• US$13.75M financing completed to accelerate clinical pathway and global commercialisation
• Establishment of NinaMED Pty Ltd, a new Australian medtech company
• NinaMED Pty Ltd secures a license from EBT Medical for exclusive global rights to NiNA System®, a non‑invasive, at‑home OAB therapy targeting a 550 million‑patient market with a drug‑free alternative
• NinaMED Board chaired by Ian Meredith, bringing world‑class medtech leadership

 NinaMED Pty Ltd (NinaMED), a newly formed Australian medical device company,  announced its establishment and US $13.75 million (AUD $19 million) in financing led by SPRIM Global Investments (SGI). NinaMED holds an exclusive license from Toronto-based EBT Medical to develop and commercialise the NiNA System®— non-invasive, at-home, drug-free, therapy for overactive bladder (OAB).

The NiNA System® is a non-invasive, wearable neuromodulation system that uses proprietary technology to activate NinaMED's patented saphenous nerve target. The novel patient-centric design enables convenient, in-home treatment sessions while significantly and persistently delivering reduced symptoms of OAB.

Established and headquartered in Melbourne, NinaMED Pty Ltd is an Australian medical device company conducting clinical development in Australia for this worldwide commercialisation opportunity. The new financing will be used to accelerate development of the NiNA System®, support the path to an Investigational Device Exemption (IDE) Application, and build out the company's operations in Australia.

NinaMED also announced its newly appointed Board of Directors, led by Chair Ian Meredith and Non-Executive Directors, Kelly Constable and Steffen Hovard, bringing deep medical device, healthcare, and global commercialisation experience to support the company's next phase of growth.

"SPRIM is excited to announce the establishment of NinaMED as a new Australian medical device company and to have led this financing. The NiNA System® represents a compelling and differentiated solution in the large and growing OAB market. We look forward to supporting NinaMED as it advances NiNA towards worldwide commercialisation," said Michael Shleifer, SPRIM Global Investments.

"SV Health Investors welcomes this important step forward for EBT Medical, the advancement of the NiNA System® technology and the establishment of NinaMED. NiNA addresses a significant unmet patient need with a compelling, novel approach. SV Health Investors looks forward to supporting the team as they advance this technology toward commercialisation." said Gregory Madden, Managing Director of SV Health Investors and EBT Board Member.

"This financing marks an important milestone in the journey of a technology we have invested deeply in, and we are pleased to see NinaMED advancing toward commercialisation with the support of SPRIM and long-standing backer SV Health Investors. EBT will continue to develop Ina, its fully implantable saphenous nerve technology, as NinaMED advances NiNA System® toward commercialisation" said Keith Carlton, Co-Founder, Chief Executive Officer, and Board Member of EBT Medical Inc.

Newly appointed Chair of NinaMED, Professor Ian Meredith said "I am excited by the strength and simplicity of the NiNA System® technology, the significant unmet need in pelvic health disorders, and the opportunity to be appointed Chair of NinaMED at such an important stage in its development. I look forward to working with the NinaMED team as it builds and maintains an Australian presence in support of a global commercialisation opportunity."

OAB affects an estimated 550 million people worldwide and represents one of the most significant underserved conditions in urology. For patients who do not want to take another pill and are not ready for surgery, NiNA System® may be an ideal alternative. Current treatments — anticholinergic medications, beta-3 agonists, botulinum toxin injections, and sacral / tibial nerve stimulation — are associated with systemic side-effects, invasiveness, or the burden of frequent in-clinic procedures.

The NiNA System® technology was discovered and patented at the University of Toronto by EBT Medical's co-founder, Professor Paul Yoo. The NiNA System® has been studied in multiple feasibility studies in the United States and Canada. The device targets the saphenous nerve — a shallow, sensory only nerve accessed in the upper calf — which operates via a centralised mechanism designed to deliver a safer, more efficacious, and more comfortable treatment experience compared with existing neuromodulation approaches.

Board of Directors

NinaMED is pleased to announce the newly appointed Board members of NinaMED:

• Ian Meredith, MD — Chair, NinaMED
  Leading Australian interventional cardiologist and medtech executive who served as EVP and Global Chief Medical Officer at Boston Scientific, with extensive experience in medtech innovation and global healthcare leadership.
• Kelly Constable — Non-Executive Director, NinaMED
  Experienced healthcare and medtech executive with a background in commercialisation, investment, and growth strategy across life sciences companies.
• Steffen Hovard - Non-Executive Director, NinaMED
  Healthcare executive with experience in medtech company leadership, commercial strategy, and innovation within the life sciences sector including direct prior relevant experience as President of Coloplast's Interventional Urology business and CEO of a start-up Sacral Neuromodulation company.

In conjunction with the financing, EBT Medical is pleased to announce the appointment of Ivan Jarry as Non-Executive Director to its Board of Directors. Ivan is a global health and medtech investor with extensive experience building international businesses, venture platforms, and early-stage health technology companies.