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Q: Oxidized cellulose hemostat source ( Answered,   1 Comment )
Subject: Oxidized cellulose hemostat source
Category: Health > Medicine
Asked by: amarsawh-ga
List Price: $150.00
Posted: 14 Apr 2004 07:55 PDT
Expires: 14 May 2004 07:55 PDT
Question ID: 330087
I am looking for a source of oxidized cellulose sheets for hemostasis
use.  Can you recommend a manufacturer who would be willing to supply
this to us?

Request for Question Clarification by umiat-ga on 14 Apr 2004 08:04 PDT
Hello, amarsawh-ga,

 Can you clarify where you are located (what country) and what type of
volume you are looking for?  Have you contacted any manufacturers
already so we might know who to rule out?  Do you have a price limit? 
Must these sheets be directly from the manufacturer or would you
consider a medical supply house?


Clarification of Question by amarsawh-ga on 14 Apr 2004 14:32 PDT
I am in the US.  We are looking for quotes on about 10,000 sheets of
12 in x 12 in for starters.  I have not contacted any manufacturers. 
Becton Dickinson no longer makes Oxycel and Ethicon (J&J) does, but do
not want to sell as OEMs.    Other manufacturers I am aware of but
have not contacted are makers of Sorbacel (Germany), Traumacel
(Bioster, Czech), and Alltracel (Ireland).  I do not know if they are
willing to supply sheets of oxidized cellulose.  Also, I need nertral
pH stuff and not acidic materials.

Request for Question Clarification by pafalafa-ga on 19 Apr 2004 19:35 PDT
Hello there,

This site:

is offering Traumacel sheets as part of a Trauma kit, and would seem
to be a potential source for your needs.

But before I contact them, I would like to know if the Traumacel
sheets will meet your needs?  If the answer is yes, then how would you
like them spec'd?

If the answer is "No", then please explain why these style Traumacel
sheets won't do the job.

And if the answer is "I'm not sure", then what, specifically, should I
be asking of my contacts in order to get you the right material you're
looking for.

Thanks for any additional info you can provide.


Clarification of Question by amarsawh-ga on 20 Apr 2004 05:01 PDT
I am not sure if the Traumacel will meet our needs.  It is worth a
try.  If it is acidic, it won't.  But if it has a neutral pH on
contact, then it should work.  Also, it needs to be suitable for
implant use and the supplier needs to be ISO compliant.  If you can
get them to send a sample (I am happy to pay for it if needed), then
that would be great.  Also, ask them if they want to supply this not
as a finished product, but as a starter material to a company in the
US.  We would be buying in bulk.  Some pricing info would be good too
(eg.  $$ per sq. meter).  Also, if the material is absorbable, then
how quickly does it absorb in the body?

Request for Question Clarification by pafalafa-ga on 20 Apr 2004 05:28 PDT
I'll check into it.

In the mean time, I notice that Alltracel offers acid-neutral,
oxidized cellulose in spray-on form.  Is this of potential use to you,
or will sheets be the only form to meet your needs?

Request for Question Clarification by pafalafa-ga on 20 Apr 2004 06:54 PDT
I believe I've found a source that will meet your requirements for
neutral, absorbable, oxidized cellulose manufactured in an
ISO-compliant facility.

I don't want to post an answer just yet, as I'm awaiting information
on the size of their product (i.e. do they have 12 x 12 inches), as
well as information on price.  I have also asked them if it is
possible to provide samples.

Once I hear back from the company, I will be glad to post the
information as an answer to your question.

Stat tuned....


Request for Question Clarification by pafalafa-ga on 21 Apr 2004 04:50 PDT
I've gotten very close, but also run into a bit of a roadblock (which
almost always happens in these sorts of situations).

The company has responded to my initial contact as follows:


Thank you for your inquiry, and let me respond as follows.

First of all, we do produce oxidised cellullose based products that are
marketed abroad. This kind of product is (as I have said) based on
oxidised cellulose, and its hydrogen calcium salt. It is availbale in
3 forms:

1. Spray
2. Powder
3. Dressing/Matrix - so called flat form

You would be probably interested in the flat form, this one is basically
available in these dimensions:


[Note from pafalafa-ga:  presumably, these are milimeters]

We use 100% cotton that is further oxidised and then neutralised. The final
product is gamma sterilised. The final products are 100% absorbable. Our
company is fully CE certified (incl. ISO, DIR etc.).

