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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): March 3, 2025

 

ORCHESTRA BIOMED HOLDINGS, INC.
(Exact name of registrant as specified in its charter)

 

Delaware
(State or other jurisdiction
of incorporation)
001-39421
(Commission
File Number)
92-2038755
(IRS Employer
Identification No.)

150 Union Square Drive
New Hope, Pennsylvania 18938
(Address of principal executive offices, including zip code)

Registrant’s telephone number, including area code: (215) 862-5797

(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:

 

¨ 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 $0.0001 per share OBIO The Nasdaq Global Market

 

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.

 

A copy of a slide presentation that Orchestra BioMed Holdings, Inc. (the “Company”) uses at investor and industry conferences and presentations is attached to this Current Report on Form 8-K (“Current Report”) as Exhibit 99.1 and is incorporated herein solely for purposes of this Item 7.01 disclosure. Additionally, the Company has posted the slide presentation on its website at https://investors.orchestrabiomed.com under the Investor Relations section.

 

The information in Item 7.01 of this Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section. The information in Item 7.01 of this Current Report, including Exhibit 99.1, shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in any such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit
Number

 

Description

99.1   Investor Presentation.
104   Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

 

2 


 

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.

 

  ORCHESTRA BIOMED HOLDINGS, INC.
   
  By: /s/ Andrew Taylor
  Name: Andrew Taylor
  Title: Chief Financial Officer
   
Date: March 3, 2025  

 

3 

 

EX-99.1 2 tm258008d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 


KƌĐŚĞƐƚƌĂ ŝŽDĞĚ ŽƌƉŽƌĂƚĞ WƌĞƐĞŶƚĂƚŝŽŶ Y ϭϮϬϮϱ ͮŽƌƉŽƌĂƚĞWƌĞƐĞŶƚĂƚŝŽŶY ϭϮϬϮϱ Ϯ Forward - Looking Statements This presentation has been prepared for informational purposes only from information supplied by Orchestra BioMed Holdings, Inc . , referred to herein as “we,” “our,” “Orchestra BioMed,” and “the Company,” and from third - party sources indicated herein . Such third - party information has not been independently verified . Orchestra BioMed makes no representation or warranty, expressed or implied, as to the accuracy or completeness of such information . Certain statements included in this document that are not historical facts are forward - looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995 . Forward - looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters . These forward - looking statements include, but are not limited to, statements relating to the potential safety and efficacy of our product candidates, the initiation, enrollment and timing of our planned pivotal trials and reporting of top - line results, expected market sizes for our product candidates, the ability of our partnerships to accelerate clinical development, and our estimated future financial performance and financial position . These statements are based on various assumptions, whether or not identified in this document, and on the current expectations of the Company’s management and are not predictions of actual performance . These forward - looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability . Actual events and circumstances are difficult or impossible to predict and may differ from assumptions . Many actual events and circumstances are beyond the control of the Company . These forward - looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions ; risks related to regulatory approval of the Company’s product candidates ; the timing of, and the Company’s ability to achieve expected regulatory and business milestones ; the impact of competitive products and product candidates ; and the risk factors discussed under the heading “Item 1 A . Risk Factors” in the Company’s annual report on Form 10 - K filed with the U . S . Securities and Exchange Commission on March 27 , 2024 as updated by any risk factors disclosed under the heading “Item 1 A . Risk Factors” in the Company’s subsequently filed quarterly reports on Form 10 - Q . The Company operates in a very competitive and rapidly changing environment . New risks emerge from time to time . Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward - looking statements, which only speak as of the date of this presentation . The Company does not plan and undertakes no obligation to update any of the forward - looking statements made herein, except as required by law .

 


