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Strong open: $6.19
I noticed that it listed 101 patients between the ages of 18 and 65. Are these details of the trials that got ReCell its FDA PMA approval in October 2018?
I noticed that it listed 101 patients between the ages of 18 and 65. Are these details of the trials for the FDA PMA approval Recell got in October 2018?
I wish I had the guts to sell my gold coins. At the time, I was considering using that money along with the 10k in Apple dividends that I used to buy my Avita stake but I chickened out...I thought that would have been way too risky to buy 50 grand of Avita in 2017. Ended up just using the Apple dividends.
I'm still kicking myself about that. I'd be up 235k today if I wasn't such a puss.
I wish I had that many shares Jugs, I've only got a little over 9,900. So far though, my gains since I bought in are up 459%. Currently, I'm up nearly 47 grand. I would not be surprised if that doubles or triples by the end of the year.
Avita stock up 40¢ for the week.
1979, from the earlier post I made, manufacturing of the device is very simple. Besides the plastic shell, there's the spray syringe, the enzyme solution, a heating element, & four double-A batteries. They are going to make bank with each kit sold.
Also, Avita should not have problems getting insurance companies to cover it since they got the more stringent FDA PMA approval. Avita’s clinical experience and regulatory pathway are superior to peers:
Clinical Experience: Avita has been studied in a number of clinical trials. This is not the status quo in wound care. For clinical decision makers (hospital value analysis committees), this clinical evidence will support use over competitive products without clinical evidence.
Regulatory Paradigm: Avita pursued the PMA pathway rather than the simpler 361 pathway that doesn't require clinical trials. Insurers are cracking down on the 361 pathway, providing a more durable reimbursement than peers.
In December 2017, the FDA revised guidelines for skin and skin substitutes. As part of the guidance, the FDA noted it would create a 36 month period ending November 2020 in which it will regulate against 361 pathway products that do not meet specific criteria.
Recently, United Health Group (UNH) updated its policy on skin and skin substitutes. In this update, UNH issued non-coverage decisions for a few skin and skin substitute products that “Due to limited studies, small sample sizes, and weak study designs, there is insufficient clinical evidence to conclude that these skin substitutes have an improved health outcome over standard therapies. Well-designed, randomized comparative clinical trials are needed to demonstrate the efficacy and safety of these products”.
Using Recell will lower hospital costs by 29% over the standard of care. I would not be surprised if Insurance companies encourage burn centers to use ReCell since it would not only save burn centers money but insurance companies as well. It's priced much cheaper than competing products:
Ditto with that sentiment Robotmaster. I wish I heard about EXAS years ago. If you invested 10 grand on Nov, 1st, 2008, you would be up 2.4 million today. My hope is that Avita builds up to that level as well. If that happens, I'd be up a million.
The stock started @ $5.58 on Monday and closed today @ $5.35, down 23¢ for the week.
I read this from a SeekingAlpha article:
One of the compelling advantages of the RECELL Autologous Cell Harvesting Device is its simplicity. As an autologous treatment, there is no need to screen donor cells, no need for cell expansion and no need for HLA matching. Unlike the allogeneic stem cell model that entails pricey manufacturing demands for cell expansion and invariably, the reliance on specialized outside manufacturers (especially in the early stages of development), the manufacturing of RECELL is very simple, so much so that the unit is disposable and runs on 4 AA batteries. Moreover, Avita was fortunate when it recently was offered the unexpected opportunity to take control of, and operate, the manufacturing facilities for the hardware components of RECELL from an S&P 500 contract manufacturer that was consolidating its operations. Interestingly, Avita obtained the manufacturing and warehouse equipment for free and simply rehired existing employees. A biotech at this stage of development is rarely able to commence commercialization with the advantage of being vertically integrated. With manufacturing now in house, Avita has publicly projected that it anticipates gross margins of 90%+ when it fully ramps up.
With the apparent simplicity of manufacturing the kits, I don't think they will have problems ramping up to meet the demand when they start making kits for ulcers & vitiligo patients.
New Motley Fool Australia story:
Why the AVITA Medical share price is up 500% in 12 months?
I've already emailed my local news stations awhile back to "Submit Story" ideas. I sent along before/after pics along with links to ReCell news stories. It only took 10 minutes out of my day. One of them replied & said they would forward it to the newsroom.
Also, I was wondering about the Value Analysis Committee (VAC). The process takes around 6 months or more. I wonder how many burn centers began the VAC process in January when Avita had their formal U.S. launch?
