The Rise Fund is committed to achieving social and environmental impact alongside financial returns. We seek to partner with creative entrepreneurs and build successful businesses that drive meaningful, measurable positive change. The Rise Fund will focus on investments in seven sectors in which independent research has shown that impact is both achievable and measurable in quantitative terms: education, energy, food and agriculture, financial services, healthcare, information, and communication technology, and industrials and infrastructure.

The Rise Fund

Optimas Capital Partners Fund provides financial assistance to various businesses. It is based in Central, Hong Kong.

Optimas Capital Partners Fund

UCB focuses on research and development of medications centered on epilepsy, parkinson's disease, and crohn's disease. Their research and development activities in neurology, immunology, and other areas.

Union Chimique Belge

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.

LivaNova

DHVC is a venture capital firm based in Palo Alto, California. We invest in Enterprise, Consumer, FinTech, and Healthcare sectors. Our team brings together decades of combined experience in entrepreneurship, operations, investment, and research to serve our portfolio companies in growing and achieving success.

DHVC

Best-in-class investments mainly in the U.S. medical devices technology, as well as biotech, and mobile healthcare sectors through early sta

Shangbay Capital

Longitude Capital specializes in making venture growth investments in biotechnology and medical technology companies that seek to improve clinical outcomes, enhance the quality of life, and/or reduce system costs. They invest in both privately held and publicly traded life science companies through a variety of investment approaches. Since 2006, Longitude Capital has raised over $1.2 billion across three funds and demonstrated an ability to source, manage and exit attractive investments across multiple market cycles. Their venture growth strategy is rooted in building a balanced portfolio of clinical-stage and commercial-stage companies with clinically de-risked assets, favorable valuations relative to risk profile, and attractive expected returns within three to five years from the initial investment. Longitude Capital seeks to identify new investment opportunities by tapping into their broad network of industry relationships or through the execution of intensive thematic research into emerging therapeutic areas or industry sub-sectors. They utilize a variety of investment structures, including traditional venture capital, asset spin-outs, recapitalizations, PIPEs, open market purchases, royalties, and other equity and equity-linked instruments.

Longitude Capital

RA Capital Management is an investment advisor based in Boston specializing in the life-sciences and drug development sectors. The company's team has been investing since 2002 and is comprised of professionals with training in biology, chemistry, and medicine and also has industry and business development experience at the executive and board levels. The company invests in companies with promising technologies and products.

RA Capital Management

Redmile Group is a healthcare investment organization that makes venture, growth, and crossover investing across healthcare.

Redmile Group

Red Tree Venture Capital operates as a venture capital firm. The firm attempts to invest in initial companies in the life sciences industry.

Red Tree Venture Capital

Ally Bridge Group is a healthcare-focused investment group committed to venture and growth capital, buyout, and hedge fund investing. Ally Bridge Group focuses on both private and public equity investments, with a particular emphasis on pioneering life sciences companies and technologies. The firm is dedicated to bridging the gap between groundbreaking healthcare innovations and global markets. By leveraging its expertise and extensive network, Ally Bridge Group supports the growth and development of its portfolio companies. Its investment strategy is centered on transformative technologies and solutions that address major unmet medical needs.

Ally Bridge Group

Ceribell

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.

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.

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

Preventive Healthcare

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.

FDA grants 510(k) clearance for electrographic status epilepticus diagnostic software

MCRA Assists Ceribell with Obtaining FDA Breakthrough Device Designation, FDA Marketing Authorization, and CMS NTAP Reimbursement for ClarityPro Device

Ceribell Receives FDA Breakthrough Device Designation for Delirium Indication

Doctors using AI-driven devices to help detect seizure activity in patients

Top 12 Medical Device Startups to Look Out For in 2024

The biggest medical device VC deals of 2022

Ceribell to Present at the 41st Annual J.P. Morgan Healthcare Conference

Ceribell’s Status Epilepticus Software Receives FDA Clearance With CMS NTAP Coverage Included

Ceribell raises $50M for seizure monitoring and detection technology

Bridging the gap between the human brain and computer

Brain-computer Interfaces

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.

Pushing the envelope in MedTech with emerging technologies

Next-gen Medical Devices

Ceribell Appoints Kristie Rodenbush as Chief People Officer and Brian Price as Senior Vice President of Marketing

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.&nbsp;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.

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.

