Medical Device Innovation

BrachyClip

Where Cancer Surgery Stops, Precise Localized Radiation Therapy Begins

High-risk tumor margins are not just predictors of local recurrence – they are predictors of Cancer Mortality. BrachyClip has a solution.

High Risk Surgical Margins

Approximate U.S. Cases a Year

0

Cancer resections (open/robotic/laparoscopic) within the chest, abdomen, pelvis and extremities.

0

Minimally invasive procedures within the chest, abdomen, pelvis and extremities.

0

Positive surgical margins

0

Local tumor recurrence

Average cost per patient: $100,000 (due to recurrence)

Recurrence 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

Dr. Douglas Arthur

Professor and Chairman, Department of Radiation Oncology

Massey Cancer Center, Virginia Commonwealth University

Patient Impact

Real Patient Stories

How intraoperative seed brachytherapy changed lives

Saving a Young Mother's Arm

I was told my cancer had wrapped around the nerves and blood vessels in my arm and that amputation might be my only option. My surgeons removed the tumor and placed tiny radioactive seeds where the cancer had been. Twenty years later, I still have my arm—and my life back.

A 42-year-old mother of four developed a fourth recurrence of breast cancer in the armpit of her dominant arm. The tumor wrapped around the artery and nerves that control the arm. Instead of amputation, surgeons placed tiny radioactive seeds along the artery and nerves. Twenty years later she still has full use of her arm and no evidence of cancer.

When Radiation Comes From the Inside

After my rectal cancer surgery, the doctors were worried a few cancer cells might still be hiding near the pelvic wall. They placed a small patch with tiny radioactive seeds right at that spot. Those seeds delivered radiation exactly where it was needed. Six years later, I’m still cancer-free.

A 61-year-old man underwent surgery for rectal cancer that had grown right up against the pelvic wall. Before closing the operation, a small mesh containing dozens of tiny radioactive seeds was placed against the pelvic wall. Six years later he remains cancer-free.

A Second Chance After Cervical Cancer Returns

My cervical cancer came back years after I had radiation. I thought I had run out of options. During surgery my doctors placed tiny seeds that slowly release radiation directly where the tumor had been. Four years later, my scans are still clear.

A 65-year-old woman faced devastating news when cervical cancer returned deep in her pelvis. Because more external radiation was not safe, doctors placed a thin patch containing tiny radioactive seeds over the area during surgery. Today, four years later, she is living an active life.

A Child's Cancer Near the Brain

Our 11-year-old son had a tumor near the base of his skull. Removing everything could have damaged important nerves. The surgeons removed most of it and placed tiny radioactive seeds to treat the rest. Today he’s back in school, playing sports, and cancer-free.

An 11-year-old boy was diagnosed with a rare tumor growing at the base of the skull near critical nerves. Surgeons placed delicate sutures containing microscopic radioactive seeds along the remaining tumor bed, protecting nearby brain structures. Today he is thriving, nine years cancer-free.

Avoiding a Permanent Colostomy

When my rectal cancer came back, I feared losing normal bowel function forever. Instead, my surgeons removed the tumor and placed tiny radiation seeds in the area where the cancer had been. Five years later I’m cancer-free—and living a normal life.

A 56-year-old woman had recurrent rectal cancer growing into the pelvic sidewall. Instead of a permanent colostomy, surgeons removed the tumor and placed a small mesh containing radioactive seeds against the pelvic wall. Five years later she has no recurrence and normal bowel function.

Tiny Seeds Protect a Major Artery

My pancreatic tumor was right next to a major artery. The surgeon removed it but said the margin was extremely close. Tiny radioactive seeds were placed along the artery to treat any remaining cells. Knowing the radiation was working exactly where it was needed gave me incredible peace of mind.

A 69-year-old woman underwent surgery for pancreatic cancer that had grown directly against a major artery. Sutures containing tiny radioactive seeds were placed along the artery. Three years later she continues to do well with no evidence of recurrence.

Treating Cancer Without Re-Radiating the Whole Neck

My throat cancer came back years after radiation therapy. I thought more radiation wasn’t possible. During surgery the doctors placed tiny seeds right next to the artery where the cancer had been. I’m four years out now and still cancer-free.

A 58-year-old man developed a recurrence of throat cancer years after receiving radiation therapy. Unlike traditional radiation, tiny radioactive seeds deliver radiation from the inside out, treating only the small area at risk. Four years later he remains cancer-free.

Saving a Teenager's Ability to Walk

My bone cancer was in my pelvis near the nerves that control my leg. The surgeons removed the tumor and placed tiny radiation seeds along the edge of the surgical area. Eight years later I’m still walking, traveling, and living my life.

A 14-year-old girl had a bone cancer growing in her pelvis next to the nerves that control the leg. Surgeons placed sutures containing tiny radioactive seeds along the edge of the surgical area. Eight years later she remains cancer-free and fully active.

