Technologies

Our Technology

Through a precision-engineered process, the spherical microporous particles of DSM are produced from plant starch. Parameters like size, charge, porosity and in-vivo degradation times can be tailored to meet different therapeutic needs.

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Mode of Action

Magle’s DSM-A material is capable of accelerating natural hemostasis. It is marketed by Davol, Inc under the tradename Arista®. Creating an osmotic pressure, the particles concentrate platelets and other blood constituents on their surfaces and as the blood becomes dehydrated, the hemostatic cascade kicks in. Magle’s DSM-S is used as an adjuvant in the treatment of liver cancer. It is marketed in Japan by Yakult under the tradename Spherex® whereas Magle holds global rights outside Japan.

 

Put to work, a sterile DSM-S suspension is co-injected with the cytostatic drug in the hepatic artery, where the microspheres cause a temporary arterial occlusion and a high local concentration of the drug. The degradation of the DSM-S particles (forming glucose) starts immediately and full resorption is reached within 60 minutes, completely restoring blood flow.

Therapeutic Advantages

DSM is a based on plant starch material that is completely enzymatically degraded by the action of the body’s amylases. This makes DSM a safe and versatile material, which is easy to register as a medical device or as a carrier of active agents.

Stage of Development

DSM is commercially available for various clinical applications including hemostasis and chemoembolisation under the brand names Arista® and Spherex® respectively. Through development initiatives currently ongoing at our facility in Kristianstad, new ideas are being turned into tomorrow’s DSM products. Information about these projects and partners is not disclosed.

Regulatory Status

DSM in their currently available commercial forms are registered medical devices. Arista® is registered by the FDA, the Japanese FDA and CE marked in Europe.

Manufacturing

Pilot- and small scale production of finished DSM products is performed at our GMP and ISO 13485 approved facility in Kristianstad, Sweden. Commercial scale DSM is manufactured under GMP conditions at our FDA approved sister company.

Future Development

Potential areas where DSM opportunities can be turned into commercial value are for instance for wound care, cell culturing, embolotherapy, ophthalmology and controlled release. Modifying degradation time, onset and duration can be adjusted from minutes to weeks. The material lends itself well to varying administration routes, such as nasal, buccal or parenteral. DSM has very good stability in wet and dry formulations and it is resistant to degradation by heat or radiation.

Intellectual Property Portfolio

Due to the uniqueness and novelty of our microspheres and the processes associated with them Magle AB currently holds a large world-wide patent portfolio made up of major jurisdictions.