Hardware Ace: Alyssa Huffman is working to craft a better biomedical screw

Anyone who has lived in an old home with plaster lath walls instantly understands the problem Alyssa Huffman of Springfield is addressing.

In a house like that, hanging a picture requires a different solution than a simple nail, which risks chipping the plaster and not supporting the weight of the frame.

Likewise, the most common mechanical issue for spinal fusion surgery is screw loosening, which happens in 30%-54% of instances, according to 2023 research in medical journal Acta Biomaterialia. Other research statistics cited on the website of Huffman’s biomedical technology company Allumin8 Inc.: Some 5.2 million spinal surgeries are performed each year worldwide, a rate that is increasing at 7.9% annually, and 21%-62% of these spinal fusion surgeries have debilitating complications.

When that home plaster fails, the result could be a gouge in the wall; ideally, the structural integrity remains intact. But when the structure of the spine fails, the problem is more than cosmetic. That’s where Allumin8 is stepping in with its bone screw technology, according to Huffman.

“There are up to 300 diseases that occur in bone, and what we’ve seen is the hardware that currently exists on the market is just hardware,” said Huffman, 45, Allumin8’s founder and CEO. “It’s like putting a screw in a wall and hanging a picture – but the problem is the wall isn’t vascular; it doesn’t have a biological response, so that might work, right? But if you have a wall that’s like mashed potatoes, it’s not going to work.”

Those who look closely at an Allumin8 bone screw will notice a subtle texture on the titanium surface. It’s a texture that attracts bone material and encourages its growth around the hardware, ensuring that the hold is firm and the picture frame that is the human spine resists collapse.

The textured screw is not the only innovation from the company, according to Huffman.

“We created a hardware that could deliver therapeutics that could treat those 300 diseases that are in the body,” she said. “Whether it be small molecules like cancer drugs – you can inject slow-release drugs through the devices.”

Branching out
Huffman said the spine is the area where Allumin8 can do the most global good, but she is talking with other companies about applying the company’s intellectual property to their implants.

“What that does is they don’t have to have new instrument sets to put the hardware in; what you can do is apply our topography, and we can 3D print it with our own proprietary 3D printing process, and now you have the ability to draw the stem cells into the device and create a device that signals and recruits, to strengthen bone and lower the infection,” she said.

Stem cells are like chameleons, Huffman said.

“What they touch they turn into,” she said. “So, if a stem cell touches bone, it creates a cascade to create new bone formation, and that’s the No. 1 reason for failure in the spine: The bone is too soft.”

There are limits to what screws alone can accomplish, according to Huffman.

“What we aim to do is 30 years down the line, in our syringes that you screw onto the hardware, we’ll have a hydrogel or a bioink that can mix with a small molecule, and then you inject it through the device and actually treat those disease states that occur in bone while giving it biomechanical stability,” she said. “You need a therapeutic to treat the biologic state. Hardware can only do so much.”

Huffman sounds like someone who has spent decades in a lab coat, but she’s not. She’s not a scientist or a medical professional; she’s a businessperson with an MBA and a thirst for knowledge.

Her LinkedIn profile reflects years of her boosting scientific articles and conference talks that excited this former orthopedic and biologic sales representative. In recent years, there are references to her own conference appearances, most recently the June 20-21 scheduled appearance in Chicago at the North American Spine Society Innovation Network Summit, in which Huffman was slated to give an address on funding essentials for securing early-stage capital for medical innovations.

One of Huffman’s posts promoting the presentation states, “Got an idea in spine, biologics, robotics, AI or something else which can benefit the ecosystem? Don’t let 10 years pass you by like I did.”

She encourages surgeons, startups, commercial leaders and sales reps who have a concept for a spine product to explore ways to bring that product to life.

FDA clearance
In June, Allumin8’s initial product, the A8 INTEGR8 Porous Pedicle Screw System, received Class 3 clearance in its premarket approval application to the U.S. Food and Drug Administration. The FDA defines Class 3 devices as those products that sustain or support life but are seen as presenting a high risk of illness or injury. Examples are pacemakers or cochlear implants. It was a milestone for the company, but Huffman was disappointed – she was aiming for Class 2, which is seen as posing moderate risk and includes surgical and therapeutic devices like infusion pumps, syringes or catheters.

The FDA’s letter to the company noted it needed just one more test for the Class 2 status.

“That was heartbreaking, but it wasn’t a rejection,” she said.

She noted the company is in the appeal process, and she expects Class 2 clearance in about 90 days.

The Class 3 clearance gave Allumin8 a premarket approval pathway, she said.

Class 2 clearance will allow the devices to be implanted into patients for the first time. That will happen at specific hospitals, including CoxHealth, under Dr. Mayur Jayarao, Huffman said; the others are Duke, Washington University, University of California at San Francisco, the Mayo Clinic and Phoenix Children’s.

Huffman said the screws have important pediatric applications, especially in serious scoliosis cases that can compress children’s spines and lead to organ failure.

“There’s a high likelihood of infection, so delivering antibiotics through the screw is a big deal for the pediatric neurosurgeons,” she said. “It’s powerful to actually give surgeons tools that lets them treat people through the devices.”

Huffman founded Allumin8 after seeing family members suffer from spinal fusion failures. Her uncle with diabetes had six spinal surgeries that failed due to infection and bone loss, and her cousin, a quadriplegic, experienced repeated spinal fusion surgeries after implanted screws backed out of the bone.

Her father, too, required spinal fusion after experiencing deterioration from cancer-related bone lesions and chemotherapy damage.

Huffman teamed up with the person who would become Allumin8’s chief technology officer, Matthew Shomper, who brought 3D printing expertise to bear, allowing the Allumin8 screw to draw bone marrow stem cells into the hardware.

Huffman said one reason for her success is that the people she partners with recognized her value and took her ideas seriously. That’s no small thing in an industry where women have few seats at the table.

“I’m casually elegant, but I’m funny, and I have a mind like a 13-year-old boy half the time,” she said. “I like to be playful. People assume, because of all of those things, that you don’t know what you’re talking about.”

But Huffman said she’s worked in clinical environments and also in sales, commercialization and executive roles.

“I’m an inventor. I am working with some of the biggest surgeons in the world,” she said. “Now you can’t minimize what I’ve done, because I did it all myself – I didn’t have anyone to get me there.”

According to Elizabeth Hofheinz and Robin Young, writing in Orthopedics This Week, Huffman is someone to watch.

“If we were to bet on any young entrepreneur, Alyssa Huffman would be at the top of the list,” they wrote in an article about the Best Technologies in Spine.

As she readies Allumin8 for Level 2 clearance, Huffman continues to raise capital with a minimum investor buy-in of $10,000. She takes pride in the fact that she got the technology to the FDA at a cost of about $1 million in an industry where $3 million is the bare minimum.

“We do more with less,” she said.

She noted that the goal for Allumin8’s capital raise is $15 million.

The process is helped by the acclaim the company has received, like a 2025 Global Impact Award from Washington University in St. Louis or like recognition of the company’s investment value through the Shanghai, China, Innovation Awards. The company was also awarded Best Technology in Spine in 2024 by Orthopedics This Week.

“We’ve gotten a lot of awards,” Huffman said. “These are things that some random girl that sketched out an idea on a piece of paper in 2009 – you wouldn’t think these things would happen.” 

She said medical technology typically boasts an improvement rate of 1%-3% in outcomes – and this after sometimes investing hundreds of millions of dollars.

“I want a collective goal of outcomes being 25% better,” she said.