Applications

Neuro Application

A cerebral aneurysm is a balloon-like swelling of the wall of a blood vessel in the brain. This weakening in the wall often leads to rupture, bleeding, and death. Cerebral aneurysms are more common in people over 65, where they are found in as high as 5% of the population. Approximately 200,000 patients with cerebral aneurysms are treated worldwide, annually. Smoking and hypertension appear to markedly increase the chances of developing a cerebral aneurysm. It is estimated that approximately 60,000 people in the United States are diagnosed each year with a cerebral aneurysm. However, there are an estimated ~10 million individuals in the U.S. that have a silent, undiagnosed cerebral aneurysm. This number is expected to grow as the population ages.

Currently, aneurysms can be treated with direct (cranial) surgery or with an endovascular approach. Direct surgery, under general anesthesia, begins by opening the skull and identifying the neck of the aneurysm (the neck is the junction between the good, strong blood vessel and the weakened, ballooned aneurysm). A clip is then put across this neck area. A cranial surgery is an arduous procedure (6-8 hours), requires lengthy hospitalization and recovery periods (1 year), and suffers from high rates of mortality and morbidity. In those patients where direct surgery is believed to have a higher risk, or be less effective, embolization may be offered.

Endovascular surgery, also under general anesthesia, is performed by navigating a small catheter, usually beginning from a leg artery, into the aneurysm under x-ray guidance. Tiny platinum coils are then fed through the catheter and into the aneurysm. The anatomical characteristics of both the patient and his/her aneurysm limit patient selection. An endovascular coil placement procedure can take up to 3-6 hours and require the placement of 2-12 coils. Larger aneurysms require even more coils. The coils create stagnation, and eventually a blood clot that relieves the pressure on the dome of the aneurysm. In 7-27% of treated aneurysms, the coils shift or become compressed. This shift opens a pathway for the blood pressure to re-enter the aneurysm, causing the aneurysm to balloon once more.

Valor Medical's easy-to-handle product, Neucrylate™ AN, can be injected directly into the aneurysm once the microcatheter is placed. This approach takes less surgical time than current procedures, reducing the cost for the surgery and the time the patient is at risk under anesthesia. During current clinical trials the time to fill an aneurysm, once the microcatheter has been placed, has taken less than three minutes. In addition, unlike coils, Neucrylate™ does not shift or compress in the aneurysm, eliminating the potential for blood pressure to re-enter the aneurysm.

Un-treated Aneurysm	Valor Post-Treatment

Additional Products

Valor Medical has also optimized specific cyanoacrylate formulations in terms of viscosity, polymerization time, and adhesion in order to serve applications in wound management and women's health.

The wound management market (liquid bandage and trauma) is projected to be approximately $1.5 billion. Valor has developed an over-the-counter (OTC) product for this indication, and a 510k has been submitted in October, 2010. The women's health market (contraception and uterine fibroid embolization) is projected to exceed $3.6 billion. Valor has identified additional clinical needs which Valor's technology could be formulated to meet the specific requirements.

The additional products created will be divested or licensed to best of breed in each specific clinical market.