Tenon Medical, Inc.
0001560293falseCA 0001560293 2022-05-31 2022-05-31 0001560293 us-gaap:CommonStockMember 2022-05-31 2022-05-31
 
 
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):
May 31, 2022
 
TENON MEDICAL, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
 
001-41364
 
45-5574718
(State or other jurisdiction
of Incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification Number)
 
104 Cooper Court
Los Gatos, CA
 
95032
(Address of registrant’s principal executive office)
 
(Zip code)
 
(408) 649-5760
(Registrant’s telephone number, including area code)
 
N/A
(Former name or former address, if changed since last report)
 
Check the appropriate box below 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 each exchange on which
registered
Common Stock, par value $0.001 per share
 
TNON
 
The Nasdaq Stock Market LLC
 
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
x
 
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 May
31
, 2022, Tenon Medical, Inc., a Delaware corporation (the “Company”) posted an updated corporate presentation on the Company’s website at
https://www.tenonmed.com/
. A copy of the Corporate Presentation is attached hereto as Exhibit 99.1 and is incorporated by reference into this Item 7.01 of this Current Report on Form 8-K. A copy of the full text of the press release referencing above is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference into this Item 7.01 of this Current Report on Form 8-K.
 
The information contained in Item 7.01 of this Current Report on Form 8-K is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing. 
 
Item 9.01. Financial Statement and Exhibits.
 
(d) Exhibits.
 
Exhibit No.
 
Description
 
 
 


 
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
Date: May
31
, 2022
TENON MEDICAL, INC.
 
 
 
 
 
 
By:
/s/ Steven M. Foster
 
 
Name:
Steven M. Foster
 
 
Title:
Chief Executive Officer and President
 
 

 

Exhibit 99.1

 

Investor Presentation June 2022

 

 

2 Safe Harbor This presentation contains “forward - looking statements,” which are statements related to events, results, activities or developments that Tenon Medical expects, believes or anticipates will or may occur in the future . Forward - looking often contain words such as “intends,” “estimates,” “anticipates,” “hopes,” “projects,” “plans,” “expects,” “seek,” “believes,” "see," “should,” “will,” “would,” “target,” and similar expressions and the negative versions thereof . Such statements are based on Tenon Medical’s experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances, and speak only as of the date made . Forward - looking statements are inherently uncertain and actual results may differ materially from assumptions, estimates or expectations reflected or contained in the forward - looking statements as a result of various factors . For details on the uncertainties that may cause our actual results to be materially different than those expressed in our forward - looking statements, please review our Registration Statement on Form S - 1 (No . 333 - 260931 ) on file with the Securities and Exchange Commission at www . sec . gov , particularly the information contained in the section entitled “Risk Factors” . We undertake no obligation to publicly update or revise any forward - looking statements to reflect new information or future events or otherwise unless required by law .

 

 

• Transformative implant system addressing significant unmet market opportunity • Large / growing underserved market • Designed to produce broad and demonstrable advantages over market competitors: • Known Approach – Away from Neural and Vascular Structures • Optimally Designed Implant • Better Outcomes and Robust Reimbursement • Capital efficient commercialization and go to market strategy • Proven and experienced management team aligned with shareholders 3 Key Highlights FDA Cleared, Reimbursement Secured, Initial Commercial Launch

 

 

4 What Are We Treating? 25% + Of All Low Back Pain (LBP) Sacroiliac (SI) Joint • Last segment of the spine • Connects Sacrum to Ilium Pain That Disrupts Quality of Life

 

 

Global Sacroiliac (SI) Joint Fusion market is estimated to grow to $661M by 2028 . SOURCE: Grand View Research, Inc. • 18% + CAGR Driven By: • Improved Surgical Approaches • Specialized Implant Design • Procedure Safety and Efficiency • Enhanced Physician Reimbursement • Physician Recognition Growing : • Adoption Rates Remain Relatively Low • Physicians Seeking Better Options 5 A Major Untapped Market Opportunity Total Market Estimated to be $2B +

 

 

