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odi01
Posted on: Feb 22 2020, 06:39 AM


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for a better world
Clinuvel is a biopharmaceutical company developing drugs for the treatment of a number of serious skin diseases. My Australian colleagues, among others, drew my attention to this company.
Its lead drug, SCENESSE, is used to treat erythropoietic protoporphyria (EPP). EPP is a rare, lifelong genetic disease characterized by severe skin intolerance to light, leading to unbearable pain, swelling and scarring. People living with EPP must avoid sunlight and often stay indoors. According to the company, approximately 10,000 people worldwide are affected by EPP.
SCENESSE is also used in the treatment of vitiligo, a common skin disease in which the skin's pigment-producing cells are missing. The company estimates that Vitiligo affects between 0.1 and 2% of the world's population (7.6 to 152 million people).
Clinuvel currently has a virtual monopoly. SCENESSE is the only drug approved for the treatment of EPP. The drug is currently approved in the EU and since October last year also in the USA.
The company continues to reinvest its (now very high) profits in new drugs and the research into further fields of application for its current active ingredients. Clinuvel could thus be able to help even more people with other diseases, some of which are serious and currently difficult to cure

https://m.onvista.de/news/3-wenig-bekannte-...-welt-330570623
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odi01
Posted on: Feb 21 2020, 07:47 PM


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https://youtu.be/dHyuESS9JuQ
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odi01
Posted on: Feb 21 2020, 07:17 PM


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https://podcasts.google.com/?feed=aHR0cHM6L...AAAAAHQAAAAAQBQ
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odi01
Posted on: Feb 20 2020, 03:42 PM


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https://www.shortman.com.au/stock?q=CUV
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odi01
Posted on: Feb 20 2020, 04:51 AM


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http://nabsociety.org/site/?page_id=1095
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odi01
Posted on: Feb 19 2020, 07:38 PM


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https://kalkinemedia.com/au/blog/how-fda-ap...althcare-stocks
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odi01
Posted on: Feb 19 2020, 02:13 PM


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https://www.asx.com.au/asx/statistics/displ...;idsId=02203898

https://www.asx.com.au/asx/statistics/displ...;idsId=02203905
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odi01
Posted on: Feb 16 2020, 07:28 PM


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https://www.eurekareport.com.au/investment-...005759#Clinuvel
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odi01
Posted on: Feb 16 2020, 12:19 AM


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https://youtu.be/ayjUR6Cghoc
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odi01
Posted on: Feb 15 2020, 03:35 PM


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https://academic.oup.com/jbcr/article/41/1/215/5642499

https://flashalert.me/?symbol=RCEL&sour...bRdYOj2VdwnuKwa
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odi01
Posted on: Feb 14 2020, 04:26 PM


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https://www.livewiremarkets.com/wires/buy-h...growth-mid-caps
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odi01
Posted on: Feb 13 2020, 01:34 PM


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https://www.gurufocus.com/news/1036707/blac...ia-holdings-inc.
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odi01
Posted on: Feb 11 2020, 06:20 PM


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https://www.livewiremarkets.com/wires/polyn...urns-innovators
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odi01
Posted on: Feb 10 2020, 11:54 PM


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It's very interesting to see a lot of famous and high quality luxury packaging exhibitors from Korea and we managed to acquire some prospective suppliers," said Clarabelle Ang, Laboratory Technician with Singapore's Vallaurix Pte Ltd.

https://markets.businessinsider.com/news/st...2019-1028720842
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odi01
Posted on: Feb 10 2020, 07:30 PM


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https://www.theaustralian.com.au/business/w...f4f1d903380c3d3
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odi01
Posted on: Feb 10 2020, 02:41 PM


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https://www.morningstar.com.au/stocks/artic...-on-skin/199295
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odi01
Posted on: Feb 9 2020, 09:23 PM


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https://youtu.be/bG5_tYCvGFo

from 32min 20sec
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odi01
Posted on: Feb 7 2020, 02:30 AM


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https://finance.yahoo.com/news/eps-growth-t...-234208043.html
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odi01
Posted on: Feb 6 2020, 06:22 AM


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6 pills everyday

https://www.instagram.com/p/BvpCAuiliZ_/?igshid=hdlsnj74petu
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odi01
Posted on: Feb 5 2020, 12:45 AM


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https://www.cnbc.com/2020/02/03/cramers-lig...-as-a-spec.html
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odi01
Posted on: Feb 4 2020, 03:37 AM


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https://www.streetinsider.com/dr/news.php?i...05596&gfv=1
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odi01
Posted on: Jan 31 2020, 05:43 PM


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https://www.fool.com.au/2020/01/31/avita-me...lf-year-update/
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odi01
Posted on: Jan 29 2020, 04:53 AM


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https://jabmauisymposium.com/

https://mobile.twitter.com/AvitaMedical/sta...202228900941825
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odi01
Posted on: Jan 28 2020, 07:25 PM


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https://www.proraris.ch/de/pionierin-bereic...heiten-475.html

When Elisabeth Minder talks about her work at the City Hospital Triemli, she does so with great dedication.
Her commitment has taken her a long way: in 1993, Elisabeth Minder became the first woman to be appointed chief physician at Triemli City Hospital. The medical laboratory institute, which she headed, employed 50 people and had a turnover of 12 million Swiss francs. After training in clinical pharmacology, she first came into contact with porphyria - a group of rare diseases almost all of which are inherited - at the University Hospital of Zurich. Typical of the most well-known form of this disease is an unbearable burning sensation on the skin caused by sunlight. In Switzerland, only about 80 patients suffer from the so-called erythropoietic protoporphyria (EPP).

More and more requests and treatments
At Triemlispital, Elisabeth Minder established the only consultation hour for porphyria patients in Switzerland to date. "That was the condition of my employment. I wanted to combine research with patient care," recalls the former head physician. Her former boss agreed. Since the opening at the beginning of the 1990s, the number of patients has been increasing year by year. Today, about 10 patients per week are received in the porphyria consultation hours - also from abroad. In addition, there are numerous enquiries from professionals and patients who ask the porphyria specialists for advice.

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odi01
Posted on: Jan 27 2020, 03:56 AM


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https://www.adelaidenow.com.au/subscribe/ne...mp;mode=premium
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odi01
Posted on: Jan 27 2020, 03:52 AM


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https://youtu.be/wPnoNUbY9DI

go to 1h.10min
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odi01
Posted on: Jan 26 2020, 02:37 AM


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https://www.azpulse.org/how-the-arizona-bur...-for-burn-care/
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odi01
Posted on: Jan 23 2020, 01:47 AM


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https://twitter.com/avitamedical/status/121...4968064001?s=21
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odi01
Posted on: Jan 23 2020, 01:41 AM


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PHILADELPHIA (KYW Newsradio) — Temple University's Burn Center is using new revolutionary biotechnology to treat burn victims. Temple is now using RECELL, a spray-on skin treatment used on burn victims that just approved by the U.S. Food and Drug Administration in January 2019. The treatment is especially helpful to those suffering from large burns. "This enables us to get the patient covered with their own skin more broadly with much less," the center's Lisa Rae said. "In the operating room," she explained, "we take a small piece of their skin, put it in a solution and spray it across the burned area." The treatment limits scaring, but Rae says ultimately, this treatment saves lives because it saves time. "Risk of infection is based on how long your wounds are open. And if we can heal faster we can decrease the overall infection risk," she added. Rae says within 24 hours, the spray-on skin adheres to the wound and begins healing immediately.



