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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.

Softhale ISO 13485

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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.

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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

July 2021

Softhale certified to ISO 13485: 2016

Softhale has successfully achieved certification of its’ quality management system for medical devices. ISO 13485 is the medical industry's optimal, internationally agreed, medical device standard. It ensures that medical devices meet the proper regulatory compliance laws and customer needs.

April 2019

Laurence Blazianu joins Softhale NV as new Chief Financial Officer

Laurence brings large and small size healthcare company and investment firm experience, supporting executive missions to secure the growth path and related corporate financing. Laurence previously worked for Hoffmann-La Roche, Credit-Suisse and is Partner at Cukierman & Co. Life Sciences.

March 2019

A series B fund raising was successfully closed

A series B fund raising was successfully closed with existing investors led by New Rhein Healthcare Investors LLC in a low double digit mEUR range. The funds will finance near-term R&D activities for our lead compounds entering into the clinic, the growth of our team and expertise to develop our portfolio of branded high-end products as well as the expansion of our collaborations evaluating the span of our technology platform.

November 2018

Iain Breakwell joins Softhale NV as Head of Project Management

Iain has a strong scientific background and significant technical project management experience, leading multiple cross-functional teams in high value, first-to-file opportunities for generic combination drug products in varied inhaled dosage forms. Iain joins Softhale from Teva (formerly Actavis) and is ex-Novartis and ex-Sanofi.

October 2018

Softhale NV announces New Board Member

We are delighted to welcome Mr. Nevan Charles Elam, J.D., on our Board. He has a rich background in management, operations, consulting, finance, and corporate law in combination with long term experiences in executive roles in pharmaceutical and medical device companies.

June 2018

Steven Dudley joins Softhale NV as Head of Development

Steven is an engineer and an expert in combination product development in the field of orally inhaled drug products for both branded and generic submissions. He brings over 20 years of experience, most recently from Teva (formerly Actavis), PA Consulting, Novartis and IVAX.

May 2018

Isabel Sequeira Lopes joins Softhale NV as Head of Formulation

With almost 15 years of experience Isabel comes from Chiesi, Hovione and Pfizer where she was the Lead Senior Scientist and Project Coordinator of more than 20 projects related with the development and manufacturing of both generic and NCE orally inhaled drug products.

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.

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