Lung Cancer Close to the Heart

My lung cancer was removed, but the tumor had reached the edge of the tissue. My doctors placed small radioactive seeds along that spot during surgery. Those seeds quietly delivered radiation where the cancer might come back. Five years later my scans are still clear.

A 72-year-old man had surgery for lung cancer located near major blood vessels in the chest. Using a special device, surgeons placed tiny radioactive seeds along the margin before closing the chest. Five years later he remains free of disease.

Protecting the Arm Nerves

My shoulder tumor was wrapped around the nerves to my arm. Losing function was a real possibility. After removing the cancer, my doctors placed tiny radiation seeds along the nerve bundle. Eight years later I have full use of my arm and no sign of cancer.

A 46-year-old man developed a recurrent soft-tissue cancer in the shoulder after earlier radiation therapy. Surgeons placed a thin mesh containing radioactive seeds along the nerve bundle. Eight years later he still has full use of his arm and no sign of recurrence.

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.

Surgeons performing intra-operative brachytherapy procedure

Current Landscape

IPSB, Though Highly Effective, Is Underutilized

Existing methods face significant limitations that restrict adoption and effectiveness

Current IPSB Strategies

"Free Hand" Seeds

"Free Hand" Seeds

Manual placement of individual radioactive seeds during surgery

Seed-Embedded Mesh

Seed-Embedded Mesh

Radioactive seeds pre-loaded into surgical mesh

Seed-Embedded Sutures

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 which now dominate the type of surgical procedures.

Unpredictable Dose Distribution

All methods result in inconsistent radiation dose delivery to the target area, as locations are not fixed and seeds can migrate

High Personnel Exposure

Methods result in increased radiation exposure to operating room personnel

BrachyClip Addresses These Challenges

Our innovative clip-based delivery system provides predictable dosimetry ensuring fixed location, enables minimally invasive application, and reduces radiation exposure to surgical personnel

What is BrachyClip®?

A novel device for precise radiation delivery during minimally invasive surgery

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 can eliminate the need for repeat surgeries

Platform Technology

Designed for multiple tumor types and future payload delivery capabilities beyond brachytherapy seeds

How It Works

Step 1

Standard I-125 Brachytherapy Seed

Uses standard available AgX100 I-125 radioactive seeds — no proprietary consumables required.

4.5mm0.8mmTITANIUM CAPSULEI-125 ON SILVER X-RAY MARKERLASER WELDLASER WELD
Step 2

Sealed in Titanium Surgical Clip

The radioactive seed is inserted and sealed into the titanium tube, ensuring immobile and precise radiation dose distribution.

BrachyClip handheld applicator with clip detail showing seed insertion
Step 3

Magazine-Loaded Delivery

Clips are loaded into a magazine of up to 20 for continuous deployment through standard laparoscopic or robotic trocars.

Internal cutaway view of BrachyClip magazine-loaded applicator

Ergonomic Handheld Device

  • Precision and ease of use in minimally invasive surgeries
  • Compatible with standard laparoscopic and robotic trocars
  • Seamless integration into existing workflows
  • Holds magazine of up to 20 clips for continuous deployment
  • Tactile feedback ensuring secure placement
BrachyClip applier being inserted through laparoscopic trocar

Titanium Clip Technology

  • Encapsulates radioactive seeds for stable positioning
  • Ensures immobile, precise radiation dose distribution
  • Uses standard available seeds incorporated into delivery system
  • Radioactive seed inserted and sealed into titanium tube
Working clip application during simulated procedure

Clinical Evidence

Endorsed by Leading Clinicians

Key opinion leaders recognize BrachyClip's potential to transform surgical margin management

With the rise of minimally invasive, robotic surgical techniques, IPSB became impractical and forgotten. BrachyClip gives us back a powerful tool to minimize the risk of local tumor recurrence.

Dr. Gyan Pareek

Chief of Urology, Lifespan Hospitals; The Warren Alpert Medical School at Brown University; President, Brown Urology

With BrachyClip, the potential benefit is so large and the risk of complications so low that I am tempted to use them on every patient.

Dr. Scott Kelley

Surgical Oncologist at Watson Clinic; Chief of General Surgery at Lakeland Regional Medical Center

Projected Clinical Impact

~$2B

Projected annual healthcare savings from reduced re-excisions and complications

Improved

Local control rates through precise radiation delivery to high-risk margins

Reduced

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

Progress & Milestones

Critical Milestones Achieved

Significant progress demonstrates technical feasibility and commercial viability

1

Prototype Development

Functional prototype completed and evaluated in pre-clinical testing

2

Manufacturing Partners

Established relationships with precision manufacturing partners

3

Strategic Partnership

Letter of support from Theragenics Corporation, market leader in brachytherapy seeds

4

Intellectual Property

Patent applications filed covering core technology and applications

5

SBIR Phase 2 Award

$2.1M funding submitted from NIH for product development through validation

6

Dosimetry Optimization

Advanced computational modeling completed by leading academics to optimize treatment planning