- € 10 million (US$ 11.5 million) raised to obtain conditional EMA market approval for treatment of Traumatic Spinal Cord Injury
- Clinical Phase I trial successfully completed: Positive safety profile and well tolerated, without product-related adverse effects
- International multi-center randomized placebo-controlled Phase II clinical study to be started soon
- Solid foundation for first therapeutic area, additional funding sought to explore broader potential of Neuro-Cells® technology platform in other primarily inflammation-driven neurological disorders
GELEEN, Netherlands, Nov. 17, 2021 /PRNewswire/ -- Dutch clinical phase biotech Neuroplast raised a total of € 10 million (US$ 11.5 million) in funding from investors Lumana Invest, Brightlands Venture Partners, LIOF, and from the Innovation Credit from the Netherlands Enterprise Agency, to further advance the clinical development of a transformative treatment for Traumatic Spinal Cord Injury (TSCI). Neuroplast will use this Series B funding to obtain conditional EMA market approval for its Neuro-Cells® stem celltherapy.
Annually, approximately 29,000 people across Europe and the USA suffer from acute Traumatic Spinal Cord Injury (TSCI), for which effective treatment is currently unavailable. Patients usually experience life-long disability and dependence, with a negative impact on quality of life. Furthermore, associated costs for society at large are estimated at over €11.4 billion ($13 billion) per year.
With the aim of giving back perspective to people that suffer from primarily inflammation-driven neurological disorders, Neuroplast has developed Neuro-Cells®, a treatment that uses the patient's own stem cells to prevent (further) loss of function during the acute phase after sustaining damage to the spinal cord, to save mobility and independence.
Marcel Kloosterman, Managing Partner at Brightlands Venture Partners (BVP), states:
"The science behind Neuroplast's technology platform is truly groundbreaking.A future in which patients can make smart use of their own cells to put a stop to further neurological damages and improve potential regeneration is getting closer and closer. For BVP it is a thrill to be part of that fascinating journey."
Neuroplast acquired a GMP1 license and received a European Orphan Designation2 that allows fast-track development. Furthermore, it has already successfully completed a clinical Phase I trial, in collaboration with Hospital Nacional de Parapléjicos in Spain, that confirmed safety and tolerability, without product-related adverse events. The Dutch Limburg-based biotech is currently preparing for an international multi-center randomized placebo-controlled Phase II study.
Tys van Elk, Director at LIOF, adds:
"Our mission is to move together towards a smarter, more sustainable, and healthier Limburg. We are pleased to see that the life sciences and health ecosystem in Limburg is a successful breeding ground for innovative companies like Neuroplast, that can really make impact."
Neuroplast will use the €10M (US$ 11.5M) Series B funding to take the next steps towards conditional EMA market approval for TSCI, which includes running Phase II and III trials, consulting the EMA and executing a Health Technology Assessment.
Next to the funded pathway for TSCI, Neuroplast aspires to explore applicability of the Neuro-Cells® technology platform to other therapeutic areas.
Wim Smit, Managing Director at Lumana Invest, comments:
"We are not only excited about the clinical progress of Neuro-Cells® treatment for TSCI, but also about the outlook of the technology to other conditions, such as Traumatic Brain Injury."
Vincent The, Chief Financial Officer at Neuroplast, concludes:
"This funding enables us to complete the Neuro-Cells® development pathway for TSCI. With the recent successful completion of our Phase I study, we now have both a good clinical as well as a solid financial foundation in place. This puts us in a great position to start exploring the broader potential of the Neuro-Cells® technology platform for other primarily inflammation-driven neurological disorders. For these activities, we are seeking complementary investment."
About Traumatic Spinal Cord Injury
Acute TSCI causes incurable impairment to the spinal cord, affecting approximately 12,000 people across Europe and 17,000 across the USA annually. The damage or trauma interrupts communication of the brain with the body regions below the site of injury. Spinal cord injuries are mainly caused by accidents and - in most of the cases - result in life-long loss of control of motor functions and sensations. After the primary injury to the spinal cord, a cascade of events leads to progressive loss of tissue which may further deteriorate the patient's prognosis. Current treatment approaches for TSCI are only symptomatic, leaving the underlying pathophysiology unchanged.
TSCI has a serious impact on the quality of life of patients, with severe implications on mobility and loss of independence. In addition, TSCI creates a lifetime financial burden for patients, payors, healthcare systems and societies at large.
Neuro-Cells® is a transformative treatment under GMP in the crucial first phase after sustaining TSCI, during which the irreversible impact of TSCI can be radically reduced. It contains non-substantially manipulated bone marrow-derived hematopoietic and mesenchymal stem cells, manufactured from a patient's own bone marrow (donor and receiver are the same person). Inflammatory inducing components and pathogens are removed during this process.
Neuroplast is a Dutch stem cell technology company focusing on fast-track development programs using autologous cell products for treatment of primarily inflammation-driven neurological disorders, with the aim of giving back perspective to people who suffer from those conditions.
The company was founded in August 2014 by physician Johannes de Munter and neurologist Erik Wolters. Current investors are Lumana Invest, Brightlands Venture Partners, LIOF and the Netherlands Enterprise Agency. Neuroplast is located in Brightlands Chemelot Campus in The Netherlands.
About Lumana Invest
Investment company Lumana was established by entrepreneurs and unique due to not having a predetermined investment horizon. The Lumana founders showcase strong commitment to their portfolio companies by actively supporting management in strategic decision making.
About Brightlands Venture Partners
Brightlands Venture Partners is the fund manager of BVP Fund IV and is a so-called ecosystem investor. BVP invests in companies benefiting from and contributing to the Brightlands campuses in the south of The Netherlands. Other funds under management are Chemelot Ventures, Brightlands Agrifood Fund and Limburg Ventures. BVP Fund IV focuses on sustainability and health and is the successor fund of the 2014 vintage Chemelot Ventures; together the funds have made over 40 investments.
LIOF is the regional development agency for Limburg and supports innovative entrepreneurs with advice, network and financing. Together with entrepreneurs and partners, LIOF is working towards a smarter, more sustainable and healthier Limburg by focusing on the transitions of energy, circularity, health and digitalization.
About The Netherlands Enterprise Agency
The Netherlands Enterprise Agency operates under the auspices of the Dutch Ministry of Economic Affairs and Climate Policy. It facilitates entrepreneurship, improves collaborations, strengthens positions and helps realize national and international ambitions with funding, networking, know-how and compliance with laws and regulations.
Forward looking statements
All statements other than statements of historical facts, including the statements about the clinical and therapeutic potential and future clinical milestones of Neuro-CellsÒ, the indications we intend to pursue and our possible clinical or other business strategies, and the timing of these events, are forward-looking statements. Forward-looking statements can be identified by terms such as "believes", "expects", "plans", "potential", "would" or similar expressions and the negative of those terms. These forward-looking statements are based on our management's current beliefs and assumptions about future events and on information currently available to management. Neuroplast B.V. does not make any representation or warranty, express or implied, as to the improper use of this article, accuracy, completeness or updated status of above-mentioned statements. Therefore, in no case whatsoever will Neuroplast B.V. be legally liable or liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.