| Corporate Presentation Q1 2025 3 KƌĐŚĞƐƚƌĂŝŽDĞĚdžĞĐƵƚŝǀĞKǀĞƌǀŝĞǁ WĂƌƚŶĞƌƐŚŝƉ Ͳ ŶĂďůĞĚƵƐŝŶĞƐƐDŽĚĞůĞƐŝŐŶĞĚƚŽ ĐĐĞůĞƌĂƚĞ/ŶŶŽǀĂƚŝŽŶƚŽWĂƚŝĞŶƚƐΘzŝĞůĚdžĐĞƉƚŝŽŶĂů&ƵƚƵƌĞWƌŽĨŝƚĂďŝůŝƚLJ Ψ ϭϬ ĂŶŶƵĂůŚLJƉĞƌƚĞŶƐŝŽŶ ƚĂƌŐĞƚ ŵĂƌŬĞƚ ^ ƚĂƚŝƐƚŝĐĂůůLJ ƐŝŐŶŝĨŝĐĂŶƚ ĞĨĨŝĐĂĐLJĚĂƚĂĨƌŽŵ ĚŽƵďůĞ Ͳ ďůŝŶĚ͕ƌĂŶĚŽŵŝnjĞĚƉŝůŽƚƐƚƵĚLJ <dŐůŽďĂůƉŝǀŽƚĂůƐƚƵĚLJ ĞŶƌŽůůŵĞŶƚƵŶĚĞƌǁĂLJ Atrioventricular Interval Modulation (AVIM) Therapy Virtue® Sirolimus AngioInfusion Balloon (SAB) $4B annual artery disease target market Strong safety & efficacy data out to 3 years in multi - center pilot study Conditional IDE approval received for coronary pivotal study Strategic collaboration ŽƵďůĞ Ͳ ĚŝŐŝƚƌĞǀĞŶƵĞƐŚĂƌĞ ^ƚƌĂƚĞŐŝĐĐŽůůĂďŽƌĂƚŝŽŶ ŽƵďůĞ Ͳ ĚŝŐŝƚƌĞǀĞŶƵĞƐŚĂƌĞ ͮŽƌƉŽƌĂƚĞWƌĞƐĞŶƚĂƚŝŽŶY ϭϮϬϮϱ 4 Orchestra BioMed’s Partnership - Enabled Model Benefits All Orchestra BioMed Development ŽŵŵĞƌĐŝĂůŝnjĂƚŝŽŶ ^ƚƌĂƚĞŐŝĐWĂƌƚŶĞƌƐ ^ŚĂƌĞĚĞŶĞĨŝƚƐ /ŶŶŽǀĂƚŝŽŶ ^ĞĐƵƌĞƐƵďƐƚĂŶƚŝĂů ůŽŶŐ Ͳ ƚĞƌŵƌŽLJĂůƚŝĞƐ KƵƚƐŽƵƌĐĞ ĐŽŵŵĞƌĐŝĂůŝnjĂƚŝŽŶ ŶĂďůĞŵƵůƚŝƉůĞƉŝƉĞůŝŶĞ ŽƉƉŽƌƚƵŶŝƚŝĞƐ Improve patient lives Accelerate development Leverage expertise & resources Enable new growth opportunities Outsource development Minimize P&L dilution

 


 


| Corporate Presentation Q1 2025 5 Clinical Pivotal Clinical Feasibility Preclinical Target Indications Product Platforms Hypertension (HTN) (pacing patients; HTN+P) s/DdŚĞƌĂƉLJ ;ĂůƐŽŬŶŽǁŶĂƐĂĐŬĞĂƚEd Ϳ High - Risk HTN (non - pacing patients) Heart Failure CNT - HF ŽƌŽŶĂƌLJ/Ŷ Ͳ ^ƚĞŶƚ ZĞƐƚĞŶŽƐŝƐ;/^ZͿ Virtue® Sirolimus AngioInfusion Balloon (SAB) ŽƌŽŶĂƌLJ^ŵĂůůsĞƐƐĞů;^sͿ ϭ Below - the - Knee (BTK) 1 Ortho, oncology, urology, GI & other SirolimusEFR / Microporous Balloon IDE Approved 1 & FDA Breakthrough FDA Breakthrough <d'ůŽďĂůWŝǀŽƚĂů^ƚƵĚLJŶƌŽůůŝŶŐ Advancing High - Impact Pipeline * FDA Breakthrough * For more detailed information relating to our pipeline, please see the disclosure under “Item 1. Business” in our Form 10 - K for the year ended December 31, 2023 filed with the SEC on March 27, 2024, as updated by our subsequently filed quarterly reports on Form 10 - Q; 1 In light of the recent FDA approval of Boston Scientific Corporation’s AGENT paclitaxel - coated balloon for the treatment of coronary ISR, we and Terumo are reviewing the design for the Virtue ISR - US pivotal study and considering alternative clinical study designs with input from our clinical steering committee for Virtue S AB | Corporate Presentation Q1 2025 6 Expert Leadership, Proven Impact 300+ Combined years in the industry experience Ϯϱ н ǀĞƌĂŐĞLJĞĂƌƐŽĨ ĞdžƉĞƌŝĞŶĐĞ͕ ďƌŝŶŐŝŶŐĚĞĞƉ ĞdžƉĞƌƚŝƐĞƚŽĞǀĞƌLJ ĐŚĂůůĞŶŐĞ 100+ Successful product approvals, delivering innovation globally 600 + Authored patents shaping the future of healthcare With a history of success and a shared vision for the future, our leadership team brings together decades of experience, deep industry expertise, and a shared passion for transforming patient care.

