BioHorizons of Henry Schein, Inc. (HSIC) reportedly accounts for 8-10% of the worlds global dental implant market. It just announced a 25 year deal with Australian listed bio-tech Orthocell (OCC.AX) in its dental application of its collagen scaffold technology, CelGro Bone (dental) aka Striate.
It is no surprise BioHorizons picked up the technology. Orthocell gained FDA 510K approval (and EMA and TGA) in CelGro Dental early in 2021 having passed the FDA's animal studies showing significant improvements to standard grafts in the market. Additionally the procedure allows for one less surgery than the traditional two stage approach and repairs tissue faster as reported in human studies at just over 4 months vs 8 months as standard.
BioHorizons of Henry Schein, Inc. (HSIC) noticeably put a number of clauses in the contract, effectively poison pills to discourage other suitors from any takeoever. The parent group may well be looking at the nerve application too. Orthocell forewent the 510K route with the FDA last year in its Nerve application of the same technology, Remplir, for a more lucrative regulatory route. This deal now explains that strategy, with sufficient funds to advance its CelGro Nerve application (Remplir) with the FDA (its already TGA approved as well) as recently highlighted on national Australian news:
It had already passed FDA pre-requisite studies for 510K approval in nerve, but recently announced 24 month data on a phase II human trial, that showed functional recovery of muscles controlled by the repaired nerve, improving to 85% (23 of 27) at 24 months post treatment and rather heart warmingly, in the quadriplegic patient cohort, functional recovery (MRC ≥3) of muscles controlled by the repaired nerve improving to 92% (11 of 12) at 24 months post-treatment. This data ofbviously cements perhaps a 'de novo' regulatory pathway with the FDA, given the higher novel proprietary advances made by the product, rather than a simple 510K route making it more attractive again to large US Pharma for further partnership in what it reports as a “global addressable market in peripheral nerve reconstruction is estimated to be worth more than US$7.5 billion per annum, with approximately 3,000,000 procedures that could use Remplir™ completed each year.”
The main other potential candidate would be Johnson and Johnson (JNJ). OCC is also overdue on announcing final data in its collaborative trial in its ATI (autologous tenocyte stem-cell injection) treatment with DePuy of Johnson and Johnson, which was guided for this quarter (suspect they will roll into July on that annoncement with this game changer). Initial data suggested:
” 95% of participants at 12 months post OrthoATI™ treatment reported a level of function of the treated shoulder consistent with a successful outcome after having received an average of 4 failed conservative treatments including physiotherapy and steroid injection.”
The company reported that “Ortho-ATI® could be applicable to >480,000 rotator cuff patients per year in the US alone, which equates to a market opportunity of approximately US$4-5 billion”. There are 4,000 tendons in the human body, with the product also having shown similar potential in achilles, gluteal, patellar and other tendons, with published medical studies in tennis elbow.
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