Quick question about today's Marketwatch stock chart:
It says that today's high was $5.73 but that spike doesn't show up in the chart. I typically view the chart in a 1-day setting. Normally, when I switch the chart to 5-day, I can see that spike, but today I don't see it.
Any idea why this happens? I've noticed this on more than one occasion.
I find it strange how the Aussie stock is playing out today after that quarterly report. It's bounced from a high of 41¢ dow to a low of 37¢. Weird.
Jugs, my hope is that we can figure out which company will be the next "Avita Medical" and buy in when it's dirt cheap.
I think this was the most interesting part of that interview:
Another study that Perry is particularly excited about is how RECELL may be used to help people suffering from vitiligo disease, a disease characterized by patches of the skin losing its pigmentation. Perry noted that it’s a problem that affects between 3 and 5 percent of people and can create serious social stigmas in certain cultures. For example, Perry noted that in parts of Asia, vitiligo is referred to as “white leprosy.”
Three to five percent of China's population would be:
42,600,000 to 71,000,000
I've read that South Koreans are crazy about their physical appearance. They spend a ton on skin whitening products for example. I don't know how much the Chinese are similar when it comes to that but it could end up being very lucrative for Avita if they are.
You might have luck with the Google Translate phone app. you can point the camera at the screen and it could translate the characters to english.
I'm assuming that it will be a really crappy translation but I guess it's better than nothing.
I'm surprised that RCAR stock is still being traded. It would be so much better for Avita if the FEDs took Renovacare down. I wonder why it's so hard to take down these boiler room scams?
What's the deal with RenovaCare? They seem to have an extremely similar product to ReCell but Avita's product has FDA approval and is being used in the burn market. Is Renovacare the burn equivalent of the company Theranos that imploded awhile back?
On my Avita reddit thread, before I found out that there were 1,825 burn beds across the country, I tried finding out that info by finding the bed counts of every burn center in the U.S. I got some help by other redditors. This is how far we got until I discovered the 1,825 figure:
Alabama
UAB Burn Center - 28 beds
Children's Hospital of Alabama - 6 beds
University of South Alabama Regional Burn & Wound Center - 18 beds
Arizona
Arizona Burn Center at Maricopa Medical Center - 37 beds
Arkansas
Arkansas Children's Hospital Burn Center - 16 beds
California
Inland Counties Regional Burn Center - 14 beds
Community Regional Leon S. Peters Burn Center - 10 beds
University of California, Irvine Medical Center - 16 beds
University of California, Davis - Regional Burn Center - 12 beds
Bothin Burn Center at Saint Francis Memorial Hospital - 16 beds
Sherman Oaks Community Hospital Burn Center - 30 beds
Georgia
JMS Burn Center - 72 beds (Largest burn center in U.S.)
Illinois
Memorial Medical Center Regional Burn Center - 10 beds
Massachusetts
Shriners Burn Center, Boston - 30 beds
Virginia
Virginia Commonwealth Med School - 16 beds
Washington
The Sacred Heart Medical Center Burn Program - 35 beds
I found this old story from 2010 about ReCell and Vitiligo.
This stood out to me:
AVITA GETS $1.452M FROM US MILITARY TO SPEED DEVICE APPROVAL.
This is the first info that I found online showing how much (I'm assuming BARDA) put in towards the trials. I wonder if that was only a portion of the money needed for the trials or if that amount covered 100% of the trials?
Quick question:
Does anyone know specifically when the quarterly report be posted online? I've heard Sunday/Monday depending on if you are in Australia or the U.S.
I'm located in the midwest (central timezone). I'm wondering if I should stay up on Sunday night or wait until Monday morning to read the results.
No worries. Hell, I'd be ecstatic if they announced a 3-4 million profit on Monday. My mind wonders when I think of the potential and then I extrapolate. We have 1,825 beds across the United States and the potential for treating 14,000 patients per year ( I don't know if those are adults only or adults and children). I've read that a burn victim that has burns on 50% of their body would need at a minimum, 5 ReCell kits (more depending on the severity of the burn).
It would be pertinent info if we could find out on average, how many kits a burn victim treated with ReCell needed.
The largest burn center in the U.S. is the Arizona Burn Center at Maricopa Medical Center. They have 37 dedicated beds for burn victims. I believe they also took part in the clinical trials and may be one of the 19 burn centers that have already ordered ReCell Kits. It would be great if we could find out:
How many ReCell Kits they ordered?
Do they plan to reorder monthly, quarterly, or every six months?
Correct me if I'm wrong but I remember reading that around 450,000 Americans go to a burn center each year for treatment and of that amount, around 14,000 are good candidates for being treated with ReCell.
