FDA grants IDE to Orchestra BioMed for cardiac neuromod trial in pacemaker patients

Rendering of the BackBeat therapy from an Orchestra BioMed YouTube demonstration.

Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its BACKBEAT trial.

BACKBEAT (bradycardia pacemaker with atrioventricular interval modulation for blood pressure treatment) evaluates the safety and efficacy of atrioventricular interval modulation (AVIM) therapy. Also known as BackBeat CNT, it treats hypertensive patients indicated for a dual-chamber cardiac pacemaker.

New Hope, Pennsylvania-based Orchestra BioMed has the backing of medtech giant Medtronic in this effort. The companies announced a strategic collaboration to develop and commercialize AVIM therapy for pacemaker patients in July 2022. Under the collaboration, Medtronic offers development, clinical and regulatory support for the BACKBEAT trial.

Medtronic also contributed to a $110 million Series D at Orchestra BioMed, which soon went public through a …

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Orchestra BioMed wins FDA IDE for drug-coated balloon study

Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its Virtue SAB.

The IDE enables the Virtue ISR-US pivotal study. It evaluates Virtue SAB, a novel AngioInfusion balloon for treating artery disease, in treating patients with coronary ISR.

New Hope, Pennslyvania-based Orchestra BioMed designed Virtue SAB to enable the protected delivery of SirolimusEFR to the artery. The device delivers the proprietary, investigational, extended-release formulation of sirolimus during balloon angioplasty. Its design doesn’t require balloon coating or a permanent implant.

Orchestra BioMed believes its Virtue SAB could address a significant unmet clinical need and improve outcomes, according to a news release.

“This IDE approval and forthcoming pivotal study reflect our commitment to accelerating innovation through our differentiated, partnership-enabled business model,” said Darren Sherman, pre…

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The biggest medical device VC deals of 2022

Enable Injections, which makes the enFuse device, raised $215 million in January 2022. [Photo courtesy of Enable Injections]

Last year was definitely a slower year for medical device VC deals than the year before.

Biofourmis was the only medical device developer in the 10 largest healthcare VC deals of 2022, according to a ranking provided to Medical Design & Outsourcing by Silicon Valley Bank (SVB).

Because we love devices at Medical Design & Outsourcing, we asked SVB for a ranking of 2022’s largest medical device VC deals after Biofourmis, which raised $325 million in its 2022 series D round. (The year before that, CMR Surgical’s $600 million Series D financing round was the largest medical device VC deal of 2021.)

SVB obliged, once again drawing upon its own proprietary information and data from Pitchbook. The dealmakers include device developers with innovative methods for …

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Orchestra BioMed to go public, partner with Medtronic on cardiac neuromodulation therapy

Orchestra BioMed today announced a slew of agreements, including a strategic collaboration with Medtronic (NYSE:MDT).

The global strategic collaboration will progress the development of Orchestra BioMed’s BackBeat Cardiac Neuromodulation Therapy (CNT) as a potential treatment for hypertension in patients who are indicated for a cardiac pacemaker.

Additionally, Orchestra BioMed closed a $110 million Series D financing, which included investments from Medtronic, funds managed by RTW Investments, LP (“RTW”), Perceptive Advisors, Terumo Corporation (“Terumo”), SternAegis Ventures and other investors.

Finally, the company entered into a definitive business combination agreement with HSAC2. The deal is structured to provide a minimum of $70 million in gross proceeds to the combined company at closing and up to $160 million in the event of no redemptions by HSAC shareholders, according to a news release. The Series D financing was not contingent on the co…

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