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Leveljump Healthcare Corp. Acquires Additional 2.3% of Real Time Medical; Exercises Right to Acquire Additional 1.5% of Shaw Lens and Shaw Vision; Provides Corporate Update

LevelJump Healthcare Corp. (TSXV: JUMP) (OTCQB: JMPHF) (FSE: 75J) ("Leveljump" or the "Company"), a Canadian leader in B2B telehealth solutions, is pleased to announce that, subject to regulatory approval, it has agreed to acquire an additional 2.3% minority equity interest in Real Time Medical Inc. ("RTM"), a private Ontario company, in exchange for 392,875 units (a "Unit") of Leveljump. Each Unit will be issued at a price of $0.50 per Unit with each Unit being comprised of three (3) Leveljump common shares at a deemed price of $0.15 per share and one (1) share purchase warrant of Leveljump, each warrant entitling the holder to acquire one additional common share of Leveljump at a price of $0.35 per common share on or before December 31, 2023.

Leveljump will now own a 16.9% interest in RTM.

Closing of the RTM purchase is subject to the consent of the TSX Venture Exchange (the "Exchange"). For further information regarding the Company's interest in RTM, please see the Company's news release dated November 25, 2021.

All securities issued will be subject to a hold period of four months and one day pursuant to applicable securities laws.

Shaw Companies

Leveljump has agreed to exercise its right of first refusal to purchase a further 1.5% minority interest in each of Shaw Lens Inc. and Shaw Vision Inc. for a total price of $15,000. The Company will be advised in approximately 30 days if it will receive the full allotment of the 1.5% interest or if other shareholders of the Shaw companies will also exercise their rights and if the shares will be pro-rated amongst all existing shareholders who make a claim to purchase the shares.

If the Company receives the full allotment of the shares for sale it will then own approximately 25.3% in the Shaw companies.

For further information regarding the Company's interest in Shaw Lens Inc. and Shaw Vision Inc., please see the Company's news release dated August 31, 2021.

Management Purchase of Shares

Subject to the consent of the Exchange and, where required, disinterested shareholder approval, both the CEO and CFO of the Company have agreed to convert an aggregate of $240,000 in accrued salary into common shares of the Company at an issue price of $0.12 per share for a total of 2,000,000 shares.

Under Exchange rules, an aggregate of up to $120,000 of the accrued salary may be converted into 1,000,000 shares without prior disinterested shareholder approval. The remaining $120,000 (1,000,000 shares) will be converted once disinterested shareholder approval has been obtained. Such approval is expected to be sought at the next annual meeting of shareholders to be held in Q2 2022.

IHF Purchase Update

The purchase of the IHF centers announced on September 28, 2021 is targeting to close towards the end of January 2022. Financing has been secured and the Company is awaiting license transfer permission from the Ministry of Health in order to close the transaction. Management is working with the seller to transfer all vendor accounts and ensure a smooth transition.

Telehospital Purchase

The Company is underway with its diligence and audit of Telehospital and working diligently on licensing and transition planning for the acquisition.

For further information regarding this transaction, please see the Company's news release dated October 1, 2021.

CTS Operations Update

CTS continues to see strong demand for its services and 2021 Q4 appears to continue this trend. The switchover from the Company's legacy PACS system to the new RamSoft PACS will be completed in Q1 2022 and will offer a more efficient workflow for radiologist users and hospital clients. The switch will help reduce costs of goods sold and increase gross margins.

Director and Management Options

Leveljump has issued options to each of its three new independent directors as disclosed in the news release on December 7th, 2021. Each of the new directors will receive 300,000 options that will vest at a rate of 1/12 per month and are exercisable at a price of $0.20 prior to December 31, 2023. The independent directors will also receive a monthly stipend of $800 per month.

The two executive directors have each been issued 500,000 options that will vest at a rate of 1/12 per month and are exercisable at a price of $0.20 prior to December 31, 2023.

Additionally, the CEO and CFO have each been issued 1,800,000 options, which will represent their total employment option grant over the next 3 years, that will vest at a rate of 1,000,000 on January 1, 2022, and 400,000 on January 1, 2023, and 400,000 on January 1, 2024. The exercise price on the options is $0.25 per share, exercisable prior to December 31, 2025.

About Leveljump Healthcare

LevelJump Healthcare Corp., (TSXV: JUMP) (OTCQB: JMPHF) (FSE: 75J) is a healthcare company with a focus on profitable telehealth solutions as well as primary care services in radiology. The Company's subsidiary, CTS, provides off-site radiology readings for hospital emergency rooms and is a leader in the teleradiology space in Ontario. As part of our growth strategy, we are acquiring healthcare companies that have strong revenue and cash flow, with room for organic growth.

