The frustration over market recognition is understandable, but this is another building block, Remplir being in a peer reviewed journal. Its a positive development. The CelGro technology has been twice TGA approved (Remplir & Striate) and once FDA approved (Striate). You have a global top 5 dental Pharma happily letting it frontline its 'Biologics' sales.
I am pleased the Prof' involved and its another acolade to his scientific reputation:
Orthocell Chief Scientific Officer, Professor Minghao Zheng, said: “This study validated Remplir’s unique mechanism of action mimicking the native structure of epineurium, providing a protective barrier and neurotrophic microenvironment for nerve regeneration. Remplir’s unique biological characteristics underpinned the consistent return of function to paralysed upper limbs, the primary goal in this study. We are delighted to see this compelling research now published in JRMO and look forward to working with surgeons to consistently return muscle function following Remplir nerve regeneration treatment.”
Slowly the market and field will get the importance of these results and this product. These are not simple nerve damage cases; a lost single finger function form a digital nerve cut with a knife perhaps in the kitchen; drop foot from a nicked Peroneal nerve in a surgery. These are major repairs to a complicated and fundamental secondary branch of the nervous system:
"The purpose of the Remplir™ study was to evaluate the biological characteristics and clinical performance of Remplir in the reconstruction of upper-extremity peripheral nerve injuries. Nineteen patients aged between 18 and 50 years were recruited for the study. A total of 36 peripheral nerve reconstructions were performed using either nerve transfer or nerve grafting.
Patients in the clinical trial suffered traumatic nerve injuries following motor vehicle, sporting and/or work-related incidents, resulting in partial or total loss of use of their arms and, in more severe cases, their legs and torso as well (quadriplegia). Patients experienced significant pain and were unable to perform basic activities of daily living (i.e. eating, bathing, dressing and toileting), play sport and/or work. Without surgery they would not have regained normal use of their injured arm and hand."
This adds a strong sales point to medical professionals, seeing peer reviewed publication adding credibility for a more conservative demand chain, that cannot doubt the paradigm change this respresents.
And as said above, its twice now this company has been unusually forthright in a very swift move to sales:
"Top-line resultsfrom US FDA Remplir nerve repairstudy are expected in Q3 CY24, and Orthocell remains on schedule to submit its US 510(K) market
authorisation application in Q4 CY24 with progression into sales soon thereafter." 30/04/24
"The Study is expected to complete in Q3 CY24, the Company remains on track to submit its US 510(K) market
authorisation application in Q4 CY24 and progression into sales soon thereafter" 25/03/24
As said above, I reckon another Henry Schein/Bio Horizons style deal is on the table, perhaps even by them. And no wonder. Its pretty ground-breaking stuff. It just takes some time to translate academic success to commercial success:
https://www.uwa.edu.au/news/article/2022/may/innovative-nerve-repair-process-helping-to-restore-function-in-paralysis...but OCC management are clearly signalling to the market, as much as they can, that they quite confident of the speed of sales to follow FDA approval.
(mkts are just very, very poor at this end of the spectrum recognising future likely earning profiles, whilst they will forecast BHP's 2025 copper output down to the ounce!).
(20min delay)