e/u trial anouncement

20 January 2005
Avastra Ltd (AVS): Avastra Heads of Agreement for EU Clinical Trial
Avastra is pleased to report signing a Heads of Agreement with the University of Pecs, Department of
Surgery, Medical Faculty, yesterday to conduct the European clinical trial of Avastra’s first product, the
BioWeld ® Tube technology for rejoining blood vessels.
Submissions to conduct the trial were also lodged this week to the University of Pecs’ Ethics Committee
and the Hungarian national regulator’s ethics committee. Professor György Weber of the University of
Pecs’ Department of Surgery, who is overseeing the Ethics Committee submissions on Avastra’s behalf,
expects a response from the respective Ethics Committees by April.
Avastra’s Australian clinical trial of its revolutionary BioWeld ® Tube is underway, being used in a human
patient in free-flap surgery for the first time last month. The free-flap procedure was chosen for human
trials because it is of low morbidity (patient risk) and should supply high quality data.
Free-flap surgery is difficult and complex, offering a good example to showcase the BioWeld ® Tube
technology in a niche market where adoption rates by reconstructive surgeons could be high and rapid.
The Company estimates between 70,000 to 100,000 free-flap operations performed worldwide each
year with the majority done in Europe. Each operation takes between 6 to 8 hours, with 3 vessels
typically being rejoined. Using the BioWeld ® Tube as a suture replacement could reduce a typical free-flap
procedure by at least one hour. Given the audited cost of theatre time alone (without medical staff)
is $A5,000 per hour in New South Wales public hospitals, the potential for premium pricing of the
BioWeld ® Tube for suture replacement is significant. The cost of sutures to join each vessel is about
$A120, making it potentially an attractive niche market for Avastra’s first product.
Dr Gabor Pavlovics and Dr George Tizedes of the University of Pecs Hospital’s Plastics Surgery
Department will be the principal investigators in the clinical trial. Pecs is Hungary’s second largest city
outside of the national capital, Budapest. As Hungary is now part of the European Union, the clinical trial
data derived there will be used to form part of Avastra’s application for EU regulatory approval of a CE
Mark to market the BioWeld ® Tube in the Europe and the UK.
Avastra chose the University of Pecs to conduct its EU clinical trial because of its high level of surgical
competency and the number of patients it treats regularly which may be suitable for the BioWeld ® Tube.
Using the same Australian clinical trial protocol, the BioWeld ® Tube will replace sutures in the joining
(anastomosis) of the artery in a free-flap surgical procedure.
The EU clinical trial is a 12 patient clinical study as is being conducted in Australia. The study,
sponsored by Avastra, is expected to last nine months including a six month follow-up with the primary
endpoints being the speed of the anastomosis (joining) of the artery and arterial patency (free blood
flow) at the end of six months.
Dr Pavlovics, a specialist in reconstructive surgery, said he averages about one patient a week requiring
a free-flap procedure where a section of the patient’s own tissue (including skin, muscle and fat) is
harvested for replanting on a damaged section. A typical free-flap procedure is a breast reconstruction
post mastectomy for breast cancer.
The most critical part of free-flap surgery is the rejoining of the blood vessels vital to the success of the
tissue re-plantation. The blood vessels are conventionally joined by sutures, which is like trying to rejoin
a garden hose with thread. Joining the artery (average vessel diameter around 2mm) can take between
20 to 40 minutes depending on the degree of difficulty and the surgeon’s skill. The longer the tissue
remains without blood supply, the lower the chance of a successful outcome. And should the join fail
resulting in no blood flow, the tissue will die.
As demonstrated in over 1,000 animals so far, a blood vessel can be joined in less than 4 minutes using
a BioWeld ® Tube. Moreover, the join is instant with a complete seal formed at the anastomotic site.
Unlike sutures, there is no leaking. As the BioWeld ® Tube remains outside the blood vessel, blood flow
is unimpeded. Sutures penetrate the vessel walls causing disturbances in blood flow which leads to
clots. The clots can get large enough to block blood flow resulting in the operation failing.
The failure rate for free-flap procedure ranges from 5% to 30%, depending upon the health of the
patient. This is unacceptably high.
Avastra’s patented BioWeld ® Tube works by laser-activation as a sort of bio-solder. Unlike sutures or
surgical staples, the BioWeld ® Tube is absorbed by the body in time.
The BioWeld ® Tube is made from human serum albumin, an abundant, universal protein found in the
blood. It is biocompatible, expanding and contracting with the blood pulse. The BioWeld ® Tube is
impregnated with a special dye called indocyanine green (ICG) which causes the BioWeld ® to become
sticky and bond to adjacent tissue when activated by laser energy of a specific wavelength. As the laser
affects only the green dye, it passes through human tissue without damage.
The BioWeld ® Tube’s raw ingredients, the human albumin and ICG, are approved for surgical use with
albumin used daily in hospitals and ICG in ophthalmic surgery and as a marker in cardio-vascular
procedures.
A video demonstration of the BioWeld ® Tube technology being performed on an animal model may be
viewed on Avastra’s website at www.avastra.com
Yours faithfully,
Paul Ralph
Managing Director
For further information contact
Mr Paul Ralph
Managing Director
02 8755 1500
www.avastra.com

REGARDS GAGA

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