Cardiomo Care is developing noninvasive wearable devices to alert users and caretakers when there are abnormalities in the heartbeat. The company’s AI engine, trained on existing and growing data sets, can predict potential heart issues up to two hours before they occur, enabling early detection and intervention for arrhythmias and other cardiovascular diseases (CVDs).The company's product, CardiomoPatch, is a waterproof, wearable patch capable of long-term wear with a 10-day battery life. The patch monitors a patient's cardiac data, including ECG outputs, breathing, and skin temperature, and transmits the data via a mobile app for analysis by Cardiomo's AI engine.&nbsp;As of May 2024, the company is yet to commercialize its product and has over 1,600 pre-orders.

Cardiomo Care

Omada is a prevention-focused digital therapeutics startup that helps members achieve health goals through lifestyle changes. It offers four evidence-based, virtual prevention programs for managing hypertension, musculoskeletal (MSK) issues, prediabetes, and diabetes.Omada offers real-time data tracking through connected devices (such as wireless scales, blood pressure, and glucose monitors) and access to personalized coaching sessions via a mobile app as part of its prevention program. It also provides an online community of peers with similar health conditions to discuss challenges and provide support. In May 2021, Omada became the first fully-virtual healthcare provider to earn the National Committee for Quality Assurance’s Population Health Program Accreditation for its type 2 diabetes and type 2 diabetes + hypertension programs.Unlike its peers, Omada operates a performance-based business model where it charges clients an enrollment fee based on the number of users and a performance fee based on how much weight their employees lose. In May 2020, the company acquired virtual physical therapy startup Physera.Key customers and partnershipsAs of May 2024, Omada had more than 1 million members from more than 1,900 enterprise clients across all 50 US states. Its B2B employer and health plan client base include key clients such as American Eagle, Kaiser Permanente, Costco Wholesale, 3M, and Marvin. Additionally, the company has partnered with health systems and hospitals such as Intermountain Healthcare to provide its preventive programs as a covered benefit.In <a href="https://sp-edge.com/updates/15587">January 2023</a>, the company partnered with health service company Castell (a subsidiary of Intermountain Healthcare) to provide its diabetes programs to members from Intermountain Healthcare’s primary care providers in its Utah Medical Group. Further in <a href="https://sp-edge.com/updates/25245">January 2024</a>, the company partnered with Amazon to expand access to its cardiometabolic program.

Omada Health

VillageMD provides primary care services for patients. It also provides tools, technology, and staffing support needed for physicians to deliver high-quality services. VillageMD’s service delivery methods include traditional freestanding clinics, Village Medical at Walgreens co-located clinics, as well as at-home and around-the-clock virtual visits. It also leverages a team-based approach to care where physicians lead nurse practitioners, pharmacists, mental health specialists, and dietitians to offer a holistic care program. The technology of VillageMD includes docOS, an operating system that enables better patient care by connecting various clinical source systems with ongoing patient-generated data coupled with an AI engine to continuously analyze messages to enable patient self-care.The company made several acquisitions to expand its footprint: 1) <a href="https://sp-edge.com/updates/14347">Summit Health</a> for USD 8.9 billion in November 2022, 2) Healthy Interactions, an interactive patient education platform, in February 2022, and 3) <a href="https://sp-edge.com/updates/16968">Starling Physicians</a>, a primary care and specialty care provider, in March 2023.Key customers and partnershipsIn June 2020, VillageMD and Walgreens Boots Alliance announced a collaborative effort to open at least 600 Village Medical centers at Walgreens across more than 30 US markets by 2025. Walgreens invested USD 5.2 billion in VillageMD (from the previously announced USD 1.0 billion), raising its ownership stake to 63% (from 30%).However, as of May 2024, Walgreens had plans to close 160 VillageMD clinics as part of a cost-cutting plan.

