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Transforming neurological care with innovation

Neurostimulation Tech

Neuros Medical is a bioelectric technology company that has developed the Altius System, a patient-controlled, on-demand device designed to alleviate chronic post-amputation pain. The Altius System incorporates Neuros' patented On-Demand Bioelectric Nerve Block technology, which delivers a high-frequency electrical signal to sensory nerves in the peripheral nervous system, effectively blocking the transmission of pain signals.
The system comprises a nerve cuff electrode placed around the affected nerve and an implantable pulse generator (IPG). Patients can initiate a 30-minute treatment session as needed to achieve targeted pain relief. Neuros' technology offers a novel approach to managing chronic post-amputation pain, a significant unmet medical need, as existing treatment options are primarily limited to opioids and gabapentinoids.
In June 2021, the Altius System received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its potential to provide more effective treatment for chronic intractable pain in adult lower limb amputees. The company completed enrollment for its pivotal QUEST (High-FreQUEncy Nerve Block for PoST-Amputation Pain) study in Fall 2021, a 180-subject, randomized, double-blinded, active sham-controlled clinical trial conducted under an Investigational Device Exemption (IDE).
In June 2022, Neuros Medical announced the completion of the QUEST Pivotal Trial's 90-day primary endpoints, with plans to submit the Altius System's Pre-Market Approval application to the FDA after the study is unblinded in Fall 2022. The company expanded its operations with a 10,000 square foot facility in Aliso Viejo, CA, certified by the European Notified Body, BSI, to International Standards Organization (ISO) 13485:2016 standards.

SetPoint Medical is a clinical-stage healthcare company developing a novel neuroimmune modulation platform to treat chronic, inflammation-mediated autoimmune diseases. The company's core technology involves a miniaturized stimulation device surgically placed on the vagus nerve through a small incision on the left side of the neck in an outpatient procedure. Once implanted, the device delivers precise vagus nerve stimulation on a preset schedule, activating anti-inflammatory and immune-restorative pathways to treat conditions like rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and multiple sclerosis (MS).
SetPoint Medical's initial focus is on rheumatoid arthritis, a debilitating autoimmune condition affecting over 1.5 million Americans and costing nearly USD 30 billion annually to manage with existing immunosuppressive therapies and biologics. The company believes its approach could offer a potentially less immunosuppressive treatment option. SetPoint Medical is currently evaluating its RA treatment in the RESET-RA pivotal trial, a multicenter, double-blind, randomized, sham-controlled study. As of January 2023, the first patient was enrolled in Stage two of the trial.
The FDA granted SetPoint Medical's device Breakthrough Device Designation for RA patients who have an incomplete response or intolerance to multiple biologic drugs. In March 2024, the company also received Breakthrough Device Designation from the FDA for using its platform to treat relapsing-remitting multiple sclerosis (RRMS), an autoimmune disorder affecting nearly 1 million Americans. SetPoint Medical is the first to initiate a clinical trial evaluating this neuroimmune modulation approach for RRMS.
Key customers and partnerships
SetPoint Medical secured an USD 80 million preferred stock financing in January 2023, co-led by new investors Norwest Venture Partners and Viking Global Investors, along with participation from Gilmartin Capital and existing investors. The financing will support the RESET-RA trial completion, FDA submissions, and early RA indication commercialization. As part of the financing, Dr. Zack Scott from Norwest joined SetPoint Medical's board of directors.
In March 2024, SetPoint Medical was accepted into the FDA's Total Product lifecycle (TPLC) Advisory Program Pilot to expedite the development and patient access of its neuroimmune modulation platform for RRMS treatment. This program facilitates earlier interactions with providers, payors, patients, and strategic advice from the FDA's Center for Devices and Radiological Health.

Saluda Medical is a global medical device company revolutionizing the field of neuromodulation with an advanced portfolio of therapies driven by closed-loop technologies designed to treat debilitating neurological disorders. The company's flagship product, the Evoke System, is a groundbreaking spinal cord stimulation (SCS) system that automatically adjusts therapy based on precise measurements of the nerves' response to stimulation over 4 million times per day. This "closed-loop" technology maintains optimal pain inhibition, providing continually optimized therapy tailored to each patient's unique spinal cord activation.
The Evoke System received FDA approval in March 2022 for treating chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. The approval was based on the pivotal EVOKE study, the first double-blind randomized controlled trial for an SCS system, which demonstrated the Evoke System's superiority over open-loop SCS in pain relief and improvements in quality of life measures like disability, mood, sleep, and health-related quality of life. Notably, the 24-month results published in JAMA Neurology in January 2024 showed durable clinical outcomes with no explants due to loss of efficacy.
After a limited commercial release in 2022, Saluda Medical expanded the Evoke System's availability in 2023, propelled by a USD 150 million equity financing round led by Wellington Management, Fidelity Management & Research Company, and TPG in April 2023. The company also redomiciled as Saluda Medical Inc., a Delaware corporation, that year. In chronic pain, a debilitating condition affecting over 19 million Americans, the Evoke System offers an innovative approach by automatically self-adjusting therapy to optimize each patient's spinal cord activation.