https://kywnewsradio.radio.com/articles/new...at-burn-victims
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odi01
Posted on: Jan 20 2020, 05:22 PM


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https://au.finance.yahoo.com/news/why-think...-055553813.html
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odi01
Posted on: Jan 20 2020, 01:28 AM


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https://m.facebook.com/story.php?story_fbid...J2Whg8QuxPI0fo4
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odi01
Posted on: Jan 14 2020, 02:02 PM


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https://www.asx.com.au/asx/statistics/displ...;idsId=02192558
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odi01
Posted on: Jan 14 2020, 02:02 PM


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https://www.asx.com.au/asx/statistics/displ...;idsId=02192558
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odi01
Posted on: Jan 14 2020, 02:01 PM


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https://www.fox8live.com/video/2020/01/07/n...mc-burn-center/
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odi01
Posted on: Jan 11 2020, 07:31 AM


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New Purchase: Avita Medical Ltd (RCEL) Larson Financial Group LLC initiated holding in Avita Medical Ltd. The purchase prices were between $7.1 and $9.7, with an estimated average price of $8.37. The stock is now traded at around $9.30. The impact to a portfolio due to this purchase was 0.02%. The holding were 3,369 shares as of

https://www.gurufocus.com/news/1013383/lars...ercadolibre-inc
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odi01
Posted on: Jan 10 2020, 03:08 PM


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https://stockhead.com.au/health/health-migh...uccess-in-2020/
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odi01
Posted on: Jan 10 2020, 03:04 PM


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https://stockhead.com.au/health/health-migh...uccess-in-2020/
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odi01
Posted on: Jan 10 2020, 02:59 PM


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https://au.finance.yahoo.com/news/2-asx-hea...-024209901.html
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odi01
Posted on: Jan 10 2020, 02:58 PM


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https://au.finance.yahoo.com/news/2-asx-hea...-024209901.html
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odi01
Posted on: Jan 10 2020, 02:53 PM


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https://seekingalpha.com/article/4316075-av...e=seeking_alpha.
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odi01
Posted on: Jan 7 2020, 05:26 PM


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https://www.fool.com/investing/2020/01/06/3...watch-list.aspx
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odi01
Posted on: Jan 3 2020, 04:56 AM


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https://simplywall.st/stocks/au/pharmaceuti...atchlist-today/
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odi01
Posted on: Jan 1 2020, 11:42 PM


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https://www.wdsu.com/article/woman-injured-...at-umc/30362386
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odi01
Posted on: Dec 30 2019, 02:08 PM


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https://au.finance.yahoo.com/news/avita-med...-220147477.html
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odi01
Posted on: Dec 30 2019, 01:40 PM


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https://www.asx.com.au/asx/statistics/displ...;idsId=02189546
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odi01
Posted on: Dec 29 2019, 03:14 AM


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https://slatersentinel.com/news/2019/12/27/...is-quarter.html
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odi01
Posted on: Dec 29 2019, 03:10 AM


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https://newsfilter.io/articles/avita-med-lt...3f1a9c1b5316278


https://finance.yahoo.com/news/biotech-rall...-191907833.html
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odi01
Posted on: Dec 26 2019, 07:22 PM


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GREENSBORO, N.C. -- A man who survived a plane crash in Boone is sharing his story to inspire others. “I wanted the nurses and doctors to know what he looked liked before the accident,” Judy Worsley said as she held up her iPhone. On the screen, was a photo of her husband John Worsley with sunglasses on, a huge smile and a head full of hair. She doesn’t know when it was taken, “only sometime before the accident.” As she showed the photo, John was sitting next to her on the family couch and staring at the phone. His left eye began to water not for sentimental reasons but because of the damage that was done to it when the plane he was on crashed. His body was severely burned and crushed the moment the plane smashed into a golf course in Boone. At 1:00 p.m. on April 25, John and two of his friends flew from the Boone Airport in a Piper PA-32 aircraft, which, according to an NTSB accident report, belonged to John. In their full report, it is stated that the plane was attempting a maneuver when its wings clipped a pair of pine trees. The plane then crashed into the ground. To this day, John still has not regained parts of his memory from that day in April. Even as he sat down with his family in Greensboro, he scratched his scarred chin and did his best to recall what he could. While John recalled that he was in the pilot's seat, and the plane, according to the NTSB, was registered to him, he has stated that he cannot remember if he was the one operating the aircraft at the time of the crash. “The first thing that I can remember is the smell of smoke. And so I was in the pilot seat and the other two people in the plane were pilots too," John said. Those two people were Benjamin Franklin Chappell, 69, and Steven Cox Berry, 43. Benjamin was killed on impact. John explained that it was a race against the clock for him and Steven to escape the plane that had begun to go up in flames. The flames and heat were beginning to crawl up their backs and spread down their arms and legs. “Steve was in the co-pilots seat and I said, ‘Steve, we’re on fire. We need to get out.’” Steve was stuck and repeatedly told John that he could not get out. John explained that he had to reach out and push open the door, and the two rolled out of the burning metal frame. Witnesses, who described how the plane quickly sped to the ground after clipping the trees, rushed over to the plane to help guide John and Steven away from the flames. The smoke filled the two pilots' eyes, which made it nearly impossible to see. John said he had to crawl on his hands and knees in the direction of where he thought their voices were coming from. The following moments are a blur to the survivor. He said he remembers asking for someone to call his wife, who was six hours away at the beach. He also recalls having a conversation with the EMS crews while he was airlifted to the hospital. Doctors told his wife that because of his age, 68, and the severity of his burns that he would not likely survive. While they did a CT scan that day, they also discovered that John had a tumor on his kidney that could likely impact his chances of making it. “I remember telling the doctors that he wasn’t the typical 68-year-old. We really kind of expected that he’d make it,” Judy said. Determined to help her husband have that fighting chance, Judy pushed for doctors to use an experimental skin regrowth treatment called “RECELL.” John said that “they take a post-it stamp size piece of your skin and they expand it to 70 to 90 times the size of the medium.” That skin is then liquified to the point to where it can be sprayed onto the burn areas in an attempt to replace and recover the damaged area. he spent the next six months in the hospital. During this time, he learned that his friend and co-pilot Steven had passed away from his injuries sustained in the crash. He also had to have his left ankle and leg pinned in place to repair, both of his hands were in casts and his ability to move was limited. With the help of the physicians, his wife and the fuel in his spirit, John walked out of the hospital in October 2016. Three years later, he is still not physically able to do what he once could. He lost his left ear and has to wear hearing aids, he can’t stand in one place for too long with hurting, his hands and fingers aren’t able to close all the way and his skin is no longer able to sweat, meaning he cannot tell when he’s getting too hot. He still has regular therapy and doctor’s visits to replace his skin as needed. However, he decided he would not let those limitations stop him. “I’ve decided that you have one of two choices. You can do whatever it is you can do, or you can sit down and wait to die," John said. He has joined a burn survivor’s group in Winston-Salem and attends the monthly meetings as often as he can. John explained that he wants to share his story to show others their life isn’t over just because the unexpected happened. He recalled a moment from a recent meeting he attended where he sat and listened to victims speak. “They were really angry, they were depressed, and I thought maybe I might be able to help some people," John said. He also said he wants to get behind the controls of a plane again and takes to the skies once more

https://www.google.com/amp/s/myfox8.com/201...olf-course/amp/
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odi01
Posted on: Dec 24 2019, 03:42 AM


