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Lone Star Neuromodulation

Fully Programmable, Modular, Rechargeable

Pulse-Generator, Controller and Wireless Powering

Technology Platform

1©2019 Lone Star Neuromodulation, Inc.

Our VisionCreate a fully programmable device platform that can be adopted for any implantable or external medical application, thereby accelerate medical research and time-to-market, while lowering R&D and materials costs, and effectively enable new and novel therapeutic indications that would target unmet clinical needs.

Our Strategy• Created an ASIC-free, universal, modular “super-set” platform using discrete, off-the-shelf parts

• Universal, modular pulse-generator from 2 to 16 electrodes (or any number in between)

• Included design-hooks for biosensors with or without low-noise amplifiers for closed-loop uses• Incorporated standard “C” language firmware to jump-start customized code development• Leveraged state-of-the-art electronic-component technologies for device-miniaturization

• Pulse-generator: 19.5 cc volume with a thickness of 8.6 mm for the 16 electrode version

• Offering universal encapsulation options for acute studies, animal tests and ultimate products• Peek (semi-hermetic) • Zirconia (hermetic)• Titanium (hermetic)

• Addressing battery longevity with a 500 mAh rechargeable Lithium Ion cell• Enabled a battery-free (wirelessly powered) operation for the pulse-generator2

©2019 Lone Star Neuromodulation, Inc.

Lone Star Neuromodulation Technology PlatformPulse Generator

• Full-Featured Implantable Pulse Generator

• 17 Tri-State Electrodes (2 x 8 leads plus 1 can electrode)

User Controller

• Near/Far-Field RF Interface

• Charging with Sure-Aim RF Tuning

RF Wand

• Battery Charging

• Near-Field Half-Duplex Communication

Demonstration GUI Software

• USB Interface

• Basic Features to Demonstrate System Attributes


The 17-electrode modular design is fully customizable for any number of electrode configuration from 2 to 16 plus 1-can electrode

Pulse Generator – Electrical Attributes• 16 Electrodes via 2 Leads• 1 Can/Indifferent Electrode• Rechargeable Li-Ion Battery• Powered by Li-Ion Battery or Directly from External RF Feed• Two Temperature Sensors• Defibrillator Protection

• Designated to Facilitate Compliance with EN-45502 and EN-50061• Constant Current/Constant Voltage• Mixed Current/Voltage Electrodes• Adjustable Amplitude

• Constant Current 0-20.0mA through tissue• Constant Voltage 0-11V across tissue

• Active or Passive Discharge• Battery-Charging/LF Communication Range

• Up to 1.75 Inches (from the Face of the Wand to the Face of the Pulse Generator)


Pulse Generator – Software Attributes

• Popular dual Microcontrollers (MCU)• C-Language Firmware• Autonomous Safety Features

• Alien Charger Detection/Rejection• Automatic Over-charge Protection• Automatic Over-discharge Protection

• Near-Field RF Communications (1.75 inches)• MedRadio-Band Far-Field Communications

• 403MHz• Adjustable Pulse Attributes

• Amplitude, Pulse Width, Frequency• Conventional Low-Frequency Pulse-Generation Support• High-Frequency Support (capable of over 40KHz operation)• On-demand or automated Impedance Measurement

Feasibility Platform Design


Pulse Generator – Physical AttributesErgonomic Pulse Generator• Contoured & Thin for Patient Comfort• Medical-Grade Liquid Silicone Rubber (LSR) Connector

Housing • Dual Suture Holes for Stability• No-Back-Out Set Screw Lead RetentionOption 1: Near-Hermetic Enclosure• Medical-Grade Conformal Coatings• Molded Medical-Grade PEEK Enclosure• Medical-Grade Epoxy Backfill• RF TransparentOption 2: Hermetic Enclosure• Titanium • Brazed Titanium Laser-Welded RF Transparent Zirconia

Volume: 19.5cc

Footprint: 24.3cm2

Weight: 37 Grams


TITANIUM, ZIRCONIA, and PEEK Materials are offered

Pulse Generator – Physical Attributes

Option 1: Hermetic Enclosure• Titanium or• Brazed Titanium & Laser-Welded Zirconia Ceramic AssemblyOption 2: Near-Hermetic Enclosure• Medical-Grade Conformal Coatings• Molded Medical-Grade PEEK Enclosure• Medical-Grade Epoxy Backfill

7

PEEK Assembly

2

Ceramic or Titanium AssemblyLaser-Welded

Hermetic Seal

1

©2019 Lone Star Neuromodulation, Inc.

TITANIUM, ZIRCONIA, and PEEK Materials are offered

Wand Controller ModuleAttributes• Powered by DC Wall Adapter• Audio and Visual Feedback Operations• Strongly-Coupled Magnetic Resonance (SCMR) RF for:

• Battery Charging• Direct RF Feeding of Pulse Generator• Near-Field Communication• Up to 1.75-Inch Operation in Air

• Optional Traditional Magnetically-Coupled Battery Charging• RF Battery-Charge Power Control/Auto-Tuning• Sure-Aim Pulse-Generator Locator for Charging• Pulse-Generator Battery-Voltage Monitor• Half-Duplex LF Near-Field Communication• MedRadio-Band; 403MHz Far-Field Communication • USB Interface to Personal Computer


RF WandAttributes • Handheld with Sure-Aim Initiation Button• Battery Charging via Strongly-Coupled Magnetic