6 A Better Option for SI Joint Fusion • Optimized surgical approach for SI Joint Fusion • A specifically designed titanium implant & delivery tools for surgery through a mini - open posterior/inferior approach • Bridges the sacrum & the ilium to stabilize the joint • Implant filled with autologous bone • Single implant surgery: “One and Done” The Catamaran™ SI Joint Fusion System

 

 

7 Optimized Surgical Approach SI - Bone / Other Lateral Catamaran™ Significant Tissue Disruption Substantial Post - Op Pain No Direct Visualization Trajectory Towards Neural and Vascular Structures Minimal Tissue Disruption Minor Post - Op Pain Known Approach (same as injection) with Visualization Trajectory Away from Neural and Vascular Structures

 

 

8 Optimized Implant Design SI - Bone / Other Lateral Catamaran™ Triangular Rods, Cages or Screws limited in function No use of Bone Graft Material critical for Fusion Multiple devices required to fixate the joint No joint preparation known to promote fusion Specifically designed implant to span the joint Designed to incorporate Bone Graft Single implant One and Done technique Direct visualization enables joint preparation Anterior Chamfered leading edge for ease of insertion Posterior Numerous fenestration to facilitate complete bridging fusion Leading edge of bridge serves as osteotome

 

 

9 Patient Outcomes – The Catamaran™ System Tenon CATAMARAN ® Published Results 58 - 74% 88% 1) Initial study with N=18 2) Schmidt GL, Bologna M, Schorr R.Orthop Surg. 2020 Dec 7. [ Epub ahead of print]. Significant and Sustained Reduction in SIJ Pain (VAS) 1,2 Early clinical experience has shown Catamaran™ has the potential to deliver significant & sustained reduction in SI Joint Pain, as well as: • Minimal Blood Loss • Minimized Radiation Exposure • Reduced Post - Op Pain • Rapid Reduction in Pain Medications • Insertion Pathway away from Neural and Vascular Structures • Known Approach for Physicians • Ideally Suited for ASC / Outpatient

 

 

10 Established Reimbursement & Coding Flexibility 58 - 74% 88% SI Joint Arthrodesis Coding Summary Existing ICD - 10 Codes (Facilities) Existing CPT Codes (Provider) Medicare averages as reported. Non - Medicare payers have their own methodology for paying providers. Licensed Coders and Reimbursement Specialist Expert Assistance with Claims / Pre - Auth / Appeals Benefit Verification Current on Dynamic Reimbursement Policy Environment

 

 

11 Compelling Benefits to all Stakeholders Physicians Hospitals Payor Patients • An established procedure with an increased revenue stream through facility payments • Access a large pool of new patients who do not qualify for minimally invasive SIJ reimbursement • Competitive differentiation • More efficient single - implant procedure • High procedural success • Emotionally rewarding • Radiographic confirmation of fusion • Reimbursement Flexibility • Proven diagnostic protocol to ensure patient will likely benefit from the procedure • Fewer complications quicker recovery • May reduce overall and long - term patient cost to payors • True same day / outpatient (optimized for ASC setting) • Safe and efficient outpatient procedure • Reduced post - op pain • Reduced revision requirements • Robust Titanium implant

 

 

12 Strong IP Position Six issued and eight pending patents for a broad range of claims including a posterior / inferior approach to Sacroiliac Joint Fusion Claims directed to systems and methods Additional patents pending OUS Developing new cases to expand claims

 

 

13 Our Go to Market Strategy Targeting • High Adoption SI Fusion Markets / Accounts • Physicians Previously Trained on SI • Build Referral Bridge Between Pain and Surgery Physicians • Established Physician Faculty • Established regional training centers (logistical optimization) • Virtual • Model Based • Cadaveric Training Support • Reimbursement Hotline support for coder/billers and physicians • Facility VAT and Access Requirements • Pricing / Contracting Advocacy • Patient – Strong online marketing (SEO, video, social media) • Referral – Target strong physician relationships The Key Driver to Sustained Growth is the Addition of New / High Potential Centers

 

 

14 Our Go to Market Strategy Training Initial Commercialization Step 2 Expansion Step 3 Expansion Step 4 Expansion P1 High Adoption Markets - Training Phase 1 Support and Advocacy P2 High Adoption Markets - Training

 

 