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https://www.instagram.com/p/B6bGIEzlUyk/?ig...d=1kdjfpdmpfxou
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odi01
Posted on: Dec 23 2019, 12:25 AM


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https://stockhead.com.au/health/dr-borehams...sion-ambitions/
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odi01
Posted on: Dec 21 2019, 05:18 PM


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https://kalkinemedia.com/2019/12/17/four-po...or-millennials/
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odi01
Posted on: Dec 21 2019, 05:09 PM


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https://au.finance.yahoo.com/news/were-best...-234810772.html
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odi01
Posted on: Dec 21 2019, 02:08 PM


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https://6abc.com/health/spray-on-skin-cells...spital/5772622/
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odi01
Posted on: Dec 21 2019, 02:04 PM


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https://www.templehealth.org/about/news/tem...of-severe-burns
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odi01
Posted on: Dec 20 2019, 01:09 AM


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https://www.youtube.com/watch?v=3eqGRMwQs8c...amp;app=desktop
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odi01
Posted on: Dec 19 2019, 05:25 PM


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https://youtu.be/HYvuqTItztc
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odi01
Posted on: Dec 16 2019, 04:43 AM


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https://thewest.com.au/business/health/red-...-ng-b881411886z
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odi01
Posted on: Dec 15 2019, 05:48 AM


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https://www.fool.com.au/2019/12/09/3-asx-sh...-value-in-2019/
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odi01
Posted on: Dec 15 2019, 05:33 AM


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https://www.abc.net.au/news/2019-12-13/how-...lainer/11796426
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odi01
Posted on: Dec 15 2019, 05:26 AM


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https://kjzz.org/content/1355141/new-zealan...oneered-arizona
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odi01
Posted on: Dec 13 2019, 07:26 PM


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https://foxbaltimore.com/news/local/new-typ...-park-fire-hero
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odi01
Posted on: Dec 13 2019, 03:27 PM


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https://www.instagram.com/p/BvpCAuiliZ_/?igshid=hdlsnj74petu


After personal contact to the user "livededfearless", I found out that she had complaints (nausea, tiredness, headaches) after taking MT 7117
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odi01
Posted on: Dec 13 2019, 03:21 PM


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https://youtu.be/gHRi16VossY
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odi01
Posted on: Dec 12 2019, 08:07 PM


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Stock letter from Homm

Clinuvel conclusion:
The price of the Clinuvel share has fallen significantly, so that our dusting limits are executed at prices around 26 AUD.
were. In the meantime, the share price has returned to the level before FDA approval. The short attacks, Phillip
Wolgen's compensation package and potential competitors seem to have a greater impact on investors than
they (probably) should.
Clinuvel presented good business figures and its long-term strategy at the Annual General Meeting.
and according to his own statements is in the "endgame". The market for the treatment of UV￾Lichtbedingten DNA damage is enormously promising. In recent years, CUV has developed
extensive experience.
The share trades only approx. 10% above the price target of an extremely one-sided and negative research report of
Moelis Research, Australia, which was published prior to FDA approval. This report has been exclusively
assessed the potential of Scenesse for the treatment of EPP in Europe and the USA at AUD 26.
This study completely ignored the potential of Scenesse for the treatment of EPP in the following markets
in Asia, South America, South Africa, Australia, Canada and New Zealand as well as for other EPP applications.
similar diseases to VP and XP. From our point of view, the XP and VP applications have a
Market potential, which should be significantly higher than for EPP (see Research Summary).
We remain convinced of Clinuvel and have even used the lower prices for acquisitions. We
confirm our price target of AUD 56 (based on the EPP valuation in Europe and the USA). Long-term hold
we offer courses of 150 AUD for possible. Patience and rationality is a virtue in investing.

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odi01
Posted on: Dec 10 2019, 02:03 PM


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https://kalkinemedia.com/2019/12/09/healthc...-avita-medical/
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odi01
Posted on: Dec 10 2019, 01:33 AM


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https://investorshub.advfn.com/boards/read_...ge_id=152687139
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odi01
Posted on: Dec 9 2019, 01:56 PM


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Avita Medical boss Mike Perry says its single-use device is revolutionising care for serious burns patients as the company eyes adjacent areas to use the unique Australian-made technology.The regenerative medicine company's Recell "spray-on skin" product was developed in Perth by Professor Fiona Wood. It aims to address unmet need in therapeutic skin restoration for adults, where patients would traditionally have to receive painful skin grafts.

"The real game-changing element of it is we are returning those melanocytes of pigment-producing cells to the skin, in addition to the skin cells themselves, and we are providing them in an aggregated form," Dr Perry said from his Californian base."We can a take skin for example from the calf of a leg and create a spray-on skin, and spray on someone's face who has second-degree burns. That will come back looking like a face, not like a leg. You are not left with disfiguring scars and from a pain perspective it's huge.

"Dr Perry explained that an adult male would need a skin sample about the size of a credit card to treat a wound on his entire back, rather than skin from both thighs and an arm for a skin graft. Avita has failed to achieve a significant level of market penetration and revenue despite being approved for commercial use outside the US for over a decade. But Dr Perry said that is changing.Avita has been one of the top performers this year on the ASX 200, up over 600 per cent, pushing its market capitalisation to over $1.2 billion despite having just $22.6 million cash, revenue of $7.9 million and no profits.

The company is being rewarded for its low-risk pipeline of new indications, he says, such as the vitiligo – a disease that causes the loss of skin colour in blotches. That market is valued at $US600 million ($877 million) in the US alone, and considered to be the bridge for expansion into the aesthetics space.Avita's next closest opportunity is the outpatient burns setting and treatment of donor sites. It's also looking to pediatrics, scalds and trauma. All up, there is a possible $US2 billion in sales, excluding gene therapy and aesthetics."Vitiligo – we have treated over 1000 patients in China with success and with no failures," Dr Perry said. "We have also had seven publications to support the adoption of Recell for vitiligo."Asia interestAvita is in early talks with possible Chinese partners, while its Japanese partner Cosmotec, owned by Tokyo-listed M3 Group, has submitted its Recell dossier to the authorities for marketing approval.

Avita recently raised $120 million to fund regulatory approvals and randomised clinical trials. It was supported by existing shareholders – Hong Kong's Karst Peak Capital, Redmile Group, and Blackcrane Capital – and by new ones such as Karara Capital and Regal Funds Management.

"Mike Perry has an impressive resume and presents the information well," said Montgomery analyst Joseph Kim. "As investors from Australia we are not always on top of the reimbursement [area]. It's critical."They seem to be on the right path with that, so it's likely why they are getting the take-up with burns units in the US."Dr Perry said he is firmly focused on the US given its size, but declined to give any outlook except to say “we are exceeding our internal targets” and 157 burns doctors out of 300 are trained to use the device in the US.Dr Perry, who took the top job in 2017 after taking early retirement from Novartis, said that using Recell also provides significant cost savings to the health system in reducing the numbers of hospital stays and procedures.

