Manufacturing Stocks List

Inphi Corporation provides high-speed analog and mixed signal semiconductor solutions for the communications, datacenter, and computing markets worldwide. The company's analog and mixed signal semiconductor solutions offers high signal integrity at data speeds while reducing system power consumption. Its semiconductor solutions are designed to address bandwidth bottlenecks in networks, maximize throughput and minimize latency in computing environments, and enable the rollout of next generation communications and datacenter infrastructures. Its solutions provide a high-speed interface between analog signals and digital information in high-performance systems, such as telecommunications transport systems, enterprise networking equipment, datacenters and enterprise servers, storage platforms, test and measurement systems, and military systems. The company also provides 25G to 600G high-speed analog semiconductor solutions for the communications market. Its products perform a range of functions, such as amplifying, encoding, multiplexing, demultiplexing, retiming signals at speeds up to 400 Gbps. Inphi Corporation sells its products directly through its sales force, as well as through a network of sales representatives and distributors to original equipment manufacturers. The company was formerly known as TCom Communications, Inc. and changed its name to Inphi Corporation in February 2001. Inphi Corporation was incorporated in 2000 and is headquartered in Santa Clara, California.

Kadmon is a clinical-stage biopharmaceutical company that discovers, develops and delivers transformative therapies for unmet medical needs. Its clinical pipeline includes treatments for immune and fibrotic diseases as well as immuno-oncology therapies.

Cantaloupe, Inc. is a software and payments company, which engages in the provision of end-to-end technology solutions for the unattended retail market. It offers Internet of Things (IoT) and machine-to-machine (M2M) services, which include the ability to remotely monitor, control, and report on the results of distributed assets containing the electronic payment solutions. The company was founded by George Raymond Jensen Jr. in January 1992 and is headquartered in Malvern, PA.

CoreCard Corp. engages in the management of emerging technology companies. It operates through CoreCard Software, Inc. and affiliate companies, which are involved in the design, development, and marketing of software solutions to corporations, financial institutions, retailers, and processors to manage credit and debit cards, prepaid cards, private label cards, fleet cards, loyalty programs, and accounts receivable and small loan transactions. The company was founded in 1973 and is headquartered in Norcross, GA.

Zhengye Biotechnology Holding Limited is a manufacturing company in the Pharmaceutical Products industry.

IEC Electronics is a provider of electronic manufacturing services ('EMS') to advanced technology companies that produce life-saving and mission critical products for the medical, industrial, and aerospace and defense sectors. The Company specializes in delivering technical solutions for the custom manufacture of complex full system assemblies by providing on-site analytical testing laboratories, custom design and test engineering services combined with a broad array of manufacturing services encompassing electronics, interconnect solutions, and precision metalworking. As a full service EMS provider, IEC holds all appropriate certifications for the market sectors it supports including ISO 9001:2015, AS9100D, ISO 13485, and is Nadcap accredited. IEC Electronics is headquartered in Newark, NY and also has operations in Rochester, NY and Albuquerque, NM.

FBR & Co. is an investment banking and institutional brokerage company. The Company focuses on the equity capital markets. The Company operates through two segments: capital markets, which includes investment banking, institutional brokerage and research, and principal investing. Through its broker-dealer operating subsidiaries, the Company focuses its business on providing: capital raising services, including underwriting and placement of public and private equity, equity-linked and debt securities; financial advisory services, including merger and acquisition (M&A) advisory, restructuring, liability management, recapitalization and strategic alternative analysis; institutional sales and trading services focused on equities, equity-linked securities, listed options, high-yield bonds, senior debt and bank loans, as well as securities lending activities, and differentiated securities research.

Orbital Infrastructure Group, Inc. engages in the acquisition, development and commercialization of electro-mechanical products and technologies worldwide. It operates through the following segments: Electric Power, Telecommunications and Renewables. The Electric Power segment provides comprehensive infrastructure solutions to customers in the electric power industry. The Telecommunications segment provides enterprise solutions to the cable and telecommunication industries. The Renewables segment focuses on utility-scale solar construction. The company was founded on April 21, 1998 and is headquartered in Houston, TX.

Tailwind Two Acquisition Corp. focuses on effecting a merger, share exchange, asset acquisition, share purchase, reorganization, or other business combination with one or more businesses or entities. The company was incorporated in 2020 and is based in New York, New York.