My question is: What do you mean by "sheet"? What kind of raw material
should it be? What is the product intended to be used for?
Basically, your inquiry is very rough, and I am afraid that at the moment I
I'm not able to give any more information.


By the way, though the note above does not mention pH, their product
literature explicitly says their oxidized cellulose:

" bio-compatible, bio-degradable, non-acidifying haemostat of natural origin"

I believe the presences of calcium salts acts as a buffer to
neutralize any potential acidity.


Anyway, I'm not sure it makes sense for me to take the dialogue any
further, since my experience has been that it always leads to futher
questions from the company that I am not able to answer, since I'm not
directly familiar with what you need.

Should I post the company name and the contact information for the
manager who contacted me, as an answer to your question?

If not, let me know, as explicitly as possible, what additional
information you would like me to get from the company so that I can
provide an answer for you.



Clarification of Question by amarsawh-ga on 21 Apr 2004 06:21 PDT
I think you are making good progress.  The flat form is probably what
we are looking for.  More specifically, I am looking for a thickness
in the range of 0.5 to 2 mm.  The material density should be in the
range of 30-100 mg/cc or in the range of 5-15 mg/cm2.  It should
absorb fully within 2 weeks to 2 months.  The form we would like this
material sent to us could be in a roll or as cut up sheets.  Pretty
much any size of sheet is OK as long as it is in multiples of 4 inches
in each dimension (so 4X4 or 8X12 etc. is OK).  We expect to sell
about 10,000 units of 4X4 sizes in 2 yrs or so.  We need the cost of a
4X4 piece of this sheet to be less than $10 or so to us, otherwise, it
becomes too expensive to produce the ultimate device.  THe intended
use of this will be to coat it with our polymers to make a tissue
reinforcement mesh.  I would like to get a sample of this material for
evaluation purposes. So, please get these clarifications and if it
seems like this is going to work, then please post the contact
information of this person and company and I will contact him
directly.  thanks for your efforts.

Request for Question Clarification by pafalafa-ga on 22 Apr 2004 18:04 PDT
Hmmm...I received a somewhat discouraging reply to my latest
communication wth the company:


I believe that I need to give you another information that I probably
had forgotten to mention. Our flat form is made from cotton bandages.
So basically it is not a sheet, but a normal bandage with loops  that
is then oxidised. It is fully absorbed within 48 - 72 hours.
I am afraid that we are not able to oxidise this kind of material -
and I am not even sure whether it is possible from the technical point
of view. Also, knowing the intended use, I would believe that it is a
completely new product, therefore new registration/certification would
be required prior to any production, incl. quite a lot of clinical
tests etc.

There  may be one more complication, the regulation related to medical
devices is rather strict, and we are not allowed to deliver to the USA
(having read your contact details) unless approved by FDA. And we do
not have any FDA approval at all - just for our radiation
sterilisation facility.
So all in all, I am afraid I have nothing to offer to your client at
the present moment.

Some of what she is saying appears to stem from difficulties with
English, while other things may be real stumbling blocks.  It's a bit
difficult to sort out which is which.

I wouldn't totally write them off as potential suppliers at this
point, but obviously there would need to be a good deal of additional
dialogue before coming to a complete understanding of what they can or
cannot offer.

If you want to engage them in this dialogue, let me know, and I can
post their contact information as an answer to your question (which,
by the way, you can adjust the price for, if the information I am
offering doesn't seem worth the maximum price that you posted

However, if that's not satisfactory to you, please let me know how you
would like to proceed at this point.



Clarification of Question by amarsawh-ga on 23 Apr 2004 06:23 PDT
Thanks.  I agree.  We obviously will do the clinical trials required
and would not be importing their product as a finished good, but as a
"raw material" to be used further.  Our device will be fully tested
pre-clinically and clinically, and we will seek the FDA registration. 
This is something that this person does not understand.  However, the
flat form having loops etc. is harder to understand and the best way
would be for us to get a sample from them marked "not for human use"
and "sample" so we can evaluate it in the lab.  Their facility not
being FDA registered may have an impact, or if we qualify the material
on our end, it may not.  So, in summary, if you can get some
additional clarifications then great, if not, go ahead and post your
reply and let me know what you would like the fees to be "adjusted"
to.  I suggest $150, since I do appreciate the time you have spent on
this.  Cheers.

