Zenosense, Inc. (ZENO) is developing and intends to market a novel device to enable hospitals to detect Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA, or Staph) bacterial contamination, a major constituent of Hospital Acquired Infections (HAIs). The annual costs of treating hospitalized MRSA patients are estimated to be between $3.2 billion and $4.2 billion in the United States alone.
Early detection of MRSA and HAIs in general is vital. Implementing prevention practices can lead to up to a 70 percent reduction in certain HAIs. The financial benefit of using these prevention practices is billions of dollars in medical cost savings in the United States alone, according to a report by the Centers for Disease Control and Prevention, part of the U.S. Department of Health and Human Sciences. Currently, no cost-effective early detection device is available.
The Zenosense MRSA detection device is expected to act like a “smoke detector” for MRSA, designed to detect the contamination in the environment or infected patient, even before a patient demonstrates any obvious symptoms.
Zenosense has a streamlined management team experienced in high-level marketing in the medical sector, supported by the outsourced Zenon Biosystem scientific/development team of qualified personnel with extensive knowledge and experience in the development of sensors. Both of these teams will fuse together through a high-level advisory board of experienced professionals. A cost-effective Zenosense MRSA detection device, once developed, is expected to be in high demand, driven by patient safety, cost, and insurance considerations.
- Addressing Lethal Global Health Threat
Co-Developing Unique Detection Device
Strong Partnership with Sgenia Group
Experienced, Strong Management
Team of Highly Qualified Biologists
Zenosense has an agreement with leading European sensor developer Sgenia Group, which is developing such a device exclusively for Zenosense through its subsidiary, Zenon Biosystem. The Zenosense device, utilizing established Sgenia programming and patent-pending hardware, utilizes a single sensor to perform an infinite number of scans, creating tens of thousands of "virtual sensors." The low cost and compact design of the Zenosense device, if successfully developed, would make it possible to be worn by individuals, as well as placed in numerous sensitive areas in the healthcare setting.
Sgenia Group, known for sensor development and a supplier of sensors used in the Tokamak device for a significant, international nuclear fusion research project, also produces an algal contamination detector for use in water supply applications. It rapidly and effectively scans for the volatile organic compounds (VOCs) emitted by the target algae, a unique “chemical signature” that determines the presence or absence of the algae. The Sgenia detector is effectively an electronic “nose” that can smell this signature.
Zenon is using essential elements of these technology platforms in a development program for the MRSA/SA device to be developed for Zenosense.
Electronic “nose” devices exist to detect bacteria from cultures, such as the Airsense system installed on the International Space Station, and the Cyranose system, which can detect eye infective bacteria.
However, these devices are relatively bulky and are prohibitively expensive to universally install, and when it comes to MRSA/SA, there is currently no cost effective system that acts like a “Smoke Alarm” to detect infection in its early stages, in the patient or in the rooms of a healthcare building.
Zenon’s device will be based on the already developed algal (water) sensor platform; at this point the intention is to use a single commercial “off-the-shelf” gas sensor to sample the air and continuously monitor for the airborne MRSA/SA VOCs signature, which is only emitted when the bacteria has infected and expressed itself as a disease in the patient. It can be detected prior to the patient being obviously symptomatic, enabling an earlier intervention.
At the detection stage, the VOC detection is electronically processed and is pattern processed in a neural network on the patented applied for Sgenia hardware. A Spanish patent application was made January, 17, 2013, under the reference P201330048 with the title (translated from Spanish) “Method of Analysis of a gas and artificial nose.”
The adapted Sgenia hardware will attempt to allow the device to effectively “learn” to establish the MRSA/SA VOC signature. The VOC signature is referenced to parameters in Sgenia’s software so as to enable continual scanning across the MRSA/SA VOC spectrum. This stage is powerful mathematical processing to recognize the VOC patterns and contamination positioning – the system can discriminate between bacterial VOCs and contamination. The algorithmic software is protected as an Industrial Secret by FPGA (Field Programmable Gate Array) “lock and key” encryption on Sgenia’s chip.
