LivaNova

Membership-based, non-insurance healthcare companies helping maintain a steady state of well being.

Preventive Healthcare

Ceribell is a medical device developer focused on detecting seizures using a proprietary non-invasive brain monitor and an EEG (electroencephalography) system. The Ceribell system consists of an adjustable headband with EEG electrodes and a connected pocket-sized monitor that displays real-time brain activity readings and transmits the data to an online portal accessible by healthcare providers. Leveraging AI and machine learning algorithms, Ceribell takes less than 10 minutes to provide EEG data to doctors, as opposed to the highly time-consuming traditional processes of 4-60 hours.The company received its initial FDA clearance in 2017 for detecting suspected seizure activity and has since secured additional clearances. Its advanced technology, branded as ClarityPro, received FDA clearance in May 2023 for diagnosing electrographic status epilepticus (ESE) in adult patients. It is the first and only acute care device with this indication.Ceribell’s brain stethoscope function interprets EEG results by converting brainwaves to sound so seizure can be detected.Funding and financialsIn September 2022, the company raised USD 50 million in an extension to its Series C funding round led by Ally Bridge Group. The funds were allocated towards expansion of its diagnostic platform to identify patients with seizures in emergency departments and intensive care units. In addition, the funds were allocated towards the development of the EEG to address other neurological conditions.

A new industry proving that digital connectivity and mental health can co-exist.

Digital Wellness

Noctrix Health is a developer of a prescription-grade non-pharmaceutical therapeutic for the treatment of moderate-to-severe Restless Leg Syndrome (RLS) in patients who are resistant to pharmaceutical treatments. The therapeutic called the NTX100 Nidra Tonic Motor Activation (TOMAC) System consists of two bands that are worn on the patient's lower legs that function as neurostimulation devices. The device electrically activates peroneal nerves bilaterally to produce muscle activation compatible with sleep and suppressing symptoms of RLS. The company has carried out studies on the therapeutic to clinically validate its treatment capabilities.In April 2023, Noctrix Health was granted its De Novo request from the FDA, allowing it to begin marketing its Nidra TOMAC system. Previously, in June 2020, Noctrix was granted FDA Breakthrough Device Designation.

Pushing the envelope in MedTech with emerging technologies

Next-gen Medical Devices

Ceribell develops an AI-powered point-of-care electroencephalogram (EEG) diagnostic system to rapidly detect and monitor seizures in acute care settings. The Ceribell system consists of a headband with electrodes and a handheld recorder that can quickly assess brain waves and transmit EEG data to a cloud portal (Ceribell EEG Portal) for remote monitoring by neurologists. The company's proprietary algorithms automatically analyze EEG signals for seizure patterns, alerting healthcare providers in real time. Ceribell's rapid EEG system enables faster seizure detection and up to 2x the diagnostic confidence for clinicians compared to conventional EEG setups, reducing treatment delays that can lead to permanent brain injury.In October 2023, Ceribell launched ClarityPro, an AI algorithm that diagnoses electrographic status epilepticus (ESE), a potentially life-threatening condition where seizures may not manifest outward signs. ClarityPro received FDA approval in May 2023 and became the first device indicated for standalone ESE diagnosis.&nbsp;Key customers and partnershipsCeribell offers its diagnostic system to the healthcare sector, focusing on acute care settings. The company’s notable customers included Abrazo West Campus, Orlando Health St. Cloud Hospital, and WVU Medicine Berkeley Medical Center.

