Oxford, UK – 24 February 2026 – Amber Therapeutics today announced a series of updates to its business highlighting the significant progress it has made since closing its $100 million (£80 million) Series A financing in July 2024—one of the largest Series A rounds ever raised by a European medical technology company.
- New appointees to Board and Leadership team bring global strategic, operational and commercial experience from across the medical device sector.
- New headquarters and state-of-the-art manufacturing site at Harwell, Oxfordshire, enables clinical-scale manufacturing, product development, and team growth.
- AURA-4X study with Amber’s fully implantable, adaptive pudendal Picostim II neuromodulation system for mixed urinary incontinence expanding to multiple European sites following successful completion of its pilot phase.
Strengthening of Board and leadership team
As part of this continued expansion, Amber has appointed Dave Amerson as an Independent Board Member and strengthened its executive leadership team with the appointment of Claire Smith as Vice President, Commercial.
Mr Amerson brings deep leadership experience from across the medical device sector. He previously served as President and CEO of NeoTract, Inc. through its $1.1 billion acquisition, and as Chairman of the Board at Palette Life Sciences through its $600 million acquisition, both by Teleflex Inc. He also served as a Board Member of Relievant Medsystems, Inc. until its acquisition by Boston Scientific in 2023. Mr Amerson currently serves on the boards of ProVerum (Chairman), Calyxo, Moximed, and the Urology Care Foundation.
Ms Smith, a seasoned commercial leader with deep experience in neuromodulation and healthcare innovation, joins Amber from Nevro. During her tenure, Ms Smith successfully led the launch of multiple innovative products, helped establish and expand new markets, and developed scalable business model solutions that enabled the delivery of world-class patient care.
Opening of New UK Headquarters
The Series A financing has also enabled Amber to significantly expand its operational footprint, including the opening of its new headquarters and manufacturing facility at Harwell (near Oxford), the UK’s leading science and innovation campus. The Harwell site will support clinical-scale manufacturing, product development, and team growth as the company prepares for pivotal trials with Picostim II and commercial readiness.
Expansion of AURA-4X to Multiple European Sites
Building on the successful AURA-2 and recently completed AURA-3 studies—which demonstrated proof-of-principle for Amber’s fully implantable, adaptive pudendal Picostim II neuromodulation system for mixed urinary incontinence—the company has completed the pilot phase of AURA-4X (Augmenting Urinary Reflex Activity) and has expanded the study into multiple European sites. AURA-4X represents Amber’s most advanced clinical study to date and is a critical step in a structured pathway toward a future US–European pivotal trial.
The study is enrolling women with mixed urinary incontinence (MUI) and includes expanded cohorts evaluating efficacy in urge urinary incontinence, stress urinary incontinence, and chronic pelvic pain.
Commenting on overall progress, Aidan Crawley, CEO of Amber Therapeutics, said:
“The establishment of our new headquarters within a fully validated, state-of-the-art manufacturing facility and the advancement of the AURA-4X clinical study from pilot phase to multiple site roll out mark two major milestones for Amber. This, coupled with the additions of Dave Amerson to our board and Claire to the leadership team adds a wealth of US industry experience and helps position us to execute at scale as we advance toward our US pivotal trial and, ultimately, commercialisation.”
Dave Amerson, Independent Board Member at Amber, added:
“I am delighted to join Amber’s board at such an exciting time for the company as it looks to convert its incredibly promising early clinical data into a US FDA approved therapy that I believe can truly transform outcomes for the sufferers of mixed urinary incontinence.”
Charles Knowles, CMO of Amber Therapeutics, said:
“The early indications from AURA-4X represent a significant step forward in our mission to deliver a truly disruptive therapy for women with MUI. Demonstrating that we can safely implant and activate the Picostim II system reflects the culmination of many years of focused R&D, addressing both the biological complexity of MUI and the engineering challenges inherent in adaptive neuromodulation.”
– ENDS –
About Urinary Incontinence and the Neuromodulation Market
Urinary incontinence (UI) is a debilitating medical condition that affects millions of women globally. Many of these women experience symptoms of both urge incontinence (urgent and uncontrollable bladder leaks) and stress incontinence (bladder leaks during physical activity or exertion). However, there is no singular therapy available to treat patients with these MUI symptoms which can bring about a sense of loss of control and shame, leading to isolation and depression. Many do not actively seek treatment, with symptoms of UI found in 40 million women in the US but only 16 million currently managed on any form of therapy.
Existing therapies focus on either urge incontinence (e.g. sacral or tibial neuromodulation) or stress incontinence (e.g. bulking agents, slings, mesh supports). Mixed urinary incontinence (both urge and stress), is a sizeable population more than double that of the urge segment that neuromodulation currently addresses.
About Amber Therapeutics
www.amber-tx.com
Contacts
Amber Therapeutics
Aidan Crawley, CEO
[email protected]
MEDiSTRAVA
Sandi Greenwood / Frazer Hall / Mark Swallow
[email protected]
- Amber Therapeutics’ new headquarters and state-of-art manufacturing facility at Harwell, near Oxford, UK.