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AWESOME news !!!!
The RECELL® System Receives PMDA Approval in Japan and AVITA Medical will Commercialize in Partnership with COSMOTEC, an M3 Group Company
https://seekingalpha.com/pr/18683803-recell-system-receives-pmda-approval-in-japan-and-avita-medical-will-commercialize-in
yes he was and we all miss him ... ;)
I'm really sorry to hear that...I know he was in his 80's, but he was one heck of a guy....
Sadly Jugs passed away quite a while ago.
Greetings one an all.....Been a long time....Where's jugs?....I see alot of familiar names still engaged in recel....
Great news for the company, shareholders and humanity...Bought some shares after market....GLTA, and God bless
Hopefully, that news will get the stock to push up tomorrow. Too bad that all the financial markets got hammered today.
Should please doctors and nurses in the application process ... ;)
AVITA Medical Announces FDA Approval of New RECELL® System with Improved Ease of Use
PDF Version
System enhanced in response to clinician workflow and usability feedback; new system simplifies process
United States product launch planned for Q2 2022
VALENCIA, Calif. and MELBOURNE, Australia, Feb. 17, 2022 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today that the United States Food and Drug Administration (FDA) has reviewed and approved the premarket approval application (PMA) supplement for RECELL® Autologous Cell Harvesting Device, an enhanced RECELL System aimed at providing clinicians a more efficient user experience and simplified workflow. The RECELL® System is a device that enables healthcare professionals to produce a suspension of Spray-On Skin™ Cells using a small sample of the patient’s own skin for the treatment of acute thermal burns.
“To ensure RECELL continues to meet the needs of our customers, we initiated a program to explore how we could improve the device, and then addressed those matters with this new system,” said Dr. Mike Perry, Chief Executive Officer of AVITA Medical. “Based upon research and human factors testing, we are confident that the new RECELL System will be positively received by the burn community. The enhancements will provide a range of benefits to clinicians using the device and in turn, patients will benefit as the procedure becomes more efficient.”
Until now, the RECELL System – which launched in the United States nearly two years ago – consisted of multiple individually packaged sterile components requiring transfer into the sterile field and required clinicians to rely on multiple people to assist during the process. AVITA Medical researchers spoke with surgeons, physician assistants and registered nurses – both experienced and new users of the device – to study how procedures with the RECELL System are being conducted in real-world scenarios and how they can be improved.
While the intended use of the device as a whole remains unchanged, the RECELL System has been modified to reduce set-up steps by approximately one-third and to enable use of the device with reduced support personnel. In a survey, 94% of users believe that the new RECELL System will allow them to prepare for a procedure faster than with the current RECELL System and more than 80% of users anticipate a faster learning curve for a newly trained user to become proficient with the system.i
The launch of the new RECELL System in the United States will begin in Q2 2022. For more information about the RECELL System, please visit www.RECELLSystem.com.
ABOUT AVITA MEDICAL, INC.
AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.
AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018 and a new ease-of-use design was approved in 2022. The RECELL System is indicated for use in the treatment of acute thermal burns. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 10,000 patients globally reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings, and precautions.
In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds, and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe. To learn more, visit www.avitamedical.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this press release include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this press release. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.
This press release was authorized by the review committee of AVITA Medical, Inc.
Avita announced today that it plans to release its July 1, 2021 to December 31, 2021 financial results after the market closes on Monday, February 28, 2022. In conjunction with such release, the Company plans to host a conference call and webcast that day at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time (Tuesday, March 1, 2022 at 8:30 a.m. Australian Eastern Daylight Time) to discuss its financial results and recent highlights.
the company's estimated earnings date is Thursday, February 10th, 2022 based off prior year's report dates.
I sold ALMOST all my RCEL a while back. I don't believe this is an all or nothing proposition. I maintain a very small stake, just to have info pushed to me and to keep the ticker in front of me. Avita has too good a solution for skin problems. At some point it will live up to it's potential and I don't want to miss it. To do that I don't have to catch the absolute bottom.
As much as I admire RECELL, I'm throwing in the towel. I've been told the goal of investing is to make money and I've lost plenty here, hoping the world would recognize this revolutionary burn therapy. I've heard lots of blaming, and cheerleading, and maybes and wonder-ifs, but I've grown weary as the share price sinks lower and lower. I tried nibbling under $10, wanting to believe that the world, or a big pharma company, would wake up and take notice. Sold it all this week. Fact is, for now, there are better opportunities elsewhere.
I sold the bulk of my shares when the sp was just under $18. My wife, however, refuses to let me sell her long shares (average cost of $7.86).I've watched as her substantial gain has dwindled to nearly nothing. Her RCEL only represents less than 1% of her portfolio. Nevertheless, she is stubbornly sentimental and loyal. She also rescues cats and dogs, and old men like me. Good thing!
Good luck to all you stubborn longs. I mean that. I hope there's a $40/share buyout tomorrow or a breakthrough with vitiligo. Avita was the first stock my wife and I bought together. I'm a little sentimental about that. But I married HER, not Avita.
And, I made one of my very best friends on this very board (RIP, Jugs). What's that worth?
I'll check in from time to time, well, just because...
Best wishes to you all,
Ken
Two things I said the last 2 years
1: this company was run into the ground by management and they killed it with reverse splits and shady ceo stock dumps.
2: If you think its bad now wait until the rest of the markets dump and then see how bad avita performs.
Yes I was right
(January 15, 2022) Zacks Investment Research upgraded shares of AVITA Medical (NASDAQ:RCEL) from a hold rating to a buy rating in a research note released on Tuesday, Zacks.com reports. They currently have $13.00 price target on the stock.
Thanks, Fmello, for the follow up.