 


Our leadership team is highly experienced , has a successful track record of bringing high - impact medical technologies to market , and includes individuals who have worked together for years Atrioventricular Interval Modulation (AVIM) therapy Also known as BackBeat CNT | Corporate Presentation Q1 2025 7

 


 


 


ͮŽƌƉŽƌĂƚĞWƌĞƐĞŶƚĂƚŝŽŶY ϭϮϬϮϱ 8 AVIM Therapy Overview Hypertension is the leading global risk factor for death, particularly for older , higher risk patients , despite pharmacotherapy Risk of High Blood Pressure Pacemaker - delivered therapy designed to immediately, substantially and persistently reduce blood pressure Initial treatment target is existing pacemaker population for whom hypertension is the #1 comorbidity Immediate Unmet Patient Need EŽǀĞůdŚĞƌĂƉLJ Collaboration with | Corporate Presentation Q 1 2025 9 $10 Billion Annual Global Opportunity Large Global Opportunity for Treating Hypertension in Target Populations * HTN + Pacemaker ~70% of pacemaker patients 1 ϳϱϬ͕ϬϬϬ ƉĂƚŝĞŶƚƐ >$2 Billion High Risk HTN ~0.2% of HTN patients 2,400,000 patients >$8 Billion Same patients, device implant, and treating physicians Existing reimbursement structure Older patients with uncontrolled hypertension and other significant comorbidities Similar demographics to pacemaker patients, high - risk, difficult - to - treat ΎdŽƚĂůĂĚĚƌĞƐƐĂďůĞŵĂƌŬĞƚŝŶ ϮϬϮϱ ďĂƐĞĚŽŶĐŽŵƉĂŶLJĞƐƚŝŵĂƚĞƐ͖ ϭ ŽŵƉĂŶLJĞƐƚŝŵĂƚĞƐďĂƐĞĚŽŶƉƵďůŝƐŚĞĚƐŽƵƌĐĞƐ͕ŝŶĐůƵĚŝŶŐ EĂƚŝŽŶĂů/ŶƉĂƚŝĞŶƚ^ƵƌǀĞLJ;E/^ͿĂŶĚEĂƚŝŽŶĂů,ĞĂůƚŚĂŶĚEƵƚƌŝƚŝŽŶdžĂŵŝŶĂƚŝŽŶ^ƵƌǀĞLJ;E,E^Ϳ͖ ĞĨŝŶŝƚŝŽŶ͗ ,LJƉĞƌƚĞŶƐŝŽŶ;,dEͿ Developed AVIM therapy ( BackBeat CNT) from concept stage O wns all related intellectual property: over 110 issued global patents Conducted all prior development and the MODERATO I & II clinical studies Sponsor for the BACKBEAT Global Pivotal Study $500 - $1,600 revenue share per AVIM - enabled device assuming existing reimbursement structures 1 Global market leader in cardiac pacing therapy: >$ 1.5 B in annual revenues Integrated AVIM therapy for download into premium commercial pacemakers for the BACKBEAT study Exclusive global commercial rights for AVIM therapy in pacemaker - indicated patients with HTN Right of first negotiation to expand global rights for the treatment of non - pacemaker patients with HTN $ 50 M equity investment in Orchestra BioMed 1 Amount is based on higher of (1) a fixed dollar amount per device (amount varies materially on a country - by - county basis) or (2) a percentage of sales AVIM Therapy Strategic Collaboration with Medtronic 10 | Corporate Presentation Q1 2025

 


 


AVIM Therapy is Designed to Substantially and Persistently Reduce Blood Pressure Through a Novel Mechanism of Action ϭϭ AVIM On Systolic BP (mmHg) Short AV intervals: Reduce cardiac preload, immediately lowering blood pressure Intermittent longer AV intervals: modulate autonomic nervous system response (baroceptor reflex) and reduce afterload (total peripheral resistance), sustaining blood pressure reduction AVIM Off AVIM Therapy U ses a Dual - chamber P acemaker to Deliver R epeated Sequences of Short and Longer AV Intervals to Reduce B lood Pressure 1 1 Kalarus et al. Journal of the American Heart Association. 2021;10:e020492ahajournals.org/ doi /10.1161/JAHA.120.020492. 2 Kuck, Hemodynamics Effects of AVIM Therapy, THT’24.

 


 