ON BEHALF OF THE BOARD OF DIRECTORS OF
LevelJump Healthcare Corp.

Mitchell Geisler, Chief Executive Officer
info@leveljumphealthcare.com
(833) 840-2020

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION

This news release contains "forward-looking information" within the meaning of applicable securities laws relating to the Company's business plans and the outlook of the Company's industry. Although the Company believes, in light of the experience of its officers and directors, current conditions and expected future developments and other factors that have been considered appropriate, that the expectations reflected in this forward-looking information are reasonable, undue reliance should not be placed on them because the Company can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. The statements in this press release are made as of the date of this release and the Company assumes no responsibility to update them or revise them to reflect new events or circumstances other than as required by applicable securities laws. The Company undertakes no obligation to comment on analyses, expectations or statements made by third parties in respect of the Company, Canadian Teleradiology Services, Inc., their securities, or their respective financial or operating results (as applicable).

Neither the Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Exchange) accepts responsibility for the adequacy or accuracy of this release.

The securities being offered have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") or any U.S. state securities laws, and may not be offered or sold in the United States or to, or for the account or benefit of, United States persons absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities in the United States, nor in any other jurisdiction.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/107931

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Leveljump Healthcare Corp. Acquires Additional 7.82% of Real Time Medical

Leveljump Healthcare Corp. Acquires Additional 7.82% of Real Time Medical

LevelJump Healthcare Corp. (TSXV: JUMP) (OTCQB: JMPHF) (FSE: 75J) ("Leveljump" or the "Company"), a Canadian leader in B2B telehealth solutions, is pleased to announce that, subject to regulatory approval and RTM board approval, it has agreed to acquire an additional 7.82% minority equity interest in Real Time Medical Inc. ("RTM"), a private Ontario company, in exchange for 1,335,961 units (a "Unit") of Leveljump. Each Unit will be issued at a price of $0.65 per Unit with each Unit being comprised of five (5) Leveljump common shares at a deemed price of $0.12 per share and one (1) share purchase warrant of Leveljump, each warrant entitling the holder to acquire one additional common share of Leveljump at a price of $0.35 per common share on or before December 31, 2023.

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Ministry of Health Grants Approval for License Transfer of IHF to JUMP

Ministry of Health Grants Approval for License Transfer of IHF to JUMP

LevelJump Healthcare Corp. (TSXV: JUMP) (OTCQB: JMPHF) (FSE: 75J) ("Leveljump" or the "Company"), a Canadian leader in B2B telehealth solutions, is pleased to announce that it has received approval from the Ontario Ministry of Health for the transfer, from the sellers to JUMP, of one of the three IHF ("Independent Health Facilities") licenses previously disclosed in a press release dated September 28th, 2021. Additionally, the Ministry has expanded the license of this IHF to include additional billing codes and procedures, which will allow the Company to offer more services to the local community as well as to increase the revenues of this IHF location.

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UPDATED - Leveljump Healthcare Corp. Announces 14.6% Minority Investment in Real Time Medical Approved by TSXV and Closed

UPDATED - Leveljump Healthcare Corp. Announces 14.6% Minority Investment in Real Time Medical Approved by TSXV and Closed

LevelJump Healthcare Corp. (TSXV: JUMP) (OTCQB: JMPHF) (FSE: 75J) ("Leveljump" or the "Company"), a Canadian leader in B2B telehealth solutions, is pleased to announce that, it has received TSXV approval, and has closed its acquisition of a 14.6% minority equity interest in Real Time Medical Inc. ("RTM"), a private Ontario company, in exchange for 2,494,576 units (a "Unit") of Leveljump. Each Unit will be issued at a price of $0.66 per Unit with each Unit being comprised of three (3) Leveljump common shares at a deemed price of $0.22 per share and one (1) share purchase warrant of Leveljump, each warrant entitling the holder to acquire one additional common share of Leveljump at a price of $0.35 per common share on or before December 31, 2023.

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Leveljump Healthcare Strengthens Board of Directors

Leveljump Healthcare Strengthens Board of Directors

LevelJump Healthcare Corp. (TSXV: JUMP) (OTCQB: JMPHF) (FSE: 75J) ("Leveljump" or the "Company"), a Canadian leader in B2B telehealth solutions, is pleased to announce new additions to its board of directors and its advisory board.