VillageMD

Cityblock Health is a value-based healthcare provider focused on delivering comprehensive care to underserved communities, primarily Medicaid and lower-income Medicare beneficiaries. The company combines primary care, behavioral health, and social services to address the complex physical, mental, and social needs of its members.Cityblock's model involves partnering with local community-based organizations and deploying multidisciplinary care teams that include doctors, nurses, behavioral health specialists, and community health workers. These teams provide personalized care through 24/7 access to multi-modal care delivery, including in-home visits, telehealth, and community health hubs.The services of Cityblock are available to members at no additional cost if they are covered by an eligible health plan.Key Customers and PartnershipsAs of May 2024, the company’s services were available in seven states across the US and served over 100,000 members.In May 2024, it partnered with <a href="https://sp-edge.com/updates/29647">Sunshine Health</a> to expand to Florida, and, in <a href="https://sp-edge.com/updates/13270">September 2022</a>, it partnered with MDwise to expand into Indiana. Prior to that, the company had partnered with insurance providers such as ConnectiCare (Connecticut), Tufts Health Plan (Massachusetts), Emblem Health (New York), Healthy Blue (North Carolina), Molina Healthcare (Ohio) and CareFirst (Washington DC).Funding and FinancialsCityblock is a spin-off of Sidewalk Labs, an Alphabet company that incubates and invests in tech companies and products to improve urban infrastructure. It completed a USD 400 million Series D funding round led by Softbank in <a href="https://sp-edge.com/updates/5326">September 2021</a>, valuing the company at USD 5.7 billion. The funds were used to expand its services.

Cityblock Health

Everside Health (formerly Paladina Health) offers preventative care for chronic conditions and primary, mental and occupational healthcare treatments for acute conditions. Patients benefit from around-the-clock access to care, same-day or next-day appointments for in-person, and virtual care visits with zero copays.Everside aims to generate around 17% healthcare cost savings in three years and 31% in five years for its corporate members by leveraging a data-driven approach to care coordination.The company leverages data from past medical records, predictive analytics, and AI in the delivery of preventative care services.Founded in 2010 under the name Paladina Health, the company was rebranded in November 2020 as Everside Health following a merger between three primary care groups (Paladina, Activate Healthcare, and Healthstat). Furthermore, in February 2024, Everside Health merged with primary care provider Marathon Health to form a combined entity that would operate as Marathon Health, and, as of May 2024, the integration was ongoing.Key customers and partnershipPost-merger with Marathon Health, the combined entity would serve 2.5 million patients through over 680 clinics across 41 states.Funding and financialsThe company received its most recent investment in July 2022, amounting to USD 164 million in growth equity funding. The round was led by New Enterprise Associates (NEA). The funds were allocated toward growing its market presence and exploring opportunities for M&amp;A as well as to enhance and improve its product features. Additionally, the firm planned to expand its coverage of specialty care services aimed at individuals, employers, and union organizations.

Everside Health

Platforms offer a subscription-based or B2B-sponsored, evidence-based program for managing a specific long-term health condition.

DPCs offer value-based primary and preventive care services addressing whole-person (social, mental, physical) needs for a fixed monthly or annual fee paid by either the patient, insurance provider, or employer.

Companies offer B2B and D2C evidence-based treatments delivered via software programs to prevent and manage a variety of chronic conditions.

Tools that collect and analyze real-time patient data that supports healthcare providers with clinical decisions,  improves patient outcomes, and reduces medical errors.

Companies offer independent physician practices and hospitals with the tools (patient engagement, care coordination, administrative services) to help manage and improve clinical health outcomes of a defined group of individuals or large populations.

Platforms are used to track and gather patient health-related information via either a connected device or at-home test kits to detect the early onset of disease and identify any abnormalities in readings—but do not include a treatment plan.

To gather large amounts of real-time data for chronic care management, DTx, and patient monitoring

XR used by some startups for chronic pain management

Offers digital means of providing direct primary care, passive remote monitoring, chronic care management, etc.

AI/ML is used in predictive analytics, diagnostics tools, and population management

Offers tailored preventive interventions and treatments to the specific needs and characteristics of each individual

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.

Neuralink is a neurotechnology company founded by Elon Musk with the goal of developing brain-computer interfaces (BCIs). The company's flagship product is the N1 Implant, a coin-sized device that is surgically implanted in the brain. The implant contains 1,024 electrodes distributed across 64 ultra-thin threads that can monitor neural activity and electrically stimulate the brain. It wirelessly transmits brain data to external devices, allowing users to control computers or mobile devices directly with their thoughts.
Neuralink's initial focus is on providing digital freedom for people with quadriplegia by enabling them to interact with technology using neural signals. The N1 Implant will be placed in the motor cortex region of the brain that controls movement intention. As of March 2024, Neuralink has implanted its device in at least one human participant, allowing them to control a computer mouse cursor and play video games purely by thinking.
The implant surgery is performed using a custom robotic system developed by Neuralink. This surgical robot automatically inserts the electrode threads into the desired brain region with high precision. Neuralink claims the robotic implantation process aims to be as minimally invasive as procedures like LASIK eye surgery.
Key customers and partnerships
In November 2023, Neuralink announced its first clinical trial, dubbed the "Prime Study," to evaluate the N1 Implant's safety and functionality in human participants with quadriplegia caused by cervical spinal cord injury or amyotrophic lateral sclerosis (ALS). The study is expected to enroll participants aged 22 and older over a period of six years.
Neuralink has previously collaborated with the University of California, Davis to conduct animal testing of its brain implants on monkeys and other research animals. However, this partnership ended in 2020 amid allegations from an animal rights group regarding the treatment of monkeys during experiments.

