies like Brainstorm (which is currently up 6.71% so far today)...so weird.
Do you think there will be a halo effect with Brainstorm stock tomorrow due to today's AMLX's FDA approval announcement?
In a report released yesterday, Ryan Zimmerman from BTIG maintained a Buy rating on Avita Medical (RCEL – Research Report), with a price target of $16.00. The company’s shares closed yesterday at $5.64.
Institutional investors own a significant stake of 43% in AVITA Medical, Inc. (ASX:AVH)
https://uk.finance.yahoo.com/news/institutional-investors-own-significant-stake-224035343.html
- I just saw this on the No More Excuses ALS Watchdog Group Facebook page:
Something that stood out to me from today's presentation:
Recell in Japan launched in Q3 of this year and the product is being sold now. That means we can expect a bump to revenue in the January quarterly report.
Don't forget that the Avita presentation is today and it starts @ 5:30 central time. Here's the link:
https://us02web.zoom.us/webinar/register/WN_ZTCqHqzbQrqxhDQwyjHXKQ
The markets are freaked out by the Fed trying to reign in our massive inflation by raising the interest rate by 75-100 basis points this Wednesday.
NurOwn Found Safe, Shows Promise in Phase 2 Trial for Progressive MS
https://multiplesclerosisnewstoday.com/news-posts/2022/09/16/nurown-safe-shows-phase-2-trial-promise-progressive-ms/
BrainStorm Brings MS Data on Heels of ALS BLA Announcement (Updated)
https://www.biospace.com/article/brainstorm-brings-ms-data-on-heels-of-als-bla-submission-announcement-/
Maxim Group analyst Jason McCarthy maintained a Buy rating on Brainstorm Cell Therapeutics (BCLI – Research Report) yesterday and set a price target of $8.00.
BrainStorm Cell Therapeutics Announces Peer Reviewed Publication of Results from the NurOwn® Phase 2 Progressive MS Trial in Multiple Sclerosis Journal
https://www.prnewswire.com/news-releases/brainstorm-cell-therapeutics-announces-peer-reviewed-publication-of-results-from-the-nurown-phase-2-progressive-ms-trial-in-multiple-sclerosis-journal-301625167.html
The presentation is about to start.
Hopefully, Nadav will spill the details in his presentation today. Fifteen minute until start time.