LadRx Corp. is a biopharmaceutical research and development company, which engages in the discovery, research, and clinical development of novel anti-cancer drug candidates. It focuses on developing the Linker Activated Drug Release (LADR) technology platform, a discovery engine to help create a pipeline of anti-cancer molecules that will avoid unacceptable systemic toxicity while delivering highly potent agents directly to the tumor. The company was founded in 1985 and is headquartered in Los Angeles, CA.

Estrella Immunopharma, Inc., a preclinical-stage biopharmaceutical company, develops T-cell therapies for blood cancers and solid tumors in the United States. The company's lead product candidates include EB103 for the treatment of diffuse large B-cell lymphoma and is in pre clinical trial; and EB104 to treat diffuse large B-cell lymphoma and acute lymphocytic leukemia. It has a collaborative partnership with Imugene Limited for the development of solid tumor treatments using Imugene's product candidate CF33-CD19t in conjunction with EB103. Estrella Immunopharma, Inc. is based in EmeryVille, California.

Electric Last Mile Solutions, Inc., a commercial electric vehicle solutions company, focuses on designing, engineering, manufacturing, and customizing electric ‘last mile' delivery and utility vehicles. It offers Class 1 commercial electric vehicle in the U.S. market and focuses on producing Class 3 Urban Utility electric vehicle. The company is headquartered in Troy, Michigan.

jupiter wellness, inc. operates as a hemp-derived cannabidiol (cbd) consumer product development company. it develops various therapeutic and medical use for cbd in the treatment of various ailment and diseases, such as cancer, arthritis, anxiety, insomnia, psoriasis, chronic pain, and others. the company markets cbd-infused sun care lotion formulas containing various sun protection factors under the canisun brand. it is also developing other products, such as cbd-infused skin care lotion under the caniskin brand; and dermatological treatments under the canidermrx brand. the company was formerly known as cbd brands, inc. jupiter wellness, inc. was founded in 2018 and is headquartered in jupiter, florida.

indie designs and manufactures custom, microcontroller-based chips, using arm cores. we replace most of the contents of a printed circuit board with a single, optimal chip designed specifically for your application. this reduces the product cost, size and power compared with solutions based around standard, off-the-shelf components. reliability, manufacturability and security are all increased. aside from its skills in mixed signal design, indie's strengths are the way we can stitch new designs together quickly and cheaply, allowing applications to get the benefits of system-on-chip technology without the normal downsides. we have multiple designs in production and ship volumes of million-plus units per month and are growing fast.

FBS Global Ltd. is a manufacturing company in the Misc. industry.

G Medical Innovations Holdings Ltd, together with its subsidiaries, an early commercial stage healthcare company, engages in the development of next generation mobile health and telemedicine solutions in the United States, China, and Israel. The company's products include Prizma, a plug-and-play medical device that measures vital signs with electronic medical records functionality and clinical grade reporting standards; and Extended Holter Patch System, a multi-channel patient-worn biosensor that captures electrocardiogram data continuously for up to 14 days. It also develops Wireless Vital Signs Monitoring System, a solution that provides continuous real time monitoring of vital signs and biometrics. In addition, it offers monitoring services, including independent diagnostic testing facility monitoring and private monitoring services. The company was incorporated in 2014 and is based in Rehovot, Israel.

adial pharmaceuticals is dedicated to personalized treatment for drug abuse and addiction. while our pipeline includes drug candidates for the treatment of opiate and amphetamine use, our two lead drug candidates are for the treatment of alcohol abuse. adial leverages its extensive knowledge of pharmacology and pharmacogenomics to change the paradigm of drug abuse treatment.

Aesther Healthcare Acquisition Corp. intends to effect a merger, capital stock exchange, asset acquisition, stock purchase, reorganization, or similar business combination with one or more businesses. The company was incorporated in 2021 and is based in New York, New York.

Welsbach Technology Metals Acquisition Corp. does not have significant operations. The company focuses on effecting a merger, stock exchange, asset acquisition, stock purchase, reorganization, or similar business combination with one or more businesses. It intends to focus on the technology metals and energy transition metals sectors. Welsbach Technology Metals Acquisition Corp. was incorporated in 2021 and is based in Lombard, Illinois.

Envoy Medical, Inc., a hearing health company, provides medical technologies for the hearing loss spectrum. Its products include hearing aids; Esteem middle ear implants; bone conduction devices, such as auditory osseointegrated implants; and Acclaim cochlear implants. The company was formerly known as Envoy Medical Corporation and changed its name to Envoy Medical, Inc. in September 2023. Envoy Medical, Inc. was founded in 1995 and is headquartered in White Bear Lake, Minnesota.

