- New pharmacokinetic data demonstrate Virtue®
SAB enables extended release of sirolimus above required tissue concentrations in target arterial sites without polymer degradation or detectable remaining polymer within 90 days of balloon delivery - AVIM therapy presentation highlighted recent clinical results showing favorable hemodynamic effects and long-term reduction in 24-hour ambulatory systolic blood pressure, as well as the design of the BACKBEAT global pivotal study now enrolling in collaboration with
Medtronic, plc (NYSE:MDT)
Virtue SAB Oral Presentation, presented by
Dr. Kereiakes’ presentation, focused on the role of drug-coated and drug-eluting balloon angioplasty systems for the treatment of coronary in-stent restenosis (“ISR”), outlined key points of differentiation and potential advantages for Virtue SAB, including:
- No surface drug coating and, therefore, no drug loss in-transit to a target arterial lesion or creation of large particulates during balloon inflation
- Focal uptake and extended release of sirolimus at tissue concentrations greater than the 1 ng/mg tissue concentration known to be required for effective control of cellular proliferation through the critical healing period.
- Supported by published preclinical data of over 750 coronary artery balloon treatments
- New preclinical PK data demonstrating that SostenocelTM, the proprietary polymer system enabling Virtue SAB’s SirolimusEFR, was shown to be eliminated in SirolimusEFR-treated stented arteries without detectable degradation, which can lead to localized tissue inflammation. Specifically, the presented PK data showed that:
- Sostenocel was undetectable at 90 days in treated arteries and at 3 days in all non-target tissues
- Molecular weight of Sostenocel remained unchanged prior to elimination, showing no evidence of in-vivo degradation.
“Virtue SAB represents a therapeutic innovation that may provide a reliable method to deliver the proven benefits of sirolimus, the gold standard therapeutic used in drug-eluting stents, during balloon angioplasty for the treatment of coronary in-stent restenosis without the potential risks associated with a permanent metal implant or a balloon surface coating,” commented
The
AVIM Therapy Oral Presentation, presented by
- The BACKBEAT global pivotal study design
- Recently reported clinical results from a long-term follow-up study showing sustained reductions of 8.9 mmHg in 24-hour ambulatory systolic blood pressure at a mean of 3.6 years from treatment activation in AVIM-treated patients
- Results from a new clinical study evaluating the impact of AVIM therapy compared to standard pacing using invasive pressure-volume loop analysis in 16 hypertensive pacemaker-indicated patients. AVIM therapy demonstrated:
- Consistent favorable hemodynamic effects using both conduction system, as well as traditional right ventricular lead placements.
- Statistically significant reductions in systolic blood pressure, intra-cardiac volumes, total peripheral resistance and stroke work, with no significant changes in stroke volume or contractility.
“The new data showing the long-term durability of blood pressure reduction in AVIM-treated patients, as well as the clear, favorable hemodynamic impact of AVIM therapy’s mechanism of action reinforces my belief in the potential benefit this novel therapy can offer hypertensive patients in the pacemaker population and beyond,” said
Orchestra
About Orchestra BioMed
Orchestra
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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 and design of the BACKBEAT pivotal study, the potential efficacy and safety of the Company’s commercial product candidates, the ability of the Company’s partnerships to accelerate clinical development, and the Company’s late-stage development programs, strategic partnerships and plans to expand its product pipeline. 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 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 quarterly report on Form 10-Q filed with the
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.
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Media Contact:
Orchestra
(484) 682-4892
kkirkellis@orchestrabiomed.com
Source:
2024 GlobeNewswire, Inc., source