Irradiating High Risk
Surgical Margins
High-risk tumor margins are not just predictors of local recurrence – they are predictors of Cancer Mortality. BrachyClip has a solution.
ACCURATE
Precisely targeted radiation delivery
PRECISE
Minimally invasive placement
ADAPTIVE
Flexible treatment planning
Approximate U.S. Cases a Year
Cancer resections (open/robotic/laparoscopic) within the chest, abdomen, pelvis and extremities.
Minimally invasive procedures within the chest, abdomen, pelvis and extremities.
Positive surgical resection and close (<2mm).
Local tumor recurrence*
Average cost $100,000 per patient
* Accounts for 35% of Cancer mortality
“Local tumor recurrence has a profound impact on the ability to cure cancer. It requires multidisciplinary management that is expensive and rarely successful. The best strategy to manage local tumor recurrence is to do everything possible to avoid it.”
Dr. Douglas Arthur
Professor and Chairman, Department of Radiation Oncology
Massey Cancer Center, Virginia Commonwealth University
It's Not an
Uncommon Story
A 42-year-old mother of four experienced local multiple recurrences of breast cancer in the high axilla of her dominant right arm.
With the fourth recurrence, the nodal disease encased the axillary artery and brachial plexus. The only surgical option presented to her was an amputation of the shoulder and arm.
Instead, she was treated with surgical debulking of the tumor and intraoperative permanent seed brachytherapy along the involved arterial structures and brachial nerves.
Now, she is 20 years past her surgery date with no recurrences and, apart from modest edema, a fully functional arm.
Intra-Operative Permanent Seed Brachytherapy (IPSB)
This technique is most frequently employed when surgical margins are close or positive.
Highly effective and minimally toxic "boost" dose of irradiation maximizes local tumor control.
Over 80 years of clinical efficacy and safety data.
IPSB, Though Highly Effective, Is Underutilized
Existing methods face significant limitations that restrict adoption and effectiveness
Current IPSB Strategies
"Free Hand" Seeds
Manual placement of individual radioactive seeds during surgery
Seed-Embedded Mesh
Radioactive seeds pre-loaded into surgical mesh
Seed-Embedded Sutures
Radioactive seeds integrated into surgical suture material
Critical Limitations of Current Methods
Not Adaptable to MIS
None of the current methods are suitable for minimally invasive surgical techniques
Unpredictable Dose Distribution
All result in inconsistent radiation dose delivery to the target area
High Personnel Exposure
All methods result in increased radiation exposure to operating room personnel
BrachyClip Addresses These Challenges
Our innovative clip-based delivery system provides predictable dosimetry, enables minimally invasive application, and significantly reduces radiation exposure to surgical personnel
Key Requirements for Minimally Invasive IPSB
"Prior techniques have been related to poor apposition of radioactive seeds. BrachyClip assures persistent placement and appropriate delivery of planned radiation."
Accurate seed placement
via any surgical approach
Secure fixation to ensure
efficacious dose distribution
Ability to precisely conform
IBSP to the residual margin
Minimal or no personnel
risk of radiation exposure
What is BrachyClip®?
Ergonomically designed, handheld device for precision and ease of use in minimally invasive surgeries.
Compatible with standard laparoscopic and robotic trocars, integrating seamlessly into existing workflows.
Holds a magazine of up to 20 clips for continuous deployment, with tactile feedback ensuring secure placement.
Titanium clips encapsulate radioactive seeds, ensuring stable, immobile positioning for precise radiation dose distribution.
Uses standard available seeds incorporated into the BrachyClip delivery system
The radioactive seed is inserted and sealed into the titanium tube
Developed by IPSB Experts
BrachyClip was engineered by leading radiation oncologists and medical physicists who pioneered IPSB techniques, specifically designed to overcome existing limitations
What Makes BrachyClip Different
Minimally Invasive
Secure positioning of radioactive seeds with minimal tissue disruption through a handheld applicator system
Precise Dosimetry
Advanced dosimetry planning ensures optimal radiation delivery while protecting healthy tissue
Immediate Treatment
Intra-operative application eliminates the need for repeat surgeries or external beam radiation courses
Platform Technology
Designed for multiple tumor types and future payload delivery capabilities beyond brachytherapy seeds
Endorsed by Leading Clinicians
Key opinion leaders recognize BrachyClip's potential to transform surgical margin management
“This is a very nice solution to a longstanding problem.”
Dr. Gyan Pareek
Chief of Urology, Miriam Hospital, The Warren Alpert Medical School of Brown University
“This is a very clever idea that should work very well!”
Dr. Scott Kelley
Surgical Oncologist, Watson Clinic; Chief of General Surgery, Lakeland Regional Medical Center
Projected Clinical Impact
Projected annual healthcare savings from reduced re-excisions and complications
Local control rates through precise radiation delivery to high-risk margins
Patient burden with single-procedure treatment vs. repeat surgeries
Comparison to Alternative Treatments
BrachyClip offers significant advantages over external beam radiation therapy (IMRT, SBRT) and systemic treatments:
- ✓Single intra-operative treatment vs. weeks of daily radiation
- ✓Localized radiation minimizes systemic side effects
- ✓Lower total cost than extended radiation courses
- ✓Improved quality of life with reduced treatment burden
Critical Milestones Achieved
Significant progress demonstrates technical feasibility and commercial viability
Prototype Development
Functional prototype completed and validated in pre-clinical testing
Prototype Development
Functional prototype completed and validated in pre-clinical testing
Manufacturing Partners
Established relationships with Design Standards Corporation and precision manufacturing partners
Manufacturing Partners
Established relationships with Design Standards Corporation and precision manufacturing partners
Strategic Partnership
Letter of support from Theragenics Corporation, market leader in brachytherapy seeds
Strategic Partnership
Letter of support from Theragenics Corporation, market leader in brachytherapy seeds
Intellectual Property
Patent applications filed covering core technology and applications
Intellectual Property
Patent applications filed covering core technology and applications
SBIR Phase 2 Award
$2.1M funding secured from NIH for product development and validation
SBIR Phase 2 Award
$2.1M funding secured from NIH for product development and validation
Dosimetry Optimization
Advanced computational modeling completed by WPI to optimize treatment planning
Dosimetry Optimization
Advanced computational modeling completed by WPI to optimize treatment planning