Nectero Medical develops a novel treatment to stabilize growth and prevent rupture of mid-sized abdominal aortic aneurysms. The company was founded in 2017 and is headquartered in Dover, Delaware, United States.

SetPoint Medical is a privately held clinical-stage healthcare company dedicated to treating patients with chronic autoimmune diseases. The company is developing a novel platform designed to stimulate the vagus nerve to activate the inflammatory reflex to produce a systemic immune-restorative effect. SetPoint Medical’s platform technology is designed to offer patients and providers a treatment alternative for rheumatoid arthritis, inflammatory bowel disease and other chronic autoimmune conditions with potentially less risk and cost than drug therapy.

Append Medical develops a next-generation transcatheter Left Atrial Appendage (LAA) closure system. The Append Medical solution is in the pre-clinical in-vivo trial phase. It is intended to become a differentiated solution in the LAA closure market, which has been estimated to reach $25B within several years. This is the second-fastest growing segment of the medical device market, with potential sales of $500M in 2019. Append Medical is a member of MEDX Xelerator,  a medtech incubator backed by Boston Scientific, Intellectual Ventures, MEDX Ventures and Sheba Medical Center.

Preventice Solutions is a privately-held company that offers a portfolio of mobile cardiac health solutions and services. It is a developer of mobile health solutions and remote monitoring services, connecting patients, clinicians, and hospitals.

Saluda Medical was established in 2013 with the goal of commercializing four years of research from NICTA, Australia’s information communications technology center of excellence. The company's team is made up of engineers, clinicians, and seasoned professionals with experience in bringing medical technologies to life.

InterVene is a medical device company focused on innovating treatments for chronic venous disease, particularly deep vein valve failure. The company’s BlueLeaf™ Endovenous Valve Formation System offers a non-implantable solution to address severe venous conditions. InterVene aims to improve patient outcomes by providing minimally invasive therapies for venous stasis ulcers and related symptoms.

Pulmonx is the global leader in interventional procedures for the treatment of COPD. It develops and markets non-surgical technologies for the assessment and treatment of patients with severe emphysema, a progressive and life-threatening form of COPD. The Pulmonx solution, which is comprised of the Zephyr Endobronchial Valve (Zephyr Valve), the Chartis Pulmonary Assessment System (Chartis System) and the StratX Lung Analysis Platform, is designed to treat severe emphysema patients who, despite medical management, are still profoundly symptomatic and either do not want or are ineligible for surgical approaches. The technology is supported by a compelling body of clinical evidence including over 100 published scientific articles regarding the clinical benefits of Zephyr Valves. FDA granted the Zephyr Valve a ‘breakthrough device’ designation, and in June 2018 Pulmonx received FDA pre-market approval to commercialize our Zephyr Valve. The Zephyr Valve is now commercially available and physicians in more than 25 countries around the world routinely use the Zephyr Valves to improve the lives of patients with severe emphysema, with over 76,000 valves used to treat more than 19,000 patients worldwide to date.

RenovoRx is a developing innovative solutions for targeted delivery of fluids, including diagnostic and therapeutic agents, to selected sites in the peripheral vascular system. RenovoRx received FDA clearance for the RenovoCath™ RC120 and is currently introducing this innovative technology to the clinical market. RenovoRx has a motivated Management Team with broad experience and an exciting vision for the future of targeted delivery. The company also has a broad Advisory Board of interventional radiologists, surgical oncologists and gastroenterologists that guide the company's clinical development strategies. RenovoRx is backed by a strong Board of Directors committed to long-term, continuous support of the company, whose members provide critical expertise in the medical and biotechnology industry and the visionary thinking to succeed.

Millipede develops a catheter-based solution to treat mitral and tricuspid regurgitation, restoring health and expanding options for physicians, and global patients.

Channel Medsystems is a medical device company offering cryotherapy devices for endometrial cryoablation. Its mission is to empower every woman to take control of her health journey and live their best life.

Neuros Medical is a neuromodulation company, is focused on developing proprietary therapies for the unmet needs of patients worldwide.  The Company's patented platform technology,  Electrical Nerve Block, is focused on the elimination of chronic pain in a variety of applications including neuroma/residual limb pain, chronic post-surgical pain, and chronic migraine.

