8-K/A

Orchestra BioMed Holdings, Inc. (OBIO)

8-K/A 2023-07-13 For: 2023-07-12
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Added on April 06, 2026

UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549

FORM 8-K/A

Amendment No. 1

CURRENT REPORTPURSUANT TO SECTION 13 OR 15(D)OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported):July 12, 2023

ORCHESTRA

BIOMED HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Delaware<br><br> <br>(State or other jurisdiction of incorporation) 001-39421<br><br> <br>(Commission File Number) 92-2038755<br><br> <br>(IRS Employer Identification No.)
150 Union Square Drive<br><br> <br>New Hope, Pennsylvania 18938<br><br> <br>(Address of principal executive offices, including zip code)<br><br> <br><br><br> <br>Registrant’s telephone number, including area code: (215) 862-5797<br><br> <br><br><br> <br>(Former name or former address, if changed since last report)<br><br> <br>****

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. ¨

Explanatory Note

This Current Report on Form 8-K/A amends the Current Report on Form 8-K previously filed by Orchestra BioMed Holdings, Inc. on July 12, 2023 (the “Original 8-K”) to correct the investor presentation filed as Exhibit 99.1 (the “Investor Presentation”). The revised Investor Presentation is attached hereto as Exhibit 99.1 and supersedes Exhibit 99.1 to the Original 8-K in its entirety. No other changes to the Original 8-K have been made.

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 No. Description
99.1 Investor Presentation
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

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/ David Hochman
Name: David P. Hochman
Title: Chief Executive Officer
Date: July 12, 2023

