|
Bio-Alcamid RECEIVES HEALTH CANADA APPROVAL! RECEIVES HEALTH CANADA APPROVAL! RECEIVES HEALTH CANADA APPROVAL!
The Injectable Filler Offers an Effective, Affordable Treatment for Facial Lipoatrophy, the Facial Wasting Associated with HIV Infection and AIDS
April 6, 2006 - : Pur Medical Corporation, a Canadian distributor of innovative medical and medical cosmetic enhancement products, has introduced Bio-Alcamid
to the Canadian market. In use in a number of European countries since 2001, Bio-Alcamid is an injectable solution which restores the natural fullness and contours of the face when injected
under the skin. The arrival of Bio-AlcamidT is exceptional news to men and women suffering from Lipoatrophy, the disfiguring condition that is often a result of the antiretroviral drugs used to treat HIV infection and AIDS.
Lipoatrophy, often referred to as facial wasting, has become the "scarlet letter" of HIV, a public mark of HIV infection. The daily arsenal of antiretroviral drugs can take a tremendous toll on the
quality of daily life causing anemia, extreme fatigue and severe gastrointestinal problems. With the addition of the facial disfigurement of Lipoatrophy, patients are forced to endure a constant visual reminder of the infection,
essentially announcing to the world that they are HIV positive or have AIDS. Often, the result is extreme depression, leading to a decision by some to forego the medication they require to survive.
"Until now, Canadian HIV patients living with facial Lipoatrophy have not had a viable treatment," says Toronto cosmetic plastic surgeon, Frank Beninger, M.D., F.R.C.S. (C). "Bio-Alcamid may be used
in the large volume necessary to restore fat loss. My patients have been thrilled with the results." Mona Loufty, M.D., F.R.C.P. (C) MPH - Infectious Disease Specialist at Toronto's Maple Leaf Medical Clinic concurs, saying "Bio-Alcamid
has reversed the affects of Lipoatrophy in all the patients that we have treated. It is a quick, simple procedure with outstanding results."
When injected under the skin, Bio-Alcamid, an injectable gel polymer, replaces depleted fat tissue, restoring the natural fullness and contours of the face. Unlike other injectable fillers that are commonly used
in cosmetic enhancement, Bio-Alcamid acts like a gel prosthesis that becomes encapsulated in a thin layer of collagen that isolates it from the host tissues. As a result, a physician can remove Bio-Alcamid should this ever be desired.
Bio-Alcamid has been used outside Canada in large volumes for the reconstruction of other anatomical areas, namely, buttocks, de-nervated shoulders, and a majority of the time in Europe for facial aesthetic enhancement.
Since November, 2004, more than 1000 Bio-Alcamid treatments have been performed in Canada, under provisions of the Special Access Program, to exceptional results. Bio-Alcamid is now approved by Health Canada's Medical Devices Bureau,
with treatments available through select, trained physicians across Canada. Potential patients can find a physician treating Lipoatrophy with Bio-Alcamid by visiting www.purmedical.com or emailing info@purmedical.com. Alternatively, further information
is also available from the Face Forward Foundation, www.faceforward.ca , a non-profit foundation that supports people dealing with the physical and psychological side effects of HIV infection.
###
Bio-Alcamid
The Facts
What is Bio-Alcamid?
Bio-Alcamid Soft Tissue Implant is a highly biocompatible, non-absorbable, yet
removable injectable filler, pre-packaged in a sterile syringe. This injectable gel polymer
(synthetic) is made up of 4% poly-alkyl-imide and 96% water and is designed for the
correction of small and large soft tissue deficits. When injected under the skin, Bio-Alcamid acts to replace depleted fat tissue, restoring the natural fullness and contours
of the face. Once implanted, Bio-Alcamid, unlike other injectable fillers, becomes
covered by a very thin collagen capsule (0.02 mm) which completely surrounds the gel,
isolating it from the host tissues. With these characteristics, Bio-Alcamid is the only
product that can be used safely for large tissue deficits in particular, but is also safe for
small deficits as well.
What are the uses of Bio-Alcamid?
Bio-Alcamid has proven to be particularly effective for those suffering from facial
lipoatrophy (facial wasting) that can be the result of anti-retroviral HIV medications.
This is the approved indication in Canada. Due to its high degree of biocompatibility and
permanency, Bio-Alcamid is also used outside Canada widely in the reconstruction of
anatomical structures affected by congenital or acquired loss of soft tissue such as
Poland's Syndrome, Pectus Excavatum, denervated shoulders and muscles and
liposuction deficits. It is also being used in lipoatrophy in the buttock (gluteus) region.
Seventy percent of its use in Europe is for aesthetic indications in the face - nasolabial
folds (nose to mouth folds), oral commissures, to enhance cheek bones, jaw lines or
chins.
Why is Bio-Alcamid preferable for the treatment of Lipoatrophy?
Other products used to treat lipoatrophy require 4-8 sessions versus the 1-2 Bio-Alcamid treatments needed to complete restoration. An unapproved alternative,
Sculptra (formerly Nu-fillT), is a biodegradable substance, requiring repeat treatments
to sustain results every 1-2 years making it a very expensive option. Also, if problems or
an undesirable result is obtained, many products, unlike Bio-Alcamid, cannot be
removed.
Who created Bio-Alcamid?
Bio-Alcamid is manufactured by Polymekon Srl (www.polymekonresearch.com)
which researches and manufacturers polymers for the medical sector. Polymekon
laboratories are located at the Science and Technology Park, National Centre for
Research and Development of Materials, in Brindisi, Italy.
To what extent has Bio-Alcamid been tested for safety and efficacy?
Bio-Alcamid has been used since 2001 in the European Union, U.K. and in many other
countries. Polymekon commissioned certified evaluation centres to test the physical
characteristics and packaging of Bio-Alcamid conforming to Canadian CMDCAS and
international standards NSF 90016, NSF 90013, BS 5081, DIN 13098, ISO 7886, ISO
594/1, ISO 594/2 and ISO 6009.
Many scientific documents have been written about Bio-Alcamid. Multi-centre clinical
evaluations in major hospitals and universities have been performed including a 2,000
patient study demonstrating the safety, efficacy and biocompatibility of the product (a
0.6% post-treatment complication rate).
Very few risks are associated with Bio-Alcamid. There is an absence of toxicity,
animal protein and migration. It is radiolucent and hypoechoic. There have been no
reports of granulomas due to its high biocompatibility. However, infection is a risk with
any implantable device and certain precautions can be taken.
|
