AVITA MEDICAL Patentrecht auf *ReCell* + *Funhale*

18.08.2009
AVITA Medical ist an der Börse notiert. Das weltweite Medizintechnik-Unternehmen, ist im Handel am Australien Stock Exchange (ASX: AVH) notiert. Auch in Frankfurt und Berlin sind Sie Notiert unter WKN: A0Q40S / ISIN: AU0000000AVH4

Das Unternehmen entwickelt und vertreibt hoch innovative Produkte in der regenerativen Medizin und der Atemwege. Das Unternehmen bieten revolutionäre Lösungen Nutzung der eigenen Haut des Patienten und die regenerativen Fähigkeiten des menschlichen Körpers zur Behandlung einer breiten Palette von Wundenheilung. Narben und Schalenfehler usw.

*** ReCell ® ist patentiert mit CE-Kennzeichnung für die EU und TGA in Australien Zugelassen ***
ReCell ® ist eine Stand-alone, rasche Ernte Zelle Gerät ermöglicht es, dass die Chirurgen zur Behandlung Schalenfehler mit patienteneigenen Zellen.  Der Chirurg kann, eine kleine Menge von Zellen innerhalb von 30 Minuten vor Ort, anstelle der aktuellen Technik der Hauttransplantationen oder die Forderung nach einer Biopsie zum Labor für die Kultur.  ReCell ® wurde für den Einsatz in einer Vielzahl von Verbrennungen, Plastische, Rekonstruktive und Ästhetische procedures.ReCell ® ist die Akzeptanz in einer Reihe von Angaben einschließlich Vitiligo, eine gemeinsame Hautpigmentierung Krankheit.

*** Die Funhaler ® hat die  Patentierung und CE-Kennzeichnung für die EU, FDA frei für die USA und TGA in Australien. ***

Darüber hinaus ist die Technologie in der Medizin zur Verbesserung von Medikamenten und deren Einhaltung bei Patienten mit chronischen Erkrankungen der Atemwege viel versprächen.  Das Unternehmen produziert und vertreibt eine Reihe von Abstandhaltern für die Kinder, Jugendlichen und Erwachsenen und ist der führende Anbieter von Abstandshaltern in Australien.  Die wichtigsten Produkte sind die Atemwege Funhaler ® Anreiz Asthma spacer speziell für die pädiatrische Markt.  Die Einbeziehung  von Funhaler auditive und visuelle Anreize zur Förderung der Kinder, um mit ihren Medikamenten und ist auch klinisch nachgewiesen, zur Verbesserung der Einhaltung der vorgeschriebenen Medikamente und die richtige Inhalationstechnik.  

*** Für die Zukunft steht für AVITA MEDICAL nichts im Wege. Nur wurde bis zum Heutigen Tag wenig Aufmerksam gezeigt. Ich muss zugeben, es ist nicht einfach Informationen zu bekommen. Die Forum`s sind leer. Aber das wird sich bestimmt jetzt bald ändern. Da jetzt die Zulassungen und Patentrechte gegeben sind, ist freie Fahrt nach Norden.

http://business.smh.com.au/business/...gulatory-ok-20090817-en23.html

Für neue News und Info bin ich in diesem Forum dankbar.
Orakel-Aktija  

http://www.finanznachrichten.de/nachrichten-aktien/avita-medical.asp  

http://www.minenportal.de/...ch-strategisches-Investment-in-Hong-Kong

AVITA MEDICAL LTD / AU000000AVH4  mit 3,5% Gewichtung im Portfolio neu dazu gekommen

https://www.wikifolio.com/de/de/w/wfmedical3

http://www.ariva.de/depot/private/positions.m?depot_id=855279

http://www.ariva.de/zertifikate/LS9L4T
 

Zitat:"AVITA Medical (ASX: AVH, OTCQX: AVMXY), a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications, today announced an institutional placement of A$16.0 million to prepare for the planned U.S. launch of the RECELL® Device in the treatment of severe burns.....Avita has received commitments from international and Australian institutional and sophisticated investors for a placement of A$16.0 million at an issue price of A$0.050 per share, with the placement to occur in two tranches. Tranche 1 of the institutional placement, totaling A$12.77 million, is expected to settle on 12 June 2018. Settlement of Tranche 2 totaling A$3.25 million is subject to shareholder approval at an Extraordinary General Meeting to be held in July 2018....." ENDE Zitat
Source:https://finance.yahoo.com/news/...titutional-placement-055800760.html  

