Fusing light and ultrasound technologies, Ornim, Inc., provides physicians with the most advanced monitoring tools to direct safe and decisive patient care when the perfusion of vital tissue (e.g. brain) is at stake. The c-FLOW™ monitor is the only FDA cleared device which enables continuous, non-invasive, easy to use blood flow changes in the brain and muscle tissue. This is key for understanding perfusion, alerting physicians to variations in blood flow to the brain, thus enabling informed intervention for better clinical results and patient care. As well as managing overall treatment and reducing the overall cost of patient care.

Clinical Need

Neurological injury is often associated with deficits in blood supply to the brain, resulting in diminished oxygen, glucose and other nutrients, key for survival of the neuronal cells. Currently, the limited ability to monitor the brain may result in short or long-term brain damage, disability, or death. This monitoring information is important not only when dealing with brain injuries, it is also important in various other states when brain perfusion may be compromised or disturbed. In cardiac surgery, use of cerebral monitoring has been shown to significantly reduce the overall complications rate including permanent stroke, and improve economic outcomes by decreasing ventilation time & ICU and hospital length of stay (LOS). Personalized patient management, based on Ornim’s monitoring platform is expected to reduce such costs by improving patient’s outcome post-surgery.

Maintaining adequate blood flow is a primary clinical goal for critical care patients. However, today, this is achievable either by using multiple invasive devices or single-session imaging studies such as CT, MR or PET which are expensive or with transcranial Doppler (TCD), which is difficult to operate continuously. Individualizing patient treatment based on targeted goals is known to improve patients’ outcome and reduce related healthcare costs. There is a strong clinical need to provide accurate multi-parameter monitoring of brain tissue perfusion that is non-invasive and cost-effective. Clinical benefits exist for multiple patient populations including high risk surgery, stroke, sepsis, traumatic brain injury (TBI), occlusive vascular disease, carotid endarterectomy, & plastic surgery patients. Studies performed with TBI patients show good correlation of non-invasive readings with Ornim’s monitor to other, invasive and more costly monitors.

Business Need

From a pure business point-of-view, the c-FLOW™ has a wide arm-length given that it has the ability and the advantage to add critical clinical knowledge and understanding within the clinical environment, be it the NICU, Emergency Room, Operation Room or other space. Moreover, the wide specialty range of clinicians gives an added advantage to the broad structure of the marketing environment and potential clients. As hospital policies change in the post “Obamacare” era, the c-FLOW™ allows for the input of the “purchase drivers” that influence hospital administrator’s decision making process –lessening of liability, reduction in costs, and improved patient care. The c-FLOW™ can impact a hospital’s bottom line by reducing disabilities and deaths resulting from secondary brain injury originating from insufficient blood supply in numerous situations, ranging from the battle field to the delivery room, TBI and more.

Even though a number of the competitor products have already established a beachhead in the OR market with some marked success, and that altogether over 1,000 studies have been conducted in the OR using these devices, it has been found that one direct measured parameter was missing, cerebral blood flow ( CBF)! Ornim’s c-FLOW™ has found a wide audience with most of the medical staff as it emphasizes the new modality of intracranial flow over oximetry as the primary and foremost parameter when monitoring brain injured patients (due to traumatic brain injury, ischemic, hemorrhagic stroke or post neuro-surgery patients). Moreover, clinical studies have demonstrated excellent results within the leading medical centers in the USA with published works expected in the near future. While anesthesiologists are used to oximetry as the main monitoring parameter, they are understanding that it is not enough and not as accurate as formally thought (as discussed at the 2014 ASA Conference). Ornim has already managed to significantly reduce adverse clinical outcomes including permanent stroke1, and improve economic outcomes by decreasing ventilation time & ICU and hospital length of stay (LOS).

Vision and Market Opportunity

Ornim vision is to be the leader in providing non-invasive monitoring (brain and muscle) of tissue perfusion, helping improve care to patients from community health to first emergency response to medical centers through guidance of therapy targeted at tissue protection and reduction of cerebral morbidity.

