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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

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

Chronic kidney disease (CKD), is the progressive loss in kidney function over a period of months or years. The severity of CKD is classified in five stages, with stage 1 being the mildest and usually causing few symptoms and stage 5 being a severe illness with poor life expectancy if untreated. Stage 5 CKD is often called end-stage renal disease (ESRD) and usually means the patient requires renal replacement therapy, which may involve a form of dialysis, but ideally constitutes a kidney transplant. At present, more than 250,000 patients in Europe are being treated with kidney dialysis machines or have kidney transplants, a number that has more than doubled over the past 15 years. If this trend were to continue, national governments would need to spend between 3-5% of their annual healthcare budgets on renal replacement therapies without taking into account its wider costs in terms of additional medical expenses, decreased quality of life, life expectancy, increased morbidity and reduced capacity to work.

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).
During this period, we have focused on redesigning the entire PD platform system, composed by the connection system, the disposable kit containing the “Cassette”, and the cycler by material selection (biopolymers) and design optimization. We have also assessed a new type of optic sensor to detect glucose, and designed the electronic sensor device and selected a plastic material for the cuvette.

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.
Our main objective is to make peritoneal dialysis the first choice as substitution therapy for chronic renal impairment, designing products that improve patients’ quality of life, reduce health costs and solve the critical points of a treatment that is performed by the patient in-home without medical assistance. Our proposed solution will satisfy the following market needs:

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 [5], 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.
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