Request for Question Clarification by pafalafa-ga on 23 Apr 2004 07:16 PDT

Thanks very much for getting back to me.

I will try one more round of communications to try and clarify the
business about the "loops" -- there is a bit of a language problem but
I'll do my best.

Thanks for offering to accept my information as an answer, and your
suggestion of $150 seems quite fair.  You will need to adjust the fee
at your end, as it is not something I have any control over (otherwise
I might be tempted to "adjust" all questions upwards to $200!!!)

The instructions for repricing a question are:


Change your question price 

You can change your price at anytime as long as your question is not
currently 'locked' and being answered by a Researcher. To change your
question price, go to "My Account," select "My Unanswered Questions"
and click on the question with the price you want to change. Then
click on "Change Question Parameters" to modify the price.


You make the adjustment as you see fit.  I'll find out what I can about "loops"

Wish us both luck...!


Request for Question Clarification by pafalafa-ga on 26 Apr 2004 06:35 PDT
Hello again, amarsawh-ga.

I wanted to let you know that I've heard back from my contact, and
have some additional information on the "loops" and other matters.

As soon as you reprice your question (as you suggested a few days ago)
I can consolidate all the information I have and post it as an
answer...I need to wait for the repricing so you won't be overcharged.


Subject: Re: Oxidized cellulose hemostat source
Answered By: pafalafa-ga on 26 Apr 2004 07:54 PDT
OK, we're ready to roll.  

The company I have been corresponding with is Bioster, in the Czech
Republic, and my direct contact there has been Ms. Eva Hrabinová,
Bioster's Sales and Marketing Director.

Ms. Hrabinová's full contact information is:

Eva Hrabinová 
Sales and Marketing Director 

BIOSTER, a.s. 
Tejny 621, 664 71 Veverská Bítýska 
Czech Republic 
tel:+420 549 429 109 
mobile: +420 736 626 031 
fax: +420 549 429 132 


In her latest email message, she gave me some additional information
about the "loops":

...what I meant by "loops" was that our flat haemostatic form is a
dressing/bandage that is oxidised and neutralised. Therefore it is
not, let me say, a piece of cloth with fibres closely next to each
other. To visualise please see our web site T  [NOTE from pafalafa-ga:  the
correct URL appears to be: ]
Also there is one limiting factor related to this kind of product and
its storage: if it is to be neutral (pH is neutral), the storage
temperature must be kept below 10 C. Otherwise, the product may tear
apart, or it may crumble after some time (half a year or so).
If any more information needed, please let me know.
With kind regards,
Eva Hrabinová 


Although the message isn't entirely clear regarding "loops", I think
the picture tells the tale -- the Traumacel T is made of gauze rather
than a tightly-woven fabric, and the gauze has what could be called an
open-loop type of weave to it...I'm pretty sure that's what she is
referring to.

There is also a good deal of additional product information on their
web site, which can be found by exploring the various product
information links at:

In all of our various correspondences, I repeatedly asked for
information about obtaining samples, but her responses were silent on
this question.  Nor did she provide any insight about shipping product
to the U.S. marked "not for human use" or some similar caveat.

Your best bet for follow-up would be to contact Ms. Hrabinová
directly.  My sense is they will be cautious about overstepping any
regulatory requirements, and may need some encouragement in this area.
 At the same time, they seem to be responsive to queries and eager to
establish a new business relationship.

I wish you all the best of luck in your communication with Bioster,
and with your project overall.

If you need any additional information or clarification regarding this
answer, please post a comment to let me know.  I'll be happy to assist
you in any way I can.



search strategy:  Google searches on: 

Oxidized cellulose 
Oxidized cellulose (Sorbacel OR Traumacel OR Bioster OR Alltracel)

also searched at for "oxidized cellulose"
Subject: Re: Oxidized cellulose hemostat source
From: jbf777-ga on 15 Apr 2004 09:03 PDT
Thought this may be of interest:

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