J-Star Holding Co., Ltd. is a manufacturing company in the Recreation industry.

Apollo Strategic Growth Capital II intends to effect a merger, share exchange, asset acquisition, share purchase, reorganization, or similar business combination with one or more businesses. The company was formerly known as APH I (Sub I), Ltd. and changed its name to Apollo Strategic Growth Capital II in December 2020. Apollo Strategic Growth Capital II was incorporated in 2008 and is based in New York, New York.

Psyence Biomedical Ltd. is a manufacturing company in the Pharmaceutical Products industry.

Spectral AI, Inc. operates as an artificial intelligence (AI) company. The company focuses on medical diagnostics for faster and accurate treatment decisions in wound care with applications involving patients with burns and diabetic foot ulcers. Its products include DeepView, a predictive diagnostic device that offers clinicians an objective and immediate assessment of a wound's healing potential prior to treatment or other medical intervention. The company is based in Dallas, Texas.

biote Corp. operates in medical practice-building business within the hormone optimization space. The company offers a platform for Biote-certified practitioners to optimize imbalances in their patient's hormone, vitamin, and mineral levels, as well as prescribe bioidentical hormone therapies and recommend dietary supplements. It also sells Biote-branded dietary supplements; and sterile pellet insertion kits for men and women. The company was founded in 2011 and is headquartered in Irvine, Texas.

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Captivision Inc. is a manufacturing company in the Electrical Equipment industry.

Palladyne AI Corp., a software company, focuses on delivering software that enhances the utility and functionality of third-party stationary and mobile robotic systems in the United States. Its Artificial Intelligence (AI)/ Machine Learning (ML) software platform enables robots to observe, learn, reason, and act in structured and unstructured environments. The company's software platform enables robotic systems to perceive their environment and quickly adapt to changing circumstances by generalizing from their experience using dynamic real-time operations without extensive programming and with minimal robot training. It serves customers from various industries, such as industrial manufacturing, warehousing and logistics, defense, infrastructure maintenance and repair, energy, aerospace and aviation, and others. The company was formerly known as Sarcos Technology and Robotics Corporation and changed its name to Palladyne AI Corp. in March 2024. Palladyne AI Corp. was founded in 2017 and is headquartered in Salt Lake City, Utah.

Chase Corporation, a specialty chemicals company, manufactures and sells protective materials for various applications worldwide. It operates through three segments: Adhesives, Sealants and Additives; Industrial Tapes; and Corrosion Protection and Waterproofing. The Adhesives, Sealants and Additives segment offers protective conformal and moisture protective electronic coatings and cleaning solutions; advanced adhesives, sealants, and coatings; polymeric microspheres; polyurethane dispersions; superabsorbent polymers; and cleaning and protection solutions for electronic assemblies. The Industrial Tapes segment provides wire and cable materials; specialty tapes and related products; insulating and conducting materials; laminated durable papers; water-blocking compounds; laminated film foils and cover tapes; and pulling and detection tapes. The Corrosion Protection and Waterproofing segment offers protective pipe-coating tapes and other protectants; polymeric asphalt additives; waterproofing membranes; waterproofing sealants, expansion joints, and accessories; technological products, and tapes and membranes; specialized high-performance coating and lining systems; waterproofing and corrosion protection systems; and pipeline protection tapes and products. It sells its products through its salespeople, as well as manufacturers' representatives and distributors. The company was founded in 1946 and is headquartered in Westwood, Massachusetts.