Transforming neurological care with innovation

Neurostimulation Tech

Noctrix Health is a medical device company that has developed the NTX100 Tonic Motor Activation (TOMAC) System, a non-pharmacologic, wearable treatment for adults with moderate to severe, drug-refractory restless legs syndrome (RLS). The system, which received De Novo authorization from the US Food and Drug Administration (FDA) in April 2023, consists of a pair of devices worn on the lower legs that electrically activate the peroneal nerves bilaterally. This produces tonic, sustained muscle activation compatible with sleep, thereby reducing RLS symptoms and improving sleep quality.
The TOMAC therapy, also known as Nidra, is the first and only FDA-approved treatment specifically designed for patients with moderate to severe RLS who do not respond to medications. Its efficacy and safety have been demonstrated in clinical studies, including the RESTFUL study, a multi-center, randomized, sham-controlled trial involving 133 participants. All seven efficacy outcomes in this study met statistical significance, with the therapy proving well-tolerated and free of significant adverse events.
A subsequent 24-week extension study further validated the long-term benefits of TOMAC therapy, with patients experiencing an average reduction of 11.3 points on the International RLS Rating Scale (IRLS) and a mean responder rate (CGI-I) of 72.7% at week 24. Notably, long-term treatment led to a substantial reduction in the frequency of RLS symptoms, from 5.9 nights to 3.2 days per week, and a mean reduction of 17.2 points on the MOS-II sleep scale.
In January 2024, Noctrix Health secured USD 40 million in Series C financing to support the commercial launch of Nidra in the US market. The funding round was led by Sectoral Asset Management, with participation from Angelini Ventures, ResMed, Asahi Kasei Corporation, OrbiMed, and Treo Ventures.

Bridging the gap between the human brain and computer

Brain-computer Interfaces

Ceribell is a medical technology startuthat specializes in developing a cloud-linked, portable electroencephalogram (EEG) device called the Ceribell Point-of-Care EEG system. This innovative technology enables rapid assessment of brain waves to identify seizures in emergency rooms and intensive care units (ICUs) within minutes.
The Ceribell Point-of-Care EEG system comprises a headband with electrodes, a handheld recorder, and a web portal for data analysis. It utilizes machine learning algorithms to analyze EEG signals and generate alerts for suspected seizure activity. The system's unique selling point is its ease of use, allowing any healthcare provider to apply the device and obtain EEG results within six minutes, without requiring specialized training.
Ceribell aims to make EEG monitoring more accessible, efficient, and cost-effective, ultimately improving the diagnosis and treatment of neurological conditions, particularly for patients at risk of seizures. The company received its first FDA 510(k) clearance for the Ceribell EEG System in 2017, and it is commercially available in the US.
In September 2022, Ceribell received FDA Breakthrough Device Designation for its delirium indication, recognizing its technology as the first-of-its-kind for detecting delirium, a condition often under-diagnosed in ICUs. Additionally, in August 2023, the FDA granted 510(k) clearance for Ceribell's ClarityPro software, which diagnoses electrographic status epilepticus (ESE) in adults, making it the first and only device cleared for this purpose. Subsequently, the Centers for Medicare and Medicaid Services (CMS) approved New Technology Add-on Payment (NTAP) reimbursement for ClarityPro, further expanding access to this vital technology.
Key customers and partnerships
Ceribell primarily serves hospitals and healthcare institutions seeking advanced tools for neurological monitoring, particularly in emergency departments and intensive care units across the US. The company's innovative technology has been widely adopted and praised by healthcare providers for its ability to streamline seizure detection and management, leading to improved patient outcomes and more efficient resource utilization.
Several healthcare providers have highlighted the benefits of Ceribell's system, including its ease of use, rapid deployment, and remote monitoring capabilities. The system has enabled healthcare facilities to provide timely and accurate neurological assessments, optimizing treatment decisions and reducing the need for unnecessary interventions or patient transfers.
Furthermore, Ceribell has partnered with renowned academic institutions and research organizations to further advance the development and validation of its technology. For instance, the company collaborated with researchers from the University of Pittsburgh and Stanford University on clinical studies evaluating the effectiveness of its system in detecting delirium, a critical step toward obtaining FDA Breakthrough Device Designation for this indication.

Cadence Neuroscience is an early-stage company developing new medical device therapies for the treatment of epilepsy, central pain, and other neurological disorders. The company's core technology has been developed at Mayo Clinic and is under clinical evaluation. Its medical device therapies provide medical practitioners with a procedure that can be used to tailor brain stimulation therapy to each individual and enhance seizure control compared to currently used protocols.  Cadence Neuroscience was established in 2017 and is headquartered in Redmond, Washington.

