Daniel Kerschensteiner
Kernersville, NC (USA)
Role(s):
Other
Cherrystone Investigations
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Startup
Location:
Kernersville
Industry:
Healthcare
Year Founded:
2012
Number Employees:
1-10 people
Business Stage:
Creation/Idea
Entity Type:
Sole Proprietorship
Description:
I am offering for sale the complete patented in vitro theranostic (a diagnostic which gives a choice of therapeutic advice) device for proteases. This are used in order to evaluate whether wounds are healing or not. My product detects general protease activity rapidly, inexpensively, in one step, at room temperature and with a passive color change from red-to-blue in the presence of proteases like those involved with wound healing. You see, in chronic or hard-to-heal wounds, which affect some 3 million Americans causing $14 billion in health care costs, somehow these proteases are at excessive levels and they cause a disruption in the normal healing process. You cannot see excessive protease levels. This biologic can be used alone, reading the result visually; or used with an inexpensive instrument like a turbidimeter, to avoid any subjective errors in reading the color differences and to obtain an objective numerical result.
Using an inexpensive turbidimeter, the results can be quantified numerically and available within 5 minutes. So, for healing or healed wounds a sample (from a swab) would give a low, no color- change result indicative of low protease activity: 25-35 NTU. A sample from a chronic or non-healing wound would give a color- changing result and a high reading of 120-155 NTU, signifying markedly high protease activity and require a change of dressing; a debridement or a collagen-type dressing that would soak up the excess proteases and allow healing to proceed. A middle reading of 40-100 NTU would indicate that the test needs to be repeated daily. This is particularly important for diabetic sores. A hand-held battery-operated portable turbidimeter would be used in the field or clinic.
Why is this important? Many of the non-healing chronic wounds have excessive levels of proteases that linger for a long time. These markers—gelatinases and some matrix metalloproteases or MMPs, and serine proteases, of which elastase is the main example-- occur in chronic wound fluid but there is presently no practical, clinical diagnostic or Point-of-Care test for the marker which could be employed routinely and economically in acute care facilities, outpatient clinics, home care and long-term care facilities. My results prove that a simple, inexpensive, sensitive, rapid, room temperature, visibly color-changing one-step diagnostic test for gelatinase using wound exudate is possible. It is not based on a synthetic substrate like blue azocoll or Congo red- collagen, and it is not immunologically-based like the Wound ChekTM, and it doesn’t require a separation and staining-destaining steps as in gelatin zymography. But it is a brand new and novel, different way to measure protease enzymes quickly, easily, and inexpensively.
Here is how it works. The healthcare provider would obtain a sample from the wound area—e.g., diabetic foot and venous leg ulcers and pressure wounds or bed sores—using a sterile swab and saline to collect the exudate. The swab is dipped into the PAT tube, swirled to remove the protease from the swab, and then it is allowed to react at room temperature for five (5) minutes. After this period, the color is assessed by eye or the tube is read in the portable turbidimeter and the results quantified numerically. If the tube has turned color to blue-grey or the reading is above 140 NTUs, the sample has high protease activity. The sample came from a wound that is not healing properly due to high protease levels.
Here is the “thera-” part in theranostic. If it is high level of proteases that are causing the wound not to heal, use a dressing such as a collagen-type dressing which traps excess proteases from the wound bed. Or use chelating agents or other inhibitors of MMPs: