Amber Therapeutics Submits IPO Prospectus for Groundbreaking Single-Therapy Solution to Mixed Urinary Incontinence Following $100M Series A Round

Urinary incontinence is a highly prevalent condition that severely affects millions of people worldwide. Moreover, the majority of patients do not receive effective treatment. According to data from the International Continence Society (ICS), the prevalence of urinary incontinence among women in China is 30.9%—nearly one-third.

Urinary incontinence can occur at any age, but it is more common in women and the elderly, affecting approximately 30% of older women and 15% of older men. Due to the significant under-recognition and underreporting of urinary incontinence, many patients do not disclose this condition during medical consultations, and many physicians do not specifically inquire about it.

As a discreet and often stigmatized condition, urinary incontinence can lead to various complications, including skin infections, urinary tract infections, social isolation, and depression, significantly diminishing patients' quality of life.

Amber Therapeutics is a University of Oxford-incubated startup headquartered in London, UK. Founded in 2021, the company is dedicated to developing next-generation intelligent bioelectronic therapies, with the aim of creating smart and innovative neuromodulation treatments for patients with functional neurological disorders. Currently, Amber Therapeutics is focusing on the development of Amber-UI, an adaptive neuromodulation therapy designed to treat mixed urinary incontinence in women, helping them restore normal physiological function.

It is estimated that 6.8 million patients in the United States are eligible for existing sacral neuromodulation therapy; however, the adoption rate of this therapy remains low, with approximately 50,000 implants performed annually, and it is currently indicated only for the treatment of urge urinary incontinence. Although the incidence of mixed urinary incontinence is more than three times that of urge urinary incontinence, there are virtually no specific monotherapies available on the market for these patients to date.

Amber Therapeutics stated that Amber-UI is the first fully implantable closed-loop bioelectronic therapy under clinical development for urinary incontinence. It can be accessed via minimally invasive surgery to target and directly stimulate the pudendal nerve, which controls urinary incontinence, while monitoring physiological responses.

Amber-UI leverages the intelligent capabilities of its next-generation neuromodulation platform, Picostim DyNeuMo, to create “synthetic reflex arcs.” These arcs can sense, interpret, and respond to individual patient signals, thereby simulating the body’s natural reflex mechanisms. By collecting and analyzing physiological data to identify issues, the system adjusts stimulation parameters and therapeutic strategies accordingly, helping patients restore normal physiological function.Amber-UI can be customized to meet individual needs, dynamically respond to various events, and adjust across different operational modes to achieve personalized adaptive pudendal nerve modulation.

This advantage stems from an acquisition undertaken by the company in 2023. On September 5, 2023, Amber Therapeutics announced the acquisition of Bioinduction and its Picostim DyNeuMo neuromodulation therapy platform, integrating the platform into Amber-UI’s closed-loop therapy.

The Picostim DyNeuMo system was initially developed as an intracranial implant for deep brain stimulation therapy in patients with Parkinson’s disease. In collaboration with an academic consortium led by the University of Oxford, the system has been further refined to support closed-loop adaptive therapy and is currently undergoing multiple first-in-human clinical trials. Amber Therapeutics leverages the next-generation Picostim DyNeuMo platform to deliver its Amber-UI therapy via an implantable system. This hardware is powered by an advanced integrated data science toolkit, enabling the rapid development of adaptive therapeutic algorithm models.

Furthermore, this acquisition brings to the company a highly skilled team with extensive experience in the development and manufacturing of neuromodulation devices for the treatment of urinary incontinence. To date, more than 4,000 such devices have been implanted through Finetech Medical, a subsidiary of Bioinduction. This acquisition will accelerate the pivotal trials required to introduce the Amber-UI therapy to the U.S. market and ultimately achieve commercialization in end markets globally.

Current treatments primarily focus on urge urinary incontinence (a sudden, intense need to empty the bladder) or stress urinary incontinence (urine leakage caused by activities such as jumping or coughing), whereas Amber-UI represents a breakthrough advancement,Becoming the first monotherapy to address mixed (urge and stress) urinary incontinence, marking a significant step forward in a field that has seen little genuine innovation over the past 25 years.

Leveraging its expertise in closed-loop neuromodulation, Amber-UI’s multimodal therapy directly modulates the urge to void while enhancing resistance to urine leakage triggered by activities such as coughing or lifting, thereby restoring normal bladder function. Acute stimulation with Amber-UI has demonstrated significant effects on barrier muscle function (assessed via sphincter and pelvic floor contractions and electromyography) and suppression of detrusor overactivity, leading to an increase in average bladder capacity and a reduction in the frequency of urinary incontinence episodes in patients with mixed urinary incontinence.