Exhibit 99.1

Orchestra<br>BioMed<br>Corporate<br>Presentation<br>Q3 2023
2 Corporate Presentation Q2 2023<br>Forward-Looking Statements<br>This presentation has been prepared for informational purposes only from information<br>supplied by Orchestra BioMed Holdings, Inc., referred to herein as “we,” “our,”<br> “Orchestra BioMed,” and “the Company,” and from third-party sources indicated<br>herein. Such third-party information has not been independently verified. Orchestra<br>BioMed makes no representation or warranty, expressed or implied, as to the accuracy<br>or completeness of such information.<br>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<br>Private Securities Litigation Reform Act of 1995. Forward-looking statements generally<br>are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,”<br> “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,”<br> “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate<br>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<br>safety and efficacy of our product candidates, the timing of our planned pivotal trials,<br>expected market sizes for our product candidates, the ability of our partnerships to<br>accelerate clinical development, and our estimated future financial performance and<br>financial position. These statements are based on various assumptions, whether or not<br>identified in this document, and on the current expectations of the Company’s<br>management and are not predictions of actual performance. These forward-looking<br>statements are provided for illustrative purposes only and are not intended to serve as<br>and must not be relied on as a guarantee, an assurance, a prediction, or a definitive<br>statement of fact or probability. Actual events and circumstances are difficult or<br>impossible to predict and may differ from assumptions. Many actual events and<br>circumstances are beyond the control of the Company. These forward-looking<br>statements are subject to a number of risks and uncertainties, including changes in<br>domestic and foreign business, market, financial, political, and legal conditions; failure<br>to realize the anticipated benefits of the business combination; risks related to<br>regulatory approval of the Company’s product candidates; the timing of, and the<br>Company’s ability to achieve expected regulatory and business milestones; the impact<br>of competitive products and product candidates; and the risk factors discussed under<br>the heading “Item 1A. Risk Factors” in the Company’s quarterly report on Form 10-Q<br>filed with the U.S. Securities and Exchange Commission on May 12, 2023 as updated by<br>any risk factors disclosed under the heading “Item 1A. Risk Factors” in the Company’s<br>subsequently filed quarterly reports on Form 10-Q.<br>The Company operates in a very competitive and rapidly changing environment. New<br>risks emerge from time to time. Given these risks and uncertainties, the Company<br>cautions against placing undue reliance on these forward-looking statements, which<br>only speak as of the date of this press release. The Company does not plan and<br>undertakes no obligation to update any of the forward-looking statements made<br>herein, except as required by law.
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Orchestra BioMed Executive Summary<br>Strong balance sheet and outstanding investors:<br>Strong 3-year multi-center preliminary trial<br>safety and efficacy data<br>Plan to initiate pivotal trial H2 2023<br>Strategic<br>collaboration<br>Double-digit revenue share<br>Virtue® SAB<br>targets >$3B annual artery disease markets<br>Protected sirolimus delivery, non-coated balloon<br>Partnership-enabled business model designed to:<br>Accelerate innovation to patients Drive strong partner and shareholder value Yield exceptional future profitability<br>Statistically significant double-blind,<br>randomized preliminary trial efficacy data<br>Plan to initiate pivotal trial H2 2023<br>Strategic<br>collaboration<br>Double-digit revenue share<br>BackBeat CNT™️<br>targets >$10B annual hypertension markets<br>Firmware upgrade to existing pacemaker<br>3 Corporate Presentation Q2 2023
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Orchestra BioMed<br>Development Commercialization<br>Shared Benefits Strategic Partners<br>Secure substantial<br>long-term royalties<br>Outsource<br>commercialization<br>Multiple pipeline<br>opportunities<br>Improve<br>patient lives<br>Accelerate<br>development<br>Leverage expertise<br> & resources<br>Enable new growth<br>opportunities<br>Outsource<br>development<br>Minimize<br>P&L dilution<br>Orchestra BioMed’s Partnership-Enabled Model Benefits All<br>4 Corporate Presentation Q2 2023
