Orchestra BioMed Reports Third Quarter 2026 Financial Results and Highlights Recent Business Updates

BACKBEAT enrollment is complete, but Medtronic’s planned marketing submission depends on positive trial results.

Rhea-AI Summary

Orchestra BioMed (Nasdaq: OBIO) reported a third-quarter 2026 loss attributable to common stockholders of $19.6 million as pivotal trials advanced. Loss per share narrowed to $0.30 from $0.40 a year earlier, while revenue fell to $91,000 from $861,000.

The BACKBEAT trial completed enrollment with 349 patients randomized, exceeding its target. Primary endpoint results are planned for submission for presentation consideration at HRS 2027. Medtronic plans an FDA marketing application supplement after presentation, assuming positive results. The Virtue trial targets enrollment completion by the end of 2027.

A public offering closed November 9, 2026, issuing 17,250,000 shares at $5.00 and raising approximately $80.5 million net. Cash, cash equivalents and marketable securities totaled $101.9 million at September 30, excluding the offering. Orchestra projects these funds and offering proceeds will support operations through 2028.

11 points · 1 major

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1 major · 11 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointApproximately $80.5 million net proceeds raised in the public offering closed November 9, 2026. 23% of market cap
• Moderate pointBACKBEAT enrollment completed above target, with 349 patients randomized across 92 sites in 15 countries.
• Moderate point$6.1 million milestone payment received September 14 in connection with Haemonetics’ acquisition of Vivasure. 1.7% of market cap
• Moderate pointQ3 common-stockholder loss narrowed to $19.617 million, or $0.30 per share, from $20.828 million, or $0.40.
• Minor point. Forward-looking: it has not happened yet and may not happen.Projected cash runway through 2028 includes September liquidity and public offering proceeds.

6 minor points

• Minor point. Forward-looking: it has not happened yet and may not happen.HRS 2027 presentation consideration is planned for BACKBEAT primary endpoint results.
• Minor pointFDA written confirmation establishes a premarket approval supplement as Medtronic’s AVIM Therapy marketing submission pathway.
• Minor point. Forward-looking: it has not happened yet and may not happen.Virtue trial site activation and enrollment advanced; enrollment completion is targeted by the end of 2027.
• Minor pointQ3 selling, general and administrative expenses decreased 21% to $5.6 million from $7.1 million a year earlier.
• Minor pointQ3 product revenue costs decreased to $28,000 from $49,000 a year earlier.
• Minor pointQ3 non-cash stock compensation decreased to $2.3 million from $3.0 million a year earlier.

Negative

• Major point17,250,000 new common shares at $5.00 each dilute existing shareholders.
• Moderate pointQ3 operating loss widened to $23.296 million from $20.313 million a year earlier.
• Moderate pointQ3 operating and fixed-asset cash use increased to $19.9 million from $14.9 million a year earlier.
• Moderate pointQ3 research and development expenses increased 26% to $17.7 million from $14.0 million a year earlier.
• Moderate pointNote payable reached $21.152 million at September 30, 2026, versus none at December 31, 2025.
• Moderate pointRoyalty purchase agreement liability increased to $36.795 million from $16.482 million at December 31, 2025.
• Moderate pointStockholders’ equity declined to $7.782 million from $53.570 million at December 31, 2025.

4 minor points

• Minor point. Forward-looking: it has not happened yet and may not happen.Medtronic’s planned AVIM submission depends on positive BACKBEAT results and follows primary endpoint presentation.
• Minor pointQ3 revenue declined to $91,000 from $861,000 a year earlier.
• Minor pointQ3 net interest expense increased to $2.463 million from $515,000 a year earlier.
• Minor pointLoan payable increased to $14.462 million from $14.268 million at December 31, 2025.

News Explained

The November 9 common-stock offering is closed; issuing additional shares reduces existing holders’ percentage ownership absent offsetting changes, while the company receives the net proceeds.

