Axogen plans prostate nerve launch in $754M market
Axogen estimates a $754 million addressable market and reports clinical experience; reimbursement and surgeon adoption are listed among forward-looking risks.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Form Type
8-K
Rhea-AI Filing Summary
Axogen, Inc. (AXGN) described its decision to move forward with a prostate-market launch of nerve reconstruction using Avance® acellular nerve allograft. The presentation estimates a $754 million total addressable market and lists approximately 110,000 cases per year and a weighted ASP of about $7,000 per procedure.
Axogen reports more than 220 patients reconstructed, including 117 with at least six months of follow-up; it says about 80% had better-than-expected erectile function and more than 95% had return of continence. Survey results include 56% of surveyed hospital administrators saying they would support adoption before broad coverage. The presentation identifies clinical outcomes, regulatory processes, reimbursement, surgeon adoption and market acceptance as factors that could affect forward-looking statements.
8-K Event Classification
2 items: 7.01, 9.01
2 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
Total addressable market: $754 million
Cases per year: ~110,000 cases per year
Weighted ASP: ~$7,000 per procedure
+4 more
7 metrics
Total addressable market
$754 million
Estimate for the prostate nerve reconstruction market
Cases per year
~110,000 cases per year
Prostate market presentation
Weighted ASP
~$7,000 per procedure
Prostate market presentation
Patients reconstructed
>220 patients
Clinical experience to date with Avance
Patients with follow-up
117 patients
At least six months of follow-up
Better-than-expected erectile function
~80%
Patients in the reported clinical experience
Return of continence
>95%
Patients in the reported clinical experience
Key Terms
acellular nerve allograft-arwx, Robotic-Assisted Radical Prostatectomies, SHIM Scores ≥15, Weighted ASP Per Procedure
4 terms
acellular nerve allograft-arwx medical
"Avance® (acellular nerve allograft-arwx)"
Robotic-Assisted Radical Prostatectomies medical
"Robotic-Assisted Radical Prostatectomies require complete removal"
SHIM Scores ≥15 medical
"SHIM Scores ≥15 for Historic Reference Controls and Reconstruction Patients"
Weighted ASP Per Procedure financial
"Weighted ASP Per Procedure ~$7,000"
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What market opportunity did AXGN identify for prostate nerve reconstruction?
Axogen estimates the total addressable market at $754 million. The presentation separately lists approximately 110,000 cases per year and a weighted ASP of about $7,000 per procedure.
What clinical experience did AXGN report for prostate nerve reconstruction?
Axogen reports more than 220 patients reconstructed, including 117 with at least six months of follow-up. It says about 80% had better-than-expected erectile function and more than 95% had return of continence.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
Current Report
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 9, 2026
(Exact Name of Registrant as Specified in Charter)
(State or Other Jurisdiction of
Incorporation or Organization)
(Commission File Number)
(I.R.S. Employer Identification No.)
(Address of principal executive offices)
(Zip Code)
(386 ) 462-6800
(Registrant's telephone number, including area code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e- 4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of exchange on which registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure
On November 9, 2026, Axogen, Inc. (the “Company”) posted a corporate presentation to its website at https://ir.axogeninc.com/news-events. The Company may use the corporate presentation from time to time in conversation with analysts, investors, and others. A copy of the presentation is furnished as Exhibit 99.1.
The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section and shall not be deemed incorporated by reference into any filing under the Securities Act or Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
Exhibit No. | Description | ||||
| 99.1 | Axogen Inc. Corporate Presentation, dated November 9, 2026 | ||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | ||||
SIGNATURES
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AXOGEN, INC. | ||||||||
Dated: November 9, 2026 | By: | /s/ Marc Began | ||||||
| Marc Began | ||||||||
| Executive Vice President, General Counsel and Chief Compliance Officer | ||||||||
Prostate Nerve Reconstruction Investor Event November 9, 2026
Forward-looking Statements 2 This presentation contains “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995, which are statements that are not historical facts and relate to future conditions, events, or results. These statements are based on management's current expectations or predictions of future conditions, events, or results based on various assumptions and management's estimates of trends and economic factors in the markets in which we are active, as well as our business plans. Words such as “expects,” “anticipates,” “objectives,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “projects,” “forecasts,” “continue,” “may,” “should,” “will,” “goals,” and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements include, but are not limited to, statements related to: clinical development activities, our potential expansion into prostate applications, market development opportunities, our strategic investments, training and education initiatives, reimbursement and market access efforts, research and development activities, and market acceptance and adoption. Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, risks related to product development and product potential, clinical outcomes, regulatory processes, reimbursement and market access, surgeon adoption, market acceptance, and data validation, as well as those risk factors described under Part I, Item 1A., “Risk Factors,” of our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, and other filings made from time to time with the Securities and Exchange Commission. Forward-looking statements are not a guarantee of future performance, and actual results may differ materially from those projected. Forward-looking statements speak only as of the date they are made and, except as required by applicable law, we assume no responsibility to publicly update or revise any forward-looking statements.