Gary Prihar - Director

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Leveljump Q3 Earnings and Results; Record Quarterly Revenues

Leveljump Q3 Earnings and Results; Record Quarterly Revenues

LevelJump Healthcare Corp. (TSXV: JUMP) (OTCQB: JMPHF) (FSE: 75J) ("Leveljump" or the "Company"), a Canadian leader in B2B telehealth solutions, is pleased to announce today it has reported financial results for the third fiscal quarter ended September 30th, 2021. All amounts are expressed in Canadian dollars.

Financial and Operational Highlights

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Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

  • One-year clinical trial data for the next-generation, investigational, Sphere-360â„¢ single-shot PFA catheter show impressive safety, performance, and efficiency results for paroxysmal Afib
  • Dual-energy (RF/PF), focal Sphere-9â„¢ catheter demonstrates efficacy for linear ablation in persistent AFib
  • Medtronic continues legacy of leadership in innovation, showcasing arrhythmia management portfolio at Heart Rhythm Society annual meeting

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced positive clinical outcomes from two studies in atrial fibrillation (AFib) patients treated with the Afferaâ„¢ family of technologies, including the next-generation Sphere-360â„¢ single-shot pulsed field ablation (PFA) catheter and the groundbreaking Sphere-9â„¢ combination mapping and dual-energy focal PFA catheter. Data were presented in High Impact Science Sessions at the Heart Rhythm Society 2025 Annual Meeting in San Diego ; the Sphere-360 study was simultaneously published in the Heart Rhythm Journal .

(PRNewsfoto/Medtronic plc)

Sphere-360 Study Safety and Performance

Sphere-360 is an investigational, first-of-its-kind, single-shot PFA mapping and ablation catheter for treatment of paroxysmal atrial fibrillation (PAF). Results for Sphere-360 at one year, in a prospective, single-arm, multi-center trial performed in European centers, demonstrated freedom from arrhythmia recurrence in 88% of patients, with chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins and no reported safety events in a sub-group treated with the most optimized waveform. The Sphere-360 catheter has a large, conformable lattice design that can be modified into various shapes, is seamlessly integrated with the Affera Mapping and Ablation System and utilizes an 8.5 Fr sheath – the smallest in any single-shot PFA technology.

"The Affera technology is a sophisticated ecosystem, including an advanced, intuitive mapping system and catheters that are seamlessly integrated to offer treatment options for different cardiac arrhythmias. It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation," said Vivek Reddy , M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City . "The study results showed Sphere-360 has a promising safety and performance profile with zero serious adverse events observed. Upon approval, Sphere-360 will be a valuable addition to Medtronic's Affera system, which has been a game changer for Afib treatment and physician workflow."

Medtronic intends to begin its U.S. pivotal trial for the Sphere-360 catheter later this calendar year. Worldwide, Sphere-360 is currently investigational and not approved for sale or distribution.

Sphere-9 for Linear Ablation

Additionally, in a sub-analysis from the Sphere Per-AF IDE study , results demonstrated that the Sphere-9 catheter can be used safely and effectively to create linear lesions in persistent AF patients. Linear ablation is often used in conjunction with PVI to improve the chances of restoring a normal heart rhythm without recurrence in persistent AF patients. The Sphere Per-AF IDE study evaluated the safety, efficacy and efficiency of Affera and Sphere-9 in persistent AF and led to the FDA approval of Affera in October 2024 .

"True to our Medtronic mission for patients and legacy of innovation, we are delivering our best-in-class technologies to physicians and improving care for AFib patients, and we are not slowing down," said Rebecca Seidel , president of the Cardiac Ablation Solutions business at Medtronic, which is part of the Cardiovascular portfolio. "These results signify another step forward and energize us as we continue to earn and build our leadership position in electrophysiology every day."

Medtronic is the only company with two PFA offerings for physicians and patients. The PulseSelectâ„¢ Pulsed Field Ablation System offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) and is now available in more than 30 countries. The Affera system together with the Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath. Affera is available in Europe , Australia and New Zealand , with global expansion ongoing.

AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. 1 Afib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases 2-5 .

For more information on the Affera PFA system and the Sphere-9 catheter, visit Medtronic.com.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References

  1. Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
  2. Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
  3. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
  4. Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
  5. Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

Dr. Reddy is a paid consultant for Medtronic.