Definitions : AV ( A trioventricular), RV (Right Ventricular ) ĞƐŝŐŶĞĚƚŽ/ŵŵĞĚŝĂƚĞůLJ͕^ƵďƐƚĂŶƚŝĂůůLJĂŶĚ WĞƌƐŝƐƚĞŶƚůLJ>ŽǁĞƌůŽŽĚWƌĞƐƐƵƌĞ Independent of lead position : compatible with traditional RV pacing or conduction system pacing 30 Sec Utilizes well - characterized physiologic mechanisms (Frank - Starling) to favorably impact circulatory hemodynamics 2 : • Reduces intra - cardiac volumes and pressures • Improves cardiovascular efficiency • No adverse impact on contractility | Corporate Presentation Q1 2025 Feasibility Study in Canine HTN Model Proof of concept Acute Feasibility Study in Subjects with HTN 2012 ϮϬϭϲ MODERATO II – Pilot Study Prospective, multi - center, randomized, controlled, double - blind pilot study; Primary endpoint data late - breaking presentation at TCT ϮϬϭϵ MODERATO I - First In - Human Implant Study Multi - center, Single - arm Study TCT Innovation Shark Tank Award Best Abstract at ICI MODERATO II Two - year and ISH results Presented at TCT ϮϬϮϭ WĞĞƌ Ͳ ZĞǀŝĞǁĞĚ WƵďůŝĐĂƚŝŽŶŽĨ DKZdK//ZĞƐƵůƚƐ ŝŶƚŚĞ:ŽƵƌŶĂůŽĨƚŚĞ ŵĞƌŝĐĂŶ,ĞĂƌƚƐƐŽĐŝĂƚŝŽŶ Existing Body of Clinical Data Supporting Efficacy and Safety Enrolling BACKBEAT Pivotal Study Prospective, multi - center, randomized, controlled, double - blind pivotal study ϮϬ 24 Strategic Partnership with Medtronic for development and commercialization of AVIM therapy for hypertensive pacemaker patients ϮϬϮϮ 12 | Corporate Presentation Q 1 2025 ^ƵďƐƚĂŶƚŝĂů Ͳ ϭϭ͘ϭ ŵŵ,ŐZĞĚƵĐƚŝŽŶ ŝŶ Ϯϰ Ͳ ,ŽƵƌĂ^WĂƚ ϲ ŵŽŶƚŚƐ Sustained - 17.5 mmHg Reduction in oSBP at 2 years 0 % Major Adverse Cardiac Events vs. 14.3 % in control group at 6 months 4 AVIM Therapy showed encouraging results in MODERATO II , a prospective, multi - center, randomized, controlled, double - blind, pilot study of pacemaker patients with persistent uncontrolled hypertension despite medical therapy 1,2 MODERATO II Randomized, Double - Blind Results Significant Reduction in Systolic Blood Pressure (SBP) Control (n=20) 3 AVIM Therapy (n=26) 6 Months Ϯϰ DŽŶƚŚƐ 24 - Hour Ambulatory SBP (aSBP) Office SBP ( o SBP) 6 Months 0 - 5 - 10 - 15 - 20 - 11.1 P < 0.001 - 12.4 P < 0.001 - 0.1 P = 0.94 Ͳ ϭϳ͘ϱ Wф Ϭ͘Ϭϭ Δ in BP (mmHg) - 3.1 P = 0.17 - 15.6 P < 0.001 - 1.5 P = 0.5 1 day Δ - 14.1 p = 0.001 Δ - 8.1 p = 0.01 ȴ Ͳ ϭϮ͘ϯ Ɖс Ϭ͘ϬϮ 1 Kalaras et al. Journal of the American Heart Association. 2021;10:e020492 ahajournals.org/ doi /10.1161/JAHA.120.020492; 2 Burkhoff MODERATO II Study 2 - Year Results TCT 2021; 3 24 - Hr aSBP Control (n=19), 1 control patient could not be measured despite repeat measurement (patient had extremely high blood pressure); 4 A blinded evaluation Data Safety Monitoring Board report for MODERATO II included a revised MACE rate, from 9.5% to 14.3%, in the control group to reflect a heart failure after publication of the study results. Definitions : Major Adverse Cardiac Events (MACE) included death, heart failure, clinically significant arrhythmias (i.e., persistent or inc reased atrial fibrillation, serious ventricular arrhythmias), myocardial infarction, stroke and renal failure in treatment group calculated per patient.

 


13 | Corporate Presentation Q 1 2025 Recent Clinical Evidence Shows Durability and Disease - Modifying Potential of AVIM Therapy | Corporate Presentation Q1 2024 14 Demonstrated Long - Term Significant Reduction in SBP Out to 3.6 Years Sustained 8.9 mmHg r eduction in 24 - hour aSBP XXX Favorably Impacted Hemodynamics in Single - Arm PV Loop Study Immediate & substantial r eduction in SBP with conduction system pacing Significant reduction in preload & afterload and no change in contractility ^ƵƐƚĂŝŶĞĚ ϭϮ͘ϱ ŵŵ,Ő ƌĞĚƵĐƚŝŽŶŝŶ Ž^W Significantly Reduced SBP in Patients with Diastolic Dysfunction Significant increase in e ’ consistent with improvement in left ventricle relaxation Significantly reduced oSBP and aSBP in patients with Diastolic Dysfunction No increase in average number of medications Feb 2024 March 2024 Feb 2025 ^ŝŐŶŝĨŝĐĂŶƚ ƌĞĚƵĐĞĚ ^ƚƌŽŬĞtŽƌŬ ǁŝƚŚŽƵƚ ƐŝŐŶŝĨŝĐĂŶƚƌĞĚƵĐĞĚ^ƚƌŽŬĞsŽůƵŵĞ Significantly reduced oSBP and aSBP in patients with diastolic d ysfunction Significant increase in E/A consistent with improved passive left ventricle filling Definitions : Pressure volume (PV)

 


