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If this board had a "like button" for posts I would have mashed it for that one DL. In the US, "We have to get over the counter", in the UK we have over the counter "We must get off the counter". In the end nobody knows we exist, closing in on 2 years approved in the US for good indications and zip in sales. I love Andy's tenacity getting us cleared while the FDA screwed the pooch, but we should have been able to turn knee clearance alone into profit. We should already be the go to tx for knee pain, that is the kind of thing loans and dilution are supposed to buy.
You're right, it was definitely a traditional 510k.
From Sree
Thank you for your message. The 510(k) that was filed does combine indications from the previous 510(k), which is why we are asking for "expanded" indications. The word "traditional" in the 510(k) is just to indicate the type of application prepared, as there are only three types. Seeking expanded indications automatically requires a "traditional" 510(k), since the other two types are for device modifications etc.
A wound care company from the UK
About Protex
A Brief History of the Company
Protex Healthcare was incorporated in the United Kingdom in 1999 with the aim of developing Vacutex™, our unique capillary action wound dressing.
Our main product, Vacutex™, has been carefully developed and protected as part of a wider portfolio of wound management products over the past 15 years, and is now an internationally recognised solution for advanced wound care. The product was developed for patients with difficult to heal wounds, and is to be used by wound care specialist practitioners.
Following a three-year development period up to 2002, which included a large multi-centred random clinical trial and an independent audit, Vacutex™ was immediately accepted into the UK NHS reimbursement regime under a newly created separate reimbursement category. Market research amongst nurses inside and outside UK has shown in 2012-2014 that there was a growing need for a product like Vacutex, in the field of chronic and difficult to heal wounds. This still reflects its innovative and unique stature as a leading global wound management solution.
Since January 2015 and due to a change in ownership, Protex Healthcare has restarted its development and manufacturing processes, in particular in the field of difficult to heal wounds.
Mission and Vision
Protex Healthcare aims to further develop, manufacture and market a restricted range of highly specialised advanced wound care products for use in growing and specialised niche markets all over the world. The products are all developed in cooperation with nurses in their everyday practise, and are backed up with significant educational support towards our users (specialised wound care nurses and other wound care professionals in both hospitals as well as home care settings).
All our products aim to improve the quality and speed of wound healing and as well as the quality of life of our patients, in the meantime reducing both total nursing time and total care costs for patients, hospitals and governments.
Some of our major areas of focus are the treatment of difficult to heal wounds, such as DFU, VLU, pressure sores and dehisced wounds as well as several kinds of ulcers.
http://protexhealthcare.co.uk/about-protex/
The adult in the pic is Steve, he is slapp'n the ASSk. Either way it's a funny visual. We can now truly say FDA decision, "Any day" now. To make any price appreciation stick, I think we need a quick follow up of a partnership or marketing deal, any deal will do. Then, it is a short wait to hear if RecoveryRx is accepted into the FDA Innovation Challenge. I would think full body clearance would bode well for it being accepted into the challenge. After that, could be a number of things that come up. Trial info, Allay 510k, probably in 2019, migraine, more deals, B Braun hopefully now ramped up for joint replacements and someday the doctors will know about ActiPatch in the UK.
A wound care company from the UK.
Protex Healthcare was incorporated in the United Kingdom in 1999 with the aim of developing Vacutex™, our unique capillary action wound dressing.
Our main product, Vacutex™, has been carefully developed and protected as part of a wider portfolio of wound management products over the past 15 years, and is now an internationally recognised solution for advanced wound care. The product was developed for patients with difficult to heal wounds, and is to be used by wound care specialist practitioners.
Following a three-year development period up to 2002, which included a large multi-centred random clinical trial and an independent audit, Vacutex™ was immediately accepted into the UK NHS reimbursement regime under a newly created separate reimbursement category. Market research amongst nurses inside and outside UK has shown in 2012-2014 that there was a growing need for a product like Vacutex, in the field of chronic and difficult to heal wounds. This still reflects its innovative and unique stature as a leading global wound management solution.
Since January 2015 and due to a change in ownership, Protex Healthcare has restarted its development and manufacturing processes, in particular in the field of difficult to heal wounds.
Mission and Vision
Protex Healthcare aims to further develop, manufacture and market a restricted range of highly specialised advanced wound care products for use in growing and specialised niche markets all over the world. The products are all developed in cooperation with nurses in their everyday practise, and are backed up with significant educational support towards our users (specialised wound care nurses and other wound care professionals in both hospitals as well as home care settings).
All our products aim to improve the quality and speed of wound healing and as well as the quality of life of our patients, in the meantime reducing both total nursing time and total care costs for patients, hospitals and governments.
Some of our major areas of focus are the treatment of difficult to heal wounds, such as DFU, VLU, pressure sores and dehisced wounds as well as several kinds of ulcers.