Wavegate Secures $26M Series A to Advance Ellipse SCS Platform for Chronic Pain

“He who fails to think thrice will surely regret; he who can endure a hundred times will have no worries.” “Endurance” is the approach many people adopt toward pain, believing that if they just tough it out, it will pass and the pain will subside once the illness resolves on its own. However, when it comes to chronic pain, such “endurance” knows no end.

As early as 2000, the World Health Organization proposed that “chronic pain is a disease,” defining pain lasting more than three months as a distinct disease entity. According to data from the Report on the Development of Pain Medicine in China (2020), there are over 300 million patients with chronic pain in China, and this number is growing at an annual rate of 10 to 20 million.

Since the adverse effects of opioids, such as high addictiveness and intolerance, have become prominent, both domestic and international efforts have been ongoing to identify new, highly effective treatments for chronic pain. In recent years, with technological advancements, neuromodulation techniques represented by spinal cord stimulation (SCS) have emerged as advanced therapies for chronic pain. Constrained by industry technical barriers, the SCS market is monopolized by industry giants. According to QYR data, Medtronic, Boston Scientific, Abbott, and Nevro collectively account for over 90% of the global market share.

This market is also no stranger to innovative forces. In December 2024, Wavegate, a startup developer of neuromodulation products, announced that it had secured $26 million in Series A financing to accelerate the development of its Ellipse spinal cord stimulation platform for the treatment of chronic pain.

Erich Wolf is the Founder, President, and Chief Innovation Officer of Wavegate Corporation. He holds an M.D. in Biomedical Engineering from Tulane University and is a Fellow of the American College of Surgeons (ACS) as well as a member of the American Association of Neurological Surgeons (AANS), with over 25 years of clinical experience in the field of neuromodulation. Additionally, Dr. Wolf holds more than 25 U.S. and international patents related to medical devices.

Dr. Erich W. Wolf II, Image source: Wavegate official website

In 2002, Dr. Wolf founded the Center for Neurosurgery and Spinal Disorders in Lake Charles, Louisiana, USA, and served as a managing member. The center has since grown into the leading private neurosurgical practice in southwestern Louisiana. Two years later, Dr. Wolf received certification from the American Board of Neurological Surgeons (ABNS), signifying that he had met the highest professional standards in the field of neurosurgery.

In addition, Dr. Wolf served as a consultant for Medtronic Spine/Biologics from 2007 to 2012, and as a neuromodulation consultant for Boston Scientific from 2009 to 2010.

As a practicing neurosurgeon, Dr. Wolf has dedicated his career to treating patients with chronic pain. The search for effective treatments for chronic pain became particularly urgent after his wife, Amiee, suffered severely from nerve damage.

Ultimately, spinal cord stimulation therapy successfully alleviated Amiee’s pain symptoms, enabling her to return to a normal life. This experience ignited Dr. Wolf’s passion for research and development—to create the most advanced and effective spinal cord stimulation system to enhance pain relief and improve the patient experience with spinal cord stimulation therapy. Thus, Wavegate Corporation was born.

Since its founding in 2019, Wavegate Corporation has focused its R&D efforts on the field of neuromodulation. Leveraging its specialized Ellipse SCS platform, the company is committed to addressing unmet clinical needs within the neuromodulation industry. The platform integrates multiple proprietary technologies, including StimuLux™ and Active Loop™.

According to information on the Wavegate website, most current spinal cord stimulators can only systematically deliver a fixed dose of electrical current. However, changes in body position cause the spinal cord to move relative to the electrode array, thereby affecting dose consistency. The study “Long-Term Safety and Efficacy of Closed-Loop Spinal Cord Stimulation for Chronic Back and Leg Pain (Evoke)” demonstrates thatEnsuring consistent therapeutic dosing can improve pain relief outcomes.

Based on this, StimuLuxTM technology optically tracks the spinal cord and adjusts current to maintain a consistent dose, achieving optimal pain relief.

Specifically, StimuLux™ technology tracks the position of the spinal cord via optical reflectometry and adjusts the electrical current in response to spinal cord movement to maintain a consistent therapeutic dose. This closed-loop adaptive stimulation technology enables real-time monitoring of neural signal firing and delivers electrotherapy based on biomarker predictions, providing personalized, precision treatment.

January 2022,FDA Grants StimuLux™ Optical Reflex System Breakthrough Device Designation，This system is used for closed-loop adaptive modulation of spinal cord stimulation.

Notably, Wavegate’s StimuLux optically active cycling technology offers a plug-and-play setup that is compatible with all stimulation paradigms, whereas the closed-loop system of ECAPS (Evoked Compound Action Potentials), the world’s first closed-loop SCS product, requires time-consuming configuration and is limited to paresthesia-based stimulation paradigms.

Overall, the greatest potential of StimuLux™ technology lies in its flexible therapeutic capabilities, achieved through real-time monitoring and adjustment of electrical currents. Specifically, treatment protocols can be dynamically optimized based on individual patient conditions and changes in body position, thereby enhancing pain relief efficacy and reducing the risk of side effects associated with fixed dosages, ultimately providing patients with a personalized and comfortable treatment experience.