Amphora Medical is a Minnesota-based developer of medical devices and instruments. The company is currently working on a novel cystoscopic device that has the potential to improve bladder function and quality of life for people with Overactive Bladder Syndrome (OAB). It was founded in 2011 and is headquartered in Minneapolis, Minnesota, United States.

NeuroTronik, spun out of medical technology incubator Synecor, is developing a medical device that could take the place of drugs currently used to heart failure. Read more about the company's technology,

Neovasc Inc. is a specialty medical device company that develops and manufactures products for the rapidly growing cardiovascular device marketplace.Neovasc Inc. offers pericardial tissue processing, vascular product development, design, and manufacturing solutions to industry partners.

Securus Medical Group engages in the development of clinical tools to improve the safety and efficacy of ablation therapy by providing real-time, non-contact, high-resolution tissue temperature monitoring, and mapping products. The company engages in developing real-time, noncontact, thermal mapping systems to determine intrabody tissue temperatures.

NxThera develops medical technologies to treat a variety of endourology conditions, including BPH. The company's technology platform utilizes a simple, minimally invasive, vapor therapy designed to measurably improve urinary flow and patient quality of life. BPH afflicts more than 32 million men in the United States.

TVA Medical, Inc. (TVA) is a medical device company developing innovative, minimally invasive therapies for treatment of End-Stage Renal Disease (ESRD). The company is funded by SantÃ© Ventures.

Sensible Medical Innovation Ltd. is introducing a breakthrough sensing and monitoring technology providing actionable and accurate data for guiding the management and treatment of several chronic medical conditions representing today’s biggest burden on US and worldwide healthcare budgets.

BAROnova, founded in 2006 and based in Goleta, CA, is a clinical-stage medical-device company focused on developing non-surgical non-pharmacologic devices to induce weight loss.

Sadra Medical is exploring new minimally invasive alternatives to traditional surgical valve replacement.  The company hopes that devices allowing such procedural advances will facilitate and enhance treatment of aortic valve disease.  Sadra Medical is dedicated to developing innovative new therapies for the treatment of aortic valve disease. By developing minimally invasive alternatives to traditional surgical valve replacement, the company seeks to help improve patient care and make valve replacement possible for broader range of patients. Treatment of aortic valve disease remains a significant and growing unmet clinical need. As many as 3 million people in U.S. have aortic valve stenosis; however, only a small percentage of those are treated with the current standard of care, valve replacement during open-heart surgery using cardiopulmonary bypass. By developing a highly effective aortic valve replacement that is designed to reduce the risks and morbidity associated with open surgical valve replacement, Sadra Medical seeks to provide a therapeutic option for patients who are not being treated today.  Sadra Medical, a subsidiary of Boston Scientific.

IntElect Medical, Inc., an early stage medical device company, develops and commercializes deep brain stimulation (DBS) therapies and technology for patients suffering with disabilities from stroke and traumatic brain injury. The company focuses on developing an implantable neuromodulation system for stroke and traumatic brain injury recovery.

Cameron Health, Inc., a development stage medical device company, is creating the next generation of implantable electronic device utilizing state-of-the-art technologies. They are a team of specialized, high technology, creative individuals with decades of experience in solving difficult medical problems. Their current target is the development of a family of devices that will afford patient treatment that has been, until now, unattainable with the current therapeutic modalities and technologies.

ORQIS Medical Corporation operates as a medical device company. It develops and sells minimally invasive devices for improving cardiac performance through aortic flow therapy. It offers Cancion System, a heart failure treatment that uses continuous aortic flow augmentation technology to improve symptoms of heart failure and change the underlying course of the disease for patients hospitalized for de-compensated heart failure. The company’s products also include Exeleras System to treat chronic heart failure patients.

Health Hero Network, Inc. develops and markets technology solutions for remote health monitoring and management. The company provides health management programs delivering personalized daily monitoring and patient education, and information to care providers. It also offers Health Buddy system that serves as the interface between patients at home and care providers, facilitating patient education and monitoring of chronic conditions. The company's Health Buddy system includes monitoring technologies, clinical information databases, Internet-enabled decision support tools, health management programs, and content development software tools. It serves hospitals, health plans, government health organizations, disease management companies, and pharmaceutical companies or universities conducting clinical trials or studies. The company was founded in 1988 and is based in Palo Alto, California. As of December 19, 2007, Health Hero Network, Inc. operates as a subsidiary of Robert Bosch GMBH.

