The St. Louis-based startup Allumin8 has managed to achieve something no other medical device company ever has: clearance from the U.S. Food and Drug Administration for a type of spinal screw that’s produced through additive manufacturing.
Allumin8 CEO Alyssa Huffman explains it’s fundamentally different from subtractive manufacturing, where a piece of metal would be whittled down into the shape of a screw. By contrast, Huffman says Allumin8’s produces its A8 INTEGR8 Porous Pedicle Screw System with a proprietary 3D printing process.
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“Just because it looks the same doesn’t mean it functions the same, and that’s why the FDA puts such tight guidelines on and really hones in on understanding the additive manufactured products,” she says. “Companies have been working to try and produce this in a 5.5-millimeter diameter screw for literal decades.”
She says the clearance means Allumin8’s screws can be used for any patient needing a spinal fusion, where surgeons insert screws into vertebrae, then fasten rods to those screws to provide structure while the vertebrae fuse and heal as one bone. It’s a therapy used to correct issues in the spine, making it more stable and reducing pain.
But Huffman explains the existing medical hardware of this nature can loosen in patients who don’t have good bone structure, leading to repeat surgeries, particularly for spine fusions. She says about one in four screws used in spinal fusions end up having this issue, which can negate the whole goal of the surgery. Her company’s newly approved screw aims to fix that by having a porous surface that mimics the natural texture of bone.
“Bone likes bony patterns, and when you have those bony patterns built into your hardware, research shows that after you put the hardware in, you create stronger, better, harder, faster bone surrounding the screw,” she says.
Huffman says her company needed to demonstrate its screw could perform just as well as other spinal screws that are cleared for use. That meant showing Allumin8’s screw could withstand millions of cycles of flexion and extension, that it wouldn’t break inside a bone and become unable to be removed, and, critically, that if the screw did break, that it did so in the same way every time.
“Not only did we meet [those testing parameters], we exceeded them far beyond our expectations of what we could deliver,” Huffman says. “That was a really profoundly impactful moment, recognizing how well we did and what type of room we have to grow [our] future products as well.”
Huffman says she has her eye on developing a screw that could eventually diagnose diseases or deliver medication where it’s placed in the body. She says the next FDA submission will be for a way to draw bone marrow stem cells into the company’s hardware.
“Therapeutic hardware is a new way for orthopedics and spine [doctors] to think about how implants work with the body, not just for biomechanical stability,” Huffman says. “That’s the overarching goal of the company is to treat the disease states.”
The breakthrough with the FDA for the spinal screw has caught the attention of the medical industry, Huffman adds, with a handful of companies already reaching out to license the product. Allumin8 is already working on contracts and has placed orders for inventory.
Huffman says she’s considering a few options for the best way to commercialize the Arch Grants-backed company’s innovation over the long term. There’s the “top tier strategic manufacturers” looking to license the screw, which would “give us the global commercialization and help achieve our goal of reducing the [spinal fusion] reoperation rate and gain mass adoption,” she says.
But there is also the opportunity to work with a collection of smaller companies who would commercialize the product with Allumin8, or the route of “raising a bunch of capital and doing it ourselves,” Huffman says. She admits she wasn’t prepared to have this much attention and plans to have a full commercialization plan in place by the end of the month.
“We have a lot of suitors, which is exciting because we didn’t have any suitors,” Huffman says. “We had a handful that were in due diligence but they weren’t taking us to the dance, so to speak. We have raised $2.2 million and we may not be raising much more.”
Whichever direction Huffman decides to go, she says the goal will be to work with partner companies who will provide the data to show that the revision rate for spinal fusions is going down because of her product.
“This is a passion project; this was developed for my family members,” she says. “This is not a money-making scheme. The money will come if we help people.”
