Axogen Announces Appointment of Jesse Bishop as Vice President of Regulatory Affairs and Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

Rhea-AI Summary

Axogen (NASDAQ: AXGN), a leader in surgical solutions for peripheral nerve injuries, has appointed Jesse Bishop as Vice President of Regulatory Affairs. Reporting to CEO Michael Dale, Bishop will lead domestic and international regulatory strategies for new product development, market approval, and regulatory initiatives.

Bishop brings over 13 years of leadership experience in regulatory strategy and CMC, CGMP manufacture of cell and gene therapies, having worked at companies including Thermo Fisher Scientific, RGI Medical Manufacturing, and Ology Bioservices. He served in the U.S. Army Special Operations as a Ranger Team Leader and Combat Medic and holds master's degrees in medical sciences and business administration from the University of Florida.

As part of his employment package starting February 3, 2025, Bishop will receive an inducement grant of 45,000 Restricted Stock Units (RSUs) on March 3, 2025. The RSUs will vest over 4 years, with 50% vesting after two years and 25% vesting annually for the following two years.

Positive

• Strategic hire with extensive regulatory experience in biologics and medical devices
• Structured RSU compensation package aligns executive interests with long-term shareholder value

Negative

• 45,000 RSU grant represents potential shareholder dilution

ALACHUA, Fla. and TAMPA, Fla., Feb. 03, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced the appointment of Jesse Bishop as Vice President of Regulatory Affairs.

Mr. Bishop will report to Michael Dale, President, and Chief Executive Officer, and will lead the development and execution of domestic and international regulatory strategies to advance company objectives related to new product development, market approval, market development and other regulatory initiatives.

Mr. Bishop will oversee all facets of Axogen’s regulatory affairs, maintenance of Axogen product registrations, licenses, accreditations and in general all related interactions and relationships with regulatory agencies and associated stakeholders. Additionally, Mr. Bishop will be responsible for working on development of regulatory policy with external groups such as Alliance for Regenerative Medicine (ARM), American Association of Tissue Banks (AATB) and others.

Mr. Bishop brings extensive experience in leading regulatory strategy and CMC, CGMP manufacture of cell and gene therapies, biologics/vaccines, medical devices and combination products. Mr. Bishop has over 13 years of leadership experience in regulatory strategy, planning and execution in companies such as Thermo Fisher Scientific – Viral Vector Services, RGI Medical Manufacturing, Ology Bioservices and Lacerta Therapeutics. He also served in the military as a Ranger Team Leader and Combat Medic within U.S. Army Special Operations.

Mr. Bishop earned his master’s in medical sciences and business administration from the University of Florida.

“We are pleased to welcome Jesse to the Axogen team," said Michael Dale, Chief Executive Officer, and Director, Axogen. "His extensive experience in regulatory strategy and deep understanding of the biologics and medical device sectors will be valuable as we continue to advance our regulatory initiatives and expand our product portfolio.”

Jesse Bishop, Vice President of Regulatory Affairs, said: “I am honored to join Axogen and contribute to advancing the regulatory pathway for peripheral nerve repair technologies."

Notice of Issuance of Inducement Grant

In connection with the commencement of his employment on February 3, 2025, and as a material inducement of employment, Mr. Bishop will be awarded an equity grant on March 3, 2025, consisting of non-qualified equity grant in the form of Restricted Stock Units (RSU) for the grant of 45,000 shares of Axogen, Inc. common stock. The shares representing the RSUs are subject to vesting over 4 years, with 50% vesting after the second year and 25% of the total shares granted vesting every year thereafter for the next two years.  

About Axogen

Axogen (AXGN) is the leading Company focused specifically on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair. Axogen employees are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or transection to peripheral nerves by providing innovative, clinically proven, and economically effective repair solutions for surgeons and health care providers. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain.

Axogen's platform for peripheral nerve repair features a comprehensive portfolio of products that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes Avance^® Nerve Graft, a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second surgical site; Axoguard Nerve Connector^®, a porcine submucosa ECM coaptation aid for tensionless repair of severed peripheral nerves; Axoguard Nerve Protector^®, a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments; Axoguard HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to provide short- and long-term protection for peripheral nerve injuries; and Axoguard Nerve Cap^®, a porcine submucosa ECM product used to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and several other countries.

Investor Contact:
Axogen, Inc.
InvestorRelations@axogeninc.com

FAQ

What are the vesting terms for Jesse Bishop's RSU grant at Axogen (AXGN)?

The 45,000 RSU grant vests over 4 years, with 50% vesting after two years and 25% vesting annually for the following two years, starting from March 3, 2025.

What is Jesse Bishop's role and responsibilities at Axogen (AXGN)?

As Vice President of Regulatory Affairs, Bishop leads domestic and international regulatory strategies for new product development, market approval, and maintains product registrations, licenses, and accreditations.

What is Jesse Bishop's professional background before joining Axogen (AXGN)?

Bishop has over 13 years of leadership experience in regulatory strategy, working at companies like Thermo Fisher Scientific, RGI Medical Manufacturing, and Ology Bioservices, and served in U.S. Army Special Operations.

When does Jesse Bishop start his position at Axogen (AXGN)?

Jesse Bishop begins his position as Vice President of Regulatory Affairs at Axogen on February 3, 2025.