Medical devices form an integral part of the healthcare industry. Among these is the blood flow measurement device which measures the intensity with which the blood flows in the blood vessels to understand whether the blood circulation is normal or abnormal. Analyzing the blood flow in the body, it becomes possible to diagnose and provide special care for various diseases which are chronic and require round the clock monitoring. Factors such as a rise in aging population, growing incidences of diabetes and cardiovascular diseases, advancement in technology and VC funding are aiding the blood flow measurement device players to grow and innovate at the same time.
New companies are entering the market with promising innovations. For example, Scinovia with a team of professionals is striving to bring technology advancement and innovation in the medical devices sector. They have developed their NOVIA platform to create several products that will disrupt the paradigm of traditional modalities. The platform eliminates two challenges to faster adoption of blood flow measurement devices; the first one is that it is safer than toxic chemical injections such as ICG fluorescence angiography and safer than pinching of fragile vessels, such as ultrasonic flow probes and the other one is that it provides better information because it reports “absolute” speeds over an area.
Our analyst, Pratik Bhosle had a conversation with Jim Sund of Scinovia so as to understand more about the company and know about their innovative product line in the blood flow measurement device market.
Inkwood: How is the non-contact blood flow measurement platform different from the current crop of blood flow measuring devices?
Scinovia: Scinovia developed next-generation biophotonics measurements that employ safe light, fast cameras and very fast computers to visualize “absolute” speeds of blood flow in tissue and vessels.
Devices offered are:
a) Ultrasonic flow probes use sound waves and require physical contact with fragile vessels and accuracy varies with how the probe is held and probe size too small for vessels result in varying degrees of pinch and resulting flow measurements.
b) Fluorescence angiography requires injection of a toxic ICG chemical and reports binary results: flow or no flow and does not report speeds. It may be risky to re-inject multiple times during surgery to see if blood flow has been improved by making corrections to newly attached vessels.
c) Non-contact lights and cameras and algorithms exist and are a decade behind Scinovia. They report ‘relative’ blood flow speeds in tissue and small vessels, so are often limited to wound care. They do not report ‘absolute’ speeds in larger vessels, which is key to being relevant to hundreds of millions of surgeries/year.
Inkwood: What are the significant advantages it offers?
Scinovia: NOVIA™ platform combines the capability of other devices; it enables simultaneous visualization of tissue perfusion and vessel blood flow speeds. Reporting “absolute” blood flow speeds enables doctors to directly compare flow before and after bypasses and transplants and many types of surgery. Non-contact means that measurements can be several times during a procedure without risk of chemical toxicity or physical damage to probes pinching fragile vessels. In addition, VU-FLOW™ mobile has a 2 meter (6 ft) arm to reach over the subject and measure ½ meter (18 in) above the subject, which in many OR settings is outside the sterile zone, so it’s fast to roll in and start visualizing measurements.
Inkwood: What is the role of AI in the product. Can you share a case study or example?
Scinovia: As cases accumulate for a given therapy, e.g., breast reconstruction, AI will be applied to the large data set to discover correlations between physiology, anatomy, symptoms and outcomes to garner new clinical insights and subsequently guide new surgeries based on real-time AI assessment of the current patient to help avert potential costly complications.
Inkwood: How will the platform be a game changer for surgery?
Scinovia: The ability to visualize ‘absolute’ blood flow speeds before, during and after a procedure will help surgeons make new choices before closing the procedure that should reduce costly complications.
Inkwood: What are the opportunity areas for this platform?
Scinovia: One of the key challenges faced by surgeons in the 300 million procedures, globally, each year is knowing if a procedure ends with sufficient blood flow for the organ or tissue to recover. Because the platform is non-contact and non-invasive and works across slow perfusion and 500X faster arterial flow, it can be used many times during the diverse procedure to find and resolve challenges with the flow. Many therapeutic areas should benefit including transplants, plastics, bypasses, general surgery, cancer and wound care.
Inkwood: Are the products under the clinical trial stage? What has been the response from healthcare professionals that have used these?
Scinovia: The first product is Class 1 exempt because it is non-contact and an optional use to aid reliance on sensory (touch, press and visual observation). Over 95% of the 312 million procedures do not use measurement devices. However, during this year, Scinovia will make equivalent clinical claims as its 510(k) predicate devices and based on same animal models. In the subsequent year, Scinovia plans to elevate its clinical relevance to guide surgery, which will likely require human clinical studies. The response for Scinovia’s 10 membered top-tier surgeons has been very positive.
Inkwood: What role do you see of this platform in hybrid operating rooms? Are you looking to tie up with Hybrid operating room manufacturers?
Scinovia: Many surgeons will become high-frequency users of VU-FLOW™ because they’ll want to always have absolute flow information at key points during each surgery. Therefore VU-FLOW™ ceiling mount will be available later this year and would be a natural part of Hybrid operating rooms.