The device is intended to be produced in two forms:
- A low cost wearable / bed positioned device, powered by a rechargeable battery to be positioned on the person; patients and medical staff. In the event of any infection, the MRSA device will detect the VOCs produced by the infected person and express an audio/visual alarm
An adapted, fixed device positioned in the room, mains powered, with culture-amplification of any MRSA/SA presence, to monitor the room volume. This would be network monitored.
In the event of a positive detection, further personal conventional tests would be used to discriminate between MRSA and SA, as both infections require specific treatment. The MRSA/SA VOC detection range is estimated to correlate to an approximate 3-meter “bubble” around an infected patient, ideal for a wearable device. However, it is the intention of Zenon to explore whether MRSA versus SA VOC signatures can be discriminated by the device during the development program. The Sgenia detection technology is very sensitive. If the VOC signature of the genetically different MRSA can be separated from the signature of SA, there is a prospect that such a discriminatory device can be developed.
Phase 1 will be to produce a prototype of MRSA/SA detection device based on the Sgenia technology, having the capacity to detect MRSA/SA contamination. This will require substantial engineering to modify and adapt existing sensor capabilities to the proposed application, as well as modification of algorithms to conform to MRSA or SA bacteria analysis. It is envisioned that all these developments will be protected as industrial secrets and will not be patented.
Phase 2 will be to produce prototypes and conduct laboratory tests with a minimum of 20 beta versions of the MRSA/SA detection device and then delivering a pre-production design suitable for hospital use. Critical to this phase will be validating the device and achieving accuracy and repeatability performance. Testing will include addressing contamination influences of environmental conditions (temperature, humidity and other gasses) and interference from other families of bacteria; and achieving the standard and quality levels required for hospital usage.
Phase 3 will be to obtain relevant regulatory approvals in the U.S. and European Union, to produce a final product ready for mass production and marketing. It is anticipated that this phase will include final testing by an external and specialist laboratory of microbiology, preparing and pursuing applications for approval and remedying any problems detected during testing, and preparation for mass production of the device once all relevant tests and approvals are obtained.
HAIs are the most frequent adverse event in healthcare delivery worldwide; hundreds of millions of patients are affected by healthcare-associated infections, leading to significant mortality and financial losses for health systems. At any given time, seven out of every 100 hospitalized patients in developed countries will acquire at least one HAI; in developing countries, 10 of every 100 hospitalized patients will acquire at least one HAI.
The Centers for Disease Control and Prevention (CDC) estimates that one in every 20 patients treated in U.S. hospitals develop an HAI. Approximately 2 million HAIs are associated with nearly 100,000 deaths each year and directly responsible for at least 23,000 deaths per year in the United States alone.
The CDC takes the view that advanced molecular detection technologies, which can identify threats much faster than current practice, are not being used as widely as necessary in the United States, and that developing better diagnostic tools to rapidly and accurately find sources of contamination will improve antibiotic use.
The proposed Zenosense device, in the case of MRSA, is expected to address these deficiencies. Recent studies suggest that implementing prevention practices can lead to up to a 70 percent reduction in certain HAIs.
The financial benefit of using these prevention practices is estimated in a report released by CDC to be as high as $25.0 billion to $31.5 billion in medical cost savings in the United States. MRSA continues to account for a significant proportion of HAIs and is regarded as one of the most important causes of antimicrobial-resistant HAIs worldwide. Furthermore MRSA is becoming resistant to a growing number of antibiotics.
MRSA is a bacterium responsible for several difficult-to-treat infections in humans. MRSA is any strain of SA that has developed a resistance to beta-lactam antibiotics, including the penicillins such as methicillin, dicloxacillin, nafcillin, oxacillin, and also the cephalosporins group. MRSA infection cannot be effectively treated with these standard antibiotic types and is accordingly more dangerous than SA.
MRSA is a particular danger in clinical settings such as hospitals and care homes. Patients with open wounds, invasive devices, and weakened immune systems have increased risk of infection. Patients contracting MRSA are likely to spend three times as long in a hospital stay at three times the cost, and are five times more likely to die than an uninfected patient.
