A Medical Device Daily

Nicast (Lod, Israel), a developer of medical devices made from its electrospinning technology, reported the receipt of the CE mark for its flagship product, the AVflo artificial vascular graft.

The device is intended to help end-stage renal failure patients who must undergo hemodialysis treatment three or more times a week. AVflo enables hemodialysis to continue without further disturbance to the veins and arteries in the patient's arms already severely damaged by the habitual needle punctures required by the treatment.

The company said AVflo is the first vascular access graft to apply what it termed "the many beneficial properties of electrospun nanofabric."

Its self-sealing, non-woven, synthetic fiber structure provides excellent primary and secondary patency (unobstructed blood flow); allows for dialysis within 24 to 48 hours after implantation; and self-seals within less than five minutes following the withdrawal of the dialysis needles.

Nicast said AVflo is simple to implant and to suture to blood vessels; the needle punctures and suture holes do not bleed. "AVflo is strong enough to withstand the pressure of blood flow, yet thin enough for blood flow to be easily felt through it," the company said in a statement.

Mandika Wijeyaratne, MD, head of vascular surgery at Colombo University Medical School and principal investigator of the AVflo clinical study in Sri Lanka, said, "The AVflo graft tolerates punctures, holds sutures very well and does not tear or cut through in the process. Suture needles puncture and drive through the graft wall with greater ease and less force compared with existing clinically approved devices. Needle withdrawal and repositioning as in the case of an inappropriate puncture does not leave behind a hole in the graft that would bleed. The graft and vessel wall apposition is achieved very easily and is snug and secure."

Nicast said it has "excellent control of the properties of electrospun nanofabric," adding that it is "able to customize products to include the numerous special properties unique to this technology."

The company said this means the potential for "a long line of superior medical devices to be used in the treatment of many indications and consequently a better quality of care."

"What is ... inspiring about today's development is that it puts Nicast on the radar as a company to watch," said Dr. Jacob Dagan, chairman of the board. "The company has gone through a remarkable turnaround in the last two years, one that has revitalized and given new direction to what is a venture rich area with unlimited product possibilities."

He added, "In the next two years the company plans to launch AVflo in the CE markets, conduct a multi-center post-marketing study of the same in Europe as well as finish the development and gain regulatory approval for the company's second product, the NovaMesh ventral hernias patch."

Dagan said Nicast is seeking an investment of $5 million at the beginning of 2009 and a second financing of $5 million at the end of 2009, with the proceeds from those financings to be used to execute its two-year development plan.

Czech Republic office for Averion

Averion International (Southborough, Massachusetts), an international clinical research organization (CRO) specializing in oncology, cardiovascular diseases and medical devices, said it has further strengthened its European operations by opening an office in the Czech Republic.

"Averion continues to expand its European footprint to meet the needs of our clients," said CEO Markus Weissbach, MD, PhD. "In the heart of Central Eastern Europe, the Czech Republic offers a strong clinical trial environment with large patient populations and well qualified investigators in a broad range of indications. These critical factors are top priorities for our clients and they are vital to the successful conduct of international trials."

The Czech Republic office, located in Prague, is led by Dr. Libor Hubacek, country manager for Averion, which he joins with more than 10 years of experience in monitoring, submissions and management of clinical trials in the Czech Republic, with particular expertise in arterial hypertension, oncology, renal impairment, pulmonology, urinary tract infection, atherosclerosis, diabetes mellitus, cystic fibrosis and others.

The new office is staffed with experienced clinical research associates and clinical trial assistants, with additional staff hiring anticipated in the coming months.

Averion's European operations are headquartered in Basel, Switzerland. It has additional U.S. offices in California, Maryland and New York; and international offices in France, the Netherlands, the UK, Poland, Russia, Israel, Germany, Austria, Ukraine and the Czech Republic, along with operation centers in Slovakia and Hungary and research partnerships in India, Asia and South America.

50 positions cut at Q-Med

Q-Med (Uppsala, Sweden) said that as part of the company's push to focus resources on the aesthetics business, personnel reductions will be made at its facility in Uppsala.

As has been previously reported, Q-Med has decided to focus on the aesthetics business, so sales and marketing of Hospital Healthcare products will be done via partners and there will be no further in-house development of new products within that area.

The company said this change "leads to redundancies at [our] facility in Uppsala. Despite the fact that Q-Med assesses that some of these redundancies can be absorbed by the aesthetics business, approximately 50 ... workers in Uppsala will need to leave the company." The company has about 700 employees overall, about 500 at Uppsala.

Q-Med primarily manufactures medical implants, the majority of which are based on the company's NASHA technology for the production of stabilized non-animal hyaluronic acid.

The product portfolio today contains Restylane for filling lines and folds, contouring and creating volume in the face, Macrolane for body contouring, Durolane for the treatment of osteoarthritis of the hip and knee joints, Deflux for the treatment of vesicoureteral reflux (VUR, a malformation of the urinary bladder) in children, and Solesta for the treatment of fecal incontinence.

Sales are made through the company's own subsidiaries or distributors in more than 70 countries.