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Improved Otologic Implants On Demand Intraoperatively with 3D CAD/CAM Autografts

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41DC015408-01
Agency Tracking Number: R41DC015408
Amount: $214,976.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIDCD
Solicitation Number: PA15-270
Solicitation Year: 2015
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-01
Award End Date (Contract End Date): 2019-08-31
Small Business Information
Jacksonville, FL 32223-4806
United States
DUNS: 079704542
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (904) 568-6516
Business Contact
Phone: (904) 568-6516
Research Institution

DESCRIPTION provided by applicant Of all the hundreds of types of synthetic middle ear implants that are used in surgery approximately of these are rejected by the body These include total ossicular replacement prostheses TORPs and partial ossicular replacement prostheses PORPs TORPs are used in general when during surgery it is noted that the malleus incus and stapes are all absent or have been removed PORPs are generally used when the stapes the last bone in the chain is present but the malleus and incus are absent or have been removed TORPs and PORPs are expensive require large inventories in the operating room and carry the risk of rejection such as with transplant surgery Autologous bone and cartilage or autografts which are materials harvested from the patient for use in the same patient can be used but they require expensive operating room time for carving to the right shape and size There is a need for prosthetics with decreased cost decreased extrusion infection rates and increased availability Nitinetics LLC has developed subtractive D CAD CAM computer assisted design and manufacture which allows the production of accurate bone and cartilage autografts in the operating room This technology can save money by reducing operating room time and reducing the need for expensive inventories of diverse middle ear prosthetic devices Since autologous materials are less likely to extrude or cause infection this could also reduce costs Additionally the cost of raw material the patientandapos s own bone is zero We intend to evaluate whether this CAD CAM technology is more cost effective and results in reduced complications compared to prosthetic devices This Phase I project will consist of a clinical trial in which consenting patients requiring middle ear reconstruction surger will be implanted with one of two middle ear implants The two middle ear implants will be as follows Sheehy Partial Ossicular Replacement Prosthesis in the control group and computer generated autograft partial ossicular replacement prosthesis with the identical design made out of the patientandapos s own bone in the experimental group The following parameters will be prospectively measured Operating room time required for fabrication cost pre and post operative hearing results infection rates and rejection rates Different sizes of each implant wil be available depending on individual patient anatomical factors Patients will be randomized in a double blind manner The computerized autograft ossicular replacement technique is anticipated to provide an improved product that will result in decreased complications such as infection rejection and or hearing loss as well as a cost benefit to patients

PUBLIC HEALTH RELEVANCE There is an unmet medical need for improved ear surgery techniques This is because many artificial middle ear implants are rejected by the body Making implants out of the patientandapos s own bone or cartilage using a computerized device in the OR will improve public health by decreasing ear surgery complications such as infection and rejection

* Information listed above is at the time of submission. *

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