Question 1

Why does the Protectus Safety Syringe provide a unique business opportunity?

Accepted Answer

Healthcare workers face the biggest risk from accidental needlesticks from needles contaminated from a range of serious - and deadly - bloodborne pathogens. Healthcare workers face this hazard every day, even though they observe the highest standards of caution and receive the best of training. Understandably, these professionals are demanding improved methods of protection and prevention. The Protectus Safety Syringe is a patented automatic, self-sheathing device that has FDA 510(k) permission to be marketed and sold in the US and meets or exceeds all OSHA requirements and federal guidelines for safety syringes. If intentional control is lost during use, the Protectus Safety Syringe becomes automatically locked and safe. There is no other safety syringe on the market today that meets this degree of safety and no other that so completely complies with the OSHA mandate.
 
Each year there are nearly one million injuries (grossly under-reported) related to accidental needlesticks in the US alone. These injuries lead to tens of thousands of cases of infectious diseases, including hepatitis and HIV. Healthcare workers face the prospect of years of physical and psychological suffering and even death as a result of this common, but preventable problem. The yearly direct cost of healthcare supplies and services required to treat the victims of accidental needlesticks is estimated to exceed $3 Billion! The total US market for syringes is over ten billion units per year with less than one-third of these being "safety" syringes. The Protectus Medical device is well-positioned to capture a significant portion of this market

Question 2

What is the federal mandate for safety syringes?

Accepted Answer

"Automatic" and "Self-Sheathing" are the operative terms and there are many references, including:

- CFR (Code of Federal Regulations: 1991 under Engineering Controls "means controls (e.g. sharps disposal containers, self-sheathing needles) that isolate or remove the blood borne pathogens hazard from the workplace."
- OSHA Federal Register: Occupational Exposure to Blood borne Pathogens; Needlesticks and Other Sharps Injuries; Final Rule. 66:5317-5325 29 CFR Part 1910.1930 effective April 2001. "Engineering Controls means controls (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that Isolate..."
- PUBLIC LAW 106-430 November 6, 2000 106th Congress amends the Bloodborne Pathogen Standard with the same wording.
- California Bill AB 1208 Feb. 1997 "1992 OSHA adopted the regulation that unequivocally states that hospitals and other health care employers must start using 'engineering controls,' such as self-sheathing needles…"

Question 3

What does automatic, self-sheathing mean?"

Accepted Answer

"Automatic" in the context of safety syringes means deployment of the safety feature of the syringe without any intentional or conscious action by the user to protect the user, the patient, other healthcare workers, trash handlers, etc., from needlestick injuries.
 
"Self-sheathing" is the particular means by which the Protectus safety syringe becomes automatically safe; that is, a sheath is automatically deployed (activated) to slide down over (and completely cover) the needle as it:
 
- Is withdrawn from the site of injection
- Is withdrawn from the vial of medication, or
- If, for some reason, the user loses or otherwise does not have intentional control of the device at any point during its use.
Once deployed, the sheath on the Protectus Safety Syringe becomes instantly locked into its position, covering the needle, and cannot be removed from this locked (safe) position without the user's conscious action to intentionally unlock the device to expose (or re-expose) the needle for continued use.
 
A safety syringe that automatically deploys its safety feature without any action by the user is called a "passive" safety syringe. The Protectus Safety Syringe is the only example of a truly "passive" device among the myriad of existing so-called safety syringes. All other safety syringes known to the Company require an intentional, conscious action by the users to activate their respective safety features; these are not automatic or self-sheathing and are, categorically, called "active" devices.

Question 4

What are the market acceptance concerns?

Accepted Answer

The success of any safety syringe depends on the assessment of five issues at center-stage at all hospitals, clinics, and medical facilities:

1. Safety features and their deployment must, above all else, protect the healthcare workers during the routine use of the device in relevant applications.
2. Ease of use, with little or no training, during routine use in normal applications.
3. Compliance with the federal and state laws, as well as with the OSHA mandate.
4. Pricing of product with respect to other devices available on the market.
5. Availability of the product once qualified and accepted by the hospital.

Question 5

Can the Protectus device be used as a pre-filled syringe for the administration of vaccines, therapeutics, narcotics or for self-administration of products such as insulin?"

Accepted Answer

Delivery and adminstration of vaccines, therapeutics and narcotics in pre-filled syringe formats are readily available niches for the Protectus Safety Syringe and the Company aims to establish itself as a 'safe delivery partner' for the manufacturers of these products. 
 
The insulin safety syringe market is also a good market, if the law covering this application is enforced, since the home-user must protect any third party, such a visiting nurse, other family members (esp. children) and trash handlers. This is particularly true if insulin users do not change the syringe or needle after each injection and store the device in the home refrigerator. Although the Protectus Safety Syringe can be adapted for pre-filled use, pre-filled syringes are currently used mostly for narcotic and vaccine administration. In any case, the law(s) are clear; wherever a needle is used, OSHA requires that safety devices will be used.

Question 6

What are the unique attributes of the Protectus Safety Syringe?

Accepted Answer

The distinct advantages and unique features of the Protectus syringe that are of paramount importance to the users, decision-makers and employers are given below. The Protectus Safety Syringe combines all the design standards that will make it the preferred device of the healthcare industry:

(a) The device is automatic, self-sheathing.
(b) The needle can be changed or replaced safely.
(c) One can safely transport the syringe without recapping the needle.
(d) The sheath maintains a barrier between hands and the needle when not in use - before or after injection.
(e) The Protectus Safety Syringe cannot be locked with the needle exposed.
(f) The Protectus Safety Syringe is locked and safe if intentional control of the device is lost.
(g) The Protectus Safety Syringe has shown strong acceptance in clinical trials.
(h) The Protectus Safety Syringe is fully compliant with federal and state laws and with the OSHA mandate.
(i) Use of the Protectus Safety Syringe provides immediate healthcare cost savings to the user institutions.
(j) The Protectus Safety Syringe is cost-effective.

Question 7

Can the Protectus Device be used for drawing blood from a patient?

Accepted Answer

Although it could, the device will not generally be used to draw blood. It may be used in the laboratory for non-invasive procedures relating to blood, but the blood-drawing procedure is usually done with a phlebotomy device coupled with a vacuum container, a future product of Protectus Medical. Over 85% of all injections are intramuscular and require use of a needle. The Protectus Safety Syringe can also be used for IV-type injections. Additionally, other injections, such as subcutaneous, can be accomplished with the Protectus device. Some procedures require a specific site of injection, such as the knee, foot, hand, mouth, etc. The Protectus device is well-suited for all standard, routine injection procedures.

Question 8

Are Intravenous (IV) devices used in the hospital today also safety-oriented, given that such devices merely screw or snap into the IV ports? What about blunt-tipped needles for injection into the IV line?"

Accepted Answer

This should be the case, since many accidental needlesticks still occur with IV needles and catheters that are inserted into the patient. Indeed, the federal mandate covers all IV catheters and Protectus Medical has already created a patented design for a Safety Catheter using its patented technology. There are needleless IV systems available that have not been universally adopted, mainly because of cost. Thus, needles are still very much used in IV applications and the OSHA mandate requires the use of safety devices in these applications, as well. It should be noted here that fluids (blood) can still travel up the IV lines to the ports and subsequently contaminate the needles. Thus, in changing that needle, needlestick injuries and subsequent infection from the patient can occur.

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