BACKBEAT Study Objective and Design Study objective: Evaluate the safety and efficacy of AVIM therapy in subjects indicated for a dual - chamber pacemaker who have hypertension (HTN) despite the use of antihypertensive medication Randomized (1:1) double - blind clinical trial Treatment Group: AVIM therapy + continued anti - HTN drug therapy Control Group: AVIM therapy not activated + continued anti - HTN drug therapy Study endpoints: Primary Efficacy endpoint: Between group difference in the change of mean 24 - hour aSBP at 3 months post randomization Primary Safety endpoint: Freedom from unanticipated serious adverse device events at 3 months post randomization Secondary/additional endpoints : Double - blind follow up will continue through 12 months to enable collection of additional clinical results and the secondary safety endpoint (CCAE rate) ŶƌŽůůĂƉƉƌŽdžŝŵĂƚĞůLJ ϱϬϬ ƉĂƚŝĞŶƚƐĂĐƌŽƐƐΕ ϭϬϬ ƐƚƵĚLJƐŝƚĞƐ ŝŶƚŚĞh^ĂŶĚƵƌŽƉĞ͖ ĐƵƌƌĞŶƚĞƐƚŝŵĂƚĞĚĐŽŵƉůĞƚŝŽŶ ŽĨĞŶƌŽůůŵĞŶƚŝŶƚŚĞĨŝƌƐƚŚĂůĨŽĨ ϮϬϮϲ 15 | Corporate Presentation Q 1 2025 Patients who have received a Medtronic dual chamber - pacemaker within 365 days or are scheduled to receive one and have hypertension despite medication* R Treatment: AVIM therapy + medical therapy Primary at 3M Control: Medical therapy &ŽůůŽǁ Ͳ ƵƉ Ăƚ ϭϮ D AVIM therapy download and set up Eligibility Assessment Top - Line Results and Regulatory Activities Blinded Study 12 months Enrollment/ Randomization Eligibility Assessment Phase Screening Primary at 3M Follow - up at 12M BACKBEAT Study Design Potential Regulatory Submissions Withdraw EŽ *Implant is decoupled from study outcomes & endpoints 16 | Corporate Presentation Q1 2025

 


 


Virtue® Sirolimus AngioInfusion Balloon (SAB) 17 | Corporate Presentation Q1 2025

 


Virtue ® SAB Overview /ŶƚĞƌǀĞŶƚŝŽŶĂůƚƌĞĂƚŵĞŶƚŽĨĂƌƚĞƌLJĚŝƐĞĂƐĞ ŵŝŐƌĂƚŝŶŐƚŽǁĂƌĚĚƌƵŐ ĐŽĂƚĞĚďĂůůŽŽŶƐ ĂƐŶĞǁƐƚĂŶĚĂƌĚŽĨĐĂƌĞĨŽƌĐĞƌƚĂŝŶŬĞLJŝŶĚŝĐĂƚŝŽŶƐ Paradigm Shift in Treatment of Artery Disease Highly Differentiated Sirolimus DEB with Sustainable Advantages *Total addressable market in 2025 based on company estimates Non - coated microporous balloon protects delivery of proprietary SirolimusEFR Extended release of “gold - standard” drug through critical healing period Designed to overcome limitations of drug - coated balloons 18 | Corporate Presentation Q1 2025 C ollaboration w ith KǀĞƌ ϯ DΎƚĂƌŐĞƚĞĚĂŶŶƵĂůƉƌŽĐĞĚƵƌĞƐ ŐůŽďĂůůLJĨŽƌ&ƌĞĂŬƚŚƌŽƵŐŚĞƐŝŐŶĂƚŝŽŶ ŝŶĐŽƌŽŶĂƌLJĂŶĚƉĞƌŝƉŚĞƌĂůŝŶĚŝĐĂƚŝŽŶƐ Large Breakthrough Market Opportunity | Corporate Presentation Q 1 2025 19 Large Global Opportunity for Virtue SAB * Coronary In - stent Restenosis, Small Vessel De Novo ~ 2,000,000 patients хΨ Ϯ͘ϰ ŝůůŝŽŶ Peripheral Below - The - Knee ~1,250,000 patients >$1.6 Billion $ 4 Billion Annual Global Opportunity Large mature market with suboptimal treatments for coronary in - stent restenosis, coronary small vessel de novo and below - the - kne e Multibillion dollar established market for additional potential vascular indications *Total addressable market in 2025 based on company estimates; Definitions: Coronary Artery Disease (CAD), Peripheral Artery Disease (PAD)

 


 