We are an exempted company with limited liability incorporated under the laws of the Cayman Islands, which is structured as a holding company whose main business operations are conducted through our subsidiaries in Switzerland and to a lesser extent, HK SAR, the People's Republic of China and Australia. We are a biotechnology company spearheading the development of oral (specifically, sublingual) delivery of peptides and proteins. Many of the more effective drugs to treat diabetes and obesity are “biologics”, the vast majority of which currently have to be injected. For example, although insulin was discovered almost 100 years ago, there has, to date, not been any commercially viable solution to administer insulin without the need for injection. Consistent with this, the delivery of peptides or proteins, such as insulin, in a non-invasive way (i.e. without needles or injections) is a very challenging endeavor from a scientific and technical perspective. Since our inception, we have focused on developing an alternative approach, known as sublingual delivery. The sublingual area lies under the tongue and is lined by a thin layer of cells which has a rich supply of blood vessels. Sublingual delivery has been successfully used commercially for many years to deliver a variety of so-called small molecule drugs, such as glyceryl trinitrate and ondansetron, which can readily penetrate this layer of cells to rapidly enter the blood stream. We hypothesized that we could similarly exploit the unique nature of the sublingual area to effectively deliver peptides and proteins, and this subsequently became the focus of our research. The main peptide used to improve the technology was exenatide, which was the first commercial glucagon-like peptide (GLP-1) receptor protein product and is routinely used to treat type 2 diabetes. During our first series of studies with exenatide, the sublingual dose required was almost 200 times the injectable dose to achieve a similar effect. After 2 to 3 years of extensive development, we were able to reduce this ratio to 5 to 10, and we now have a “platform” of formulations (the “BioLingus Platform”) and expertise on how formulations should be designed for better performance. During the course of our research and testing of various peptides and proteins across several different disease indications, it has become clear to us that there are two areas for our technology with significant commercial potential: . Metabolic disease, in particular diabetes and obesity and related metabolic disorders such as nonalcoholic steatohepatitis (“NASH”); and . Immunology (mainly allergy and auto-immune disorders)(1). (1) A perpetual and irrevocable license has been granted to all non-metabolic applications from BioLingus IP GmbH to BioLingus IP II GmbH. BioLingus IP GmbH only holds the rights to the metabolic applications. In 2019, BioLingus IP II GmbH was spun-out of BioLingus IP GmbH and we no longer own BioLingus IP II GmbH. Our principal executive office is located at Grossmatt 6, CH-6052 Hergiswil NW, Switzerland. Our registered offices in the Cayman Islands are located at Ogier Global (Cayman) Limited, 89 Nexus Way, Camana Bay, Grand Cayman, KY1-9009, Cayman Islands.

Chase Corporation, a specialty chemicals company, manufactures and sells protective materials for various applications worldwide. It operates through three segments: Adhesives, Sealants and Additives; Industrial Tapes; and Corrosion Protection and Waterproofing. The Adhesives, Sealants and Additives segment offers protective conformal and moisture protective electronic coatings and cleaning solutions; advanced adhesives, sealants, and coatings; polymeric microspheres; polyurethane dispersions; superabsorbent polymers; and cleaning and protection solutions for electronic assemblies. The Industrial Tapes segment provides wire and cable materials; specialty tapes and related products; insulating and conducting materials; laminated durable papers; water-blocking compounds; laminated film foils and cover tapes; and pulling and detection tapes. The Corrosion Protection and Waterproofing segment offers protective pipe-coating tapes and other protectants; polymeric asphalt additives; waterproofing membranes; waterproofing sealants, expansion joints, and accessories; technological products, and tapes and membranes; specialized high-performance coating and lining systems; waterproofing and corrosion protection systems; and pipeline protection tapes and products. It sells its products through its salespeople, as well as manufacturers' representatives and distributors. The company was founded in 1946 and is headquartered in Westwood, Massachusetts.

Sharing Economy International, Inc. develops technologies, products and services with a view to minimise pollution and wastage to protect the environment. It operates through the following segments: Dyeing and Finishing Equipment and Sharing Economy. The Dyeing and Finishing Equipment segment involves in the manufacture and sell of textile dyeing and finishing machines. The Sharing Economy segment targets the technology and global sharing economy markets, by developing online platforms and rental business partnerships that will drive the global development of sharing through economical rental business models. The company was founded by Jian Hua Wu in 1987 and is headquartered in Hong Kong.

ToughBuilt Industries Inc. is an advanced product design, manufacturer and distributor with emphasis on innovative products. Currently focused on tools and other accessories for the professional and do-it-yourself construction industries. The Company markets and distributes various home improvement and construction product lines for both the do-it-yourself and professional markets under the TOUGHBUILT brand name, within the global multibillion dollar per year tool market industry. All of its products are designed by its in-house design team. Since launching product sales in 2013, the company has experienced significant annual sales growth. Its current product line includes three major categories, with several additional categories in various stages of development, consisting of Soft Goods & Kneepads and Sawhorses & Work Products. Its mission is to provide products to the building and home improvement communities that are innovative, of superior quality derived in part from enlightened creativity for its end users while enhancing performance, improving well-being and building high brand loyalty.