My estimates would be downright small if we could treat 14,000 patients each year.
This is my rough estimate from the info I've gleaned off the internet:
Avita has said that 19 burn centers have already ordered ReCell kits. That's 15.2% of the burn centers across the country. 15.2% of the 1,825 designated burn beds across the U.S. comes out to 277 beds. If burn centers ordered one kit for each of those beds, that would be:
277 kits x $7,500 = $2,077,500
If they ordered two kits for each bed:
554 kits x $7500 = $4,155,000
Three kits per bed:
831 kits x $7,500 = $6,232,500
I don't know about you but I like those numbers. Just think about in 1-2 years when every burn center in the U.S. orders ReCell:
1 kit per bed:
1,825 kits x $7,500 = $13,687,500
2 kits per bed:
3,650 kits x $7,500 = $27,375,000
3 kits per bed:
5,475 kits x $7,500 = $41,062,500
And finally, double those amounts when they reorder each 6 months.
I'd be happy if it closes above $6 by the closing bell.
Can't wait!
Tdeck, you've written that you think Avita will announce a profit around 4.5-5 million. What do you think the stock will do if it's a total blowout and they announce 7.5-10 million profit, along with approximate dates for the shift to the NASDAQ and the Pediatric ReCell FDA PMA approval?
My guess is that the stock will slowly trickle downwards a few pennies a day until the quarterly report...then an explosive boost to the stock.
I was wondering, how many shares do you guys have? I assume that Tdeck is currently in first place. I used my Apple dividends to buy 9,914 @ $1.06 per share. My hope is after our Avita stock reaches its peak, we can search for the next Avita and buy in at less than a buck and go on this ride all over again.
Here are some other before and after pics and vids that I've posted on my Avita Reddit thread:
News story about Tiara del Rio. She had 3rd & 4th degree burns on 50% of her body including her face.
And here's a follow-up video of Tiara after healing up.
News story of road rash victim Brian Shepard (fast forward to 1:19)
Follow-up video of Brian.
ReCell donor sites:
48-year-old man that received 2nd degree burns on his face.
1-year-olds w/deep dermal burns.
Pics from elective procedures.
Road Rash
Quick questions:
Are there any countries that will start using ReCell when it receives U.S. FDA approval or does each country goes through it's own form of FDA approval process?
If there are countries that accept U.S. FDA approval for product certification, is there a list of those countries?
It has been mentioned on this forum and others that getting FDA approval is a very expensive process. BARDA helped fund the trials for ReCell's FDA PMA approval. Does anyone know approximately how much that cost? Is it one million? Five? I can't seem to find any info about that.
I managed to find one before & after pic for StrataGraft:
I'm still trying to find info about the costs associated with it and if they are in the process of getting FDA PMA approval as well. Looks like it doesn't need donor sites (which is a plus) and there seems to be minimal scarring. I haven't found any info if it would be used with elective procedures as well.
In comparison, here are some before and after pics of elective procedures treated with ReCell:
I've never heard of the StrataGraft treatment before. Do you think this can be a solid competitor to ReCell? With SkinTe & Epicel, I see the advantages that ReCell has over those two but I don't know anything about StrataGraft to compare if ReCell has advantages over it.
I tried coming up with a rough estimate about what their sales could be this quarter. Avita has said that 19 burn centers have already ordered ReCell kits. That's 15.2% of the burn centers across the country. There are 1,825 designated burn beds across the U.S., 15.2% comes out to 277 beds. If burn centers ordered three kits for each of those beds, that would be:
831 kits x $7,500 = $6,232,500
Now again, this would just be a rough estimate. But even if it was plus or minus $1,000,000 either way, that would end up being between $5,232,500 on the low end and $7,232,500 on the high end. Either amount would be a great quarter.
Also, I did a search for ReCell on the ClinicalTrials.gov website & came up with 15 results.
https://clinicaltrials.gov/ct2/results?cond=&term=Recell&cntry=&state=&city=&dist=
Hi.
First time posting here. I've been bouncing between here, the Hot Copper forum, the Yahoo Finance thread, and the Avita Medical Discussion thread that I started on Reddit's r/stocks subreddit. I bought in @ $1.06 (holding long).
I've been reading the thread today about Avita being bought by a big company like Novartis but what are your thoughts about Avita growing into a large company instead of being bought out? My hope is Avita will grow like EXACT Sciences Corp. (EXAS). They closed today @ $95 per share. Three years ago on February 1, 2016, that stock was @ $5.96.
What are the chances of Avita to getting to that level instead getting bought out?