LIM Innovations is developing prosthetic socket technology to meet important unmet clinical needs in the amputee population. With current methods, sockets take 1 month to fabricate, do not accommodate limb volume changes, demonstrate high cost through a labor intensive system, and lack satisfaction in the areas of comfort and fit. Our device will decrease fitting time to 1 day, allow the patient to adjust their socket, limit dependence on the prosthetist for follow-up modifications, and provide moisture management advancements. Through a blend of structural design, materials, and modularity this socket will improve both comfort and access.
There are 625,000 major limb amputees in the USA with 75,000 new amputations performed each year. The prosthetic/orthotic field is a $5B industry in the USA when services is included . This is a craft industry ripe for change especially as modern health care demands greater accountability for outcomes and cost.
Our entry to market will begin with adoption through utilization of the exiting infrastructure of service provision marketing, and distribution. We anticipate rapid uptake through low regulatory challenges (minimal FDA, 510K, and GMP burden) and a tight-knit community of knowledgeable users. The LIM Innovations socket will present a new product line for various prosthetic/orthotic distributors and also a novel means to provide service to amputees. Thus strategic partnerships with device manufacturers and service providers will provide key added value through purchase orders and licensing agreements.
LIM Innovations was founded by Andrew Pedtke MD (an orthopaedic surgeon) and Garrett Hurley CPO (a certified prosthetist/orthotist). We are a lean start up with a dedicated and passionate team addressing design, engineering, business, IP, legal, and marketing.
LIM Innovations is seeking $1.3 million in financing to develop our first scalable product. Our key future milestones include implementation of a quality system, FDA submission and CE mark, a 10 – 20 subject preference study, securing a distribution/sales partner, performing outreach to providers/payers, and building out our IP portfolio.