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PLC Medical Systems Inc.
HCID Member | Medical Devices & Tech
459 Fortune Boulevard
Milford, MA 01757 USA
phone:(508) 541-8800
fax:(508) 541-7980
Symbol PLCSF
Exchange OTC BB
Founded 1987
Employees 8
www.plcmed.com
Research Sector Medical Devices & Tech
Summary Description
Technologies for cardiac and vascular markets, prevention of CIN
Management
Edward H. Pendergast, Chairman of the Board; Mark R. Tauscher, President and CEO; Gregory Mann, CFO Kenneth J. Luppi, Vice President, Operations; Susan Papalia, R.N., B.S.N., Vice President, Clinical Affairs; Andrew Halpert, Director of Marketing; Howard R. Levin, M.D., Special Scientific Advisor
Ownership
Financials


* numbers in thousands
 

Keywords
RenalGuard, Kidney, Catheterization, Contrast Induced Nephropathy, CO2 Heart Laser 2, Transmyocardial Revascularization, TMR, PLC Medical Systems

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Updated: Feb. 01, 2012

Description
PLC Medical Systems specializes in innovative technologies for the cardiac and vascular markets. RenalGuard®, the Company's newest product, has been developed to help prevent the onset of contrast-induced nephropathy (CIN) in at-risk patients undergoing procedures that use iodinated contrast. Patients who develop CIN after image-guided cardiology and radiology procedures are at increased risk of developing major complications, including dialysis and death. One of the few therapies that has been proven to prevent CIN is high urine rates, based on the idea of flushing the contrast through the kidney fast enough to prevent contrast from damaging the tubules of the kidney. The tools currently available to the clinician do not allow them to safely and reliably induce high urine rates in patients at risk for CIN. RenalGuard Therapy® enables the clinician to safely induce high urine rates by accurately measuring a patient's urine output and automatically infusing an equal volume of normal saline in real-time. This later-stage medical device company has completed two European studies of the device; both have shown RenalGuard Therapy to be significantly better than the standard of care at reducing the incidence of CIN and related complications. RenalGuard is approved for sale in Europe, and the pivotal study to secure US FDA approval is ongoing.
Products / Services
RenalGuard Therapy is designed to prevent the toxic effects that contrast media can have on the kidneys in patients with pre-existing kidney disease. Physicians describe significant damage to the kidney as contrast-induced nephropathy (CIN). Patients who develop CIN go on to develop many more co-morbidities, including increased mortality. High urine rates have been shown to reduce the incidence of CIN, but early research found that it is very difficult to cause high urine rates in most patients with poor kidney function. These are the same patients who are most at risk of CIN. RenalGuard Therapy enables the clinician to induce high urine rates in patients with poor kidney function while reducing the risk of over- or under- hydration.

High urine rates may reduce the incidence of Contrast-Induced Nephropathy via a combination of known physiological factors, including: - More rapid transit of contrast through the kidneys; - Dilution of contrast when it is in the kidney; - Reduced oxidative stress on the kidney due to a reduced workload on the kidney;

The real-time fluid matching of RenalGuard enables the clinician to achieve high urine rates safely and predictably. RenalGuard measures the patient?s urine output and automatically replaces it in real-time with an equal volume of sterile saline. This matched fluid replacement aims to minimize the risk of over- or under-hydration which can lead to increased patient risks.

RenalGuard is comprised of a Console and a RenalGuard Single Use Set for infusion and urine collection. The Single Use Set contains a urine collection set which connects to a patient's Foley catheter and an infusion set which connects to a standard IV catheter. The Console measures the volume of urine in the collection set and infuses an equal volume of hydration fluid to match the patient's urine output. The Console relies on proprietary, patented software and electronic weight measurements to control the rate at which fluid is infused and to monitor urine volume.

The Console includes a proprietary
Technology / Differentiation
RenalGuard Therapy works by safely inducing high urine rates. RenalGuard achieves these urine rates by matching the patient's urine output milliliter-for-milliliter, minute-by-minute. The accurate automated balancing of RenalGuard reduces the risk of over- or under-hydration relative to standard infusion.

Iodinated Contrast enables many of the life-saving procedures that are performed in cath labs around the world every day by allowing the vasculature to be imaged using x-ray. Unfortunately, that same contrast can also cause damage to a patient's kidney if it remains in the kidney for very long. RenalGuard Therapy has been designed to reduce the dwell time of contrast in the kidney by: - Increasing urine rates, and thus increasing the rate contrast is expelled from the kidney; - Increasing the patients level of hydration, which should dilute the contrast in the kidney; - Reducing the workload of the kidney, which will reduce the oxidative stress on nephrons. This should make the nephrons less susceptible to damage from contrast.
Market / Customers
PLC Medical Systems addresses the cardiac and vascular markets in the EU and US. RenalGuard can be used anywhere iodinated contrast is used to image the cardiac or vascular space.
Competitors / Substitutes / Alternatives
Osprey Medical
Status
RenalGuard is approved for sale in the EU. Two investigator-sponsored European studies have demonstrated RenalGuard's effectiveness at preventing CIN. One of these studies, REMEDIAL II, was recently published in the journal Circulation. The results of the second study, MYTHOS, were presented at TCT 2010 and are expected to be published soon. RenalGuard is being studied in a pivotal trial in the U.S., as required for approval by FDA.

With successful funding completed, PLC will deliver material milestones over the next 12 months: - Initiation of U.S. FDA Pivotal Clinical Trial; - Publication of MYTHOS trial; - Presentation of trial results at scientific meetings; - Issuance of Multiple Patents in U.S. - Method and Device; - Expansion of Distribution to largest OUS markets; - Acceleration of OUS Product Sales and Market Adoption.


2012-02-08-2970