Frequently Asked Questions
Clear, detailed answers to the most common questions about OctoNerv, the EBNI system, our development process, and future clinical roadmap.
What is the Electronic Breast Nipple Implant (EBNI)?
The Electronic Breast Nipple Implant (EBNI) is an innovative, fully implantable device designed to restore dynamic nipple projection for individuals who have undergone mastectomy and breast reconstruction. Traditional reconstruction methods often flatten over time or fail to create a sense of connection to the reconstructed breast. EBNI introduces the world’s first engineered nipple solution using a miniature actuator, sensors, wireless charging, and onboard electronics housed within a soft silicone form.
What problem does EBNI solve?
Many survivors experience:
- Nipple flattening within months of reconstruction
- Lack of long-term shape retention
- Dissatisfaction with tattoo-only or 3D reconstruction
- Limited reconstructive options due to thin tissue or radiation history
EBNI aims to provide a more lifelike, durable, and customizable solution that traditional surgical techniques cannot achieve.
Who is EBNI for?
EBNI is being designed for individuals who:
- Have undergone mastectomy and breast reconstruction
- Desire a stable, natural nipple appearance
- Have experienced flattening of previous reconstructions
- Are unable to undergo further reconstructive surgery
How does the implant work?
EBNI uses a miniature linear actuator embedded inside a soft silicone form to create controlled projection motion. The device includes:
- A microcontroller for projection control
- Wireless BLE communication for clinical configuration
- Internal sensors for future adaptive behavior
- A rechargeable LiPo battery
- A wireless charging coil compatible with external pads
When activated, the actuator extends or retracts the nipple to create dynamic projection.
Is EBNI safe?
Safety guides every engineering decision. EBNI is being developed following:
- ISO 10993 — Biocompatibility
- IEC 60601 — Electrical safety
- ISO 14971 — Risk management for medical devices
Before human use, the implant will undergo mechanical testing, silicone integrity evaluations, biocompatibility screening, and regulatory review.
Is EBNI available for patients?
Not yet. EBNI is an early-stage investigational device. OctoNerv is actively conducting engineering development toward preclinical testing and regulatory readiness.
Will patients control the nipple projection?
Early versions will be controlled solely by clinicians during follow-up visits using a secure mobile app. Future versions may allow supervised patient-side control with regulatory clearance.
Does EBNI restore nipple sensation?
No. Current versions focus on restoring projection only. Sensory feedback is a potential long-term research pathway being evaluated for future development.
How long does the internal battery last?
The actuator only uses power during projection changes, which significantly reduces energy consumption. Wireless charging through an external pad allows discreet, periodic recharging as needed.
What are the next development milestones?
Upcoming steps include:
- Engineering refinement of internal electronics
- Silicone form factor molding and fit testing
- Preclinical mechanical and durability studies
- Regulatory pathway preparation
- Early feasibility collaboration with breast centers
How can surgeons or hospitals collaborate with OctoNerv?
OctoNerv welcomes partnerships with:
- Breast reconstruction surgeons
- Medical device research institutions
- Clinical trial sites
- Investors and strategic device manufacturers
To inquire about collaboration, please email steven@octonervs.com.