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OCC - Orthocell Limited

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Orthocell is focused on developing treatments for a variety of tendon, cartilage and soft tissue injuries. Its treatments include Autologous Tenocyte Implantation (Ortho-ATI™), a world-first stem cell therapy that uses a patient’s own cells to repair damaged tendons and ligaments and CelGro™, a collagen-based scaffold which provides mechanical strength to facilitate tissue repair and healing in a variety of reconstructive surgical applications and is in late stage development.

http://www.orthocell.com.au
 
After reaching an all-time low recently of 10.5c, Orthocell Limited has experienced a reversal of fortunes today after announcing that that the first four patients have successfully completed participation in the CelGro® nerve regeneration clinical trial. Following surgery with CelGro®, patients have regained muscle function and/or sensation of affected limbs and have returned to work, sport and activities of daily living.

This is extremely significant news for the company as CelGro is proving itself as an alternative to costly microsurgery in the treatment of peripheral nerve injury. To put the potential market in perspective, in the US alone over 20 million people suffer from peripheral nerve injury as a result of motor vehicle, sporting or work-related incidents every year, at an annual cost of approximately US$150 billion.

The OCC share price has surged a massive 160.87% to 30c today, reaching an intraday high of 34c on volume of around 20 million shares. This is the highest daily volume in the company's history.

Looking at a 12 month chart, 30c appears to be an area of resistance, so it will be interesting to see if OCC can get and consolidate above this level.

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This is one of the reasons why I generally (not never) shy away from Biotech and even speculative pharma. share price can be a real roller coaster ! On a day like today an existing shareholder may feel euphoric but on another day when a trial fails the rug will be pulled from underneath them :blackeye:

I have no problem investing in established biotech (such as CSL) and established big pharma (such as API). Although nothing is certain in investing, generally speaking these type of companies have lower volatility and easier to manage in a portfolio.
 
....and the article, so much excitement over four patients in a clinical trial.

Orthocell unveils first clinical trial results for nerve regeneration platform CelGro

Regenerative medicine company Orthocell (ASX: OCC) has provided the first batch of evidence supporting the efficacy of its CelGro nerve regeneration platform.


The company published results of the first four patients to complete the clinical trial using CelGro, with patients experiencing an 83% improvement in muscle power.


The trial is ongoing and undertaken in association with leading West Australian orthopaedic nerve specialist, Dr Alex O’Beirne of St John of God Subiaco Hospital and Professor Ming Hao Zheng of the University of Western Australia.


Orthocell said it conducted the trial to demonstrate the effectiveness of CelGro and confirm that the platform can be used to guide and promote “tensionless nerve regeneration in damaged peripheral nerves of the hand and upper limb”.


If successfully proven, Orthocell plans to market its CelGro platform in Europe and other major markets globally. In the US, alone, over 20 million people suffer from peripheral nerve injury as a result of acute muscle injuries every year, at an annual cost of approximately US$150 billion (A$213 billion).More...
 
For me, this announcement marks a real breakthrough, or the makings of one. I fully expect a RCT would show its effectiveness, and I never say that about any biotech stock (most biotech anns are drivel). It wouldn't surprise me if it went hard again tommorow, it's that good...IMO.
 
Orthocell up another 45.2% to 61c today, finishing the day just half a cent off its high of 61.5c.

No news today, just continued positive sentiment driving it higher.
 
greggles said:
Orthocell up another 45.2% to 61c today, finishing the day just half a cent off its high of 61.5c.

No news today, just continued positive sentiment driving it higher.
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Sentiment has remained very high even with the CR and the inevitable come down following the May euphoria. Might be ready for another run.
 
OCC is getting some validation in the regenerative medicine / cell repair area of biotechnology which has a lot of future potential in my opinion, with the encouraging news out today:

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For some reason, I put OCC in my 2020 stock tip as one of four (likely the fourth?). Am trying to work out why.

