SBIR-STTR Award

Digital Surgical Magnification Device for Lymphatic Surgery
Award last edited on: 1/24/2023

Sponsored Program
SBIR
Awarding Agency
NIH : NHLBI
Total Award Amount
$399,846
Award Phase
1
Solicitation Topic Code
837
Principal Investigator
Maziyar K Askari

Company Information

Unify Medical (AKA: I-Imaging LLC)

30548 Royal Woods Place
Westlake, OH 44145
   (216) 309-8144
   N/A
   www.unifymedical.com
Location: Single
Congr. District: 16
County: Cuyahoga

Phase I

Contract Number: 1R43HL158365-01
Start Date: 7/1/2021    Completed: 12/31/2022
Phase I year
2021
Phase I Amount
$399,846
There are more patients suffering from lymphatic diseases than patients suffering from humanimmunodeficiency virus (HIV). In the US alone, 56% of breast cancer survivors develop lymphedema at twoyears, leading to approximately two million lymphedema patients annually. Lymphatic surgery relies onmicrosurgery and supermicrosurgery due to the small size of lymph vessels. Effective surgical visualizationand high-power magnification are critical to lymphatic surgery. The lack of clinical tools available to lymphaticsurgeons makes the already complicated lymphatic surgery even more challenging. The long-term goal is toimprove outcomes of lymphatic surgery by enhancing surgical visualization. The overall objective of thisapplication is to develop a wearable high-power digital magnification device for lymphatic surgery. The projectwill be guided by the following specific aims: Aim 1. Develop a wearable high-power digital magnificationdevice for lymphatic surgery. A compact prototype will be developed that offers dynamic high-power 3Dmagnification with augmented reality (AR) for computer-aided lymphatic surgery. 4X-20X dynamicmagnification will be developed for optimal surgical visualization of lymphatics. Autofocus and voice control willbe implemented to cater to the demanding environment of lymphatic surgery. Aim 2. Characterize the wearabledigital magnification device and demonstrate its utility in lymphatic surgery. System performance will becomprehensively characterized. The device will be applied to lymphatic surgery in a biological training modelbased on a chicken thigh and in vivo in a rodent model. The proposed project is innovative, in the applicant'sopinion, because it represents a substantive departure from the status quo by offering dynamic 3D digitalmagnification with AR capability in a wearable system. The proposed project is significant because it isexpected to provide strong evidence-based proof of principle for further development and future clinical trials ofwearable high-power digital magnification devices in lymphatic surgery. If the proposed device is successfullycommercialized, lymphatic surgeons and other microsurgeons will have access to an innovative product thatcan improve surgical outcomes and reduce surgical costs.

Public Health Relevance Statement:
The proposed project is relevant to public health because it focuses on developing a novel wearable high- power digital magnification device for lymphatic surgery. Once such a device is developed and commercialized, lymphatic surgeons and other microsurgeons will have access to an innovative product that can improve surgical outcomes and reduce surgical costs. Thus, the proposed project is relevant to the part of the NIH's mission that pertains to reducing illness and disability.

Project Terms:
Adoption ; Felis catus ; Cats ; Cats Mammals ; Domestic Cats ; Feline Species ; Felis domestica ; Felis domesticus ; Felis sylvestris catus ; Chickens ; Gallus domesticus ; Gallus gallus ; Gallus gallus domesticus ; Clinical Trials ; Edema ; Dropsy ; Hydrops ; Education ; Educational aspects ; Environment ; Feedback ; Freedom ; Liberty ; Future ; Goals ; HIV ; AIDS Virus ; Acquired Immune Deficiency Syndrome Virus ; Acquired Immunodeficiency Syndrome Virus ; Human Immunodeficiency Viruses ; LAV-HTLV-III ; Lymphadenopathy-Associated Virus ; Virus-HIV ; Infection ; Interview ; Iowa ; Joints ; Laws ; Lead ; Pb element ; heavy metal Pb ; heavy metal lead ; Learning ; lymphangiosarcoma ; Lymphangioendothelial Sarcoma ; Malignant Lymphangioendothelioma ; Lymphatic Diseases ; lymphatic disorder ; Lymphatic System ; Lymph System ; Lymphatic Network ; Lymphatic System Reticuloendothelial System ; Lymphedema ; lymph edema ; lymphatic edema ; Marketing ; Medical Device ; Microsurgery ; Mission ; Biological Models ; Biologic Models ; Model System ; Motion ; United States National Institutes of Health ; NIH ; National Institutes of Health ; Ohio ; Legal patent ; Patents ; Patients ; Privatization ; Public Health ; Research ; Thigh structure ; Thigh ; Traction ; Universities ; Voice ; Telemedicine ; base ; Microscope ; improved ; Clinical ; Phase ; Biological ; Medical ; Training ; lymphatic vessel ; lymph channel ; lymph vessel ; lymphatic channel ; disability ; Intuition ; Funding ; tool ; programs ; Techniques ; System ; 3-D ; 3D ; three dimensional ; 3-Dimensional ; Spinal ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; meetings ; Surgeon ; experience ; Performance ; Animal Models and Related Studies ; model of animal ; model organism ; Animal Model ; lymphatic surgery ; novel ; Agreement ; Devices ; Reporting ; Position ; Positioning Attribute ; Modeling ; Address ; Curative Surgery ; Regulatory Affairs ; Regulatory Pathway ; in vivo ; Rodent Model ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Lymphatic ; Development ; developmental ; cost ; digital ; Computer Assisted ; computer aided ; Outcome ; innovation ; innovate ; innovative ; user-friendly ; prototype ; evidence base ; product development ; Breast Cancer survivor ; Augmented Reality ; Innovation Corps ; I-Corps ; improved outcome ; wearable sensor technology ; body sensor ; body worn sensor ; wearable biosensor ; wearable sensor ; wearable system ; wireless sensor technology ; surgery outcome ; surgical outcome ; augmented reality headset ; augmented reality goggles ; Visualization ; Lymphatic Research ;

Phase II

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Start Date: 00/00/00    Completed: 00/00/00
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