Our Company
Softhale is a privately held Belgium-based respiratory company focused on the development of pharmaceutical products with superior clinical performance based upon differentiated technology delivered by our next generation Soft Mist Inhalation (SMI) device to the lungs.
The Company’s proprietary, propellant-free, purely mechanical device delivers medication to the lungs more effectively than other types of inhalers and is poised to change the treatment paradigm in large markets including asthma and COPD. Softhale’s products to be used for pharmaceutical development and approval processes are innovative as well as cost-optimized.
Softhale is ISO 13485: 2016 certified.
Our Product
Our next generation SMI products incorporate a proprietary set of technical configurations to spray a propellant-free liquid formulation in a highly efficient way. SMI technology is the latest technology, which more effectively delivers drug product to patients’ lungs and improves outcomes.
Our technology creates an ultra-fine mist using a mechanically-driven impinging working principle, offering a variety of patient benefits:
They help the medication pass the natural curve of the throat
They give users time to naturally breathe in the medication
They help users get the medication deep into their lungs
The Softhaler® can be tailored and adapted to further support the performance and profile of new products.
Our Journey
2012
In 2012, the founding members of Softhale met and started their conceptual work on a new generation Soft Mist Inhaler (SMI). The team had proven expertise in the microfluidic, medical device, pharmaceutical, and business development competencies, and the collaboration resulted in a business concept to start a pharmaceutical company.
2013
The first patent was filed by the group in 2013.
2014-2015
The team then conducted concept validation work and initial freedom-to-operate analysis, followed by the creation of a business plan. This plan – coupled with the team’s strong background – helped Softhale raise seed funding, leading to early-stage proof-of-concept work in 2014-2015.
2016
Since then, the Softhale team has successfully expanded collaborations across geographies, attracting series of funding and investing in a proprietary, innovative approach to inhalation therapy. This led to a successful Series A round, a more than €1 million grant, and a first customer-funded proof-of-concept study in 2016.
Softhale NV was established in Diepenbeek, Belgium in 2016, and development activities related to our proprietary next-generation SMI intensified.
2018-2019
In 2018 and 2019, the internal team grew with the recruitment of leading industry experts in the respiratory field with a long track record of bringing inhalable branded and generic products to market.
Softhale’s proprietary device technology is protected by 15+ patents. Our portfolio also expanded with a branded high-end product. Our current activities are financed by the successful series B fundraising closed in early 2019.
2021
Sino Biopharmaceuticals takes the main stake in Softhale NV.
Over the past years, our investors have played a fundamental role in transforming Softhale from its medical technology-driven origins into a highly specialized developer of respiratory medicines. Also, in accelerating the development of our pipeline with operational expertise, resources, and a global network they played a crucial role.
At this moment in time, at this crucial point of our development, Sino Biopharm is a great partner on our mission to further advance and broaden the development of our platform and to build and launch a new generation of highly effective inhalable medicines on a global scale.
Dr. Jan-Torsten Tews, CEO of Softhale
March 22, 2021
News
Get to know us
Softhale is a pharmaceutical company which develops inhalable therapeutics, based on our next generation Soft Mist Inhaler (SMI) device. Our primary focus is on the development of improved treatment options for the growing number of asthma and COPD patients worldwide. At the same time, we also explore tailored inhalation products outside the prescription driven market with our partners.