days like today

Days like today can call into question ones judgement, so I went to the notes from the Annual Report for support!! This is what was said about the "Novosorb" dressing (see pages 15 & 16)

Wound analysis:
NovoSorb™ dressings were found to display characteristics that could potentially solve several serious
complications highlighted by the FDA notices on topical negative pressure dressings and reduce the overall cost
of treatment. These factors can be used as major commercial arguments favoring the use of NovoSorb™
dressings over the alternatives.
? Dressing removal
‘Difficult’ dressing removals were only ever reported where GranuFoam™ was the interface device in
ischial (a sore with a large cavity and small skin wound at surface, often caused by extensive sitting)
wounds. Of 50 dressing changes in ischial wounds treated with GranuFoam™, ‘difficult’ foam removals
were recorded in 40 (80%) of cases. All NovoSorb™ dressing changes, in all wound types, were
reported to be ‘easy’ in 72/72 (100%) of cases.
? Foam dressing fragmentation/ retention
The NovoSorbTM foam had lower levels of foam dressing fragmentation and retention when compared
to GranuFoamTM. Overall 28.4% of GranuFoamTM treatments reported foam fragmentation, compared
to 19.4% of NovoSorbTM treatments. In ischial treatments, GranuFoamTM fragmentation was reported in
42% of cases as compared with 31% of NovoSorbTM treatments.
Foam fragmentation/retention is a major cause of infection as per the FDA notices. Less fragmentation and less
retention equates to less infection.
Retention of material was recorded in five patients, all with ischial sores - four with GranuFoam™, one with
NovoSorb™. In the case of NovoSorb™, the retained foam was successfully washed out of the cavity with
saline with no subsequent infection. The four patients with GranuFoam™ retention represented five episodes
(one patient had two episodes of retention in the trial period). With this GranuFoam™ retention - sharp
debridement and removal with scissors was required on four occasions in the following few days leading to
infection in three patients.
Regulatory Strategy
PolyNovo will file a 510(k) application, during Q3 2013, seeking FDA clearance of the NovoSorb™ dressing in
the US. A 510(k) application is a pre-market submission made to the FDA to demonstrate that a device to be
marketed is as safe and as effective as an existing predicate device being sold in the US. In 98% of cases,
devices seeking 510(k) clearance are approved for sale within 150 days of submission. A device that receives a
510(k) clearance can be marketed in the US.
Commercialisation

As for the 510k for BTM in full thickness surgical wounds, CZD/Polynovo have sought help with this 510k and could probably help in terms of partnering this application for BTM.

PolyNovo has engaged the Emergo Group, a global regulatory consulting firm for medical devices, to define the
regulatory and reimbursement strategies in Europe and the US for the BTM technology. The intention is to lodge
a 510(k) application in Q4 calendar 2013 with the US FDA for the BTM device in surgical wounds. A 510(k)
application is a pre-market submission made to the FDA to demonstrate that a device to be marketed is as safe
and as effective as an existing predicate device being sold in the USA. The BTM full thickness burn device may
require a pre-market approval (PMA) which will require a larger multi centre clinical trial. As such PMA approval
is unlikely to be achieved prior to the end of calendar 2015.

I feel better now and today was a buying opportunity!