Innoblative Designs

Innoblative Designs

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Private Company

Total funding raised: $4.5M

Overview

Innoblative Designs is an emerging, privately-held medtech company focused on innovative surgical ablation technologies for oncology. Its core achievement is the SIRA® device, a radiofrequency ablation (RFA) tool cleared for use as an adjunct in breast-conserving surgery to provide localized margin control and reduce reoperation rates. The company is in the early commercial and clinical evidence generation stage, having secured critical regulatory approvals and a Category III CPT code, positioning it to address a significant need in breast cancer surgery. With a seasoned leadership team and multiple platform devices in development, Innoblative aims to expand its impact within soft tissue surgical oncology.

OncologySurgical Oncology

Technology Platform

Radiofrequency ablation (RFA) platform for intraoperative coagulation and ablation of soft tissue, designed as single-use disposable applicators for use with standard electrosurgical generators.

Funding History

2
Total raised:$4.5M
Seed$4M
Grant$500K

Opportunities

The significant unmet need in breast-conserving surgery to reduce high reoperation rates (20-30%) provides a large and addressable market.
Recent FDA Breakthrough Device Designation and the approval of a Category III CPT® code are major catalysts for clinical adoption and reimbursement, lowering commercial barriers.
The platform technology has potential for expansion into ablation procedures for other soft tissue cancers and diseases.

Risk Factors

Clinical adoption risk: Surgeons may be slow to change established lumpectomy workflows, and the long-term clinical benefit on cancer recurrence needs robust validation.
Commercialization risk: As a small, private company, scaling a direct sales force and achieving market penetration against potential competitors is challenging and capital-intensive.
Reimbursement risk: The Category III CPT code is temporary; securing a permanent Category I code is not guaranteed and is critical for stable long-term reimbursement.

Competitive Landscape

Competition includes other intraoperative margin management technologies such as intraoperative radiation therapy (IORT) systems (e.g., Zeiss Intrabeam, Elekta IntraOp), cryoablation devices, and advanced pathology/imaging systems for frozen section analysis. Innoblative's SIRA® differentiates by using familiar RFA energy in a novel, single-use applicator designed for immediate cavity ablation, potentially offering a simpler and more cost-effective workflow integration compared to some alternatives.