ĞǀĞůŽƉĞĚsŝƌƚƵĞ^ ;^ŝƌŽůŝŵƵƐ&Z͕ŶŐŝŽ/ŶĨƵƐŝŽŶďĂůůŽŽŶͿ ĨƌŽŵĐŽŶĐĞƉƚƐƚĂŐĞ ͖ ŽǁŶƐĂůůƌĞůĂƚĞĚ/W ŽŶĚƵĐƚĞĚĂůůƉƌŝŽƌĚĞǀĞůŽƉŵĞŶƚǁŽƌŬŝŶĐůƵĚŝŶŐ^Z ƐƚƵĚLJŝŶĐŽƌŽŶĂƌLJ/^Z ^ƉŽŶƐŽƌŝŶŐƚŚĞsŝƌƚƵĞ/^Z Ͳ h^ƉŝǀŽƚĂůƐƚƵĚLJ;ĐŽŶĚŝƚŝŽŶĂů/ ŐƌĂŶƚĞĚͿ ϭϬ Ͳ ϭϱ йƌŽLJĂůƚLJŽŶŶĞƚƐĂůĞƐW>h^ƉĞƌƵŶŝƚƉĂLJŵĞŶƚƐ ĨŽƌ ^ŝƌŽůŝŵƵƐ&Z ZĞƚĂŝŶĞĚƌŝŐŚƚƐĨŽƌĂůůŶŽŶ Ͳ ǀĂƐĐƵůĂƌŝŶĚŝĐĂƚŝŽŶƐ Global leader in interventional cardiology accessory devices: >$2.4B in annual revenues 1 Completed a $30M upfront payment to and $5M equity investment in Orchestra BioMed Responsible for clinical/regulatory costs (excluding Virtue ISR - US study), device supply & commercialization Potential for Virtue SAB to become Terumo’s flagship therapeutic offering Currently negotiating restructuring of milestone payments and other key terms Strategic Collaboration with Terumo 1 Based on Terumo’s consolidated financial results for the fiscal year ended March 31, 2023; Initiation of Virtue ISR - US pivotal study of Virtue SAB for the treatment of coronary ISR, as well as submissions to Japanese PMDA in coronary ISR and small vessel disease are pending ongoi ng operational and financial plan calibration with Terumo 20 | Corporate Presentation Q 1 2025 Compelling Opportunity For Virtue SAB Coatings have limitations including risk of emboli from large coating particulates, drug loss in transit and rapid navigation requirements ŶŽǀĞůƐŽůƵƚŝŽŶŝƐƌĞƋƵŝƌĞĚƚŽƌĞĂůŝnjĞĂĚǀĂŶƚĂŐĞƐŽĨƐŝƌŽůŝŵƵƐ 1 Xinlin Zhang, et.

 


al. PLOS ONE 2014 May 20;9(5):e97934 Superiority of sirolimus safety and efficacy over paclitaxel demonstrated in large meta - analysis of 76 drug - eluting stent studies including 26 RCTs 1 Sirolimus requires extended release through the critical healing period to achieve full benefits (~30 days of >1ng/mg tissue concentration) Paclitaxel became “drug of choice” for coated balloons because it is easier, not better (fast tissue absorption and long tissue retention) + Angioplasty with Protected Delivery of Extended Release Sirolimus = ^ŝƌŽůŝŵƵƐ&Z DŝĐƌŽƉŽƌŽƵƐ ŶŐŝŽ/ŶĨƵƐŝŽŶ ĂůůŽŽŶ 21 | Corporate Presentation Q1 2025 1000 100 10 1 Ϭ͘ϭ Ϭ͘Ϭϭ 0.001 0.0001 Lung, liver & kidney below level of assay quantification (0.1 ng/mg) in <1 week 0 5 10 ϭϱ ϮϬ 25 30 Target Lesion Distal Myocardium Kidney Liver Lung Time (Days) N = 753 porcine coronary artery segments Sirolimus Tissue Concentration (ng/mg) WƵďůŝƐŚĞĚĂƚĂĞŵŽŶƐƚƌĂƚĞƐ dŚĞƌĂƉĞƵƚŝĐ^ŝƌŽůŝŵƵƐdŝƐƐƵĞ ŽŶĐĞŶƚƌĂƚŝŽŶ dŚƌŽƵŐŚ ƌŝƚŝĐĂů,ĞĂůŝŶŐWĞƌŝŽĚ;Ε ϯϬ ĂLJƐͿ WƌŽƚĞĐƚĞĚĞůŝǀĞƌLJŽĨ džƚĞŶĚĞĚZĞůĞĂƐĞ^ŝƌŽůŝŵƵƐ Virtue ® SAB – Optimal Drug, Revolutionary Delivery 1 Granada et al.

 


EuroIntervention 2016;12:740 - 747 ^ŝƌŽůŝŵƵƐ&Z DŝĐƌŽƉŽƌŽƵƐŶŐŝŽ/ŶĨƵƐŝŽŶ ĂůůŽŽŶ Precise dose loaded and protected in Dose Unit No coating = no drug loss in transit Intended dose delivered through balloon micropores No coating = no large particulate ^ƚĂŶĚĂƌĚŶĂǀŝŐĂƚŝŽŶƚŽ ůĞƐŝŽŶ EŽĐŽĂƚŝŶŐ сŶŽƌƵƐŚƚŽ ƚĂƌŐĞƚůĞƐŝŽŶ ϮϮ Required Therapeutic Concentration > 1 ng/mg | Corporate Presentation Q1 2025 ͞ >ŝŵƵƐ ͟ dŝƐƐƵĞŽŶĐĞŶƚƌĂƚŝŽŶ;ŶŐͬŵŐͿ sŝƌƚƵĞ^ĐŚŝĞǀĞƐ dŚĞƌĂƉĞƵƚŝĐ^ŝƌŽůŝŵƵƐdŝƐƐƵĞŽŶĐĞŶƚƌĂƚŝŽŶƐ dŚƌŽƵŐŚƚŚĞƌŝƚŝĐĂů,ĞĂůŝŶŐWĞƌŝŽĚ | Corporate Presentation Q1 2025 23 0.1 1.0 10.0 100.0 0 10 20 30 dĂƌŐĞƚdŚĞƌĂƉĞƵƚŝĐŽŶĐĞŶƚƌĂƚŝŽŶ х ϭ ŶŐͬŵŐ sŝƌƚƵĞ^ΘWƌŽǀĞŶ^ĐŚŝĞǀĞdŚĞƌĂƉĞƵƚŝĐ^ŝƌŽůŝŵƵƐdŝƐƐƵĞŽŶĐĞŶƚƌĂƚŝŽŶƐdŚƌŽƵŐŚƌŝƚŝĐĂů,ĞĂůŝŶŐWĞƌŝŽĚ;Ε ϯϬ ĚĂLJƐ Ϳ 1 Granada J, et al.