Arizona's Maricopa Integrated Health System estimated it could could save $US28 million a year by using Recell, while a burns centre in Memphis projected to cut costs by up to $US21 million.

Avita also has a powerful ally, US Biomedical Advanced Research and Development Authority, with whom it has long-term funding support. BARDA plans to stockpile its product in case of a burns disaster like a major terrorist attack.

Bell Potter analyst John Hester recently upgraded his call to a buy (speculative) from hold and raised his valuation to 83¢ per share from 69¢. The stock closed Friday at 60¢.He said Recell unit growth in the September quarter was much higher than expected. He is tipping 480 US Recell unit sales in the first quarter of 2020, and 2500 for the full year. The cost per unit is about $7,500.
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odi01
Posted on: Dec 9 2019, 01:54 PM


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https://www.afr.com/companies/healthcare-an...20191205-p53hbz
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odi01
Posted on: Dec 8 2019, 09:43 PM


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WASHINGTON, DC – Tacy Gash's whole life changed in five minutes on Memorial Day 2018 when her family home exploded.
Tacy and her husband Bill had just come home from grocery shopping, when they noticed a strong smell of gas.

"I remember the click," said Tacy.
"I remember the whoosh of air cause it was really hot. Strong whoosh of air. And I remember seeing pink."
"When I woke up in the hospital, I had burn marks that came around my face.  It's because the flames came around and clapped my face, then moved on."
The flames burned Tacy on 20% of her body.
Her hands and legs were the worst.   The heat had melted her skin to the carpet.

There are three types of burns:

First-degree burns damage only the outer layer of skin

Second-degree burns damage the outer layer and the layer underneath

Third-degree burns damage or destroy the deepest layer of skin and tissues underneath

During her two weeks in the hospital, doctors recruited Tacy for a clinical trial of ReCell.
It's a kit containing everything a doctor needs to take a small sample of a patient's own skin and turn it into a liquid with the cells needed to regrow new skin.
"Then it gets sucked up into a syringe and then the syringe is outfitted with an atomizer so that you can spray it on," Dr. Jeffrey Shupp, MedStar Washington Burn Center director

Tacy says the areas treated with the spray skin healed *** and the color is better than her burns treated with skin grafted from other areas of her body.
With recell, a piece of healthy skin the size of a postage stamp, can treat a burn 80 times that size.
"It means less donor sites for the patients, which decreases their total wound burden," said Dr. Shupp.
Tacy's husband Bill was not treated with the ReCell because his burns covered 60% of his body and his injuries were too severe.

Bill and Tacy are still recovering from those injuries.
The ReCell kit and spray skin procedure were approved by the FDA.
If this story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Jim Mertens at jim.mertens@wqad.com or Marjorie Bekaert Thomas at mthomas@ivanhoe.com.


https://wqad.com/2019/12/06/your-health-spr...ng-on-new-skin/
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The Patient Perspective: A Matter of Minutes
Swiss Society for Porphyria - www.porphyria.ch
1. DEZ. 2019 —

The Patient, the scientific journal dedicated to patient-centered outcomes research, has published a commentary authored by Rocco Falchetto, describing how patient input can contribute to medical product research and development processes, regulatory reviews, health technology assessments and reimbursement decision making. The article builds directly from Falchetto’s presentation in the symposium, “Patient preferences in the medical treatment lifecycle” at the 10th Meeting of the International Academy of Health Preference Research (IAHPR) in Basel, Switzerland, on the 13th of July 2019. It focuses on the arduous years-long patient journey to access afamelanotide, illustrates challenges and opportunities in the inclusion of the patient voice in the lifecylce of medicines, and calls for a stronger integration of the patient perspective in health systems’ decision-making processes.

We look forward to the article contributing to raising awareness on the urgent need for a full integration of the perspective of patients in decisions affecting their health and well-being as well as to a better understanding of EPP and the benefits of afamelanotide. As Falchetto concludes in his article, we hope that skeptical decision makers will reconsider their views on the value of this life-changing treatment, giving those who suffer from EPP a second chance to finally step out from the shadows and into life as fully productive and engaged members of society.

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Changes in index house MSCI's country indexes has sparked some heavy trading at the close on Tuesday. . . .

The MSCI Australia Index is designed to measure the performance of Australia's large and mid cap segments and has about 70 members.There was also some unusual trading at the smaller end of the market to reflect changes to the MSCI Australia Small Cap Index.MSCI's additions included Austal, Avita Medical, Bank of Queensland, Centuria Metropolitan REIT, Ecofibre, EML Payments, IMF Bentham, Ingenia, iSignthis, Perseus Mining, Polynovo and Ramelius Resources. Deletions included OFX Group, Speedcast, Syrah, Wagners and WiseTech."
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Another new addition is the Australian company Clinuvel Pharmaceuticals. The pharmaceutical manufacturer specializes in the treatment of rare diseases. In October, the US approval of the drug for the treatment of the light intolerance disease EPP was celebrated. Further approvals are in the pipeline, so we expect the positive development to continue.

https://www.fondsdiscount.de/magazin/news/t...nt-in-den-4404/
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0,44 min
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We have also included Clinuvel Pharmaceuticals Ltd. in our portfolio. The company specializes in skin diseases caused by genetic defects. The drug Scenesse is the only product in Europe that is used to treat EPP. The therapy enables patients to live in the light again, which was previously impossible or only possible under severe pain. In the USA, the health authorities are currently deciding on the approval there.

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3:30 – 4:00
pm
Burn Care Without Borders
Judy L. Placek, MSN, APRN Karen L. Winn, MSN, ACNP, RN
Nurse Practitioner, Plastic & Burn Surgery Manager, Medical Education
Nebraska Medicine, Omaha, NE Avita Medical, Valencia, CA

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Three hours of sun - New studies on EPP under treatment!

Jasmine Barman Aksözene
Mannheim, AL, Germany


17TH SEP. 2019 —

Normally, EPP patients experience the first symptoms such as burning and pain within a few minutes in the sun. When treated with afamelanotide, they can lead an almost completely normal life and spend hours outdoors.

How long exactly has now been recorded in two studies with patients from Switzerland, the Netherlands and the USA, which were presented at the International Congress on Porphyria, 8-11 September in Milan: In the Swiss study, the tolerance for phototoxic reactions increased from a median of 10 minutes to a median of 180 minutes. In the Netherlands and USA, where a different protocol was used to record time, many patients claimed to be able to spend more than 360 minutes outdoors without symptoms.

These results finally reflect the patients' experience! Instead of calculating mean values as in previous studies, where rainy days and time spent in the office of course massively dilute the measured effect, the treatment centres now document what is relevant for us patients: How long can I actually stay outside on sunny days without suffering massive burns and pain - if I have the time and the sun is shining. Both manuscripts are in preparation for submission to scientific journals.

This adaptation in the measuring procedure represents an important step in learning how to measure the effect of treatment with EPP - since there has never been an effective therapy for EPP before, the first studies did not know exactly how best to measure the effect of afamelanotide. This makes it all the more important to listen to the patients and their caregivers in rare diseases, because they know best whether a treatment will benefit them or not. We hope that the European Medicines Agency and the FDA finally understand and acknowledge the benefits of treatment for us patients on the basis of these data and change their unscientific conclusions, which currently make access to treatment considerably more difficult. It is unacceptable that patients should not have access to the only and demonstrably highly effective treatment for their disease, or that they should fear that this new life will be taken away from them in the light and without burns.

