Develop market leadership by offering advanced solutions that set new standards for high-performance medical device sterilization and verification.
- Successful Sterilization Tests – Duodenoscope
- Low temperature (<60oC)
- 2 continuously non-toxic and non-corrosive aqueous solvents and 2 energies
- Rapid (< 60 min)
- Sterile elevator mechanism and lumens
- Challenge organism is G. stearothermophilus
- U.S. and foreign patent applications pending and 3 issued U.S. patents
- Testing durability of sterilized duodenoscopes
- Advancing FDA communications
De-Risked, High-Performance Technology Platforms
Based in Massachusetts, the Company owns WAVEPulse Sterilization and SterileTest Verification, novel platforms for reprocessing temperature-sensitive medical devices
- Sterilizes bio-pathogens, super bugs, viruses, and other potentially lethal substances
- Destroys proteins and other critical biomolecules so can no longer cause infection or allergic reaction
- Fractures Prions, the extremely stable infectious proteins that can cause Creutzfeldt-Jakob Disease and Bovine Spongiform Encephalopathy (BSE/” mad cow disease”); incurable and fatal brain diseases
- Attains Sterility Assurance Level (SAL) of 10-10, far exceeding 10-4 to 10-6 levels currently available.
Large Addressable Market Opportunities
- Sterilization and verification failures in reprocessed medical devices
- Complex, minimally invasive devices
- Rubber, plastic, metals and adhesive materials with complex articulating parts and long lumens
- More than 15 million endoscopy procedures annually in US
- Inability to destroy Prions by existing processes for patients undergoing brain, spinal and eye surgeries (>100,000/year)
- Reduction of hospital-acquired infections (HAI) in alignment with goals of Affordable Care Act
- Reprocessing medical devices in hospitals, clinics, nursing homes and ambulatory surgical centers
- Supplying FDA-cleared exclusive consumables required for WAVEPulse Sterilization and SterileTest Verification
Intellectual Property Portfolio
The Company owns U.S. patents, one of which was recently issued April 2019. There are additional U.S. and foreign patent applications that were filed in 2016 and 2017. The Company is not subject to any restrictive licenses, assignments or fields of use.
The Company has an experienced executive team. Their backgrounds encompass operations, manufacturing, life sciences, startup business experience, strategic planning, technology development, finance, fundraising, high growth expertise, mergers and acquisitions and high exit multiples.
Forward Looking Statements
The Company believes that the information included on this website contains forward-looking statements. Such forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could cause results to differ materially from the forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result of new information or future events or developments, except as required by law.