3 Michael Dale President and Chief Executive Officer
To restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. Our Mission 4
Our Decision to Move Forward with a Prostate Market Launch Market Opportunity 5 Surgical Technique with Avance ® (acellular nerve allograft-arwx) Clinical ImpactClinical Need Is the need real and meaningful to patients? Is market opportunity substantial enough to warrant allocating people and capital? Can we develop a scalable standardized technique? Do clinical outcomes demonstrate a positive benefit-to-risk signal?
6 Jens Kemp Chief Marketing Officer
Erectile Dysfunction and Incontinence are Significant Side Effects of Prostatectomy with Substantial Quality of Life Impact 7 ~14%-90% of Robotic-Assisted Radical Prostatectomies require complete removal of one or both nerve bundles with significant impact to recovery2 ~40% Recovery of erectile function can be highly variable post robotic prostatectomy1 1. Tillier CN et al. Support Care Cancer. 2024. 2. FSI-Axogen Market Research. 2026.
8 Patients Expect Prostate Cancer Control Without Sacrificing Quality of Life 87% Changes in erectile function affected quality of life 95% Doctors should do everything possible to preserve or restore erectile function 93% Quality of life is as important as cancer control 82% Avoid or delay treatment because of concern about erectile dysfunction or incontinence Source: FSI-Axogen Patient Survey Findings. 2026.
9 Patient Intent Suggests Access to Nerve Reconstruction Would Influence the Care Pathway 78% of radiation patients surveyed would have been more likely to choose surgery 76% of active surveillance patients surveyed would have chosen surgery 88% Would ask their surgeon about nerve reconstruction 87% Would switch surgeons 81% Would switch hospitals 77% Would pay out of pocket Source: Inspired Health Patient Survey Report,2026, FSI-Axogen Patient Survey Findings. 2026.
Hospitals Indicate Pre-reimbursement Pathway is Possible 80% Meaningful improvement in ED recovery can justify pre-coverage adoption 84% Rated improvement in erectile function recovery as very or extremely important 56% Would support adoption before broad coverage 87% Of urology administrators rate an erectile-function recovery benefit as important Source: FSI-Axogen Hospital Administrator Survey Findings. 2026.
Total Addressable Market 11 Active Surveillance Radiation Therapy EBRT Focal/Ablative therapies Surgical Therapy RARP Robotic Assisted Prostatectomy ~110,000 cases per year (~66k | ~60%) Nerve sparing Unilateral non- sparing (~22k | ~20%) Bilateral non-sparing (~22k | ~20%) Nerve Protection Nerve Protection & Reconstruction Nerve Reconstruction No nerve excision One side excision Both sides excision Weighted ASP Per Procedure ~$7,000 TAM $754m Market Expansion Growth Drivers o U.S. prostate cancer diagnoses have been increasing approximately 3% annually, expanding the underlying eligible patient treatment population o Converting patients from other treatments such as radiation to surgery o Earlier conversion of patients on active surveillance to surgery o Use of nerve grafting in nerve sparing procedures with partial resection
12 Erick DeVinney Chief Scientific Officer
COAPT A Nerve Reconstruction Technique Designed for Robotic Workflow 13 Locate proximal and distal recipient targetsIDENTIFY Determine the nerve deficit lengthMEASURE Thaw, size, and trim graft as needed PREPARE Position and suture both the distal and proximal ends Inspect alignment, tension and fixation CONFIRM Image courtesy of Dr. R. Mordkin 1 2 3 4 5 Cavernous Nerve Reconstruction Technique