Neuralink

Kernel is a neurotechnology company developing non-invasive brain imaging devices. Their flagship product, Kernel Flow, is a wearable headset that uses time-domain functional near-infrared spectroscopy (TD-fNIRS) technology to measure brain activity. Kernel Flow emits near-infrared light and detects changes in blood oxygenation levels in the brain's cortical areas, similar to functional magnetic resonance imaging (fMRI). However, it offers advantages such as portability, affordability, and the ability to measure brain activity in natural environments.
Kernel Flow features 52 modules arranged in four plates that fit on either side of the head. Each module contains two laser sources that generate picosecond pulses of light and six detectors that capture the reflected light. By recording the photon arrival times, the system can measure changes in oxyhemoglobin and deoxyhemoglobin concentrations, providing insights into brain function.
Kernel has conducted studies demonstrating the efficacy of Kernel Flow in various applications, including measuring the psychedelic effects of ketamine, predicting gaming expertise, and assessing cognitive decline. As of January 2022, the company had provided 50 systems to partners for evaluation and launched commercial sales for research teams.

Kernel

Synchron is a neurotechnology company developing an implantable brain-computer interface (BCI) system designed to enable patients with severe paralysis to wirelessly control digital devices through their thoughts and improve functional independence. Their flagship technology, the Stentrode, is an endovascular brain implant that is inserted into the brain's motor cortex via the jugular vein using a minimally invasive endovascular procedure, eliminating the need for open brain surgery.
The Stentrode contains electrodes that detect motor intent signals from the brain, which are wirelessly transmitted to an external device. Using machine learning algorithms and signal processing techniques, these neural signals are then translated into digital commands, allowing the user to control personal devices like computers and smartphones for tasks such as texting, emailing, online shopping, and accessing telehealth services.
In August 2020, Synchron received FDA Breakthrough Device designation, followed by the first Investigational Device Exemption (IDE) in July 2021 for evaluating a permanently implanted BCI. The company has conducted clinical trials in Australia and the US, with the first US implantation occurring in July 2022 at Mount Sinai Health System in New York. As of January 2023, Synchron reported that the Stentrode remained safe and functional in four Australian patients after 12 months, with no serious adverse events or significant signal deterioration.

Synchron

Paradromics is an Austin, Texas-based neurotechnology company developing a high data-rate brain-computer interface (BCI) called the Connexus Direct Data Interface (DDI). The Connexus DDI is designed to collect an unprecedented number of individual neural signals from the brain using a fully implantable device intended for long-term daily use.
The first application of the Connexus DDI is an assistive communication device that translates brain signals into speech and movement in real-time. This revolutionary technology aims to restore the ability to communicate and interact with technology independently for people with conditions like ALS, spinal cord injuries, and stroke that cause severe motor impairment.
In May 2023, Paradromics raised USD 33 million in a Series A funding round led by Prime Movers Lab, with participation from Westcott Investment Group, Dolby Family Ventures, and Green Sands Equity. This investment will enable the company to launch its first-in-human clinical trial for the Connexus DDI.
Additionally, in a significant milestone, the US Food and Drug Administration (FDA) granted the Connexus DDI a Breakthrough Device Designation in May 2023. This designation recognizes the transformative potential of the device and allows for an expedited review process, accelerating its availability to patients.