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5 Corporate Presentation Q2 2023<br>BackBeat CNT<br>in collaboration with in collaboration with<br>Virtue SAB<br>Global market leader in pacemakers:<br> >$1.5B in annual revenues<br>Providing leading device plus clinical & regulatory resources<br>Exclusive global commercial rights for HTN+Pacemaker market<br>$50M equity investment in Orchestra BioMed<br>Right of first negotiation to expand global rights<br>for the treatment of non-pacemaker HTN patients<br>Global leader in interventional cardiology:<br> >$2.5B in annual revenues2<br>$30M upfront payment and potential future milestones<br>$5M equity investment in Orchestra BioMed<br>Responsible for clinical and regulatory expenses, excluding Virtue ISR-US<br>study, as well as device supply chain and commercialization<br>Positioned to become Terumo’s flagship therapeutic offering<br>Sponsor for BackBeat CNT HTN + Pacemaker global pivotal study<br>$500 - $1,600 per BackBeat CNT-enabled device sold1 under existing<br>reimbursement codes<br>*Total addressable market in 2025 based on company estimates; 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. 2 Based on Terumo’s consolidated financial results for the fiscal year ended March 31, 2022<br>Sponsor for Virtue ISR-US pivotal study<br>10-15% royalty PLUS per unit payments for SirolimusEFR™<br>Retains rights to Virtue SAB for clinical applications outside<br>of coronary and vascular interventions<br>Role and Revenue Share Role and Revenue Share<br>Strong Collaborations Position Us for Long-term Success
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Advancing High-Impact Pipeline<br>1Plan to leverage existing coronary ISR data to support potential Pivotal Study, although there have only been limited discussions with the FDA or a comparable foreign regulator in this regard. 2Will seek to leverage data from HTN+P pilot and pivotal trials to support clinical and regulatory development for High-Risk HTN indication given that age and other<br>demographic factors of the target population are expected to be similar, the type of hypertension treated will likely be isolated systolic hypertension which is predominant in the HTN+P population, and other co-morbidities are also expected to be common to both target populations. However, there have been no discussions with the FDA or a comparable<br>foreign regulator in this regard. 3Virtue SAB has received Breakthrough Device Designation for the balloon dilatation of the stenotic portion (up to 26 mm length) of a stented coronary artery (in-stent restenosis (ISR)) that is 2.25 to 4.0 mm in diameter, for the purpose of improving lumen diameter; 4Virtue SAB has received Breakthrough Device Designation for<br>the balloon dilatation of the de novo stenotic portion (up to 26mm in lesion length) of a native coronary artery of 2.0 mm to 2.5 mm in diameter (small coronary arteries), for the purpose of improving lumen diameter; 5Virtue SAB has received Breakthrough Device Designation for the balloon dilatation of the stenotic portion (up to 18 mm length) of an<br>infrapopliteal artery (P-3 segment or distal, below the knee, with reference vessel diameter (RVD) 2.25 - 4.0 mm), for the purpose of improving lumen diameter. All references to clinical study initiations for HTN+P, Coronary ISR and Coronary SV indications are based on ongoing interactions with US FDA regarding IDE approvals or Japan PMDA regarding CTN<br>approvals, which are required to start clinical studies. With respect to BackBeat CNT for HTN, Orchestra and Medtronic have had initial interactions with the FDA regarding IDE approval and expect to continue interactions regarding clinical trial design and submission requirements ahead of submitting documentation for approval in the second half of 2023. A<br>pre-CTN discussion with the PMDA is planned for December 2022 with submission for CTN approval anticipated in the second half of 2023. With respect to Virtue SAB for Coronary ISR, Orchestra has been working on IDE approval with the FDA under the breakthrough designation program to define all of the elements necessary for IDE approval and Orchestra<br>expects to complete the agreed upon work and submit documentation for approval in Q1 of 2023. Orchestra and Terumo have had initial interactions with the PMDA and expect to submit for CTN approval for Coronary ISR and SV studies in the second half of 2023. FDA and PMDA responses are expected approximately 30 days following formal submissions;<br>clinical study enrollment is expected to begin approximately 6-8 weeks after regulatory approvals; study enrollment timelines are currently estimated to be 12-18 months for all referenced studies although actual study enrollment timeframes may be longer; final primary endpoint results for all studies are at 12 months from enrollment with the exception of<br>Japan Coronary ISR & SV studies, which are expected to be at 6 months from enrollment.