Photo: International Porphyria Patient Network (IPPN) in front of the posters on the successful appeal procedure in England and the poster on acute hepatic porphyria in science slam style.

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Stereotaxis - Acquisition Of Robotic Vascular Peer Underscores Substantial Upside Potential, Private Placement Another Positive
Sept. 3, 2019 2:05 PM ETStereotaxis, Inc. (STXS)AVMXY, CVRS, ISRG...13 Comments
Summary
Active M&A environment in Robotic Medical Device Segment continues with Siemens Healthineers’ $1.1 billion acquisition of Stereotaxis’ peer Corindus Vascular Robotics.
CVRS acquisition validates significant market potential for robotics in cardiac and neurovascular markets, and the P/S multiples paid for it would imply a $13-26/share valuation for STXS.
As per the latest of 350+ peer-reviewed publications, Stereotaxis robotic platform now carries trifecta of clinical superiority, safety and speed.
Securing $25 million via private placement from smart healthcare funds, including Redmile Group, provides foundation for faster growth and expansion of procedure indications.
Stereotaxis recently discussed opportunity to target cancer for first time, and that's noteworthy on heels of J&J's $5 billion Auris Health acquisition.
Active M&A Environment in Robotic Medical Device Segment Continues; Following J&J’s Acquisition of Auris Health for $5 Billion in February 2019, Stereotaxis’ Robotic Vascular Peer Corindus Vascular Robotics (NYSEMKT:CVRS) is being Acquired for $1.1 Billion by Siemens Healthineers; Notably Stereotaxis has Similar (if not Larger) Growth Opportunity Ahead

In the valuation/summary section of the prior SA article posted in May 2019 entitled Stereotaxis: Well Positioned To Become 'Intuitive Surgical Of Endovascular Surgery' With Genesis Launch And Proprietary Catheter Development, Corindus Vascular Robotics was highlighted as one of two robotic medical peers trading at a significantly higher P/Sales multiple than Stereotaxis (OTC:STXS). Since that analysis, Siemens Healthineers (OTCPK:SMMNY) has bid $1.1 billion to acquire Corindus, making Stereotaxis’ current valuation even more attractive, especially considering their higher revenues, lower cash burn, nearness to profitability, larger install base, and similar (if not greater) growth opportunity ahead.


Placing comparable P/S multiples on Stereotaxis for what Corindus was acquired for (102x, ~61X, and ~38X on actual FY18, estimated FY19, and estimated FY20 revenues respectively) would yield a value between $13-26/share for STXS today. This valuation range takes into consideration Stereotaxis’ higher shares outstanding, now approximately 114 million shares after the recent $25 million private placement led by Redmile Group.

Clearly these valuation levels reflect a takeout price of a robotic vascular peer, and this section is not suggesting that Stereotaxis is worth those levels today based on its fundamentals. Yet the future growth opportunity is arguably just as large, if not larger, for Stereotaxis as it is for Corindus as well as for Auris Health, which was acquired by J&J (JNJ) for $5 billion in February 2019.

As discussed in the prior SA article, Stereotaxis has broad regulatory clearance across the vascular system, including neurovascular, peripheral anatomy, and coronary vasculature procedures, making its total addressable market quite significant. Its unique robotic "pull" mechanism of action utilizes magnetism to more precisely and safely steer devices throughout the vascular system, as opposed to other robotic and manual approaches that use a “push” mechanism of action. This magnetic “pull” approach allows reach into areas of the vascular system that would be otherwise inaccessible via “push” approaches, including robotic and manual.

In light of this significant market opportunity and superior approach, under an acquisition scenario I do believe Stereotaxis can garner a value closer to $13-16/share based on similar forward P/sales metrics for FY2019 & FY2020 that Corindus is receiving at the $1.1 billion price tag, or even higher when taking into consideration the $5 billion ($3.4 billion in cash upfront) J&J paid for Auris Health earlier this year. This ‘takeout’ valuation level for STXS conservatively assumes $29 million in FY2019 sales growing to $38 million in FY2020, representing 31% year-over-year growth. Beyond 2020, Stereotaxis should see continued rapid growth for multiple years driven by new/replacement sales of its Genesis system along with the launch of its proprietary catheter currently under development. On its recent Q2’2019 conference call, CEO David Fischel noted that since unveiling their Innovation Plan three months ago it has been“an amazingly energetic period…The broad enthusiastic response validates that our innovation and strategic decisions were sound…We are confident in our expectation for significant revenue growth in the years ahead”.


Source: http://www.roboticep.com

Here is some more detail on the revenue estimates provided for FY2019, FY2020, and beyond:

For FY2019 - The $29 million estimate is based on ~$28 million in recurring high-margin revenue plus one new Niobe system sale to the Kansas City Heart Rhythm Institute to treat arrhythmia patients, which will be recognized in fiscal Q3’2019. This updated estimate for FY2019 factors in the receipt of a CE Mark for its Genesis system in May 2019 and a 6+ month sales cycle. On the Q2 call the CEO provided the following detail on Europe, US, Q3 outlook and color around new/replacement Genesis cycle: “In Europe, where we have regulatory clearance for the full robotic lab solution, including Genesis and Stereotaxis Imaging, we've begun engaging with existing hospital customers on replacement projects and with new potential customers on building robotic EP labs. In the US, we are advancing towards regulatory approval...In the third quarter, we expect to recognize the sale of a new Niobe robotic system to Overland Park Regional Medical Center, part of HCA Midwest Health. We expect in the coming months to be able to provide you with additional confidence that the replacement cycle opportunity for Genesis is real, and that our innovations support robotic adoption by new customers”.
For FY2020 - The $38 million estimate suggests growth of 31% y-o-y and represents the beginning of a multi-year replacement cycle for the Genesis system, with contributions from both Europe (CE Mark received in May 2019) and the US (pending FDA approval of the system which I anticipate within the next 4-6 months). As previously detailed in the prior SA article, management sees potential for ~$15 million annually from a Genesis replacement cycle. Considering (1) a 6+ month sales cycle, (2) CE Mark approval in May 2019, and (3) expected FDA approval near year-end, the $38 million revenue estimate for FY2020 factors the company achieving $9 million in replacement and new Genesis system sales. With respect to potential timing of FDA approval and a full global launch, management stated on the Q2 call: “We still think that some timeline around the end of this year, beginning of next year as a full launch globally seems reasonable”.
Beyond FY2020 - While this analysis will not look past 2020 in terms of specific revenue estimates, moving into FY2021 and beyond I’d anticipate the Genesis replacement cycle will be closer to management’s $15 million annual estimate. Stereotaxis’ other major driver of future sales is their proprietary catheter currently under development in collaboration with Osypka. As discussed in the prior SA article, management estimated that using just their existing global procedure volume its proprietary ablation catheter could generate "over $20 million in incremental high-margin annual revenue". That suggests potentially ~$48 million in high-margin recurring revenues annually after the launch of the catheter, without adding a single new customer. From a timeline perspective, management anticipates potential European approval for its proprietary catheters by the end of 2020 and potential FDA approval by 2022/2023, based off their comments on their Q1'2019 call.

