Closed Loop Medicine secures UKCA marking and receives CE designation for a Medical Device that will form part of its insomnia product CLM-IN01

The company has secured UKCA and CE Medical Device marking for its software as a Medical Device (SaMD) component of its drug + SaMD combination product for chronic insomnia.

London, UK, 03 June 2021: Closed Loop Medicine Ltd, a healthcare company focused on developing drug + digital combination products, the next generation of patient centric pharmaceutical products, announces securing its UKCA (UK Conformity Assessed) marking approval and also achieving its CE mark as a Medical Device for the software that will form part of its combination product CLM-IN01 for patients with chronic insomnia.

CLM-IN01 is currently in development, the final product aims to transform a patient’s care by integrating drug therapy and digital care solutions at an individual level, delivered through the Company’s proprietary Software as a Medical Device (SaMD) platform.

Earlier in the year the company reported completion of a clinical study designed to evaluate the drug component of the combination product. This latest news combined with previous clinical study completion places the company in a strong position ahead of a planned regulatory submission.

Insomnia is the most common sleep disorder, characterized as disturbed and inadequate sleep and affects 10-15% of the adult population. Patients with insomnia have difficulty initiating sleep, difficulty in maintaining sleep, and/or experience nocturnal and early morning awakenings without the ability to return to sleep. Due to its chronicity, insomnia is associated with substantial impairments to an individual’s quality of life.

The combination products being developed by Closed Loop Medicine, including its product for insomnia, will allow greater access to integrated care solutions tailored at an individual level.

Dr Hakim Yadi OBE, Chief Executive Officer commented: “This is a company-wide achievement, the whole team has come together to deliver a critical component of our combination product that we hope will enable people suffering from insomnia a path back to better sleep”. 

About Closed Loop Medicine

Closed Loop Medicine is a healthcare company developing drug+digital combination products, transforming drug effectiveness by providing every drug with its real time digital companion.  The company was founded by an experienced team of healthcare professionals, entrepreneurs and life scientists with experience of both drug and software development, as well as extensive health system innovation experience. Closed Loop Medicine is developing a new product class, a combinational therapy that binds drug therapy with digital therapy to personalise care for patients. Whilst the company is currently focused on products for hypertension and sleep, it aims to further develop its pipeline with additional single-prescription combination products for a wide portfolio of chronic diseases, ensuring that both patient and clinician are at the centre of its products and solutions.

 For more information, please contact Dr Yadi at info@closedloopmedicine.com.