 


EuroIntervention 2016 ; 12:740 - 747 . 2 Balakrishnan et al, J Control Release. 2008 , 131 ( 3 ): 173 – 180 . 3 Perkins et al, J Int Cardiol 2009 ; 22 ( Suppl 1 ): S 28 - S 40 . XIENCE V is a trademark of the Abbott Group of Companies . Cypher Sirolimus - eluting Coronary Stent is a trademark of Cordis Coporation Virtue SAB E с ϭϱ Ͳ Ϯϰϳ ͬƚŝŵĞƉŽŝŶƚ 0.1 1 10 100 0 10 20 30 dĂƌŐĞƚdŚĞƌĂƉĞƵƚŝĐŽŶĐĞŶƚƌĂƚŝŽŶ х ϭ ŶŐͬŵŐ Cypher Sirolimus - eluting Coronary Stent N = 6 /time point 0.1 1 10 100 0 10 20 30 dŝŵĞ;ĂLJƐͿ dĂƌŐĞƚdŚĞƌĂƉĞƵƚŝĐŽŶĐĞŶƚƌĂƚŝŽŶ х ϭ ŶŐͬŵŐ Xience V Everolimus Eluting Coronary Stent N = up to 30/time point ĚĂƉƚĞĚĨƌŽŵ ϯ ƐĞƉĂƌĂƚĞƉƌĞĐůŝŶŝĐĂůƉŽƌĐŝŶĞƐƚƵĚŝĞƐ ϭ͕Ϯ͕ϯ >Žǁ Ϯ͘ϴ йdĂƌŐĞƚ>ĞƐŝŽŶ&ĂŝůƵƌĞ ;d>&ͿĂƚ ϭ LJĞĂƌ Low 0.12mm Late Lumen Loss (LLL) at 6 - months 0 % Target Lesion Revascularization (TLR) between 1 - 3 years sŝƌƚƵĞΠ^ ĚĞŵŽŶƐƚƌĂƚĞĚ ĞŶĐŽƵƌĂŐŝŶŐƐĂĨĞƚLJ ĂŶĚĞĨĨŝĐĂĐLJƌĞƐƵůƚƐ ŝŶƉĂƚŝĞŶƚƐǁŝƚŚ ĐŽƌŽŶĂƌLJŝŶ Ͳ ƐƚĞŶƚ ƌĞƐƚĞŶŽƐŝƐ ;/^ZͿŝŶ ƉƌŽƐƉĞĐƚŝǀĞ͕ŵƵůƚŝ Ͳ ĐĞŶƚĞƌ^ZdƌŝĂů ϭ͕Ϯ͕ϯ ŽŵƉĞůůŝŶŐ^ZdƌŝĂůZĞƐƵůƚƐŝŶŽƌŽŶĂƌLJ/^ZWĂƚŝĞŶƚƐ Low Event Rates Out to 3 Years 0% 5% 10% 15% 20% 25% 5.6% Ϯ͘ϴ й Ϯ͘ϴ й 2.8% 0 % Ϭ й Ϭ й 0 % 0% Ϭ й Ϭ й 2.8% Cardiac Death ds Ͳ D/ d>Z TLF Event Rates (%) ϯϬ ĚĂLJƐ ϭ Ͳ LJĞĂƌ ϯ Ͳ LJĞĂƌƐ Ϯϰ | Corporate Presentation Q1 2025 1 Verheye et al.