Cortigent, through its predecessor Second Sight Medical Products, Inc., is a pioneer in developing precision (targeted) neurostimulation systems to help patients recover critical body functions. Our technology combines advanced neuroscience with proprietary microelectronics, software, and data processing capabilities to provide artificial vision and potentially restore muscle movement. Our first commercial system, Argus II®, a retinal implant, was approved by the U.S. Food and Drug Administration (“FDA”) under a Humanitarian Device Exemption (“HDE”) and has provided artificial vision to hundreds of profoundly blind people who were implanted with this device. Building on this neurostimulation platform we have completed an early feasibility clinical trial to evaluate a more advanced system for artificial vision that we call “Orion.” We are further exploring the application of our Orion® neurostimulation technology for accelerating the recovery of arm and hand function in patients who are partially paralyzed due to stroke. In February 2023, we held a meeting with FDA staff to commence discussions of an early feasibility clinical study in stroke victims. We believe that additional future applications of our platform technology may have the potential to generate substantial business growth over time. Both the Argus II and Orion devices create artificial vision by using electrical stimulation. Artificial vision does not restore normal stereoscopic vision or vision with color but rather perceptions of light and shapes requiring implantees to interpret their environment through specialized training. This artificial vision can aid in supporting basic tasks such as finding a doorway, detecting another person’s presence, following a sidewalk or locating an object. For the Argus II device, the stimulation is delivered to the surviving cells of the retina which convey the activity to the brain via the optic nerve. For the Orion device, electrical stimulation is delivered directly to the visual cortex, the region of the brain responsible for vision. The pattern of electrical stimulation corresponds to the images captured by a small video camera mounted in the center of the glasses that the patient wears and is connected to the video processing unit (“VPU”). The VPU is a battery-powered device worn by the user, typically on a belt or a strap, that sends power and stimulation commands to the implant and receives diagnostic information from the implant via the external antenna of the glasses. Argus II users undergo surgery to implant an electrode array inside the eye on the surface of the retina and affix a small electronics case (like a metal button) and an antenna to the outer surface of the eye. A small cable traverses the eye wall, connecting the electronics case to the array. Orion users undergo cranial surgery to implant an electrode array placed on the surface of the brain on the visual cortex and have a small electronics case and an antenna implanted on the outside of the skull, but completely covered by the scalp. A small cable passes through the skull to connect the array to the electronics case. No part of the device penetrates or cuts into the brain tissue itself. The quality of the artificial vision created by both the Argus II and Orion systems varies from patient to patient. The perception typically appears as a collection of up to 60 small points of light that correspond to the brightness of the different regions of the visual image detected by a camera. With scanning and repetition, patients can use their perception of the lights to construct a better understanding of their environment. The Argus II design process began in 2004. The Argus II was a novel device that required the components to be developed internally. The Argus II feasibility study commenced in 2006. In March 2011, the Argus II® Retinal Prosthesis System was approved for commercial use in the European Union to provide visual perception in patients with profound blindness due to retinitis pigmentosa (“RP”), a rare condition. The device was initially available in the United Kingdom, France, Germany and several other countries at a price of approximately USD $115,000. In February 2013, the U.S. Food and Drug Administration (FDA) approved Argus II under a Humanitarian Device Exemption, and in August 2013 the reimbursement price for Medicare patients was approved at approximately $150,000. More than 350 profoundly blind people around the world have received Argus II retinal implants. Many of these patients have been using their Argus implants for more than ten years, confirming our high manufacturing standards and product reliability. The market opportunity for the Argus II was limited to the small number of patients who have profound blindness due to RP, and we discontinued production and marketing of the Argus system in 2019 due to resulting commercial considerations. To make artificial vision available to a much larger group of individuals who are blind due to a wider range of causes, including glaucoma, diabetic retinopathy, optic nerve injury or disease and eye injury, we designed and built our next generation system, the Orion® Visual Cortical Prosthesis System (“Orion”). The Orion system leverages our 20 years of experience in precision neurostimulation for artificial vision. To be eligible for the Orion system, patients must be bilaterally blind with bare or no light perception. This is defined as non-measurable binocular visual acuity, or 5° or less visual field in each eye. We refer to these eligibility criteria as “profound blindness.” Cranial surgery is required to place the electrode array onto the brain’s surface; the Orion system has been designed not to penetrate the brain tissue. The design process began in 2014 and required substantial changes to the Argus II implant electronics to generate higher currents with a redesigned array for implantation on the brain cortex rather than