From an overall profit perspective, the $38 million sales estimate for FY2020 could lead to a similar profit margin near the 72% achieved in FY2015; that is the last year the company had $10 million in hardware sales (generated from Niobe and Odyssey system sales). Given the costs that have been removed from the model in recent years, that could mean Stereotaxis reaching profitability next year just on the Genesis replacement cycle alone. Additionally, based on management commentary we may see some proprietary catheter sales beginning in 2H of 2020 in their sizeable European market, that would be additive to any replacement or new Genesis system sales. The sooner-than-later accretive nature of Stereotaxis should bolster its potential as a takeover candidate…more on that potential later.

Stereotaxis Robotic System has Regulatory Clearance for Navigation of Interventional Devices Broadly Throughout Vascular System; Recent $25 Million Private Placement Led by Redmile Group Will Help Speed Up Innovation in Electrophysiology and Kickstart Novel Applications Beyond Cardiac Ablation; Attracting Healthcare-Focused Institutional Investor Like Redmile Group is a Positive Development

From an expansion of procedures perspective, Stereotaxis has remained prudently focused on its large opportunity in cardiac ablation procedures, yet it has broad regulatory clearance throughout the vascular system, including cardiac, neurovascular and peripheral vascular procedures. Management has referred to the Genesis robotic system as a launching pad for future expansion noting "it serves as a platform on which potential future ventures in new endovascular anatomies are possible" and it is “a platform able to accommodate significant innovation in the future".

As mentioned, the total addressable market between cardiac, neurovascular, and peripheral procedures is quite significant. Stereotaxis has been cash constrained for years limiting its focus to cardiac ablation procedures, but thanks to a management/Board-led investment of $34 million in recent years and a new $25 million private placement in August 2019, that is changing for the better creating a substantial opportunity ahead for current and future shareholders. When discussing that $25 million private placement led by Redmile Group LLC on the Q2 call, the CEO had the following comments on broadening applications beyond cardiac ablation and expanding the sales team to better capture Stereotaxis’ significant opportunity ahead:

“This financing will allow us to initiate earlier, and advance more rapidly, multiple undisclosed innovation projects. I classify these projects into two general categories: a second wave of innovation in electrophysiology and novel applications for robotic magnetic navigation in interventional medicine. These projects will not have near-term impact on revenue, but are expected to have highly attractive IRRs to fuel future market share growth in electrophysiology and to create additional pillars of value for Stereotaxis outside of electrophysiology. I look forward to sharing additional updates as appropriate..."
"…A strong balance sheet will accelerate and support our commercial growth activities…While I'm confident the existing teams will be able to successfully commercialize our Genesis robotic system and next-generation ablation catheter at existing customers, we have limited bandwidth to focus on the 99% of the electrophysiology market that is not currently robotic. There's a real opportunity is that Stereotaxis has less than 1% share of a $4 billion and growing market. Given the clinical benefits of our technology, every electrophysiology lab should have a robotic system. This financing will allow us to thoughtfully expand our global commercial teams and execute on the opportunity.”
Management commentary on recent quarterly calls highlight that future expansion beyond cardiac is now clearly in focus for Stereotaxis, and their intent to expand procedure indications is more evident today than it has been since the company originally went public. The prior SA article discussed potential expansion into neurovascular applications (in particular for stroke patients), peripheral anatomy, pulmonary indications, and bronchial anatomy. Another indication has come to light since that last SA article was published in May 2019…cancer.


While the July 2019 article in Robotics Tomorrow entitled “Treating Heart Disease with Robotic Precision and Safety” did not have much new info, it was the first time I've ever seen cancer specifically mentioned as an area of potential focus. When asked "What type of patients does it impact now and who might it help in the future?”, Stereotaxis CEO answered: “Stereotaxis RMN is currently used to help treat patients suffering from cardiac arrhythmias... arrhythmias affect tens of millions of individuals worldwide. The technology serves as a platform for performing minimally invasive endovascular procedures. Looking ahead, Stereotaxis intends to apply the benefits of its robotic technology and proven safety into other fields, such as in the treatment of stroke, vascular disease, and various cancers." As mentioned in the prior SA article, the $5+ billion acquisition of Auris Health by J&J carries implications for Stereotaxis, and notably Auris' initial focus is on lung cancer...more on that later.

Shifting back to Redmile Group LLC, it is a ~$3 billion fund known for their healthcare focus and expertise that according to Bloomberg has 97% of its portfolio invested in healthcare. Having them lead the $25 million private placement is a major win for Stereotaxis and represents an inflection point in the management/Board led turnaround effort. With respect to my own experience with Redmile Group, I’ve had the good fortune of being involved in another medical device name that they also led a private placement in. That company is Avita Medical (OTCQX:AVMXY, AVH.AU), and from a 10,000-foot level there are broad similarities between the two companies including:

both have promising technologies that under prior management had not reached their full potential,
both have next generation platforms that could be transformational to their respective markets,
both are in a situation where a large capital infusion can help advance “idle-waiting-to-be-kickstarted” applications & pipeline opportunities into additional high-value areas, and
both have a clear edge from a clinical perspective, including efficacy and safety, over current ‘standard-of-care’ conventional approaches.
Let’s hope there is one other similarity here; Avita Medical shares have appreciated roughly 500% in the 9 months since its private placement that Redmile Group led in December 2018. I believe Stereotaxis has similar potential over the next 12-18 months, and it is reassuring to see smart institutional money like Redmile invest in the company at these levels and at this juncture.

https://seekingalpha.com/article/4289369-st...pside-potential

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odi01
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https://finfeed.com/small-caps/biotech/heal...-sector-part-1/
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odi01
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https://vimeo.com/344750025

Sorry
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odi01
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https://vimeo.com/357821778
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odi01
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https://www.finnewsnetwork.com.au/archives/...work263896.html
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odi01
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https://www.asx.com.au/asx/statistics/displ...;idsId=02144031
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odi01
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https://www.sciencedirect.com/science/artic...305417918308830
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odi01
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https://www.fool.com.au/2019/09/04/why-brav...ed-lower-today/
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odi01
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https://hotcopper.com.au/threads/par-v-cuv....ost_id=40282980
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odi01
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https://www.livewiremarkets.com/wires/a-loo...ed-to-tailwinds
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https://onlinelibrary.wiley.com/doi/full/10.1111/pcmr.12802
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https://www.instagram.com/p/B1tEogChL5t/
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https://kalkinemedia.com/2019/08/28/clinuve...-revenue-up-22/
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odi01
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https://westfaironline.com/115630/bridgepor...r-burn-victims/
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https://www.asx.com.au/asx/statistics/displ...;idsId=02137474
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https://abc6onyourside.com/news/local/spray...-wound-patients
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https://www.sciencedirect.com/science/artic...305417918308830
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odi01
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https://journals.sagepub.com/doi/full/10.11...399202619865167
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odi01
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https://www.fool.com.au/2019/08/07/is-the-c...n-the-buy-zone/
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odi01
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https://spotonohio.com/central-ohio/631204/...ner-center.html
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odi01
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https://backend.otcmarkets.com/otcapi/compa...r/report/AVMXY/
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odi01
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https://seekingalpha.com/article/4279341-ho...neration-device
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odi01
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https://www.avitamedical.com/uploads/pdf/AV...019-Final32.pdf
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odi01
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https://www.gesundheitsstadt-berlin.de/wenn...rankheit-13366/

