By Karen-Janine Cohen
FloSpine, a spinal medical device maker, has now raised $1.7 million in funding after recently closing on $530,000 in seed capital. Peter Harris, president and CEO of the Boca Raton-based company, said the funds come from a group of high-net worth individuals, including business people, physicians and a Silicon Valley firm.
FloSpine has developed several medical devices dedicated to improving spinal health, and at the moment its main focus is on KeyLift, a product crafted to relieve the compression that is a consequence of spinal stenosis. The company bills it as the first expandable interlaminar stabilization procedure for the condition, which at any one time affects about 600,000 people in the United States.
“The KeyLift is our flagship product,” said Harris [pictured above]. “It is very different.” Spinal stenosis, he explained, is a narrowing of the spinal canal, which affects and compresses the nerve roots. It is most common in older people, and occurs when vertebral discs, which separate the vertebra, begin to collapse or break down. That leads to nerve compression and pain, usually known as sciatica. KeyLift is designed to replicate the function of the discs, which relieves the pain while stabilizing the spine.
The device, said Harris, is a step up from the competition. KeyLift, as well as other products with the same function, are all inserted into the spinal column. However, explained Harris, the KeyLift, goes deeper, into the spine’s lamina – the back part of the vertebral bone. When KeyLift is expanded – a key part of its design and innovation – the device’s tiny teeth hook onto and into the bone. “Once in the patient you can turn a screw and expand and open it. It is not going to move.”
That is an important point. One critique about some other products, said Harris, is that, though they are also inserted in a similar manner, they do not go as deep and they are not rigidly fixed. Over time, the inner movement can wear down the bone, he said.
Harris was born in England and moved with his family to South Africa at 6 years old. He trained as a mechanical engineer, and worked in the South African aerospace industry, then moved to California where he also worked in the oil and gas sector. In the early 2000s, with air force bases shutting down, he went into electronics, which led to the medical device field.
Then came the days when the internet and advancing technology fed the startup trend. Harris worked for several medical technology and device companies that focused on the spine, and eventually decided to start his own company. I’d made a lot of good products for different spine companies,” he said.
FloSpine, founded in 2011 and located in the Research Park at Florida Atlantic University, is now a team of 12 and part of a thriving medical technology sector in South Florida. The company holds eight patents for devices geared toward the spine, including the KeyLift.
The KeyLift itself was developed alongside Dr. Cheng-Lun Soo, a practicing surgeon in Oklahoma City, who had been using FloSpine products for several years. The device received FDA clearance last fall and already has been used in several procedures.
The concept of the KeyLift revolves around catching the spinal stenosis condition when it is causing pain, but before the patient may need more extensive back surgery. “The KeyLift is for a certain subset of patient,” Harris said, explaining that someone typically complains of back pain, and is sent to physical therapy and possibly given cortisone shots. The condition often deteriorates, eventually leading to insertion of spinal fusion, using rods and screws. “We want to be in between, before you get to the hospital for rods and screws,” Harris said.
The KeyLift system intervention is geared toward when the pain is still mild, and it can be inserted on an outpatient basis.
Harris says the sales team is focused on promoting the product to surgical centers, which grew during and after the pandemic, when big hospitals, swamped with Covid patients, were closed to non-emergency patients. Meanwhile, said Harris, interventional pain physicians are doing more of these kinds of insertion procedures.
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