<br>Product Platforms Target Indications Preclinical Clinical<br>Feasibility<br>Clinical<br>Pivotal Partner Study Sponsor<br>BackBeat<br>Cardiac<br>Neuromodulation<br>Therapy (CNT™️)<br>Hypertension (HTN)<br>(pacing patients; HTN+P)<br>High-Risk HTN<br>(non-pacing patients) ROFN<br>CNT - HF Heart Failure<br>Virtue®<br>Sirolimus<br>AngioInfusion™️<br>Balloon (SAB)<br>Coronary In-Stent<br>Restenosis (ISR)<br>Coronary Small Vessel (SV)1<br>Below-the-Knee (BTK)1<br>SirolimusEFR™ /<br>Microporous Balloon Urology, orthopedics, oncology & other<br>FDA Breakthrough3<br>FDA Breakthrough4<br>FDA Breakthrough5<br>6 Corporate Presentation Q2 2023
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Executive Team: >350 Years of Experience ~25 Avg Industry Years >100 Product Approvals >600 Authored Patents<br>David Hochman<br>Chairman, CEO,<br>Founder<br>Darren R. Sherman<br>President, COO,<br>Director, Founder<br>Andrew Taylor<br>Chief Financial Officer<br>Yuval Mika, Ph.D.<br>GM & CTO,<br>Bioelectronic Therapies<br>George Papandreou,<br>Ph.D.<br>GM & SVP,<br>Focal Therapies<br>Hans-Peter Stoll,<br>M.D., Ph.D.<br>Chief Clinical Officer<br>Bill Little<br>EVP, Corporate Dev.<br> & Strategy<br>Avi Fischer, M.D.<br>SVP, Medical Affairs<br> & Innovation<br>J.C. Simeon<br>SVP, Quality<br>Inessa R. Wheeler<br>VP, Marketing<br>Bob Laughner<br>VP, Regulatory Affairs<br>Stephen A. Zielinski<br>VP, Product Dev.,<br>Bioelectronic Therapies<br>Ziv Belsky<br>VP, Research,<br>Bioelectronic Therapies<br>Juan Lorenzo<br>VP, Product Dev.,<br>Focal Therapies<br>Highly Accomplished Executive Team & Board<br>Board members<br>Jason Aryeh Pamela Connealy Eric S. Fain, M.D. Eric A. Rose, M.D. Geoffrey W. Smith<br>7 Corporate Presentation Q2 2023
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BackBeat Cardiac<br>Neuromodulation<br>Therapy™️ (CNT ™)<br>8 Corporate Presentation Q2 2023
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BackBeat CNT™️ Overview<br>1Company estimates based on published sources, including National Inpatient Survey (NIS) and National Health and Nutrition Examination Survey (NHANES); 2Kalaras et al.<br>Journal of the American Heart Association. ahajournals.org/doi/10.1161/JAHA.120.020492;<br>3Burkhoff. MODERATO II Study 2-Year Results TCT 2021;. Definitions: Ambulatory Systolic Blood Pressure (aSBP) and Office Systolic Blood Pressure (oSBP)<br>o Hypertension is the leading global risk factor for death and #1<br>comorbidity in pacemaker population, affecting over 70% of patients1<br>o Older population at increased risk for major events<br> & challenges with drug compliance<br>o Additional opportunity to treat high-risk patients<br>not indicated for a pacemaker<br>Unmet Need<br>o Bioelectronic therapy designed to substantially<br> & persistently lower blood pressure<br>o Compatible with standard pacemaker devices<br> & leverages existing treatment paradigm<br>o Compelling clinical data from double-blind randomized study:<br>significant 8.1 mmHg net reduction in 24-Hr aSBP at 6 months<br> & 17.5 mmHg reduction in oSBP at 2 years2,3<br>Innovation<br>Collaboration with<br>9 Corporate Presentation Q2 2023
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10 Corporate Presentation Q2 2023<br>Large Global Opportunity for Treating Hypertension in<br>Target Populations<br>*Total addressable market in 2025 based on company estimates; 1Company estimates based on published sources, including National Inpatient Survey (NIS) and<br>National Health and Nutrition Examination Survey (NHANES); 2Known and well-characterized population, multiple references available; Definition: Hypertension (HTN)<br>Annual Global<br>Opportunity<br>High Risk HTN<br>~0.2% of HTN patients<br>2,400,000 patients<br> >$8 Billion<br>HTN + Pacemaker<br>~70% of pacemaker patients<br>750,000 patients<br> >$2 Billion<br> >$10 Billion Potential Annual<br>Global Market Opportunity*<br> >3.1M Addressable HTN Patients<br>High Risk HTN (Non-pacemaker) -Older<br>patients with isolated systolic<br>hypertension (ISH) and comorbidities<br>Medtronic is the global pacemaker leader<br>with >50% of U.S. market share
