Orthocell Receives CE Mark for CelGro®
Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to announce receipt of European regulatory approval (CE Mark) for its CelGro® collagen medical device. CelGro®, for a range of dental bone and soft tissue regeneration procedures, can now be marketed and sold within the European Union (EU).
“European regulatory approval for CelGro® marks a major milestone for Orthocell as it enables commercial rollout in the lucrative dental bone and soft tissue regeneration market, where there is a significant and growing demand and market opportunity. This provides a strong foundation for Orthocell to progress additional dental regulatory applications in key markets, such as the US, Japan and Australia,” Orthocell Managing Director Paul Anderson said.
“The CE Mark also validates the potential of the entire technology platform by endorsing CelGro®’s clinical performance and quality manufacturing. In addition, the achievement of this CE Mark supports regulatory applications for additional indications.”
CE Mark approval for dental bone and soft tissue regeneration
Orthocell has received market authorisation (CE Mark) of CelGro® collagen scaffold medical device in the EU for dental bone and soft tissue applications. The CE Mark allows CelGro® to be sold within EU countries, validates CelGro®’s quality manufacturing and product performance, and provides a strong foundation for indication expansion and regulatory approvals.
Orthocell has a clear commercialisation strategy in place to drive initial sales of CelGro® and the Company is in discussion with strategic commercial partners for product distribution in Europe and other key regions. Orthocell is also currently in discussions with selected Key Opinion Leaders in the dental and bone regeneration fields, who play an important role in driving broader market adoption.
CelGro® is manufactured by Orthocell at its quality controlled Good Manufacturing Practices (GMP) licensed facility in WA, using the Company’s proprietary SMRTTM tissue engineering process, developed in conjunction with Professor Minghao Zheng and the University of Western Australia. CelGro® plays a critical role in dental bone and soft tissue regeneration therapy as it offers superior functionality over existing products for improved tissue repair.
Key Opinion Leader, Dr Brent Allan (oral & maxillofacial surgeon) commented, “CelGro® is an exciting new product with clear advantages over the available alternatives. I prefer to use CelGro® over existing scaffolds. It is easy to handle and enables a high quality tissue repair.”
CelGro®’s dental addressable market is estimated to be worth more than US$600 million per annum, with approximately 1.5m procedures that utilize these types of scaffolds being completed each year. Market growth is expected to be underpinned by an aging population, significant growing demand for dental therapies and the surgeons’ preference for quality and functional bio-absorbable membranes. With the CE Mark achieved, Orthocell is well positioned to capture a significant share of a large and growing market given CelGro® has demonstrated in clinical studies, superior bone regeneration.
Expanding CelGro® indications
Securing the CE Mark approval for the dental and soft tissue application of CelGro® is a critical milestone for Orthocell. The CE Mark regulatory approval further validates the CelGro® technology platform and can be leveraged across a range of additional applications including:
- neurological: peripheral nerve repair;
- orthopaedic: tendon, ligaments, cartilage and bone; and
- other: general surgery (including hernia repair) and urogynaelogical.
CelGro® is targeted to a variety of orthopedic, reconstructive and surgical applications. The company believes it represents a breakthrough in soft tissue reconstruction and offers significant global commercial potential in its existing addressable markets of bone, tendon, nerve and cartilage as well as much wider applications in general surgical and soft tissue reconstructive applications.