within the eye. In November 2017 we commenced an Early Feasibility Study (EFS) of Orion in six patients who enrolled at two medical sites, the Ronald Reagan UCLA Medical Center in Los Angeles (“UCLA”) and the Baylor College of Medicine in Houston (“Baylor”). Regularly scheduled visits at both sites were paused in mid-March 2020 due to the COVID-19 outbreak; visits at UCLA resumed in September 2020 and at Baylor in December 2020. Three of the six patients were explanted after the third year of the study and the remaining three patients continue to use their devices outside of the clinic. We have three-year safety data for all six subjects, and five-year safety data for three subjects: . Orion safety data: Five subjects experienced a total of seventeen adverse events (AEs) and one subject did not report any adverse events related to the device or to surgery through July 2024. One was considered a serious adverse event (SAE) and all other adverse events were not serious. The single SAE, a seizure, occurred about three months post-implant, was resolved safely and quickly, and did not require a hospital stay. The investigators determined that this SAE was device-related and not unexpected as it had been disclosed as a potential safety risk in the patient informed consent form. The SAE occurred as we attempted to explore the optimal treatment frequency, which is a key stimulation parameter. The SAE occurred at a specific frequency. All adverse events are evaluated by an independent medical safety monitoring (IMSM) committee. With the IMSM committee’s input, we thereafter kept stimulation frequencies for all patients below the level that induced the SAE, and we have not observed any other seizures in this or any other participant. The FDA requires medical device manufacturers to follow 21 CFR 820 and maintain a Quality Management System (QMS). As a part of our QMS, we conform to ISO 14971, an FDA-recognized standard, to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. There have been no serious adverse events due to the device or surgery since June 2018. One patient chose to have the device explanted before the 36th month due to an unrelated medical condition. Two other patients subsequently requested explantation for reasons unrelated to the device’s efficacy or safety. Cortigent’s independent medical safety monitor (IMSM) has determined that the reasons for these explants were not related to the device or the surgery. We have three-year efficacy data for five of the six original subjects (one did not participate in this assessment), and five-year efficacy data for three subjects: . Orion efficacy data: We assess efficacy by looking at three measures of visual function: 1) Square localization – Orion subjects sit in front of a touch screen and are asked to touch within the boundaries of a square when it appears; 2) Direction of motion – Subjects are asked to identify the direction of the motion of a line that traverses a screen; and 3) Grating visual acuity – a measure of visual acuity that is adapted for very low vision. Five of the six original subjects completed the planned efficacy assessments at 36 months post-implant and three completed these assessments at 60 months. – For square localization, at 36 months five of the six original subjects remained in the study and all performed significantly better with the system turned on versus turned off. At 60 months, three of the six original subjects remained in the study and all performed significantly better. – For direction of motion, at 36 months the five subjects remaining in the study all performed significantly better with the system turned on than with it turned off. At 60 months, the three subjects remaining in the study all performed significantly better. – For grating visual acuity, at 36 months two of the five subjects remaining in the study had measurable visual acuity with the system turned on compared to none with the device turned off. At 60 months, two of three remaining subjects had measurable visual acuity. Another efficacy measurement of day-to-day functionality and benefit is the Functional Low-Vision Observer Rated Assessment (FLORA). The FLORA assessments were performed by an independent, third-party specialist who spent time with the subjects in their homes. The specialist asked each subject a series of questions and observed them performing 15 or more daily living tasks with the Orion system turned on and with it turned off, such as finding light sources, following a sidewalk, or sorting laundry. The specialist then determined if the system was providing a benefit, was neutral, or impaired the subject’s ability to perform these tasks. Four of four subjects who completed the FLORA evaluation at 36 months had positive or mildly positive results indicating that the Orion system was providing benefit. This evaluation was not performed at the 60-month timepoint. Cortigent is planning to work with the FDA to gain agreement on the additional clinical studies that will be required to secure marketing approval for Orion. The FDA categorizes electronic medical devices that are implanted as Class III. Both the Argus II and Orion are in this Class III category and require FDA approval. Class III devices face higher burdens to attain regulatory approval; Cortigent (formerly Second Sight Medical) successfully navigated this approval process with the Argus II system. The Argus II clinical trial enrolled patients with late-stage retinitis pigmentosa, a rare disease, affecting less than four thousand Americans. This small potential market size of fewer than 8,000 individuals enabled the Argus II to qualify for a Humanitarian Device Exemption (HDE) which the FDA granted in February 2013. In November 2017, the FDA granted an Expedited Access Pathway (EAP) designation to the Orion system to treat individuals who are bilaterally blind due to non-cortical etiology and who are not candidates for any other