Key Figures

BACKBEAT patients randomized: 349 patients Virtue Trial planned enrollment: Approximately 740 patients Public offering net proceeds: Approximately $80.5 million +5 more

BACKBEAT patients randomized

349 patients

Enrollment completed; the article says the trial exceeded its enrollment target

Virtue Trial planned enrollment

Approximately 740 patients

Completion target by the end of 2027

Public offering net proceeds

Approximately $80.5 million

Underwritten public offering closed November 9, 2026

Offering shares and price

17,250,000 shares at $5.00 per share

Underwritten public offering

Cash, cash equivalents and marketable securities

$101.9 million

As of September 30, 2026; the company projected cash runway through 2028 including offering proceeds

Net cash used in operations and fixed-asset purchases

$19.9 million, compared with $14.9 million

Third quarter 2026 versus third quarter 2025

Research and development expenses

$17.7 million, compared with $14.0 million

Third quarter 2026 versus third quarter 2025; increase of 26%

Net loss attributable to common stockholders

$19.6 million, or $0.30 per share, compared with $20.8 million, or $0.40 per share

Third quarter 2026 versus third quarter 2025

Previous Earnings Reports

1 past event · Latest: Aug 10

Same Type 1 event

1. Aug 10

   Quarterly results

   24h Move

   +1.4%

   Reported BACKBEAT progress and $110.0 million in quarter-end cash, with projected runway into Q4 2027.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

pma supplement, investigational device exemption, non-inferiority trial, in-stent restenosis, +1 more

5 terms

pma supplement regulatory

"submit AVIM Therapy Premarket Approval (“PMA”) supplement to the FDA"

A PMA supplement is a regulatory filing submitted to the U.S. Food and Drug Administration to request approval for changes to a medical device that already has premarket approval. Think of it like asking permission to alter a trusted product’s recipe, packaging, or manufacturing process; the agency reviews whether the change affects safety or performance. For investors, the outcome influences how quickly a modified product can be sold, the cost and risk of bringing updates to market, and potential sales or liability impacts.

investigational device exemption regulatory

"Company’s U.S. Investigational Device Exemption (“IDE”) pivotal trial"

An investigational device exemption (IDE) is a regulatory permission that allows a medical device maker to test an unapproved device in people so the device’s safety and effectiveness can be studied. For investors, an IDE matters because it marks a formal step toward regulatory approval—like getting a temporary test-drive permit—and influences clinical cost, timelines, and the likelihood a device will reach the market and generate revenue.

non-inferiority trial medical

"randomized, single-blind, non-inferiority trial"

A non-inferiority trial is a clinical study designed to show that a new treatment or drug is not meaningfully worse than an existing standard therapy by a pre-set amount. For investors, these trials matter because they can enable regulatory approval and market entry when a new product offers similar benefit with other advantages (lower cost, easier use, fewer side effects); think of it like proving a new smartphone’s battery lasts nearly as long as the market leader so buyers will consider it.

in-stent restenosis medical

"balloon for coronary in-stent restenosis (“ISR”)"

In-stent restenosis is the re-narrowing of an artery at the site where a metal or drug-coated tube (stent) was placed to keep it open, caused by scar tissue or cell growth inside the stent. For investors, it matters because it drives demand for follow-up treatments, influences the perceived effectiveness and safety of stent products, and can affect regulatory scrutiny, reimbursement and long-term sales for companies that make stents or therapies to prevent or treat re-narrowing.

paclitaxel-coated balloon medical

"commercially available AGENT™ paclitaxel-coated balloon"

A paclitaxel-coated balloon is a thin, inflatable medical balloon used inside blood vessels during minimally invasive procedures that carries a layer of the drug paclitaxel on its surface; when the balloon is briefly inflated, the drug transfers to the vessel wall to help prevent the artery from re-narrowing. Think of it like a paint-coated balloon that deposits a protective coat where it’s needed. Investors care because clinical results, safety signals, regulatory approval, reimbursement and potential legal exposure directly affect sales, market adoption and company valuations.

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• BACKBEAT Global Pivotal Trial evaluating AVIM Therapy completed enrollment and exceeded enrollment target, with a total of 349 patients randomized.
• BACKBEAT Trial primary endpoint data planned to be submitted for late-breaking presentation at the Heart Rhythm Society 2027 (“HRS 2027”).
• Medtronic planning to submit AVIM Therapy Premarket Approval (“PMA”) supplement to the FDA following data presentation, assuming positive trial results.
  
• Site activation and patient enrollment accelerating in the Virtue Trial, the Company’s U.S. Investigational Device Exemption (“IDE”) pivotal trial comparing Virtue SAB head-to-head with the commercially available AGENT™ paclitaxel-coated balloon for coronary In-Stent Restenosis.
• Raised approximately $80.5 million in net proceeds through an underwritten public offering of common stock, which closed on November 9, 2026, including proceeds from the underwriters’ full exercise of their option to purchase additional shares. 
• $101.9 million of cash and cash equivalents, and marketable securities as of September 30, 2026 and public offering proceeds provide projected cash runway through 2028.
  
