Advancements in Medical Device Innovation

ADM Tronics ADMT is a diversified technology company, specializing in the development and manufacturing of innovative products across three primary areas including Proprietary Electronic Medical Devices, Engineering, Regulatory, and Manufacturing Services, and Eco-Friendly, Water-Based Formulations. The company has remained active in the Medical Device Electrotherapy industry since 1969, and is known for its contributions to innovation spanning four generations of the DiMino family. Founded by the late Dr. Alfonso DiMino, ADM now operates under the leadership of his son, Andre' DiMino. ADM Tronics remains focused on research and development, producing therapeutic and diagnostic medical devices across various fields including audiology, physical medicine, wound therapy, neurology, and urology. Reflecting a commitment to environmental sustainability, ADM Tronics prioritizes the production of environmentally safe products.

Proprietary Electrotherapy Technology

Respiratory Health

ADMT partnered with QoL Devices, Inc. to develop Alvio™, a respiratory therapy and training platform. The Alvio^® Respiratory Training System offers a unique approach to improving respiratory health. It serves as a respiratory muscle trainer, Bluetooth game controller, and symptom tracker, all in one. By gamifying lung workouts, Alvio^® encourages users to "Play Your Way to Better Breathing!™" using a smartphone or tablet. This non-pharmacological solution, assembled in the U.S. by ADM Tronics, provides engaging games that can be tailored to individual needs with adjustable resistance levels.

The platform targets both non-regulated respiratory training applications and medical respiratory indications. With over 80 million people in the U.S. and over 1 billion worldwide suffering from respiratory challenges like COPD, CHF, and Asthma, there remains a significant need for specialized breathing monitoring and therapeutic devices. Alvio's cloud-connected devices have the potential to lower costs and improve patient outcomes in hospitals and at home.

Tinnitus

ADMT and Gama Research and Development have collaborated to create "Tinnitus Shield™", a hearing protection device tailored for those affected by tinnitus. With up to 50 million sufferers in the U.S. and 250 million worldwide, tinnitus is prevalent, often resulting from inner ear damage due to noise exposure. Tinnitus Shield™ features a patent-pending membrane filter designed to absorb sound waves evenly, providing natural sound suppression akin to a second eardrum for enhanced hearing protection.

ADMT is undergoing a redesign of the company's patented, non-invasive, FDA-approved medical device, the Aurex-3^®, used for treating and managing tinnitus. The updated version will feature state-of-the-art digital controls, enabling integration with smartphones, tablets, and cloud platforms, aiming to enhance patient usability and compliance. Moreover, the redesigned Aurex-3^® will offer wireless monitoring capabilities, allowing patient progress to be forwarded directly to physicians. Following completion of the redesign process, the new version of Aurex-3^® will be submitted to the FDA for clearance.

Pain Management

Vet-Sonotron is a non-invasive device utilizing pulsed radio frequency therapy (PRFT) technology designed for veterinary use. The device employs advanced non-invasive technology to stimulate tissue repair, reduce inflammation, and alleviate pain, offering an alternative to drugs or surgery. This innovative approach aims to enhance the well-being of animals while minimizing stress for both animals and owners. The device consists of a handheld applicator connected to a base unit, emitting long-wave RF and audio frequency. Treatment sessions involve applying a varying number of 15-second outputs, termed a Treatment Units (TU), depending on the treatment. Users have reported pain relief and increased range of motion lasting four to six months after a series of three to five treatment sessions. ADMT is preparing to launch Vet-Sonotron treatments for pets, with thousands of veterinary hospitals and veterinarians, and numerous large retail stores as potential distribution locations. ADM recently secured an agreement with a company specializing in providing leases for veterinary equipment, streamlining the leasing process for potential Vet-Sonotron purchasers with a simple one-page application for 3- or 5-year leases.

Building on this success, ADMT is developing a human medical version, the Sonotron, aimed at treating chronic and acute musculoskeletal pain conditions. Upon completion of development, ADMT plans to seek FDA clearance through a 510(k) submission. The company has already distributed the initial version in Southeast Asia and is currently upgrading the device with digital and wireless connectivity for improved usability and compliance. The non-invasive nature of Sonotron therapy, coupled with its lack of known side effects, offers a potential alternative to pain medications with associated risks and dependencies. With applications in treating various painful conditions, Sonotron is targeting a significant market opportunity.

Engineering

ADM Tronics also specializes in Electronic and Electromechanical Design, Engineering, Prototyping, and Production for Medical Electronics & Precision Devices. The company's in-house team of engineers, scientists, and technicians leverages extensive experience in electronic medical device development and regulatory compliance, and can provide a comprehensive range of electrical and electronics engineering capabilities, software development expertise, and mechanical engineering services. Additionally, ADM Tronics offers turn-key manufacturing services for electronic and electromechanical devices, with a focus on medical electronics. The team excels in guiding projects from concept to commercialization, offering cost-efficient U.S.-based design and manufacturing expertise.

Regulatory Services

ADM offers comprehensive electronics design and engineering services for medical electronics within the company's FDA-Registered Medical Device Manufacturing facility. ADM has developed therapeutic and diagnostic electronic medical devices across different fields. With extensive regulatory expertise spanning various standards, including FDA, GMP, CE, and ISO-13485, ADM Tronics provides turnkey documentation and quality control systems. In addition, ADM Tronics' multi-disciplinary team ensures cost-competitive U.S.-based design and manufacturing. For international clients, ADM offers access to the company's U.S.-based FDA-Registered facility, expediting regulatory clearances for non-U.S. medical devices in the U.S. market.

Financials

ADMT reported a decline in revenues for the three and nine months ending December 31, 2023, primarily driven by reduced sales across all segments, including Engineering, Electronics, and Chemical. Gross profit also decreased for both periods, reflecting the downturn in sales. Loss from operations for the three months ended December 31, 2023, was $105,387, compared to income from operations of $92,753 for the same period in 2022.

ADMT anticipates generating cash flows from operating activities in fiscal 2024 through growth in profitable customers and continued focus on acquiring new customers. With existing cash and cash equivalents totaling $661,985 as of December 31, 2023, coupled with potential additional cash sources, the company expects to meet its cash requirements.

Conclusion

In summary, ADM Tronics is a diversified technology company with a strong focus on innovation and healthcare. Through its proprietary electrotherapy technology, ADM remains dedicated to addressing diverse healthcare needs. Alongside product innovation, the company excels in engineering, manufacturing, and regulatory compliance. Despite facing challenges such as supply chain disruptions, ADM remains resilient and focused on driving growth and profitability in Fiscal Year 2024. With a robust portfolio and ongoing research efforts, ADM Tronics is well positioned to continue to make impactful contributions to the healthcare industry.