Ann: Trading Halt, page-52

Some interesting comments. Safe to say all have been frustrated with the pace of commercial progression and nice to see some objective talk beyond a falling share price and dissatisfaction therein, instead delving into potential revenues.

Whilst certainly in the past guilty of failing to meet their own timelines, the company has kicked regulatory goals, with TGA, EMA and FDA approval in Striate and TGA approval in Remplir. At last we are about to get some tangible commercial progression beyond the executive teams promises, with a global exclusive license and manufacturing agreement for its Striate.

Might be a good idea to revisit the original success of Striate over its rivals and remember Striate was granted FDA approval well ahead of expected schedule:

"The [FDA 510K] Study outcomes reinforce previous dental implant clinical study results indicating that CelGro® results in rapid mature bone formation around dental implants. All patients successfully generated enough new bone to stabilise their implants and complete their treatment in an average of approximately four months – this is almost half the time of the usual two-stage (eight month) dental implant treatment."

"Summary results of the study:
• CelGro® resulted in almost 60% more bone growth following dental implant treatment compared
to bone growth without a collagen membrane (Figure 1);
• CelGro® was biocompatible with no evidence of adverse tissue reactions;
• CelGro® was completely resorbed by week 12; and
• CelGro® performance in facilitating bone regeneration supports substantial equivalence evaluation, a component of the US 510(k) regulatory application."

That was reinforcing the earlier human trials that showed CelGro Bone (Striate) far more efficient in bone regeneration times in human trials:



The cream always rises to the top eventually, and this is going to be a very attractive improvement for both Dental Physicians, patients and insurance companies alike.

"[Traditional] GBR is performed with dental implant treatment when there is not enough bone to securely anchor and stabilise implants in the jaw. The traditional two-stage procedure involves an initial surgery to place the implant into the jaw. A second surgery, approximately six months later to allow bone regeneration to occur, is required to place the implant abutment connecting the implant to the prosthetic tooth. The procedure is completed four-to-six weeks later when the prosthetic tooth is installed. Single-stage procedures are shorter and avoid a second surgery and anaesthetic, by placing the implant and abutment in the jaw at the same time. The prosthetic tooth is placed four-to-six months later once there is sufficient bone to stabilise the implant"