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OCC, Orthocell Ltd
nipper
post Posted: Jan 14 2021, 03:06 PM
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Orthocell advised it has achieved 510(k) clearance from the United States Food and Drug Administration (FDA) to market and supply its CelGro device.

CelGro is a collagen scaffold that supports tissue reconstruction and repair, with a wide range of uses in orthopaedics, general, gynaecology and ENT surgeries. In the United States however, CelGro will be used for dental bone and tissue regenerations procedures. This includes dental bone repairs, growth around dental implants in extraction sockets, and tissue regeneration in intrabony defects.

The approved clearance will see Orthocell supply Striate+ for the United States dental market. Striate+, formerly branded as CelGro Dental, is manufactured in Australia, using the company's SMRT technology.

Following the milestone achievement, Orthocell will now seek negotiations with United States dental companies for marketing and distribution rights. Orthocell highlighted that after this recent success, it is confident of securing a distribution partner to bring the product to market.

Orthocell stated that CelGro can be further developed to service the peripheral nerve repair market. It is estimated that this sector alone is worth more than US$7.5 billion per annum, with 3 million potential CelGro procedures each year.

Orthocell managing director Mr Paul Anderson welcomed the positive outcome, saying:
QUOTE
US approval has come sooner than expected and is a significant inflection point for our Company. I am excited by this strategic milestone and the positive step it represents on our pathway to partnering Striate+ in dental GBR indications. I look forward to working with our leading dental surgeons to introduce the new global brand, Striate+, previously branded as CelGro Dental, and to make a meaningful impact in the US market.


up 25% to 58c




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"Every long-term security is nothing more than a claim on some expected future stream of cash that will be delivered into the hands of investors over time. For a given stream of expected future cash payments, the higher the price investors pay today for that stream of cash, the lower the long-term return they will achieve on their investment over time." - Dr John Hussman

"If I had even the slightest grasp upon my own faculties, I would not make essays, I would make decisions." ― Michel de Montaigne

Said 'Thanks' for this post: rlane  
 
nipper
post Posted: Dec 4 2019, 10:46 AM
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QUOTE
• Orthocell receives firm commitments for a A$13m Placement
• Demand for the Placement well in excess of funds sought with support from existing shareholders, new institutions and other sophisticated investors
• Share purchase plan for eligible shareholders for up to approximately A$5m
• Combined proceeds to be used to accelerate US, EU and AUS regulatory approvals and commercialisation of CelGro®; advance the commercialisation of Ortho-ATI® and scale up manufacturing facilities
50c a share .... which is where it is trading today



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"Every long-term security is nothing more than a claim on some expected future stream of cash that will be delivered into the hands of investors over time. For a given stream of expected future cash payments, the higher the price investors pay today for that stream of cash, the lower the long-term return they will achieve on their investment over time." - Dr John Hussman

"If I had even the slightest grasp upon my own faculties, I would not make essays, I would make decisions." ― Michel de Montaigne
 
nipper
post Posted: Dec 2 2019, 09:38 AM
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In Reply To: nipper's post @ Nov 30 2019, 08:47 PM

and here comes the Pause, setting up for the Capital Raise.



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"Every long-term security is nothing more than a claim on some expected future stream of cash that will be delivered into the hands of investors over time. For a given stream of expected future cash payments, the higher the price investors pay today for that stream of cash, the lower the long-term return they will achieve on their investment over time." - Dr John Hussman

"If I had even the slightest grasp upon my own faculties, I would not make essays, I would make decisions." ― Michel de Montaigne
 
nipper
post Posted: Nov 30 2019, 08:47 PM
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In Reply To: nipper's post @ Nov 30 2019, 08:11 PM

QUOTE
...rather than repairing skin related defects, the Company’s CelGro technology repairs soft tissue such as Anterior Curcial Ligament (ACL), rotator cuff and other tendon injuries.

More significant, in my view, is the application of CelGro to repair damaged nerves, particularly in the application of paralysed muscles. Think paraplegics and quadriplegics
.
still got the phase 3 and FDA pathway issues. Big market, though.



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"Every long-term security is nothing more than a claim on some expected future stream of cash that will be delivered into the hands of investors over time. For a given stream of expected future cash payments, the higher the price investors pay today for that stream of cash, the lower the long-term return they will achieve on their investment over time." - Dr John Hussman

"If I had even the slightest grasp upon my own faculties, I would not make essays, I would make decisions." ― Michel de Montaigne
 
nipper
post Posted: Nov 30 2019, 08:11 PM
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In Reply To: mullokintyre's post @ Nov 30 2019, 07:26 PM

That's what he's saying.

Though at 60c day traders are all over it. Would have been better with 100,000 at 20c



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"Every long-term security is nothing more than a claim on some expected future stream of cash that will be delivered into the hands of investors over time. For a given stream of expected future cash payments, the higher the price investors pay today for that stream of cash, the lower the long-term return they will achieve on their investment over time." - Dr John Hussman

"If I had even the slightest grasp upon my own faculties, I would not make essays, I would make decisions." ― Michel de Montaigne
 
mullokintyre
post Posted: Nov 30 2019, 07:26 PM
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In Reply To: nipper's post @ Nov 30 2019, 09:03 AM

One of those where ya buy 10,000 and put it in the bottom drawer for a few years/
Mick



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sent from my Olivetti Typewriter.
 


nipper
post Posted: Nov 30 2019, 09:03 AM
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Deserves its own thread
Orthocell – The Next Big Winner In The Regenerative Sector

https://www.sharecafe.com.au/2019/11/29/ort...erative-sector/



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"Every long-term security is nothing more than a claim on some expected future stream of cash that will be delivered into the hands of investors over time. For a given stream of expected future cash payments, the higher the price investors pay today for that stream of cash, the lower the long-term return they will achieve on their investment over time." - Dr John Hussman

"If I had even the slightest grasp upon my own faculties, I would not make essays, I would make decisions." ― Michel de Montaigne
 
 



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