15 National Distribution 58 - 74% 88% Tom Mitchell President and CEO SpineSource is Tenon’s Exclusive National Distributor with 30+ years of orthopedic sales experience and 700+ independent sales personnel spanning the US • Commission based agreement (not a stocking distributor) • Tenon Medical Quality System, Invoicing, Pricing Customer Service Loaner / Logistics Trade - Show / Event Contracting / Pricing More Than Just A Distributor……

 

 

16 SpineSource Partnership Competitive Advantage 58 - 74% 88% Tom Mitchell President and CEO • Immediate Nationwide Access to Skilled and Knowledgeable Distributors • Cost Effective Approach vs. Tenon Hiring Internal Personnel To Handle Many Functions • Competitors Spending 90%+ on Sales and Marketing. SpineSource at 60% and Grows in Line with Revenue • Tenon has Flexibility to Add Direct Personnel After 2 Year Window – Further Improving Overall Operating Expenses Why A National Distributor? SPEED Messaging Across the Country on Day 1 Case Coverage Local Relationships / Local Intel Experienced Reps SCALE 50 States on Day 1 Virtual Messaging and Training Targeting Critical to Success EXPENSE MANAGEMENT Fixed Commission Rate Commission Growth Matches Sales Growth Leading Competitor Still Spending 100% + of Revenue on Sales and Marketing after 12 years on the market

 

 

17 Tenon Medical – 2021 and Early 2022 58 - 74% 88% Tenon 2021 Accomplishments • Physician Advisors Identified • Finalized Instrumentation and Technique Refinement • Secured Supply Chain to Meet 2022 Demand • Hired Key Personnel to support 2022 Plan • Refined Physician Training Program • National Distributor and Supplier Audit • Hosted 5 Physician Training Events – excellent feedback • Implemented State of the Art eQMS • Launched tenonmed.com • Defined Full Marketing Package – nearing completion Finalized Commercial Ready Product and First Cases Completed

 

 

18 Experienced Management Team 58 - 74% 88% Track Record of Building Successful MedTech Companies Richard Ferrari, Founder, Executive Chairman Steven Foster President and CEO Steve Van Dick Executive VP and CFO Richard Ginn Founder, CTO

 

 

19 Investment Rational FDA Cleared, Reimbursement Secured, Commercial Stage • Near Term Revenue – Launching Q1, 2022 • SI Joint Market Growing at 18% CAGR • Clear Opportunity and Need for a Better Way • Optimized Approach • Optimized Implant • Authentic and Demonstrable Fusion • Procedure Efficiency and Enhanced Physician Reimbursement • Talented Management Team With Clear Track Record of Success

 

 

20 Key Takeaways Catamaran™ SI Fusion System Delivers: • Radiographic Confirmation of Fusion • Fixation with enhanced surface area spanning the joint A Picture is Worth a Thousand Words

 

 

21 Contact Us 58 - 74% 88% Tenon Medical, Inc. 104 Cooper Court Los Gatos, CA 95032 (408) 649 - 5760 www.tenonmed.com Investor Relations Contact: Shannon Devine Managing Director 203 - 741 - 8811 [email protected]

 

 

 

Exhibit 99.2

 

Tenon Medical, Inc. Announces the Posting of New Corporate Presentation via the Investor Relations Website

 

Los Gatos, CA, May 31, 2022 - Tenon Medical, Inc. (“Tenon” or the “Company”), a medical device company that has developed a proprietary, U.S. Food and Drug Administration (“FDA”) cleared surgical implant system for sacroiliac joint (“SI Joint”) fixation/fusion surgery, today announced the Company has posted its new corporate presentation accessible via the Company’s Investor Relations website at http://ir.tenonmed.com/.

 

About Tenon Medical, Inc.

 

Tenon Medical, Inc., a medical device company formed in 2012, has developed a proprietary, FDA cleared surgical implant system, which is designed to optimize SI-Joint fixation / fusion surgery and corresponding outcomes. Tenon is preparing a national launch of this system to address the greatly underserved market opportunity that exists in this space. For more information, please visit https://www.tenonmed.com/.

 

Investor Contact

Shannon Devine

MZ North America

203-741-8811

[email protected]