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Technology Overview

Metronomic Marvel

A Significant Leap Forward: SINNAIS™—the first AI driven smart implantable pump

The SINNAIS™ implantable Smart Pump device combines a fully implantable programable pump capable of local delivery with metronomic and biofeedback capability.

This proprietary, state-of-the-art piezoelectric micropump can deliver precise 1 µL doses according to a preprogrammed schedule, achieving 10 times greater accuracy in drug delivery compared to current implantable pumps on the market.

It features a double single lumen intraventricular catheter, microprocessor for wireless control and communication with external devices. This device is a companion device that supports delivery of neurological and therapeutics chemotherapeutic agents, including small, large and biological molecules directly to the brain, with applications in brain cancers, CAR-T cell, and gene therapy.

From research and development in life sciences, through evidence generation, clinical decision support, and personalized treatments, to operational excellence, and end-to-end marketing, digital technologies enable better and more intelligent processes and ways of working.

Sinnais IPB-05-MTX

Unveiling Cutting-Edge Advancements

SINNAIS™ sets a new standard in controlled therapeutic drug delivery, outclassing other implantable pumps with its multiple advantages over current market offerings and those in development.

SINNAIS Implantable Pump Graphic

Microdialysis of Brain Technology

SINNAIS™ microdialysis of brain technology allows cerebrospinal fluid (CSF) to be siphoned, filtered, and analyzed for beta-amyloid concentration, with results reported to a physician’s tablet, while the clean CSF is returned to the spinal canal.
  • Measures CSF Abeta levels in real-time
  • Can be recharged inductively
  • Siphons CSF
  • Can be refilled
  • Measures CSF p-Tau and total Tau levels in real-time
  • Provides real-time feedback on rates of Abeta clearance from the brain
  • Uses a proprietary biological filter to run CSF through a filter and remove Abeta, p-Tau, and other protein debris
  • Customizes and optimizes dosage to patients’ specific pharmacokinetic and pharmacodynamic needs—Personalized Medicine
  • SMART Shunt and Smart Optical Sensor (SOS) can monitor drug toxicity and concentration in real-time, with a wireless connection to the cloud
Local Delivery
SINNAIS™ is expected to be the first approved implantable pump for intraventricular or direct delivery to the brain ventricle, which reduces toxicity and ensures a more optimal dosage.
Metronomic Delivery
SINNAIS™ offers metronomic drug delivery, a departure from the standard intraventricular approach of single bolus doses at long intervals. Using an advanced piezoelectric pump, it ensures precise sub-microliter-level drug amounts delivered consistently in a programmed regimen.
Intraventricular Delivery
SINNAIS™ is set to become the first FDA-approved pump capable of delivering drugs directly into the brain cerebrospinal fluid (CSF). Currently, FDA-approved drug delivery methods include systemic delivery, intrathecal delivery, and the use of the Ommaya reservoir, a funnel-shaped plastic device that requires surgical implantation into the brain on a temporary basis.
Flushing Mechanism
The SINNAIS™ catheter incorporates a port that enables the physician to flush the catheter with saline to keep minerals, salts, and crystalline deposits from building up and blocking the eye of the catheter. This is a common problem with existing drug pumps, and often requires surgery to remove and replace a clogged catheter.
Inlet Safety Valve
An inlet safety valve in SINNAIS™ prevents excess drug flow into the patient's body, mitigating the risk of over-infusion, a dangerous issue observed in some existing pumps, leading to adverse effects and fatalities.
Wireless Monitoring and Programming
SINNAIS™ Cloud Connectivity enables wireless monitoring and programming of patient care, allowing healthcare providers to remotely manage and track health conditions in real-time.
SINNAIS™ MRI Compatibility
SINNAIS™ is fully MRI compatible. Many medical devices, such as implanted devices (e.g., pacemakers, neurostimulators) and external monitoring systems (e.g., glucose monitors, ECG devices), must be designed to function safely and effectively in an MRI environment.
MRI machines generate strong magnetic fields and radiofrequency energy, which can interfere with or even damage electronic components. As a result, medical devices with wireless monitoring and programming capabilities must be specifically engineered or modified to withstand these conditions without compromising patient safety or device performance.

SINNAIS™ Innovation Pipeline

With its embedded programmable parameters, including dose, time, sensory outputs, and closed-loop controls, SINNAIS™ architecture offers the flexibility to incorporate additional features in the future.

Despite efforts to individualize dosages, toxicity and efficacy outcomes of chemotherapy vary considerably among patients due to the highly variable and unpredictable biochemistry of the individual. The next generation of SINNAIS™ under development is expected to incorporate an on-board sensor that will monitor the concentrations of the delivered therapeutic in the cerebrospinal fluid (CSF) as well as other parameters, such as CSF pressure, that can be relevant to the management of patient therapy. The device is expected to be able to modify its delivery rate accordingly or communicate the data to clinicians and enable them to make appropriate changes to the delivery rate of the pump in real-time for individual patients.