Zitat:"AVITA Medical ......announced today that results from a pivotal clinical trial demonstrating the effectiveness and clinical benefits of the RECELL® Autologous Cell Harvesting Device in the treatment of deep partial-thickness (second-degree) burns were published for the first time in a major peer-reviewed journal, the Journal of Burn Care & Research..... " ENDE Zitat
Quelle:https://www.otcmarkets.com/stock/AVMXY/news/...re--Research?id=196416  

ein Leben bereits im Dienste der Forschung...

Wood worked at a major British hospital before marrying Western Australian,.... She completed her training in plastic surgery between having four more children....

In October 2002, Wood was propelled into the media spotlight when the largest proportion of survivors from the 2002 Bali bombings arrived at Royal Perth Hospital. ...

She led a team working to save 28 patients suffering from between 2 and 92 per cent body burns, deadly infections and delayed shock.

She was named a Member of the Order of Australia (AM) in 2003. She was named Australian of the Year for 2005 by Australian Prime Minister John Howard at a ceremony in Canberra to mark Australia Day.

In March 2007, following the crash landing of Garuda Indonesia Flight 200, Wood travelled to Yogyakarta, to assist in the emergency medical response for burn victims...

She is an Australian Living Treasure. In 2005, Wood won the Western Australia Citizen of the Year award for her contribution to Medicine in the field of burns research.

https://en.wikipedia.org/wiki/Fiona_Wood  

..aus 2016 !  ( schade,... geriet diese IMO interessante Info irgendwie in Vergessenheit...)

Zitat:"NORTHRIDGE, CA and CAMBRIDGE, UNITED KINGDOM--(Marketwired - Feb 5, 2016) -  Avita Medical Limited (ASX: AVH), (OTCQX: AVMXY), a regenerative medicine company specializing in the treatment of wounds and skin defects, has completed the sale of its respiratory business to Medical Developments International Limited (ASX: MVP) for $2.47m.....The strategic divestment of the respiratory business will allow Avita to concentrate exclusively on its core business of regenerative medicine and wound care................Avita Medical's respiratory business included two products, Breath-A-Tech® and Funhaler®, which are both asthma spacers aimed at optimizing the use of medicinal puffers. The products are marketed in pharmacies throughout Australia.
The transaction was comprised of $2.029m cash, plus 117,894 new MVP shares escrowed for 6 months valued at $0.44m at the time of closing.......the sale represents the second input of non-dilutive capital Avita has received in recent months, following last September's conclusion of a deal worth up to USD $54.9m from the US federal disaster preparedness agency BARDA. ...."With the sale of the respiratory business, we now have complete focus on our most valuable asset -- our ReCell® autologous cell harvesting technology," said Avita Medical's CEO, Adam Kelliher. "The sale proceeds will enable us to focus on our core commercialisation and clinical goals, such as completing our ReCell® FDA approval trial, currently underway in the US."...  " ENDE Zitat
Quelle:http://www.marketwired.com/press-release/...-247m-asx-avh-2094291.htm  

Zitat:"AVITA Medical......today announced that it has entered into an agreement to acquire a manufacturing facility to support the planned U.S. launch of the RECELL® Autologous Cell Harvesting Device in the treatment of burns. The facility is currently operated by a Fortune 500 contract manufacturer that assembles the RECELL Device for AVITA Medical. AVITA Medical will take over operations of the 2,200 square meter (23,000 square foot) manufacturing plant, located in Ventura, California, effective July 1, 2018.......acquisition of the manufacturing facility is to occur with Avita Medical taking an exclusive lease of the relevant facilities. Avita Medical will not own the facilities, rather Avita Medical will pay a commercial rent for the exclusive right under the lease for those facilities. The initial lease term is for 39 months with options for 3 additional 3-year terms at prevailing standard market rates...." ENDE Zitat
Quelle:https://www.otcmarkets.com/stock/AVMXF/news/...ing-Facility?id=196796
 

