Periodic Reporting for period 1 - ProSpace (BioProtect Balloon Implant System – Enabling Safe Prostate Radiation Treatment even at extreme dosage)
Okres sprawozdawczy: 2023-10-01 do 2024-09-30
Prostate cancer causes 375k annual deaths globally. With more than 1.4 million men diagnosed annually, prostate is 2nd leading cancer in men globally. 50% of prostate cancer suffering men are treated with radiation therapy. During radiation, a highly prevalent complication is rectal toxicity which stems from the rectum’s close proximity to the prostate. Despite technological advancements & meticulous treatment planning, prostate movements within or in between radiation sessions leave parts of rectal wall exposed to high radiation doses, which results in rectal toxicity or proctitis.
Patients with existing ulcerative colitis or Crohn disease, are at even higher risk of rectal complications due to pre-existing inflammation, fibrosis, adhesions and scarring in the pelvic region which exacerbate the radiation-linked toxicities. Up to 35% of patients undergoing radiation treatment experience rectal toxicity side effects (e.g. bleeding, urinary, bowl & erectile dysfunction) which results in extended hospital stay, additional costs and poor quality of life.
Our BioProtect Balloon Spacer 'ProSpace' is an implantable, biodegradable device designed to create a consistent and defined separation of up to 18mm between the prostate and rectum during prostate radiation therapy. This separation minimizes radiation exposure to the rectum, reducing the risk of rectal toxicity and other adverse effects. Visible under CT, MRI, and ultrasound, the balloon provides a safe buffer zone, enhancing the safety and precision of the treatment.
ProSpace is the world's first implantable balloon system which has been specifically designed to completely eliminate the risk of rectal and blood vessel perforation. By negating the risk of rectal toxicity and enabling high dose (hypofractionation) shorter treatments with fewer sessions, patients, clinicians and the global healthcare systems will all benefit from ProSpace.
Project Objectives:
1. Refine the spacer balloon manufacturing process to meet ISO 13485 standards, accommodating copolymer property variations.
2. Conduct clinical trials with 100 patients to validate the safety and efficacy of the balloon spacer produced at commercial scale.
3. Collect clinical data to support FDA and MDR regulatory submissions, with comparative analysis against BarriGel and SpaceOAR.
Patients with existing ulcerative colitis or Crohn disease, are at even higher risk of rectal complications due to pre-existing inflammation, fibrosis, adhesions and scarring in the pelvic region which exacerbate the radiation-linked toxicities. Up to 35% of patients undergoing radiation treatment experience rectal toxicity side effects (e.g. bleeding, urinary, bowl & erectile dysfunction) which results in extended hospital stay, additional costs and poor quality of life.
Our BioProtect Balloon Spacer 'ProSpace' is an implantable, biodegradable device designed to create a consistent and defined separation of up to 18mm between the prostate and rectum during prostate radiation therapy. This separation minimizes radiation exposure to the rectum, reducing the risk of rectal toxicity and other adverse effects. Visible under CT, MRI, and ultrasound, the balloon provides a safe buffer zone, enhancing the safety and precision of the treatment.
ProSpace is the world's first implantable balloon system which has been specifically designed to completely eliminate the risk of rectal and blood vessel perforation. By negating the risk of rectal toxicity and enabling high dose (hypofractionation) shorter treatments with fewer sessions, patients, clinicians and the global healthcare systems will all benefit from ProSpace.
Project Objectives:
1. Refine the spacer balloon manufacturing process to meet ISO 13485 standards, accommodating copolymer property variations.
2. Conduct clinical trials with 100 patients to validate the safety and efficacy of the balloon spacer produced at commercial scale.
3. Collect clinical data to support FDA and MDR regulatory submissions, with comparative analysis against BarriGel and SpaceOAR.
Key technical focus of the first reporting period was to deliver WP2 (Manufacturing Process Optimisation), progress the ongoing Clinical Trials (WP3), strengthen the Regulatory Approvals (WP4) pathways and undertake communication and dissemination activities (WP5).
During WP2, we have developed a new cleaning room at our new facilities in Netanaya, Israel. This room has met all production and regulatory requirements and has also gained DEKRA approval.
- Developed and implemented a new robotic balloon-folding process, replacing two production technicians. This custom-built machine folds balloons into a precise s-shape at controlled temperatures, achieving a high throughput of over 10 balloons per hour with consistent performance.
- Designed and deployed a second-generation dipping system, increasing yield and throughput by expanding chamber capacity, integrating actuating motors, and optimizing the dipping solution. This setup enables multiple balloon molds per cycle, boosting production efficiency.
- Validated the updated manufacturing process, ensuring compliance with regulatory standards. We produced and approved 200 complete device sets (balloon, dilators, and Ecognic needle) for clinical trials.
