VersaWrap is an absorbable implant (device), designed to serve as an interface between target tissues and surrounding tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan. VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet to render the Sheet a gelatinous, tissue adherent layer (gel in situ). The aqueous citrate Solution is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.

VersaWrap is an absorbable implant (device), designed to serve as an interface between target tissues and surrounding tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan. VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet to render the Sheet a gelatinous, tissue adherent layer (gel in situ). The aqueous citrate Solution is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.

Cutaneous Electrode Garment

Gait-enhancement electrical stimulation system, external

The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct toseizure monitoring in adults in the home or healthcare facilities during periods of rest. Thedevice is to be used on the belly of the biceps muscle to analyze surface electromyographs(sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures and toprovide an alarm to alert caregivers of unilateral, appendicular, tonic extension that could beassociated with a GTC seizure. The System records and stores sEMG data for subsequentreview by a trained healthcare professional.

The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and AlertingSystem, is a physiological, surface electromyography (sEMG) monitor with or without alarms that recordsand stores data for review by a physician for characterization of seizure events.The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed withan algorithm using the default threshold or by a modified threshold ordered by the physician.The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTCseizures and provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern thatmay be associated with such seizures are detected.The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcareprofessionals) for post-hoc review so that they may quantify and qualify the types of seizure events thattheir patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replacedwith the second sEMG Monitor on the opposite arm of the patient.The sEMG Monitor that is removed after 24-hours is then attached to a Base Station. By connecting thesEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the BaseStation. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit,Data Distribution System (DDS), where it awaits review by a physician. All patient data is cyber-securedwithin Microsoft Azure which is FedRAMP certified.

The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and AlertingSystem, is a physiological, surface electromyography (sEMG) monitor with or without alarms that recordsand stores data for review by a physician for characterization of seizure events.The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed withan algorithm using the default threshold or by a modified threshold ordered by the physician.The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTCseizures and provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern thatmay be associated with such seizures are detected.The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcareprofessionals) for post-hoc review so that they may quantify and qualify the types of seizure events thattheir patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replacedwith the second sEMG Monitor on the opposite arm of the patient.The sEMG Monitor that is removed after 24-hours is then attached to a Base Station. By connecting thesEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the BaseStation. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit,Data Distribution System (DDS), where it awaits review by a physician. All patient data is cyber-securedwithin Microsoft Azure which is FedRAMP certified.

The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and AlertingSystem, is a physiological, surface electromyography (sEMG) monitor with or without alarms that recordsand stores data for review by a physician for characterization of seizure events.The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed withan algorithm using the default threshold or by a modified threshold ordered by the physician.The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTCseizures and provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern thatmay be associated with such seizures are detected.The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcareprofessionals) for post-hoc review so that they may quantify and qualify the types of seizure events thattheir patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replacedwith the second sEMG Monitor on the opposite arm of the patient.The sEMG Monitor that is removed after 24-hours is then attached to a Base Station. By connecting thesEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the BaseStation. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit,Data Distribution System (DDS), where it awaits review by a physician. All patient data is cyber-securedwithin Microsoft Azure which is FedRAMP certified.

360CAS Navigation System Software is a bespoke software developed by Kico for surgical navigation. The software contains two modules, 360CAS Knee and 360CAS Hip.

Small CAS Tracker

Large CAS Tracker

Resection Guide Tool

CAS Pointer

Pin Guide

Tracker Universal Grip

CAS Flex Driver

Bone Fixator

4mm Hex Driver Long

ASM Cut Block

ASM Horseshoe Fixation

360CAS Accessories Set