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First and Only Soft Tissue Support Device to Improve Patient Experience and System Cost in Breast Reconstruction

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44CA247273-01
Agency Tracking Number: R44CA247273
Amount: $1,984,603.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: PA18-573
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-20
Award End Date (Contract End Date): 2021-08-31
Small Business Information
1221 N DEARBORN ST, STE 612S
Chicago, IL 60610-8383
United States
DUNS: 080468582
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 ALEXEI MLODINOW
 (626) 372-4884
 amlodinow@surgicalinnovationassociates.com
Business Contact
 ALEXEI MLODINOW
Phone: (626) 372-4884
Email: amlodinow@surgicalinnovationassociates.com
Research Institution
N/A
Abstract

NOTE: These pages contain proprietary/privileged information. SIA requests that they not be released to personsoutside the Government, except for purposes of review and evaluation.
Project Summary/Abstract
DuraSorb™ is poised to significantly improve the lives of the over 100,000 US women undergoing post-
mastectomy breast reconstruction every year.
The current standard of care in implant-based breast reconstruction (IBBR) is the use of cadaveric acellular
dermal matrix (ADM) as a sling for the implant, rather than placing the implant fully under the pectoralis
muscle. ADM was introduced 10+ years ago to provide technical benefits of decreased pain, fewer return visits
between reconstructive stages, better cosmetic results, and decreased rates of capsular contracture around
the implant. However, it has been associated with a 10% increase in risk of surgical site complications
including seroma, infection, and flap necrosis. Furthermore, it has an unsustainable cost of $3,500-$4,850 per
breast. Alternative synthetic meshes have been being investigated as early as 2007. However, to date, studies
are limited to small case series with short follow-up and utilize meshes that may be tolerated in a hernia repair,
but present clinical problems in the setting of a mastectomy skin flap with tenuous vascularity.
DuraSorb™ is made of polydioxanone, a well-known polymer that is among the least inflammatory used in
implantable devices. The minimal inflammatory response to the material and its full-degradation over 6-9
months prevent chronic inflammation and give DuraSorb™ the characteristics of a biologic mesh. Additionally,
its open-knit, macroporous design allows for tissue integration. Further, it is produced with monofilament fibers,
which are less prone to biofilm formation than ADM. The unique properties of synthetic DuraSorb™ could
deliver the technical benefits of ADM without the increased complications, and at a fifth of the cost.
In this Direct to Phase II SBIR proposal, SIA will acquire the clinical data required to achieve the first and only
FDA clearance for prosthetic breast reconstruction in the US, above and beyond the clinical data collected for
510(k) clearance (August 2018, K181094). A 100 patient multi-center single arm trial will be conducted with a
retrospective, propensity-matched control to demonstrate performance and safety of DuraSorb™ and to
evaluate patient reported outcomes in a clinical trial.
NOTE: These pages contain proprietary/privileged information. SIA requests that they not be released to personsoutside the Government, except for purposes of review and evaluation.Project Narrative
Women undergoing mastectomy for breast cancer most often undergo implant-based breast reconstruction.
Traditionally, implants were completely covered with muscle, a procedure that often caused pain and poor breast
appearance. To overcome this, biologic meshes can be placed with the implant for support, but this technique
can be cost prohibitive and cause clinical complications. In this project, a new cost-effective, fully synthetic mesh
designed specifically to reduce breast reconstruction complications will be investigated.

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

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