Nalu Medical Submits IPO Prospectus Highlighting 69% Average Pain Reduction with Its Pioneering Neurostimulation Therapy

Dec 04, 2024 22:15 CST Updated 22:15

Nalu Medical

Medical Device Developer

Nalu MedicalPublished in the journal *Anesthesia & Pain Medicine* on neurostimulators for the treatment of chronic pain---Nalu Neurostimulationclinical study data (Nalu COMFORT), demonstrating that afterNalu NeurostimulationTreatment enables patients to achieve sustained pain relief.

Specific Research Data (One Year Postoperatively)

87% of patients experienced 50% or greater pain relief;
Average pain reduction of 69%;
95% of patients reported overall improvement;
78% of patients reported a reduction in depressive symptoms;
73% of patients reported a reduction in disability rates;
70% of patients reported an improvement in quality of life.

PI Evaluation

“This study demonstrates that Nalu PNS therapy provides robust, consistent, and durable statistically significant improvements in pain, disability, quality of life, and mood. The level of long-term improvement with PNS across a range of anatomical regions has never before been reported. Equally important to note is that, beyond significant long-term pain relief, patients receiving Nalu PNS therapy are generally able to return to a more satisfying life experience.”

---John Hatheway, Principal Investigator

Executive Evaluation

“These results confirm that Nalu patients achieved significant and sustained improvements in pain, quality of life, and function. The one-year postoperative outcomes were markedly superior to those reported in other randomized controlled trials of permanent PNS, and these data are consistent with the impressive results observed in real-world experience with Nalu. These findings underscore the undeniable value and clinical impact of our technology in providing lasting relief for patients with chronic, refractory pain.”

---Tom West, CEO and President of Nalu Medical

Chronic pain refers to pain that persists for more than one month (previously defined as three months or six months). Some people liken chronic pain to an "undying cancer." Currently, there are at least 100 million patients with chronic pain in China.

Current treatment technologies for chronic pain still fail to meet patients' true needs.For example, although opioid analgesics can relieve pain, they are prone to misuse, leading to drug resistance.as well as patient addiction potential. It is evident that this treatment modality is suboptimal. Spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) have gradually emerged as important options for the management of chronic pain and are internationally recognized as advanced therapies.

Due to the large market size and high technical barriers, this market is primarily dominated by Medtronic (34%), Abbott (29%), and Boston Scientific (23%), which together account for more than 80% of the neuromodulation market. However, the products of these three giants are all traditional types, generallyImplantable Pulse Generator (IPG), electrodes, test stimulator, patient programmer/charger, and external controlleretc. Implantable pulse generators are generally bulky, resulting in poor patient comfort post-implantation, while their operational complexity leads to a steep learning curve for physicians. Additionally, the high cost of traditional stimulators makes them unaffordable for many patients.

In addition,Implantable PulseThe limited battery capacity of the generator results in a short lifespan, making lifespan extension a key focus for the three major industry leaders.

Nalu MedicalAs a latecomer, it has achieved disruptive innovation based on previous work, reducing the volume of the implantable pulse generator to 1/27th that of traditional stimulators, significantly improving patient comfort after implantation. MeanwhileNalu Neurostimulation SystemThe pulse generator is battery-free and powered by an external treatment pad, eliminating patient concerns about battery life. According toNalu MedicalIntroductionNalu NeurostimulationLifespan of up to 18 years,is currentlyFDA ApprovalMakeLongest service lifeofSlowSexual PainPain Implantable Pulse Generator.

Nalu Neurostimulation

Nalu Neurostimulation It is a neurostimulation product approved by the FDA in 2019, indicated for SCS and PNS applications to treat chronic pain in the back, legs, and neuropathic conditions.

Nalu NeurostimulationByIt consists of a fully functional, battery-free, miniature implantable pulse generator (IPG), lead wires, a treatment pad, and a remotely controllable app.Miniature ImplantablePulse GeneratorImplantable Pulse Generator (IPG)by externalThe wearable treatment tray is wirelessly powered, and viaAPPPerform remote control.

Advantages of Nalu Neurostimulation:

Smaller, Less Invasive Implants: 27 Times Smaller Than the Largest Commercially Available Implantable Pulse Generator (IPG).
Battery-free miniature IPG: Powered externally via a replaceable, wearable therapy disc, eliminating the need for an implanted battery and battery replacement surgery.
Upgrade Without Surgery: The software can be upgraded wirelessly, without the need for surgery.
Durable Use: Expected service life of 18 years, for long-term treatment of chronic intractable pain

Nalu Neurostimulation Demo

Nalu Medical

Nalu MedicalNalu Medical, Inc. is an innovative medical device company headquartered in California, focused on developing and commercializing innovative minimally invasive solutions for patients with chronic neuropathic pain.Nalu NeurostimulationDelivers gentle electrical pulses to the nervous system, modulating pain signals before they reach the brain.Nalu NeurostimulationAimed at addressing the major unmet needs in the treatment of chronic neuropathic pain and providing a differentiated value proposition for patients and physicians.