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A medical technology and pharmaceutical company in development stage with unique technology

PRO-MED AG, based in Linz, Austria, is a drug delivery company based on the SmartDose® ‘plug & play’ disposable infusion system. Originally developed in San Diego and licensed to Pro-Med, the technology and IP is now owned by the company.

The aim of SmartDose is to provide a safer, simpler and cost-effective method of drug infusion, replacing conventional infusion methods. This, with the full patient mobility allowed during infusion, increases patient compliance, which in turn improves drug acceptance and efficacy.

“Drug infusion is a delicate and dangerous phase during the treatment process. It calls for trained staff, skill, expensive equipment, time consuming handling procedures as well as considerable safety precautions.

Therefore, drug efficiency relies greatly on how the drug has been administered. By using a customized SmartDose product, for the first time, a pharmaceutical company can control drug delivery from the vial to the infusion point, eliminating possible handling errors,” Tomas J Svoboda, CEO, explained to Partnering Focus. “The combination of our high flow precision with our unique pre-filled disposable pump technology is setting SmartDose as the standard of care in controlled infusion in line with the worldwide efforts to increase the safety and efficacy of out of hospital (emergency & homecare) therapy whilst decreasing its cost and complexity.”

SmartDose can be used for intravenous and subcutaneous infusion, irrigation, and enteral or parenteral nutrition. The delivery system itself comprises a self-powered, pre-filled container with an inlet port for closed drug transfer and an outlet port for drug infusion. The system delivers the infusion precisely over a specific time with a predetermined or adjustable administration rate, and is powered by a patented effervescent system, producing only aqueous buffered sodium citrate as waste. The polypropylene construction of the system is compatible with proprietary and generic pharmaceuticals, and can be incinerated safely.

SmartDose provides adjustable volume, pressure, infusion duration, flow rate, number of chambers, material and accessories according to specific drug entity, application field or therapy pattern, and the system can be delivered to partners empty, diluent pre-filled or drug prefilled. Using SmartDose as a delivery system can also help with drug lifecycle management, by providing a marketing differentiator and improving safety. An additional advantage of SmartDose is that it allows the client company to retain control of its formulation—drugs in pre-filled SmartDose products are dosed exactly as the pharmaceutical company wants, whereas drugs delivered lyophilized in a vial are vulnerable to variations in reconstitution and administration.

SmartDose (empty and pre-filled) is approved as a medical device in the USA by the FDA; in Europe, the product has a CE market as a device, and the pre-filled version is approved as a drug. Now that the company has the in-depth medical files required for this approval, these can be easily combined with client’s drug files for individual product approval.

PRO-MED’s strategy is to work with strategic partners to customize SmartDose’s delivery of partner’s drugs, improving handling safety and ease of use, rather than selling directly to end users. Initially, the company’s targets are higher price drugs where the impact of the increased cost of delivery is not so great (for example emergency medicine) and out-patient ambulatory infusion drugs, where increased convenience, discretion and compliance are key to the drug efficacy. SmartDose products are gravity-independent, so are unaffected by hypo- and hyperbaric conditions. This means that the military is also a potential market, but PRO-MED opted to pursue this market segment only with a partner already well established in this stringent segment.

Pro-Med aims to match the price of existing products + packaging, and is not positioning SmartDose as a disposable infusion pump, but as part of the drug packaging. Partners can sell the combined drug and delivery system in a number of ways: in their packaging; in a kit form including drug vial and SmartDose; or as a bundle of two separate products.

Pro-Med is in late-stage negotiation with three undisclosed companies, and expects to complete its first partnership agreement this year. Over the next few years, Pro-Med expects to conclude several other deals—these will be flexible, and include exclusive licenses by drug or disease area, as well as non-exclusive deals, and will be in return for upfront payment, milestone, transfer and/or royalty payments.

The SmartDose system has strong intellectual property coverage, and every new development undergoes a patent antecedent scrutiny, triggering immediate patent filing when applicable. SmartDose received the Pharmapack Award in January 2003.

Pro-Med is backed by a large French venture capital company, and closed its second round end of May 2004 with an additional VC company based in Vienna. In five years, PRO-MED expects to either have developed or acquired in additional technologies and floated on the stock market, or continued specializing the SmartDose system under an umbrella or a larger organization.

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