Funny: "today announced preliminary unaudited estimates."
I found this on SeekingAlpha:
Why no link to the source? I believe you're giving preliminary and unaudited info. Right? Why not link to the best, most trustworthy Big Boy numbers possible?
And provide a link for us. I love to read financials.
JP Morgan Healthcare Conference Presentation
https://hotcopper.com.au/threads/ann-jp-morgan-healthcare-conference-presentation.6526016/?post_id=58772384
What does this have to do to go up 35%up revenue
Total revenue increased 35% to $6.9 million in the quarter ended December 31, 2021, compared to $5.1 million over the same quarter in the prior year.
Seems like a small step in the right direction? Holdong a very small long position. I'm still not diving in yet, but I am testing the waters with my toes again. GLTA
Compare two wildly different Nasdaq stocks: Microsoft vs_AVITA. The tiers are clearly stated.
* Microsoft Corp (MSFT)
NasdaqGS -
Market Cap $2.357T(trillion)
* AVITA Medical, Inc. (RCEL)
NasdaqCM -
Market Cap $277.666M (million)
NASDAQ's lowest tier, NASDAQ-CM, is full of_junk which is why I often advise shunning its stocks. NASDAQ has three tiers. I only buy NYSE listings and a few stocks on NASDAQ's top tier.
* Capital Market (NASDAQ-CM small cap) is an equity market for companies that have relatively small levels of market capitalization. Listing requirements for such "small cap" companies are less stringent than for other Nasdaq markets that list larger companies with significantly higher market capitalization.[37]
* Global Market (NASDAQ-GM mid cap) is made up of stocks that represent the Nasdaq Global Market. The Global Market consists of 1,450 stocks that meet Nasdaq's strict financial and liquidity requirements, and corporate governance standards. The Global Market is less exclusive than the Global Select Market.[38]
* Global Select Market (NASDAQ-GS large cap) is a market capitalization-weighted index made up of US-based and international stocks that represent the Global Select Market Composite. The Global Select Market consists of 1,200 stocks that meet Nasdaq's strict financial and liquidity requirements and corporate governance standards. The Global Select Market is more exclusive than the Global Market. Every October, the Nasdaq Listing Qualifications Department reviews the Global Market Composite to determine if any of its stocks have become eligible for listing on the Global Select Market.[39][40]
The main NASDAQ average, ^IXIC, is doing very well, as is the NASDAQ 100, the famous QQQ.
https://en.wikipedia.org/wiki/Nasdaq
Just saw an article on Bloomberg saying 40% of stocks listed on NASDAQ are down 50% or more. This has been a very narrow market.
AVITA Medical Establishes Proof of Concept for Novel Treatments Using Genetically-Modified Skin Cells
https://seekingalpha.com/pr/18620963-avita-medical-establishes-proof-of-concept-for-novel-treatments-using-genetically-modified
Patient capital is likely to be rewarded at these levels
Chillax
AVITA Medical Is Interesting, But Not Just Yet
https://seekingalpha.com/article/4476116-avita-medical-is-interesting-not-just-yet?messageid=2800&utm_campaign=4476116&utm_medium=email&utm_source=seeking_alpha&utm_term=RTA+Article+Smart
How many enrollees are in that "pivotal" test? They could go 100 years with tiny, statistically meaningless "tests." Only surefire winners are insiders drawing fat paychecks.
AVITA Medical Completes Enrollment in Pivotal Trial Evaluating the RECELL® System for Repigmentation of Stable Vitiligo
https://seekingalpha.com/pr/18603001-avita-medical-completes-enrollment-in-pivotal-trial-evaluating-recell-system-for
Should read "4-8% higher"
A close of 12.43 would put us at par with the AVH close in Australia. AVH has been trading 4-8% than RCEL for several days now.
Nevermind, no quorum, postponed until December 22nd.
If anyone attended the virtual ASM I'd appreciate a short summary, couldn't make it due to dental appointment.
Don't know but all the financial markets are in the red today again...that could be a factor.
Any idea why the arse is falling out of this share
Regards steve
$12.66-0.08 (-0.63%)
At close: 04:00PM EST
Hi guys
We’re did that 5% drop come from is it just trading range
$7 fair value per share of AVH. 5 AVH shares per CDI equals 1 share of RCEL. What Pete posted is correct, US equivalent around $25 per share of RCEL.
I was waiting for you as that is your stick.
Geez. Every excuse in the book how about just address the elephant in the room. Poor management. Reverse split. Dear company. Dead stock
I agree it will go down in this market especially this month with tax loss selling on top of a unsettled market.
No worries as it is way down and may drop before it comes back. But when people quit the fear of dying from Covid and the world survives to be burned for real, RCEL will be there and Big Pharma will be interested.
JMO but it is based on much before and after real evidence, and people saved, scaring avoided.
I will agee the Principals are overpaid until it becomes what it should become. Never liked corporate graft. I would prefer a royalty trust set up for people to invest in.
The inventor is busy doing her teaching and Hospital work in Western Australia, but her foundation still owns this technology. There are royalties in the future.
-pete
I am not going to argue.
Incorrect It is AVH on ASX and RCELon US Nasdaq
Exchange is 1 dollar + 1.40 Aussie dollar
BUT the shares of AVH are not 1:1 They are 5:1 to RCEL
Current AVH 3.70 coverts to about $2.64 + or - a penny
5 AVH for 1 RCEL
A $7 PT in Australia is $24.88 for Equal RCEL if you do the math based on todays exchange
$35 X .7109 = $24.88
I will hold my free shares till at least $20 here in the US. Let's see what happens long term.
GLTA!
-pete
corrections welcomed!
That is only $5 US.
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