SCS is a therapeutic approach that employs low-intensity electrical stimulation of the spinal cord nerves to block pain signals from reaching the brain, thereby masking specific painful areas with a comfortable, massage-like tingling sensation. The treatment protocol typically involves the following steps:

First, a preoperative assessment is conducted to determine the patient’s indications and contraindications. Next, during the trial phase, the physician implants temporary electrodes in the patient and connects them to an external temporary stimulator to evaluate pain relief efficacy. If the trial is successful and the patient achieves satisfactory pain relief, permanent implantation is performed by placing the electrodes in the spinal epidural space and implanting the pulse generator. Otherwise, the electrodes are removed.

In simple terms, spinal cord stimulation (SCS) therapy is a minimally invasive surgical procedure whose efficacy has been widely recognized after years of clinical application. However, as an implantable neuromodulation device, it raises two primary concerns among physicians and patients: the discomfort associated with the surgical procedure and strategies to extend battery life during use.

Generally, implantable surgeries involve the issue of contact between the implant and other tissues within the body. One of the common complications in spinal cord stimulation surgery is pain at the implantation site, which is usually caused by excessive surface contact pressure between the implant and the surrounding soft tissue. Wavegate Corporation’s oval-shaped implantable pulse generator adopts a super-elliptical design similar to that of a pebble. This design results in the lowest surface contact pressure in the industry, thereby enhancing patient comfort.

Spinal cord stimulation, as the name suggests, involves stimulating the spinal cord with electrical impulses to block pain signals from reaching the brain. Unlike traditional fixed-frequency stimulation systems, Wavegate Corporation’s Spread Spectrum Stimulation (S-Cubed) paradigm for neuromodulation does not deliver a single fixed high or low frequency; instead, it randomly distributes energy across a broad frequency range.

The S-Cubed paradigm is designed to activate specific neuronal populations within the spinal cord, helping to modulate pain signals and thereby provide relief for patients with chronic pain. Furthermore, by employing randomized stimulation, the S-Cubed paradigm can reduce patient adaptation to specific frequency stimuli, potentially enhancing the durability of therapeutic effects. In other words, by delivering energy randomly across a broad spectrum, the S-Cubed paradigm achieves more comprehensive activation of spinal neurons, leading to more effective pain management.

In addition to innovations in stimulation frequency, it also differs significantly from conventional approaches in modulating pain pathways.Conventional spinal cord stimulation modulates ascending pain pathways. Wavegate’s patented random binary stimulation paradigm leverages the power of somatosensory event-related evoked potentials to activate descending pain inhibitory tracts via specific neural pathways, thereby achieving therapeutic effects for chronic pain.

Specifically, the neural pathway involved in this technique is MPC (periaqueductal gray, PAG)-ACC (anterior cingulate cortex)-PAG (periaqueductal gray)-RVM (rostroventral medulla)-DH (descending pain modulatory system).

A second question arises after the surgery: How long does the implant last, and how often does the battery need to be replaced?

Several factors determine charging time, including: the degree of battery depletion, battery lifespan, alignment between the charger and the implant, and the depth of the implant beneath the skin. To enhance patient compliance, Wavegate Corporation employs low-power electronic chipsets to optimize battery conversion efficiency, which may extend battery life to over eight years, while typical charging times remain under two hours.

Over the past decade, spinal cord stimulation (SCS) has been gradually introduced into the management of patients with chronic pain in China.

In 2021, China’s first set of guidelines on SCS applications—the “Expert Consensus on Spinal Cord Stimulation for the Treatment of Chronic Pain”—was released. Subsequently, in 2024, a working group comprising multidisciplinary experts from both domestic and international backgrounds under the Sino-US consensus initiative on SCS management of chronic pain revised the document into the “Sino-US Expert Consensus on Spinal Cord Stimulation for the Management of Chronic Pain (2024).”

As early as January 2022, the implantable SCS manufactured by PINS Medical was approved for market launch, marking China’s first domestically produced implantable spinal cord stimulator to receive such approval. This product series was developed by Tsinghua University in collaboration with Beijing PINS Medical Equipment Co., Ltd. under the “"13th Five-Year" National Key R&D Program Project, developed with the support of projects such as the Beijing Municipal Science and Technology Plan, and commercially produced by PINS Medical through technological achievement transformation. It marks China’s breakthrough of foreign monopolies in this field and fills a technological gap.YesChina's First Series of Spinal Cord Stimulation Products with Independent Intellectual Property Rights.

In September of the same year, Ruishen’an Medical’s self-developed implantable spinal cord stimulation (SCS) product also received marketing approval from the National Medical Products Administration (NMPA). In its clinical trial involving 66 patients, the effective rate at 180 days post-operation (defined as the proportion of patients with a ≥50% reduction in pain Visual Analog Scale [VAS] scores) was 81.7%, with the mean VAS score decreasing by 4.23 ± 1.61.

October 2024, New Cloud Medical“R&D of AI Closed-Loop Implantable Spinal Cord Stimulator”The project has been approved for special funding under the “AI + Health Collaborative Innovation Incubation” initiative of the Beijing Municipal Science and Technology Plan.

According to the "Analysis Report on Market Share and Investment Prospects of China's Implantable Spinal Cord Stimulation (SCS) System Industry," China's SCS market size was approximately RMB 1.5 billion in 2023, and is projected to reach RMB 2.5 billion by 2025, with a compound annual growth rate (CAGR) of approximately 16%.