IR-Med Stock

IR-Med Inc. operates as a development stage medical device company.

The company engages in developing non-invasive devices for various medical indications, by detecting and measuring various biomarkers and molecules in the blood and in human tissue in real-time, allowing healthcare professionals to detect and measure different molecules in the blood and in human tissue in real-time without any invasive procedures. Its initial product candidates are in various stages of development.

The company's initial product under development, which it calls PressureSafe, is a handheld optical monitoring device that is being developed to support early detection of pressure injuries (PI) to the skin and underlying tissue, regardless of skin tone and which calibrated personally to each patient's skin, primarily caused by prolonged pressure associated with bed confinement. Its skin-device-interphase development of personalized medical devices allows high accuracy readings from the human body in a non-invasive method, that may provide caregiver the optimal decision support-system in cases where uncertainties disturb physicians in their decision processes.

The company is also in the preliminary stage of research and development of an innovative otoscope, which it calls Nobiotics, to support physicians with an immediate indication as to whether mid-ear infection (Otitis Media), a common malady in children, is of a bacterial origin and thus requiring antibiotic treatment, or of a viral origin and does not require antibiotic treatment.

The company's technology platform utilizes Artificial Intelligence (AI).

The company's initial focus is on the development of DSS solutions utilizing its proprietary platform for the pre-emptive diagnosis of pressure injuries (PI) and of mid-ear infections detection. Its business plan focuses on two principal medical devices in development:

PressureSafe: A handheld optical monitoring device that is being developed to support early detection of pressure injuries (PI) to the skin and underlying tissue, primarily caused by prolonged pressure associated with bed confinement; and

Nobiotics: An innovative otoscope, being designed to support physicians with an immediate indication as to whether mid-ear infection (Otitis Media), a common malady in children, is of a bacterial origin and thus requiring antibiotic treatment, or of a viral origin and does not require antibiotic treatment.

The company's product candidates are in various stages of development. The PressureSafe device is in an advanced stage of development and is planned to be the company's first go-to-market product, and the NoBiotics is in initial stage of research and development.

The company has completed the development of the first generation PressureSafe prototype in the second quarter of 2022 In June 2022, IR Med. Ltd., its wholly owned subsidiary, entered into a study agreement with Beit Rivka, a Large Geriatric Hospital in Israel associated with Clalit, the largest Health Insurance Fund in Israel, to conduct a usability study of Pressuresafe. In August 2022, IR Med. Ltd., entered into an agreement with an Israeli boutique industrial design company specializing in the design of medical devices and diagnostic products servicing a broad array of companies, including large multinational companies, for the design of the PressureSafe device in its advanced configuration, which incorporates preliminary results from a usability study being performed in Israel, including feedback from healthcare professionals. In February 2023, the company's subsidiary IR-Med Ltd. entered into an agreement with Rabin Medical Center (RMC) in Israel to perform a usability study, as an additional study center to the study that it has been performing at Beit-Rivka, a large geriatrics hospital in Israel. The agreement is to conduct a usability study of the company's proprietary and patent protected 'PressureSafe' device, which it plans to launch as a decision support system (DSS) tool for care givers in Hospitals, Nursing homes, and Home-Care companies.

The company is working on completing the development of the commercial version of the PressureSafe device, planned to be launched during 2023, pending FDA clearance.

In 2022, the company began preparations in anticipation of commercialization of PressureSafe in the United States pending regulatory approvals. A distribution agreement was entered into with PI Prevention Care LLC (the 'Distributor'), a newly formed entity focused on marketing to the senior care facility, hospital, and homecare markets. The Distributor, which received exclusive rights for PressureSafe distribution across the United States, includes personnel who have many years' experience in addressing and responding to the needs of these types of organizations. Under the terms of the Agreement, which were previously disclosed, to maintain exclusivity the Distributor is obligated to comply with minimum purchase requirements of the device and accompanying disposables.

PressureSafe

The company engages in designing and developing PressureSafe, a novel device that has the potential to provide a reliable method of monitoring and recording patients providing additional information to healthcare providers as where and when a PI may occur. The technology platform is designed to record information relating to each patient. The IR based core technologies underlying the PressureSafe device are patent-protected (U.S. Patent No. US 10,709,365) and (U.S. Patent No. US10,772,541). The company's technology is based on the fact that tissues of the human body absorb and reflect the light that surrounds it in different wave lengths (from the UV through visual light to infra-red light) and the light is reflected and scattered back from inside the body through the skin. The PressureSafe is being designed to capture, analyze, and identify tissue status to make early PI diagnosis using Spectrographic Analysis while AI learning software is planned to improve diagnostic accuracy. The PressureSafe device will illuminate the skin with a miniature LEDs for a few seconds. The emitted light photons from the device will be absorbed, scattered, and reflected back. The device will then measure the absorption and reflectance, and using algorithms, will process the signals to identify and diagnose the scanned area.

As every person's skin properties are unique, the diagnosing physician must calibrate the device to the specific patient's skin, a process that takes merely a few seconds and allows personalized diagnosis, improving diagnostic process effectiveness as the PressureSafe device is designed to be indifferent to the skin color. The company's technology is being developed to enable the assessment of different subdermal layers by scanning through these skin layers, thus improving the identification of the damage and assessing the subdermal damaged tissue volume, assisting with additional information to allow better treatment efficacy. The bio-signals that the company's algorithm detects occur in the early inflammatory process, as soon as local subcutaneous tissue function is disturbed, and cells begin to be damaged.