Solace Therapeutics is a medical device company that develops and commercializes non-surgical office-based treatments for common bladder disorders, such as stress urinary incontinence (SUI), overactive bladder (OAB), male voiding dysfunction and lower urinary tract symptoms (LUTS). It is dedicated to improving the patient’s quality of life by eliminating side effects typically associated with current drug and surgical therapies. The company offers a technology that is designed to offer patients an office-based therapy that does not require anesthesia or surgery, no lifestyle change required, before or after treatment, and reversible at any time.

Adiana, Inc. engages in the development and testing of transcervical sterilization system for permanent birth control. It develops Complete TCS, which consists of a radiofrequency generator, delivery catheter, and implantable matrix. The company was founded in 1997 and is based in Redwood City, California. As of March 16, 2007, Adiana, Inc. is a subsidiary of CYTYC Corp.

BrainsGate's platform technology involves electrical stimulation of the Spheno-Palatine Ganglion (SPG), a nervous center known to increase cerebral blood flow. BrainsGate is exploring several applications for its technology, and is currently focusing on treatment of acute ischemic stroke. Building on its technology, the Company has developed the ISS, based on a miniature electrode implanted at the roof of the mouth in a bed side, minimally invasive, local anesthesia procedure comparable to dental treatment. In 2008, the company completed ImPACT-1, a pilot clinical trial for acute ischemic stroke with promising results. In 2011 the Company completed a 300 patients RCT pivotal trial that further substantiated the safety and efficacy of its treatment for acute ischemic stroke patients. BrainsGate is currently running the ImpACT-24b, a multi-national, randomized, double-blind, sham-controlled pivotal study to assess the safety and efficacy of its treatment for stroke patients in a 24-hour window.

3F Therapeutics develops, manufactures, and markets cardiovascular devices. It offers invasive and transapical aortic heart replacement technology, including enabling aortic heart valve, entrata aortic valve system, and endurance valve system to reduce surgical cross-clamp and cardio-pulmonary bypass time, utilization for congestive heart failure.

VisionCare Ophthalmic Technologies, Inc., a Saratoga, CA-based developer of advanced visual prosthetic devices designed to improve vision in patients with end-stage age-related macular degeneration (AMD).  VisionCare Ophthalmic Technologies (VisionCare) is a privately held specialty medical device company engaged in the research, development, manufacture, and marketing of proprietary implantable ophthalmic devices and technologies that are intended to significantly improve vision and quality of life for individuals with untreatable retinal disorders.  Our lead product, the Implantable Miniature Telescope (by Dr. Isaac Lipshitz), is the first FDA-approved implantable medical device demonstrated to improve vision and quality of life in individuals with the most advanced, irreversible form of age-related macular degeneration (AMD) – End-Stage AMD. End-Stage AMD is the leading cause of blindness in older Americans.  The telescope implant is integral to the CentraSight™ treatment program which has been developed to help patients follow the necessary steps for proper diagnosis, surgical evaluation, and postoperative care.  Our goal is to help patients reconnect to the things in life they love to see and do. To help achieve this, we will establish a high level of collaboration with our healthcare provider customers through a broad range of direct support programs and services.

REVA Medical develops bio resorbable polymers for vascular applications, to restore patient health for life through the application of biomaterials in the development and sale of implantable medical devices.

Broncus Technologies is a medical technology company focused on developing minimally-invasive medical devices for emphysema and other lung diseases. Broncus is investigating the Exhale emphysema product line to perform our patented treatment method called Airway Bypass. Airway Bypass could be the first minimally-invasive procedure for the treatment of homogeneous, or diffuse, emphysema, which constitutes the majority of the emphysema patient population.  Broncus is currently enrolling patients worldwide in our pivotal EASE Trial investigating a treatment of severe homogeneous emphysema.  Broncus is located in Mountain View, CA (San Francisco Bay area).  Broncus International is located in Nyon, Switzerland.

Proxima Therapeutics develops radiation delivery systems for the treatment of solid cancerous tumors, with an initial focus on brain and breast cancer.   Founded in 1996, the company’s marketed products include GliaSite RTS for brain cancer and MammoSite RTS for breast cancer. Proxima Therapeutics was acquired by Cytec Industries Inc. in 2005.

BioSurface Engineering Technologies, Inc., also known as BioSET, engages in developing proprietary therapeutic peptides as medical devices to improve bone and soft tissue repair. The company focuses on developing devices for orthobiologics applications. Its products include AMPLEX, an implantable combination device of the B2A peptide and a synthetic ceramic scaffold for use as a surgical bone graft implant for lumbar degenerative disc disease, as well as for use in spine, cervical spine, and foot and ankle fusion surgeries. The company also develops products for sports medicine applications based on its F2A peptide; and peptide signaling molecules and various scaffold biomaterials for use in musculoskeletal applications, including trauma, fracture repair, and other soft tissue treatments. BioSurface Engineering Technologies, Inc. was founded in 2001 and is based in Rockville, Maryland.