• Company hosting R&D Day on Thursday, November 12, 2026, in New York City and via live webcast, featuring in-depth reviews of AVIM Therapy and Virtue SAB with leading physician investigators.
  
  

NEW HOPE, Pa., Nov. 10, 2026 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies, today announced financial results for the third quarter ended September 30, 2026, and provided a business update on its two pivotal-stage investigational cardiovascular programs: Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) for the treatment of uncontrolled hypertension, for which the Company has a strategic collaboration with Medtronic (NYSE: MDT) for the treatment of pacemaker-indicated patients, and Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”) for the treatment of coronary artery disease.

David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed, stated, “With the completion of enrollment of the BACKBEAT Trial, AVIM Therapy is nearing pivotal primary endpoint results. Alongside our collaborators at Medtronic, we now move to the completion of three-month follow-up in all patients, locking the primary endpoint database, and submitting a robustly powered data set for late-breaking presentation at HRS 2027 in May. We believe the results from the BACKBEAT Trial could set AVIM Therapy on a clear course to redefining the clinical impact of cardiac pacing and provide a powerful new therapeutic option for millions of higher-risk hypertensive patients who remain above blood pressure target despite medication.”

Hochman continued, “The third quarter also saw Virtue Sirolimus AngioInfusion™ Balloon advance in its own IDE pivotal, randomized trial. The Virtue^® Trial is testing Virtue SAB’s fundamentally different approach to arterial drug delivery, liquid infusion of SirolimusEFR™ directly into the vessel wall without the need for a fragile balloon coating. We are also grateful to our new and existing shareholders that participated in the oversubscribed public equity offering we closed yesterday. The net proceeds from our public offering along with the over $100 million we had at the end of the quarter provide funding through 2028. We are in a strong position to deliver key value-creating milestones for both pivotal stage programs and support Medtronic as they drive toward potential global commercialization of AVIM Therapy. We look forward to showcasing both of our high-impact therapeutic device platforms at our investor R&D Day this Thursday, where leading physician investigators will join us to examine the clinical and commercial potential of AVIM Therapy and Virtue SAB.”

Q3 2026 and Recent Business Highlights:

• Completed enrollment in the BACKBEAT Trial in collaboration with Medtronic. A total of 349 patients with uncontrolled hypertension and an implanted dual-chamber pacemaker were randomized across 92 sites in 15 countries. Orchestra BioMed and Medtronic intend to submit primary endpoint results for late-breaking presentation consideration at HRS 2027.
• Received written confirmation from FDA that Medtronic's marketing submission for AVIM Therapy will be a PMA supplement. The submission is planned to be made promptly following presentation of the primary endpoint results of the BACKBEAT Trial, assuming positive trial results.
• Advanced site activation and patient enrollment in the Virtue Trial, the Company’s U.S. IDE pivotal trial comparing Virtue SAB head-to-head with the commercially available AGENT™ paclitaxel-coated balloon for coronary in-stent restenosis (“ISR”). The prospective, multicenter, randomized, single-blind, non-inferiority trial has a planned enrollment of approximately 740 patients, with an enrollment completion target date by the end of 2027.
  
• Virtue SAB mechanistic and clinical evidence presented at Transcatheter Cardiovascular Therapeutics 2026. On November 1, 2026, Allen Jeremias, MD, Co-Principal Investigator of the Virtue Trial, presented Virtue SAB’s differentiated mechanism of action for infusing a large liquid volume of submicron, particle-encapsulated SirolimusEFR™ directly into the vessel wall. Dr. Jeremias also outlined existing preclinical and clinical evidence and the pivotal IDE trial design.
• AVIM Therapy was featured in two sessions at HRX Live 2026 in Atlanta, including a sponsored roundtable on the Medtronic–Orchestra BioMed strategic collaboration and a panel exploring the expanding role of permanent cardiac pacing beyond bradycardia. The discussions highlighted AVIM Therapy’s mechanism of action, clinical evidence and potential in hypertensive heart disease. A recording of the roundtable is available on the Company’s website.
• Received a $6.1 million milestone payment on September 14, 2026, in connection with Haemonetics Corporation’s (NYSE: HAE) acquisition of Vivasure Medical Limited (“Vivasure”). Together with approximately $5 million received in January 2026, total cash proceeds received from the transaction are approximately $11 million. The FDA recently approved the PerQseal® Elite vascular closure system, originally developed by Vivasure, for large-bore arterial procedures.
  
