A Medical Device Daily

Kuros Biosurgery (Zurich, Switzerland) reported the results from the first of two reporting points in follow-up to its Phase IIa clinical trial assessing the potential of KUR-212, its platelet-derived growth factor (PDGF) and fibrin combination product for use in treating patients with burns requiring autologous meshed skin grafting.

In the one-month follow-up of the study, there were no treatment-related adverse events, meeting the primary endpoint (safety) of the study. A total of 10 patients from one center participated in the study.

The Phase IIa trial is designed to assess the safety and effects on wound closure (full re-epithelialization) of KUR-212 over two separately reported periods of one and 12 months, respectively. The 12-month data will be reported in 2Q09.

Autologous mesh grafting is a procedure in which a patient's skin is taken from an unaffected site on his or her body, meshed so that it can cover a larger area and applied to the burn site.

Kuros noted that KUR212 is intended to replace staples as the standard fixation method for skin grafts and, due to the presence of the growth factor, aims to improve the healing of the damaged tissue.

Patients served as their own control in this study, with an area of graft that was stapled and an area of graft that was treated with KUR-212.

No treatment-related adverse events or safety issues were observed in any of the 10 patients during the one-month follow-up. A difference was observed in the time to wound closure between treatments for the 1:3 meshing ratio, with a shorter time for the KUR-212-treated sites, and it also was observed that patients expressed a preference for KUR-212 over staples.

One of a family of Kuros combination products, KUR-212 consists of a variant of PDGF incorporated into a fibrin sealant. The growth factor is gradually released during cell infiltration of the matrix, stimulating cell growth and thus promoting the skin repair process. The company said this mechanism has been shown to lead to improved wound healing in a number of pre-clinical models.

KUR-212 is licensed to Baxter Healthcare (Deerfield, Illinois) under a collaboration and license agreement that was signed in 2005.

CDO Didier Cowling said, "Given the promising one-month follow-up results seen in this study, we look forward to advancing into a Phase IIb study [that] we hope ... will further demonstrate the potential of KUR-212 as an important new treatment in skin graft procedures."

Study boosts Orthokine therapy

Orthogen (Dusseldorf, Germany) said the results of a two-year representative study of knee osteoarthritis, published in the journal Osteoarthritis and Cartilage, confirm the safety and effectiveness of the company's Orthokine therapy, in which anti-inflammatory proteins obtained from the patient's own blood are injected into the arthritic joint.

Researchers at Heinrich Heine University (also Dusseldorf) compared three treatments to determine which one produces the best long-term results for treatment of knee osteoarthritis. A total of 310 patients received a series of injections — one of Orthokine, hyaluronic acid (a joint lubricant) or a placebo.

Two years after the initial treatment, 188 of the 310 patients still were experiencing reduced pain and improved function of the affected joint.

Orthogen said the Orthokine group had the fewest patients who went on to seek further treatment, and patients who received Orthokine treatment had the greatest improvements in VAS and WOMAC scores.

For the WOMAC test in particular, the outcomes were significant. Starting from an initial WOMAC score of 124, the Orthokine group saw a reduction to a score of 58, while the final WOMAC scores for the other two groups remained well above that at 88 and 84.

"This study shows that Orthokine treatment is a safe alternative to conventional methods," said study physician Carsten Moser.

ISO certification for Endosense

Endosense (Geneva, Switzerland), a company focused on enabling the broad adoption of catheter ablation for the treatment of cardiac arrhythmias, has been awarded ISO 13485:2003 certification for its quality management system by the certification authority NSAI.

The international standard for the medical device industry, ISO 13485:2003 verifies the company's ability to provide devices and related services that consistently meet customer needs and regulatory requirements.

Endosense's flagship product is the TactiCath, which it terms "the first force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure."

The company said that without this measure, electrophysiologists have had to estimate – and frequently guess – the level of contact force required, as too little force may render the procedure ineffective and too great a force may perforate the heart wall.

The TactiCath is an 8.5 Fr sheath compatible, open irrigated, steerable catheter that integrates Endosense's Touch+ fiber-optic sensor technology at the catheter tip.

Eric Le Royer, president/CEO, said, "Receiving ISO 13485 certification confirms that our quality standards are among the best in the industry, and it represents a major step towards the successful clinical evaluation and commercialization of our breakthrough TactiCath product."

He said the company anticipates having the first human case performed in Europe within the current quarter and expects to receive the CE mark for the product in 2009.

Endosense's growing body of study data on TactiCath has been the subject of nine abstracts presented at annual meetings of the Heart Rhythm Society (Washington), American College of Cardiology (also Washington) and American Heart Association (Dallas).