Currently, we have two fully functional bioprinters:
One is dedicated to pre-clinical studies and has already been used successfully for that purpose. The second is an upgraded version with the same functionalities, intended for use in first-in-human clinical trials. A second device of this upgraded version will be ready soon to support parallel surgeries at the participating hospitals. We have enhanced our secured IP portfolio from 4 to 5 patent families.
We have developed trade secrets, protocols for cell isolation and expansion, and proprietary pre-clinical data.
We established a Quality Management System (QMS) in collaboration with a Regulatory consulting company based in USA, to ensure compliance with regulatory requirements of both EMA and FDA. Within this QMS system, a design control process was initiated in May 2023 and is currently underway. The primary outcome of Phase I of the QMS implementation was the definition of product requirements, upon which, the design of the clinical device is based.
Each requirement on this list is translated into a specification for the final clinical device, thereby determining the characteristics of the device to comply with MDR745 and the surgical/printing protocol complies with Advanced Therapeutic Medicinal Product requirements produced under GMP requirements. We are currently in Phase 2 of this process.
Key accomplishments WP1:
1. We developed a printer which can print large grafts areas in vivo.
2. A clinical version of this device is now ready for first-in-human trials. Following PhosPrint's QMS design control procedures, the final design and critical functionalities of the device have been successfully established and validated.
3. Additionally, PhosPrint has developed proprietary software to control the printer, ensuring it meets all applicable medical device standards and regulatory requirements. This device and software are now prepared for FIH use.
Key Accomplishments WP 2:
4. Optimization of D-LIB application in pigs
PhosPrint optimized the pig urothelial cell isolation protocol from bladder biopsies. The timing and biospy collection procedure have been fully established. Applying this methodology, fully autologous D-LIB treatment in pigs is realized. Additional improvements and oprimizations in the surgical protocol have been implemented after intensive experimentation in 17 surgeries.
Moreover, we have identified swine cell-compatible antibodies which allow us to histologically characterize cells in culture but also within the D-LIB generated graft upon sacrificing the experimental animals (see below).
Additionally, we have been adapting published protocols and developing own protocols for the expansion of human urothelial cells from healthy human bladder biopsies. Media composition, coating agents and passaging solutions have been tested and optimized for efficient isolation and expansion of human urothelial cells under GMP compliance.
5. Preclinical validation study
A preclinical study was designed and implemented in 12 pigs. Control and D-LIB treated animals were monitored for two months after surgery, and blood and urine samples were also collected at pre-defined time-points. The entire process was continuously monitored and documented complying to our QMS. The preclinical protocol investigated the safety and effectiveness of the D-LIB approach in different drug (cell numbers) doses. The preclinical trial was completed successfully and validated the safety and superiority of D-LIB application to the current gold standard treatment. D-LIB treated animals at 2 months post-surgery, were free from mucus and metabolic defects, in sharp contrast to controls that developed all known side-effects observed in orthotopic neobladder patients.
Key Accomplishments WP 3:
6. Investor update
Significant break-through in our on-going focus and efforts to attract interest from a strategic/lead co-investor that started from day 1 of the project.
We have the commitment of €100k from angel investor, Lars Rasmussen. Greek VC Fund Coralia Ventures VC, following a successful proposal submission and interview, has confirmed their interest and intent to invest in PhosPrint (via email on Friday afternoon) and offered a pre-money valuation of PhosPrint at €4M, to initiate the negotiation and proceed with due diligence.
Additionally, Capital Cell Online investment platform in Healthcare and Biotechnology will be hosting PhosPrint on their Capital Cell funding platform following the successful review from the BioExpert network in February and given that we have the participation from Coralia VC since their policy is to co-invest with another investor. Capital Cell investment can be up to €500K.
