Micro-Leads Medical Secures $10 Million to Advance High-Resolution Spinal Cord Stimulation Therapy for Localized Pain Relief

VCBeat (WeChat ID: vcbeat) has learned that on December 3, 2019, Micro-Leads Medical announced it had been awarded $10 million in therapeutic development funding. The funding comes from the U.S. National Institutes of Health (NIH) and private investors, with disbursement planned over several years.

It is reported that Micro-Leads will use the funding to further develop its HD64™ implantable therapy system and conduct clinical research under the leadership of Dr. Julie Pilitsis, Professor of Neurosurgery and Chair of the Department of Neuroscience and Experimental Therapeutics at Albany Medical College.

Micro-Leads is a medical technology company dedicated to developing innovative therapies for the neuromodulation and bioelectronic medicine markets. The spinal cord stimulation (SCS) market, currently valued at $2.5 billion, is experiencing steady annual growth. In 2019, an estimated 75,000 SCS procedures were performed worldwide. Although this therapy is widely used to treat chronic pain, approximately 40% of patients implanted with existing low-resolution SCS devices fail to achieve long-term pain relief, necessitating revision surgeries or prolonged opioid use.

Currently, Micro-Leads is developing a high-resolution spinal cord stimulation (SCS) therapy aimed at treating chronic lower back pain and localized pain in the trunk and limbs. Compared to traditional SCS, Micro-Leads’ HD64™ high-resolution therapy delivers electrical stimulation to a broader range of pain fiber locations on the spinal cord, thereby achieving greater pain relief while precisely targeting to eliminate side effects. The HD64 system enables interventional pain specialists and neurosurgeons to achieve predictable SCS outcomes and streamline workflows. By eliminating the need for intraoperative trials, it doubles the probability of trial success, while expanded selectivity provides superior coverage and targeted therapy.

Prior to securing this funding, Micro-Leads had already obtained substantial development funding from Galvani Bioelectronics, the U.S. National Institutes of Health (NIH), the Defense Advanced Research Projects Agency (DARPA), the National Science Foundation (NSF), and the Massachusetts Center for Life Sciences to develop foundational closed-loop neuromodulation device technology.

The clinical team at Albany Medical College will use advanced neuromonitoring techniques to demonstrate fiber-specific stimulation: targeting previously inaccessible spinal cord fibers to provide better pain relief solutions for patients with complex pain.

Dr. Pilitsis stated, “Because HD64 therapy effectively doubles the number of treatment targets, it is more likely to help each patient achieve pain relief. HD64 therapy places more electrodes in the spinal cord to target specific pain fibers, which is not achievable with current low-resolution devices.”

The HD64 TM therapy utilizes conformal surgical techniques and percutaneous guidance technology to deliver maximum doses of low- and high-frequency stimulation without side effects. Dr. Giancarlo Barolat, Clinical Chairman of Micro-Leads, stated, “HD64 therapy overcomes the limitations of devices used for decades to treat localized pain in the back and extremities. By addressing all types of pain within a single device, HD64 therapy has the potential to transform the landscape of spinal cord stimulation (SCS).”

Dr. Bryan McLaughlin, CEO of Micro-Leads, stated, “HD64 offers the most extensive and highest-resolution spinal cord stimulation (SCS) therapy ever available. We believe HD64 will maximize the treatment coverage, and we hope that every patient everywhere can achieve pain relief with their first SCS procedure.”

(Compiled by Jiang Ying)