Clinical Experience to Date 14 At 6 months . >220 Patients reconstructed with Avance® 117 Patients treated with at least six months of follow-up 86 Unilateral reconstruction 31 Bilateral reconstruction ~80% Of patients had better than expected erectile function >95% Of patients had return of continence 15 Clinical sites 15 Surgeons Clinical Experience Study
Shu et al., Findings: Recovery of Erectile Function Was Higher Following Nerve Reconstruction Than in Published Historical Controls 15Data Courtesy of Tung Shu MD, Vanguard Urologic Institute, Houston TX 48.5% 80.0% 4.9% 60.0% 0% 20% 40% 60% 80% 100% Historical Control: Unilateral Non- Reconstructed Unilateral Allograft Reconstruction Historical Control: Bilateral Non- Reconstructed Bilateral Allograft Reconstruction P at ie nt s A ch ie vi ng E re ct ile F un ct io n (% ) SHIM Scores ≥15 for Historic Reference Controls and Reconstruction Patients 1. Krishnan R, et al., Erectile function recovery in patients after non-nerve sparing radical prostatectomy. Andrology. 2014. 2. Zorn KC et al., Long-term functional and oncological outcomes of patients undergoing sural nerve interposition grafting during robot-assisted laparoscopic radical prostatectomy. J Endourol. 2008. 3. Borchers H et al., Erectile function after non-nerve-sparing radical prostatectomy: fact or fiction? Urol Int. 2006. 4. di Giovanni A., Erectile Dysfunction Treatment Outcomes Following Bilateral Non-Nerve- Sparing Robot-Assisted Radical Prostatectomy. JSM Sexual Med 2026. 1,2 1,3,4 38 Patients reconstructed with Avance® 25 Unilateral reconstruction 13 Bilateral reconstruction Patients with Subjective Assessment of Erectile Function Positive Response Rate 80% 62% B i l a te r a l A l l o g ra f t R e c o n s t ru c t i o n U n i l a t e ra l A l l o g ra f t R e c o n s t ru c t i o n P o s i t iv e R e s p o n s e R a t e 62% (n=13)80% (n=25) P a t i e n t S u b j e c t i v e A s s e ssm e n t o f A c h i e v i n g E r e c t i l e F u n c t i o n 60% (n=10)80% (n=20) Q u a n t i t a t i v e S H I M S c o r e ≥ 1 5 Unilateral Non-Reconstructed Historical Control Weighted Mean: 48.5% (Range: 33-56%; N=426) Bilateral Non-Reconstructed Historical Control Weighted Mean: 4.9% (Range: 1.6-13% N=467)
Dr. David I. Lee, MD Professor of Clinical Urology – University of California, Irvine EDUCATION • MD – Loma Linda University School of Medicine (1995) • Intern in General Surgery – Thomas Jefferson University Hospital (1995-1996) • Resident in General Surgery – Thomas Jefferson University Hospital (1996-1997) • Resident in Urology – Thomas Jefferson University Hospital (1997-2001) • Minimally Invasive Urology Fellow – Washington University (2001-2002) • Endourology Fellow – University of California Irvine (2002-2003) CURRENT APPOINTMENTS • Professor of Clinical Urology - University of California, Irvine (2021 – Present) • Director of Comprehensive Prostate Cancer Program – UCI Health (2021 – Present) • Vice Chair of the Department of Urology – University of California, Irvine (2023 – Present) • Board Member, Han-Eol (2005 – Present) PROFESSIONAL SOCIETY INVOLVEMENT • American Urological Association • Endourological Society • Society of Urologic Robotic Surgery • American Medical Association • Society of Laparoendoscopic Surgeons • Society of Urologic Oncology • Society of Robotic Surgery 16
Q&A 17 President and Chief Executive Officer Michael Dale Chief Marketing Officer Jens Kemp Chief Scientific Officer Erick DeVinney Chief Financial Officer Lindsey Hartley VP, Global Health Economics, Reimbursement & Policy Rick Ditto Professor of Clinical Urology – University of California, Irvine Dr. David I. Lee, MD
Thank you © 2026 Axogen Corporation. All rights reserved. The stylized "a" logo is a registered trademark of Axogen Corporation.