If you are a medical device manufacturer dealing with the need for safer radiotherapy tools — this project developed a biodegradable copolymer balloon that creates a 18mm separation. This reduces the risk of rectal toxicity and allows for shorter, high-dose treatments.
Biodegradable Balloon Implant to Prevent Rectal Damage During Prostate Radiation Therapy
Imagine trying to paint a wall but needing to protect a fragile vase sitting right against it. This device acts like a temporary, inflatable cushion that pushes the rectum away from the prostate. Once the radiation treatment is finished, the cushion simply dissolves on its own inside the body.
What needed solving
Up to 35% of prostate radiation patients suffer from rectal toxicity due to the close proximity of the rectum to the treatment area. This leads to increased hospital costs and severely reduced quality of life for patients.
What was built
A biodegradable copolymer balloon spacer (ProSpace) that creates a 1.8cm buffer zone between the prostate and rectum.
Who needs this
Who can put this to work
If you are a clinic dealing with high rates of post-radiation complications — this project developed the ProSpace system that minimizes rectal exposure. This can reduce the 35% of patients who experience toxicity side effects, lowering extended hospital stays.
If you are a materials firm dealing with the challenge of creating absorbable medical spacers — this project developed a specific 70:30 Poly L-Lactide-co-ε-Caprolactone copolymer balloon. It proves the efficacy of this material in high-radiation environments.
Quick answers
What is the cost or price of the ProSpace system?
Based on available project data, the specific unit price or cost of the device is not mentioned.
Is the manufacturing process ready for industrial scale?
The project aims to refine the manufacturing process to meet ISO 13485 standards and validate the balloon produced at commercial scale through clinical trials.
What is the IP or licensing status?
Based on available project data, specific patent numbers or licensing terms are not provided, though the project is led by BIOPROTECT LTD.
Which regulatory approvals are being targeted?
The project is collecting clinical data to support submissions for FDA and MDR regulatory approval.
What is the timeline for clinical validation?
The project period runs from 2023-10-01 to 2025-09-30, with a goal to conduct trials with 100 patients.
Who built it
The project is managed by a single-partner consortium consisting of BIOPROTECT LTD, an Israeli SME. This indicates a highly streamlined, company-led development path with 100% industry participation, focusing on rapid commercialization rather than academic research.
Contact BIOPROTECT LTD in Israel for licensing and clinical trial data.
Talk to the team behind this work.
Contact us to explore partnership opportunities with BIOPROTECT LTD.