Completed product validation, including biocompatibility, safety, packaging, and compatibility testing, in accordance with MDR and FDA requirements.
During WP3, we have;
- Prepared an investigator brochure for ethics committee submission
- A total of 91 patients were recruited from five centers for the study: 36 patients from Poland (EC number: 98/2021), 18 from Rabin Hospital in Israel (EC number: 0773-21-RMC), 14 from Assuta Hospital in Israel (EC number: AAA-0001-22), 16 from MAASTRO Hospital in the Netherlands (EC number: 2022-3111), and 6 from Dublin (EC number: 19-38).
During WP4, we have;
- Received the new European certification from MDR.
- Received FDA approval and certification.
- Received Product validation (safety, packaging and compatibility testing as per MDR and FDA requirements).
During WP5, we have published two articles.
During WP1, we have undertaken weekly review meetings to ensure timely delivery of the deliverables and milestones. We have doubled our human resources to 83 (50 in Israel and 33 in the USA) over the past year.
During WP2, we have developed a new cleaning room at our new facilities in Netanaya, Israel. This room has met all production and regulatory requirements and has also gained DEKRA approval.
- Developed and implemented a new robotic balloon-folding process, replacing two production technicians. This custom-built machine folds balloons into a precise s-shape at controlled temperatures, achieving a high throughput of over 10 balloons per hour with consistent performance.
- Designed and deployed a second-generation dipping system, increasing yield and throughput by expanding chamber capacity, integrating actuating motors, and optimizing the dipping solution. This setup enables multiple balloon molds per cycle, boosting production efficiency.
- Validated the updated manufacturing process, ensuring compliance with regulatory standards. We produced and approved 200 complete device sets (balloon, dilators, and Ecognic needle) for clinical trials.
Completed product validation, including biocompatibility, safety, packaging, and compatibility testing, in accordance with MDR and FDA requirements.
During WP3, we have;
- Prepared an investigator brochure for ethics committee submission
- A total of 91 patients were recruited from five centers for the study: 36 patients from Poland (EC number: 98/2021), 18 from Rabin Hospital in Israel (EC number: 0773-21-RMC), 14 from Assuta Hospital in Israel (EC number: AAA-0001-22), 16 from MAASTRO Hospital in the Netherlands (EC number: 2022-3111), and 6 from Dublin (EC number: 19-38).
During WP4, we have;
- Received the new European certification from MDR.
- Received FDA approval and certification.
- Received Product validation (safety, packaging and compatibility testing as per MDR and FDA requirements).
During WP5, we have published two articles.
During WP1, we have undertaken weekly review meetings to ensure timely delivery of the deliverables and milestones. We have doubled our human resources to 83 (50 in Israel and 33 in the USA) over the past year.
ProSpace offers several key advantages over competing products:
- Provides a consistent, larger separation (~1.8 cm) between the radiated prostate and rectum, enhancing efficacy and significantly reducing side effects.
- Fully visible on CT, MRI, and ultrasound for precise imaging and placement.
- Features a symmetrical, reproducible shape that facilitates accurate control and treatment planning.
- Designed for easy deflation, removal, and repositioning if necessary.
- Spacer material remains confined without spreading, ensuring stable placement.
- Reduces rectal radiation dose by 63%, with no grade 3 adverse events observed.
- Utilizes a blunt dissection technique, minimizing the risk of organ injury by eliminating needle use.
- Proven safe even at high hypofractionated radiotherapy doses (up to 50 Gy, average 36.25 Gy), enabling the treatment course to be shortened from five weeks to one.
- Prevents 95% of radiation from reaching healthy tissue, allowing for higher therapeutic doses with fewer sessions.
- Can be implanted simultaneously with radiopaque markers, requiring no additional procedure.
- Provides a consistent, larger separation (~1.8 cm) between the radiated prostate and rectum, enhancing efficacy and significantly reducing side effects.
- Fully visible on CT, MRI, and ultrasound for precise imaging and placement.
- Features a symmetrical, reproducible shape that facilitates accurate control and treatment planning.
- Designed for easy deflation, removal, and repositioning if necessary.
- Spacer material remains confined without spreading, ensuring stable placement.
- Reduces rectal radiation dose by 63%, with no grade 3 adverse events observed.
- Utilizes a blunt dissection technique, minimizing the risk of organ injury by eliminating needle use.
- Proven safe even at high hypofractionated radiotherapy doses (up to 50 Gy, average 36.25 Gy), enabling the treatment course to be shortened from five weeks to one.
- Prevents 95% of radiation from reaching healthy tissue, allowing for higher therapeutic doses with fewer sessions.
- Can be implanted simultaneously with radiopaque markers, requiring no additional procedure.