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BackBeat CNT™️<br>Designed to Substantially and Persistently<br>Lower Blood Pressure<br>Bioelectronic therapy designed to leverage<br>standard dual-chamber pacemaker<br>o Same implant procedure and lead positions<br>o Large trained physician pool that already implant pacemakers<br>o Same target patient population that already need pacemakers<br>o Leverageable existing reimbursement with robust payment opportunity for<br>novel devices with novel capabilities<br>Mechanism of action<br>o Designed to substantially reduce blood pressure by reducing preload<br>through programmed pacing with short AV delays<br>o Designed to maintain reduction by modulating sympathetic tone and<br>reducing afterload through programmed variable pressure patterns<br>Designed to Substantially Lower BP<br> & Maintain Reduction<br>Reducing<br>Preload<br>Lowers BP<br>Modulating Sympathetic Tone<br> & Reducing Afterload Maintains<br>Reduction in BP<br>SBP (mmHg)<br>Time (s)<br>155<br>0 50 100. 150 200 250 300<br>150<br>145<br>140<br>135<br>130<br>1<br>2<br>11 Corporate Presentation Q2 2023
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MODERATO II Double-Blind, Randomized Results<br>1Kalaras et al. Journal of the American Heart Association. 2021;10:e020492 ahajournals.org/doi/10.1161/JAHA.120.020492; 2Burkhoff MODERATO II Study 2-Year Results TCT 2021; 324-Hr aSBP<br>Control (n=19),1 control patient could not be measured despite repeat measurement (patient had extremely high blood pressure); Definitions: Major Adverse Cardiac Events (MACE) included death,<br>heart failure, clinically significant arrhythmias (i.e., persistent or increased atrial fibrillation, serious ventricular arrhythmias), myocardial infarction, stroke and renal failure in treatment group<br>calculated per patient, Office Systolic Blood Pressure (oSBP), Ambulatory Systolic Blood Pressure (aSBP)<br>150<br>145<br>140<br>135<br>130<br>125<br>120<br>115<br>110<br>00:00<br>01:00<br>02:00<br>03:00<br>04:00<br>05:00<br>06:00<br>07:00<br>08:00<br>09:00<br>10:00<br>11:00<br>12:00<br>13:00<br>14:00<br>15:00<br>16:00<br>17:00<br>18:00<br>19:00<br>20:00<br>21:00<br>22:00<br>23:00<br>24-Hr aSBP (mmHg)<br>P < 0.01 for all times of day<br>Pre-activation (n=26)<br>6 months (n=26)<br>6 Month Mean<br>Pre-activation Mean<br>Significant Reduction in 24-Hr aSBP and oSBP Significant Reduction in aSBP 24 Hours a Day 1,2<br>6 Months 24 Months<br>aSBP oSBP<br>6 Months<br>0<br>-5<br>-10<br>-15<br>-20<br>-11.1<br>P < 0.001 -12.4<br>P < 0.001<br>-0.1<br>P = 0.94<br>-17.5<br>P < 0.01<br> Δ -12.3<br>p = 0.02<br> Δ -8.1<br>p = 0.01<br> Δ in BP (mmHg)<br>Control (n=20)3<br>BackBeat CNT (n=26)<br>-3.1<br>P =0.17<br>BackBeat CNT™ showed encouraging results in MODERATO II, a<br>prospective, multi-center, randomized, (BackBeat CNT + Medical<br>Therapy vs. Continued Medical Therapy), double-blind, pilot study of<br>pacemaker patients with persistent hypertension<br>-11.1 mmHg<br>in 24-Hour<br>aSBP at 6<br>months<br>-17.5 mmHg<br>in oSBP at<br>2 years<br>0%<br>MACE vs. 9.5%<br>in control group<br>at 6 months<br>85%<br>of patients with<br>reduction in<br>aSBP<br>12 Corporate Presentation Q2 2023
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BackBeat CNT™️ Pivotal Trial Design<br>Current anticipated trial design:<br>Prospective, multi-center, double-blind study investigating the efficacy of BackBeat CNT™ in patients with uncontrolled hypertension<br>(HTN) despite the use of antihypertensive medications, who are indicated for a dual-chamber pacemaker<br>Inclusion and exclusion criteria for enrollment in the BackBeat CNT Pivotal Study will be<br>similar to the criteria used in the MODERATO II study<br>Patients will be randomized 1:1 in a double-blinded manner to either active treatment with BackBeat CNT with continued antihypertensive<br>medications or standard pacing only with continued antihypertensive medications<br>Anticipated primary efficacy and safety endpoints:<br>Efficacy endpoint: Superiority of treatment as compared to control based on mean change in 24-hour aSBP at 3 months post<br>randomization<br>Safety endpoint: Safety assessment will include evaluation of differences in composite cardiovascular adverse events (CCAE)<br>between groups at 12 months<br>Enroll patients across ~80 study sites planned for United States, Europe and, potentially, Japan<br>13 Corporate Presentation Q2 2023