Paul Anderson, +61 8 9360 2888
Investor and Media enquiries
Ben Walsh, + 61 411 520 012
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Manchester United Shoots for Success with a “Digital Experience Platform” Powered by HCL16.8.2018 22:02 | Tiedote
Manchester United (NYSE:MANU) has today announced a major milestone on its digital transformation journey with HCL Technologies, with the successful launch of the Manchester United Official app powered by HCL’s digital experience platform. The launch is part of the ongoing digital transformation of the club to provide a real-time, engaging, personalized, and unified experience to Manchester United’s 659 million global followers, which supports the club’s strategy to become a Digital Sports Enterprise. At the heart of this transformation is the digital platform developed by HCL, providing the club with a single view of fans across web and app touchpoints, offering fans a one-stop shop for everything Manchester United. Manchester United’s Group Managing Director Richard Arnold comments: “This app will allow our 659 million Manchester United followers to easily connect to the club they love, wherever they are in the world. Fans will now have the opportunity to follow all Manchester United
4K 4Charity Fun Run Announces Open Registration for IBC201816.8.2018 20:41 | Tiedote
AWS Elemental, an Amazon Web Services (AWS) company, today announced that the fifth annual 4K 4Charity Fun Run at IBC Show will take place at 7:00 a.m. local time on Saturday, Sept. 15 at Amstelpark in Amsterdam. Registration is open at https://4k4charity.com/ibc. Among the non-profits supported by the 4K 4Charity Fun Run at IBC Show is Amsterdam-based StichtingNewTechKids, which provides computer science education for girls, minorities, and economically challenged youth in the Netherlands. The organization supports a computer science teacher training program for primary school teachers with proceeds from 4K 4Charity. Also supported is Iridescent, a global education non-profit that empowers underrepresented young people to become innovators and leaders through engineering and technology. Through their two programs, Curiosity Machine AI Family Challenge and Technovation, Iridescent introduces underserved communities to new technologies and empowers and equips them to apply those technol
2018 D.I.C.E. Cannes Announced Round 3 Speakers16.8.2018 17:01 | Tiedote
The Academy of Interactive Arts & Sciences’ D.I.C.E. Cannes event will take place 9-11 September 2018 at the Hotel Barrière Le Majestic Cannes in France. Leading video game executives will participate in the premier networking opportunities, listen to key speakers address the conference theme - Trailblazers - to tackle some of the industry’s biggest ideas and trends. Newly announced speakers include: Craig Duncan, Studio Head at Rare – Duncan will share his studio’s experience and learnings with “A Rare Voyage of Adventure.” Duncan will provide insight into Rare’s bold new IP Sea of Thieves, a game that has inspired friendships and players creating stories together. David Hubert, Animation and Cinematic Director at Eidos Montreal – In Hubert’s talk he will discuss how cinematics are redefining AAA story-driven games and how they will continue to shape the medium to push the envelope throughout the production process. Adam Orth – In a session titled “Digging for Fire: Virtual Reality 20
GN Hearing and Google Announce Partnership to Bring Direct Mobile Streaming from Android Devices to Hearing Aids16.8.2018 16:00 | Tiedote
GN Hearing and Google have today announced a new technology partnership that will make GN Hearing the first manufacturer to enable a full spectrum of direct audio streaming from Android devices to hearing aids. The expectations are that direct streaming will become available to hearing aid users of the recently launched hearing aids ReSound LiNX Quattro™ and Beltone Amaze™ in a future Android release. “According to the World Health Organization, around 466 million people worldwide have disabling hearing loss. This number is expected to increase to 900 million people by the year 2050. Google is working with GN Hearing to create a new open specification for hearing aid streaming support on future versions of Android devices,” states Seang Chau, Vice President of Engineering at Google. Users will be able to connect and monitor their hearing aids, so they can get the full advantages of their Android devices without using an intermediate device for streaming to their hearing aids. This will
Zurich Expands Global Use of Guidewire InsurancePlatform with Selection of Guidewire Cyence Risk Analytics16.8.2018 15:55 | Tiedote
Guidewire Software, Inc. (NYSE: GWRE), the provider of the industry platform Property and Casualty (P&C) insurers rely upon, today announced that Zurich Insurance Group (Zurich) has selected Guidewire Cyence™ Risk Analytics (Cyence) to leverage the cyber risk knowledge and insights the solution provides to help the company prospect, underwrite, and price risks. Zurich will roll out Cyence globally with an emphasis on enhanced analytics and intelligence for risk selection. Unprecedented technological advances of the 21st century have shifted the nature of risk across the P&C insurance industry. Ever-evolving cyber risks present unique challenges including limited availability of traditional actuarial data needed to model these risks. Cyence combines economic modeling, cybersecurity, machine learning and Internet scale data collection to help risk takers assess the financial impact of cyber risk. “After conducting a thorough search, we found that the capabilities of Guidewire Cyence Risk
Scientist.com Named One of America’s Ten Fastest-Growing Private Companies by Inc. Magazine16.8.2018 15:06 | Tiedote
Scientist.com, the world’s leading marketplace for outsourced scientific services, today announced that it ranked no. 9 on Inc. magazine’s 2018 list of the 5,000 fastest-growing, privately owned companies in America. Scientist.com ranked no. 2 nationally in the Health category and no. 2 in the state of California. The San Diego-based company builds private marketplaces that connect life science research organizations with a global network of over 2,600 contract research organizations (CROs) and providers of scientific services. “Our mission is to empower and connect scientists worldwide and make it possible to cure all human diseases by 2050,” stated Kevin Lustig, Scientist.com’s CEO and Founder. “On Scientist.com, a single, highly trained scientist can run an entire drug discovery program from concept to clinic from his or her laptop without ever physically entering a laboratory.” The pharmaceutical industry spends about $150B a year on medical research and produces about 25 new medic
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme