IC Surgical has a strong proprietary technical foundation
IC Surgical’s first innovation is the transformative new medical technology, Interi. The company has a robust patent portfolio, and IC Surgical’s Interi System is covered under one or more of the following 16 issued patents and 6 patents pending.
| US 8,715,267 US 8,551,075 US 8,585,683 EP 2,029,191 ES 2,488,920 T3 CA 2,653,961 US 9,814,808 US10,695,469 US 16/878,991 (P) |
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| Method for drawing tissues together using negative pressure and internal conduit |
| US 7,699,831 |
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| Utilizing a material capable of being absorbed by the body |
| US 9,474,883 US 10,342,901 US 10,543,300 US 11,638,779 US 18/189,687 (P) EP 2928515B1 EP 3466457B1 EP 23156762.9 (P) |
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| Internal Manifold conduit in "peel apart" configuration |
| US 10,548,778 US 16/717,097 (P) EP 19717667.0 (P) CN 2020/120701861380 (P) |
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| Methods and designs for delivering negative pressure |
This information is provided to satisfy the virtual patent marking provisions of various jurisdictions including the America Invents Act and 35 U.S.C. § 287(a). Additional patents may be issued or pending in the US and elsewhere.
Pipeline opportunities for IC Surgical core technology
There are several dimensions to the growth opportunities for IC Surgical’s technology including surgical and non-surgical applications, extensions of the Interi platform, and new innovations.
Surgical applications
IC Surgical core technology has the potential to impact outcomes across nearly all surgical specialities given that tissue damage is inherent in all procedures. Interi will launch initially in the plastic surgery aesthetic and reconstructive markets including abdomen, body contouring, and breast procedures (>700k relevant procedures in the U.S.). The next commercial focus will be the general surgery market including complex hernia repair, surgical oncology, and orthopedic procedures (>500k relevant procedures in the U.S.). Other surgical specialties and international markets will be pursued in the future.
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| Commercialization Timeframe | |||
|---|---|---|---|
| Phase 1 |
Phase 2 |
Phase 3 | |
| Aesthetic - breast | |||
| Aesthetic - body | |||
| Plastic reconstructive | |||
| Ventral hernia |
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| Aesthetic - face |
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| Orthopedic - hips |
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| Othopedic - knees |
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| Cancer reconstruction |
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| Spinal surgery |
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Non-surgical Applications
The Interi System Mechanism of Action has the potential to deliver outcomes improvements to patients with other endemic fluid accumulation conditions and existing complications. Adaptations to system components can be engineered to address unmet needs of non-operative patients.
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| Commercialization Timeframe | |||
|---|---|---|---|
| Phase 1 |
Phase 2 |
Phase 3 | |
| Seroma treatment system |
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| Lymphedema system |
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Line extensions
The company’s technology platform can be modified to include specific features for various patient populations. For example, the proprietary Manifold can be adapted for application in smaller anatomical spaces such as facial, cranial, or spinal procedures. Other Manifold configurations and Therapy Unit sizes are under exploration. These line extension products will expand the number of patients who can benefit from the Mechanism of Action of the Interi System in various surgical markets.
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| Commercialization Timeframe | |||
|---|---|---|---|
| Phase 1 |
Phase 2 |
Phase 3 | |
| Dual Manifold system |
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| Alternate sized Therapy Units |
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| Petite Manifold |
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| Expanded branching Manifold |
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| Therapy Unit additional features |
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Innovation
The company’s vision to transform clinical outcomes with novel technologies encompasses a broad range of potential innovations. For example, an additional technology in the IC Surgical patent portfolio is the potential to develop a bioabsorbable internal Manifold which will obviate the need for removal. Also, there are further applications of the technology that may expand to delivery of drugs, anti-infectives, or other therapeutic agents to internal tissue planes.
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| Commercialization Timeframe | |||
|---|---|---|---|
| Phase 1 |
Phase 2 |
Phase 3 | |
| Fluid absorption device |
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| Bioabsorbable Manifold |
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| Drug eluting Manifold |
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Commercial strategy
IC Surgical plans a phased launch approach of the Interi System. Our initial focus on plastic surgery is based on the performance and system effectiveness demonstrated in our pilot clinical study in a population that has an exceptionally high rate of seroma and other complications. Company founders have extensive experience developing markets and launching successful medical technology products. Our expansion to other surgical applications will involve significant interaction with key opinion leaders to gain early experience, gather data, and engage with clinicians in the marketplace to educate on best practices.
While IC Surgical believes these opportunities are reasonable, projections are based upon current estimates and assumptions and are subject to various risks and uncertainties.