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Virtue® Sirolimus<br>AngioInfusion™️<br>Balloon (SAB)<br>14 Corporate Presentation Q2 2023
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Virtue® SAB Overview<br>1von Birgelen et al. JACC Vol. 59, No. 15, 2012 April 10, 2012:1350–61; Virtue SAB has received Breakthrough Device Designation for: 2The balloon dilatation of the stenotic portion (up to 26 mm length) of a stented<br>coronary artery (in-stent restenosis (ISR)) that is 2.25 to 4.0 mm in diameter, for the purpose of improving lumen diameter; 3The balloon dilation of the de novo stenotic portion (up to 26mm in lesion length) of a<br>native coronary artery of 2.0 mm to 2.5 mm in diameter (small coronary arteries), for the purpose of improving lumen diameter; 4The balloon dilatation of the stenotic portion (up to 18 mm length) of an<br>infrapopliteal artery (P-3 segment or distal, below the knee, with reference vessel diameter (RVD) 2.25 - 4.0 mm), for the purpose of improving lumen diameter.<br>o Artery disease is the leading cause of death in the U.S.<br>and worldwide<br>o Global paradigm shift toward drug-eluting balloons away from stents<br>for the treatment of coronary indications<br>o Current treatment options are suboptimal and are associated with long-term risks and complications<br>Unmet Need<br>o Highly-differentiated, non-coated drug/device combination product<br>candidate designed to reduce long-term complications by enabling<br>angioplasty with protected delivery of extended release sirolimus<br>o Compelling clinical results in multi-center coronary ISR clinical trial with<br>3-year follow-up1<br>o FDA Breakthrough Device Designation received for indications in<br>coronary ISR2<br>, coronary SV3 and BTK4<br>Innovation<br>Collaboration with<br>15 Corporate Presentation Q2 2023
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*Total addressable market in 2025 based on company estimates; Definitions: Coronary Artery Disease (CAD), Peripheral Artery Disease (PAD), In-stent Restenosis (ISR),<br>Small Vessel (SV, ≤2.5mm), High bleeding Risk De Novo (>2.5mm), Below-the-Knee (BTK, Rutherford 3-6, w/out severe comorbidities).<br>Peripheral<br>BTK<br>~1,250,000 patients<br> >$1.2 Billion<br>Coronary<br>ISR, SV De Novo, High Bleed Risk<br>~2,000,000 patients<br> >$1.8 Billion<br> >$3 Billion<br>Annual Global CAD & PAD Market Opportunity*<br>Large Opportunity for Novel AngioInfusion Balloon<br>Artery disease is the primary cause of death worldwide<br> >3.2M<br>Addressable CAD & PAD Patients<br>Large mature market with suboptimal treatments<br>for coronary ISR, coronary SV de novo and BTK<br>Designed to leverage existing treatment paradigm & established<br>technologies: sirolimus and balloon angioplasty<br>Annual Global<br>Opportunity<br>16 Corporate Presentation Q2 2023
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Virtue® SAB<br>Designed to Enable Angioplasty with Protected Sirolimus Delivery while Leaving No Metal Behind<br>AngioInfusion™️ Balloon<br>designed to enable angioplasty with protected drug delivery to dilate vessel, to<br>consistently deliver intended dose and to leave no metal behind<br>1000<br>100<br>10<br>1<br>0.1<br>0.01<br>0.001<br>0.0001<br>Required Therapeutic Concentration > 1ng/mg<br>Lung, liver & kidney below level of assay<br>quantification (0.1 ng/mg) in <1 week<br>0 5 10 15 20 25 30<br>Coronary<br>Distal<br>Kidney<br>Liver<br>Lung<br>Time (Days)<br>N = 753 porcine coronary artery segments<br>Sirolimus Tissue Concentration (ng/mg)<br>SirolimusEFR™️ Formulation<br>provided extended focal release of therapeutic levels of sirolimus<br>through critical healing period (≈30 days)1<br>Precise dose protected in<br>dose unit<br>Protected Delivery/No Drug Coating<br>o No drug loss in transit<br>o No time limits on delivery<br>o No drug coating particulates<br>Inflated to deliver dose through<br>micropores<br>17 Corporate Presentation Q2 2023 1Granada et al. EuroIntervention 2016;12:740-747