MRSA has recently been estimated to be responsible for 11,000 deaths and 80,000 invasive infections per year in the United States alone. Patients with MRSA can be twice as likely to die as patients with Staph infections that can be treated with methicillin and the annual costs of treating hospitalized MRSA patients are between $3.2 billion and $4.2 billion in the United States (according to an Issue Brief released by the Pew Charitable Trust on April 3, 2012 ).
*Source: CDC - A case is classified as hospital-onset (HO) if the MRSA culture was obtained on or after the fourth calendar day of hospitalization, where admission is hospital day 1; as healthcare-associated community-onset (HACO) if the culture was obtained in an outpatient setting or before the fourth calendar day of hospitalization and had one of more of the following: 1) a history of hospitalization, surgery, dialysis, or residence in a long term care facility in the previous year, or 2) the presence of a central vascular catheter (CVC) within 2 days prior to MRSA culture; and as community-associated (CA) if none of the previously mentioned criteria are met.
The direct costs of HAIs, both in the United States and around the world, of which MRSA is a major constituent, are therefore very substantial.
The high financial toll on private and public health care systems by MRSA is therefore a critical issue for healthcare providers and authorities. A considerable and expensive effort is accordingly directed at hygiene, deep cleaning and early identification of infected patients. Patients may be pre-screened for MRSA, surfaces are sanitized and hand-washing regimes are implemented.
A patient may be tested for MRSA/SA infection with a lab test from cultured samples, involving extensive incubation times of 24 hours or more and a 2-3 day result turnaround. More expensive tests are also available with shorter (just hours) turnaround times.
Zenosense has a streamlined management team experienced in high-level marketing in the medical sector, supported by the outsourced Zenon Biosystem scientific/development team of qualified personnel with extensive knowledge and experience in the development of sensors.
Carlos Jose Gil, BSc (Engineering) - President, CEO, CFO
Carlos Jose Gil joined the company in October 2013 as a member of the board. He has experience in high-level sales management and the development of sales teams in the health care sector. From 2012 to 2013, Gil served as a managing director of Porsche Car Spain. From 2009 to 2012, Gil was sales manager at Pharmaceutic Laboratory PersanFarma. From 1994 to 2009, Gil was a medical consultant in Medical Affairs and then an account manager at Pharmaceutic Laboratory Janssen-Cilag (Johnson & Johnson). Gil holds a Bachelor of Science in Chemical Science from Valencia University, Spain.
Development Team (Zenon)
J. Lama, MBA, BSc
J. Lama is an engineer with a Master of Business Administration and a Bachelor of Science (Physics). His experience includes material engineering, solid state physics, electronics, renewable energy, the automotive industry and developing technological business.
M. Querol, MS
M. Querol is a mechanical engineer with a Master of Science in Telecommunications Engineering. His experience includes market development of global solutions for Aeronautical, Naval and Defense sectors, market development of internalization strategy development, and market development of industrial engineering solutions.
M. I. Gil, DEA, BSc
M. I. Gil has a Master of Advanced Studies in Fluids Mechanics from Centro Politecnico Superior of University of Zaragoza in Spain, as well as a Bachelor of Telecommunication Engineering. Gil has wide experience in sensor technologies and advanced technical and software developing.
G. Roman Perez, PhD, MAS, BSc
G. Roman Perez has a PhD in physics from the Autonomous University of Madrid (UAM), with Cum Laude distinction. He also has a Master of Advanced Studies in Condensed Matter Physics, a Master of Biophysics and a Bachelor of Physics, all issued by UAM. His work has been published in several different publications and he has spoken at conferences in France, Italy, Spain and the USA.
The company will also rely upon a team of three biologists contracted to Zenon for the development of the Sgenia Products. This team is comprised of molecular biologists and biochemists specializing in bacterial physiology and genetics, clinical microbiology and molecular biology. All hold relevant PhDs, and two hold Masters, in disciplines highly relevant to optimizing the company’s sensor for the detection of MRSA/SA. The team’s combined skillset includes deep knowledge of the clinical genetics to be addressed in order to program and refine the sensor so that it can detect SA and ideally discriminate between MRSA and SA. Variously, members of the team are business (biotechnology) management qualified, have co-authored numerous scientific publications, taught as professor, have experience of the practical clinical setting in hospital and have co-invented patents for others.
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