Avance is an acellular nerve scaffold for the treatment of adult and pediatric patients aged 1 month or older with sensory, mixed, and motor peripheral nerve discontinuities.

Read more about Axogen Announces FDA Approval of Biologics License Application for AVANCE®.

“I am proud of the significant progress our team has made towards the regulatory transition of Avance from a tissue to a biologic,” said Michael Dale, CEO and Director of Axogen, Inc. “We will continue to collaborate closely with the FDA as they review our application.”

Read more about Axogen Completes Submission of Biologics License Application to U.S. Food and Drug Administration for Avance Nerve Graft®.

Avive+ is intended for use as a soft tissue barrier and is a resorbable, multi-layer amniotic membrane allograft that provides temporary protection and tissue separation during the critical phase of peripheral nerve healing.

“Product innovation is integral to our mission at Axogen,” stated Karen Zaderej, Chairman, CEO, and President of Axogen, which incubated at UF Innovate | Accelerate @ Sid Martin Biotech in Alachua. “With the introduction of Avive+ Soft Tissue Matrix, we are excited to enhance our comprehensive solutions for nerve protection and address a significant need for patients with compression or non-transected nerve injuries.”

Axogen, Inc. Announces Full Launch of Avive+ Soft Tissue Matrix.

“We are excited to expand our offering in nerve protection with the introduction of this resorbable barrier to support the critical phases of healing for nerve injuries,” said Karen Zaderej, chairman, CEO, and president. “We are pleased with initial surgeon feedback and look forward to making Avive+ Soft Tissue Matrix available to more surgeons during our national launch, which is anticipated in the second quarter of 2024.”

Avive+ Soft Tissue Matrix is a resorbable, multi-layer, placenta-based allograft that provides temporary protection and tissue separation during the critical phase of healing for nerves. Avive+ is processed and distributed as a 361 tissue product in accordance with U.S. Food and Drug Administration (FDA) Good Tissue Practices under 21 CFR part 1271 regulations.

AxoGen Announces First Surgical Implants of Avive+ Soft Tissue Matrix.

Founded in 2002 by John Engels and Jamie Grooms, Axogen was a pioneer in the startup space and helped launch the entrepreneurial hub that Gainesville is today. Through innovative nerve repair technology and investment in other health and biotech startups, Axogen’s partnership with the University of Florida has improved the lives of patients and fostered a spirit of innovation.

“We are thrilled to welcome Ms. Zaderej to our Board of Directors,” said Nancy Lurker, Chief Executive Officer at EyePoint Pharmaceuticals. “Karen’s passion for discovering innovative solutions in medicine, coupled with her track record of successful drug and medical device development and commercial leadership make her a compelling addition to the Board. We look forward to her valuable insight as we continue to advance the clinical development of our lead pipeline asset, EYP-1901, for multiple ophthalmic indications and our commercial products, based on our proprietary and proven Durasert^® technology for sustained intraocular drug delivery.”

RECON reached its enrollment target of 220 subjects in July 2020. The study remains on schedule with a top line study data read-out expected in the second quarter of 2022, followed by filing of the BLA submission in 2023. RECON compares Avance Nerve Graft to manufactured conduits in digital nerve injuries with a primary endpoint of recovery of static two-point discrimination, a measure of sensation, and secondary endpoints for quality of life and subject satisfaction. The BLA will transition Avance Nerve Graft from a human tissue product to a biological product.

“We are pleased to have reached this milestone and thank the study investigators and research teams for their dedication and commitment to this landmark study,” commented Karen Zaderej, chairman, CEO, and president of Axogen. “The RECON study is designed to provide Level 1 clinical data for our BLA, and will provide additional evidence for surgeons in their clinical decision making for the repair of peripheral nerve injuries.”

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Axogen, which works with hospitals in Tampa and St. Pete, has its second HQ in the Tampa Heights building where it currently occupies two floors, the fifth and the sixth, that overlook the Hillsborough River.

“We have the fourth floor, but we haven’t put employees there. Covid gave us a great opportunity to create a large meeting space. We have this 200-foot screen and we can set up these tables where people can be distanced,” Pete Mariani told the St. Pete Catalyst while describing how his team watched the Stanley Cup boat parade from inside the building.

Axogen was still in the process of building out its space when the pandemic took hold of the region. The firm had been temporarily using a facility in the Tampa Bay Times building while awaiting completion.

Axogen eventually moved into the building last fall; however, when the pandemic ensued, Axogen deployed a hybrid work-from-home policy for its employees in Tampa and at its Alachua campus, which is where the company was founded and has labs.

“When you take a building with three floors that was meant for 350 people, and you only have 70 people at the time, you have the ability to spread out,” Mariani said.

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But they’ve also done okay on the real estate front.

Three years ago, the company, founded in Gainesville, signed a 75,000-square-foot lease for a second headquarters at Tampa’s Heights Union, which was at that point still under construction — as were office buildings in developments like Water Street Tampa and Midtown Tampa. Since then, many of those office buildings have opened up and signed even more tenants. Heights Union, for example, recently signed pharmaceutical giant Pfizer to a lease of more than 100,000 square feet.

“We were trying to think about what attracts talent,” CEO Karen Zaderej said of Axogen’s headquarters search. “We wanted the work environment to be that work-live-play environment, where you can pop in and grab food easily at a restaurant, you can go for a run or a walk, you can go work out. Those are the things that we were looking for. We just felt the Heights offered all of those things.”

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