Project title: SUTURELESS REPAIR OF BLOOD VESSELS

Company name : HDH MEDICAL LTD.

TECHNOLOGICAL FIELD
Medical Devices

KEY WORDS
Vascular Graft,
Suture-less Vascular Anastomosis, Abdominal Aortic Aneurysm (AAA)
Repair

PROJECT SUMMARY
HDH MEDICAL Ltd. has developed an innovative Hermetic Docking
Head (HDH) vascular device, supported by surgical instruments
(insertion tool and forceps) and a suture-less open surgical
procedure, which is capable of significantly enhancing the
existing treatment of aortic and peripheral aneurysms, arterial
occlusions and blood vessel traumas.

The HDH device is used to connect any standard vascular graft to
the blood vessel of a patient. Suture-less and leak proof
anastomosis is performed in less than two minutes, even for major
vessels, which shortens the cross-clamping time by an order of
magnitude, and reduces the operative and post operative
complications providing unrestricted blood flow.

The first target market segment is open Abdominal Aortic Aneurysm
repair, where the shorter time in surgery, reduction of operative
and post-operative complications, shorter ICU and hospital stays,
and fewer blood transfusions needed for open repair using the HDH
devices with a standard graft, generate a direct economic value
of over US $5000 per case. Over 100,000 AAA repairs were
performed in Europe and the USA in 2003 with an average cost
exceeding US $50,000/procedure.

Additional applications to be addressed in the future include
repair of other types of aneurysms, Femoral-popliteal bypass, and
AV shunts.

ENTREPRENEURS
Mr. Igor Waysbeyn - The founder,
experienced in the fields of medical engineering and emergency
medicine.
Dr. Boris Yoffe M.D. - FACS, the Medical
Director serves as the Head of the Department of General and
Vascular Surgery at Barzilai Medical Center, Israel
Ms. Irina Vaysbeyn - CEO, MBA degree
from Derby University and a B.Sc. Chemical Engineering.
Dr. Yuri Urin - Senior
Researcher, Ph.D. in Mechanical Engineering. 61 Patents and more
than 130 scientific publications.

PROJECT STATUS
HDH prototypes have been successfully tested in-vitro in the lab,
on a test bench, and in-vivo in animal trials (in Israel, Ukraine
and Germany) and human cadaver trials (in Russia), using the
vascular grafts of three leading graft manufacturers. The
interest of graft manufacturers has been aroused, they provided
material and advice gratis, and one of them performed their own
animal studies with our assistance. Results of these trials
showed that the HDH device provides a permanent leak-proof
anastomosis, and upon histological examination, the device +
graft integrate with tissue similarly to the graft alone,
providing a smooth blood flow channel at the point of
anastomosis. The Company has received the approvals to begin
first human clinical trials shortly, and approval for trials in a
second country is pending.

Development of a laparoscopic procedure for using the HDH device
has begun, for non-emergency AAA cases where less invasive
procedures are desired, without the expense, frequent
complications and technical difficulties involved in endoscopic
repair.

COOPERATION REQUIRED
HDH is seeking an investment to fund the completion of the first
human trials and then the larger studies (about 60 patients)
towards regulatory approval. The company believes that upon
completion of these trials and the initial development of the
laparoscopic device for AAA, HDH MEDICAL will be well positioned
to either raise funds in order to proceed independently towards
marketing the device, or for some type of strategic alliance with
a larger company.

Request for more information, about this project.

Note - you have to be registered in this server to request information. If you haven't done so yet, please:
Register in this server and your requests will be forwarded to the developer, who will contact you directly

List of projects that you already requested more information about