Noctrix Health is an early-stage medical device company that focuses on developing a revolutionary therapy for a chronic illness.

ShiraTronics develops neuromodulation technology to combat debilitating chronic migraine. The company is driven by a mission to transform the lives of those living with chronic migraine.

Ceribell focuses on making electroencephalography (EEG) widely accessible, more efficient, and more cost-effective. The company creates and validates an FDA cleared instant EEG system that does not require an EEG technologist or specialist interpreter, which allows for faster results and clinical decision-making. The Ceribell EEG System can be set up by any healthcare provider in 6 minutes and offers a proprietary Brain Stethoscope function that dramatically simplifies interpretation of EEG results by converting brainwaves to sound so seizures can be detected by listening. Earlier diagnosis and focused treatment for patients with seizures, including non-convulsive seizures that can only be diagnosed with EEG, can significantly lower mortality, secondary brain injury, length of stay, and risk of complications.

HighLife is a company focused on Transcatheter Mitral Valve Replacement (TMVR). The technology is intended for treatment of patients suffering from mitral valve regurgitation and is currently in a stage of clinical evaluation. The company was co-founded in 2010 by Mr. Georg Börtlein, President & CEO. The intent is to provide a minimally invasive prosthetic mitral valve that is implanted on a beating heart, while preserving the native valve structure and respecting the surrounding anatomy. Ease and safety of use and delivery are key elements of the HighLife technology.

MD Start is an incubator and fund dedicated to medical technologies.  MD Start creates, develops, and operates medical projects, turning them into new companies with both strategic and hands-on approaches, in order to bring them to investment stage and commercial development.

LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. They are committed to improving the lives of patients and families who deal with chronic disease, and they support the healthcare professionals who dedicate their lives to helping them. LivaNova is also dedicated to the highest standards, and they operate at the topmost level of business ethics and compliance. As a strong, market-leading medical technology and solutions company, they understand the importance of bringing both clinical and economic value to their customers. LivaNova offers a diverse product portfolio with a differentiated pipeline. Their global reach is broad with a presence in more than 100 countries and approximately 4,000 employees.

<div> LivaNova PLC (Nasdaq: LIVN) is a global medical technology company focused on developing devices for cardiac surgery and neuromodulation. The company was formed in 2015 through a merger between Cyberonics and Sorin Group. Headquartered in London, LivaNova employs approximately 2,900 people worldwide and has a presence in over 100 countries. For the full year 2023, LivaNova reported revenue of USD 1.15 billion. LivaNova's product portfolio includes: <ul> <li> Cardiopulmonary products: Heart-lung machines, oxygenators, perfusion tubing sets, cannulae and other related accessories. The company's Essenz Perfusion System supports cardiopulmonary bypass procedures. </li> </ul> <ul> <li> Neuromodulation devices: Implantable pulse generators and related leads for the treatment of drug-resistant epilepsy and depression. This includes the SenTiva Duo device for vagus nerve stimulation therapy. </li> </ul> <ul> <li> Cardiac surgery products: Heart valves and repair products. </li> </ul> <ul> <li> Advanced circulatory support devices: The LifeSPARC system for temporary life support. </li> </ul> In 2023, LivaNova achieved double-digit revenue growth across all regions, driven by increased sales of its Essenz Perfusion System and strong demand for oxygenators. The company is conducting clinical trials for new indications, including a study on using neuromodulation to treat obstructive sleep apnea. In early 2024, LivaNova announced plans to wind down its Advanced Circulatory Support business to focus on its core Cardiopulmonary and Neuromodulation segments. The company appointed Vladimir A. Makatsaria as its new CEO effective March 1, 2024. </div>

LivaNova sees FY24 adjusted EPS $3.30-$3.40, consensus $3.16

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.

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