Product Overview:

The Company has been developing two products based on its platform technology. The initial market priority focus is to commercialize a highly accurate, rapid, 2X productive, pain-free allergy test system in the U.S. ($1.5 billion market growing at a compounded rate of 7%). Several prototypes have been made and a proof-of-concept human clinical study has been completed. The second product, based on the same technology, is a unique portable glucose monitor ($10 billion market growing at a compounded rate of 7%). This highly differentiated device, which is currently under development, consists of a patch having multiple, individually addressable sensors that are activated in accordance with the patient’s test schedule, automatically measuring the glucose level without bio-fouling, clogging or daily calibration.

The Allergy Test System offers the allergist an objective, painless, allergy testing system that consists of the following:

  1. A disposable microlancet chip/cartridge that painlessly and rapidly administers the allergens.
  2. A compact imaging module/digital imager that captures real-time allergic reactions and sends images and data wirelessly or via a USB interface to a computer provided at no cost.
  3. User-friendly software that allows the user to monitor the allergic reaction that provides a method for easy measurement of the reaction area. An e-record patient report is automatically created which can be printed or transmitted.

Sensivida believes that the SensiVida Allergy Test system will be eligible for approval pursuant to a pre-market notification filing under section 510(k) of the Food Drug and Cosmetic Act (the “FDCA”) since the system uses FDA approved allergens and it is based on the well-known predicate device, the Skin Prick Test.

The Glucose Monitoring System is an unobtrusive, wearable device with a disposable microlancet chip having individually-monitored sensors that are actuated in accordance to the patient’s test schedule. The uniqueness and advantage over the existing offerings are:

  1. automated measurements without bio-fouling or clogging;
  2. accuracy equivalent to fingerstick test since it is a direct chemical test;
  3. hygiene benefits since no blood is extracted;
  4. the test is painless.

The first version of this product will target hospital use and then migrate to personal/mobile use. The glucose monitor will be comfortably worn as a band or patch.  At user-defined time intervals, each needle of the array is individually deployed by an actuator, causing insertion into the patient’s skin.

Value Proposition: Health Care Facility

1. Hygiene benefits- no blood is extracted
2. Convenient data recording- direct input to digital patient records
3. Minimally invasive
4. Densely spaced sensors permit many measurements over extended times
5. Periodic calibration (automatic)
6. Wireless transmission to nursing station and/or alerts for dangerous levels
7. Painless- patient friendly to children and elderly
8. Microlancets are much less invasive- reduced puncture skin damage
9. Automated data recording and management, improved compliance
10. Less disruption to patient during meals, nighttime, activities at hospital or home
11. More continuous operation reveals high-low glucose levels
12. Comparable cost per test as current fingerstick test
13. Opportunity for closed loop smart system using insulin pump
14. Automated timed measurements- reduced monitoring by the medical staff