 


JACC Cardiovasc Interv 2017 Oct 23 ; 10 ( 20 ): 2029 - 2037 . DOI: 10.1016 /j.jcin. 2017.06.021 . 2 Revised per protocol analysis set meets the criteria of the proposed In - Stent Restenosis IDE study population. Definitions: Target lesion failure (TLF), late lumen loss (LLL), target lesion revascularization (TLR) and Myocardial Infarction (MI). 3 Granada 3 - Year Clinical Results TCT 2018 . Definitions: Target lesion failure (TLF), late lumen loss (LLL), target lesion revascularization (TLR) and Target vessel myocardial fnfarction (TV - MI)

 


ϭϯ͘ϱ йd>&Ăƚ ϭ LJĞĂƌ EŽĂŶŐŝŽŐƌĂƉŚŝĐĨŽůůŽǁ Ͳ ƵƉ To date, 1 year follow - up only AGENT IDE demonstrated a reduction vs. POBA in TLF at 1 - year in patients with single - layer restenosis 'Ed/ZĞƐƵůƚƐ Ϯϱ | Corporate Presentation Q1 2025 0% 5% 10% 15% 20% 25% 20.2 % ϭϯ͘ϱ й d>& TLF Event Rates (%) 'Ed WK ;Ŷс ϯϰϭ Ϳ The AGENT IDE Randomized Clinical Results Out to 1 year 1 Single - Layer Restenosis ϭ zĞŚZt͕ ^ŚůŽĨŵŝƚnj Z͕DŽƐĞƐ:͕ĞƚĂů͘:D͘ ϮϬϮϰ ͖ ϯϯϭ ; ϭϮ Ϳ͗ ϭϬϭϱ ʹ ϭϬϮϰ ͘ĚŽŝ͗ ϭϬ͘ϭϬϬϭ ͬũĂŵĂ͘ ϮϬϮϰ͘ϭϯϲ ͖ ĞĨŝŶŝƚŝŽŶƐ͗ dĂƌŐĞƚůĞƐŝŽŶ ĨĂŝůƵƌĞ;d>&Ϳ͕ůĂƚĞůƵŵĞŶůŽƐƐ;>>>Ϳ͕ƚĂƌŐĞƚůĞƐŝŽŶƌĞǀĂƐĐƵůĂƌŝnjĂƚŝŽŶ;d>ZͿĂŶĚdĂƌŐĞƚǀĞƐƐĞůŵLJŽĐĂƌĚŝĂů ŝ ŶĨĂƌĐƚŝŽŶ ;ds Ͳ D/Ϳ͖WůĂŝŶ ŽůĚďĂůůŽŽŶĂŶŐŝŽƉůĂƐƚLJ;WKͿ hƉĐŽŵŝŶŐsŝƌƚƵĞ^WƌŽŐƌĂŵDŝůĞƐƚŽŶĞƐ Planning to conduct US pivotal study in coronary ISR randomizing Virtue SAB vs. BSC AGENT DCB 26 ͮŽƌƉŽƌĂƚĞWƌĞƐĞŶƚĂƚŝŽŶY ϭϮϬϮϱ WƌŝŵĂƌLJĞŶĚƉŽŝŶƚd>&ŶŽŶ Ͳ ŝŶĨĞƌŝŽƌŝƚLJ ^ƚƵĚLJƚŽĞŶƌŽůůĂƉƉƌŽdžŝŵĂƚĞůLJ ϳϰϬ ƉĂƚŝĞŶƚƐ /ĂŵĞŶĚŵĞŶƚĞdžƉĞĐƚĞĚ ϭ , ϮϬϮϱ dĂƌŐĞƚŝŶŐŝŶŝƚŝĂƚŝŽŶŽĨƐƚƵĚLJŝŶ Ϯ , ϮϬϮϱ Active partnership restructuring negotiations with Terumo are ongoing

 


 


Lead Partnered Program Enrolling Pivotal Study <ĞLJ/ŶǀĞƐƚŵĞŶƚ,ŝŐŚůŝŐŚƚƐ ^ƚƌŽŶŐ^ŚĂƌĞŚŽůĚĞƌĂƐĞ AVIM Therapy is compelling HTN therapy in pivotal study Actively enrolling with market - leading strategic partner S ubstantial revenue share with s ignificant follow - on market opportunity Enabled by partnerships Capital efficient Designed to yield exceptional future profitability sŝƌƚƵĞ^ŝƐĂŚŝŐŚůLJĚŝĨĨĞƌĞŶƚŝĂƚĞĚƐŽůƵƚŝŽŶĨŽƌůĂƌŐĞĞdžŝƐƚŝŶŐŵĂƌŬĞƚ WůĂŶŶŝŶŐƌĂŶĚŽŵŝnjĞĚh^ƉŝǀŽƚĂůƐƚƵĚLJǀƐ͘ ŵĂƌŬĞƚůĞĂĚĞƌ ^ŝŐŶŝĨŝĐĂŶƚŶĞĂƌ Ͳ ƚĞƌŵƉŽƚĞŶƚŝĂůŵŝůĞƐƚŽŶĞƐ WĂƌƚŶĞƌĞĚWƌŽŐƌĂŵ ƉƉƌŽǀĞĚ&ŽƌWŝǀŽƚĂů^ƚƵĚLJ Differentiated Business Model 27 ͮŽƌƉŽƌĂƚĞWƌĞƐĞŶƚĂƚŝŽŶY ϭϮϬϮϱ ƌŝŶŐŝŶŐDĞĚŝĐĂů /ŶŶŽǀĂƚŝŽŶƐƚŽ>ŝĨĞ dŚƌŽƵŐŚWĂƌƚŶĞƌƐŚŝƉƐ 28 | Corporate Presentation Q1 2025