News | Left Atrial Appendage (LAA) Occluders | August 06, 2020

Conformal Medical Secures $85 Million in Funding for Left Atrial Appendage Occluder Trial

Funding will support U.S. pivotal trial of CLAAS Stroke Prevention Technology

The Conformal Medical CLAAS device, a next-generation transcatheter left atrial appendage (LAA) closure occluder for patients with atrial fibrillation (AF). LAA occlusion allows AFib patients to go off of life-long anticoagulation therapy. #LAA #LAAC

The Conformal Medical CLAAS device, a next-generation transcatheter left atrial appendage (LAA) closure occluder for patients with atrial fibrillation (AF). LAA occlusion allows AFib patients to go off of life-long anticoagulation therapy.


August 6, 2020 – Conformal Medical Inc. announced it secured $85 million in Series C financing to support the company’s U.S. pivotal trial of its novel CLAAS device, a next-generation transcatheter left atrial appendage (LAA) closure occluder for patients with atrial fibrillation (AF). LAA occlusion allows AFib patients to go off of life-long anticoagulation therapy.

The financing syndicate included participation from new investors Fidelity Management and Research Company LLC and an undisclosed strategic investor, as well as Catalyst Health Ventures (CHV) and many returning Series A and B investors. 

“We are extremely pleased with the strong support of our investment partners, validating the potential of our next-generation technology in the growing LAAC market,” commented Andy Levine, president and CEO of Conformal. “With this significant raise, we look forward to initiating our pivotal trial and taking the next step to establish the CLAAS implant as a cornerstone stroke reduction strategy for patients with AFib.”

Current risk-reduction strategies have significant limitations and leave a clear unmet need in this space,” said Joshua Phillips, managing partner at Catalyst Health Ventures. “The CLAAS technology provides a differentiated solution and we are excited to strengthen our partnership with this proven team and welcome our new funding partners.”

The CLAAS system features a proprietary foam-based architecture designed to accommodate most anatomies with only two sizes and simplified delivery without the need for procedural transesophageal echo (TEE) allowing physicians to perform LAAC without general anesthesia.

Conformal’s randomized pivotal trial is expected to enroll over 1,300 patients at multiple sites globally beginning in early 2021, to investigate the safety and effectiveness of the CLAAS technology, as compared to Boston Scientific’s Watchman products.

“The LAA, is a pouch off the left atrium where clots associated with stroke form in patients with AFib. First generation technology has demonstrated effectiveness compared to oral anticoagulation and fueled early market growth, despite procedural limitations” explained Aaron V. Kaplan, M.D., professor of medicine at Dartmouth and Conformal’s co-founder and chief medical officer. “The CLAAS technology aims to address these limitations and enable physicians to routinely close the LAA without general anesthesia.”

More than 6 million people in the United States suffer from AFib, placing them at an increased risk of stroke.[1] Current standard of care for stroke prevention is chronic oral anticoagulants, which are not well accepted by patients due to concern about associated risk of bleeding. Left atrial appendage closure (LAAC) is emerging as an important alternative to blood thinners for preventing strokes in patients with AFib. Currently, first-generation LAAC devices are an estimated $600 million global market and are expected to grow to over $1 million in the next five years.

For more information: https://conformalmedical.com/

Reference:

1. https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm
 


Related Content

News | Atrial Fibrillation

November 10, 2022 — Biosense Webster, Inc., the global leader in cardiac arrhythmia treatment and part of Johnson & ...

Home November 10, 2022
Home
News | Atrial Fibrillation

November 10, 2022 — A national study led by UBC researchers at the Centre for Cardiovascular Innovation is shedding ...

Home November 10, 2022
Home
News | Atrial Fibrillation

October 31, 2022 — Atrial fibrillation – a form of irregular heartbeat, or arrhythmia – leads to more than 454,000 ...

Home October 31, 2022
Home
News | Atrial Fibrillation

October 26, 2022 — A new study from University of Louisville researchers in the Christina Lee Brown Envirome Institute ...

Home October 26, 2022
Home
News | Atrial Fibrillation

September 14, 2022 — In recognition of Atrial Fibrillation (AFib) Awareness Month, Biosense Webster, Inc., part of ...

Home September 14, 2022
Home
News | Atrial Fibrillation

September 9, 2 022 — A large-scale international study led by Mount Sinai has yielded the first risk score that can help ...

Home September 09, 2022
Home
News | Atrial Fibrillation

August 31, 2022 — Science has long shown that men are at greater risk for developing atrial fibrillation (AFib) than ...

Home August 31, 2022
Home
News | Atrial Fibrillation

July 29, 2022 — A cohort study of persons with incident atrial fibrillation (AF) has found that AF after noncardiac ...

Home July 29, 2022
Home
News | Atrial Fibrillation

July 20, 2022 — CardioFocus, Inc., a medical device company dedicated to advancing ablation treatments for atrial ...

Home July 20, 2022
Home
News | Atrial Fibrillation

July 6, 2022 — Atrial fibrillation (AF) is a prevalent cardiovascular condition with one of the highest rates of ...

Home July 06, 2022
Home
Subscribe Now