PressureSafe is a hand-held scanner designed to provide additional information as a decision support system (DSS), to support the care giver effectively with the main diagnostic ability to identify PI and to differentiate between Deep Tissue PI (before it becomes visible) and Stage 1 PI. Deep tissue PI are serious, hospital-acquired deep PIs that form under intact skin, spread in deep tissues and eventually present themselves as full thickness wounds. The PressureSafe is composed of a handheld optic probe device, which utilizes harmless infra-red light, that is placed for a few seconds on suspected areas for performing mearurements; a disposable probe tip component, changed between patients to avoid cross-contamination; a software component containing machine learning algorithm for analyzing the collected data; and software for connectivity and downloading the collected data and measurements results to the EMR/EHR systems used by the medical center or homecare company.

PressureSafe is a non-invasive real-time optical monitoring device to support early intervention in PI treatment prior to skin breakage. The device performs a reflectance spectroscopy scan to generate information for the decision maker, while collecting data of subdermal physiological changes together with other bio-signals typical to early formation of PI in the three skin layers, thus detecting the appearance of life risking pressure injuries. PressureSafe is designed to detect changes at a depth of 1-5 mm in the skin, regardless of skin tone, by measuring differences of subdermal fluid content and bio-signals. As soon as local subcutaneous tissue function is disturbed and cells begin to disintegrate by pressure excreted upon by dependent body areas, the company's scanner is designed to be able to support detecting this as a very early inflammatory process. The technology will allow patient monitoring and immediate reading in a non-invasive way. It has the potential to help to reduce the number of PI dramatically, through early detection, making it attractive for public and private healthcare systems worldwide.

The PressureSafe first generation device is undergoing usability studies, and the commercial version is now in development and is planned to be launched during the second half of 2023.

The company is conducting usability studies at two medical centers in Israel, a Geriatric hospital and a general hospital, planned to be completed during 2023. It also plans to start useability studies in the U.S. during 2023 in order to validate the efficacy of the device for the U.S. cohort, including patients with dark skin tones.

The company's POC study began in the first quarter of 2018 at the Rambam Healthcare campus, located in Haifa, Israel and at the Beit Lowenstein Rehabilitation Center, located in Raanana, Israel.

Nobiotics

The Nobiotics device is planned to be an otoscope for supporting noninvasive detection of otitis media (ear infection). The device is in initial stages of development as an ear examination device that will give the physician an immediate indication if the infection is from a Viral or Bacterial source and then the physician will make a decision if to prescribe an antibiotic or not (DSS). The device works on a similar IR-spectrographic analysis method as being developed in the PressureSafe device. The Nobiotics otoscope is based on infrared light reflection and absorption by the effluents behind the ear drum. Target customers for the Nobiotics device are general practitioners (GPs), pediatricians, and ear nose and throat (ENT) specialists.

Strategy

The key elements of the company's strategy include developing and expanding a balanced and diverse pipeline of products and product candidates; targeting large and growing patient populations with significant unmet medical needs; maintaining a global, diverse network of specialists to accelerate knowledge synergies and innovation; and establishing distribution channels to maximize the commercial potential of its products.

Intellectual Property

The IR based core technologies underlying the PressureSafe device are covered by patent issued (U.S. Patent No. US 10,709,365) and (U.S. Patent No. US10,772,541) issued on July 14, 2020, and September 15, 2020, respectively. All the company's patents are marked under 'system and method for noninvasive analysis of subcutaneous tissue'. Such patents are owned by IR-Med Ltd. and are valid through August 2034.

During 2022 IR-Med applied for two new provisional patents in the U.S. and European Union, one for the PressureSafe device and one for NoBiotics.

As December 31, 2022, a significant portion of the company's granted U.S. patent applications and pending patent applications in foreign jurisdictions were directed to enhance both the PressureSafe and other future applications devices.

Research and Development

The company's research and development expenses were $1,885,000 on for the year ended December 31, 2022.

Distribution Agreement

On October 7, 2022, IR. Med, Ltd. and PI Prevention Care LLC, a Delaware limited liability company (the 'Distributor') entered into an exclusive Distribution and License Agreement (the 'Distribution Agreement') pursuant to which the Distributor received exclusive royalty bearing rights to promote, market, and sell solely in the United States the company's PressureSafe monitoring device.

Manufacturing

Manufacturers of the company's products are required among other things, to comply with applicable FDA/EMA manufacturing requirements contained in the FDA/EMA's Quality System Regulation (QSR).

Distribution and Revenue Generation

The company intends to establish sales and marketing structures and strategic partnerships in the United States, the U.K., and in Europe to support all of its product candidates.

The target market for the company's PressureSafe device is relevant Health care setting (i.e., hospitals, senior care facilities, home care companies etc.), nursing homes, and a growing segment of long terms home care givers. Towards that end, in third quarter of 2022, the company began preparations in anticipation of commercialization of PressureSafe in the United States during 2023, pending regulatory approvals.

Nobiotics' target users will be pediatricians, family doctors, pediatricians and Ear, Nose and Throat (ENT) doctors. The distribution of the Nobiotics is expected to be carried out by companies who are suppling devices and disposables to the target audience.

In both the PressureSafe and the Nobiotics devices, the revenue stream is expected to be generated mainly from the disposables and PSaaS (PressureSafe solution as a service) that are needed for the proper operation of the device, while the device itself likely be given under lease agreements.

Government Regulations

Unless an exemption applies, each medical device, such as the company's PressureSafe and Nobiotics that is intended to be commercially distributed in the United States requires 510(k) clearance from the FDA.

For the PressureSafe device, the company is working closely with its FDA regulatory consultants to complete its pre-market notification to the FDA for 510(k) clearance and all other necessary design and manufacturing processes.

In the United States, the company's activities are potentially subject to regulation by various federal, state, and local authorities in addition to the FDA, including the Centers for Medicare and Medicaid Services, other divisions of the United States Department of Health and Human Services (e.g., the Office of Inspector General), the United States Department of Justice and individual United States Attorney offices within the Department of Justice, and state and local governments.