Deal To Watch: GPS Technology for the Body

Summary

At time of publication, December 3rd, Centerline Biomedical had raised $261,500.

Problem

Current protocol for minimally invasive vascular surgery, such as placing stent graphs, uses X-ray fluoroscopy. X-ray fluoroscopy is continuous x-ray images on a monitor. A crude analogy is old school cartoons where every image is drawn and filmed rapidly together to create a movie.

X-ray fluoroscopy takes multiple images and pieces them together, so the surgeon can have a live view guiding the procedure. The product for the surgeon is a dull, 2D grayscale image.

X-ray fluoroscopy, an over half a century old technology, has some other issues. This type of older technology has latency issues, so surgeons must factor in wait time in the OR (operating room) to allow the imaging to report true real time images.

Think about a television made over fifty years ago… Do you want to rely on that technology for your surgeon to place a vascular graft? Guess what, this is the best offered today.

X-ray technology relies on radiation, which even at small doses, increases risk of cancer to the patient and the professionals in the room. The FDA and other leading authorities claim the risk is worth the benefits to the patients and health care professionals

It is believed the radiation exposure does not have significant exposure to be concerning, yet there is almost no research on this type of radiation exposure to health care workers. Anecdotally, there is an emergence of concern regarding the impact of radiation exposure to health care works as rare cancers have killed some of the pioneers in this industry. Either way, no radiation exposure is ideal.

If the assessment/procedure involves soft tissues, contrast dye must be injected to highlight the situation. Contrast dye is toxic to the kidneys and can result in complications.

We can send a document halfway across the world with the push of a button, yet we are still injecting toxic dye in our bodies to understand what is occurring inside. Technology has gone through tremendous advances in the past fifty plus years, it is time to bring medical technology along to the modern age.

Finally, due to the poor visibility of the current grayscale 2D technology, surgeons waste expensive OR/surgical time waiting for the images to catch up with where they are in the patient’s body. The grainy images can result in the stent being placed in the wrong place, making the procedure a failure as it will not fix the problem.

Solution

The Cleveland Clinic’s biotechnical incubator recently spun off Centerline Biomedical, which brings modern technological advances to minimally invasive vascular surgery. To be clear the Cleveland Clinic is known as one of the most innovative and forward thinking hospitals / innovation hubs for healthcare in the world.

 The technology uses GPS-like technology in a smart 3D color multi-perspective display. This dramatically limits radiation exposure and the need to inject poison into the human body.

 The core technology is IOPS (Intra-Operative Positioning System). IOPS core value is to reduce exposure to cancer causing radiation and kidney-damaging contrast dyes.

 Centerline is also testing the system with HoloLens, the mixed-reality glasses by Microsoft Corp. The glasses will place a real time 3-D image of the patient’s vascular system in the surgeons’ field of vision. Cleveland Clinic’s director of medical-device solutions, Karl West, declared it is “like having X-ray vision.”

Why We Like it

1. Quality of Care: Centerline’s IOPS technology is more precise than the current standard of care x-ray fluoroscopy. This will result in better outcomes for patients and greater quality of care.
2. Surgeons will have to repeat less procedures because utilizing Centerline’s IOPS technology will provide surgeons with the technology to greatly increase the probability of placing the stent correctly the first time.
3. Operational Efficiencies: Centerline’s flagship product is designed to thrill even the most Scrooge like hospital administrator. The IOPS product provides a clear, latency free image for surgeons.
4. This translates into significant time savings per surgery, thus enabling less OR and surgical time per procedure. The device sits on a mobile cart and can easily be rolled between OR’s to further maximize efficient use of the product.
5. Safety: Recent research has begun to question the safety of healthcare workers in fluoroscopy guided interventions. There have been few studies on health care workers since its emergence on the market in the 1960’s.
6. A Korea University study called into question the safety of health workers being exposed to radiation in the OR, and determined there is not enough research to conclude it is safe. Population explosions, and access to medical technologies have dramatically increased the number of fluoroscopy procedures done today and this trend is likely to continue in the future.
7. Leadership Team: Centerline has assembled a world class team of seasoned executives. The founder, Vikash Goel, is an expert in developing vascular surgical solutions.
8. CEO, Jai Gupta is the founder of EER systems which creates scientific systems for various federal agencies, the military and NASA. Jim Zalar has over twenty years of experience in health care operations.
9. Mr. Zalar has experience bringing innovative medical technologies to market. The advisory board members from Massachusetts General Hospital, University of North Carolina and Cleveland Clinic create diverse field locations for the product to be tested.
10. FDA Approval: Centerline had a positive pre-submission meeting with the FDA to present the test plan and regulatory strategy. It is finalizing the 510(K) application which will take approximately 4 to 6 months for the FDA to approve the product for market.
11. Centerline has already successfully garnered 11 patents and has 11 pending patents to demonstrate their ability to pass regulations.

Rating

Centerline Biomedical is offering a disruptive technology which will solve multiple issues. The technology will improve outcomes, reduce surgical time and reduce exposure to harmful substances in both the patient and the healthcare team. </ p>

The technology appears to work based on the successful trials at some of the best research hospitals in the country, which are included as evidence in the 510(K) application. 

The Centerline team has already secured 11 patents, so it seems the team understands how to navigate the complicated regulatory approval process. The biggest unknown is if the Centerline team can successfully sell the product and provide support to continue its success.

There are many large players in the healthcare market who could jump on this disruptive train and derail Centerline’s first to market advantage. What is more likely is the goliath players in the market will simply purchase the technology rather than waste time to build it.

Due to the uncertainties of approvals associated with the healthcare industry and the challenge of getting payers to cover more expensive technologies like Centerline’s product in the early days we rate this as a Deal To Watch to reflect the risks of downside involved with a new healthcare technology like this.

Afterall, the market leaders in medical technology know they have grainy, gray scale, latency plagued machines in OR’s today, these leaders will have to make a change once Centerline hits the market. If interested in this potentially life saving technology be sure to invest HERE.