Like most biotechs, it's tricky. Many hold a dance card, but few get up to dance, and even fewer get noticed. The field: novel collagen medical devices and cellular therapies for the repair and regeneration of human tendons, bone, nerve and cartilage defects; is large, for sporting and especially degeneration associated with ageing and side-effects of other interventions.

Likely events in 2020:
... CelGro Dental : Q1, Australian market authorisation; Q2; USA market authorisation. They use cow bone now, not too much of a leap? EU (CE mark) already achieved
... CelGro Tendon and Nerve : Q1 Nerve repair clinical data
... OrthoATI - looks to be slipping? Research underway with J&J (clinical study versus corticosteroid injections), possible commercialisation

(Neuropathic degeneration/ repair looms large in my view; it is one of the really pressing issues)
 
Dona Ferentes said:
For some reason, I put OCC in my 2020 stock tip as one of four (likely the fourth?). Am trying to work out why.
The field: novel collagen medical devices and cellular therapies for the repair and regeneration of human tendons, bone, nerve and cartilage defects; is large, for sporting and especially degeneration associated with ageing and side-effects of other interventions.
(Neuropathic degeneration/ repair looms large in my view; it is one of the really pressing issues)
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The observations are in; but is OCC the critical factor in success?

• 87.5% respondents satisfied with treatment outcomes in Orthocell’s annual quality study using Ortho-ATI® cell therapy for treatment of chronic tendon injuries in the shoulder
• 74.3% patient satisfaction in all patient groups including, elbow, hip, knee and ankle
• Strong correlation to clinical study outcomes published in leading scientific journals, including the American Journal of Sports Medicine
 
Positive results in CelGro® nerve repair study
● New clinical data 24-months after treatment shows nerve repair with CelGro® resulted in long term, predictable and consistent restoration of arm and hand function
● All quadriplegic patients regained voluntary movement of impaired or paralysed upper limbs within 12 months
● Patient enrolment is now complete involving repair of 35 nerves (19 patients)
● Progressing regulatory program in the US

( one of my 2020 tips; don't hold )
 
CelGro® receives Australian market approval
● Orthocell receives Australian market approval to supply CelGro® in dental bone and tissue regeneration procedures
● Validates the CelGro® platform technology and positions Orthocell to achieve further approvals in nerve and tendon repair
● Potential for Australian reimbursement by Q2 CY2021 which will assist with further technical and market validation for CelGro®
● Positions Orthocell well for US FDA approval targeted for CY2021

- hasn't woken it up
 
Dona Ferentes said:
CelGro® receives Australian market approval
● Positions Orthocell well for US FDA approval targeted for CY2021

- hasn't woken it up
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but this did.
Orthocell advised it has achieved 510(k) clearance from the United States Food and Drug Administration (FDA) to market and supply its CelGro device.
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MD Paul Anderson welcomed the positive outcome, saying:
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.
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Dona Ferentes said:
ditto. ... and I lost interest.
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and a long time between drinks. OCC has been exploring the depths, from 60c a year ago it had halved, then last week a jump from 30c to 45c (now 41c) on news of signing a 25-year exclusive patent and trademark license deal with BioHorizons for the manufacture of Striate+.

Under the deal, US-based BioHorizons has agreed to pay Orthocell $23.1 million in return for the granting of an exclusive licence of intellectual property (IP) for Striate+. The licence relates to the Striate+ products for dental and oral-maxillofacial procedures.’

Specifically, Orthocell will grant BioHorizons an exclusive licence of two patent families covering a collagen scaffold for cell growth, and a method for producing a collagen membrane. This will incorporate all associated patent applications, improvements and know-how, as well as the Striate+ trademark.
 
Company has been stagnant in the .40 cent to .50 cent range for a few years. This is due to change soon.

OCC have over $20 million in the bank ( from a licence agreement) and their Striate+ dental membrane is now selling in America through BioHorizon who have it as the front product on their web page.

Their second product REMPLIR, a nerve repair membrane, is now being used by 90 orthopedic surgeons in Australia and the Company is working on a late 2024/early 2025 FDA approval in America.
 
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