Paradromics

Cognixion is a leading developer of non-invasive Brain-Computer Interface (BCI) and Augmented Reality (AR) technology. Their flagship product, the Cognixion ONE Axon, utilizes electroencephalogram (EEG) technology to provide a non-invasive brain-computer interface. It enables patients with advanced disease progression, such as Amyotrophic Lateral Sclerosis (ALS), Motor Neuron Disease (MND), traumatic injuries, and cerebral palsy, to communicate their responses with their thoughts and mental attention in a wearable, augmented reality headset.
The Cognixion ONE Axon integrates Artificial Intelligence (AI), including GPT large language models, to rapidly support the user's communication intentions and desired outcomes. It provides contextual predictions and suggestions that can be quickly selected and communicated audibly and visually on the front visor as a communication aid. The device aims to become the first FDA-cleared device allowing fully paralyzed or locked-in patients to communicate via a non-invasive brain-computer interface once eye-tracking is no longer usable due to ocular motor decline.
Cognixion's technology combines AI, Augmented Reality, and Assistive Technology, designed to help people with severe motor impairments communicate and interact more effectively and independently with the world around them. Unlike invasive BCI technologies, Cognixion's device can be prescribed and utilized without surgical procedures or significant training, providing a new level of independence and autonomy.
Key customers and partnerships
In May 2023, the Cognixion ONE Axon received US Food and Drug Administration (FDA) Breakthrough Device designation, which will streamline its development and validation process with prioritized feedback from FDA review staff. This designation is awarded to devices that demonstrate the potential to provide more effective treatment for life-threatening or debilitating conditions where no clear alternatives exist.

Cognixion

Non-invasive hardware typically involving wearable devices that can record, monitor and interact with brain activity using methods like electroencephalography (EEG), enabling the control of prosthetic limbs, operating computers, and more

Physical devices implanted in the body, often in the brain, to interface with neural signals such as electrodes or neural implants

Companies that offer software platforms for BCI applications, including cloud platforms that enables neural data storage

Companies that gather, store, analyze, and interpret neural data collected via BCIs in order to generate valuable insights for clinical decision making

Most BCI companies personalize the BCI devices based on the patient's condition and goals

Most BCI companies leverage a digital means of extracting and interpreting neural data, some of which use mobile applications to provide insights

The products/platforms offered by most companies utilize AI/ML in enhancing their offering

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.

Convergent Dental, Inc. is a privately owned dental equipment and technology company. Its flagship product, Solea, is the only CO2 laser cleared by the FDA for all-tissue indications, delivering an anesthesia-free, blood-free, and suture-free experience for dentists and patients. Solea represents a breakthrough in dental laser technology, offering a distinct experience compared to traditional instruments or earlier laser treatments.
Solea is a novel 9.3-micron CO2 laser that nears the peak absorption of hydroxyapatite (enamel), enabling it to vaporize enamel with speed and precision. This unique wavelength, coupled with computer-controlled motors (galvos) that manipulate the beam thousands of times per second, allows dentists to perform procedures ranging from hard tissue to soft tissue with total control and efficiency.
A key feature of Solea is its variable-speed foot pedal, which lets dentists seamlessly transition from hard to soft tissue by adjusting the pressure applied. This intuitive design streamlines the learning curve for dentists accustomed to using a drill. Solea's three ergonomic handpieces – Contra-Angle, Straight, and Ultraguide – further enhance its versatility across various procedures.
Solea not only improves patient experiences but also offers practice benefits such as increased productivity, new patient flow, and efficiency gains. In October 2022, Convergent Dental received FDA clearance for Solea to aid in reducing mineral loss in dental enamel, protecting teeth against acid attack and caries development. This breakthrough application was commercially launched in November 2023 under the name Solea Protect.

Convergent Dental

Ossio is an orthopedic fixation technology company that has developed OSSIOfiber Intelligent Bone Regeneration Technology, a breakthrough implant material designed to securely fixate and fully integrate into the body's native anatomy without leaving any permanent hardware behind. This technology addresses the limitations of conventional metal and resorbable implants, combining unparalleled mechanical strength with natural bone healing.
Made from a proprietary mineral fiber matrix held together by a naturally degradable polymer, OSSIOfiber implants provide surgeons with a more biologically friendly way to restore patient stability and mobility. These implants are engineered to provide the strength required for functional fixation while allowing full integration into the native bone without adverse biological response.
Ossio's product portfolio includes compression screws, trimmable fixation nails, hammertoe fixation systems, suture anchors, and compression staples, all made with OSSIOfiber technology. These implants have received multiple FDA clearances since 2019, and the company has initiated commercialization of its products in the US. As of March 2022, over 6,000 implantations of OSSIOfiber products had been performed, demonstrating adoption of this innovative technology.
OSSIOfiber Intelligent Bone Regeneration Technology can address various surgical applications through the manufacturing of implant designs like nails, screws, staples, anchors, and plates. Ossio plans to pursue multiple applications in distal extremities, trauma, sports, reconstruction, pediatrics, and spine segments.
In February 2023, Ossio launched the world's first and only non-permanent compression staple made with OSSIOfiber technology, designed for predictable bone in-growth, regeneration, and replacement.

