Medtronic’s busy with mergers, FDA, alliances

Departments - FDA, Mergers, & Funding

Heartware Int'l merger agreement; Ascensia Diabetes Care renews alliance; FDA approves slate study for common form of epilepsy; Trelleborg acquires manufacturer of silicone components for the medical device market; $20M round of growth financing for SI-BONE

August 15, 2016

HeartWare Int’l merger agreement

Medtronic plc has signed a definitive agreement to acquire HeartWare Int’l Inc. in a transaction valued at approximately $1.1 billion. Under the terms of the agreement, Medtronic will commence a cash tender offer for all outstanding shares of HeartWare common stock for $58 per share. The boards of directors of both Medtronic and HeartWare have unanimously approved the transaction. The acquisition, expected to close during Medtronic’s second fiscal quarter ending Oct. 28, 2016, is subject to the satisfaction of customary closing conditions.

Acquiring HeartWare will expand Medtronic’s portfolio of diagnostic tools, therapies, and services for patients suffering from heart failure.

HeartWare’s HVAD System features the world’s smallest full-support ventricular assist device (VAD) and is designed to reduce surgical invasiveness, improve patient recovery times, and enhance patient outcomes. HeartWare has multiple technologies in development designed to offer progressively less-invasive mechanical circulatory support options for patients with end-stage heart failure. Medtronic estimates that the global VAD market is approximately $800 million worldwide and is expected to grow in the mid-to-high single digits for CY16-17, and accelerate to high-single/low-double digits beyond CY17.

Ascensia Diabetes Care renews alliance

Medtronic plc and Ascensia Diabetes Care have renewed their global alliance to develop and market diabetes management solutions for patients worldwide. Ascensia Diabetes Care will continue to exclusively co-develop and supply Contour Next Link and Contour Plus Link blood glucose meters that are wirelessly compatible with Medtronic’s integrated insulin pump and continuous glucose monitoring (CGM) systems. The renewal lasts for five years, and follows more than eight years of worldwide collaboration.

Ascensia Diabetes Care CEO Michael Kloss explains, “To date we have launched three meter generations with Medtronic MiniMed insulin pump systems across the world and have seen tremendous success with this alliance. Medtronic is leading the path towards the artificial pancreas through its research and development. It is a testament to the high quality and remarkable accuracy of our blood glucose monitoring systems that Medtronic has chosen them as part of their MiniMed insulin pump systems.”

Alejandro Galindo, president of the Intensive Insulin Management Business at Medtronic says, “Medtronic aims to transform diabetes care around the world through continuous product innovations so that people living with diabetes can enjoy greater freedom and better health.”

FDA approves SLATE study for common form of epilepsy

The U.S. Food and Drug Administrations (FDA) approved the Investigational Device Exemption (IDE) application for the pivotal stereotactic laser ablation for temporal lobe epilepsy (SLATE) study. The clinical investigation is designed to support the expanded indication of Medtronic Visualase MRI-guided laser ablation technology for treatment of epilepsy in patients with drug-resistant mesial temporal lobe epilepsy (MTLE) – the most common form of partial or localization-related epilepsy.

The study will include approximately 120 adults with drug-resistant MTLE treated at selected epilepsy centers across the U.S. After the Visualase procedure, patients will be followed for 12 months and evaluated for freedom from seizures, quality of life, neuropsychological outcomes, and adverse events.

The Visualase MRI-guided laser ablation system is 510(k) cleared by the FDA to necrotize or coagulate soft tissue in neurosurgery and other surgical specialties. Through a minimally invasive procedure, laser energy is delivered to the target area using a laser applicator. As light is delivered through the laser applicator, temperatures in the target area begin to rise, coagulating the unwanted soft tissue under real-time MRI guidance.

Trelleborg acquires manufacturer of silicone components for the medical device market

Trelleborg Sealing Solutions has agreed to acquire Specialty Silicone Fabricators Inc. (SSF), a U.S.-based privately-owned manufacturer of high-precision silicone components for medical technology original equipment manufacturers (OEMs). The acquired company is a significant player in the important, high-growth U.S. life sciences market, providing Trelleborg with a strong platform for future development.

Headquartered in Tustin, California, SSF has production facilities in Tustin and Paso Robles, California, as well as in Elk Rapids, Michigan. Sales amounted to approximately $39 million in 2015.

“SSF is a leading player in silicone products for the U.S. market, with a strong reputation, track record, and an attractive base of OEM customers. The acquired company differentiates itself by focusing on advanced, challenging applications and by providing support and value to the customer from initial design – a similar positioning and approach to Trelleborg,” says Claus Barsøe, president, Trelleborg Sealing Solutions.

$20M round of growth financing for SI-BONE

SI-BONE Inc., developer of the iFuse Implant System triangular minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, has closed a $20 million round of growth capital financing. Arboretum Ventures led the round, and all of SI-BONE’s existing major investors participated. Proceeds will be used primarily to fund expansion of U.S. sales following recent health plan decisions to cover MIS SI joint fusion. Additional proceeds will be used on R&D for new products to surgically treat the SI joint.

Tim Petersen, managing director at Arboretum Ventures says, “SI-BONE has built an impressive portfolio of clinical evidence that provides a strong foundation for significant growth in the years ahead.”