Medical Devices

BREVITEST TECHNOLOGIES is developing a biomedical immunoassay platform technology that could allow consumers, patients, caregivers, and others to more easily detect and quantify molecules of interest from a variety of sample types like blood, saliva, urine and water. This approach provides for a compact, portable, point-of-care device that is sensitive, specific and rapid. The BreviTest platform can be applied to a broad array of diagnostic tests, including those in emergency and non-emergency settings, allergen detection, home monitoring of chronic diseases as well as physiological conditions.

This is a broadly applicable platform technology targeted towards markets with an unmet need for a sensitive, easy-to-use, point-of-care method to quantify molecules. BreviTest’s product not only provides solutions for the traditional point-of-care clinical markets, estimated to be $25 billion worldwide by 2016, but also has the potential for use in diverse other areas where a cheap, portable, quick and user-friendly bioanalytical method is needed. We are working with co-developmental partners to develop and test the technology further with the goal of reaching a wide range of markets including clinical, veterinary, law enforcement, population screening, forensic, environmental, toxicology, and lifestyle applications. Some of our current collaborators include Cayman Chemical Company, APC Health LLC, CDC, antibody manufacturers, and health sciences universities.

COMPETITIVE ADVANTAGE 1. Platform technology: Can test for a variety of analytes, including proteins, small molecules, and serum antibodies (serology). 2. Accurate: Inherently similar to laboratory ELISA tests. 3. Rapid. 4. Portable: Length 9”; form factor of a sub sandwich; long-life battery. 5. Economical. 6. User-friendly: Single-point user intervention via smartphone or PC. 7. Complete system: Analyzer performs entire ELISA, including optical reading and data upload to cloud; no additional equipment needed.

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STENT-X Every year, thousands of children have double-J ureteral stents placed following reconstructive or transplant surgery to alleviate an obstruction between the kidney and the bladder. The ureteral stent is removed at a follow-up visit by pulling on a dangler string attached to the stent and threaded through the urethra or via cystoscopy. The dangler string can only be used following certain procedures (e.g. kidney stone) and in most cases is not used in children due to infection and accidental stent removal concerns. Children must then undergo an invasive procedure via cystoscopy, which consists of inserting a scope into the urethra under general anesthesia to remove the stent. While adult cystoscopies can be performed in the physician’s office under local anesthesia, children are routinely placed under general anesthesia to minimize the discomfort and stress associated with the invasive procedure. The FDA recently issued a warning that repeated exposure of young children to general anesthesia may put them at an increased risk of long-term cognitive deficits in language and abstract reasoning.

The Stent-X device is a minimally-invasive ureteral stent removal system. A standard ureteral stent has been modified by securely attaching a coated magnetic bead to the distal curl of the stent. For removal, a specially-designed catheter with a magnetic tip is inserted through the urethra into the bladder where it makes contact with the target bead. Once in contact, the retrieval device can be used to smoothly guide the stent out of the patient’s body without the need of general anesthesia. This solution shortens the retrieval process, reduces the cost of the procedure and minimizes the risk of cognitive deficits in children from early overexposure to general anesthesia. The Stent-X device will also be developed in adult sizes, and will provide physicians with an elegant solution for patients where a dangler string or cystoscopy is not preferred.

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CHORIOANCHOR Our ChorioAnchor device provides a way of securing the chorioamniotic membranes of pregnant mothers to the uterine wall to prevent preterm premature rupture of the membranes (pPROM), which can lead to complications for the mother and her baby. The current method for reducing the risk of pPROM is to make an open incision in the mother’s abdomen to gain access to the uterus and suture the membranes to the uterine wall. However, the skin incision requires the procedure to be performed under general anesthesia, increasing the risk of harm to the mother and baby. The ChorioAnchor device has the potential to assist in surgeries to correct congenital defects, such as Spina Bifida, and is one of the first devices under development for the relatively new field of fetal surgery.

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