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It Believes that Its Catheter Lock Solution is Well Positioned to Unlock Significant Shareholder Value

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CorMedix Inc. (CRMD)

Intravascular catheters are indispensable in modern-day medical practice, particularly in intensive care units. Although such catheters provide necessary vascular access, their use puts patients at risk for local and systemic infectious complications, including local site infection, catheter-related bloodstream infections (CRBI), septic thrombophlebitis, endocarditis, and other metastatic infections (e.g., lung abscess, brain abscess, osteomyelitis, and endophthalmitis)

Health-care institutions purchase millions of intravascular catheters each year. The incidence of CRBIs varies considerably by type of catheter, frequency of catheter manipulation, and patient-related factors (e.g., underlying disease and acuity of illness).

CRMD's Neutrolin(R) is a catheter lock solution for the prevention of catheter-related bloodstream infections (CRBI), and maintenance of catheter patency in Hemodialysis patients.

It is a broad-spectrum antimicrobial/antifungal and anticoagulant combination that is active against common microbes including antibiotic-resistant strains and in addition may prevent biofilm formation. CRMD believes that using Neutrolin as a catheter lock solution will significantly reduce the incidence of CRBIs, thus reducing the need for local and systemic antibiotics while prolonging catheter life.

CRMD reported the progress of on-going discussions with the U.S. Food and Drug Administration (FDA) for a planned pivotal Phase 3 randomized controlled trial for Neutrolin for use in hemodialysis patients with a central venous catheter.

CRMD worked with the FDA to develop the protocol design for the planned trial for a marketing application. Based on FDA input, the planned Phase 3 clinical trial will be a multi-center, randomized, controlled study conducted in the U.S. and Europe. Dr. Michael Allon, Professor, Department of Medicine, Division of Nephrology, University of Alabama, Birmingham will be the Study Chair of the Neutrolin Phase 3 program.

In addition, CRMD has earlier submitted detailed information to TUV-SUD for the purpose of advancing its label expansion in the European Union to include oncology, total parenteral nutrition and intensive care patients.

CRMD believes that Neutrolin is well positioned to unlock significant shareholder value.

CRMD is a commercial-stage pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. CRMD's first commercial product in Germany is Neutrolin(R), a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients.

More about CorMedix Inc. (CRMD) at www.cormedix.com

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Alimera Sciences, Inc. (ALIM)

According to the 2014 National Diabetes Statistics Report, 29.1 million people or 9.3% of the population in the United States have diabetes.

People with diabetes are at an increased risk for developing eye problems. One reason is because diabetes and other complications can cause damage to the blood vessels of the retina (diabetic retinopathy), resulting in vision impairment. Left untreated, these blood vessels begin to build up pressure in the eye and leak fluid, causing Diabetic Macular Edema (DME).

DME, the major cause of vision loss in people with diabetic retinopathy, is an accumulation of fluid in the macula—part of the retina that controls our most detailed vision abilities—due to leaking blood vessels. These leaks cause the macula to thicken and swell, progressively distorting acute vision. While the swelling may not lead to blindness, the effect can cause a severe loss in central vision.

ALIM reported that the Italian Medicines Agency (Agenzia Italiana del Farmaco) has granted marketing authorization to ILUVIEN(R) for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

Designated a C Class product in Italy, ILUVIEN will be available initially to private paying patients. ALIM is pursuing H Class designation for ILUVIEN with the Italian regulatory authorities, which, if granted, would expand patient access to the product.

ILUVIEN is a sustained release intravitreal implant used to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide. ILUVIEN is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound.

ALIM is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals.

More about Alimera Sciences, Inc. (ALIM) at www.alimerasciences.com

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