Overview of Xmorphe

Xmorphe’s product portfolio includes a prosthetic ankle-foot system that embodies multiple functionalities in a compact design, compared to existing systems in the market. It enables amputees walk on uneven surfaces and in outdoor conditions with much more comfort and ease. The ankle-foot system is already approved for Medicare L-codes that will provide prosthetic clinics/providers sufficient reimbursement and profit margin. The current phase of innovation is a size-specific, clinically tested, commercially available product called GoraliPaa SFT. The complete line of all foot sizes is in development to launch in Summer 2026. Xmorphe has a second prosthetic product, which is a passive, modular ankle component product called Goralign PSA3 (GPSA3) that uses a highly non-linear compliant mechanism for real-time self-alignment and adaptation to gait and terrain changes in all three planes of motion plus vertical shock absorption. GPSA3 is also PDAC approved for Medicare/insurance reimbursement and ready for the market. The modular ankle component can be used with any low/moderate-functioning prosthetic foot and transform it into an advanced functioning foot system that enables the user (lower limb amputee) to walk on uneven terrain and conduct outdoor activities with sustainable comfort.

Our vision is to enhance the quality of life of amputees and people with reduced mobility by restoring mobility for sustainable comfort. Our mission is to develop and commercialize mechanical systems, with a focus on Prosthetic and Orthotic systems.

Our self-aligning prosthetic ankle will enhance comfort and mobility for military and civilian personnel suffering from lower limb loss due to injuries and diabetes. The ankle-foot system provides complete comfort to amputee end users and an appealing profit margin to prosthetic clinics, our direct customers. The self-alignment feature, along with vertical shock absorption in the modular ankle component contributes to comfort and biomechanical perfection, reduced amputee-prosthetist time, and lower cost. Roughly 185,000 amputation-related hospital discharges occur in the United States each year, with an approximate hospital cost of $8.7 billion. Our passive products offer comparable performance at lower prices than current robotic prosthetics.

The end users of our products are civilian and military amputees who wish to restore mobility to improve their quality of life. Our direct customers are prosthetic clinics and prosthetic distributors. Existing passive/mechanical prosthetic legs and leg components suffer from misalignment over time, and often times are not suitable for or unable to adapt in real time to gait and terrain changes of outdoor walking conditions. These issues cause pain while walking. 51% of below-knee amputees suffer from prosthetic misalignment. In the longer term, misaligned prosthetics can cause a range of additional maladies from lower back pain to double amputation, which can lead to a higher mortality rate, particularly in the case of diabetes. Existing prosthetic leg alignment involves more than forty gait parameters. Even with the same patient-prosthetist, the process is subjective and iterative. One integrated leg system cannot provide all the functionalities needed for outdoor, rugged walking conditions without being too bulky and heavy. In the case of robotic legs and ankle-feet, the leg/ankle systems need batteries that are cumbersome and need charging. In addition, robotic leg/ankle-foot systems are many times too expensive for insurance and Medicare/Medicaid approval process, or amputees being able to pay for the co-pay/insurance.

Our strategy for business acceleration is through partnerships with manufacturers, clinics, and marketing and sales experts.

We are looking for potential funding of $500,000 that will be used for:

* Supporting the business roadmap for product launch: Patient testing (Clinical trial not required to market the product), manufacturing optimization, and
promo units manufacturing.

*Operational Expenses: Engineering, Administrative, Go-to-Marketing (Consulting-contracting), Tradeshow, Sales, Social Media