A Medical Device Daily

Cinvention (Wiesbaden, Germany) reported extension of a license and supply agreement with Relisys Medical (Hyderabad, India) for the manufacture, marketing and sale of a non-eluting coronary stent with a bioactive nano-structured carbon-composite coating with pro-healing properties.

Relisys’ new stent consists of a Cobalt-Chromium Stent, coated with a porous carbon/carbon composite nano-structured matrix with a surface design for improved endothelialization.

Dr. Krishna Reddy, chairman of Relisys, said that this version of a coronary stent has the potential to overcome concerns with current drug-eluting stents (DES). He said that the animal study results at Cardiovascular Research Institute (Washington), published in April, indicated that the bioactive nano-porous carbon coating, that has no polymer, might address the issues of endothelialization, thrombosis, and continuing inflammation, the issues of concern with current polymer-based DES.

The coating has been developed by Cinvention, formerly Blue Membranes, which specializes in materials and surface engineering for biomedical applications. The Cinvention coating eliminates the use of polymers and provides a bioactive surface with less thrombogeneity and pro-endothelialization properties — thus reducing tissue inflammation and reaction, but enhancing engraftment, according to the company.

N.G. Badari Narayan, managing director of Relisys, said additional animal studies to validate the coating are ongoing.

Narayan also reported that Relisys will focus on receiving the CE mark for its non-eluting stent this year and also is targeting eventual FDA approval.

The next step will be a multicenter clinical trial with 15 international centers to evaluate both non-eluting as well as the DES devices of Relisys.

Dr. Soh il Asgari, CEO and chief technology officer of Cinvention, said, “We have embedded a bioactive surface that attracts endothelial cells and promotes endothelial cell attachment and growth on these nano-structured carbons. Compared to other systems we also do not need to use questionable drugs, that are less selective, and also do not use any biologics that have to be attached on the surface previously. The coatings were derived from our cell cultivation knowledge and our products in the field of bio-manufacturing using mammalian cells.”

Cinvention’s portfolio of nano-composite systems includes: drug delivery coatings; multi-functional device coatings; advanced carrier systems for bio-processing; tissue engineered biomaterials; and carbon/ceramic and mixed matrix membranes

Relisys manufactures DES, angiographic/angioplasty catheters; occlusive devices, cardiac surgery disposables and other critical care products.

Harvest to begin trial with BMAC in Berlin

Harvest Technologies (Plymouth, Massachusetts), reported that Berthold Amann, MD, a specialist in vascular medicine, has received IRB approval to begin a 90-patient clinical trial at the Vascular Center of Franziskus Hospital (Berlin) using Harvest’s Bone Marrow Autologous Concentrate (BMAC) device — a point-of-care system for concentrating autologous bone marrow stem cells — to treat patients with end-stage Critical Limb Ischemia (CLI) who face leg amputation.

In a pilot study by Dr. Amann, 23 end-stage CLI patients with ischemic legs that were threatened by amputation were injected with their own bone marrow stem cells. Sixteen (70%) of these patients were able to have their limbs salvaged and their CLI disease arrested as a result of the stem cell therapy, according to Amann.

Equally important, Amann reported that concentrating bone marrow with the Harvest BMAC system made the procedure a simple, 15-minute bedside protocol and it eliminated the risks of contaminating the sample or damaging the cells by sending the bone marrow to a specialized laboratory.

Gary Tureski, president of Harvest, said, “It’s certainly no secret that autologous adult stem cells derived from bone marrow offer great promise as therapies. But the major obstacle has been that they are extremely difficult to process outside of the body — until now. Our BMAC technology is now making it practical to harvest and concentrate them easily and quickly, at the point of care — thereby endowing European physicians such as Dr. Berthold Amann to develop non-surgical approaches for deadly diseases, today.”

Amann added: “The concentrate produced by the BMAC System requires a lower volume of bone marrow aspirate compared to traditional methods, is less painful, and does not require general anesthesia.”

Harvest says that its BMAC System is the only technique that produces clinically significant amounts of stem and precursor cells from a small aspirate of autologous bone marrow in just 15 minutes. Injected autologous adult stem cell concentrates from bone marrow have been shown in international clinical studies to be significantly effective in achieving tissue regeneration in vascular, orthopedic and cardiovascular disease.

In the U.S., the BMAC System is currently marketed for use in “the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of . . . a cell concentrate from bone marrow.”

Harvest said it is now “actively in discussions” with the FDA to commence a multi-center clinical trial in the U.S. using the BMAC System to induce the growth of new blood vessels in patients with CLI.

Neuralstem in European patent award

Neuralstem (Rockville, Maryland) reported receiving European patent application No. 97923569.4, titled: “Isolation, Propagation and Directed Differentiation of Stem Cells From Embryonic and Adult Central Nervous System of Mammals.”

“We are pleased to see that the first of our core technology patents is going to be granted internationally,” said Richard Garr, Neuralstem’s president/CEO. “This patent, already issued in the United States, covers the basic technology for creating human neural stem cells and also their composition of matter.”

Neuralstem’s technology offers, for the first time, it says, the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells into mature, physiologically relevant human neurons and glia.