Zita:" AVITA Medical announced today that results from two
U.S. pivotal clinical trials  and the U.S. Compassionate U
se  program demonstrating the effectiveness and clinical benefits of the RECELL
® Autologous Cell Harvesting  Device were presented at
the  2nd Changhai Academic Week for Burns Treatment in Shanghai, China. T
he  results were presented by Jeffrey Carter, MD, FACS, Medical Director & Associate Professor of Surgery at  University Medical Center Burn Center & Louisiana State University School of Medicine, New Orleans, LA. "As Burn Surgeons we cannot cho
ose our patie nts? severity of injury, age, nor any combination of other
injuries or illness that complicate their course of care, said Dr. Carter. ?Thanks to the RECELL device, we can choose to minimize the burden of patient donor sites, and offer a treatment that prov
ides repigmented wounds capable of becoming subtle scars to the most discerning eye."
Key highlights of Dr. Carter?s presentation included:
?
The pivotal, controlled clinical trial of the RECELL Device in the treatment of second-
degree burns
demonstrated
statistically significant reduction i
n donor skin requirements (97.5 percent
reduction)
and pain, increased patient satisfaction and im
proved donor scar outcomes.
?
The pivotal trial in third-
degree burns met its co
-primary endpoints and demonstrated statistically
significant reduction in donor skin requirements.
?
Results from  two patients enrolled under Compassionate Use with second
-degree facial burns showed excellent cosmetic outcomes.
The presentation at the Changhai Academic Week follows the commencement this year of a government funded clinical trial of RECELL for the treatment of burns in China. The clinical trial entitled ?Key Technique and Clinical Pathway for Burn Treatment? is a
controlled clinical trial in which  burn patients are  be ing randomized
for treat ment with either standard of care, the RECELL Device,
or one of two other treatments.  
Also in 2018
,  the Company collaborated with the Plastic Surgery Department of Peking Union
Medical
College Hospital (PUMCH), one of the most renowned hospitals in China, to establish a RECELL Device
training center based in Beijing. The training center is designed to standardize the
protocol for the use of  RECELL, train surgeons  in the use of t
he RECELL Device nationwide, and encourage the expansion of the use  of this innovative treatment to hospitals across China.  The first national training course encompassing the  treatment of vitiligo and scars with the RECELL Device was completed last month  at PUMCH.    
In the U.S., the  RECELL Device is an investigational medical device that is designed to enable medical
professionals to produce, at the point-/of  -care, a REGENERATIVE EPIDERMAL SUSPENSION? (RES
?)....." ENDE Zitat
Quelle:https://www.asx.com.au/asx/share-price-research/company/AVH
https://www.asx.com.au/asxpdf/20180627/pdf/43w2f72r1kckhg.pdf  

Zitat:"AVITA Medical Announces FDA Approval of the RECELL® System for the Treatment of Severe Burns in the U.S.Press Release | 09/20/2018  /September 20, 2018.....AVITA Medical....), a global regenerative medicine company, today announced that the U.S. Food and Drug Administration (FDA) approved the Companys Premarket Approval (PMA) application to market the RECELL® Autologous Cell Harvesting Device (RECELL® System) to treat severe thermal burns in patients 18 years and older. The RECELL System uses a small amount of a patients own skin to prepare Spray-On Skin Cells at the point of care in as little as 30 minutes, providing a new way to treat thermal burns. The two randomized, controlled clinical trials supporting the FDA approval demonstrated that treatment of acute burn wounds with the RECELL System required substantially less donor skin than required with conventional split-thickness autografts to achieve closure of burn wounds...." ENDE Zitat
Quelle/n:https://www.otcmarkets.com/stock/AVMXF/news/...ns-in-the-US?id=204452
https://backend.otcmarkets.com/otcapi/company/dns/...nt/32921/content  