The total available market (WW) for non-invasive monitoring of blood flow and oxygen saturation, in multiple markets, is estimated at $5.4B growing at a CAGR of over 20%2. The initial target markets Ornim Inc. will enter represent a market potential of over $2.1B in annual revenues in the US from disposables only. Ornim will ramp to distribution sales OUS once revenue stream has been established.

Why is c-FLOW™ needed?

  • Cerebral blood flow should be monitored in patients with moderate to severe Traumatic Brain Injury (TBI) in order to ensure timely interventions that prevent unnecessary brain tissue death.
  • Cerebral blood flow monitoring in patients with strokes may help to guide therapy and improve outcomes in the acute and convalescent stages.
  • Patients should be monitored for loss of and restoration of cerebral blood flow during cerebrovascular procedures such as carotid endartectomy.
  • Patients with cardiac arrest would benefit from monitoring of cerebral blood flow during cardiopulmonary resuscitation.
  • There is a significant unmet need for measuring cerebral blood flow in infants who are premature. Monitoring these infants may lead to decreased rates of brain hemorrhage and cerebral palsy.
  • ALL patients who undergo general anesthesia are at risk for impoverishment of cerebral blood flow and should be considered for monitoring.
  • Patients undergoing circulation restoration procedures to the limbs should be monitored to reduce the risk of limb ischemia.
  • Patients undergoing chiropractic manipulation of the neck should be monitored for potentially harmful changes in cerebral blood flow.
  • Headache clinics would benefit their patients to monitor cerebral blood flow and gauge the effects of their acute migraine treatments.
  • Occupational fitness can be decided in part by assessing cerebrovascular reserve in particularly high-risk professions, such as airline pilots, commercial truck drivers, fishermen, and politicians.
  • Patients with dementia should be screened for cerebral blood flow irregularities that may be treatable and possibly prevent unnecessary cognitive decline.

Technology & IP

Ornim’s unique technology, protected by 18 worldwide granted and 15 worldwide pending patents, overcome limitations of Near-Infrared Spectroscopy (NIRS) and ultrasound Doppler. The patented UTLight™ technology employs the combination of light and ultrasound to provide a non-invasive measure of regional blood flow. UTLight™ technology is unique among all other commercially available NIRS technologies, since it also analyzes the light speckle signal and does not rely solely on the intensity of light reaching the detector.

Ornim’ c-FLOW™ monitor was born out of a need – a need to measure blood flow directly at its source. In other words, the product has the capabilities of direct measurement of Cerebral Blood Flow (CBF) – not surrogate like tissue oximetry; it is spontaneous and comprehensive while at the same time highly actionable; the management of blood pressure (BP) according to CBF is intuitive; the measurement is robust and finally when adding the BP signal, the Autoregulation function of the organ can be assessed directly. Ornim has developed an unparalleled non-invasive platform for measuring both microcirculation blood flow (via Doppler analysis) and localized oxygen saturation (via spectral analysis).

Highlights

  • c-FLOW™ is the only FDA cleared device that measures cerebral blood flow non-invasively, directly, continuously, and in real time
  • Initiated commercialization of c-FLOW™ in the USA
  • High demand from leading hospitals and clinicians
  • Two independent clinical studies & publications validating the clinical value and potential of the device
  • Six sites with ongoing clinical studies and data collection from leading US, Europe & Israeli medical Centers;
  • Novel technology, overcoming the shortcoming of conventional Near-Infrared Spectroscopy (NIRS) device
  • c-FLOW™ allows for the early monitoring of brain’s blood flow and perfusion even before the patient reaches the hospital (e.g. in the ambulance) allowing the medical team to prepare a customized line of therapy
  • Strong IP protection

Highly qualified and experienced management team and Scientific Advisory Board with investment by OrbiMed, Agate Medical Investments LP and GE.

References:

  1. Murkin JM, Perioperative Detection of Brain Oxygenation and Clinical Outcomes in Cardiac Surgery., Semin Cardiothorac Vasc Anesth. 2004 Mar;8(1):13-4.
  2. Medtech Insight U.S. Markets for Patient Monitoring Products, June 2008.