Resonance • Up to 1.75 Inches in Air

• Half-Duplex Near-Field Communication• Up to 1.75 Inches in Air

Feasibility Design


Demonstration GUI SoftwareTri-State Electrode/Arbitrary Selection• Demo GUI Pairs Any Two ElectrodesSquare-Wave Section• Amplitude• Frequency• Sleep Time (Cycling)Near-Field Communication• LF Communications:

• Battery-Voltage Inquiry• Battery-Temperature Inquiry• Charging Control

UHF (403MHz) Far-Field Communication• Impedance Measurement• Pulse Generator Case-Temperature

Measurement• Battery-Voltage Inquiry• Pulse and Discharge Mode Controls


Pulse Mode & LongevityConstant Current/Active Discharge

Low Setting CC-L-AD Nominal Setting CC-M-AD High Setting CC-H-AD

Amplitude 3.2 mA 6.5 mA 8.6 mA

Cathodic Pulse Width 200µS 200µS 200µS

Frequency 70 Hz 70 Hz 70 Hz

Avg. Current Consumption 1.68mADC[1] 2.01mADC[1] 2.22mADC[1]

Time Between Recharges ~5.3 days[2] [3] ~4.5 days[2] [3] ~4.1 days[2] [3]

[1] Measured across a 1-Ohm precision resistor in series with battery feed in the mV range of the meter for accuracy[2] Assumes only 78% of overall battery capacity is used (full charge is limited to 80%; discharge is halted at 2%)

[3] Battery-longevity calculation includes MedRadio idle power consumption of 0.129mA average (70mS on time and 8.9 seconds sleep time)


Typical performance of a 17-electrode (16 lead electrodes + 1 indifferent can electrode) “super set” prototype platform

Pulse-Mode DemonstrationConstant Current Low/Mid/High Passive Discharge (CC-L/M/H-PD)

Low Setting CC-L-PD Nominal Setting CC-M-PD High Setting CC-H-PD

Amplitude 3.2 mA 6.5 mA 8.6 mA




Pulse-Mode DemonstrationConstant Voltage Low/Mid/High Active Discharge (CV-L/M/H-AD)

Low Setting CV-L-AD Nominal Setting CV-M-AD High Setting CV-H-AD

AmplitudeVoltage applied to provide

3.2 mA to a load of 500 Ohms

Voltage applied to provide 6.5 mA to a

load of 500 Ohms

Voltage applied to provide 8.6 mA to a load of 500 Ohms




Pulse-Mode DemonstrationConstant Voltage Low/Mid/High Passive Discharge (CV-L/M/H-PD)

Low Setting CV-L-PD Nominal Setting CV-M-PD High Setting CV-H-PD

AmplitudeVoltage applied to provide

3.2 mA to a load of 500 Ohms






Burst-Mode DemonstrationBurst-Mode GUI Controls

• Amplitude

• Frequency

• Sleep Time (Cycling)


Waveform Options & FeaturesApplies to All 17 Electrodes

Independent Sources• 2 Constant Currents, OR• 2 Constant Voltages, OR• 1 Current AND 1 VoltageDischarge Methods• Active Discharge• Passive DischargeProgrammable Features• Amplitude: 0-20.0mA / 0–11V (0.1mA or 0.01V Steps)• Pulse Width: 10µS –1000µS (10µS Steps )• Frequency:

• 1–1000Hz Traditional• 1–40KHz High Frequency

PassiveDischarge

Active Discharge


Sure-Aim Charging Location DemoSure-Aim• Push-Button Feature• Locates the Pulse Generator• Auto-Tunes the SCMR RF Generator• Provides Audio-Visual Feedback

** Click on this image for a video demonstration of Sure-Aim **Feasibility Design


Additional Features

Sure-Hold• Temporary Suspension of Operation

• Operation of the pulse generator can be temporarily suspended via an external magnet.• Upon removal of the magnet, the controller can issue a command to resume operation.

Sure-Protect• The pulse generator can detect high voltages being transmitted by alien RF sources and open the power

path for safety.

Sure-Power• The pulse generator can be operated via external RF power while also charging—even when the battery is

fully discharged.


Optional Features

Sure-Temp• Charging Current Adjustment Based Upon the User’s Body Temperature

• If the user is running a fever, charging current can be programmed to be lower.

Sure-Lock• The pulse generator can authenticate a charging power source through the use of a unique serial

number located in the pulse generator’s hardware. Power from an alien source can then be blocked if authentication fails.

Sure-Gauge• The pulse generator can also measure current into and out of the battery in order to gauge battery

capacity.

Note: These features are supported by the hardware design, however, they have not been implemented in the demonstration firmware.


Product Notes:The Lone Star Neuromodulation system is a universal platform NOT intended for any specific indication, as the goal is toenable any traditional or future application. As such, the prototype platform has not been subjected to clinical trials toevaluate its safety and efficacy for any specific indication.

However, safety and efficacy were carefully considered in the design and manufacturing of the generic-purpose prototypedevice and in laboratory testing to date. Several industry standards and agency guidelines, including (but not limited to) thefollowing have been employed in the design and manufacture of the prototype:

• FDA cGMP 21 CFR 820• ISO 13485 Revision 2016• ISO 10993-1• ISO 14708• ISO 14971• IEC 60601-1 Edition 3.1• 47 CFR Part 15• EN 62304• EN 62366• UL/IEC/EN 60950• 93/42 / EEC, 90/385 / EEC

Lone Star Neuromodulation will support any required testing and evaluation. As with any implantable medicalproduct, the results of future testing may vary for the intended applications.


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