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Compelling SABRE Trial Results in Coronary ISR Patients<br>1Verheye et al. JACC Cardiovasc Interv 2017 Oct 23;10(20):2029-2037. DOI: 10.1016/j.jcin.2017.06.021.<br>2Granada 3-Year Clinical Results TCT 2018.<br>3-Year SABRE Trial Clinical Report on file. Definitions: Target lesion failure (TLF), late lumen loss (LLL), target lesion revascularization (TLR) and Myocardial Infarction (MI).<br>Demonstrated Preliminary Safety Data<br>with Low Safety Event Rates Out to 3 Years2<br>Preliminary Efficacy Results Showed<br>Low 0.12mm Late Loss<br>Virtue® SAB preliminarily demonstrated encouraging safety and<br>efficacy results in patients with coronary in-stent restenosis (ISR) in<br>prospective, multi-center SABRE Trial1<br>0.12mm<br>LLL at 6-months<br>2.8%<br>Target Lesion<br>Failure at 1 year<br>0%<br>New TLR between<br>1 to 3 years<br>5.6%<br>2.8% 2.8% 2.8%<br>0% 0% 0% 0% 0% 0% 0%<br>2.8%<br>Cardiac Death TV-MI TLR TLF<br>Event Rates (%)<br>30 days<br>1-year<br>3-years<br>Per Protocol4<br>n 36<br>Reference Vessel Dianeter (RVD) mm1 2.52 ± 0.32<br>Minimum Lumen Diameter (MLD) mm 1.96 ± 0.32<br>% Diameter Stenosis 22.3 ± 9.4<br>Change in % Diameter Stenosis 5.2 ± 11.4<br>Late Lumen Loss (LLL) mm2 0.12 ± 0.33<br>Binary Restenosis3 2.8%<br>1RVD reported using Internormal values; 2Trial primary performance endpoint; 3Trial secondary performance endpoint<br>(binary restenosis = >50% lumen diameter stenosis). 4Data is based on per protocol population criteria revised to be<br>consistent with proposed Virtue ISR-US pivotal study population.<br>18 Corporate Presentation Q2 2023
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Virtue® SAB Coronary ISR US Pivotal Trial<br>Statistical Assumption<br>90% powered for superiority<br>Virtue SAB TLF ≤ 19% vs. PBA TLF ≥ 30%<br>Success Considerations<br>Virtue SAB: 2.8% TLF at 12 months<br>in SABRE trial per protocol population<br>PBA: 33-46% TLF at 12 months<br>in coronary ISR published studies<br>Study Objective<br>Provide additional clinical data in support<br>of use in double-layer Coronary ISR<br>without confounding TLF performance<br>results in single-layer Coronary ISR<br>R<br>Key Inclusion<br>RVD 2.5 to 4.0 mm,<br> <30% DS<br>(vs. RVD 2.5 to 3.5, <40%<br>DS SABRE1 Trial)<br>Randomized Study Arm to Support Regulatory Approval: Single-Layer Coronary ISR<br>Non-Randomized Study Arm: Double-Layer Coronary ISR<br>Primary Endpoint<br>12 Month Primary<br>Endpoint<br>12-18 Months Enrollment<br>Key Inclusion<br>RVD 2.5 to 4.0 mm,<br> <30% DS<br>(vs. RVD 2.5 to 3.5, <40%<br>DS SABRE1 Trial)<br>1Verheye S. JACC Cardiovasc Interv. 2017; 10: 2029-37. Definitions: Coronary In-stent Restenosis (ISR), Diameter Stenosis (DS), Plain Balloon Angioplasty (PBA). Revised per protocol<br>analysis set meets the criteria of the proposed In-Stent Restenosis IDE study population.<br>Double-blind, multi-center, prospective,<br>randomized<br>controlled study<br>in patients with<br>single-layer coronary<br>ISR<br>Prospective,<br>single-arm,<br>controlled study<br>in patients with<br>double-layer coronary<br>ISR<br>Virtue® SAB<br>N=100<br>Target Lesion Failure<br>(CD, TV-MI and TLR) at<br>12 months<br>Virtue® SAB<br>N=200<br>PBA<br>N=100<br>Primary Endpoint<br>Target Lesion Failure<br>(CD, TV-MI and TLR) at<br>12 months<br>19 Corporate Presentation Q2 2023
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2023 - Anticipated Milestones<br>BackBeat CNT<br>HTN + Pacemaker 1<br>st Pt. Enrollment<br>Planned Regulatory Milestones Planned Clinical Milestones<br>BackBeat CNT<br>HTN + Pacemaker FDA IDE Approval<br>Virtue SAB<br>Virtue-ISR US FDA IDE Approval<br>Japan PMDA CTN Coronary ISR Approval1<br>Japan PMDA CTN Coronary SV Approval1<br>1Timing estimated and subject to Terumo execution since Terumo controls development of Virtue SAB for SV indication and for ISR in Japan<br>Virtue SAB<br>Virtue-ISR US 1st Pt. Enrollment<br>CNT-HF and SirolimusEFR<br>Program Updates<br>20 Corporate Presentation Q2 2023
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Bringing<br>Medical<br>Innovations<br>to Life<br>Through<br>Partnerships<br>Two Programs Targeting Large<br>Markets Supported<br>by Promising Trial Data<br>Entering Pivotal Trials<br>Strong Balance Sheet<br> & Committed<br>Strategic & Financial<br>Investors<br>Partnership-Enabled<br>Business Model &<br>Accomplished<br>Leadership Team<br>Designed to accelerate<br>innovation to patients,<br>enable pipeline expansion<br>and drive strong partner<br>and shareholder value<br>Highly experienced<br>team with proven<br>track record<br>of innovation and<br>execution<br>Virtue® SAB<br>BackBeat CNT™️<br> ∼$3 billion annual market<br>3-year pilot study results show<br>potential safety & efficacy<br>Partnered with<br> >$10 billion annual market<br>Randomized, controlled study<br>shows efficacy potential<br>Collaboration with<br>21 Corporate Presentation Q2 2023
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