commercially approved vision restoration therapy. The Breakthrough Device Program (BDP) subsumed the EAP program and its devices in December 2018. Breakthrough Device designations, such as granted to Orion, are intended to accelerate medical device development, assessment, and review, while preserving the statutory standards for premarket approval. The potential patient population for Orion is expected to include blindness due to most common causes, including glaucoma, diabetic retinopathy, eye trauma, optic nerve damage, and retinitis pigmentosa. According to a company-sponsored 2018 study by Fletcher Spaght Inc., there are about 82,000 Americans who could potentially benefit from the Orion system. We are developing a platform technology with multiple potential applications: Our current-generation miniature neurostimulation device with 60 independently controlled cortical stimulation channels, supported by reliability data from the Argus II and Orion programs, is expected to serve as a platform for targeting other conditions with high unmet medical need. Technical evaluations of potential new indications for the technology began in 2021. We believe that our most promising next target will be to apply cortical neurostimulation to improve recovery of arm and hand function in partially paralyzed stroke patients who are undergoing rehabilitation after stroke. This medical treatment concept is supported by evidence from clinical studies conducted by Northstar Neuroscience, Inc. in the early 2000s using a single-channel electrical stimulation device that was placed on the motor cortex, the area of the brain surface that controls hand and arm motion (the same surface area of the brain where our device will be placed). Northstar reported achieving positive patient results in its Phase 1 and Phase 2 clinical studies (Cramer 2007) but a pivotal Phase 3 study failed to achieve statistical significance at the 4-week primary endpoint. Northstar was unable to obtain FDA approval and was eventually dissolved. It has been reported that a clinical benefit was demonstrated at six months (Levy 2016). We believe that our 60-channel cortical stimulation device has the potential to target neuron bundles more precisely and generate favorable clinical results. Like Orion, the stroke recovery system will require cranial surgery; in this case to place the electrode array on the motor cortex. We began to design the stroke system in 2022, and during February 2023 we studied what we believe to be the optimal array placement on the motor cortex of a cadaver. We have filed an NIH grant application to seek non-dilutive funding to support this program but it was not initially awarded. We plan to reapply for grant funding in early 2025. In addition, in February 2023 we held a pre-submission (“Pre-Sub”) meeting with FDA staff to discuss commencing an Early Feasibility Study of the stroke recovery system. We applied for a Breakthrough Device designation for the stroke recovery system in April 2023 and the FDA responded that human clinical data will be needed to make this determination. If we fail to secure this designation, we may experience slower interactions with the FDA that could delay our projected development timelines. We are targeting substantial revenue opportunities: The Orion system, designed to provide visual perception to profoundly blind people, has a target market of approximately 82,000 individuals in the U.S., assuming the planned indication is achieved (profound blindness due to glaucoma, diabetic retinopathy, optic nerve injury or disease and eye injury), based on a study by an independent market research firm engaged by Cortigent. We believe that about one-third of these patients could be reached by a marketing program. Depending on study results to assess clinical utility, Cortigent may seek reimbursement similar to or higher than the $150,000 per device that was approved by the Centers for Medicare and Medicaid Services (“CMS”) for the Argus II system. These assumptions translate into an estimated total addressable U.S. market size that could potentially exceed $4 billion at the time of launch. We believe that there are substantially more blind people who could potentially benefit from Orion in Europe, Asia and other world areas. There are approximately 7.6 million living Americans who have reported a stroke in their lifetime. (Tsao 2022). Consequently, we believe that the sales potential for a medical device system that can help improve motoric function in partially paralyzed stroke victims is very large. Each year approximately 610,000 Americans have a first stroke (Kissela 2012). Among the over 80% of people who survive a first stroke, the most common neurological deficit is motor weakness on one side of the body (hemiparesis), and approximately 40% of these stroke victims suffer moderate to severe motor impairment that requires special care (Gresham 1995). If our device achieves treatment success, as to which we can make no assurance, we estimate that it could potentially benefit up to 195,000 U.S. stroke victims each year, creating a total addressable market estimated at approximately $6 billion by the time of system launch. Several critical development and regulatory milestones must be accomplished in order to complete and market the Orion and stroke recovery systems. We face the material risks of failing to achieve successful clinical trials, to attain regulatory approvals, and to secure favorable product reimbursement for patients covered by Medicare and other types of insurance. Even with a successful trial, it could be determined that certain patient subpopulations cannot be effectively treated by our devices which would reduce our product sales potential. The development process may take longer and be more costly than anticipated and we may not achieve reimbursement levels similar to the one we received for our Argus II device or obtain other suitable reimbursement