CONFORM Trial: Memos to File

January 5, 2026

CONFORM Investigators & Research Teams,

It brings us great pleasure to share with you that Conformal Medical has entered into a definitive agreement to be acquired by W.L.Gore & Associates.

What this means for you and the CONFORM Pivotal Trial:

Conformal will remain as a wholly owned subsidiary of Gore and will continue serving as your partner for the ongoing CONFORM Pivotal Trial.
Your Conformal Therapy Development Team and your site managers will continue to be your primary points of contact.
No change/impact to the enrollment process or how we continue to support CONFORM Sites and the patients who have been enrolled into the study.
This partnership will enable Conformal to leverage Gore’s global presence, accelerating our mission of shaping the future of stroke prevention

Read the Press Release Here >

Gore firmly believes in the CLAAS® AcuFORM™ LAAO Technology and views it as an ideal fit with their endovascular portfolio, complementing their existing cardiac products assuming the device receives approvals. This acquisition advances the Gore's expansion into adjacent endovascular treatments and reflects the company's long-term commitment to developing and investing in breakthrough medical technologies.

The transaction is expected to close in early 2026, and we will retain the Conformal name and operate as a wholly owned subsidiary aligned with the Gore's medical products business. Dr. Kaplan and I want to assure you that this agreement will not impact how we work and support you and your site. Completion of the CONFORM Pivotal Trial remains our primary focus, and you should not experience any disruptions or changes.

We appreciate your continued support and commitment to the CONFORM Trial.

James & Dr. Aaron Kaplan

James Reinstein | President and CEO

Aaron Kaplan MD. | Chairman & Chief Medical Officer

View The Press Release

Have suggestions or questions about this newsletter?

Drop us a note at info@conformalmedical.com.

CAUTION: Investigational Device. Limited by federal (or United States) law to investigational use. Outside the United States, the device is intended exclusively for clinical investigation. Not approved for commercial use.

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