Preventing Acute Kidney Injury Creates Investment Opportunity

The administration of radiocontrast media can lead to an usually reversible form of acute kidney injury (formerly called acute renal failure) that begins soon after the contrast is administered. In most cases, there are no permanent sequelae, but there is some evidence that its development is associated with adverse outcomes.

Contrast-induced nephropathy ("CIN") is defined as the impairment of renal function and is measured as either a 25% increase in serum creatinine from baseline or 0.5 mg/dL (44 µmol/L) increase in absolute value, within 48-72 hours of intravenous contrast administration.

For renal insufficiency ("RI") to be attributable to contrast administration, it should be acute, usually within 2-3 days, although it has been suggested that RI up to 7 days post-contrast administration be considered CIN; it should also not be attributable to any other identifiable cause of renal failure.

The CIN market is a more than $500 million market which can be conquered by niche players such as AngoDynamics (ANGO), PLC Systems (PLCSF.OB) and Australian listed Osprey Medical. Bristol-Meyers Squibb (BMY) has a lack of clear supporting clinical data for its preventive product so they will not profit from this market going forward.

Current Treatment Methods for CIN
The only clinically accepted and routinely utilized preventive measure for patients at risk for CIN is pre- and post- procedure overnight hydration, which is inconvenient, expensive and time-consuming for hospital staff.

There is currently no FDA-approved device or drug for CIN prevention, but it is expected that this will change soon.

Due to the attractiveness of the potential market, there are a number of other companies developing or investigating potential new CIN preventive drugs, devices and therapies.

Preventive measures being used in clinical practice today include:

Mucomyst® N-acetylcysteine (Mucomyst®)
Mucomyst is both a renal vasodilator and antioxidant. It is produced by Bristol-Meyers Squibb . It is prescribed by a doctor prior to the start of an interventional procedure and is taken by the patient in prearranged doses that may start the day before the procedure. This therapy is employed by many physicians due to an extremely low risk profile and cost. A team of Brazilian researchers 10-Q filing I noticed that in the first quarter the company incurred a net loss from operations before taxes of approximately $7,808,000 and used cash in operations of approximately $2,158,000. As of March 31, 2013, cash and cash equivalents were $1,863,000. Management expects that quarterly losses and negative cash flows will continue during 2013. Based upon the current financial condition of the company and the expectation of continued quarterly losses during 2013, management is currently investigating ways to raise additional capital that can be completed in the next several months.

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The company believes that its existing resources, based on its currently projected financial results, are sufficient to fund operations through the third quarter of 2013. Based upon current and anticipated revenue projections from foreign sales of our RenalGuard product, and the anticipated costs of its U.S. clinical trial, PLC Systems expect that they will need to raise additional capital during the remainder of 2013. The company was able to raise an additional $4,040,000 in capital on February 22, 2013, through the completion of financing with Palladium Capital Advisors LLC..

With the sale of their TMR business in February 2011, the company's future prospects are solely dependent upon the successful commercialization of RenalGuard. To date PLC Systems has recorded only a limited amount of sales of RenalGuard, principally to a single customer in one country, Italy.

The ability to effectively market RenalGuard outside the U.S. is largely dependent on the reception of the results of the MYTHOS and REMEDIAL II investigator-sponsored clinical trials.
The RenalGuard System has only had limited testing in a clinical setting in the United States so the company may need to modify it substantially in the future for it to be commercially acceptable in the broader market.

Despite all these financial risks mentioned above I think the company offers a compelling opportunity to profit from the growing CIN market with a market value of more than $500 million.

Final Note
CIN is one of the leading causes of hospital-acquired acute renal failure. It is associated with a significantly higher risk of in-hospital and 1-year mortality, even in patients who do not need dialysis.
Nonrenal complications include procedural cardiac complications, vascular complications, and systemic complications.

There is a complicated relationship between CIN, comorbidity, and mortality. Most patients who develop CIN do not die from renal failure. Death, if it does occur, is more commonly from either a preexisting nonrenal complication or a procedural complication.

Many physicians who refer patients for contrast procedures and some who perform the procedure themselves are not fully informed about the risk of CIN. A survey found that less than half of referring physicians were aware of potential risk factors, including diabetes mellitus.

Patients with risk factors for CIN should be educated about the necessity of follow-up care with their physicians with a postprocedure SCr estimation, especially if the initial procedure was done on an outpatient basis.

Specifically, prevention strategies involving calcium-channel blockers, endothelin receptor antagonists, theophylline, prostaglandins, diuretics, anti-oxidants, or other reno-protective drugs have been shown to have no benefit or to have little consistent effect.

I believe the Benefit Catether of AngioDynamics and the RenalGuard Therapy of PLC Systems are until now the only two successful treatments hospitals are looking for.

Written By: Dutch Trader