Ossio

Casana is a healthcare technology company that has developed the Heart Seat, an innovative toilet seat that enables effortless, integrated, and consistent in-home health monitoring. The Heart Seat is a replacement for a standard toilet seat and is designed to measure key clinical parameters such as heart rate, blood oxygen saturation (SpO2), and blood pressure.
In May 2023, Casana received FDA clearance for the Heart Seat to measure heart rate and SpO2 in adults aged 22 years and older, weighing between 90 to 350 pounds. The company plans to file for additional indications, including systolic and diastolic blood pressure, with the goal of launching the product in the market by the end of 2023.
The Heart Seat is equipped with sensors that passively capture health data whenever the seat is used, eliminating the need for user compliance or behavior changes. The data is automatically uploaded to the Casana Cloud, where it can be viewed by healthcare providers, enabling them to monitor patients' health trends and respond to changes in near real-time.
Casana's technology allows for the effortless collection of consistent and reliable data, assisting medical teams in monitoring chronic conditions beyond the hospital or physician's office. The company aims to unlock a new category in healthcare technologies that enables seamless, integrated, and continuous in-home health monitoring.
In January 2022, Casana was acquired by an undisclosed entity, further accelerating the commercialization of the Heart Seat.

Casana

Neurent Medical is a company pioneering innovative non-surgical interventions to treat chronic inflammatory sinonasal diseases, particularly chronic rhinitis. The company's flagship product is the NEUROMARK System, a device that received US Food and Drug Administration (FDA) 510(k) clearance in October 2021.
The NEUROMARK System is designed to gently apply controlled low-power radio frequency (RF) energy to target regions of the nasal cavity, disrupting the parasympathetic nerve signals that can trigger an inflammatory response. This alleviates chronic rhinitis symptoms such as persistent congestion, rhinorrhea (runny nose), swelling of the mucosal membrane, sneezing, and nasal itching. The system's unique flexible leaflet design and proprietary smart algorithms enable precise neurolysis (disruption) of the posterior nasal nerves (PNN) and accessory pathways, accommodating a range of patient anatomies while maintaining mucosal and vascular integrity.
Neurent Medical announced the limited market release of the NEUROMARK System in the US in February 2023, following the establishment of a new Category I Current Procedural Terminology (CPT) code by the American Medical Association (AMA) for PNN procedures, effective January 2024. The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) also endorsed the PNN procedure in 2023.

Neurent Medical

Genetesis is a medical imaging company specializing in biomagnetic cardiac imaging solutions. It has developed CardioFlux, a flagship magnetocardiography (MCG) system that non-invasively identifies myocardial ischemia, a condition where blood flow to the heart muscle is reduced. The technology measures the magnetic fields generated by the heart's electrical activity to detect ischemia within minutes, without using pharmaceuticals or radiation. CardioFlux MCG is designed to provide advanced imaging while prioritizing patient comfort.
The company's solutions target the diagnosis of coronary microvascular disease (CMD), a condition that has been challenging to identify due to a lack of effective functional diagnostics. By offering an accurate and rapid test for CMD, Genetesis aims to address an unmet clinical need and enable timely management of the condition.
In April 2023, the US Food and Drug Administration (FDA) granted CardioFlux MCG Breakthrough Device designation for the non-invasive diagnosis of myocardial ischemia in patients suspected of having CMD.
Genetesis was founded in 2013 and is headquartered in Mason, Ohio. The company has received over USD 40 million in funding to date, including a USD 17.5 million Series C round in October 2022. In April 2020, TDK Ventures, the corporate venture capital arm of TDK Corporation, invested in Genetesis, providing access to TDK's expertise in areas like biomagnetic sensors and magnetic noise suppression.

Genetesis

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Companies that develop implantable medical devices designed to be surgically placed inside the human body, either temporarily or permanently, including devices such as pacemakers, artificial joints, stents, and cochlear implants

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Companies that develop monitoring devices that are used in a hospital setting to measure patient vital signs and ensure patient well-being post-treatment, such as cardiac and respiratory monitoring systems

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Providers of software that helps manage risks, ensure quality, and streamline audit processes during medical device development

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