levels that we may require. Since we currently have no commercial revenues, any of these outcomes could require substantial additional funding. No assurance can be made that clinical trials will demonstrate safety and efficacy or will lead to commercial products. Clinical trial planning: The five-year Orion Early Feasibility Study was completed in July 2023, and at our election is being extended by approximately another year to allow for additional exploratory research to improve vision quality, for example by enhanced contrast filtering or by other software modifications. The next step will be to manufacture and validate new Orion devices for a planned pivotal clinical trial that we expect will involve approximately 60 profoundly blind subjects at approximately 10 U.S. trial centers. These are internal estimates and the size of the Orion pivotal clinical trial will depend upon further review and collaborations with the FDA. Our intended target is to commence the pivotal trial by or about mid 2026, complete it by approximately mid 2028, and if successful to obtain FDA clearance and launch Orion on the US market in early 2029. For the stroke recovery system, we anticipate manufacturing modified clinical trial devices for the planned Early Feasibility Study (EFS) in parallel with manufacturing of the Orion devices. Our intended target is to commence this EFS for the stroke recovery system in mid 2026. We anticipate a shorter time for stroke recovery patients to reach the primary study endpoint than for Orion (nine months versus 12 months, respectively). Patient population size and other terms of the stroke recovery system pivotal trial will depend upon the outcomes of the stroke recovery systems EFS and on further review and collaboration with the FDA. Our intended target is to commence a pivotal clinical trial for the stroke recovery system in late-2027, complete it by mid 2029, and if successful to be able to launch the stroke recovery system in late 2029. The target clinical development timelines for Orion and the stroke recovery system, shown in the diagram below, are subject to further discussions and collaborations with the FDA and assume that adequate financing will be available to fund the execution of our clinical development programs. Clinical trials require FDA approvals and clearances. No assurance can be given that we will be able to obtain these approvals and clearances, that we will obtain approval of a marketable device or that we will be able to launch commercially successful products. --- The timeline presented represents management’s estimate of the time required to complete each stage. No assurance can be given that these timelines will prove correct. Intellectual property: Cortigent has amassed an extensive intellectual property estate consisting of rights (as of September 30, 2024) to 207 issued U.S. patents, 20 issued European patents (nationalized in France and Germany, or a unitary patent plus Great Britain), two pending U.S. patent applications, including a recent filing covering the stroke recovery device under development, two pending European patent applications, four issued U.S. design patents and four issued European design registrations (with six corresponding issued British design registrations). Our patent estate covers the technologies invented during the development of the Argus and Orion devices. Our patent estate primarily covers the core technologies of implant neurostimulation techniques and achieving implant longevity, which are integral to our current and future product lines, including the planned stroke rehabilitation system. Pre-Revenue company: We are a pre-revenue company with a history extending from 1998, including the history of our predecessor Second Sight Medical Products, Inc., of recurring operating losses that are likely to continue for the foreseeable future. We will require substantial additional capital, including the proceeds of this offering, to continue development of our products and fund clinical trials. Relationship with Vivani Prior to this offering Cortigent has been a wholly owned subsidiary of Vivani Medical, Inc. (Nasdaq: VANI), formerly known as Second Sight Medical Products, Inc. (“Second Sight”). Second Sight had historically operated as a standalone public company but completed a merger with Nano Precision Medical, Inc. as of August 2022. Vivani Medical, Inc. is the resulting entity of this August 2022 merger of Nano Precision Medical Inc. into a subsidiary of Second Sight Medical Products, Inc. Cortigent includes personnel, technologies, intellectual property and other assets that formerly comprised the vision operations of Second Sight Medical Products, Inc. Cortigent was organized as a Delaware corporation in November 2022 as a successor to the business and operations formerly conducted by Second Sight Medical Products, Inc. Our principal executive offices are located in 27200 Tourney Road, Suite 315 Valencia, California.

4D pharma plc, together with its subsidiaries, engages in the research, development, and production of live biotherapeutic products. The company develops therapeutic candidates, such as MRx0518; MRx-4DP000 for the treatment of asthma and COVID-19; MRx0029 the treatment of central nervous system disorders; Blautix for irritable bowel syndrome; and Thetanix for pediatric crohn's disease. It also develops products candidates, including MRx1299 for solid tumors, MRx0005 for neurodegeneration, MRx0006 for rheumatoid arthritis, and MRx0002 for multiple sclerosis. The company develops MicroRx platform to discover new LBP candidates for major diseases. 4D pharma plc has a collaboration agreement with Merck & Co., Inc. to conduct a clinical trial evaluating the combination of Keytruda and MRx0518 in patients with solid tumors. The company was formerly known as Schosween 18 Limited. 4D pharma plc was incorporated in 2014 and is headquartered in Leeds, the United Kingdom.