EndoTex Interventional Systems, Inc., a development stage medical device company, engages in the development and manufacture of less-invasive medical devices for use in the vascular system. It provides solutions for treating carotid artery disease. The company was founded in 1995 and is based in Cupertino, California.   As of January 4, 2007, EndoTex Interventional Systems, Inc. is a subsidiary of Boston Scientific Corp.

Boston Scientific is an innovator of medical solutions that improve the health of patients around the world. Boston Scientific's products and technologies are used to diagnose or treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular, urological, women's health, and chronic pain conditions. Boston Scientific has advanced the practice of less-invasive medicine by providing a broad and deep portfolio of innovative products, technologies, and services across a wide range of medical specialties. These less-invasive medical technologies provide alternatives to major surgery and other medical procedures that are typically traumatic to the body. In less-invasive procedures, devices are usually inserted into the body through natural openings or small incisions and can be guided to most areas of the anatomy to diagnose and treat a wide range of medical problems. Boston Scientific continues to innovate in these areas and is extending its innovations into new geographies and high-growth adjacency markets. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Boston Scientific acts with integrity and compassion to support patients, customers, our communities, and each other.

<div> Boston Scientific Corporation (NYSE: BSX) is a biomedical/biotechnology engineering firm and a producer and distributor of medical equipment used in numerous interventional medical disciplines. The company has been listed on the NYSE since 1992. Boston Scientific generated USD 14.2 billion in revenue in 2023. The two reportable segments that makeup Boston Scientific's core businesses are Cardiovascular (~62% of total revenue in 2023) and MedSurg (~39%). The Cardiovascular segment includes therapies for cardiovascular diseases and carries interventional cardiology therapies, cardiac rhythm management, and electrophysiology subunits. The MedSurg segment consists of endoscopy, urology, and neuromodulation businesses.&nbsp; The US market accounted for ~59% of Boston Scientific&rsquo;s total sales in 2023, followed by the EMEA (Europe, Middle East, and Africa; ~20%) and the Asia-Pacific (~17%) regions. Boston Scientific estimates revenue growth of 8.5%&ndash;9.5% for 2024 (from 12.3% in 2023). The company expects to achieve carbon neutrality across all its manufacturing and distribution facilities by 2030 and reach net-zero status by 2050. </div>

Pain Management Devices Global Analysis Report 2024-2034 Featuring Abbott Laboratories, Boston Scientific, Medtronic, Nevro, Baxter, OMRON, Stryker, Teleflex, ICU Medical, AtriCure, and Zynex

Companies that offer solutions for pain management, neuropathies, and related disorders and migraines.

Companies that provide solutions for Parkinson's disease, epilepsy, and speech and movement disorders.

Companies that offer treatments for depression, Alzheimer's, and other mental health-related disorders.

Companies that offer solutions for heart-related medical issues such as acute decompensated heart failure and high blood pressure.

Companies that offer solutions for urinary or fecal incontinence, autoimmune diseases and other functional impairments

Companies that offer solutions for hearing or vision impairment, sleep-related conditions, and other disorders, including obesity treatments.

Pushing the envelope in MedTech with emerging technologies

Next-gen Medical Devices

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INCUMBENTS_PRESENT

<div>
 Boston Scientific has announced its plan to acquire Intera Oncology, a medical device company specialising in hepatic artery infusion pumps and chemotherapy drugs. The financial details of the transaction have not been disclosed.
 The acquisition, set to conclude in the first half of 2025, will become a significant move for Boston Scientific in extending its range of treatments for primary and metastatic liver cancer.
 The product portfolio of Intera Oncology includes FDA-approved products like the Intera 3000 Hepatic Artery Infusion Pump and floxuridine, a chemotherapy drug. The unique pump is surgically implanted under the skin to deliver a consistent infusion of chemotherapy, aiming specifically at liver tumors resulting from metastatic colorectal cancer.
</div> Analyst QuickTake: 
 Earlier in <a href="https: 
//sp-edge.com/updates/35630"> November 2024 </a> , Boston Scientific also announced the acquisition of Cortex, a company specializing in diagnostic mapping for atrial fibrillation. Both deals, set to close in the first half of 2025, reflect Boston Scientific's efforts to diversify its portfolio with advanced, specialized technologies addressing complex medical conditions.

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