Moreover, most current implantable therapies for urinary incontinence are static or can only indirectly affect the bladder (such as sacral nerve or tibial nerve stimulation). In contrast, Amber-UI can stimulate the pudendal nerve, which is the natural pathway for controlling urinary incontinence, and can enhance existing physiological reflexes when needed.Amber-UI’s sensor-integrated, patient-controlled adaptive algorithm enables real-time in vivo detection and classification of physiological biomarkers associated with pelvic neuromuscular activity, executing a fully adaptive (closed-loop) stimulation control strategy.

On February 27, 2024, Amber Therapeutics announced positive preliminary results from the first-in-human trial of Amber-UI. The initial data from this study were presented at the annual meeting of the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) in February 2024.

The AURA-2 trial enrolled 13 women with severe, refractory urge urinary incontinence or mixed urinary incontinence. The trial met its primary endpoint, demonstrating the safety and feasibility of Amber Therapeutics’ novel surgical procedure and validating a scalable approach for the accurate implantation of two electrode leads into the pudendal nerve.

Meanwhile, the therapy has demonstrated compelling preliminary evidence of efficacy, particularly in women with mixed urinary incontinence, among whom four out of five study completers achieved complete resolution of incontinence episodes at the six-month follow-up. Clinically significant improvements in symptom-related quality of life were observed in patients with both mixed and refractory urge urinary incontinence.

As a startup founded in 2021, Amber Therapeutics’ breakthrough innovations in the field of urinary incontinence are underpinned by its highly professional core team.

Co-founder and CEO Aidan Crawley founded the company in 2021 while serving as an Entrepreneur in Residence at Oxford Science Enterprises. Aidan has extensive experience in founding and managing early-stage technology companies. He was Addepar’s first business hire in the United States, where he served as Head of Business Development, helping the company grow from zero revenue to $50 million and achieve a valuation exceeding $1 billion.

Chief Engineer Tim Denison and Chief Scientist Stefan De Wachter have provided robust professional support to Amber Therapeutics in the areas of neurological disease treatment, algorithmic technologies, and therapeutic innovation.

Tim Denison, Co-founder and Chief Engineer of Amber Therapeutics, leads the company’s technology development and engineering efforts. Additionally, he holds a joint appointment in the Departments of Engineering Science and Clinical Neuroscience at the University of Oxford, where he has extensive experience in elucidating the fundamental principles of physiological closed-loop systems. Notably, prior to this role, Tim served as a Technical Fellow and Vice President of Research and Core Technologies for Medtronic’s Restorative Therapies Group. In that capacity, he led and oversaw the design of next-generation neural interface and algorithmic technologies for the treatment of chronic neurological disorders, developing key sensors and algorithms for commercialized brain- and spinal cord-based therapies.

Co-founder and Chief Scientist Stefan De Wachter oversees therapy design and clinical innovation. Stefan also serves as the Director of the Department of Urology at Antwerp University Hospital and Professor of Urology at the University of Antwerp. His primary research focus is on the neurophysiology of the bladder and urethra, with a particular emphasis on novel diagnostic and therapeutic approaches for voiding dysfunction using neuromodulation techniques. He has published more than 200 peer-reviewed papers. As a globally recognized innovator in the field of pelvic health, he has made significant contributions to nearly all major pivotal trials related to advancing new therapies over the past two decades, and he was awarded Fellowship of the European Board of Urology in 2012.

On June 10, 2024, Amber Therapeutics announced the successful completion of its Series A financing round,This financing round is one of the largest Series A funding rounds ever for a European medtech company,Led by New Enterprise Associates (NEA), with participation from new investors F-Prime Capital, Lightstone Ventures, and Intuitive Ventures, as well as existing investors Oxford Science Enterprises (OSE) and 8VC, the company has raised a total of $100 million (approximately RMB 725 million). The proceeds from this financing will be used to advance the development of Amber-UI and to secure U.S. regulatory approval through pilot programs and pivotal studies.

At the conclusion of its Series A financing round, NEA’s Tiffany Le, Lightstone Ventures partner Caroline Gaynor, and F-Prime’s Kevin Chu joined the board of directors of Amber Therapeutics. Additionally, OSE head Liliane Chamas also serves as a board member.

Following preliminary discussions with regulatory authorities, the pilot study in Europe and the pivotal trial in the United States for Amber-UI have been initiated, with results from full enrollment expected to be announced in the second half of 2024.

Amber Therapeutics’ versatile technology platform is poised to explore novel therapeutic applications in the pelvic region and the broader nervous system. Moving forward, Amber Therapeutics will remain dedicated to advancing intelligent bioelectronic therapies, fundamentally transforming the quality of life for women suffering from mixed urinary incontinence, while continuing to drive innovation and technological development to address unmet clinical needs worldwide.