  

Public Offering

On November 9, 2026, the Company closed an underwritten public offering of 17,250,000 shares of its common stock at a price to the public of $5.00 per share, resulting in net proceeds to the Company of approximately $80.5 million (including proceeds from the underwriters’ full exercise of their option to purchase additional shares), after deducting underwriting discounts and commissions and estimated offering expenses (the “Public Offering”).

R&D Day: Thursday, November 12, 2026

The Company will host its R&D Day on Thursday, November 12, 2026, at 3:00 p.m. ET in New York City and via live webcast. Company leadership, leading cardiologists and trial investigators will discuss the clinical and treatment burden associated with uncontrolled hypertension in pacemaker-indicated patients and restenosis in coronary stent interventions, the potential for AVIM Therapy and Virtue SAB to address these unmet needs, key upcoming clinical milestones and the commercial potential of AVIM Therapy and Virtue SAB. Physician speakers include Vivek Reddy, MD, Marat Fudim, MD, Dean Kereiakes, MD, and Allen Jeremias, MD. Webcast of the R&D Day is available for registered participants and a replay of the event will be available through the Investors section of the Company’s website.

Financial Results for the Third Quarter Ended September 30, 2026

• Cash and cash equivalents and Marketable securities totaled $101.9 million as of September 30, 2026, not including the $80.5 million in net proceeds from the Public Offering.
• Net cash used in operating activities and for the purchase of fixed assets was $19.9 million during the third quarter of 2026, compared with $14.9 million for the third quarter in 2025, with the primary drivers being increased research and development costs, including clinical trial activities, as well as personnel and consulting expenditures during the third quarter of 2026.
• Research and development expenses for the third quarter of 2026 were $17.7 million, compared with $14.0 million for the third quarter in 2025, which represents an increase of 26%. The increase was primarily due to additional costs associated with the ongoing BACKBEAT Trial and to advance the Virtue SAB program, including the Virtue Trial.
• Selling, general and administrative expenses for the third quarter of 2026 were $5.6 million, compared with $7.1 million for the third quarter of 2025, which represents a decrease of 21%. The decrease was primarily due to a decrease in legal and professional fees.
• Net loss attributable to common stockholders for the third quarter of 2026 was $19.6 million, or ($0.30) per share, compared with a net loss attributable to common stockholders of $20.8 million, or ($0.40) per share, for the third quarter of 2025, which represents a decrease of 6%. Net loss attributable to common stockholders for the third quarter of 2026 included $3.4 million in net interest expense for the third quarter of 2026 as compared to $1.2 million for the same period in 2025, of which a portion was non-cash in each period. Non-cash stock-based compensation expense was $2.3 million as compared to $3.0 million for the same period in 2025.
  
  

About Orchestra BioMed

Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates, Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB), are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities.

AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered by a pacemaker and achieve immediate, substantial, and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic (NYSE: MDT), one of the largest medical device companies in the world and the global leader in cardiac pacing therapies, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has two FDA Breakthrough Device Designations. The BACKBEAT Trial has completed enrollment.

Virtue SAB is a first-of-its-kind, non-coated drug delivery AngioInfusion balloon system designed to infuse a large liquid dose of a proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB exceeded the published tissue concentrations of leading limus drug-eluting stents and demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multicenter, prospective, independent core laboratory–adjudicated pilot clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary in-stent restenosis, coronary small vessel disease, and below-the-knee peripheral artery disease, in each case, within specified parameters. The Virtue Trial evaluating Virtue SAB for the treatment of coronary in-stent restenosis is currently enrolling patients.

CAUTION: Investigational devices. Limited by United States law to investigational use.

For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn.

Forward-Looking Statements

Certain statements included in this press release 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 enrollment, timing, implementation, results and design of the Company’s ongoing pivotal trials, the timing of the presentation of clinical data, the timing of regulatory submissions, realizing the clinical and commercial value of AVIM Therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, the size of the potential markets for the Company’s product candidates, the ability of the Company’s partnerships to accelerate clinical development and the Company’s projected cash runway. These statements are based on various assumptions, whether or not identified in this press release, 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 commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; 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 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 12, 2026. 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 press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law.