Zitat:"AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative medicine company, today announced that it has received a Research and Development Tax Incentive cash rebate from the Australian Tax Office in the amount of A$1.0 million for the year ending 30 June 2017. The R&D Tax Credit incentive program provides a cash rebate to support companies in Australia in undertaking research and development projects. Qualifying projects undertaken by AVITA Medical qualifying for the rebate included the development of its RECELL® Autologous Cell Harvesting Device (RECELL® System), which was approved by the U.S. Food and Drug Administration (FDA) last week to treat severe thermal burns in the U.S..... " ENDE Zitat
Quelle:https://www.otcmarkets.com/stock/AVMXY/news/...t-Tax-Credit?id=204940  

Zitat:" AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative medicine company, today announced that it has received the first commercial sales orders from U.S. burn centers for the RECELL® Autologous Cell Harvesting Device (RECELL® System) and has commenced commercial shipment of the product. ......Erin Liberto, Chief Commercial Officer. ?Our immediate commercial focus is completing the recruitment and training of our U.S. field force. However, we are in a unique position as many large burn centers already have substantial experience using our product through our clinical trials and Compassionate Use and Continued Access Programs. Moreover, some burn centers have indicated their desire to adopt the RECELL System in advance of our national market launch. In general, we expect most burn centers will adhere to the standard process for novel devices of initially evaluating the product and thereafter advancing it through their Hospital?s Value Analysis Committee prior to purchasing for regular use. This process can sometimes be a lengthy one and may take 6 months or more to complete. That said, we are excited to see some of the larger burn centers accelerate this process and commence incorporating the RECELL System into their practice.?..Of the 134 burns centers in the U.S., 24 already have experience using the RECELL System through participation in clinical trials and the Compassionate Use and Continued Access programs. Notably, these 24 burn centers are estimated to treat over 30 percent of the U.S. burn patients annually...." ENDE Zitat
Quelle: https://www.stockwatch.com/News/...1017&symbol=AVMXY&region=U  

Nach jahrelanger Entwicklung und der Zulassung im September 2018 ist RECELL System seit Anfang Januar auf dem US-Markt.

Die Nachfrage ist groß - so auch der Kursanstieg.

https://www.avitamedical.com/uploads/pdf/...Launch-8-January-2019.pdf  

U.S. Verkäufe:
2018      2017
1.102    -

International:
2018     2017
711       608

Gesamteinnahmen:
2018     2017
6.822   4.465

Die Kosten für operative Aufgaben haben sich verdoppelt.

https://www.avitamedical.com/uploads/pdf/...2018-28-February-2019.pdf  

Avita Medical gibt am 04.03.19 bekannt, dass es mit Cosmotec, einer japanischen Firma der M3-Gruppe zusammenarbeit, um sein Produkt in Japan zu vermarkten.

In Japan gibt es jährlich 6.000 Patienten, deren Verbrennungen in Krankenhäusern behandelt werden.

M3 MK:      5,4 Mrd $    
M3 Kurs:   16,7 $

https://www.avitamedical.com/uploads/pdf/...boration-4-March-2019.pdf  

03/13/2019
March 13, 2019

https://backend.otcmarkets.com/otcapi/company/dns/...nt/35394/content  

Quelle:https://backend.otcmarkets.com/otcapi/company/dns/...nt/35394/content  

sieht doch gut aus.
Die Presentation hat mich beeindruckt.

 

Ja, so kann es meiner Meinung nach ruhig noch ein bisschen weiter gehen  

durch unverbindliche Vormerkungen, um Zulassungsverfahren und Zulassung zum Handel beantragen zu können,...  Besten Dank !

https://www.wikifolio.com/de/de/p/medical
https://www.wikifolio.com/de/de/w/wf000tier1
https://www.wikifolio.com/de/de/w/wf0mbrella
 

Nach einer Studie wurden 98 % der Verbrennungen bei pädiatrischen Patienten, die mit Spray-On-Hautzellen in Kombination mit Transplantaten behandelt wurden, innerhalb von vier Wochen der Behandlung geheilt.

https://www.avitamedical.com/uploads/pdf/...erm-Data-8-April-2019.pdf  

https://www.otcmarkets.com/stock/AVMXY/news/...mpany-Update?id=226299  

Hallo. Hat irgendwie jemand eine Idee oder Wunschgedanken wie sich der Kurs in den nächsten 12 bis 24 Monaten entwickeln könnte?  

etwas passiert das wir heute so abgehen?