Periodic Reporting for period 1 - TheraPD (TheraPD: Smart and safer automated peritoneal dialysis by means of sterile connectivity, bio-sensors control systems and more biocompatible solutions for preventing rapid degradation of peritoneal mem)
Reporting period: 2016-10-01 to 2017-09-30
TheraPD solution provide the most safe and efficient automated peritoneal dialysis therapy to date. It entails a comprehensive system composed by a sterile connector (renders peritonitis risk almost zero), a biosensing control system (avoids overfilling), and a new biocompatible dialysate for preventing rapid degradation of peritoneal membrane cells. Another innovation is that our cycler will be equipped with special biosensors capable of measuring the concentration of glucose and pH, this allows to customize the dialysis prescription according to the ultrafiltration capacity of the patient, it increases safety level of the treatment and it allows to monitor the uptake of glucose by the patient. By solving these unmet clinical needs, we will increase PD usage by expanding it to people who were not previously eligible, reduce treatment frequency or duration, customize the dialysis treatment (personalized) according to the response of the patient’s body, increase patients’ comfort and significantly reduce healthcare spending. With EC’s support we will achieve all these societal and individual benefits while earning €4.7M profit, penetrating 1.15% of the world’s PD market, and generating a solid ROI of 1.65 after 5 years from launch.
the specific objectives and expected outcome of the TheraPD project are:
During our 24 months project we aim to be ready to market an entire solution for PD, global service, composed by:
Sterile connecting system (DesmoPD): Reduce the cost of production of our prototype (from 4€ to 0.50€ per unit) by deep industrialization of our single-use disposable device that facilitates the sterile removal of the caps by patients, increasing safety (lowering contamination risk). The expected outcome are the mouldings for the device and a predefined industrial manufacturing process that guarantees sterility.
Biosensing control system (SmartPD): A new industrial design of our cycler prototype and cartridges, including:
- Cycler: Deep industrialization process, increase serviceability adding biosensors to the cartridge and Wi-Fi for doctors to remotely access data (to avoid costly training and increase comfort of patient), new simpler industrial design, and the plastic mouldings to scale-up the production.
- Cartridge: A cassette for the machine in which we will integrate into the existing prototype a glucose sensor (detect 8.5 mmol/L) to monitor real-time how much glucose is entering the stream, and a pH meter for safety (constant acidity check). This will enable the machine to monitor patients’ glucose and personalize the mixing of different commercial concentrations.
Biocompatible solution (PolyThera): Safe (pharma grade) and stable (shelf life of 3yrs on standard conditions) composition of a glucose-free (prevent glucose toxicity) peritoneal dialysis medium (poly-dextran).
The purpose of tasks related with cycler designer was oriented to optimize and industrialize the design of an existing prototype, implementing new biosensors, developing a new electronics and motherboard with an up-to date microprocessor, developing the user interface, developing, debugging and testing the firmware and software, developing the external body with an industrial design concept to a full scale production, reducing the weight to less than 10.0 Kg, while reducing significantly the overall manufacturing direct cost.
We will aim to develop a new more biocompatible pharmaceutical infusion solution containing an alternative to glucose as main solute. It will enhance the effectivity of the treatment and prevent glucose toxicity and absorption by the peritoneum. Our target is to find and implement an equivalent solute that can mimic the osmotic behaviour of glucose, by using a poly-dextran molecule stand-alone or in combination with other osmotic agents.
1. To solve unmet clinical needs: As described before, the primary cause of the abandonment of this treatment modality is due to peritonitis (caused by bacterial infections), poorly biocompatible dialysates, and issues caused by the overfilling of the peritoneal cavity in APD.
2. To increase PD usage: Governments, physicians and guidelines are pushing for an increase of PD over HD , solving current disadvantages of PD will make this option more attractive to decision makers by overcoming the stringent criteria for patient selection. Moreover, we will expand PD to people that was not eligible previously (i.e. diabetics because of glucose-free media).
3.Reduce treatment frequency or duration: providing a PD system that substantially increases the efficiency of PD, allows the possibility of reducing the dialysis frequency from every day to 6 times a week or less.