Research & Development
Medlogics’ Product Pipeline provides a staged approach for a ramping impact to
the interventional cardiology industry and provides a real business enterprise
opportunity beyond a single technology or product.
More than 1200 stents have been implanted in chronic animal studies, demonstrating safety and efficacy of Medlogics’ products and pipeline. With COBRA as the chassis for Medlogics’ drug eluting stent (DES) program, we have several combinations of biocompatible coatings and drugs in development.
Medlogics PROPRIETARY DRUG DELIVERY PLATFORM #1— SYNERGYTM — is a surface treatment that represents what is expected to be the leading non-polymeric alternative for DES. This proprietary process builds upon the passive metal oxide layer to transform a stent into a DES without the need for the typical polymer coatings.
The Synergy Biomatrix surface modification improves upon all recognized shortcomings of plastic coverings: more specifically biocompatibility, simplicity, repeatability, speed of manufacture, yields, profile, and integrity through stent expansion. Synergy Biomatrix is also a co-deposition process, immediately transforming the stent surface into a drug eluting surface. This proprietary process was derived from technology licensed from Stanford University and developed in cooperation with Stanford. This surface treatment is enabling on stainless steel, nickel titanium and cobalt chromium alloys to name a few of the compatible materials which are also the three leading stent materials. Elution of multiple drugs, in vitro, has been conducted from all leading stent alloys. Remarkably, the Synergy Biomatrix surface is <2 µm thick in the primary DES platforms being advanced by Medlogics – this is an industry-leading reduction in thickness over polymer coatings whose thickness typically range between 7.5-10µm. Synergy Biomatrix is also biodegradable, reverting to a bare metal stent after releasing its therapeutic payload of drug.
CAUTION: Investigational device. Limited by Federal (or U.S.) law to investigational use.
Medlogics PROPRIETARY DRUG DELIVERY PLATFORM #2 – CVT BIOPOLYMER – is a bioerodible coating with highly controllable drug-release rate and excellent vascular biocompatibility. It comprises a tie layer covalently bound to the stent surface with a drug container layer grafted to the tie layer, and, optionally, a release-controlling skin. The covalently grafted binding layer affords high coating integrity and long-term stability with no visible peeling or cracking. The drug release rate is tunable for different drugs. This coating technology was developed by CV Therapeutics in collaboration with the Institute of Macromolecular Chemistry and is proprietary to Medlogics under exclusive license for endolumenal (including DES) applications.
CAUTION: Investigational device. Limited by Federal (or U.S.) law to investigational use.
Medlogics DRUG PROGRAM — COBRA-P and COBRA-Q. Medlogics has demonstrated that Synergy Biomatrix works exceptionally well for delivering an approved DES drug i.e., paclitaxel. In head-to-head pre-clinical testing, COBRA-P (paclitaxel) demonstrated equivalent percent stenosis reduction to the Taxus stent sold by Boston Scientific (the top selling paclitaxel eluting stent on the market today). Unlike the Taxus stent, however, Medlogic’s paclitaxel eluting stent includes the Synergy Biomatrix drug elution platform that is non-plastic and bioabsorbable. And, strikingly, it accomplishes these similar pre-clinical results with approximately 95% less paclitaxel than the Taxus stent.
Medlogics is also developing Synergy Biomatrix with another approved drug -- code named Drug-Q. Drug-Q is an FDA approved drug that is proprietary under exclusive license to Medlogics for DES use. Unlike “limus” and paclitaxel platforms, Medlogics’ Drug-Q was developed to treat CAD. Also unlike limus and paclitaxel platforms -- which non-specifically inhibit both smooth muscle cells and the endothelium necessary to heal -- Drug-Q inhibits smooth muscle cell proliferation in similar concentrations to paclitaxel, but without inhibiting endothelial growth at such concentration. Put simply, it is expected to reduce smooth muscle proliferation without the adverse impact on healing as with the limus and paclitaxel approaches. Medlogics’ Drug-Q conversely sets up a desired environment for healing.
CAUTION: Investigational device. Limited by Federal (or U.S.) law to investigational use.