The active ingredient is administered in the form of a small capsule which is placed under the skin and dissolves there for two months. "This treatment must be carried out every two months, preferably throughout the year," describes Stephan Grabbe
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odi01
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https://www.ctpost.com/local/article/Bridge...ts-14188634.php
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odi01
Posted on: Jul 24 2019, 07:11 PM


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Und dann
endlich, nach all der Leidenszeit,
bekam sie eine Therapie, die wirk-
lich half. Ein riesiges Glück, denn
derzeit können längst nicht alle
Betroffenen behandelt werden.
„Am 26. Juni 2017, das weiß ich
noch genau, bekam ich das erste
Scenesse-Implantat“, erzählt sie.
Und das Medikament wirkte. Doch
die Angst vor den Schmerzen blieb
– erst mal. „Ich habe mich ein Jahr
kaum in die Sonne getraut – jetzt
genieße ich es, dass ich, zumindest
stundenweise, ganz normal leben
kann – draußen, im Licht


And then
finally, after all this time of suffering,
she got therapy that worked.
helped. A gigantic luck, because
at the moment by no means all of the
to be treated.
"On June 26, 2017, I know that.
I was given the first
Scenesse implant," she says.
And the drug worked. But
the fear of pain remained
- for now. "I spent a year
hardly trusted in the sun - now
I enjoy that I, at least.
by the hour, just normal life
can - outside, in the light

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odi01
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http://www.epp-deutschland.de/mediapool/21..._30_1_.2019.pdf
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odi01
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https://au.finance.yahoo.com/news/why-costa...o2-z3aRAiUaYLc-
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odi01
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https://seekingalpha.com/article/4274537-eyes-biotech-m
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odi01
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https://www.greeleytribune.com/news/western...atment-options/
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odi01
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https://www.biotechdaily.com.au/
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odi01
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Very questionable, the FDA's decision

https://endpts.com/karyopharm-bags-an-upset...-of-objections/
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odi01
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https://au.finance.yahoo.com/news/10-best-s...o2-z3aRAiUaYLc-
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odi01
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https://smallcaps.com.au/avita-medical-publ...-recell-system/
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https://www.asx.com.au/asx/statistics/displ...;idsId=02119008
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odi01
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https://www.fool.com.au/2019/06/27/why-bubs...-value-in-2019/
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odi01
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https://kalkinemedia.com/2019/06/24/5-stock...ers-fy20-picks/

https://logmi.jp/business/articles/321338
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odi01
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https://gallery.mailchimp.com/73ce8c5905e2e...ks_for_FY20.pdf
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odi01
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https://thewest.com.au/business/markets/avi...-ng-b881232020z
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odi01
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http://www.aviseanalytics.com/scientific-b...-with-vitiligo/
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odi01
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https://seekingalpha.com/article/4270372-st...&app=1#alt1
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odi01
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https://freeshkreli.blogspot.com/2019/06/61...ml#comment-form
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odi01
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https://finance.yahoo.com/news/avita-medica...-023800060.html
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odi01
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https://www.asx.com.au/asx/statistics/displ...;idsId=02113142
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odi01
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http://www.epp-deutschland.de/mediapool/21...htkranke_1_.pdf

http://www.epp-deutschland.de/mediapool/21...rankheit_1_.pdf
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odi01
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From Hotcopper

Adoption Rate Continues to Grow
Less than 6 months into its launch in the United States, the commercialisation of
ReCell continues to gather momentum at a faster rate than we had anticipated. There
are now 98 hospitals in the US either ordering or in evaluation of the Recell kits. This
represents approximately 70% of the specialist burns units in the country. By the end
of the year we expect the vast majority of these will have ordered product.
The recent American Burns Association Conference featured ten presentations
sponsored by Avita including a summary of the health economics for hospitals using
ReCell compared to the standard of care (SOC). The paper confirmed significant
savings to hospital operators in the treatment of burns patients. The savings are
estimated at between 14% to 17% per patient (across all burn sizes), with savings
increased for more severe burns requiring longer stays in hospital. This data is
compelling for value analysis committees and more than justifies the US$7,500 list
price for the ReCell kit. The major savings come from reduced volume of surgical
procedures per patient, reduced length of stay and reduced rehabilitation costs.
Finally, the company’s clinical program is advancing. A recent interim analysis of
Recell use in a paediatric population was awarded ‘Best Of The Best Abstract’ at the
American Burns Association Conference. In the study of 107 burn injuries, 98%
achieved closure within 4 weeks of treatment. This data is likely to be included in the
data dossier to extend the label claim for Recell to include children. The company will
begin enrolling patients in additional paediatric studies later this year.
Upgrade to Buy, Valuation raised to $0.68
The commercialisation of Recell is progressing well in the US and consequently we
have upgraded our unit sales forecast for FY21. We have also extended our
discounted cash flow model to 9 years. Valuation in raised to $$0.68 from $0.38 and
we upgrade our recommendation to Buy Speculative (from Hold)


Each account represents an individual hospital rather than a health care system or group.
The company had previously signalled its intention to target Burn Centres, hence it is not
unreasonable to assume most of the target accounts will specialise in the treatment of
burns. Collectively there are 98 hospitals across all three categories representing 70% of
the 134 specialist burns centres in the US.
The vast majority of accounts in the ‘prospecting’ stage are expected to proceed to Value
Analysis Committee (VAC).
We note a total of 45 burn accounts (including 106 burn surgeons) have been trained
relative to the 28 active accounts (i.e. ordering product). The difference between the
number of accounts trained vs ordering is most likely because 17 of the hospitals that have
received training are at Value Analysis Committee – i.e. normally surgeons have to be
trained in the use of the product and gain experience with its use prior to proposing a new
device to the VAC.
The key take out being that interest in the use of the ReCell system continues to grow.
These statistics are supportive of expectations for future sales growth. For surgeons, the
key driver of use is the patient outcome. Early results from first commercial use continue
to reflect the experience of users in the compassionate use program which operated in the
US prior to product approval.
Avita Medical sold approximately 224 recell kits for the March quarter to approximately 20
accounts. Prior to the official launch (Jan 2019) approximately 100 units has been sold in
the December quarter.
It seems reasonably clear that interest continues to swell. We do not expect there is any
significant stockpiling by hospital users, hence we are optimistic that the volume of sales in
the June quarter should grow by at least 50% (i.e. ~330 unit sales in the June 2019
quarter).
The company has not provided revenue guidance.



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odi01
Posted on: May 30 2019, 11:16 PM


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http://www.unimedizin-mainz.de/presse/pres...erkrankung.html
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odi01
Posted on: May 30 2019, 11:08 PM


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An estimated 400 patients have been diagnosed in Germany, and the number of unreported cases is very high," said Grabbe. "Here in Mainz, we expect about 50 patients per year."
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odi01
Posted on: May 30 2019, 11:03 PM


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New treatment centre in Mainz

In the Haut- und Poliklink of the Universitätsmedizin Mainz, the treatment of patients with EPP will begin in the foreseeable future. Here is the press release:



Department of Dermatology of the University Medical Center Mainz offers help for rare skin diseases

A drug approved on the German market since 2017 promises help for "erythropoietic protoporphyria" - application only possible at specialized centers

(Mainz, 28 May 2019, rdr) The Department of Dermatology at the University Medical Center Mainz is one of the few centers in Germany to offer a new treatment option for adult patients suffering from a rare hereditary disease, erythropoietic protoporphyria (EPP). EPP is associated with a painful sensitivity to light and sun and represents a great burden and restriction of quality of life for those affected.

