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Class I medical device status for Biodose Connect®

Class I medical device status for Biodose Connect®

Quantum Pharma Plc (AIM: QP.), the growing, service-led niche pharmaceutical manufacturer, developer and supplier to the health and care sectors, is pleased to announce that the Group's innovative telemedicine technology, Biodose Connect® ("the device") has successfully completed formal validation testing and now has Class I medical device status. Quantum can now implement its commercialisation strategy for the device.

The Class I medical device status of Biodose Connect® means that it now has CE mark authorisation. The process is governed by the Medicines and Healthcare products Regulatory Agency (MHRA), the UK healthcare regulatory authority.

Biodose Connect® is now ready for use in live patient settings, allowing the patient, carer, doctor or pharmacist to be alerted by remote monitoring if medicines are not taken as prescribed, with the aim of reducing the costs of poor medication adherence to both the NHS and social care fund holders.

The Quantum Board believes this is an exciting development that presents healthcare professionals with an opportunity to remotely monitor patients and to gather empirical data on adherence to the relevant prescription regime for their medication. It is estimated that between a third and half of all medicines prescribed for long-term conditions are not taken as recommended with an estimated cost of waste medication alone of around £100m per year, excluding any associated social or healthcare costs of not achieving the intended health outcomes from treatment1. A report published by the Department of Health said that medication errors contributed to 5 to 8% of hospital admissions in the UK 2.

Quantum is now able to move forward with its commercialisation strategy for this device, which will be branded as "Biodose Connect® by Vaica". Quantum has been working with Vaica Medical Ltd, a leader in the medical adherence industry, to develop the device since November 2014. Vaica has expertise in developing devices and associated IT to support patients with their adherence and Biodose Connect® works in conjunction with Vaica's software and further IT applications developed within the Quantum Group.

There will be an initial soft launch of Biodose Connect® by Vaica to the private pay market through selected pharmacies that are part of a national pharmacy chain. Quantum is also planning services to independent pharmacies on a regional basis. The product's use will then be extended to trials with Clinical Commissioning Groups (CCGs) which it is hoped will lead to funded services and in time to services funded by large pharmaceutical companies.

Biodose Connect® is an extension of Biodose® that supports the delivery of medicines with real-time information delivered electronically to carers and clinicians about their patients' adherence to their medication regime. Biodose® consists of a tray, 28 medicine pods and a seal, used to arrange medication in a patient specific format. It is currently used by around 50,000 patients across the UK and Ireland in either a care home or domiciliary care and transforms medication management in these settings. It is the only medication delivery system on the market that accommodates both liquid and solid doses.

Andrew Scaife, Chief Executive of Quantum Pharma Plc, commented: "We are delighted that our Biodose Connect® device now has Class I medical device status and we can start to commercialise it. It is an exciting product that we believe will provide a huge benefit to the NHS, social care providers and pharmaceutical companies, not only by reducing the burden created by medication non-adherence, but also in allowing patients to be treated at home. We look forward to bringing Biodose Connect® to the market and showcasing its strong benefits."


1) Medicines Adherence: Involving patients in decisions about prescribed medicines and supporting adherence (CG76) Jan 2009 NICE

2) Exploring the costs of unsafe care in the NHS. A Report prepared for the Department of Health. Frontier Economics Oct 2014

Posted by: Quantum Webmaster on 1st June 2016