Contacts:
Leslie Williamson
Public Relations
+1-612-227-5099

Ryan Weispfenning
Investor Relations
+1-763-505-4626

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-affera-pulsed-field-ablation-technologies-continue-to-demonstrate-promising-evidence-for-atrial-fibrillation-patients-302439006.html

SOURCE Medtronic plc

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Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo robotic-assisted surgery system

Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo robotic-assisted surgery system

Largest multi-center prospective Investigational Device Exemption (IDE) study for multi-port robotic-assisted urologic surgery   in the U.S. presented as a late-breaker at the American Urologic Association annual meeting

Company confirms Hugo RAS system submission to the U.S. Food and Drug Administration

Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced that the Expand URO Investigational Device Exemption (IDE) clinical study, the largest such study for robotic-assisted urologic surgery ever conducted, met both primary safety and effectiveness endpoints. The prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures using the Hugoâ„¢ robotic-assisted surgery (RAS) system.

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Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Adding to the Medtronic portfolio of catheter-based lead solutions, the novel OmniaSecure defibrillation lead allows for precise delivery and placement in the right ventricle

Heart Rhythm 2025: Late-breaking clinical study results evaluating the OmniaSecure lead for investigational use in the LBBAP location show high defibrillation success

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Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform.

(PRNewsfoto/Medtronic plc)

The submissions included a 510(k) application for its MiniMedâ„¢ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuardâ„¢ algorithm as an interoperable automated glycemic controller (iAGC).

"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, EVP & president, Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."

This milestone follows the announcement last August that the companies will collaborate on an integrated system based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.

More details will be shared when FDA clearance is secured.

About the Diabetes Business at Medtronic ( www.medtronicdiabetes.com )
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law.

Contacts:
Janet Cho
Public Relations
+1-818-403-7028

Ryan Weispfenning
Investor Relations
+1-763-505-4626

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-advances-abbott-cgm-partnership-with-fda-submission-of-interoperable-insulin-pump-302437337.html

SOURCE Medtronic plc

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Orchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting

Orchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting

  • FDA recently granted Breakthrough Device Designation to AVIM therapy for use in patients with uncontrolled hypertension at increased cardiovascular risk
  • HRS Satellite Symposium will feature leading experts in electrophysiology, hypertension management and heart failure
  • Presentations will detail clinical results from prior studies demonstrating AVIM therapy's ability to immediately, substantially and persistently reduce systolic blood pressure, as well as improve cardiac function
  • Symposium will also feature presentation on the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced it will host an industry-sponsored satellite symposium at the Heart Rhythm Society ("HRS") 2025 Annual Meeting, taking place April 24–27, 2025, in San Diego, California featuring recent advancements in the Company's atrioventricular interval modulation ("AVIM") therapy program. The April 25 th 6:45 am PT symposium titled " The Future of Cardiac Pacing: Unlocking the Potential of Atrioventricular Interval Modulation (AVIM) Therapy " will convene leading electrophysiologists, hypertension and heart failure specialists to discuss the unmet need in hypertension, AVIM therapy mechanism of action, and growing body of clinical evidence supporting this novel therapy for the treatment of patients with uncontrolled hypertension who have increased cardiovascular risk with or without an indication for a pacemaker.

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Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

  • Breakthrough Device Designation ("BDD") applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular risk
  • BDD also encompasses pacemaker-indicated patients with uncontrolled hypertension who are the focus of the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)
  • BDD status provides accelerated FDA engagement and reviews for AVIM therapy; it also supports potential pathways to secure higher reimbursement for AVIM-enabled devices in the future

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) ("Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Device Designation ("BDD") for atrioventricular interval modulation ("AVIM") therapy.

Specifically, the BDD is for an implantable system (i.e., a pacemaker) to deliver AVIM therapy using conduction system pacing to reduce blood pressure in patients with increased ten-year atherosclerotic cardiovascular disease ("ASCVD") risk, preserved left ventricular systolic function, and uncontrolled hypertension, despite the use of anti-hypertensive medications or in patients who may have intolerance to anti-hypertensive medications. Orchestra BioMed estimates that there are over 7.7 million patients in the U.S. that meet the criteria for the BDD for AVIM therapy. AVIM therapy is currently being evaluated under an FDA investigational device exemption ("IDE") in the BACKBEAT global pivotal study which is being conducted by Orchestra BioMed in collaboration with Medtronic. The BACKBEAT pivotal study is enrolling pacemaker-indicated patients with uncontrolled hypertension despite the use of anti-hypertensive medication, a key subpopulation under the BDD for which Orchestra BioMed believes AVIM therapy may offer optimal clinical benefit.

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