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Accurate, Precise Microlitre Dosing

With an ageing population, development of novel therapeutics, and an increasing number of patients with uncontrolled diabetes, the number of microlitre injections is projected to continue to rise. Since 2006, the number of microlitre injections has dramatically increased due to the availability of new treatments for conditions such as agerelated macular degeneration, diabetic macular edema, and vein occlusions. This trend is projected to be replicated with treatments in dermatology, neurology, and oncology; therapeutic treatments include small molecules, monoclonal antibodies, and cell and gene therapies.

Currently, treatments requiring microlitre dosing are primarily administered using hypodermic or insulin syringes. Delivering with these syringes requires the user to draw up the drug into the syringe and align the plunger seal with an external dose marking. It is widely reported in the literature that all syringes currently used for microlitre dosing (50μl or lower) are inaccurate and imprecise. This is because these syringes, indicated for use in general aspiration and dispensing, are operating at the limits of human capability and at the technical limits of the syringe itself.

Additionally, drugs are often stored in these syringes for several months. The lack of availability of syringe-based injection systems that are more suitable for applications requiring microlitre dosing has resulted in several reports of syringe-related adverse events. This problem is compounded by significant off-label use of both syringes and drugs. In early 2018, several reports of sterile intraocular inflammation were reported in the US associated with the injection of certain lots of Eylea®. Subsequently, Regeneron Pharmaceuticals notified clinicians of their decision to not distribute the hypodermic syringe as part of its drug kit. This was a case where even the short residence time of the drug can result in a serious adverse event. Syringebased delivery systems have severely lagged advancements in drug treatments requiring microlitre dosing.

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Congruence Medical Solutions, LLC, a privately held company based in Baltimore, Maryland, US, is pioneering development and supply of microlitre injection device systems. Incorporated in 2015, Congruence Medical Solutions has developed its lead product: the Microliter Dosing Syringe (MDS) platform for single microlitre dose applications. With a strong team and a proven track record in injectable drug delivery space, Congruence Medical Solutions aims to supply variants of the MDS and other device platforms to pharma companies. Some variants of the MDS can be available for clinical use as early as January 2020.
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