"People who suffer from EPP experience severe pain when exposed to sunlight. Often no visible changes of the skin occur", describes Univ.-Prof. Dr. Stephan Grabbe, Director of the Mainz Skin Clinic. "On the one hand, this makes the diagnosis very difficult and, on the other hand, can lead to the fact that the patients' complaints are sometimes not taken seriously by the environment". All in all, the patients' level of suffering is high and their quality of life very limited, as they often have to avoid any sunlight, especially in the summer months.

EPP is caused by a genetic defect that causes the production of the red blood pigment to malfunction. In healthy people, this is produced in a final stage by the incorporation of iron into a chemical precursor - the protoporphyrin that gives the disease its name. If not enough iron can be incorporated, protoporphyrin is present in much larger quantities than usual. It then accumulates in the red blood cells and is responsible for the light intolerance. The reason for this is an interaction with visible light in the violet to blue range, which damages the tissue through various reactions and thus causes severe pain.

Until now, the only possible "remedy" was to consistently avoid sunlight and wear appropriate clothing with dense fabric, long sleeves and trouser legs, headgear, gloves and additionally an umbrella - i.e. textile sun protection. "Conventional UV sun creams do not protect, since the UV portion of the sunlight is not the problem", describes Stephan Grabbe. But now there is new hope for adult EPP patients - in the form of a medicine approved only under conditions. Its active ingredient, afamelanotide, stimulates the immune system and a protein that tans the skin; it thus stimulates pigmentation and the increased formation of pigment provides protection from within.

The special: The responsible authorities have only granted a limited approval for the drug because the safety of the drug could not yet be conclusively assessed due to the rarity of the disease and the relatively small number of patients associated with it. Treatment is only permitted to a few specialised centres, which collect further study data in the course of application. These centres now also include the university

Hautklinik Mainz - as one of now four centres in Germany and the only one in Southern Germany.
"EPP is still not curable, but for the first time we have a drug on hand with which we can significantly alleviate the symptoms of the disease," says Stephan Grabbe. "This is an enormous benefit for the patients. The active ingredient is administered in the form of a small capsule that is placed under the skin and dissolves there for 2 months. "This treatment must be carried out every 2 months, preferably throughout the whole year," describes Stephan Grabbe. "It is estimated that 400 patients are diagnosed in Germany and that the number of unreported cases is very high," says Grabbe. "Here in Mainz, we therefore expect about 50 patients per year."

"Since there is not yet a treatment place for every adult patient, the start of treatment in Mainz represents an enormous opportunity for many patients to live a life with a better quality of life," comments the board of directors of Selbsthilfe EPP e.V. on this news.



Contact:
University Professor Dr. Stephan Grabbe
Director of the Department of Dermatology and Polyclinic, Universitätsmedizin Mainz,
Tel. 06131 / 17 4412, Fax 06131 / 17 6629, E-Mail:

stephan.grabbe@unimedizin-mainz.de

Press contact:
Dr. Renée Dillinger-Reiter, Corporate Communications Department, University Medicine Mainz,
Tel. 06131 / 17 7428, Fax 06131 / 17 3496, E-Mail: pr@unimedizin-mainz.de

About the University Medicine of the Johannes Gutenberg-University Mainz
The university medicine of the Johannes Gutenberg-University Mainz is the only medical institution of the Supramaxima
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odi01
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Subject: Treatment option for adult patients with "Erythropoietic Protoporphyria - EPP" with the only available drug "Scenesse" / active substance "Afamelanotide" as well as difficult to access or inadequate care.

Dear Ladies and Gentlemen
As the first board member of Selbsthilfe EPP e. V. and accredited patient representative in the G-BA, I would like to ask you today for information in order to understand and clarify how a long-term treatment option is available to every adult patient with EPP.
On the facts: EPP is a genetic metabolic disease. Since the beginning of 2017, the only drug with the active ingredient "afamelanotide" has been approved on the German market. The requirements of the EMA/ December 2016/ are: Treatment / administration of the drug is only possible in certified centres / in a dermatological outpatient clinic / combined with a register study.
There are 3 centres in Germany: Charité Berlin/ ca.30 patients, Klinikum Chemnitz/ 20 patients and Uniklinik Düsseldorf/60 patients.
We know that in Düsseldorf alone 30 patients are on the waiting list.
The problem of the treatment on the part of the patients does not only consist in the high costs and time expenditure for the trips to the centres - travel costs and possibly necessary overnight stays are usually not taken over by the KK, working patients have to take a holiday / free, certificates of incapacity for work are hardly issued - but above all in the fact that there are not enough places for the treatment, so that patients are still waiting for the treatment. In Düsseldorf alone, there are 30 patients on a waiting list that cannot be processed in the foreseeable future due to a lack of personnel resources. Also our experience in the exchange with the therapists lets us assume that a durable treatment is not secured. At the beginning of 2019, for example, the University Hospital had not allocated any treatment appointments for its patients for the first time, as further treatment depended on the decision of the Executive Board. After our intervention, the treatment was confirmed for 2019 and appointments were made. "The treatment does not pay off" - we hear this again and again! Clinics say that costs for the medication are loss-making because the manufacturer does not give a "pharmacy discount". And ... and ... and ......
So far we know by contact with the PU that despite numerous inquiries no other clinics have decided for the treatment.
Our questions to you:
Who is responsible/who ensures that patients have access to treatment?
Why can hospitals refuse treatment?
The "pharmacist discount" situation in the clinics: does this also apply to orphan drugs?
What is the financing requirement for a treatment and what role does the so-called flat rate per case play?
The described facts are very complex, the so far experienced "hurdles and obstacles" in the treatment are very extensive in order to list them - which I like to do - but with this letter I first look for the conversation with you.
In a conversation with your predecessor, Mr. Laumann, as well as the employees Mr. Kronauer and Mrs. Wittchen, we were able to discuss the following issues with you.
Yours sincerely, Elke Hauke/ 1st Board Self-help EPP

http://www.epp-deutschland.de/mediapool/21...0513_Brief.docx
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odi01
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https://www.google.com/url?sa=t&source=...A28r3Zs-QQKUJlx
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odi01
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https://technobleak.com/regenerative-artifi...ming-worldwide/
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odi01
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https://finance.yahoo.com/news/does-clinuve...-222005039.html
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odi01
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https://hotcopper.com.au/documentdownload?i...eFxke92GA%3D%3D
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odi01
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https://www.asx.com.au/asx/statistics/displ...;idsId=02107242
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odi01
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http://blackcranecap.com/avita-medical-par...n-regeneration/
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http://life.eastmoney.com/a/201905171126582145.html
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http://www.stockta.com/cgi-bin/analysis.pl...&mode=stock
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https://www.fool.com.au/2019/05/16/why-the-...6-higher-today/
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odi01
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https://www.asx.com.au/asx/statistics/displ...;idsId=02105271
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odi01
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https://medtech.pharmaintelligence.informa....Pediatric-Trial
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