The Company will further develop its high-resolution spinal cord stimulation focal pain therapy and perform clinical studies.
Micro-Leads Medical, Inc. (Somerville, MA), a clinical neurostimulation startup developing a high-resolution spinal cord stimulation therapy for treating chronic focal pain without opioids, announced today that it was awarded $10 million in therapy development funding. With the funding Micro-Leads will further develop its HD64TM implantable therapy system and launch a clinical study in patients led by Julie Pilitsis, M.D., Ph.D., chair of the Department of Neuroscience and Experimental Therapeutics and professor of Neurosurgery at Albany Medical College. The funding is from the National Institutes of Health initiative Helping to End Addiction Long-Term (HEAL) and private investors and will span multiple years pending completion of milestones.
Micro-Leads’ high-resolution spinal cord stimulation (SCS) offers a disruptive therapy delivery solution designed to treat chronic low-back pain and focal pains of the trunk and extremities. Approximately 40% of people who have an existing low-resolution SCS device implantation fail to experience lasting pain relief and face repeat surgeries or long-term opioid use. Micro-Leads’ HD64TM high-resolution therapy delivers electrical stimulation to two-times more pain fiber locations on the spinal cord to provide a greater reduction of pain and precision localization of therapy to eliminate side effects.
“Because HD64 therapy effectively doubles the number of therapy points, there is a greater probability of providing pain relief for every patient,” said Dr. Pilitsis. “HD64 therapy places more electrodes across the spinal cord to deliver therapy to specific pain fibers which existing low-resolution devices cannot currently reach.” The clinical team at Albany Medical College, will use advanced neuromonitoring methods to demonstrate fiber specific stimulation. Stimulating previously inaccessible spinal cord fibers represents an opportunity to provide better pain relief for people with complex pain.
HD64 TM therapy uses conformal surgical and percutaneous lead technology to deliver maximum dosing of low- and high-frequency stimulation without side effects such as discomfort or repeat surgeries from loss of therapy. “The HD64 therapy overcomes device limitations that have made it difficult to treat focal pains in the low-back and extremities for decades,” said Giancarlo Barolat, M.D. who serves as Micro-Leads’ clinical chairman. “HD64 therapy could transform the SCS landscape by treating all types of pain in a single device.”
Currently a $2.5 billion market, SCS has experienced steady annual growth. An estimated 75,000 procedures took place worldwide in 2019. Despite its widespread use for treating chronic pain, conventional SCS devices have provided unpredictable outcomes or unsuccessful pain relief in approximately 30-40% of implanted subjects – and a 20% repeat procedure rate to reposition the implanted leads.
“HD64 provides the most expansive and high-resolution delivery of SCS therapy of any device ever made. We believe HD64 will maximize the therapeutic window across the board and enable practitioners to achieve more successful and consistent outcomes by eliminating the lead-alignment guesswork imposed by virtually every low-resolution SCS device on the market,” said Bryan McLaughlin, Ph.D., CEO of Micro-Leads Medical. “We want every patient, everywhere, to experience pain relief with the first SCS procedure – not the third.”
Prior to this award, Micro-Leads has received extensive development funding from Galvani Bioelectronics, the National Institutes of Health, Defense Advanced Research Projects Agency, the National Science Foundation, and the Massachusetts Life Science Center to develop the underlying closed-loop neuromodulation device technology.
About Micro-Leads Medical
Micro-Leads Medical is a medical technology company dedicated to developing innovative therapies that address the neuromodulation and bioelectronic medicine market. Micro-Leads is developing a high-resolution spinal cord stimulation therapy to treat chronic back and focal pains without opioids.
For more information please visit www.micro-leads.com.
About Albany Med
Albany Med, northeastern New York’s only academic health sciences center, is one of the largest private employers in the Capital Region. It incorporates the 766-bed Albany Medical Center Hospital, which offers the widest range of medical and surgical services in the region, and Albany Medical College, which trains the next generation of doctors, scientists and other healthcare professionals. It also includes a biomedical research enterprise and the region’s largest physicians’ practice, with more than 500 doctors. Albany Med is affiliated with Columbia Memorial Health and Saratoga Hospital to provide the largest locally governed health system in the region. Combined, the system has more than 1,100 beds and nearly 100 outpatient locations throughout the Capital Region. Albany Med works with dozens of community partners to improve the region’s health and quality of life.
For more information: www.amc.edu or www.facebook.com/albanymedicalcenter.
Contact
Bryan McLaughlin
Chief Executive Officer
info@micro-leads.com
Disclaimer: Certain statements in this press release may be forward-looking information or statements, including future oriented financial information and financial outlook, under applicable securities laws (collectively “forward-looking statements”). Forward-looking statements are naturally subject to risks and uncertainties. Factors such as the development of general economic conditions, future market conditions, unusual catastrophic loss events, changes in the capital markets and other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. Micro-Leads Inc. does not make any representation or warranty, express or implied, as to the accuracy, completeness or updated status of such statements. Therefore, in no case whatsoever will Micro-Leads be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.
