Medical Device Dailys

Manufacturing conglomerate Lisi Group (Belfort, France) reported the creation of a new medical division that will consolidate its recent acquisitions of medical implant makers.

Over the past 18 months the aeronautics division of Lisi bought four companies with strong portfolios as subcontractors for medical and dental implants and this month formally set up a stand-alone group with consolidated revenues of €25 million ($38.5 million).

Customers for the consolidated operations include original equipment manufacturers Zimmer (Warsaw, Indiana), Stryker (Kalamazoo, Michigan), Synthes (Solothurn, Switzerland) and DePuy (also Warsaw), as well as France's Scient'x (Guyancourt) and Medicrea (Lyon).

"This new group is growing in a dynamic market with high growth rates in certain segments in double digits," said Emmanuel Viellard, who heads up the aeronautics group and also serves as vice president and directeur général for Lisi Group.

Viellard added, "To be sure, Lisi is not entering the medical sector just to stay at the current levels of the affiliates, which are very low on the scale of the group."

Lisi reported revenues for 2007 of €816 million ($1.2 billion) with 52% from automotive, 42% from the aeronautics division, and 6% from cosmetics.

The acquisition of Hugueny (Fleurieux sur l'Arbresle, France) in January 2007 was a first, but small step, in the strategic move by Lisi, as that manufacturer of spinal and orthopedic implants serves primarily French OEMs and reported revenues of revenues of €3.2 million ($5 million).

Four months later Lisi reported that it had acquired Jeropa Swiss Precision (Escondido, California), a dental implant manufacturer with revenues approaching $11 million.

In December 2007, Lisi fully took over the companies Seignol and Intermed Application, both located in Neyron, France, near Lyon, with combined 2007 revenues of €11 million ($17 million).

Seignol is a specialized subcontractor for surgical implants for feet, hands, traumatology and maxillo-facial uses, as well as a manufacturer of surgical instruments.

Through Seignol, Lisi also picked up the manufacturing operations of Lixus Industrie (Tanher, Morocco).

Intermed Application specializes in metal and surface treatments, laser cutting and quality controls, primarily for medical applications.

In reporting the creation of the new division, Lisi executives said combining the companies creates opportunities for organic growth with prototypes already being developed with customers that include acetabulum of the pelvis, screws for the vertical column, shoulder prosthesis, cervical disks and dental implants

1st enrollee in Kuros biomaterial trial

Kuros Biosurgery (Zurich, Switzerland), which is focused on the development of biomaterials and bioactive-biomaterial combinations for trauma, wound and spinal indications, said it has recruited the first patient into a Phase IIb clinical trial with KUR113, investigating the treatment of acute, open tibial shaft fractures.

The company said such fractures are associated with a high incidence of complications and may take many months to heal.

The investigational combination product, KUR-113, consists of a modified variant of parathyroid hormone (PTH) incorporated into a fibrin sealant. When mixed together, the bioactive ingredient and sealant generate a fibrin composite that forms to the shape of the bone defect. KUR-113 is applied to the site of the fracture following surgical fixation with intramedullary nailing or plating.

The Phase IIb clinical trial is a multi-center, randomized, controlled, open-label, dose-finding study that will evaluate the efficacy and safety of KUR-113 as an adjunct to current standard of care in the treatment of patients with acute open tibial shaft fractures.

With patients recruited in about 30 centers across Europe, the study will compare the proportion of patients healed six months after treatment with various doses of KUR-113 as an adjunct to surgical management vs. surgical management alone.

Kuros said that KUR113 not only provides a matrix into which bone-healing cells can migrate, but also enables the delivery of PTH locally into the bone. It said the product is designed to gradually release PTH from the matrix, resulting in the stimulation of bone-forming cells, promotion of bone formation and acceleration of fracture repair.

KUR-113 is licensed to Baxter (Deerfield, Illinois) under a collaboration and license agreement that was signed in 2005. Under the terms of this agreement, recruitment of the first patient into the study triggers a milestone payment to Kuros.

CE mark for Scoreflex catheter

OrbusNeich (Hong Kong) said it has received CE-mark approval for its Scoreflex coronary dilatation catheter. The new product, which rounds out the company's balloon catheter portfolio, is designed for use in focused force angioplasty, a technique in which the force resulting from balloon inflation in a stenotic lesion is concentrated at one or more locations within the stenosis.

Published research has shown that focused force angioplasty is effective in resolving resistant stenosis while reducing the frequency of complications with its use of gradual, low-pressure inflations.

The Scoreflex dual-wire system creates a focal stress pattern to facilitate effective controlled plaque fracture at low-resolution pressure. In addition to its effective dilatation, OrbusNeich said Scoreflex has a low crossing profile and "unbeatable trackability."

The company said it expects rapid adoption and integration of the balloon catheter into interventional cardiologists' practices.

Italian distributor signed by SpectraScience

SpectraScience (San Diego) said it has established a distribution partnership for its WavSTAT Optical Biopsy System in the Italian market through Medimar Italia (Milan).

Michel Vaudry, director of international sales, said, "We are pleased to have added our second European distributor in the past two months. Medimar is a respected and well-established medical device distributor and its decision to add the WavSTAT Optical Biopsy System to its portfolio is a strong validation of our technology."

Medimar's president, Francesco Torelli, said, "SpectraScience's WavSTAT cancer diagnosis system has tremendous potential to impact the marketplace here in Italy. The importance of earlier and more effective screening for colon cancer cannot be stressed enough; we look forward to representing the product and [building] a strong Italian market presence."

The WavSTAT Optical Biopsy System helps physicians discern between normal and pre-cancerous tissue in the GI tract, providing additional information that allows for a more informed decision on leaving polyps on-site if they are not pre-cancerous.