Investor Contact:
Silas Newcomb
Orchestra BioMed
snewcomb@orchestrabiomed.com

Media Contact:
Nina Premutico
Orchestra BioMed
npremutico@orchestrabiomed.com

ORCHESTRA BIOMED HOLDINGS, INC. Condensed Consolidated Balance Sheets (in thousands, except share and per share data) (Unaudited)
	September 30,				December 31,
	2026				2025
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$	27,761			$	34,690
Marketable securities		74,146				71,822
Accounts receivable, net		56				95
Inventory		221				310
Prepaid expenses and other current assets		987				994
Total current assets		103,171				107,911
Property and equipment, net		2,284				1,715
Right-of-use assets		1,001				1,496
Strategic investments		—				2,495
Deposits and other assets		1,280				1,240
TOTAL ASSETS	$	107,736			$	114,857
LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable	$	5,030			$	6,095
Accrued expenses and other liabilities		8,367				9,890
Operating lease liability, current portion		831				751
Total current liabilities		14,228				16,736
Royalty purchase agreement		36,795				16,482
Note payable		21,152				—
Loan payable		14,462				14,268
Derivative liability		1,593				2,749
Operating lease liability, less current portion		304				936
Other long-term liabilities		456				308
TOTAL LIABILITIES		88,990				51,479
Series A Preferred Stock, $0.0001 par value per share; 200,000 issued and outstanding at September 30, 2026 and December 31, 2025; aggregate liquidation preference of $20,000		10,964				9,808
STOCKHOLDERS’ EQUITY
Preferred stock, $0.0001 par value, 10,000,000 shares authorized		—				—
Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 61,453,041 and 57,032,963 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively.		6				6
Additional paid-in capital		433,704				416,083
Accumulated other comprehensive (loss) income		(153	)			60
Accumulated deficit		(425,775	)			(362,579	)
TOTAL STOCKHOLDERS’ EQUITY		7,782				53,570
TOTAL LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY	$	107,736			$	114,857

ORCHESTRA BIOMED HOLDINGS, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (Unaudited)
	Three Months Ended September 30,
	2026				2025
Revenue:
Partnership revenue	$	—			$	721
Product revenue		91				140
Total revenue		91				861
Expenses:
Cost of product revenues		28				49
Research and development		17,734				14,027
Selling, general and administrative		5,625				7,098
Total expenses		23,387				21,174
Loss from operations		(23,296	)			(20,313	)
Other income (expense):
Interest expense, net		(2,463	)			(515	)
Change in the fair value of derivative liability		867				—
Gain on sale of strategic investments		6,142				—
Total other income (expense)		4,546				(515	)
Net loss		(18,750	)			(20,828	)
Adjustment to carrying value of Series A Preferred Stock		(867	)			—
Net loss attributable to common stockholders	$	(19,617	)		$	(20,828	)
Net loss attributable to common stockholders per share
Basic and diluted	$	(0.30	)		$	(0.40	)
Weighted-average shares used in computing net loss attributable to common stockholders per share, basic and diluted		64,620,127				52,186,503
Comprehensive loss
Net loss	$	(18,750	)		$	(20,828	)
Unrealized (loss) gain on marketable securities		(72	)			29
Comprehensive loss	$	(18,822	)		$	(20,799	)

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How much did Orchestra BioMed raise in its November 2026 stock offering?

Orchestra BioMed raised approximately $80.5 million in net proceeds from an offering of 17,250,000 common shares at $5.00 per share, closed November 9, 2026. The proceeds include the underwriters’ full exercise of their additional-share option and reflect underwriting discounts, commissions and estimated offering expenses.

When are Orchestra BioMed’s BACKBEAT trial results expected to be presented?

Orchestra BioMed and Medtronic intend to submit BACKBEAT primary endpoint results for late-breaking presentation consideration at HRS 2027 in May. Enrollment is complete, with 349 patients randomized. Medtronic plans to submit an FDA premarket approval supplement promptly after presentation, assuming positive trial results.

What does Orchestra BioMed’s Virtue pivotal trial compare?

The Virtue trial compares Virtue SAB with the commercially available AGENT paclitaxel-coated balloon for coronary in-stent restenosis, or renewed narrowing inside a coronary stent. The prospective, multicenter, randomized, single-blind trial tests whether Virtue SAB is not inferior to its comparator and plans to enroll approximately 740 patients.