An inductive charging unit is under development that will allow patients to charge SINNAIS™ overnight by simply placing the charger over their skin, directly above the device. Inductive charging will enable prolonged usage and will be necessary if we decide to pursue development of SINNAIS™ for treating conditions that have longer life expectancy.

SINNAIS™ employs two proprietary intercranial catheters, one tailored for Leptomeningeal Carcinomatosis (LC) and the other designed for the treatment of brain tumors. These catheters are expected to have three lumens: the first will facilitate drug delivery to the desired locations, the second will transmit power from the pump’s internal battery to the catheter’s tip, connecting it to a sensor, and the third will flush the catheter’s tip to unclog blockages.

Cerebral microdialysis involves implanting an intracranial catheter that extends from the head into the channel where cerebrospinal fluid (CSF) is moving around. The catheter tip is equipped with four LEDs (smart optical sensor: SOS) and a miniaturized mirror. When a physician needs to measure the concentration of proteins (such as beta-amyloid and tau) in the CSF, they can command and activate this proprietary technology.

Upon command, the four LEDs at the catheter tip emit light into the CSF channel, illuminating the surrounding fluid. As light interacts with the proteins in the CSF, specific light signatures associated with each protein are reflected back to the miniaturized mirror at the catheter tip. Each protein, including beta-amyloid and tau, has a unique light signature. The device uses a look-up table to match the returning light spectrum with the corresponding protein, enabling accurate real-time identification and measurement of protein concentrations in the CSF.

After each measurement the SOS relays this data, including protein concentrations, temperature, and pressure to a Smart Shunt. The Smart Shunt then transmits the information to the physician's tablet, allowing for real-time monitoring and analysis. This innovative system aids physicians in assessing the disease's prognosis and diagnosis based on the patient’s biomarker profile.

SINNAIS™ Future Possibilities

SINNAIS™ incorporates an onboard microprocessor and wireless communication capabilities that allow the device to transmit patient data to the cloud for further evaluation by healthcare professionals and hospitals. Using sophisticated AI algorithms to ensure the security and authentication of a large number of patients within our healthcare ecosystem, SINNAIS™ employs blockchain software.

SINNAIS™ with AI capability brings personalized medicine to life by delivering highly individualized, real-time treatment tailored to each patient’s unique needs and health goals. Key features include real-time data collection and analysis, predictive analytics for early intervention, adaptive treatment delivery, patient-specific learning, enhanced diagnostics, precision in drug delivery, remote monitoring, integration with genetic and lifestyle data, and continuous improvement through machine learning.

We envision SINNAIS™ with AI evolving to meet each patient’s unique needs, advancing preventive and predictive care, and shifting healthcare toward a personalized approach that maximize patient outcomes.

SINNAIS™ enables continuous, AI-driven patient monitoring that supports real-time health data analysis, creating a virtual presence that mirrors a physician’s oversight. This feature offers key functions such as continuous monitoring and alerts, tracking patient vitals and biometrics, and immediately notifying the patient and physician of any concerning deviations for faster intervention.

Additional capabilities include predictive analytics, automated diagnostics, and remote adjustments, allowing physicians to fine-tune devices based on the latest data without an in-person visit. SINNAIS™ also organizes patient data for structured insights, enhancing patient-physician consultations with data-driven discussions.

In essence, the Virtual Physician feature provides continuous, intelligent care that reduces the need for frequent check-ups, enhances patient safety, and supports proactive, personalized healthcare.

SINNAIS™ is pioneering personalized medicine and virtual physician capabilities with its patented technology, "Method and Apparatus for Forming a Homeostatic Loop Employing an Aptamer Biosensor" (US 8,145,434 B2, issued March 27, 2012). This platform positions SINNAIS™ to evolve into an artificial organ, capable of replicating essential biological functions.

For SINNAIS™ to become a true artificial organ, it must emulate key physiological functions similar to natural organs. Currently, devices like insulin pumps and pacemakers perform limited organ functions; future SINNAIS™ iterations could take on complex tasks such as blood filtration, like an artificial kidney, or blood sugar regulation, like an artificial pancreas.

Key capabilities include integration with biological systems, autonomous adaptation, biocompatibility, longevity, and regenerative support through stem cells.

We envision in the future, medical devices will continue to evolve from basic supportive implants to highly integrated, adaptive, and responsive systems that could fully replace or replicate the function of natural organs, transforming into true artificial organs.