Axogen launches nerve repair products for trauma, cancer patients

Tampa-based Axogen, a life science company developing products for nerve repair, is readying to launch new medical devices and get them into the hands of surgeons. 

Inside Axogen’s 75,000-square-foot corporate headquarters overlooking the Hillsborough River, the company is testing and commercializing products to address two primary areas of the market for peripheral nerve regeneration and repair: Emergent procedures, which are a result of traditional trauma cases and nerve damage discovered through hospital settings, and scheduled or elective procedures. 

Axogen’s lobby in the Tampa Heights Union building. 

Emergent trauma was the primary category Axogen initially specialized in; however, over the past several years, Axogen has introduced several new nerve repair applications that utilize its Avance and Axoguard product lines. 

Patients of scheduled procedures are seeking relief from a condition caused by a nerve defect or surgical procedure. These include breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. 

In the second quarter, Axogen’s revenue was $38.2 million. The company, which works directly with surgeons, estimated that scheduled non-trauma procedures represented roughly half of the generated revenue. 

“This [scheduled procedures] was a growing area pre-pandemic and may be considered elective, but it is needed especially for cancer patients. We focus on developing products to serve women with breast cancer or who are genetically predisposed to it and decide to have a mastectomy,” Axogen CEO Karen Zaderej said. “Traditionally, nerves aren’t always considered when they have breast reconstruction surgery. It’s hard to feel normal when they hug their children and feel numbness across their chest. We want to improve their quality of life and bring them back to feeling like themselves.” 

Axogen’s Resensation product and surgical technique make it possible to connect the nerves in the newly restored breast. It’s performed simultaneously with autologous reconstruction surgery, which involves using a woman’s own tissue to recreate the breast.

“Getting a good understanding of patients is a lot of work that we’ve done over the last five years to help build out these cases. The cases and data were up and down during the pandemic [due to postponed procedures],” Zaderej said. “What we hear over and over from women is, ‘I wish I had known before my surgery that I would be numb.’ We want them to be informed and at least not have regret. The first priority is to live, but this is pretty high up on the list.” 

Zaderej explained how cancer survivors may have been informed about the nerve issues that can occur after a mastectomy, but the patient may be too overwhelmed to absorb the information. 

Additionally, Axogen is focused on creating solutions for people living with chronic pain. 

“One of the causes of chronic pain is an anomaly in the nerve and not knowing if it’s nerve-base so people will get pain medications and stimulator trying to do something to manage the pain to get back their quality of life. For many patients, it’s actually solvable. You don’t need to manage the pain – you need to eliminate it. We think there’s an opportunity to make patients aware that there’s a surgical technique to take out this ‘bad section’ of nerves,” Zaderej said. 

Nerve central: Leveraging innovation 

The company is introducing a new product called Axoguard HA+ Nerve Protector, which will provide short- and long-term protection for peripheral nerve injuries. 

“When you have nerves injured from trauma, it can be painful. Nerves can stick to the tissue, which leads to long-term pain because your nerves need to glide. The surgical procedure entails freeing up any tissue attachments, but then the surgeon needs to wrap it to protect it from soft tissue attachments in the future. We’ve developed a protection product with a hyaluronate-alginate gel that allows the tissue to glide freely,” Zaderej said. 

The company received federal clearance for the Axoguard HA + Nerve Protector in April and has been testing the device among its peer group. 

“We continue to invest in innovation and will launch another protection product in the first quarter of next year,” Zaderej said. 

The company has a manufacturing facility outside of Dayton, Ohio. Axogen also has contracts with manufacturers in Indiana. 

Axogen’s executive team opened the Tampa hub several years ago to attract robust talent. 

“The Alachua (County) area is a great college town, but getting people from Boston and those areas to move to Gainesville became increasingly challenging. With the Tampa site, we haven’t any issues. People love it,” Zaderej said. 

Axogen’s Alachua site is still operating with over 50 employees.